Samuel Mongoni, Traditional Healers and Traditional Medicine Foundation

Lead Author: Samuel Mongoni
Organization: Traditional Healers and Traditional Medicine Foundation (Thetramed)
Country: Kenya

Abstract

Traditional Medicine can address the issues of availability of Medicine in our health sector, when the issue of the herbal products will be integrated with conventional Medicine within our health care facilities. In Kenya the National process to develop medicinal and aromatic plant species was started in November 2001 when a draft strategy and action plan was formulated by working groups on medicinal and aromatic plants, the aim of this groups was to promote the conservation, sustainable utilization and equitable sharing of benefits arising from Maps for improvement of both human and animal health, and for socio-economic development. But up now their is nothing has come up in side of policy development and implementation of Traditional Medicine in our country we need support from the United nations for health development.

Submission

Traditional Medicine and Healthcare.
Although less development, the traditional medicine system was the main Healthcare system before the advent of colonialism. In particular, the practice forms a significant part of Traditional rural Healthcare. For most of the rural population, it is usually the only accessible Healthcare system. This had been mainly due to the fact modern Healthcare facilities are often beyond reach in terms of distance, awareness and finance. Other factors contributing to the heavy reliance on traditional medicine include social, psychological and cultural. This happens in most of the population in Turkana County in Northern Kenya, has little or no contact with modern Medicine. There are at least 6,000 registered TMPs in Kenya, a greater majority of whom are found in rural areas. This figure represents only a portion of practicing TMPs, through their practice, they manage a wide range of disease conditions. They thus contribute to disease burden amelioration, they are many disease that modern Medicine has failed to manage effectively, for example asthma, diabetes, hypertension, sterility, cancer, etc, but ethnobotanical and ethnomedical surveys among various rural communities have revealed that these can be effectively managed by traditional medicine. The Government focus on research and development on traditional knowledge and medicine has been marginal. Research on traditional knowledge has been scanty and mostly supported by external donor funding, we request more support for development of Traditional Medicine.

Bibliography and References 

TMPs means Traditional Medical Practitioners

James Love, KNOWLEDGE ECOLOGY INTERNATIONAL_A

Lead Author: James Love
Organization: Knowledge Ecology International
Country: USA

Abstract

This submission describes efforts to create a new agreement in the World Trade Organization (WTO), or in other trade agreements, on the supply of public goods. Public goods are defined broadly, and are described in the submission as social/public goods.

Such an agreement or agreements would expand the supply of social/public goods that have global or cross-border benefits. The mechanism would be a schedule where governments could voluntarily agree to make binding commitments to supply a heterogeneous set of social/public goods. These commitments would then be subject to dispute resolution under the trade agreement framework, with certain modifications. The objective of such a schedule would be to enhance the confidence among governments that the commitments necessary to enable collective action to supply social/public goods will be credible and sustainable over time.

There is considerable interest in the health community in finding a way to undertake the production of knowledge as a public good, particularly as this relates to new drugs and vaccines, and to address the vast inequalities in access to medicines, vaccines and medical care in general. Such efforts require considerable resources, and collaboration among countries on funding. A schedule on the supply of social/public goods within a trade framework offers an innovative way to make such collaborations more credible in terms of the scale, duration, and sustainability and reliability of the commitments that are needed.
An agreement on the supply of social/public goods within the WTO or other trade agreements will strengthen, perhaps dramatically, the ability of governments to create new ways to funding R&D for new drugs and vaccines, and to progressively delink the costs of R&D from the prices of products. This proposal can be seen as a complement to others addressing the funding of medical R&D or care as a public good.
 

Submission

Introduction

The chronic undersupply of goods that have public and social benefits is a persistent problem at all levels of society. Governments have tools to address these issues through taxation and regulatory measures on the local and the national level, but the international dimension suffers from a lack of enforceable mechanisms to ensure that collective action to supply social/public goods will be credible and sustainable over time.

The proposal to create an agreement on the supply of social goods, as described in this submission, was motivated in part by evidence that global public goods and social investments are often underfunded and undersupplied, and secondly, by experiences and frustrations related to negotiations at the World Health Organization (WHO) for an agreement on funding biomedical R&D.

In the WHO negotiations, some governments were clearly uncomfortable with obligations to fund biomedical R&D that did not match their own specific priorities, and wanted to express their preferences regarding the management of funds, including the possibility of using domestic institutions, or the pooled funding mechanism of their choice.

There was also of a lack of confidence that other governments would follow through on funding commitments, and a resistance among some to create new institutions that would require additional investments in time, money and diplomatic skills to manage and monitor.

We considered first, and are currently evaluating, the possibility of creating an agreement within the World Trade Organization (WTO) to address the issue of the enforceability of commitments to fund or otherwise supply social/public goods in a wide range of areas, including but not limited to health.

The WTO is a well-funded institution with its own secretariat, designed to enforce a number of diverse agreements. There are currently 162 members of the WTO, and another 22 countries seeking membership. The WTO is notable for being a club that nearly every country wants to join, and which has the most important enforcement powers of any multilateral international organization.

The proposed agreement within the WTO would permit governments to make binding and enforceable commitments to supply social/public goods that have global or cross-border benefits, among coalitions of like minded countries and around specific initiatives where there are shared interests in projects or standards.

The proposal was modeled in part on the WTO’s General Agreement on Trade in Services (GATS). The GATS has schedules that are populated with offers by WTO members to undertake certain actions, some very narrow, to liberalize trade in the services sector. The voluntary offers become binding once placed on the schedule. These offers may be unique to one WTO member, or negotiations may create de facto or soft standards.

In discussions with a former lead USTR negotiator on services and intellectual property, Joe Papovich, the question was posed, “why would a WTO member agree to make binding commitments on services, where they can be subject to dispute resolution and fines, when a country can undertake the policies voluntary, without the liability of a WTO commitment?” The answer provided by USTR was, “you might think no one would make offers in the GATS, but they do. This is because, every country that agrees to meet a commitment wants something else.” The commitments one can make in the GATS become part of the “asks” and “offers” that can be traded for other things in WTO negotiations, which involve several different agreements.

In looking at the GATS model, a few things seemed highly relevant. First, countries could make commitments to fund or embrace standards that matched their own priorities. For example, countries interested in funding R&D for Chagas disease, or new diagnostic tools for fever, could move forward in collaboration with other coalitions of the willing and interested. Second, once a schedule was created, there would be no need to create a new governance structure. Additionally, the WTO has stronger enforcement mechanisms than any multilateral institution. One journalist described the proposal as a “hack” of the WTO. [1]

In the original presentations, the proposal was described as an agreement on the supply of public goods, noting that this included a liberal definition of a public good, including goods that that were designed to address challenges in climate change, health, knowledge generation, international security, and measures to address poverty, underdevelopment and the needs of marginalized populations.

Public Goods or Social Goods?

The proponents of the proposal are also considering changing the name to social goods, to avoid controversies over the definitions of public goods.

The term global public goods can lead to confusion, in part because of an influential definition offered by the economist Paul Samuelson in the mid-1950s as a special case of market failure.

In 1955, Samuelson published a paper [2] that presented an “extreme” and “polar” definition of “pure” public goods, which had as their most important characteristics that they were both non-rival in consumption and it was impossible to exclude access to the good. In defending his definition, Samuelson said:

“Doctrinal history shows that theoretical insight often comes from considering strong or extreme cases. The grand Walrasian model of competitive general equilibrium is one such extreme polar case. We can formulate it so stringently as to leave no economic role for government. What strong polar case shall the student of public expenditure set alongside this pure private economy?

. . . A public consumption good, like an outdoor circus or national defense, which is provided for each person to enjoy or not, according to his tastes. I assume the public good can be varied in total quantity, and write X2 for its magnitude. It differs from a private consumption good in that each man's consumption of it, X1 and X2 respectively, is related to the total X, by a condition of equality rather than of summation. Thus, by definition, X1 = X, and X2 = X.

Obviously, I am introducing a strong polar case. We could easily lighten the stringency of our assumptions. But on reflection, I think most economists will see that this is a natural antipodal case to the admittedly extreme polar case of traditional individualistic general equilibrium. The careful empiricist will recognize that many - though not all -of the realistic cases of government activity can be fruitfully analyzed as some kind of a blend of these two extreme polar cases.”

Paul A. Samuelson, "Diagrammatic Exposition of a Theory of Public Expenditure," The Review of Economics and Statistics, Vol. 37, No. 4. (Nov., 1955), pp. 350-356.

It is ironic that Samuelson’s efforts to create an extreme and very limited definition of public goods has had a significant and often unhelpful influence on many policy makers seeking to consider frameworks for the supply of public goods, since in practice, only a limited subset of goods fit the narrow definition offered by Samuelson in 1955.

In an 2015 draft of a proposed agreement, the following definitions for social/public goods were considered:


For the purposes of this Agreement, social/public goods are defined as:

goods and services that are directly supplied, financed, subsidized, mandated or the supply is otherwise induced for the benefit of the public, and is limited to

goods (or services) for which consumption is not decided by the individual consumer but by the society to address a social purpose or public interest.

The definition of social/public goods shall be interpreted broadly to be inclusive of goods and services provided on a non-commercial basis by governments and intergovernmental organizations.

The definition of social/public goods includes but is not limited to goods and services that are non-excludable and non-rivalrous in consumption.

The definition of social/public goods shall include goods and services relating to the production of and access to knowledge, the provision of security, humanitarian services, public health programs, the protection and enhancement of the environment, programs to promote development and alleviate poverty, and other purposes.

The definition of a social/public good shall include goods and services for which it is rational, from the perspective of a group of nations collectively, to produce for universal consumption, or to expand production and/or consumption due to positive externalities or to achieve a social purpose.

2. For the purposes of this Agreement, international social/public goods are defined as social/public goods that are directly or indirectly supplied by one Member for the benefit of the public in the territory of any other Member.

3. For the purposes of this Agreement:

(a) "measures by Members" means measures taken by:

(i) central, regional or local governments and authorities; and

(ii) non-governmental bodies in the exercise of powers delegated by central, regional or local governments or authorities.


The benefits of a WTO agreement on public goods would be several. For an interesting set of collective action challenges, it could eliminate the need to set up a separate treaty or agreement, and allow coalitions of governments to use the WTO’s existing governance structure and secretariat. On the other hand, a WTO schedule on the supply of social/public goods could complement separate treaties or agreements by lending the WTO’s enforcement powers to third party agreements. If the WHO is successful in negotiating R&D funding agreements (and we hope they are), the members signing could register the WHO agreement as a commitment in the WTO schedule on the supply of social/public goods.

By introducing social/public goods into the WTO environment, the culture of the WTO may also be profoundly changed. “Asks” and “offers” in the WTO negotiations would no longer be exclusively about the private goods market, or about the privatization and enclosure of knowledge itself. There would be a shift to consider the competing benefits of greater openness, and a larger global commons. Knowledge that was produced to be “free” would have a new value as a trading chip in the WTO environment.

In the health sector, for example, potential asks/offers could include collaborative funding of biomedical research in areas of priority, such as new antibiotics; vaccines for avian flu; treatments or vaccines for Ebola, Zika or HIV/AIDS; sustainable funding for UNITAID or the Global Funding for HIV/AIDS, Tuberculosis and Malaria; funding for independent clinical trials to evaluate the safety and efficacy of drugs; creating databases and libraries to advance medical science; and countless other projects.

There are several challenges in this proposal, including not only the path to accepting such an agreement within the WTO (or another trade agreement with enforcement powers), but also in addressing modifications in the dispute resolution mechanisms that may be necessary for social/public goods.

Implementation

KEI proposed an agreement on public goods within the WTO in 2008, and has made several presentations of the proposal since. In between 2008 and 2013, KEI worked a variety of other topics, including a negotiation at the World Intellectual Property Organization (WIPO) on a new UN treaty on copyright exceptions for persons who are blind or have other disabilities." Following the 2013 successful conclusion of the WIPO Marrakesh Treaty for the Blind, KEI has revised the WTO project. In 2015, KEI Europe collaborated with the Heinrich Böll Foundation (HBF) to convene two consultations in Berlin and Geneva on a proposed text for such an agreement. The meetings were attended by a diverse group of experts, including negotiators from governments in Europe, Africa, Asia and the Americas, as well as academic experts and stakeholders from a variety of NGOs with a connection to global social/public goods.

The next steps will include new drafts of a proposed agreement; modeling and simulating possible negotiations among countries to specific social/public goods commitments; and additional discussions regarding the possible modalities for the negotiations on such an agreement within the WTO. There is also the possibility of considering such a schedule in regional trade agreements, including for example, the Transatlantic Trade and Investment Partnership (TTIP).


III. Policy Coherence

There is considerable interest in the health community in finding a way to undertake the production of knowledge as a public good, particularly as this relates to new drugs and vaccines, and to address the vast inequalities in access to medicines, vaccines and medical care in general. Such efforts require considerable resources, and collaboration among countries on funding. A schedule on the supply of social/public goods within a trade framework offers an innovative way to make such collaborations more credible in terms of the scale, duration and sustainability and reliability of the commitments that are needed.


IV. Impact on Access to Medicines

An agreement on the supply of social/public goods within the WTO or other trade agreements will strengthen, perhaps dramatically, the ability of governments to create new ways of funding R&D for new drugs and vaccines, and to progressively delink the costs of R&D from the prices of products. This proposal can be seen as a complement to other proposals that relate to the funding of medical R&D or care as a public good.
 

Bibliography and References 

[1] David Bollier, An Ingenious Hack on the World Trade Organization. News and Perspectives on the Commons. February 17, 2009.
[2] 1954. Paul A. Samuelson, The Pure Theory of Public Expenditure,The Review of Economics and Statistics,Vol. 36, No. 4 (Nov., 1954), pp. 387-389.
[3] June 2008. James Love and Manon Ress. KEI Proposal: A WTO Agreement on the Supply of Knowledge as a Global Public Good, Presented at Columbia University.

Additional References
1999. "Introducing global public goods." Global Public Goods: International Cooperation in the 21st Century. Eds: Inge Kaul, Isabelle Grunberg, and Marc Stern. New York: Oxford University Press.

2001. Sagasti, Francisco and Keith Bezanson. Financing and Providing Global Public Goods: Expectations and Prospects, Prepared for the Ministry of Foreign Affairs of Sweden on behalf of the Institute of Development Studies Sussex. Study 2001:2.

2002. Gardiner, Rosalie and Katell Le Goulven. Sustaining our Global Public Goods, A briefing paper prepared for the Heinrich Boll Foundation World Summit 2002 in Johannesburg, South Africa. http://www.worldsummit2002.de/downloads/Globalpublicgoods.pdf

2003. Woodward, D. and R. Smith. Global Public Goods for Health: a health economic and public health perspective. Eds: Smith, R., Beaglehole, R., Woodward, D., and Drager, N. Oxford: Oxford University Press.

2004. Maskus, Keith and Jerome Reichman. The Globalization of Private Knowledge Goods and the Privatization of Global Public Goods. Journal of International Economic Law. Cambridge University Press. Vol. 7, No. 2. pp. 279-320.

2005. Love, James and Tim Hubbard. "Paying for Public Goods." Code: Collaborative Ownership and the Digital Economy. Ed: Rishab Aiyer Ghosh. Cambridge: MIT Press. pp. 207-229.

2006. International Task Force on Global Public Goods. Meeting Challenges: International Cooperation in the National Interest. Summary Report of the International Task Force on Global Public Goods. Stockholm: Erlanders Infologistics Vast AB.

2014. The United Kingdom of Great Britain and Northern Ireland's All-Party Parliamentary Group on Global Tuberculosis (APPGTB) released a report entitled, Dying for a Cure: Research and Development for Global Health, pages 81-83.

2016. Thiru Balasubramaniam, Report of the Berlin meeting to consider a possible WTO Agreement on the supply of social/public goods (Forthcoming)
July 6, 2014. Duncan Green, Jamie Love’s Next Big Idea: Making the WTO into a force for good in Public Health. http://oxfamblogs.org/fp2p/jamie-loves-next-big-idea-making-the-wto-into-a-force-for-good-in-world-health/

Marcela Vieira, WORKING GROUP ON INTELLECTUAL PROPERTY OF THE BRAZILIAN NETWORK FOR THE INTEGRATION OF THE PEOPLES_B

Lead Author: Marcela Vieira
Additional Author: Pedro Villardi, Felipe Carvalho, Gonzalo Berron
Organization: Grupo de Trabalho sobre Propriedade Intelectual da Rede Brasileira pela Integração dos Povos (GTPI-Rebrip), Transnation Institute (TNI)
Country: Brazil

Abstract 

This contribution is addressed to the United Nations Secretary-General’s High-Level Panel on Access to Medicines call for contributions. While the call is open enough to provide for a wide range of contributions, we focus on an aspect of the debate that is not much discussed by the available literature: the responsibility of the private sector for the systematic gross-violation of human rights related to the lack of innovation and access to health technologies, specially through the abuse of the patent system.

The debate around business and human rights has recently grown within the UN system, as well as the recognition that there is a lack of existing mechanisms that can be used to remedy human rights violations committed by the private sector. There is an urgent need that companies can also be held accountable for systematic violations of human rights, including in the access to medicines area. This contribution will be, therefore, about the need to establish mechanisms that could hold pharmaceutical companies accountable for their human rights violations.

We first discuss the right to access medicines as an element of the the right to health; then we address the systematic violation of this right by pharmaceutical and biotechnology companies, followed by a brief presentation on the obstacles faced to hold companies accountable for violations of human rights and finally we address the need to create an international legal framework that could make transnational companies (TNCs) responsible for the violation of human rights. We call on the UN High-Level Panel on Access to Medicines to recommend the creation of a binding instrument that has the potential to hold companies accountable for human rights violations, as well as monitoring of the Intergovernmental Working Group for the Treaty on TNCs and other businesses in the context of Human Rights.

Submission

Introduction – Statement of the problem

The right to health is a fundamental part of human rights and also a part of the right to an adequate standard of living. However, the right to health is still far from assured for a substantial part of the world’s population. The right to health is not fulfilled when access to essential medicines is not implemented. When a human right is violated systematically and leads to loss of work capacity, underdevelopment and death to people in several parts of the world, it is necessary to undertake review measures, punishment and reparation, which should be a matter of concern and action of governments and multilateral organizations. The right to health (and in some cases more broadly the right to life) implies the action or inaction of multiple actors, beyond individuals and States. Among them are the pharmaceutical companies.
This contribution aims to bring attention to the imperative need to put private companies in the lights, as they are also responsible for systematic violations of human rights related to lack of access to medicines. The warranty of impunity backed by the legal obstacles to accountability of human rights violations by the private sector and the absence of appropriate instruments to mitigate and repair the violations is a strong barriers to the achievement of universal access to essential medicines and therefore the implementation of the Sustainable Development Goals by 2030.
It is important to emphasize that the right to health is not only a programmatic long-term goal. One must take into account the need for immediate satisfaction of health needs, imposing emergency obligations of States, even if considering budget constraints. The interrelationship and interdependence of the various human rights require the observance of the right to health not only as an end in itself but also as it comprises and it is related to other human rights such as the right to life, work, water, and development, among others.
It is clear the responsibility of States to respect, protect and fulfill the right to health and, therefore, also provide essential medicines. However, it is necessary to advance the recognition of the role and responsibility of the private sector in the respect, protection and fulfillment of the right to health. More than that, it is crucial to implement forms of reparation in the event of rights violations perpetrated by other parties in addition to the States. In this document, we must pay attention particularly to pharmaceutical companies, given their crucial role in access to medicines.
Impact on remedying policy incoherence

It is well known that the application of human rights obligations to non-state actors, such as pharmaceutical companies, is still an unsolved matter in the context of international law (1). In the classical conception, it is generally the States that have to comply with respect for human rights. Nevertheless, in recent years we have seen increasing pressure for the recognition of non-state actors, such as corporations, as holders of human rights obligations, with clear responsibilities (2).
Another important aspect is the decisive role of companies in the globalized world. Some, often, are more powerful than entire States. Just as an illustration, in 2006 the hundred largest companies in the world had about a third of global GDP (3). However, the decision-making power is often diluted among several legal entities, affiliates and subcontractors, leaving them with a comfortable and convenient anonymous face.
All this economic power translates into political power. Powerful companies, especially those that for some reason are monopolists in the market, have an enormous capacity to influence States. It is well known that in the field of access to medicines the practice of monopoly and the search for its maintenance is a practice and not an exception, given its direct connection with the ownership of intangible assets through intellectual property rights.
Non-state actors, whether they act along with States or by their own, that violates human rights must be hold accountable. The current international legal framework is not adequate and is far from sufficient to generate this responsibility and compensate victims of human rights violations perpetrated by companies. In other words, private businesses should not be alien and should not be protected from the obligation to respect human rights and human dignity and therefore there is an urgent need to adapt the international legal tools so that it is in line with the reality of current social dynamics.
Impact on public health

Systematic human rights violations by pharmaceutical companies
Pharmaceutical companies are key actors in the field of development and distribution of medicines and health technologies in the world. Therefore, they are involved in many crucial decisions: elect disease and target molecules (define priorities in public health); conduct and/or finance clinical trials (involving a complex skein of rights with strong ethical implications); are responsible for quality issues of drugs distributed to the public (shared responsibility for their supervision with state agencies); pressure and lobby States, multilateral organizations, health professionals and even competitors to advance their interests in domestic and international level; file for registration of medicines according to their discretion; set high selling prices; just to name some actions with direct impact on human rights and on public health. In all of the examples above, human rights violations may occur, both directly and/or with the connivance of state through actions or omissions.
Space limitations prevent us from enlisting examples of violations perpetrated for each of the above elements. However, it seems important to illustrate with concrete cases the enormous responsibility involved in the pharmaceutical field and the scope of human rights violations that can be performed by these companies.
As discussed above, access to medicines is a key component to the fulfillment of the right to health, and in some cases to the right to life. The lack of access may have consequences that can be classified as gross human rights violations that cause intentionally great suffering or serious injury to mental or physical health of the population, especially the most vulnerable. Acts of such a category of gravity should be subject of tools at its height, being unacceptable that they still remain in the field of voluntariness, as discussed below.
- Innovation and Intellectual Property: excluding millions of people from the right to health
In general, companies advocate that their role is to innovate and develop medicines and that such developments imply high costs. Therefore, they need monopolies to recover investments. The monopoly in the pharmaceutical field is guaranteed by the protection of IP via patents, withdrawing medical technologies from the public domain for a certain period of time. This system directly impacts the definition of priorities in research and development, given that it is a clearly a market-driven system.
There are lots of public health implications on this. Evidences shows that the IP system failed to provide the necessary health innovation for the largest part of global disease burden (4, 5) that simply do not constitute a profitable market for transnational companies (TNCs). When the technologies are developed, treatments under patent consume a large proportion of national health budgets forcing governments to ration treatment, jeopardising universal access programs and diverting resources that could be spent on R&D for other diseases.
A recent example of lack of prioritization of health needs is the diseases transmitted by the Aedes Aegypti mosquito, especially dengue fever and zika. Reports of the Pan American Health Organization (PAHO) show that first dengue epidemic in the Americas occurred in Peru, at the beginning of the 19th century. After, the mosquito has become the villain of health, being a vector responsible for other diseases, including the zika virus. These, among many other diseases, have never been considered a priority in the development of drugs and vaccines not because they did not affect a large number of people but because they did not affect people in rich countries. The discretion of the companies to choose targets in health, relegating millions of people to suffering as result of obsolete therapies or no therapies at all often occurs. Even worse, it is naturalized with the justification that companies are profit-driven and not health-driven. In these cases, human rights are never taken into account.
The monopoly based-profit driven model of innovation also discourages the timely development of best possible treatments. "Activists and the scientific community have known about the potential benefits of TAF, over those of TDF, for twelve years; it is disappointing that its clinical development was delayed until the twilight of TDF’s patent protection." (6). Although TDF is the backbone of HIV treatment programmes, its liver and kidney toxicity concerns were insufficient to prompt Gilead towards the early development of TAF, thus having deliberately endangered the lives and health of millions of PLHIV. For those co-infected with HepatitisC, Gilead's monopolistic moves have been even more costly as they are more likely to suffer renal failure with TDF-based regimens and would have better tolerated TAF-based regimens. Gilead's deadly game of monopoly for people living with Hepatitis C continues with its refusal to collaborate on a possible treatment in order to maintain the HCV market entirely for its own medicines.
Another element that is directly related to access to medicines are the extensively documented high prices charged because of patents, which allow monopolistic practices. The entry of medicines in the trade arena and the wide global spread of pharmaceutical patents have their origin in the Agreement on Trade-Related Aspects of Intellectual Property Rights. The TRIPS Agreement got in history as one of the most controversial components of the of the World Trade Organization (WTO) system. Approved 20 years ago under unbearable pressure from developed countries, it resulted in one of the most inequitable international agreement currently in force.
The TRIPS Agreement established high standards of intellectual property and perhaps this is the reason why the pharmaceutical industry is the most profitable industry in the world. Pharmaceutical companies operate with a profit margin of around 18.5% of sales, while in other industrial sectors’ margin is approximately 3.3% (7). Thus, even if the need to have profit for return of investments could be justifiable, this level of such high profit is not. Specially, when millions of people around the world have poor health condition or even lose their lives because they cannot pay for an existing product that is sold at exorbitant prices to generate exorbitant profits for the pharmaceutical industry. WHO estimates that deaths of 18 million people, 1/3rd of all deaths, are caused by treatable medical conditions (8) and about 100 million people globally are pushed below the poverty line due to healthcare expenditure (9).
A clear example comes from Hepatitis C. In 2015, a new treatment was released: sofosbuvir. Gilead had its patent application granted in the US, which allowed the company to stipulate the price under monopoly conditions: "the $1,000 pill". The three-month treatment course is being marketed in the US for $84,000, a price that absolutely excludes millions of people from accessing the drug. The issue becomes even more dramatic by knowing the extent of Hepatitis C epidemic worldwide - roughly 185 million people or 3% of the world's population - and the production cost of the 12-week treatment estimated by University of Liverpool: between US$68 and US$136 (10). In Brazil, estimates, point that it would be necessary more than 11 billion dollars to provide sofosbuvir to all people living with hepatitis C in Brazil, more than double of the current available budget to purchase all the medicines distributes in the public health system (11). Although recurrent argument of pharmaceutical industry, the need to recover investments in R&D does not stand ahead data. According to a study at Columbia University, it was invested between 300 and 500 million dollars to develop sofosbuvir. Recent estimates indicate that Gilead has earned only on sales of sofosbuvir medicine in only one country (the US), more than 15 billion dollars in one year (12).
The logic of recovering R&D costs with remuneration obtained by commercialization of products with exclusive rights is the very basis of the IP system; therefore it is not possible to think of solutions within the system to solve the problem of access and profit-driven innovation. However, beyond the very nature of the system, its current practice is also permeated by abuses, such as underserved protection extension.
- Drugs quality and ethical abuses
Multiple cases have occurred throughout the history of pharmaceutical companies practices that led to disability, chronic illness and death, a practice that have been characterized as a case of "institutional corruption". According to LIGHT et.al., an extensive range of studies document strategies by which pharmaceutical companies hide, ignore or misrepresent evidence on new drugs; distort medical literature; and misrepresent their products to prescribers (13).
In 2008, GTPI denounced the pharmaceutical company Boehringer Ingelheim to the Permanent Peoples' Tribunal (TPP), accusing it of violating the right to health of the Brazilian population and ethical research standards in humans (Declaration of Helsinki) for its refusal to register the antiretroviral tipranavir, which was subject on clinical trials in Brazil. The Brazilian population were fit to undertake the risks of developing the drug, but not to benefit from it (14).
Furthermore, most "new" products marketed are, in fact, imitation products (me-too), namely molecules equivalent to those already on the market. Most R&D resources are directed towards the development of therapeutically similar drugs, which usually involves less risk and lower cost to producers. Pharmaceutical companies actually direct only 1.3% of its net revenue for the discovery of new molecules (13).
Impact on human rights

Corporations: the freedom to violate
In June 2011, the United Nations Human Rights Council (UNHRC) approved by consensus the Guiding Principles on Business and Human Rights prepared by John Ruggie. Essentially, the guidelines foresee that companies should respect human rights and this means that they must avoid infringing human rights and address the negative impacts on human rights in which they have some involvement. The report also predicted that the responsibility to respect human rights requires companies to avoid their own activities generate negative impacts on human rights and confront these consequences when they do occur. The same Professor John Ruggie was one of the main architects of the Global Compact, launched in 2000 and today is considered the biggest initiative of Corporate Social Responsibility (CSR) in the world with more than 7000 companies. The Global Compact was designed as a learning forum for the promotion of socially responsible practices in the areas of human rights, and in his own words "is the archetype of voluntarism."
It does not seem reasonable that the debate on human rights and business follow in arrays as loose and elastic, characterized by voluntarism. In addition, this framework does not compel companies to repair human rights violations and it works, in the end of the day, as corporate advertising tool. To respect human rights should not be a slogan.
Something must be absolutely clear when addressing the business and human rights topic, applying to pharmaceutical companies: all victims of human rights violations have the right to an effective remedy, this is a maximum of human rights legislation. The right to an effective remedy is pacified in several international treaties as well as customary law. This implies: equitable and effective access to justice; adequate compensation, effective and easy to damage suffered (restitution, compensation, rehabilitation, satisfaction and guarantees of non-repetition) and access to information concerning human rights violations and reparation mechanisms. However, many obstacles are placed to the scope of an appeal in case of rights violations by companies, especially but not only, transnational corporations.
Some of the obstacles are:
- States have a duty to protect its people from abuse by companies. The language proposed in the s Guiding Principles of John Ruggie and incorporated by the Inter-American Court of Human Rights has called it 'Due Diligence'. However, as noted above, non-state entities are often more powerful than States. So how to ensure that due diligence will be made? Moreover, on several occasions companies and states violate conjugated and accomplice way, being a longa manus one another.
- Lack of clarity about who violates and who responds, large companies operate regularly through subsidiaries, sub-contractors, contracting chains, associations, cooperatives, conglomerated companies, etc. In practice, the tangle of legal personalities prevents the accuracy accountability for violations.
- Legal impediments to filing extraterritorial legal action: business groups can run away from answering for violations committed in a country given that its headquarters may be beyond the boundaries of where the violation happened. The transnational nature of a company should not be a blanket of impunity and build walls to prevent the access of victims to reparation. However, this happens routinely.
Implementation
The urgent need to advance international law

In order to advance on the fulfillment of the right to health and access to medicines, there is a need to address one of the supporting pillars of their violation: corporate impunity. It is urgent to build the real possibility that pharmaceutical and biotechnology companies find themselves compelled to respect human rights and that there is a sufficiently robust legal and judicial framework allowing reparations for victims. This necessity has also a preventive effect, since the certainty or high probability of impunity generates the maintenance of violations and perpetration new violations.
We urge the High-Level Panel on Access to Medicines to adopt the following recommendations (15):
To follow the work of the Intergovernmental Working Group for the Treaty on TNCs and other businesses in the context of Human Rights
That the UN system formulates and that states adopt a Binding Treaty that will hold companies accountable for human rights violations, including solutions to many current obstacles faced for effective access to resources for victims;
That the treaty contains, among other points: the obligation of developed countries - where companies have their headquarters - to prevent the adoption of double standard regarding respect for human rights;
That all companies respect human rights broadly; that the legally binding international instrument reaffirm the hierarchical superiority of human rights standards on other international treaties, including free trade and investment;
That the binding instrument establishes civil and criminal liability of companies and their directors as well as joint and several liability of its subsidiaries, providers, licensees and subcontractors; and
To recommend that the United Nations system working to establish mechanisms at the international level to enforce the treaty and control their application.

Bibliography and References 

References:
1) FORMAN, Lisa, KOHLER, Jillian Clare. Access to Medicines as a Human Right: Implications for Pharmaceutical Industry Responsibility. University of Toronto Press, 2012.
2) A. Grover, B. Citro, M. Mankad, and F. Lander, “Pharmaceutical companies and global lack of access to medicines: Strengthening accountability under the right to health,” Journal of Law, Medicine and Ethics 40/2 (2012), pp. 234-250.
3) STIGLITZ, Joseph. Making globalization work. New York-London, WW Norton Company, 2006.
4) PEDRIQUE, B. et al. The drug and vaccine landscape for neglected diseases (2000–11): a systematic assessment. Lancet Global Health, 2013. doi:10.1016/S2214-109X(13)70078-0. Available at: http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(13)70078-0/fulltext
5) WHO - World Health Organization. Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination. Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). Geneva, 2012. Available at: http://www.who.int/phi/news/cewg_2011/en/
6) TAG - Treatment Action Group. Tenefovir Alafenamide Fumarate (TAF) Sign-On Letter to Gilead. 2013. Available at http://www.treatmentactiongroup.org/hiv/taf-letter
7) ANGELL, M. The Truth About the Drug Companies. Random House Trade, 2005.
8) WORLD HEALTH ORGANIZATION, The World Health Report 2004.
9) WHO. Health and Human Rights Fact sheet N°323. December 2015. Available at: http://www.who.int/mediacentre/factsheets/fs323/en/.
10) HILL, A. et. al. Minimum costs for producing Hepatitis C Direct Acting Antivirals, for use in large-scale treatment access programs in developing countries. Oxford University Press. Clin Infect Dis. (2014) doi: 10.1093/cid/ciu012. First published online: January 6, 2014
11) GTPI. Preço de tratamento mantém a cura da hepatite C fora do alcance dos pacientes, 2015. Available at: http://deolhonaspatentes.org.br/blog/blog/preco_de_tratamento_mantem_a_cura_da_hepatite_c_fora_do_alcance_dos_pacientes.html
12) SACHS, Jeffrey. The Drug That Is Bankrupting America. The Huffington Post. February, 16, 2015. Available at: http://www.huffingtonpost.com/jeffrey-sachs/the-drug-that-is-bankrupt_b_6692340.html
13) LIGHT, Donald; LEXCHIN, Joel; DARROW, Jonathan. Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs. Journal of Law, Medicine and Ethics, Vol. 14, No. 3, 2013. Available at http://ssrn.com/abstract=2282014.
14) GTPI. EMPRESAS TRANSNACIONAIS EUROPÉIAS NA AMÉRICA LATINA: ESTUDO DE CASO DE TRANSNACIONAIS FARMACÊUTICAS NO BRASIL. 2008. Available at: http://www.enlazandoalternativas.org/IMG/pdf/5-POR.pdf
15) Stop Corporate Power. 8 proposals for the new legally binding international instrument on Transnational Corporations (TNCs) and Human Rights. Availabe at: http://www.stopcorporateimpunity.org/wp-content/uploads/2015/07/CampaignSubmission-EN-jul2015.pdf

Bibliography
HOLGUIN, German. La Guerra Contra los Medicamentos Genéricos: Un Crimen Silencioso”. Editorial Aguilar, 2014.
TNI, State of Power 2015. Available at: https://www.tni.org/en/stateofpower2015
TNI, A transatlantic corporate bill of rights. Available at: https://www.tni.org/en/briefing/transatlantic-corporate-bill-rights
Peoples Sovereignty vs. Impunity Inc: Counterpower and struggles for Justice. Transnational Institute (TNI), Observatorio de la Deuda en la Globalización (ODG), available at: https://www.tni.org/files/publication-downloads/impunidadsaen.pdf, 2015

GREGG ALTON, Gilead Sciences, Inc.

Lead Author: Gregg Alton
Organization: Gilead Sciences, Inc.
Country: USA

Abstract 

Gilead Sciences, Inc.
Contribution Submission
UN High-Level Panel on Access to Medicines

Gilead Sciences, Inc. and the UN High-Level Panel on Access to Medicines share a commitment to upholding human rights and delivering innovative medicines to patients around the world. Gilead’s unique approach enables timely access to affordable, high-quality medicines, particularly in the developing world. Today, 865,000 patients in the United States and Europe and 8.7 million patients in the developing world receive Gilead HIV medicines. Since 2013, 770,000 patients have received Gilead’s hepatitis C medicines globally - 200,000 of whom live in low- and middle-income countries. Gilead works with governments and other payers around the world to determine appropriate pricing for its medicines based on a country’s:

• economic means
• disease prevalence
• willingness to invest in broad patient access across all subpopulations

We recommend the Panel consider the access approach we outline in our submission– specifically partnership with governments, tiered pricing, support services, and voluntary licensing – as effective ways to address the interests and objectives of patients, civil society, governments and innovator companies by advancing the public health and human rights goal of ensuring broad access to medicines to patients regardless of where they live or their economic status, while incentivizing innovation.

Submission

Gilead Sciences, Inc.
Contribution Submission
UN High-Level Panel on Access to Medicines

Introduction

Gilead Sciences, Inc. and the UN High-Level Panel on Access to Medicines share a commitment to upholding human rights and delivering innovative medicines to patients around the world. Gilead’s unique approach enables timely access to affordable, high-quality medicines, particularly in the developing world. Today, 865,000 patients in the United States and Europe and 8.7 million patients in the developing world receive Gilead HIV medicines. Since 2013, 770,000 patients have received Gilead’s hepatitis C medicines globally - 200,000 of whom live in low- and middle-income countries. Gilead works with governments and other payers around the world to determine appropriate pricing for its medicines based on a country’s:

• economic means
• disease prevalence
• willingness to invest in broad patient access across all subpopulations

We recommend the Panel consider the access approach we outline below – specifically partnership with governments, tiered pricing, support services, and voluntary licensing – as effective ways to address the interests and objectives of patients, civil society, governments and innovator companies by advancing the public health and human rights goal of ensuring broad access to medicines to patients regardless of where they live or their economic status, while incentivizing innovation.

About Gilead

Gilead is a research-based biopharmaceutical company with headquarters in Foster City, California, that discovers and develops medicines for people living with life-threatening illnesses. The company’s main therapeutic areas include antiretroviral (ARV) treatments for HIV and hepatitis B virus (HBV), and antivirals for hepatitis C virus (HCV) infection.

HIV/AIDS

Nearly 37 million people live with HIV/AIDS worldwide. Gilead’s portfolio of HIV medicines includes several category firsts such as complete HIV treatment regimens in a once-daily pill and the first oral pill to reduce the risk of acquiring HIV in certain high-risk adults. The active ingredient in Gilead’s HIV medicines, tenofovir disoproxil fumarate (TDF), is the most widely prescribed molecule for HIV therapy worldwide. Gilead continues to innovate to meet the evolving needs of HIV patients. Gilead has made exciting progress with regimens containing tenofovir alafenamide (TAF), which have demonstrated high antiviral efficacy and an improved renal and bone safety profile.

Hepatitis C

The World Health Organization (WHO) estimates that more than 170 million people worldwide are infected with HCV, which can cause serious liver disease including cirrhosis, cancer and liver failure. Gilead’s new HCV therapies, Sovaldi® (sofosbuvir) and Harvoni® (ledipasvir/sofosbuvir), are breakthrough direct-acting antivirals. In both clinical trials and real-world settings, Sovaldi and Harvoni regimens were shown to cure, on average, more than 90 percent of patients with HCV infection. They are more effective than the prior standard of care, which offered average cure rates of 50 percent. They are also safer, more tolerable, easier to administer and completed in a shorter period of time (as few as 8 weeks vs. up to 48 weeks). Gilead remains focused on advancing care for HCV patients with its investigational regimen, sofosbuvir/velpatasvir, which has the potential to cure patients, regardless of genotype.

Ensuring Access in the Developed World

In the U.S., Europe and other high-income countries, Gilead works to ensure broad access to its medicines through strong partnerships with payers, including governments, as well as through patient assistance programs. Recognizing that there are competing demands on healthcare systems, Gilead endeavors to deliver its medicines in a way that is economically sustainable and respects healthcare budgets.
United States

HIV/AIDS

Approximately half of all patients taking Gilead HIV medicines in the U.S. receive them through federal and state programs at substantially discounted prices. Gilead has worked with state AIDS Drug Assistance Programs (ADAPs) to provide pricing for its HIV medicines lower than required by legally mandated discounts. In 2008, the company instituted a voluntary price freeze and additional discounts for ADAPs for all Gilead HIV products that will continue through 2016. Gilead also established U.S. patient assistance programs, which help make Gilead HIV therapies accessible for uninsured individuals and those who need financial assistance.

Hepatitis C

Despite the significant advancement (i.e., high cure rates, shorter treatment duration) that Gilead’s new HCV treatments offer, Sovaldi and Harvoni are responsibly priced at parity with older, less effective treatments. Gilead conducted extensive research with public and private payers to establish a price that would permit broad patient access. The Wyden-Grassley Senate Committee on Finance expressed the opinion that Gilead priced Sovaldi to maximize profits. However, as source documents included in the report indicate, Gilead priced Sovaldi with a strong focus on access – not profit maximization -- considering guidance received from payers.

To date, approximately ten percent of patients infected with HCV in the U.S. have been treated with a sofosbuvir-based regimen. Approximately 60 percent of patients receive treatment through federal and state programs, all of which receive substantial discounts off U.S. list prices. Payers like Medicaid and Veterans Affairs (VA), for example, receive discounts in excess of 50 percent on Harvoni. An estimated 25 percent of HCV-infected patients in the VA population have been treated to date. Gilead continues to partner with Medicaid and the VA and to identify innovative, value-based arrangements that ensure access to all patients, not just those with advanced liver disease.

To help ensure eligible HCV patients in the U.S. have access to Harvoni and Sovaldi, Gilead established the Support Path® program. Through this program, the majority of commercially insured patients are able to access Harvoni and Sovaldi for a five dollar (USD) co-pay per month. And for eligible patients with no insurance, the Support Path Patient Assistance Program provides Harvoni and Sovaldi at no charge.

Europe

As with other developed countries, Gilead has negotiated pricing agreements in European markets, taking into account each country’s economic means, burden of disease and commitment to investing in HIV and HCV patient access. With the availability of more effective HCV treatments, several countries have significantly increased their treatment rates. France, for example, treated 6,000 HCV patients in 2013, increasing to 14,000 in 2015. The rate of reimbursement for HCV treatments has also been impressive – within one year of European regulatory approval, Harvoni is reimbursed in 23 of the 28 EU member states, including Bulgaria, Slovakia, and Slovenia.

Political will is critical to increasing the number of patients receiving treatment. Some national authorities have used innovative financing arrangements to reach ambitious treatment goals. One approach – volume discounts – significantly reduces treatment costs and incentivizes wider patient access by encouraging governments to treat all HCV patients, not just those with advanced disease. For example:

• Spain: In July 2015, Spain’s health ministry published a national strategic plan to combat HCV, and their finance ministry established regional loans to fund treatment. To date, over 40,000 patients have been treated through the program at a significantly discounted price – far exceeding the original commitment.
• Portugal: The Portuguese government has established a dedicated funding line for HCV treatment. An estimated 6,000 people, regardless of disease progression, have been treated to date at a significantly discounted price. This represents a six-fold increase over previous treatment rates.
• Italy: As of January 2016, 32,500 patients have initiated HCV treatment as a result of a national pricing agreement that incentivizes broad access – more than double the historic HCV treatment rate.

Australia

More than 230,000 Australians are living with HCV. The Australian government is investing $1 billion over five years to make new HCV medicines available to all patients, regardless of disease progression.

Ensuring Access in the Developing World

Over the past 13 years, Gilead has developed a pioneering access approach that has helped support the rapid scale-up of HIV/AIDS treatment in the developing world. Today, Gilead has adopted a similar model to make its HCV medicines available at a more accelerated pace.

The access approach in the developing world consists of: 1) discounts on branded medicines based on a country’s Gross National Income per capita, disease burden and willingness to invest in broad HIV and HCV patient access across all populations, especially vulnerable groups; and 2) voluntary licensing of Gilead’s innovative medicines to generic drug companies (both directly and through the UN-backed Medicines Patent Pool), which can set their own prices and sell the medicines in a defined number of low- and middle-income countries. Success is measured, not by revenue but by the breadth of access achieved in a geographic region, as well as by improved public health outcomes.

Gilead also works closely with local governments, non-governmental organizations (NGOs), businesses and medical communities to register products, provide medical and clinical education, forecast demand to prevent shortages or stock-outs and conduct collaborative research. In total, Gilead works with more than 30 manufacturers, regional and local distributors and generic licensees to expand access to its medicines, including those currently in the company’s R&D pipeline.

Gilead’s approach in the developing world has been shaped by over a decade of experience and adaption. The following is an overview of Gilead’s access model’s evolution over time.

2003-2004

In 2003 and 2004, Gilead made two of its HIV medicines -- Viread® (TDF) and Truvada® (TDF/FTC) – available at no-profit pricing in 68 countries. Since the company had no manufacturing facilities or drug registrations outside the developed world, Gilead shipped its medicines directly from North American and European facilities to partner organizations in developing countries. Import permits granted by national health ministries allowed limited quantities of medicines to go to specific organizations or patients. Despite an ambitious vision, this initial approach reached very few patients.

2005

In 2005, Gilead increased the number of developing countries receiving price reductions to 97. The company also stopped using import permits, which were not sufficiently flexible to ensure efficient delivery of medicines. To avoid a lengthy country-by-country registration process, Gilead submitted a single registration dossier to approximately 50 countries. The company also submitted its HIV medicines for WHO pre-qualification. While these measures led to improvements, only 30,000 patients were receiving Gilead HIV medicines by the end of 2005, and only one country responded to the regulatory dossier with an approval.

2006-2011

In 2006, Gilead overhauled its access approach, establishing a team separate from the company’s commercial operations. This team laid the foundations of Gilead’s current approach by establishing voluntary licensing agreements with generic drug manufacturers in India. These companies were free to brand, price and differentiate themselves in a competitive market. Under the agreements, the licensees could sell generic TDF in 95 countries–later expanding to 112 countries.

Gilead also assembled a portfolio of support activities, including tackling the lengthy process of registering medicines. Gilead identified business partners to build a sophisticated distribution network, and also engaged in medical education and supply chain management.

2011-present

As Gilead continued to innovate, it incorporated its newer medicines under the access model, including the once-daily single tablet regimen Stribild®. The company also supported new mechanisms to enable access, such as the Medicines Patent Pool (MPP). Gilead was the first innovator pharmaceutical company to join the MPP.

In 2014 and 2015, Gilead expanded its MPP licensing agreements by granting generic manufacturers in India, China and South Africa future rights to develop the investigational compound TAF for HIV and HBV treatment in 112 resource-limited countries, contingent on the medicine’s U.S. regulatory approval. Today, Gilead licenses TDF, TDF-containing regimens and TAF through the MPP.

Starting in September 2014, Gilead extended and adapted its access model to include its HCV medicines, Sovaldi and Harvoni. Gilead developed the following access strategy for HCV:

• Single lowest branded price in generic territory: In 101 countries, which represent more than half of the global HCV burden, Gilead-branded Sovaldi is available at $900 per treatment course and, in combination with other therapies, offers a cure for the vast majority of patients. Harvoni is available at $1,200 per treatment course and has even higher cure rates (93 – 99 percent).
• Preferential pricing: In other middle-income countries, prices are determined on a country-by-country basis, following negotiations with governments.
• Licensed generics: Voluntary licensing agreements allow licensees to manufacture and distribute generic versions of Gilead’s medicines to the same 101 developing countries referenced above. Licensees pay a modest royalty to Gilead, which is reinvested to ensure sustainability of the program.
• Product registration and business partnerships: Gilead engages with regional partners to register medicines with regulatory authorities, coordinate distribution, conduct safety reporting and track inventory to prevent supply disruptions.
• Research:
- Clinical Trials: Gilead collaborates with regulatory authorities, NGOs and local thought leaders to carry out clinical trials in diverse patient populations. Clinical studies are completed or ongoing in countries that require local trials for product approval, including China, India, Russia and Vietnam. Additional studies to address local unmet medical needs and generate in-country data are ongoing or planned in Brazil, Cameroon, Egypt, India, Ivory Coast, Malaysia, Mexico, Rwanda, Senegal and Thailand.
- Demonstration projects: Gilead supports numerous in-country research programs and demonstration projects, including a pilot program in Ukraine providing HCV treatment to injecting drug users and other affected populations. Gilead is also piloting linkage-to-care models in resource-limited settings, with a focus on point-of-care diagnostics, task shifting and innovative health financing.

Progress to Date

HIV/AIDS

As of January 2016, nearly two-thirds – 8.7 million – of the 13.5 million people in the developing world receiving HIV treatment are on Gilead therapies. Driven by competition among generic manufacturers holding voluntary licenses, the cost of Gilead’s HIV medicines in these regions has fallen by more than 80 percent since 2006. Generic versions of Gilead’s Viread are available for as little as $42 per patient per year in the developing world.

Hepatitis C

Gilead works concurrently to make both branded and generic versions of its products available as quickly as possible. Gilead licensed Sovaldi to generic manufacturers within one year of its U.S. approval. Harvoni was also included in the licensing agreement at that time – prior to its U.S. regulatory approval. To date, roughly 10 percent of HCV patients receiving treatment in developing countries are taking generic versions of Gilead’s medicines, and some generic prices have dropped to approximately $360 per three month treatment course. Sovaldi has been approved in 16 developing countries and dossiers have been filed in 13 others. Harvoni is approved in five developing countries and dossiers have been filed in 14 others.

Additionally, Gilead is working with countries and regions to expedite HCV treatment scale-up.

• Egypt: Egypt has the highest prevalence of HCV in the world - as much as 15 percent. Gilead has partnered with the Ministry of Health to implement an ambitious HCV treatment program. Gilead provides branded Sovaldi at its lowest branded price and supports the health ministry’s medical education and prevention efforts. Since October 2014, more than 135,000 Egyptians have begun treatment with Sovaldi.
• Pakistan: Pakistan has one of the highest HCV burdens. Sovaldi is also available in Pakistan at the lowest branded price and since February 2015, 45,000 patients have initiated treatment.
• Georgia: Georgia has the world’s third-highest HCV prevalence (7%). Gilead is partnering with Georgia’s Ministry of Health and the U.S. Centers for Disease Control and Prevention to eliminate HCV in the country. The partnership aims to demonstrate the impact of widespread HCV screening and universal treatment. Gilead is donating Sovaldi and Harvoni, and 5,250 people have initiated treatment to date.
• Latin America: In November 2015, following negotiations with MERCOSUR, Gilead agreed to provide Sovaldi at its lowest price in the region to Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guyana, Paraguay, Peru, Suriname, Uruguay and Venezuela.
• Brazil: An estimated two million people are infected with HCV in Brazil. Gilead has reached an agreement with the Ministry of Health to provide Sovaldi through the national public health system. The ministry has committed to scaling-up treatment nearly threefold.

Although the number of patients receiving affordable, quality HCV treatment has increased, there are many more patients in need of treatment. Gilead is working with donor organizations, country governments and development banks to address a significant barrier to access– health financing. Gilead is exploring creative approaches to secure funding for HCV including loans, innovative financing mechanisms and employer test-treat-cure programs.

Gilead and Agenda 2030

Agenda 2030 urges United Nations member states to accelerate the pace of progress in fighting epidemics, including HIV/AIDS and viral hepatitis. It also calls for a revitalized global partnership for sustainable development, including the involvement of the private sector. For more than a decade, Gilead has worked toward these goals, in partnership with stakeholders, and developed access initiatives that are both bold enough to improve public health and fiscally sustainable, offering an example for others to replicate and adapt. Gilead will continue to adapt and evolve its approach to ensure patients have access to its innovations, regardless of where they live or their economic status.

Bibliography and References

Gilead Sciences, Inc.
Contribution Submission
UN High-Level Panel on Access to Medicines

Endnotes

i. In December 2013, the FDA approved Gilead’s Sovaldi for the treatment of patients with chronic infection with HCV genotypes 1, 2, 3 and 4 in combination with ribavirin and, depending on genotype, interferon. The Sovaldi regimen offers patients a short-duration course of treatment with a high cure rate. In October 2014, the FDA approved Gilead’s Harvoni to treat patients with HCV genotype 1. Harvoni, which combines Sovaldi with Gilead’s NS5A inhibitor ledipasvir, is the first and only HCV treatment to provide a complete regimen and potential cure in one tablet taken once daily, without interferon or ribavirin. Patients take Harvoni for eight, 12 or 24 weeks. In November 2015, the FDA expanded use of Harvoni to include patients with genotypes 4, 5 and 6 and patients co-infected with HIV. Harvoni in combination with ribavirin for 12 weeks can be considered for treatment-experienced genotype 1 patients with cirrhosis. In global guidelines published in 2014, the World Health Organization (WHO) recommended Sovaldi to treat HCV genotypes 1, 2, 3 and 4 prescribed in combination with ribavirin and, depending on genotype, interferon.

ii. HCV is classified by genotype, and the prevalence (number of people infected) of each of six genotypes and subtypes varies by country. The diversity of genotypes requires different treatment approaches and different drug regimens.

iii. Gilead’s HIV/AIDS patient assistance programs include: U.S. Advancing Access®; Atripla® Patient Access Program; and Truvada® for PrEP Medication Assistance Program.

iv. List prices serve as a starting point for payer negotiations in the U.S. All payers in the United States have received a discount to date.

v. Spain’s original commitment was to treat 52,000 over a three year period.

vi. Stribild (TDF/FTC/COBI/EVG)

vii. Gilead joined the MPP in 2011.

viii. These estimates are based on suggested public/government prices of USD $300 per bottle of Sovaldi and $400 per bottle of Harvoni. One bottle is the equivalent of one month of treatment. The cost per treatment course estimate is based on a three month treatment duration - $900 for three months of Sovaldi and $1,200 for three months of Harvoni. Treatment duration can vary from patient to patient depending on hepatitis C genotype, current health status and past treatment experience. A full course of treatment with Sovaldi, in combination with other therapies, or Harvoni represents a cure for the majority of patients (average 90% cure rate for Sovaldi and 93 – 99% cure rate for Harvoni). Cost per treatment course estimates do not include the cost of diagnostics, monitoring or additional medicines, such as interferon and/or ribavirin. Costs can vary country-by-country depending on the exchange rate.

ix. Harvoni received U.S. regulatory approval in December 2014.

x. This estimate is based on a publicized price of USD $120/bottle of generic Sovaldi (sofosbuvir). One bottle is the equivalent of one month of treatment. The cost per treatment course estimate is based on a three month treatment duration - $360 for three months of generic sofosbuvir. Treatment duration can vary from patient to patient depending on hepatitis C genotype, current health status and past treatment experience. Cost per treatment course estimates do not include the cost of diagnostics, monitoring or additional medicines, such as interferon and/or ribavirin. Costs can vary country-by-country depending on the exchange rate.

Bibliography

HIV

• Gilead Sciences (B) Implementing the Gilead Access Program for HIV Drugs, Stanford Graduate School of Business, 2007. Available here: https://www.gsb.stanford.edu/faculty-research/case-studies/gilead-sciences-b-implementing-gilead-access-program-hiv-drugs.

• Gilead Sciences, Inc.: Access Program, Harvard Business Review, October 2009 (Revised July 2013). Available here: http://www.hbs.edu/faculty/Pages/item.aspx?num=37998.

• Innovative Licensing Expands Access To HIV Treatments, WIPO Magazine, November 2012. Available here: http://www.wipo.int/wipo_magazine/en/2012/06/article_0005.html.

• Collaborative Commercialization At Gilead Sciences: Resolving The Innovation Vs. Access Tradeoff, Indian School of Business, June 30, 2013. Available here: https://cb.hbsp.harvard.edu/cbmp/product/ISB025-PDF-ENG.

• U.S. Food and Drug Administration Approves Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection. Gilead Press Release, November 5, 2015. Available here: https://www.gilead.com/news/press-releases/2015/11/us-food-and-drug-administration-approves-gileads-single-tablet-regimen-genvoya-elvitegravir-cobicistat-emtricitabine-and-tenofovir-alafenamide-for-treatment-of-hiv1-infection.

• World AIDS Day Brief. CDC, December 2015. Available here: http://www.cdc.gov/features/worldaidsday/.

• Scaling Up Antiretroviral Treatment Sustainably. Gilead Sciences, Last updated February 2016. Available here: http://gilead.com/~/media/files/pdfs/other/hivaccessbackgrounderus20816.pdf.

Medicines Patent Pool

• Medicines Patent Pool Announces First Licensing Agreement with a Pharmaceutical Company. Medicines Patent Pool Press Release, July 12, 2011. Available here: http://www.medicinespatentpool.org/medicines-patent-pool-announces-first-licensing-agreement-with-a-pharmaceutical-company/.

• UN welcomes pact to improve access of patented AIDS drugs in poor countries. United Nations Statement, July 12, 2011. Available here: http://www.un.org/apps/news/story.asp?NewsID=39018#.Vs9TZvkrIy5.

• Gilead Expands Access Program for Medications in Developing World. Gilead Sciences Press Release, July 12, 2011. Available here: http://gilead.com/news/press-releases/2011/7/gilead-expands-access-program-for-medications-in-developing-world.

• Gilead Announces New Agreement with Medicines Patent Pool for Access to Medicines in Developing World Countries. Gilead Sciences Press Release, July 24, 2014. Available here: http://www.gilead.com/news/press-releases/2014/7/gilead-announces-new-agreement-with-medicines-patent-pool-for-access-to-medicines-in-developing-world-countries.

• The Medicines Patent Pool (MPP) Broadens Collaboration with Gilead Sciences: Signs Licence for Phase III Medicine Tenofovir Alafenamide (TAF), Medicines Patent Pool Press Release, July 24, 2014, Available here: http://www.medicinespatentpool.org/the-medicines-patent-pool-mpp-broadens-collaboration-with-gilead-sciences-signs-licence-for-phase-iii-medicine-tenofovir-alafenamide-taf/.

• The Medicines Patent Pool and Gilead Sciences Expand Licence to Allow Generic Manufacture of Medicines in South Africa. Medicines Patent Pool Press Release, June 11, 2015. Available here: http://www.medicinespatentpool.org/the-medicines-patent-pool-and-gilead-sciences-expand-licence-to-allow-generic-manufacture-of-medicines-in-south-africa/.

• Current list of Medicines Patent Pool Licenses. Medicines Patent Pool, Last accessed February 13, 2016. Accessible here: http://www.medicinespatentpool.org/current-licences/.

Hepatitis C

• U.S. Food and Drug Administration Approves Gilead’s Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C. Gilead Sciences Press Release, December 6, 2013. Available here: http://gilead.com/news/press-releases/2013/12/us-food-and-drug-administration-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-chronic-hepatitis-c.

• Gilead Announces Generic Licensing Agreements to Increase Access to Hepatitis C Treatments in Developing Countries. Gilead Sciences Press Release, September 15, 2014. Available here: http://www.gilead.com/news/press-releases/2014/9/gilead-announces-generic-licensing-agreements-to-increase-access-to-hepatitis-c-treatments-in-developing-countries.

• KEI welcomes the Gilead HCV licenses, as a step to expand access to treatments. Notes challenges that remain. Knowledge Ecology International. September 15, 2014. Available here: http://keionline.org/node/2082.

• Gilead Briefs Nirmala Sitharaman About Their Licensing Agreements With Seven India Based Generic Pharmaceutical Manufacturers. Government of India Ministry of Commerce and Industry Press Release, September 17, 2014. Available here: http://commerce.nic.in/pressrelease/pressrelease_detail.asp?id=3119.

• U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C, Gilead Sciences Press Release, October 10, 2014. Available here: http://gilead.com/news/press-releases/2014/10/us-food-and-drug-administration-approves-gileads-harvoni-ledipasvirsofosbuvir-the-first-oncedaily-single-tablet-regimen-for-the-treatment-of-genotype-1-chronic-hepatitis-c

• Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic Agent. Gilead Sciences Press Release, January 26, 2015. Available here: https://www.gilead.com/news/press-releases/2015/1/gilead-expands-hepatitis-c-generic-licensing-agreements-to-include-investigational-pangenotypic-agent.

• Gilead Targets Elimination of Hepatitis C. WIPO Magazine, February 2015. Available here: http://www.wipo.int/wipo_magazine/en/2015/01/article_0001.html.

• Gilead: Hepatitis-C Access Strategy (A). Harvard Business Review, October 2014 (Revised July 2015). Available here: http://www.hbs.edu/faculty/Pages/item.aspx?num=48208.

• Gilead: Hepatitis-C Access Strategy (B). Harvard Business Review, October 2014 (Revised July 2015). Available here: http://www.hbs.edu/faculty/Pages/item.aspx?num=48211.

• Gilead Announces SVR12 Rates from Four Phase 3 Studies Evaluating a Once-Daily, Fixed-Dose Combination of Sofosbuvir (SOF) and Velpatasvir (VEL) (GS-5816) for the Treatment of All Six Hepatitis C Genotypes. Gilead Press Release, September 21, 2015. Available here: http://www.gilead.com/news/press-releases/2015/9/gilead-announces-svr12-rates-from-four-phase-3-studies-evaluating-a-oncedaily-fixeddose-combination-of-sofosbuvir-sof-and-velpatasvir-vel-gs5816-for-the-treatment-of-all-six-hepatitis-c-genotypes. .

• Chronic Hepatitis C Treatment Expansion: Generic Manufacturing for Developing Countries. Gilead Sciences, Last updated October 2015. Available here: http://gilead.com/~/media/files/pdfs/other/hcv%20generic%20agreement%20fast%20facts%20101615.pdf.

• Expanding Chronic Hepatitis C Treatment in Low- and Middle-Income Countries. Gilead Sciences, October 2015. Available here: http://gilead.com/~/media/files/pdfs/other/hcv%20access%20fact%20sheet%20%20101615.pdf.

Sustainable Development Goals

• “The scale and ambition of the new Agenda requires a revitalized Global Partnership to ensure its implementation. We fully commit to this…It will facilitate an intensive global engagement in support of implementation of all the Goals and targets, bringing together Governments, the private sector, civil society, the United Nations system and other actors and mobilizing all available resources.” Agenda 2030, paragraph 39. United Nations, September 2015. Available here: https://sustainabledevelopment.un.org/content/documents/21252030%20Agenda%20for%20Sustainable%20Development%20web.pdf.

Australia

• Turnbull Government Invests over $1 billion to Cure HEP C. Australian Ministry for Health, December 20, 2015. Available here: https://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2015-ley154.htm.

• New Hepatitis C medicines – Factsheet for patients and consumers. Turnbull Government, December 2015. Available here: https://www.health.gov.au/internet/ministers/publishing.nsf/Content/FAE2B65331456243CA257F20006D4C48/$File/Hepatitis%20C%20Factsheet%20for%20patients%20and%20consumers.pdf.

Brazil

• Ministry of Health to offer innovative treatment for Hepatitis C. Brazil Department of STD, AIDS, and Viral Hepatitis, June 17, 2015. Available here: http://www.aids.gov.br/en/noticia/2015/ministry-health-offer-innovative-treatment-hepatitis-c.

Egypt

• Plan of Action for the Prevention, Care & Treatment of Viral Hepatitis, Egypt 2014-2018. Egyptian Ministry of Health and Population. Available here: http://www.emro.who.int/images/stories/egypt/VH_Plan_of_Action_FINAL_PRINT1.pdf.

France

• How to improve access to therapy in France? Presentation by Victor De Ledinghen at the Paris Hepatitis Conference, January 11, 2016. Available here: http://www.aphc.info/wp-content/uploads/2016/01/PHC_2016.pdf.

Georgia

• California Biopharmaceutical Company Signs Historic Agreement to Eliminate Hepatitis C in Georgia (April 21), Embassy of the United States to Georgia News, April 21, 2015. Available here: http://georgia.usembassy.gov/news-events/emb_news2015t/21042015c.html/.

• Hepatitis C Treatments Will Be Free In Georgia, Prime Minister of Georgia Press Release, April 21, 2015. Available here: http://gov.ge/index.php?lang_id=ENG&sec_id=412&info_id=48577.

Italy

• The Italian Payers’ approach to new anti-hepatitis C drugs. Italian Medicines Agency Statement, April 9, 2015. Available here: http://www.epac.it/notizie/default.asp?id=890&id_n=14877.

Portugal

• Portugal agrees to treat 13,000 Hepatitis C sufferers for free. Digital Journal, February 8, 2015. Available here: http://www.digitaljournal.com/life/health/portugal-agrees-to-treat-13-000-hepatitis-c-sufferers-for-free/article/425590.

• Balanço do programa da Hepatite C. Infarmed: Autoridade Nacional do Medicamento e Produtos de Saude I.P. Press Release, July 28, 2015. Available here: http://www.infarmed.pt/portal/pls/portal/docs/1/11154356.PDF.

• Reunião do Ministério da Saúde com os hospitais do SNS - Hepatite C. Infarmed: Autoridade Nacional do Medicamento e Produtos de Saude I.P. Press Release, February 18, 2015. Available here: http://www.infarmed.pt/portal/page/portal/INFARMED/MAIS_NOVIDADES/DETALHE_NOVIDADE?itemid=10427427.

• Hepatite C – Monitorização dos tratamentos. Infarmed: Autoridade Nacional do Medicamento e Produtos de Saude I.P. Data released, February 22, 2016. Available here: http://www.infarmed.pt/portal/page/portal/SOBRE_O_INFARMED/ESTRUTURA_E_ORGANIZACAO/CTE/Comissao_Nacional_de_Farmacia_Terapeutica/FNM/HepC_Monitorizacao_29Set2015.pdf.

• “Impact of the Universal Drug Coverage Program to Eradicate the Burden of Hepatitis C in Portugal.” AASLD 2016 abstract presented by Eurico C. Alves.

Spain

• Plan Estratégico Para El Abordaje De La Hepatitis C En El Sistema Nacional De Salud. Miniserio De Sanidad, Servicios Sociales e Igualdad, May 21, 2015. Available here: http://www.msssi.gob.es/ciudadanos/enfLesiones/enfTransmisibles/docs/plan_estrategico_hepatitis_C.pdf

• Más de 40.000 pacientes de Hepatitis C han recibido tratamiento en España desde el 1 de enero de 2015 con medicamentos de última generación. Press Release from Miniserio De Sanidad, Servicios Sociales e Igualdad, February 23, 2016. Available here: http://www.msssi.gob.es/gabinete/notasPrensa.do?id=3909.

United States

• Gilead Sciences and ADAP Crisis Task Force Announce New Initiatives to Support AIDS Drug Assistance Programs (ADAPs). Gilead Sciences Press Release, June 4, 2010. Available here: http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1434629#sthash.giMqQhLr.dpuf

• The Price of Sovaldi and its Impact on the U.S. Health Care System. United States Senate Committee on Finance, December 1, 2015. Available here: http://www.finance.senate.gov/imo/media/doc/1%20The%20Price%20of%20Sovaldi%20and%20Its%20Impact%20on%20the%20U.S.%20Health%20Care%20System%20(Full%20Report).pdf.

• U.S. Patient Access. Gilead Sciences website, accessed February 25, 2016. Available here: http://gilead.com/responsibility/us-patient-access.

• U.S. Advancing Access. Gilead Sciences website, accessed February 25, 2016. Available here: http://gilead.com/responsibility/us-patient-access/us%20advancing%20access.

• Atripla Patient Access Program. Gilead Sciences website, accessed February 25, 2016. Available here: http://gilead.com/responsibility/us-patient-access/atripla%20patient%20access%20program.

• Truvada for PrEP Medication Assistance Program. Gilead Sciences website, accessed February 25, 2016. Available here: http://gilead.com/responsibility/us-patient-access/truvada%20for%20prep%20medication%20assistance%20program.

• Support Path for Sovaldi and Harvoni. Gilead Sciences website, accessed February 25, 2016. Available here: http://gilead.com/responsibility/us-patient-access/support%20path%20for%20sovaldi%20and%20harvoni.

KATIE DAIN, NCD Alliance

Lead Author: Katie Dain
Additional Author(s): Priya Kanayson, Tiphaine Lagarde
Organization: NCD Alliance
Country: UK, USA, Switzerland 

Abstract

Non-communicable diseases (NCDs) – including cancers, cardiovascular diseases, chronic respiratory diseases, diabetes, and mental health and neurological disorders – are the leading causes of death worldwide, accounting for 38 million of the world’s 56 million deaths in 2012. Populations in low- and middle-income countries (LMICs) bear a disproportionate share of the burden, with over 80% of all preventable deaths under the age of 70 occurring in these countries, resulting in high economic losses. Due to their chronic and sometimes life-long nature, NCDs demand a responsive, person-centred health system. People living with NCDs often have multiple interactions with the health system over long periods and may require disability management and long-term care. Access to essential medicines and technologies is a vital component of chronic-disease management, and in many LMICs, availability and access is inadequate, with large disparities persisting between and within countries. WHO estimates that there are 5.5 billion people living with minimal or no access to adequate pain treatment, of which millions endure pain due to acute illness or end of life. Understanding the current environment around availability and affordability of essential medicines and basic technologies for NCDs is key to identifying structural bottlenecks and implementing adequate approaches to improve access to these commodities.

Submission 

We welcome the opportunity to submit a contribution for consideration by the United Nations Secretary-General’s High-Level Panel on Access to Medicines. The NCD Alliance is a global civil society network of over 2,000 organisations working collectively to elevate the profile of non-communicable diseases on the global development agenda.

Non-communicable diseases (NCDs) – including cancers, cardiovascular diseases, chronic respiratory diseases, diabetes, and mental health and neurological disorders – are the leading causes of death worldwide, accounting for 38 million of the world’s 56 million deaths in 2012. Populations in low- and middle-income countries (LMICs) bear a disproportionate share of the burden, with over 80% of all preventable deaths under the age of 70 occurring in these countries, resulting in high economic losses. Due to their chronic and sometimes life-long nature, NCDs demand a responsive, person-centred health system. People living with NCDs often have multiple interactions with the health system over long periods and may require disability management and long-term care.

Access to essential medicines and technologies is a vital component of chronic-disease management, and in many LMICs, availability and access is inadequate, with large disparities persisting between and within countries. Studies show that mean availability of essential NCD medicines in 36 LMICs is very low, and lower than availability for medicines targeting acute diseases. In the public sector, availability for NCDs was 36% compared to 54% for acute diseases, while in the private sector the comparison was 55% versus 66%. A particular issue is the insufficient access to controlled opioid analgesics for pain relief and palliative care. WHO estimates that there are 5.5 billion people living with minimal or no access to adequate pain treatment, of which millions endure pain due to acute illness or end of life. Understanding the current environment around availability and affordability of essential medicines and basic technologies for NCDs is key to identifying structural bottlenecks and implementing adequate approaches to improve access to these commodities.

Numerous political commitments have been made to reducing the global burden of NCDs and investment in NCD diagnosis, treatment, and care. These commitments include the WHO Global Action Plan (GAP) on the prevention and control of NCDs, which specifies a target on achieving 80% availability of affordable basic technologies and essential medicines required for NCDs by 2020 ; the 2030 Agenda for Sustainable Development, which discusses a target on reducing the burden of NCDs and supporting research and development of vaccines and medicines; and the 2011 United Nations Political Declaration on the Prevention and Control of NCDs. Achieving the targets set forth in these commitments is critical to reducing the global burden of NCDs and improving the health and wellbeing of all.

The difficulties in access to essential NCD medicines and basic technologies highlight a number of factors and complexities that can arise at multiple levels across the patient’s healthcare ecosystem, including prevention, early detection, screening, treatment, care and disease management. It is important to consider access to essential medicines and technologies for NCDs from a holistic perspective to recognise the special and varied needs of people at risk or living with NCDs along the life-course, e.g., the mismatch between global palliative care needs and medicines and technologies available. Understanding issues from a patient’s individual socio-economic context is also critical to improving the availability of medicines and technologies for NCDs and as part of a broader universal health care (UHC) agenda. For example, the availability of medicines and technologies at treatment facilities is irrelevant if patients are unable to access them due to distance and cost of transport.

In most cases, the reasons for inadequate access to essential medicines lie with important factors such as underdeveloped national health infrastructures and financing systems rather than patents. Given that the majority of essential medicines for NCDs are off patent (including all bar 3 of the cancer medications on the WHO Essential Medicines List), it would suggest that procurement price is less an issue than the effective distribution and delivery of medicines and technologies to those most in need.

Optimisation of supply chains for NCD medicines and technologies requires procurement of quality goods, with involvement from government and both private and public sector partners. In many LMICs, essential medicines and technologies for NCDs are available in the private sector, but at a much higher cost than in the public sector. Fragmentation between the private and public sectors results in further inequalities in access to medicines and technologies, the brunt of which is often borne by those already in poverty. Additionally, in many countries, mark-ups and duties are disproportionately high, making essential medicines for NCDs further out of reach. Reconciling these gaps and pursuing responsible public-private partnerships will be vital for governments as they develop national plans.

Health systems should be able to react to new medicines, technologies, and guidelines through continuing professional education to ensure the best care for patients. Given the central role played by health workers in NCD management, it is critical they have the skills and knowledge to treat and care NCD patients throughout the life-course, and to make the most appropriate choices about the use of medicines and technologies available to them.

A further issue relates to the disconnect between international guidelines, e.g., WHO Essential Medicines List, and their use and translation at national levels. Work needs to be done to counter the misperception that NCD medicines and technologies, and particularly those for treatment of cancer, are too complex and expensive to be feasible.

Health system strengthening is essential for achieving equitable and affordable access to essential medicines for NCDs. This can be achieved by implementing UHC, fulfillment of which will ensure that all people can access the health services they need without financial hardship. Increased resource allocation to strengthening health systems will rely on increased domestic resource mobilisation and continued international assistance, both of which were outlined in the Addis Ababa Action Agenda that was adopted at the Third International Conference on Financing for Development in July 2015.

As governments scale up services in order to increase coverage, the quality of services must be maintained. Due to poor quality control, procurement practices, and regulation, a particular challenge for NCDs is ensuring safe, quality-assured essential NCD medicines and technologies. In Rwanda for example, 20% of hypertensive medicines purchased on the market were of substandard content and 70% were of insufficient stability. Quality assurance systems and mechanisms established for other health issues, such as HIV/AIDS, could be drawn upon to improve quality and access for NCDs; and, equal attention must be given to both NCD medicines and technologies. Research, innovation, and cost-effectiveness are critical elements for improving quality of care.

While the ultimate responsibility to provide essential medicines and basic technologies lies with national governments with guidance provided by WHO, other stakeholders can and do have an important role to play. International non-governmental organisations have significant experience in implementing programs and projects to facilitate improved access to medicines and technologies for health. As such, they have a series of important roles to play: a) dispelling myths and misconceptions around the cost and feasibility of access to essential NCD medicines and technologies amongst governments and donors; b) delivery and planning of NCD services, including before and during humanitarian emergencies; and, c) holding governments, service providers, and international organisations accountable to their commitments. Investing directly in capacity building for NCD community organisations and alliances will facilitate implementation, evaluation, and monitoring of activities, and can result in improved care and reduced cost of NCD treatments and services. The private sector can also play a role in developing and delivering training and support for essential medicines and technologies. Building on these relationships will unlock a wealth of experience and expertise to further advance the prevention and control of NCDs.

In addition to the targets set forth in the WHO GAP, the WHO Global Coordinating Mechanism has recommended a set of low-cost key interventions to improve access to essential medicines and affordable technologies required for detection and treatment of NCDs. These recommendations are developed around four components: rational selection of medicines; affordable pricing; universal health coverage and sustainable financing; and reliable health and supply systems. We strongly urge the High-Level Panel to take these under consideration and highlight that Member States, particularly LMICs, need more detailed technical guidance in implementing the recommendations and must take concerted action to ensure essential medicines for NCDs are included as a core component of the WHO Model List of Essential Medicines.

The NCD Alliance and its network stand ready to support the High-Level Panel and Member States as they work to improve access to essential medicines and technologies that will improve the health and wellbeing of all.

Bibliography and References 

WHO. Global status report on noncommunicable diseases, 2014. http://apps.who.int/iris/bitstream/10665/148114/1/9789241564854_eng.pdf.
WHO. Global Coordination Mechanism on the Prevention and Control of NCDs. Policy Brief: Strengthening efforts to improve access to and affordability of medicines and technologies in the prevention and control of NCDs, 2014. http://www.who.int/medicines/areas/policy/access_noncommunicable/NCDbriefingdocument.pdf?ua=1
Hogerzeil HV, Liberman J, Wirtz VJ, et al, on behalf of The Lancet NCD Action Group (2013). Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration. Lancet, 381: 680-689.
World Health Organization (2012). Access to Controlled Medications Programme: Improving access to medications controlled under international drug conventions. World Health Organization Briefing Note.
WHO. Global Action Plan for the Prevention and Control of NCDs 2013 – 2020. http://apps.who.int/iris/bitstream/10665/94384/1/9789241506236_eng.pdf?ua=1
Smith L, Yadav P. Improving Access to Medicines for Noncommunicable Diseases through better supply chains. Noncommunicable Diseases in the Developing World: Addressing Gaps in Global Policy and Research, p52-81, 2014.
Twagirumukiza M, Cosijns A, Pringels E et al (2009). Influence of tropical climate conditions on the quality of antihypertensive drugs from Rwandan pharmacies. Am J Trop Med Hyg, 81: 776–781.

MOHAMMAD SHAHZAD, Universities Allied for Essential Medicines (UAEM)

Lead Author: Mohammad Shahzad
Additional Author(s): Thi-Yen Nguyen, Juliana Veras, Rachel Kiddell-Monroe
Organization: Universities Allied for Essential Medicines (UAEM)
Country: Canada, Netherlands, France

Abstract

Intellectual property (IP) management at universities and public research institutions (PRIs) has the potential to enable or restrict access to university-derived health technologies in all countries, but most notably low-resource settings. Today, universities own patents on nearly one in five drugs and are an indispensable part of the biomedical R&D process. Given their fundamental role in research as well as their responsibility to prioritize public interests in research and innovation, policy incentives for licensing of technologies derived from universities and PRIs must actively promote, and not restrict, access to health.

To address the incoherence that can arise from misaligned policy incentives, UAEM strongly advocates for the adoption and implementation of Global Access Licensing (GAL) policies at universities and PRIs. Having a GAL policy will allow universities and PRIs to incorporate access provisions in licensing agreements with industry partners to ensure access to the end product in low-resource settings. This is in contrast to socially responsible licensing - a broader set of approaches including attempts to safeguard access to the end product - which UAEM believes is insufficient for achieving global access of health technologies derived from universities and PRIs.

In order to assess how universities and PRIs can best manage their IP in accordance with public health objectives, UAEM recently conducted a survey of experiences in policy implementation of GAL in selected universities. Through interviews with licensing officers at technology transfer offices (TTOs) of universities including Harvard, Yale, and Oxford, we highlight specific GAL provisions utilized by these TTOs in licensing agreements to ensure global access of their health technologies.

UAEM recommends that the High Level Panel urges implementation of GAL policies at universities and PRIs, sharing of best practices among universities and PRIs, and development of adequate metrics of global health impact for licensed technologies resulting from publicly-funded research.

Submission

Submission to the UN High Level Panel on Access to Medicines (Submitted by Universities Allied for Essential Medicines)

Adoption of Global Access Licensing at Universities and Public Research Institutions



Summary

Universities Allied for Essential Medicines (UAEM) urges the High Level Panel to prioritise implementation of policies to ensure Global Access Licensing (GAL) of health related discoveries in universities and public research institutions (PRIs). This will be a key element in achieving the 2030 Agenda for Sustainable Development and, in particular, Sustainable Development Goal 3: to improve health and well-being for all. Given their fundamental role in research as well as their responsibility to prioritize public interests in research and innovation, universities and PRIs must seek policy incentives which actively promote, not restrict, access to medical technologies in low-resource settings.

Introduction

Dear Members of the UN High Level Panel on Access to Medicines,

UAEM welcomes the opportunity to make a submission on “Adoption of Global Access Licensing at universities and public research institutions”, to support the attainment of Sustainable Development Goal 3 and the 2030 Agenda for Sustainable Development.

As a student-led movement anchored in universities and PRIs worldwide, UAEM promotes global access to health innovations, notably through local and global advocacy for the implementation of GAL policies within universities and PRIs. We work to ensure that licensing of health-related technology is coherent with the social mandate of the institution, ensuring that products originating at universities make their greatest impact worldwide.



1. Background: Addressing the policy incoherence

In order to guarantee the fulfilment of the right to health, WHO member states have recognized the urgent need to scale-up global access to health technologies. In particular, Sustainable Development Goal 3 of the 2030 Agenda for Sustainable Development clearly states the need to "support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health." Despite major achievements in public health international provisions, national innovation policies are lagging behind in the creation of effective incentives to attain these goals.

Prevailing innovation policies, in some cases emulating the US Bayh-Dole Act of 1980, have historically addressed the problems of local competitiveness and economic growth by stimulating the creation of clusters of private product-development entities around universities(1), without considering their impact on future access to health products(2). The priority in this approach is the transfer of research advances to industry in order to create “spin-off” companies, high-revenue products, and investor returns.

National policies have encouraged universities to seek broad patent protection, while allowing them to establish internal policies on how to out-license rights to patented technologies, and allowing universities to have ownership of inventions resulting from publicly sponsored research(3). However, current legal frameworks pertaining to university Intellectual Property (IP) management do not address how IP should best be managed in order to protect public health.

University Technology Transfer Offices (TTOs) are relatively new entities arising from the Bayh-Dole (and similar) legislation. They play a crucial role in facilitating the translation of basic research into downstream health products through the management of licensing agreements with industrial partners. There is mounting pressure on TTOs to generate income, which is thought to have an impact on the way universities' IP is managed. Today universities own patents on nearly one in five drugs(4). In addition, a growing trend of competition among research institutions has pushed universities in the direction of IP maximalism(5).

Civil society and representatives of academia have extensively criticised current innovation policies. for example, they have said:

- current policies are ineffective in avoiding market failures to develop treatments for health problems that disproportionately affect developing countries(6);

- innovation policies have created incentives for universities "to develop independent technology transfer programs and to manage IP in a highly individualized and even competitive framework, with respect to other universities", not only increasing transaction costs and delays in making research inputs accessible, but also encouraging the "underutilization of proprietary technologies"(7);

- current policies and incentives have not been able to guarantee sustainable and affordable access to resulting health innovations(8);

- where they exist, measurement criteria to evaluate the social impact of current innovation policy incentives have been reduced to traditional, inadequate metrics such as numbers of patents filed, revenue obtained from licensed patents, and number of startup companies created to commercialize university IP(9);

- TTOs are encouraged to adopt strategies of patent licensing that maximize revenue, while neglecting how university-based IP can be best managed in order to maximize the social impact of research(10).

The Commission on Intellectual Property Rights, Innovation and Public Health(CIPH)(11), the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPoA)(12), and the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG)(13), have all stressed the importance of developing licensing strategies to promote the management of IP rights to prioritise public health. In line with these WHO recommendations, UAEM is committed to advocating for sustainable IP management strategies at universities to maximise social impact(14).



2. Global Access Licensing as part of the solution

a. The Principles

UAEM drafted the Global Access Licensing (GAL) framework to guide the design of patent licenses. It aimed to ensure rapid access to the end product in low-resource settings, with minimum administrative burden and maximum use of dynamic market mechanisms (i.e. generic competition) to reduce prices in these settings as quickly as possible(15).


GAL Framework:

Goals
1. Access to medicines and health-related technologies for all is the primary purpose of technology transfer of health-related innovations.
2. Technology transfer should preserve future innovation by ensuring that IP does not act as a barrier to further research.

Strategies
3. Generic competition is the most efficient method of facilitating affordable access to medicines in resource-limited countries.
4. Proactive licensing provisions are essential to ensure that follow-on patents and data exclusivity cannot be used to block generic production.
5. University technology transfer programs should facilitate future innovation by patenting only when truly necessary.
6. A global access licensing policy should be systematic in its approach, sufficiently transparent to verify its effectiveness, and based on explicit metrics that measure the success of technology transfer by its impact on access and continued innovation(15).

We define GAL as any license that satisfies the criteria set out in the GAL framework. On the other hand, we define ‘socially responsible licensing’ (SRL) as a broader set of approaches to IP licensing that includes any attempt to safeguard access to the end product. Such an attempt was made by Association of University Technology Managers (AUTM) in 2009, when they published their SRL principles; the Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies, along with six leading research universities in collaboration with UAEM. Today, it's endorsed by universities all over the world(14) In our view, some approaches to SRL, which are not compliant with the GAL framework, are inadequate(16). That being said, we've witnessed numerous examples of good attempts at SRL and we applaud institutions who commit to such SRL strategies. We recognize that these are not as sufficient as GAL, but they're important steps in the right direction.

b. University experiences with implementation of GAL

In January 2016, the World Health Organization (WHO) and the Institut Pasteur organized a workshop that addressed the role of academic research and public health institutions’ licensing policies in ensuring development, affordability and availability of new health products. UAEM contributed a survey of the management of IP in line with public health objectives at universities and TTOs focusing on the implementation experiences of universities that have adopted access policies with elements of the GAL framework(17). This survey explored:
- Principles of GAL activities at the universities;
- GAL provisions included in contracts negotiated by the TTO;
- Examples of university-derived health technologies licensed under GAL provisions;
- Challenges and monitoring of access policy implementation.

The UAEM survey concluded:
- Having an access policy in place at the university/PRI increases the ability for the TTO to include GAL provisions in negotiated license agreements;
- Information about implementation of access policies by TTOs is scarce, and specific metrics or formal evaluation of implementation are largely absent;
- Anecdotally speaking, greater experience of access policy implementation decreases the challenges TTO face in implementation (such as successfully overcoming doubts of the prospective licensee);
- Access policy implementation does not pose a significant threat to university income nor to securing eventual licensing of patented technologies(18).

The workshop focused on how IP licensing is managed by universities and PRIs and how this impacts access to new health products. In particular, the lack of information and guidance on GAL poses a barrier to progress in IP management strategies. In order to close this information gap, a more systematic analysis of existing practices is needed and TTOs can contribute by sharing their experiences(19).



3. Implementation of GAL

UAEM believes that universities and PRIs should adhere to principles of public research for the broader benefit of society and patients. Many universities and PRIs have recognized the importance of providing access to public research and resulting health-related products through their patenting and licensing practices. Below we give selected survey examples of how universities incorporate access considerations into their IP management.

1. Formal adoption of a GAL policy
By formally adopting a GAL policy or framework, universities and PRIs commit themselves and private partners to principles which must guide licensing negotiations for all medical and health-related technologies.

In our survey, several TTOs reported that having a formal global access policy in place increases their success in including access provisions in licensing agreements with industry partners(12).

“Having the UCL policy in place has greatly increased our ability to negotiate GAL principles [...] there was [...] great difficulty in securing any changes to the terms of existing licences in place before GAL principles were adopted” - University College London TTO


2. Contractual and specific licensing approaches
a. Term sheet: universities and PRIs can gain leverage in the negotiation process by defining GAL and introducing the concept of global access at the outset of negotiations with potential licensees(18)
"We discuss at the very beginning what types of global access provisions will be relevant and included in the discussion. If we have a term sheet, we will include them [global access provisions] on a higher level on that term sheet" - Harvard University TTO

b. Contractual Definitions: Definitions are an important part of the license agreement. Exhaustive definitions of terms such as geographical market areas and pricing greatly increase the potential efficacy of included provisions.


c. Global Access provisions:
Examples:
Due diligence requirements
“The licensee agrees to use Diligent Efforts to develop and commercially exploit licensed Products in a manner consistent with [ethical and socially responsible licensing principles]” - University College London TTO

March-in rights
"If the therapeutic is a compound that just needs to be made and our licensee isn’t making fast enough to meet the need, than you have stronger provisions that say, basically, we can bring someone else in to meet that need.” - Harvard University TTO

Limited patenting in developing countries
“...Discretion for Harvard to refuse to file or maintain Patent Rights in any Developing Country unless: (a) Licensee demonstrates that doing so would materially increase the locally-affordable availability of Licensed Products or equivalents thereof (e.g., generic products) in such country and (b) Licensee agrees that Harvard holds final decision-making authority re enforcement of such Patent Rights in such country.” - Harvard University TTO


Non-Suit obligation
‘licensee won’t file its own patents that would claim licensed products in those developing world territories’, but that’s a tall order to get into a licensing agreements – but one fallback that we’re often successful with is that they agree not to pursue infringers of those patents in developing world provided that the infringing activity is not intended to export the product back to a major market country” - Yale University TTO

Monitoring/reporting product development
"Every company that we enter into a license agreement with has to report no less frequently than annually on the development activities that they have undertaken” - University of British Columbia TTO

Marketing territories and pricing
“The Licensee shall use Diligent Efforts to supply the Licensed Products to customers in At-Cost Markets at a Cost-Based Price [and to meet market demand for the Licensed Products in those markets]” - University College London TTO


GAL is feasible for universities. Many of the same concerns are raised over and again by TTOs questioning the impact of introducing such policies. What we have seen and heard is that revenue generated from technology transfer practices at universities and PRIs does not constitute a significant source of university income. (Patent royalties comprise only 0.5-2% of total university revenue(20) and TTOs often do not break-even(21,22) ).

Furthermore, the economic realities of market segmentation for low- and middle-income countries (LMICs) support the position that adoption of GAL practices will not pose a threat to pharmaceutical sales or university royalties(20). LMICs represent a very small source of revenues and profits for pharmaceutical companies. PhRMA’s annual industry reports reveal that 93.2% of all total pharmaceutical revenues in the year of 2013 came from consumers in the US, Canada, Europe, and Japan(23).

Some TTOs are also concerned that parallel importation will allow technologies licensed under global access terms in LMICs to be be illegally diverted back to high-income countries (HICs)(17). However, there is no empirical data or evidence to suggest such flows of medicines and drugs from LMICs to HICs(24). Furthermore, this potential concern can be addressed in the licensing agreement through steps taken by the WTO: requiring use of different packaging, pill color, and pill shape to facilitate identification of illegal importations, where this is feasible and does not significantly increase the price of the product(25).



4. Impact on the right to health: using GAL in practice

The antiretroviral Stavudine, discovered and patented by researchers at Yale University, was exclusively licensed to Bristol-Myers Squibb (BMS). BMS's price was prohibitively expensive for most countries with high HIV prevalence. In 2001, public pressure from students, researchers, and MSF led Yale and BMS to allow South Africa’s leading generic manufacturer, Aspen Pharmacare, to produce generic Stavudine. The price dropped 30-fold from $1600 per patient per year to just $55, representing a 96% reduction(26). This case is one of many examples demonstrating how IP management at universities and PRIs can restrict access to university-derived health technologies(27).

When GAL is implemented, the result is strikingly different. In 2008, Dr. Kishor M Wasan developed an oral formulation of Amphotericin B, a novel agent against Leishmaniasis, at the University of British Columbia (UBC). This was the first technology where the rights to commercialization were licensed using UBC’s Global Access Principles, a policy adopted by the University Industry Liaison Office at UBC in 2007. In return for rights to develop and sell the drug for blood-borne fungal infections in the developed world, iCo Therapeutics agreed to produce and distribute the drug at-cost for treating leishmaniasis in the developing world(26).

By leveraging their ownership rights and managing their IP in a socially responsible manner, universities and PRIs can address the legal barriers to global access of health-related technologies posed by patents and data exclusivity.

5. Limitations around GAL implementation

It is clear that simply having a GAL provision on paper will not be enough to ensure access. To achieve GAL universities and PRI will need to address certain key issues which at present are often absent in the way universities and PRIs implement GAL. For instance, there has been a notable lack of transparency and information asymmetry in the licensing environment between academic institutions and industry partners can make it difficult to assess challenges and opportunities faced by universities seeking to facilitate global access of their medical technologies. Additionally, there is very limited sharing of experiences and best practices regarding socially responsible management of IP by universities and PRIs. This is, in part, due to the confidentiality and lack of transparency associated with licensing agreements and contracts.

It is important to note that GAL is just one of many measures needed to ensure global access to medicines and health technology. Alone, GAL does not solve issues such as chronic underfunding of diseases which primarily affect poor patient populations.


6. Recommendations

To promote availability of affordable health technologies, UAEM calls upon the High Level Panel to recommend governments:

- Make Global Access Licensing of health technologies at universities and PRIs mandatory for all publicly funded research. Develop and implement policies to ensure fully open and transparent technology transfer processes at universities and PRIs;
- Ensure fully open and transparent access to downstream development stages of the product;
- Actively facilitate open sharing of best practices between universities and PRIs on the socially responsible management of IP;
- Require the implementation of global health impact metrics for all health technologies produced by publicly funded research, such as those utilized by UAEM’s University Report Card(28).


7. Conclusion

The management of IP at universities and PRIs has the potential to enable or restrict access to university-derived health technologies(2). UAEM strongly advocates for the adoption and implementation of a formal GAL policy at universities and PRIs. Having seen the adoption of such policies in some of the world’s leading research universities, we seek to engage in constructive dialogue with the UN High Level Panel on Access to Medicines, regarding the potential that GAL offers, and how we can best achieve it.

"University research matters. It has the capacity to make an impact locally, nationally and globally; enriching our lives, driving our economy and contributing to greater global understanding. We also recognize that the role of a research university extends beyond innovation and encompasses a responsibility to promote a global, civil society.”(29) - University of British Columbia TTO

We welcome the opportunity to present our findings to the UN High Level Panel and to help drive this critical agenda forward so as to ensure that the fruits of publicly funded biomedical research are available for all.

Bibliography and References 

1 Mowery D. and Sampat B. Universities in national innovation systems.
2 Boettiger S and Bennet A. BayhDole: if we knew then what we know now. Nature Biotechnology, vol. 24(3), March 2006, pp. 320323.
3 Boettiger S and Bennet A., Ibid.
4 Reuters T. The Changing Role of Chemistry in Drug Discovery. International Year of Chemistry 2011. P. 13
5 Angell M. The Truth About the Drug Companies: How They Deceive Us and What to Do About It. Random House Trade Paperbacks. 2005.
6 Røttingen JA, Chamas C. A New Deal for Global Health R&D? The Recommendations of the Consultative Expert Working Group on Research
and Development (CEWG), PLoS Med 9(5): e1001219, 2012.
7 Boettiger S, Bennet, Ibid ; Heller M A, Eisenberg R S. Can Patents Deter Innovation? The Anticommons in Biomedical Research. Science, vol. 280, May 1998, pp. 698701.
8 Røttingen and Chamas, ibid ; Boettiger and Bennet, ibid.
9 Mimura C. Technology Licensing for the Benefit of the Developing World: UC Berkeley’s Socially Responsible Licensing Program. Journal of
the Association of University Technology Managers, 2006, pp. 1528.
10 Mimura C., ibid.
11 WHO. Commission on Intellectual Property Rights, Innovation and Public Health. Geneva. 2006.
12 WHO. The Global Strategy and Plan of Action on Public Health, Innovation and IP. Point 28, Section 2.4d, May 2008. http://www.who.int/phi/implementation/phi_globstat_action/en/
13 WHO. Consultative Expert Working Group on Research and Development: Financing and Coordination. Geneva. Subsection: Strengthening
R&D capacity and technology transfer : November 2012. h ttp://www.who.int/phi/cewg/en/
14 Association of University Technology Managers (AUTM). Statement of principles and strategies for the equitable dissemination of medical technologies (SPS). 2007.
15 UAEM. Global Access Licensing Framework. Essential Medicines, April 2010, pp 16.
16 UAEM. UAEM’s response to SPS. Essentialmedicine.org. February 2010.
17 Some TTO’s in Europe often refer to SRL but since SRL is less stringent than GAL we refer to GAL provisions.
18 UAEM: Aftab F., le Dous N., Gotham D., Nguyen T., Shahzad M., Veras J., Whitten C. Recent experiences in policy implementation of
socially responsible licensing in selected universities. Joint workshop organized by the World Health Organization & Institut Pasteur; 2016; Paris.
List of Participants: Bill and Melinda Gates Foundation, Drugs for Neglected Diseases Initiative, Innovative Medicines Initiative, Institut Pasteur,
Medicines Patent Pool, Médecins Sans Frontières, Public Health Agency of Canada, Shanghai Health Develop Research Centre, South Africa:
Department of Science of Technology, UAEM, University of Oldenburg, WHO, World Intellectual Property Organization, World Trade
Organization.
19 Licensing policies of PRIs: optimizing health benefits. Joint Workshop organized by the World Health Organization & Institut Pasteur;January 2016; Paris.
20 Kapczynski A, Chaifetz S, Benkler Y, Katz Z. Addressing Global Health Inequities: An Open Licensing Approach for University Innovations. Berkeley Technology Law Journal, Vol. 20, 2005.
21 Wil li am R. Brody, From Minds to Minefields: Negotiating the Demilitarized Zone Between Industry and Academia, Remarks at Biomedical Engineering Lecture Series (Apr. 6, 1999).
22 Bhaven N. Sampat, The Effects of Bayh Dole
on Technology Transfer and the Academic Enterprise: A Survey of the Empirical Literature 1213 (2004).
23 Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2009 (Washington, DC: PhRMA, April 2009).
24 Sanjay Basu, Pharmaceutical Product Diversion: Diverting attention away from the real problem? (Oxfam Briefing Paper No. 35, 2005).
25 WTO, Paragraph 6, supra note 141, § 2(b)(ii) (requiring product differentiation).
26 Chen CE, Gilliland CT, Purcell J, Kishore SP. 2010. The silent epidemic of exclusive university licensing policies on compounds for neglected diseases and beyond. PLoS Negl. Trop. Dis. 4:e570.
27 Stevens AJ, Effort AE. 2008. Using Academic License Agreements to Promote Global Social Responsibility. Journal of the Licensing Executives Society International. Volume XLIII No. 2.
28 http://globalhealthgrades.org/ - a tool used to measure the impact of licensing practices at universities in North America and the UK through a series of global health-related metrics to hold universities accountable to.
29 Wasan KM, Thornton SJ, Bell I, Goulding RE, Gretes M, et al. (2009) The global access initiative at the University of British Columbia (UBC): Availability of UBC discoveries and technologies to the developing world. J Pharm Sci 98: 791–794.

Brian Citro and Mihir Mankad, INTERNATIONAL HUMAN RIGHTS CLINIC, UNIVERSITY OF CHICAGO LAW SCHOOL

Lead Author: Brian Citro and Mihir Mankad
Additional Author(s): Kiran Raj Pandey, Evan Lyon, Stop TB Partnership, Treatment Action Group, Kenya Legal and Ethical Issues Network on HIV and AIDS (KELIN)
Organization(s): International Human Rights Clinic, University of Chicago Law School; Department of Medicine, University of Chicago; Stop TB Partnership;Treatment Action Group; Kenya Legal and Ethical Issues Network on HIV and AIDS (KELIN)
Country: USA

Abstract

Innovation of and Access to Health Technologies and the Right to Health

Health technologies, including medicines, vaccines and diagnostics, are often unaffordable to those who need them, or simply unavailable—i.e., nonexistent—due to a lack of research and development. In this submission, we examine what is required of States and the international community pursuant to the right to health to ensure innovation of and access to health technologies.

At the core, there exists a legal and policy incoherence wherein the rights of inventors are prioritized over the rights of people who need medicines and other health technologies. However, States have a legal obligation under international law to respect, protect, and fulfil the right to health. Among other things, this requires States to ensure health goods, services, and information are available and accessible, without discrimination, especially for vulnerable or marginalized groups.

To meet these obligations, State must intervene when markets alone do not facilitate access to health technologies for people who need them or spur research and development of new technologies for conditions primarily affecting the poor. State interventions to ensure affordability include, among others, use of TRIPS flexibilities, development of mechanisms for pre- and post-grant challenges to patents for health technologies based on international human rights law, and creation of independent government bodies to review health technology patent applications in light of the right to health. State interventions to ensure health technologies are available, particularly for neglected diseases and conditions primarily affecting the poor, include development of a treaty-based system of mandatory resource pooling and coordination for research and development of new health technologies, and increasing investments in alternative incentive models based on the principles of delinkage, open innovation, and licensing for access.

Submission

Innovation of and Access to Health Technologies and the Right to Health

The Problem

The access to medicines crisis first came to global attention as the result of the efforts of health and human rights activists in response to the global HIV epidemic in the late 1990s and early 2000s. Since then, the global community has sought to address the crisis in various, largely ad hoc, ways. Nonetheless, due to structural factors, such as increasing economic inequality, the globalization of intellectual property laws, and an innovation system in which profit motivations outweigh public health considerations, the problem persists. The current situation is one in which health technologies, including medicines, vaccines and diagnostics, are often unaffordable to those who need them or simply unavailable—i.e., nonexistent—due to a lack of research and development. At the core, there exists a legal and policy incoherence wherein the rights of inventors are prioritized over the rights of people who need medicines and other health technologies.

Unaffordability

Many health conditions affect high, middle, and low income countries alike. New health technologies developed for these conditions receive patents, and producers target populations who can afford to pay high prices. Since the globalization of intellectual property rights through the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), these populations have included both people in wealthy countries and wealthy people in poorer countries, because patents can now be obtained in all World Trade Organization (WTO) Member States. The intellectual property system operates on the premise that a grant of market exclusivity through a patent for a limited period of time incentivizes innovation and commercialization of new discoveries. By its very nature, the regime encourages patentholders to maximize profits during the life of their patent. The standard 20 year grant of market exclusivity for pharmaceutical patents allows developers to both recoup the costs of investments in research and development and generate profits. This may not be a concern for luxury goods and other non-essential items, but for medicines, vaccines, and diagnostics it has led to a global health crisis.

As a result, we have repeatedly seen medicines developed and brought to market for diseases such as cancer, HIV, hepatitis, TB, and others and that are unaffordable for many who need them, including for governments of poor countries. The consequence of restricting or eliminating patents and allowing generic competition for new medicines, on the other hand, is dramatic. For example, before generic competition, prices for patent-protected HIV medicines were approximately $12,000/year in 2000. Once generic competition entered the market, prices reduced by nearly 99% within two years, to about $150 year.

Unavailability

For many health conditions, including neglected diseases and conditions primarily affecting the poor, medicines, vaccines, and diagnostics simply do not exist. They are unavailable because the research and development needed to create them has not been undertaken due to a lack of financial incentives. In other words, there is market failure: innovation does not occur for these conditions because profitable markets for related health technologies do not exist under the current regime. For example, in 2014 the private pharmaceutical sector contributed only 16% of the total funding for research and development for neglected diseases—a mere 534 million dollars. By comparison, the industry claims it costs $1.5 billion on average to develop a single new medicine. Funding for all neglected diseases in 2014 thus amounted to just a third of what the industry claims it costs to develop a single drug. Compounding this problem, the current incentive model rewards incremental innovation, whereby it is more profitable to slightly modify a patent and earn additional market exclusivity, rather than to produce wholly new compounds that require much greater investment. The result is that innovation of health technologies is driven primarily by market forces rather than global health needs.

The Right to Health

In this submission, we examine what is required of States and the international community pursuant to the right to health to ensure innovation of and access to health technologies. States that have ratified international human rights treaties have committed themselves to incorporating human rights, including the right to health, into their domestic law and ensuring existing laws comply with human rights. This includes laws and regulations related to intellectual property, research and development of health technologies, and trade. These laws must comply with States’ obligations under the right to health—at the very least they must not violate the right.

The right to health is enshrined in the Universal Declaration of Human Rights, the WHO Constitution, the International Covenant on Economic, Social and Cultural Rights, the Convention on the Elimination of Discrimination Against Women, the Convention on the Rights of the Child, and other major international human rights treaties. The right to health is also enshrined in more than 130 constitutions around the world.

States have a legal obligation under international law to respect, protect, and fulfil the right to health. Among other things, this requires States to ensure health goods, services, and information are available, accessible, acceptable, and of good quality, without discrimination, especially for vulnerable or marginalized groups. States also have an obligation to ensure adequate, equitable, and sustainable financing of their health systems to this end, including for health technologies, and to promote medical research. While many States may have limited resources, they must take necessary steps to the maximum of their available resources to meet these obligations. At the international level, States should cooperate to take joint and separate action to fully realize the right to health. Finally, the right to health requires the participation of affected populations in all health-related decision-making at the community, national, and international levels.

State obligations to ensure affordability

The obligation to fulfill the right to health requires States to take all necessary steps to ensure health technologies are financially accessible, i.e., affordable, on a nondiscriminatory basis. When markets alone do not facilitate access to health technologies for people who need them, States must intervene in order to fulfill the right to health, particularly for vulnerable or marginalized groups. In most cases, this will require States to both (1) enact effective laws and regulations in the private health sector and (2) engage directly in procurement and distribution of health technologies.

The obligation to protect the right to health requires States to prevent non-state actors from interfering with individuals’ enjoyment of the right to health. This includes an obligation to implement effective laws and regulations in the private health sector, in order to prevent infringements on the right to health by private entities, such as through prohibitively high pricing of health technologies.

The obligation to respect the right to health requires States to refrain from enacting laws or regulations that violate the right to health, including those that restrict access to health technologies. This includes an obligation to refrain from entering into bilateral or multilateral agreements that result in infringements of the right to health, such as those that impose strict requirements in the area of intellectual property rights for health technologies, resulting in unaffordable prices.

State obligations to ensure availability

The obligation to fulfil the right to health requires States to ensure health technologies are available for those who need them, on a nondiscriminatory basis, especially for vulnerable or marginalized groups. When health technologies do not exist because of the structure of incentive systems for research and development, States must intervene, including through promotion of medical research. As with efforts to address unaffordability, in most cases, this will require States to both (1) enact effective laws and regulations in the private health sector and (2) engage directly in the funding, research, and development of health technologies. That is, in order to ensure health technologies are available for those who need them, States must act to create an enabling environment that spurs research and development in the private sector that meets public health needs, as well as fund and conduct public research and development of their own.

The obligation to protect the right to health requires States to ensure innovation of health technologies in the private sector does not infringe the right to health. This includes an obligation to ensure research and development priorities do not result in de facto discrimination, such as when medicines are not available for conditions affecting certain groups, and that special attention is paid to the needs of vulnerable or marginalized groups. The State must intervene in either case to guide private research and development through laws and regulations aimed at protecting the right to health.

The obligation to respect the right to health requires States to refrain from acting in ways that make health technologies unavailable. This includes, as with unaffordability, an obligation to refrain from enacting laws or policies that make health technologies unavailable, including those imposed through bilateral and multilateral agreements.

Solutions to Ensure Affordability and Availability of Health Technologies as Required by the Right to Health

In this section, we consider specific ways States can meet their obligations to respect, protect, and fulfill the right to health, as outlined above, to ensure affordability and availability of health technologies. We discuss both fixes to the current system and solutions that contribute to the development of new incentive mechanisms to promote innovation that meets global health needs.

Solutions to ensure affordability of health technologies

The global system of research and development of health technologies must ensure access to the fruits of innovation—most importantly, that health technologies are affordable to those who need them. This is especially true in the case of publically funded health technologies. In some cases, in order to ensure health technologies are available, States must engage directly in funding and research, as noted above. In the current system, publicly funded research is often used by private developers to produce health technologies that are later sold at prohibitively high prices. Such practices contravene the right to health. To ensure this does not occur, private use of public funds and publicly funded research must be strictly conditioned upon ensuring access to the resulting health technologies, particularly for vulnerable or marginalized groups. Ideally, this will involve ex ante negotiations to set affordable prices prior to the allocation of public funds or use of public research, but it may also involve compulsory price reductions after production. To facilitate this, information about public contributions to research and development should be made transparent and easily accessible, in line with States’ obligation under the right to health to ensure access to health information.

A number of fixes to the current global intellectual property system are available for use by States to ensure health technologies are affordable pursuant to the right to health:

First, flexibilities allowed under the TRIPS Agreement must be fully utilized in order to ensure intellectual property protections do not result in unaffordable health technologies. These include: use of compulsory licenses for production of patented health technologies; limitations on the scope of patentability for health technologies; and prohibition of data exclusivity, especially for technologies developed through use of public funds or research. For example, in India, Section 3(d) of The Patents Act, 1970 limits the scope of patentability for pharmaceutical products by requiring producers to demonstrate an “enhancement of the known efficacy” of new forms of known substances.

Second, the TRIPS Agreement should be amended to make clear that it is subject to international human rights law. While the Doha Declaration on the TRIPS Agreement and Public Health makes explicit that TRIPS must not prevent Member States from taking steps to protect public health, the WTO must go further and explicitly allow States to consider their obligations under the right to health during TRIPS implementation. The WTO Dispute Settlement Body (DSB) should also explicitly consider the requirements of international human rights law, and the right to health in particular, during disputes involving health technologies. International human rights experts, including the UN Committee on Economic, Social and Cultural Rights and the UN Special Rapporteur on the right to health, should provide guidance and analysis to Member States and the DSB on States’ obligations under the right to health in relation to the TRIPS Agreement.

Third, States should develop mechanisms that allow for pre- and post-grant challenges to patents for health technologies based on international human rights law. In particular, such mechanisms should allow interested parties, including civil society and patients groups, to oppose patent applications and recent patent grants that threaten to make health technologies unaffordable in violation of the right to health. Similar mechanisms exist and have been used with success in some States, including India. In addition to denying or invalidating patents, successful pre- or post-grant challenges based on the right to health could result in the granting of a compulsory license or other forms of relief. In order to ensure such challenges are adjudicated properly, the capacity of domestic intellectual property tribunals to consider human rights grounds must be strengthened through training and inclusion of judges with appropriate expertise.

Fourth, States should consider creating an independent government body that reviews all health technology patent applications in light of the right to health and the obligation to ensure health technologies are affordable for all who need them. Such a body should be comprised of public health and human rights experts and representatives from affected communities, patients groups, and civil society. The body should have the authority to reject or modify patents that threaten to infringe the right to health and to condition the grant of a patent on ensuring affordability, such as through voluntary licensing or pre-negotiated prices. The Brazilian Health Surveillance Agency (ANVISA) represents a body with similar authority that may serve as a model.

Fifth, when public funds or public research are used by private producers to develop health technologies, States must ensure there is complete transparency and that all commercialization is contingent upon on ensuring access to people who need the technologies. This could entail a number of things, including publishing the terms of contracts between the State and private developers, ensuring all contracts explicitly provide for post-clinical trial access, and providing for public comment and participation in the development of public research agendas.

Solutions to ensure availability of health technologies

In order to satisfy the demands of the right to health, the global system of research and development must ensure health technologies are available to those who need them, without discrimination and with special attention paid to vulnerable or marginalized groups. Systems must be developed that promote innovation tailored to meet public health needs, particularly for neglected diseases and other conditions primarily affecting the poor. This requires States to act to overcome the primary obstacle to such innovation—market failure.

A treaty-based system of mandatory resource pooling and coordination for research and development of new health technologies founded on States’ obligations under the right to health presents one option toward this end. The UN Consultative Expert Working Group (CEWG) on Research and Development: Financing and Coordination has recommended that steps be taken to develop a global framework convention based on articles 19, 21, and 23 of the WHO Constitution under which global financial resources would be pooled and coordinated to promote research and development. Contributions would be mandatory and based on States’ ability to pay, as negotiated under the terms of a treaty. The CEWG proposes the framework not to replace the current global intellectual property system, but to function as a “supplementary instrument”; however, the framework could be the primary mechanism for research and development of health technologies for neglected diseases and conditions primarily affecting the poor. Given the WHO’s global remit and role as standard setter, it is best situated to take on the role of coordinator. However, in accordance with the right to health, the framework must establish a central role for affected communities, patients groups, and civil society in all its processes.

It is not sufficient, however, only to overcome market failure. The design of the global system for research and development must also ensure the affordability of new health technologies pursuant to States’ obligations under the right to health. As discussed, the current incentive system based on intellectual property rights and patents results in prohibitively high prices for new technologies, due to producers’ ability to exclude competition and charge monopolist prices. In order to both overcome market failure and ensure affordability, States should increase investments in alternative incentive models based on three principles: (1) delinkage (2) open innovation, and (3) licensing for access. This can be done unilaterally by individual States and through the targeted use of funds pooled and coordinated under the treaty-based system discussed above.

Each principle serves a specific function in either reducing the price of new health technologies or promoting development of technologies that meet public health needs. Delinkage disconnects the price of new technologies from investments in their research and development in order to ensure they are affordable. Open innovation facilitates the sharing of critical technical expertise, manufacturing know-how, and other information essential to developing safe and effective health technologies. Licensing for access, through voluntary and compulsory licenses, allows producers, including generic manufacturers, to make use of existing patents to create new products, therapeutic combinations, or reformulations, and to sell existing patented products at lower prices. Alternative development models in use now, including prize funds, open laboratories, and advanced market commitments, make use of some or all of these principles.

Bibliography and References 

World Intellectual Property Organization, “What is Intellectual Property?”, WIPO Publication No. 450(E)
http://www.wipo.int/edocs/pubdocs/en/intproperty/450/wipo_pub_450.pdf.

TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, THE LEGAL TEXTS: THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS 320 (1999), 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994).

MSF, Untangling the Web of Antiretroviral Price Reductions, 17th Edition, 2014.

GFinder, Neglected Disease Research and Development: The Ebola Effect, GFinder 2015 annual report, Policy Cure, 2015. Available at http://www.policycures.org/downloads/Y8%20GFINDER%20full%20report%20web.pdf.

International Federation of Pharmaceutical Manufacturers and Associations, The Pharmaceutical Industry and Global Health: Facts and Figures 2014. 2014. Available at http://www.ifpma.org/fileadmin/content/Publication/2014/IFPMA_-_Facts_And_Figures_2014.pdf.

UN General Assembly, Universal Declaration of Human Rights, 10 December 1948, 217 A (III); Constitution of the World Health Organization. Geneva: World Health Organization; 1948; UN General Assembly, International Covenant on Economic, Social and Cultural Rights, 16 December 1966, United Nations, Treaty Series, vol. 993, p. 3; UN General Assembly, Convention on the Elimination of All Forms of Discrimination Against Women, 18 December 1979, United Nations, Treaty Series, vol. 1249, p. 13; UN General Assembly, Convention on the Rights of the Child, 20 November 1989, United Nations, Treaty Series, vol. 1577, p. 3.

Constitute Project. Available at https://www.constituteproject.org/search?lang=en&key=health.

UN Committee on Economic, Social and Cultural Rights, General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12 of the Covenant), 11 August 2000, E/C.12/2000/4.

A/67/302, Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Anand Grover, 13 August 2012. Available at https://documents-dds-ny.un.org/doc/UNDOC/GEN/N12/461/01/PDF/N1246101.pdf?OpenElement.

Patents (Amendment) Act, 2005 (Act No. 15 of 2005) of India.

Homepage, Brazilian Health Surveillance Agency,http://portal.anvisa.gov.br/wps/portal/anvisa-ingles/anvisaingles.

WHO, Research and Development to Meet Health Needs in Developing Countries:
Strengthening global financing and coordination, Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination, WHO, Geneva, 2012.

Faunce, Thomas Alured, and Hitoshi Nasu. "Three Proposals for Rewarding Novel Health Technologies Benefiting People Living in Poverty. A Comparative Analysis of Prize Funds, Health Impact Funds and a Cost-Effectiveness/Competitive Tender Treaty." Public Health Ethics (2008): phn013.

Berndt, Ernst R., et al. "Advance market commitments for vaccines against neglected diseases: estimating costs and effectiveness." Health Economics 16.5 (2007): 491-512.

JORDAN JARVIS, The Lancet Youth Commission on Essential Medicines Policies

Lead Author: Jordan Jarvis
Additional Author: Other members of The Lancet Youth Commission on Essential Medicines Policies
Organization: The Lancet Youth Commission on Essential Medicines Policies
Country: USA

Abstract

The Lancet Youth Commission on Essential Medicines Policies (YCEMP) was convened in March 2015 to examine access and promotion policies for Essential Medicines worldwide through a youth lens. The Youth Commission is comprised of 17 young professionals from 15 different countries, representing every region in the world.

We believe medicines should be available to all who need them, for both individuals and societies to realize their full potential, and to realize the human right to health and the right to science and culture, as recognised in the United Nations International Covenant on Economic, Social and Cultural Rights. This makes sense from both a public health perspective, and an economic perspective.

To achieve this, scientific progress and knowledge should be acknowledged as global public goods. This has significant implications for the current intellectual property and trade system, which places a disproportionate emphasis on the rights of innovators. Although those who develop drugs should benefit from their work, this cannot be at the expense of human lives. We can no longer tolerate a situation wherein the majority of the world does not have the opportunity to benefit from these developments. Indeed, the problems in the current systems restricting access to medicines, such as lack of affordability, will increasingly apply to all countries as costs of healthcare continue to rise dramatically, and new drugs are created.

In this submission, we outline specific recommendations for the High-Level Panel, and intergovernmental agencies. We recommend that:

1. An interagency task force on access to medicines be created to ensure policy coherence and improve access to medicines;
2. The task force develop indicators and monitor access to medicines in accordance with Sustainable Development Goal 3;
3. Global norms be devised to protect essential medicines within free trade agreements; and
4. Consolidation and coordination among UN agencies and disease-specific initiatives occur, to collect information around access to essential medicines.

Submission

Ensuring access to essential medicines is critical to reach Sustainable Development Goal (SDG) 3 calling for global action by Member States and stakeholders to achieve universal health care coverage, including “access to safe, effective, quality and affordable essential medicines and vaccines for all”. To ensure sustainable access to medicines, it is also necessary to focus on another target more relevant for the High-Level Panel on Access to Medicines (hereafter “HLP”): how to “promote research, development, innovation and increase access to medicines, vaccines, diagnostics and related health technologies to improve the health and wellbeing of all”.

This SDG target specifically states that this should be done in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) regarding flexibilities such as compulsory licensing and parallel importation to protect public health. Although we agree that this should occur, we would also urge the HLP not to be constrained by existing agreements and practices, and to consider novel solutions that might replace TRIPS.

RECOMMENDATION 1
Creation of an interagency task force on access to medicines to ensure policy coherence and improve access to medicines across all disease areas

YCEMP submits that concerns around innovation and access to essential medicines have been addressed to varying degrees across policy fora, typically directed towards specific disease areas such as HIV/AIDS, maternal and child health, or noncommunicable diseases (NCDs), and that this model could be replicated in achieving improved access to medicines more broadly.

For example, in 1996, the UN established the Joint United Nations Programme on HIV/AIDS (UNAIDS) to strengthen coordination across countries and intergovernmental agencies to address the HIV/AIDS crisis. Though its operations have not been without criticism, many would argue that UNAIDS has played a pivotal role in improving access to HIV treatment. In 2015, the target of providing 15 million people with treatment was reached - the first time in history that a treatment target has been reached by the deadline (UNAIDS, 2015).

In acknowledging that HIV/AIDS is a cross-cutting issue that impacts sectors outside of just health, UNAIDS took a multisectoral approach towards innovation and access to treatment. More recently, the UN Interagency Taskforce on the Prevention and Control of NCDs was formed to similarly assemble diverse actors from across the UN system to support the realization of government commitments the 2011 UN High-level Political Declaration on NCDs. How this taskforce will support the WHO goal to reach 80% availability of affordable essential medicines and technologies to treat NCDs in the public and private sector remains unclear. One of the objectives of the taskforce, however, is to address national capacity for R&D for the prevention and control of NCDs. Yet, concerted efforts must be made to link these efforts to broader discussions on R&D and access to medicines across other vertical disease programs and processes (WHO, 2014).

Discussions around health, trade, and intellectual property with regards to access to medicines illustrate that this is not only a health problem, but entrenched in other domains. It is only through ensuring policy coherence between different processes and disease areas, with an appropriate focus on access to medicines, that improvements will be made.

We envisage that the three key functions of an interagency task force on access to medicines would be as follows:
1. Coordination of interactions between health, trade and intellectual property organizations to ensure that access to medicines remains a priority in all activities;
2. Facilitation of a process to secure consensus around establishing a new and more equitable system protecting and balancing innovators’ and patients’ rights, which would ultimately replace TRIPS (and the current system of pharmaceutical patent protection); and
3. Provision of technical assistance to public research institutions to implement humanitarian licensing, as well as to educate researchers on their rights and moral obligation as innovators to ensure equitable access to innovations by the public.

Coordination between health, trade and IP organisations
An interagency task force would play a key role in ensuring that different policy processes in the fields of health, trade and intellectual property remain coherent, and do not actively undermine access to medicines, as has occurred too frequently in the past. An interagency task force would interact with other health, trade and IP organizations, such as the World Health Organization (WHO), the World Trade Organization (WTO), and the World Intellectual Property Organization (WIPO) as well as other UN agencies to maintain access to medicines as a priority goal of each of these organizations, and facilitate collaboration between these bodies to continually improve access to medicines. We do not propose to establish a new UN agency; this would be inefficient, and supplant existing agencies’ roles. Rather, an inter-agency task force would ensure coherence and collaboration between these agencies, and can assist in follow-up of the recommendations of the HLP.

This model has been used successfully in tackling other complex tasks, and we believe it could be replicated in the access to medicines space to improve coherence and facilitate agreement between stakeholders. Other settings in which this approach has been successful include:
- The interagency task force on noncommunicable diseases
- UNAIDS
- Every Woman Every Child initiative (within the office of the UN Secretary General)

Facilitation of new access to medicines consensus
It is the view of YCEMP that simply creating new mechanisms to promote the use of TRIPS flexibilities, or the enforcement of the Doha Declaration, will be insufficient to secure the system changes that are needed to make access to medicines genuinely equitable worldwide. Instead, an new system should be developed to replace the present TRIPS/pharmaceutical patents system that recognises the public importance of medicines, and better balances the rights of patients and consumers with those of innovators, for a number of reasons.

Firstly, pharmaceuticals have only recently become a key element of trade law, and indeed, have frequently been excluded from patent protection entirely in the past in certain countries. In the view of YCEMP, recent misconceptions that pharmaceutical patent protections are inevitable, and inseparable from trade law, undermine access to medicines and stymie discussions around implementation of a replacement system that could work more effectively for all stakeholders. TRIPS represented the first time that intellectual property was conceptualized as a trade issue (Dreyfuss, 2010). Until 1995, although many countries provided protection to pharmaceutical products, other countries had not, primarily on the basis that these products were too important to the welfare of their citizens (Dreyfuss, 2010). Indeed, in 1986 over fifty countries did not recognize patent protection for pharmaceuticals (So and Oh, 2011). Certain developing-country members of WTO, opposed to the inclusion of IP in trade agreements, were ultimately won over by concessions in other areas of manufacture, and bilateral trade pressure from the USA (Ottersen et al, 2014). YCEMP is of the view that TRIPS is now (incorrectly) seen as an entrenched institution from which pharmaceuticals cannot be removed, and stringent intellectual property protections for pharmaceuticals are also perceived as inarguable. This is simply untrue. TRIPS and its attendant requirements for reform of individual countries’ patent protections for pharmaceuticals do not adequately balance the needs and rights of innovators and patients, and there is no sufficiently compelling historical or public policy reason why this system in its current form need remain in place.

Secondly, TRIPS has proven to create an environment hostile to the realization of legitimate public health goals, despite repeated attempts to redress the present imbalance between innovator and patient rights. In the past, TRIPS flexibilities have infrequently been implemented by developing countries. Although these have started to be more aggressively utilized over recent years, such use is still “exceptional” (Ottersen, 2014). The Doha Declaration, too, does not appear to have provided developing countries with comfort that they would not be subject to penalties or trade sanctions for taking advantage of TRIPS flexibilities. Since 2006, use of compulsory licences has “diminished markedly”, and even where countries have strong incentives to utilize them, equally strong countervailing pressures exist not to utilize compulsory licences (Beall and Kuhn, 2012). Indeed, the Doha Declaration has been said to have “promoted only to a limited extent” the incorporation of TRIPS flexibilities into domestic law (Correa and Matthews, 2011). Repeated attempts have been made by WTO and other organizations, including WHO, to encourage countries to utilize the “Paragraph 6 System”, allowing for compulsory licences for certain pharmaceuticals to be issued in developing countries for production of medications for sale solely in countries with insufficient or no manufacturing capacity (Beall and Kuhn, 2012); this system has only been used once. In YCEMP’s view, the fact that these extraordinary, laudable efforts to improve the operation of TRIPS vis-a-vis consumers of medicines have only slightly redressed access problems, indicates that it is necessary for the present system to be entirely reexamined for change to occur at the required scale.

Thirdly, the TRIPS agreement has also been noted to have paved the way for intellectual property to become essential in trade agreements – not just those negotiated through the WTO – with the result that changes to national IP regimes are made not for health improvement, but to effectively pay for trade concessions, with the immediate effect of preventing access to medicines (Smith et. al., 2009). For countries with weak legal and economic infrastructures, the immediate benefits of increased trade “easily overshadow” the effects on increased IP protection on social welfare, which are more difficult to quantify (Dinwoodie and Dreyfuss, 145). Some have even noted that there is no clear evidence that costs incurred are compensated by “often volatile” trade advantages obtained in exchange for increases in IP protection (Smith et. al., 2009).

Finally, the inherent imbalance in TRIPS away from public health, and towards increased patent protection for pharmaceuticals, has raised the price of medicines in developing countries, putting the benefits of research out of reach for many. According to certain commentators, TRIPS “virtually assures” that diseases affecting the poor will be neglected (Dreyfuss, 2010). Moreover, as developing countries represent a small share of the world’s pharmaceutical market, the marginal added value of stronger patent protection in LMICs has been estimated to be small, and unlikely to outweigh access costs (El Said and Kapczynski, 2011). The promised direct benefits of TRIPS accession for LMICs, such as technology transfer and increased innovation, have also largely failed to materialise (Baker and Avafia, 2011).

It is for these reason that the Youth Commission believes that the current system needs to be revisited ab initio, rather than repeatedly modified in an attempt to improve access to medicines. Agreement must be reached on a new, fairer system of protections that more equally balance the rights of innovators with those of consumers of medicines, whilst minimising any chilling effect on research, development and distribution of those medicines.

An inter-agency task force could create a process bringing together all key stakeholders in the access to medicines space, with a view to securing consensus necessary to create a formal agreement (a treaty or otherwise) concerning access to medicines. It is only through a formal process involving all stakeholders – including the pharmaceutical industry – that a consensus can be reached that could translate into a corresponding unanimous vote at WTO to remove pharmaceutical patent protection from TRIPS altogether. Although we note that reaching consensus on a fair system that better balances rights would be challenging, and that it is difficult to predict what such an agreement would look like, it is the submission of the Youth Commission that this process is both necessary and overdue.

Provision of technical assistance to public research institutions
Public sector research institutions, such as universities and nonprofit research institutes, play a significant role in medical innovation. Such institutions have been estimated to have contributed to the discovery of as many as 21% of new drugs developed recently in the United States (Stevens et al, 2011). In the United States, the passage of Bayh-Dole Act (Public Law 96-517) allowed universities to file, own, and license the IP generated with government research funds. Many countries have since adopted similar practices (Cervantes, 2016). Universities have established "technology transfer offices" (TTOs) to transfer knowledge to the marketplace, by either by licensing a technology or facilitating methods for commercialization . However, there is a large diversity in the structure and organization of TTOs, both within and across countries (OECD, 2003). We are concerned that the licensing decisions made by TTOs may substantially undermine the sharing of research and other products developed in universities. This has implication on access to medicines because a lack of technical expertise, awareness of the diversity of licensing options, and asymmetrical power relations between researcher and licensing corporation may hinder the adoption and implementation of humanitarian licensing.

In its report, WHO Consultative Expert Working Group on Research and Development: Finance and Coordination (CEWG) highlighted the role of humanitarian licensing as a way to solve the issue of high prices due to monopoly by introducing licensing strategies to ensure these products become available in LMIC either through further sublicenses with generic companies, or else by requiring the private company to ensure affordable access (Chen et al. 2010). With a strong push from civil society and academia, some universities have already adopted similar policies in their TTOs. For example, the “Global Access License Principles” of University of British Columbia (Wasan et al., 2009) encourages licensee to ensure global access. The policy saw a success shortly after it was implemented, leading to an agreement for oral Amphotericin B, a novel agent against leishmaniasis developed by a university researcher, to be sold at lower price in developing countries. Similar example of licensing policies or guidelines can be found in other universities such as Emory University, University of Edinburgh, University of Oxford, University of Washington, the University College of London, and Boston University (Chen et al. 2010). There is, however, little data on universities outside the USA and Europe.

Patenting university research has been shown to facilitate the transfer of technology from university to industry, but also to delay systematically the publication of research findings and hinder the dissemination of scientific knowledge (Penin, 2010). There is also an increasing number and stacking of “upstream” patents for basic research results, accompanied with a high portion of exclusive licensing (Sterckx, 2009; Lemley, 2007) without consideration of ensuring access in the future. We are concerned that licensing decisions made by many public institutions and their researchers may not be fully informed, as a result of lack of knowledge on humanitarian licensing; moreover, at the current pace, many universities are lagging behind in terms of adopting such important practices in IP to facilitate local and global access.

The High-Level Panel has the opportunity to lead globally and to set international norms that will influence the landscape and culture of research institutions towards equitable access. We therefore call for the establishment of a working group, as part of the interagency task force on access to medicines, which could serve the following functions:
1. Provide technical support to TTOs, and share best practices, for humanitarian licensing if patented discoveries and/or other licensing approaches that prioritise access to the end product globally
2. Leading a process establishing international norms whereby the success of research teams is not merely based on numbers of patents obtained, but rather, the accessibility and effectiveness of innovations, , especially within LMICs.

RECOMMENDATION 2
Functions of the interagency task force on access to medicines to include selecting measurable indicators and working with relevant stakeholders to create an Essential Medicines Scorecard to monitor access to essential medicines

An interagency task force could have an important role in determining the indicators and data required for monitoring of access to medicines under the SDGs. While the Millennium Development Goals (MDGs) incorporated access to medicines as a necessary precondition to achieving certain targets, and then later became a target itself as part of MDG 8, the monitoring of progress around access to medicines received little political attention, especially in comparison to other targets. The SDG agenda provides a renewed opportunity to better address access to medicines by setting specific indicators for measurement on access for SDG targets 3.8 and 3.9. To ensure progress towards these targets, there must be better measurement of access indicators across countries, but also greater accountability of all relevant stakeholders - particularly at the national level. The interagency task force should collect regular reports and data from UN Member States on policies and progress, which should be made publicly available through a WHO-hosted essential medicines data repository (see Recommendation 4).

As part of this regular data collection, YCEMP recommends that an “Essential Medicines Scorecard” be developed, to monitor the implementation and impact of national essential medicines lists (NEMLs) on access to medicines locally. YCEMP envisages that the interagency task force would convene relevant stakeholders to devise the Scorecard, and assist WHO in collecting relevant data from Member States.

Essential Medicines Scorecard: an accountability tool
A national essential medicines list (NEML) should describe medicines deemed essential for the population and serve as a guide for “procurement and supply of medicines in the public sector, schemes that reimburse medicine costs, medicine donations, and local medicine production” (WHO, 2016). NEMLs can also be used as an advocacy tool to improve availability and accessibility of essential medicines (Hill et al, 2012). Research across various countries has demonstrated that, when medicines are included in NEMLs, they are more frequently available than non-essential medicines (Bazargani et al, 2014) and are often more affordable than those which are not on NEMLs (Twagirumuzika et al, 2010). One reason for this is because inclusion on NEMLs can prompt governments or other purchasing bodies to take action to obtain lower prices. For example, after implementation of a NEML in Palestine in an effort to contain costs, average medicine prices declined, along with utilization (Hamidi et al, 2008).

95% of developing countries have published NEMLs, and 86% of these have been updated in the past five years (WHO, 2010). Although a number of these countries employ an evidence-based drug selection process (Pharasi and Miot, 2013), in many countries the process and criteria for selection onto NEMLs are unclear due to a lack of transparent reporting. How NEMLs are determined, as well as who determines these, have a great impact on people’s health, so transparency is vital for accountability. Moreover, the current paucity of data on availability and accessibility of medicines restricts the monitoring and evaluation of country progress. However, increased investment in research in this area, and consolidation of national data on essential medicines in a WHO repository, would also allow for future evaluation of country progress utilizing the Availability, Accessibility, Acceptability and Quality (AAAQ) framework in accordance with a right-to-health approach.

For the above reasons, we suggest that an Essential Medicines Scorecard be developed by the proposed interagency task force, in collaboration with relevant stakeholders, as an accountability tool. The Scorecard might evaluate the following areas:
1. Monitoring the impact of NEMLs on essential medicines through:
a. Use of the NEMLs to ensure affordability, accessibility, acceptability and quality of medicines (especially in improving economic accessibility through lowering out-of-pocket medicine expenditures)
b. Removal of regulatory barriers and implementation of mechanisms for fast-tracking of essential medicines as priority goods, which may involve recognition of WHO prequalification
c. Availability of NEMLs and clinical guidelines for use in all health care facilities and by all health care providers
d. Effect of NEMLs in lowering public and out-of-pocket medicine expenditures

2. Monitoring the process by which Member States develop and maintain NEMLs
a. Occurrence of periodic, evidence-based revisions to select essential medicines for NEMLs
b. Application of clear and transparent criteria and procedures for NEML selection and revisions, including standard operating procedures, public participation, and public reporting of selection outcomes and justifications
c. A national drug policy framework supporting the EML and its implementation

A periodic review of each state’s scorecard would allow for public evaluation and comparison of countries’ progress towards realizing access to affordable essential medicines. YCEMP recommends that the proposed UN interagency task force be involved in the development of the Scorecard, but that an external body that is not governed by Member States undertake administration and implementation of the Scorecard.

RECOMMENDATION 3
Development of global norms to protect essential medicines within free trade agreements.
through trilateral cooperation between the World Health Organization, World Trade Organization, and World Intellectual Property Organization

High income countries have dominated shaping the implementation of TRIPS and its flexibilities across both countries and regions, through free trade agreements. Most notably, the U.S.has adopted a method of “forum shifting” in pursuing its IP agenda, thereby increasing the odds of successful negotiation by not limiting its efforts to an international arena (Sell 2011). Through this approach, governments voluntarily concede to expand IP protection in ways that restrict access to affordable medicines, in exchange for market access. With each FTA’s IP provisions becoming the baseline for the next agreement, the U.S. has been largely successful in pursuing an increasingly stronger IP rights agenda for medicines (Lopert & Gleeson, 2013).

Methods used for expanding IP protection in free trade agreements include provisions that enable “evergreening”, whereby minor modifications, such as new doses or delivery mechanisms, can result in new patents being granted over existing medications without any proof of increased clinical efficacy, extending monopoly protection by up to 20 years (Collier, 2013). Another IP provision commonly pursued in FTAs is requiring periods of ‘data exclusivity’ for biologic drugs, with terms lasting beyond the typical 20-year patent period. Data exclusivity prohibits drug companies from citing the patent holder's clinical trial data when seeking a marketing license from regulators (Reichman, 2009). In practice, this would mean that if a generics manufacturer wished to receive approval for a generic version of a medicine before the expiration of data exclusivity, they would need to conduct their own clinical trials - something that would be in contravention of the Helsinki Declaration (World Medical Association, 2001). These methods of seeking expanded pharmaceutical IP protections, however, are not exclusive to FTAs.

Since the early 2000s, multinational pharmaceutical companies have sought to influence high income countries’ IP agenda by serving in key advisory positions to trade ministers while other low- and middle-income countries may have more limited technical expertise in these same areas inhibiting their ability to create a counter agenda that would uphold TRIPS flexibilities (Lopert & Gleeson 2013). Additionally, public access to negotiating texts have become progressively more restricted, and agreements have provisions that bar release of the finalized text until two to four years after adoption (ref). For example, the recently signed Trans-Pacific Partnership (TPP) negotiations have been criticized for its lack of transparency. Civil society had no access to the negotiating text, while concurrently, the U.S. Trade Representative (USTR) has solicited input from industry both formally through its Trade Advisory Committee (Love et al. 2011) and informally through direct requests for input to negotiating text [REF].

It has become imperative that all stakeholders come together to develop a more balanced and inclusive approach to IP rights trade agreement negotiations, specifically in regard to access to medicines. The recently developed multilateral body of the WTO, WHO, and World Intellectual Property Organization (WIPO) Trilateral Cooperation is an ideal forum to bring together stakeholders to develop best practices in IP rights provisions coherent with already established WTO rules and resolutions passed through the WHO and WIPO (WIPO 2014).The body was formed in 2008 to pool together expertise to study pricing and procurement practices of medicines and increase inter-organizational cooperation (WIPO 2014).

Multilateral organizations have also been concerned about the impact of the FTAs in undermining their role (Blanco 2013). In July 2013, the Trilateral Cooperation published a report, with contributions from both civil society and industry, in response to an increasing demand “for strengthened capacity for informed policy-making in areas of intersection between health, trade, and IP, focusing on access to and innovation of medicines and other medical technologies” (WIPO, WHO, WTO 2013). The report also acknowledges the intensifying “need for cooperation and coherence at the international level”. Finally, middle income countries with large generics markets have been active in passing legislation to modify their patent system to protect public health. In October 2013, the South African Department of Trade and Industries launched its much-anticipated Draft National Policy on Intellectual Property, which includes recommendations to reform South African patent law to allow for the use of TRIPS flexibilities (Daniels, 2013).

Thus, the time is ripe for the Trilateral Cooperation, with its established networks of both state and non-state actors, to convene stakeholders to draft a best practices template for IP provisions in FTAs.

The creation and adoption of model language around intellectual property and pharmaceutical products will allow for a norm-setting process in which essential medicines are protected within these agreements. Such adoption will also prevent forum-shifting and ratcheting up of intellectual property rights by developed countries and industry creating a form of “soft law” for Member States to look to for guidance.

We acknowledge that the process will be lengthy and difficult, given the requirement of resolutions at each of the three multilateral organizations, as well as influence from powerful vested interests in developed countries.However, there is resounding support at the national and regional level from civil society and international organizations to put forth such recommendations. Such model language, however, will only have true effect if adopted by Member States through their legislative processes.

Accordingly, YCEMP recommends that best practice guidelines for intellectual property and pharmaceutical products within Free Trade Agreements should be created by the WHO/WTO/WIPO trilateral cooperation mechanism, and that countries should utilize these guidelines to draft model language, and adopt and implement legislation to realize the protection of essential medicines within Free Trade Agreements.

RECOMMENDATION 4
Consolidation and coordination among UN agencies to collect information around access to essential medicines

As alluded to in the second recommendation, we propose that WHO host a comprehensive and transparent essential medicines data repository. Member States should be encouraged, through incentive structures, to submit regular reports on their progress toward the access to medicines indicators set by the UN interagency task force and other stakeholders on access to medicines. The UN interagency task force should facilitate technical assistance and take steps to mobilize resources to assist Member States in collecting and evaluating data on national progress toward universal and equitable access to medicines. Additionally, the interagency task force should support WHO in consolidating relevant data from diverse UN agencies, global procurement agencies and donors and hold actor accountable to meet the SDGs.

This data should include standard operating procedures and processes for the selection of essential medicines (via National Essential Medicines Lists); steps taken and progress on making medicines on the NEML available, affordable, accessible and of high quality within the country; concrete steps taken toward Universal Health Coverage; and the submission of public data on essential medicines availability, accessibility and affordability (using evidence-based tools, such as the WHO/Health Action International Survey Methodology).

Bibliography and References

Baker, B and Afavia, T (2011), The Evolution of IPRs from Humble Beginnings to the Modern Day TRIPS-Plus Era: Implications for Treatment Access. Working Paper prepared for the Third Meeting of the Technical Advisory Group of the Global Commission on HIV and the Law, 7-9 July 2011.

Bazargani, Y. T., Ewen, M., de Boer, A., Leufkens, H. G., & Mantel-Teeuwisse, A. K. (2014). Essential medicines are more available than other medicines around the globe. PLoS One, 9(2), e87576.

Beall and Kuhn, R (2012), Trends in Compulsory Licensing of Pharmaceuticals Since the Doha Declaration: A Database Analysis. PLoS Med, 9(1):e1001154.

Blanco, H. (2013, March 21). Blanco: Free Trade Agreements are Rendering WTO Rules Obsolete, THISDAY LIVE. Retrieved from http://www.thisdaylive.com/articles/blanco-free-trade-agreements-are-rendering-wto-rules-obsolete/14275/

Cervantes M. (undated), Academic Patenting: How universities and public research organizations are using their intellectual property to boost research and spur innovative start-ups. Available at: http://www.wipo.int/sme/en/documents/academic_patenting.html.

Chen, C., Gilliland, C., Purcell, J. and Kishore, S. (2010). The Silent Epidemic of Exclusive University Licensing Policies on Compounds for Neglected Diseases and Beyond. PLoS Negl Trop Dis, 4(3), p.e570.

Collier, R (2013), Drug patents: the evergreening problem. Canadian Medical Association Journal, 185(9):E385–E386.

Correa, C and Matthews, D (2011), The Doha Declaration Ten Years on and Its Impact on Access to Medicines and the Right to Health. UNDP: New York, USA.

Daniels, L. (2013), New Draft South African IP Policy Receives Initial Positive Reactions | Intellectual Property Watch. Intellectual Property Watch. Available from: http://www.ip-watch.org/2013/09/09/new-south-african-ip-policy-receives-initial-positive-reactions/

Dinwoodie, G and Dreyfuss, R (2012), A Neofederalist Vision of TRIPS: The Resilience of the International Intellectual Property Regime. Oxford University Press, UK.

Dreyfuss, R (2010), “TRIPS and essential medicines: must one size fit all? Making the WTO responsive to the global health crisis” in Pogge, Rimmer and Rubenstein, Incentives for Global Public Health: Patent Law and Access to Essential Medicines. Cambridge University Press, UK.

El Said, M., and Kapczynski, A., (2011), Access to medicines: The role of intellectual property law and policy. Working Paper prepared for the Third Meeting of the Technical Advisory Group of the Global Commission on HIV and the Law, 7-9 July 2011.

Hamidi, S., Younis, M. Z.,Forgione, D. A., & Hartmann, M. (2009). Rational use effects of implementing an essential medicines list in West Bank, Palestinian Territories. Expert review of pharmacoeconomics & outcomes research, 9(3), 243-250.

Hill, S., Yang, A., & Bero, L. (2012). Priority medicines for maternal and child health: a global survey of national essential medicines lists. PloS one, 7(5), e38055.

Lemley, M. (2007). Are universities patent trolls? Stanford Public Law Working Paper. Fordham
Intellectual Property, Media & Entertainment Law Journal, 18, 611. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=980776

Lopert, R. and Gleeson, D. (2013), The High Price of “Free” Trade: U.S. Trade Agreements and Access to Medicines. The Journal of Law, Medicine & Ethics, 41: 199–223.

Love, J., et al (2011, March 22), Complaint about the Trans-Pacific Partnership Agreement Negotiation to Anand Grover, Special Rapporteur for the United Nations on the right of everyone to the enjoyment of the highest attainable standard of health. Available from: http://keionline.org/sites/default/files/r2h_anand_grover_tpp_22march2011.pdf

OECD (2003). Turning Science into Business : Patenting and Licensing at Public Research Organisations.

Ottersen et. al. (2014), The political origins of health inequity: prospects for change. Lancet, 383(9917):630.

Penin, J. (2010). On the Consequences of Patenting University Research: Lessons from a Survey of French Academic Inventors. Industry & Innovation, 17(5), pp.445-468.

Pharasi B, Miot J. Medicines Selection and Procurement in South Africa. S Afr Health Rev
2013;117-85

Reichman, K (2009), Rethinking the role of clinical trial data in international intellectual property law: The case for a public goods approach. Marquette Intellectual Property Law Review, 13(1):1-68.

Smith, R, Correa, C, and Oh, C (2009), Trade, TRIPS and Pharmaceuticals. Lancet, 373:684-91.

Stevens, A et al (2011), The Role of Public-Sector Research in the Discovery of Drugs and Vaccines. New England Journal of Medicine, 364:535-541. Available from: http://www.nejm.org/doi/full/10.1056/NEJMsa1008268?viewType=Print

Sterckx, S. (2009). Patenting and Licensing of University Research: Promoting Innovation or Undermining Academic Values?. Sci Eng Ethics, 17(1), pp.45-64.

Twagirumukiza, M., Annemans, L., Kips, J. G., Bienvenu, E., & Van Bortel, L. M. (2010). Prices of antihypertensive medicines in sub‐Saharan Africa and alignment to WHO’s model list of essential medicines. Tropical Medicine & International Health, 15(3), 350-361.

Wasan, K., Thornton, S., Bell, I., Goulding, R., Gretes, M., Gray, A., Hancock, R. and Campbell, B. (2009). The Global Access Initiative at the University of British Columbia (UBC): Availability of UBC Discoveries and Technologies to the Developing World. Journal of Pharmaceutical Sciences, 98(3), pp.791-794.

World Health Organization (2014). Terms of Reference for the UN Interagency Task Force on the Prevention and Control of Noncommunicable Diseases. Available at: http://www.who.int/nmh/ncd-task-force/un-tf.PDF?ua=1

WIPO, WHO and WTO (2013), Promoting Access to Medical Technologies and Innovation - Intersections between public health, intellectual property and trade. Available from: http://www.wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf

World Medical Association. (2001). World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects.Bulletin of the World Health Organization, 79(4), 373.

James Love and Judit Rius, KNOWLEDGE ECOLOGY INTERNATIONAL

Lead Author: James Love
Additional Author: Judit Rius
Organization: Knowledge Ecology International and Médecins Sans Frontières
Country: USA

*The This submission is endorsed by the following organizations: Coalition Plus; Commons Network; European Public Health Alliance (EPHA); Health Action International (HAI); Innovarte; Knowledge Ecology International (KEI); KEI Europe; Misión Salud; Salud y Fármacos; Stop AIDS; Treatment Action Campaign; Union for Affordable Cancer Treatment (UACT); Young Professionals Chronic Disease Network (YP-CDN)

This submission is endorsed by the following members of the European Parliament: Julia Reda, Sergio Cofferati, and Ska Kellern 

Abstract

High prices are the disease that kills policy coherence, and de-linkage is the cure. To implement de-linkage globally, there is a need for practical steps to address cross-border obligations to ensure robust and sustainable funding for R&D.

We propose the UN initiate a Member State-led process to negotiate one or more global agreement(s) on the funding, coordination and performance of biomedical research and development (R&D) to promote innovation and access to medicines, vaccines, diagnostics, and medical devices (‘health technologies’) for all health needs.

The agreement(s) would establish mechanisms to ensure sustainable funding of biomedical R&D, including in areas of unmet need, in a manner that is consistent with commitments to the human right to health and the Sustainable Development Goals (SDGs), including the need to provide universal, equitable, and affordable access to medicines for all, and the ambition to achieve universal health coverage.

The goal is to create a pathway for Member States to collectively improve global, regional, and national R&D outcomes by progressively de-linking the cost of R&D from product prices, and not relying on high prices and monopolies to pay for innovation.

This contribution recognizes and complements or builds upon previous recommendations on the need for norms to coordinate and improve the biomedical R&D system, but is flexible on how Member States and other R&D stakeholders fund and conduct biomedical R&D, and the form of the final agreement(s), while fulfilling the objective of implementing progressive reforms to ensure that biomedical R&D outcomes are consistent with the human right to health and SDGs.

This contribution should be considered in combination with other contributions dealing with the need to address existing intellectual property barriers to ensure affordable access to health technologies under the current biomedical R&D system.

Submission

Introduction – The need for change

The current system, including the use of research grants, subsidies, and intellectual property rights to fund and create incentives to invest in R&D, has had success in bringing a number of health technologies to market, and many of those innovations are important. However, access to innovations is limited during the period when a monopoly is granted, leading to the rationing of medical care and causing death and suffering for millions of people. Even when access is achieved, the costs of the monopolies created under the current system are high and increasing at an alarming rate, as populations are aging in both the developing and the developed world.

Access and health outcomes are unequal, and mechanisms to induce R&D investments predictably conflict with and violate human rights as well as a plethora of norms regarding universal access and fairness.

It is well known that the grant of temporary monopolies is a poor mechanism to stimulate R&D for some diseases and medical innovations, and also other types of research not easily monetized by the grant of a monopoly. Examples of such market failures include inadequate investment and/or perverse incentives for:

Research that advances basic knowledge;
Development of new and rational uses of generic products;
Identification and reporting of adverse effects of medicines;
Development of products that are most useful when used sparingly, such as antibiotics;
Development of products that treat illnesses primarily affecting poor people, such as new drugs for neglected tropical diseases;
Development of low-cost and interoperable point-of-care diagnostics;
Sharing the knowledge, materials and technologies necessary for successful product development; and
Developing vaccines and diagnostics for emerging infections, such as Ebola and Zika.

(The appalling lack of transparency in the current markets for medicines is addressed in more detail in a separate contribution).

The current global trade framework has a laser focus on creating new and expanding existing intellectual property privileges for pharmaceutical companies, and does not provide the tools to support robust funding of the research grants and subsidies critical to the advancement of science or the development of products in many areas.

Governments need to continue to develop new approaches to fund R&D that will expand access, address inefficiencies and research gaps, and improve cost effectiveness and affordability of products, including the progressive implementation of policies that de-link R&D costs from product prices. A number of proposals to do so have been made over the past fifteen years, but there has been a lack of leadership in moving such negotiations forward. In some cases, the negotiations have divided countries or limited ambitions in ways that have delayed the recognition that new approaches to funding R&D are needed globally, leaving a system that leads to huge inequality in achieving the right to health and SDGs.

The proposal

We ask the UN Secretary General to initiate a process for Member States to negotiate one or more global agreement(s) on the funding, coordination, and performance of biomedical research and development (R&D) to promote innovation and access to medicines, vaccines, diagnostics, and medical devices (‘health technologies’).

The goal is to create a pathway for Member States to improve global, regional, and national R&D outcomes coherent with the principles of access to medicines for all, and with States’ and other actors’ obligations and responsibilities under human rights law, by progressively de-linking R&D costs from product prices.

Recognizing and complementing or building on previous recommendations on the need for global norms to coordinate and improve the biomedical R&D system, this contribution is flexible on how Member States fund and conduct biomedical R&D and the form of the final agreement, while fulfilling the objective of progressively implementing reforms needed to ensure that the mechanisms to fund R&D are coherent with access to medicine objectives and human rights obligations.

To do so, governments must have the ability to ensure, expand, and introduce sustainable and robust funding of R&D, without relying upon high prices for products. While traditional intellectual property-based incentives may remain through the medium term, the goal is to progressively eliminate the reliance on monopolies and the associated high prices to support funding for R&D.

The process and negotiations can build upon the on-going efforts at the World Health Organization (WHO) and other forums to identify new approaches to fund and coordinate R&D, but can also provide a broader mandate and a fresh context.

For more than fifteen years, the WHO has been engaged in discussions over new approaches to funding and coordinating R&D. Many of those initiatives have focused on research targets that primarily affect low-income persons living in low-income countries, with a particular focus on infectious and tropical neglected diseases. These initiatives are important and laudable, but have not gone far enough and have not addressed the access and affordability challenges for other products that have important societal impact, such as drugs for cancer, rare diseases, and broad categories of non-communicable diseases. Negotiators from high-income countries have unfortunately perceived these initiatives as wealth transfers from high-income to lower income countries with little relevance to their own countries’ health needs. Such perceptions limit the ambition and impact of negotiations in ways that are harmful to health, including in developing countries, which are also facing challenges dealing with cancer and non-communicable diseases, and which aspire to provide treatments for rare diseases. The more comprehensive and universal the research targets, the greater the benefits for all patients, and the higher likelihood such agreements will be perceived as an alternative to the strategy of higher product prices. Indeed, efforts at the WHO and other forums to support new models for the development of products to address antimicrobial resistance illustrate the possibility that coalitions that include governments can in fact embrace new efforts to cooperate on R&D funding, including endorsements of de-linkage.

The suggestions presented in this contribution are an example of a practical approach that can be followed. There are also other variations or approaches that would achieve positive results.

A. Core norms for a public health-driven R&D system

Biomedical R&D efforts and initiatives should be coherent with the right to health and the SDGs. We endorse the following norms and principles, developed jointly with others:

R&D Funding

The agreement should ensure sustainable and robust funding for biomedical R&D, including sufficient funding for areas of priority.

Priority-setting

The agreement should provide mechanisms for identifying unmet needs and areas of priority for biomedical R&D.

Affordability, equity and progressive de-linkage

The agreement should support efforts to make health technologies universally affordable and available. The mechanisms to fund R&D should be progressively de-linked from product prices.

Access to knowledge and openness

The agreement should encourage and, when appropriate, require open sharing of data, scientific, and technological knowledge. Openness of data and cooperation and/or collaboration among R&D funders, researchers, and other stakeholders should be promoted to increase rapid progress and efficiency as well as ensure responsible and ethically sound conduct in research activities and outputs.

Transparency

The agreement should encourage, facilitate, and progressively mandate transparency of all aspects of the biomedical R&D system and the market for products including, for example, clinical trial costs; medical outcomes and patient level data sets from clinical trials and reporting of post-approval patient outcomes; patent status information; terms and conditions of licensing agreements; manufacturing costs; product prices and sales; government funding and subsidies (including grants, tax credits, etc.); and other information that is critical for evaluating and designing appropriate policies.

Governance

Governments and institutions engaged in R&D processes should operate in a transparent manner and provide the means and mechanisms for the public to have meaningful access to information and the ability to participate to ensure full accountability.

B. Basic elements of a global R&D agreement

There are a variety of potential elements that could be part of a global agreement(s) on biomedical R&D. The basic elements of a biomedical R&D agreement could include:

A transparent process to identify medical R&D needs and priorities;
Global and country-specific targets for both overall levels and priority R&D spending;
Guiding norms for a public-health driven R&D system;
Norms and procedures for transparency, reporting obligations, and evaluation procedures;
Norms and procedures to address technology transfer and access to know-how, for example, to facilitate more cost-effective procurement of biologic drugs and vaccines, and drugs with small client populations, and open sharing of data and knowledge; and
Various incentives for governments to join the agreement.

Governments could also have flexibility in progressively meeting several of the elements of the agreement and being provided with options on how to meet the commitments. For example, the source of funding for R&D can be left to member countries. Governments already pay for R&D through a variety of sources, including high prices on patented drugs, public funding, and subsidies. Some countries may want to implement policies that lower product prices and use the savings to fund R&D through grants and/or innovation inducement prizes. In these cases, there is no need for increased taxes, and on the contrary, there is an opportunity for cost savings. In other cases, a government may have to increase levels of spending on R&D. The government would have the freedom to increase funding through a variety of mechanisms, including through general or special tax revenues or innovative financing mechanisms.

C. Progressive implementation of de-linkage

A key objective of this agreement is for the reform of R&D funding mechanisms to progressively implement the principle of de-linkage so that the costs of research and development of new health technologies are not linked to (i.e. financed by) high product prices.

We can define de-linkage in the negative, by saying that the R&D funding should not be tied to the price of the product.

R&D incentives and funding mechanisms that involve granting or extending a product monopoly to charge high prices are not de-linkage mechanisms.

There are multiple and complementary mechanisms to fund R&D, many of which are already in place, that can meet the de-linkage criteria if appropriately designed. The problem is that currently not only are these mechanisms typically implemented without regard to affordability of products, but on the contrary, high prices are seen as the primary reward and incentive for product development.

Direct grants and contracts (such as NIH or EU Framework grants, for example) and R&D subsidies (such as orphan drug tax credits) can be expanded and reformed so that products are put on the market at lower and eventually affordable generic prices. Incentive mechanisms that now rely on the granting of product monopolies and high prices (patents, test data monopolies, orphan drug exclusivity, etc.), can be progressively replaced with new incentives including, most importantly, cash innovation inducement prizes or prize funds.

There can be confusion or ambiguity about the role of patents and other intellectual property in a de-linkage system. Research grants, contracts, and innovation inducement prizes can be implemented with or without patents, as patents can be managed with or without the subsequent creation of monopolies. For example, patents could be used to establish a claim on prize revenues, when the prize is provided as a substitute for the monopoly, rather than as a complement, an approach proposed by Senator Bernie Sanders in the United States.

Progressive de-linkage means that governments implement reforms over time that sequentially and progressively move prices closer and closer to affordable generic prices, and reform incentives so they no longer rely upon high prices.

D. Form of agreement(s)

The proposal for one or more global R&D agreement(s) can take a variety of forms, and can evolve over time, with different forms for different elements.

Some have called for a framework agreement, either modelled loosely on the WHO Framework Convention on Tobacco Control, or the proposed Framework Convention on Global Health to achieve universal health coverage. In 2012, the WHO CEWG report recommended for Member States to start negotiating a global R&D convention and provided specific recommendations on the potential elements, including binding government R&D funding targets. The 2005 Medical Research and Development Treaty proposal provided for specific targets for national obligations to fund R&D, mechanisms to induce funding in areas of priority, greater openness of research, and a mechanism to eliminate relevant TRIPS dispute resolution between members of the treaty when governments satisfied the funding norms. There have been numerous proposals by governments, NGOs, experts, and academics that are mentioned in the bibliography and which will not be described here, due to length constraints.

The UN can consider the merits of building upon existing efforts and proposals, many of which are relevant and reference de-linkage as an objective, make some modification or remix, or propose something completely new, so long as the strategy follows the guiding principles described above. What is important is not only to begin or reinvigorate negotiations on R&D funding, but to be explicit that one objective is to strengthen the mechanisms that can facilitate the progressive de-linkage of R&D funding from product prices, and make it clear that some elements will not only increase innovation and expand access, but will lower and not increase healthcare costs, making it even more compelling for governments to engage.

E. Enforceability

The primary rationale to join and implement such an agreement is to collaboratively reform and eventually replace a dysfunctional set of global norms for funding R&D through high prices with a more flexible and less expensive approach that expands rather than restricts access to medicines. To the extent that global norms on R&D funding through means other than high prices address a more comprehensive set of diseases, conditions and medical research needs, these reforms become even more compelling, particularly as governments everywhere are confronted with uncomfortable tradeoffs between access and innovation under the current system. That said, the negotiations may also want to consider and address other incentives for governments to join and implement the elements of the agreement or agreements. Some proposals for additional incentives have been controversial, such as, for example, preferred access to grants and R&D rewards for researchers and entities located in countries that are members of the agreement, and reduced obligations regarding either product pricing or intellectual property enforcement. It may be important to reflect upon the need for and nature of incentives that are necessary and appropriate to induce participation.

The enforceability of the agreement will depend upon a variety of factors, including the degree to which the agreement is perceived as useful and welfare-enhancing, and the consequences under the agreement for non-performance in terms of the norms.

There are other options to make adherence to the norms more binding and enforceable. For example, in many cases, there are so-called binding agreements that in practice are weak on enforceability on their own, such as various WIPO or human rights treaties. However, when WIPO treaties are included as an obligation in trade agreements, and made subject to dispute resolution, they become more enforceable.

We further note there is a proposal, described in a separate contribution, to create a schedule for the supply of public goods in the WTO, which could allow commitments in an R&D agreement to become subject to WTO dispute resolution.

We note that international agreements dealing with climate change have been undertaken outside of trade agreement frameworks.

The extent to which agreements are in practice enforceable is not only a legal matter. When there is a consensus among governments that certain policies or norms are collectively in everyone’s best interest, the informal pressures to conform can be quite consequential, and, indeed, one can argue that many of the most important outcomes of intellectual property rules are decisions made in response to non-legal expectations rather than the binding legal norms.

Impact on policy coherence

The full implementation of de-linkage to fund and incentivize biomedical innovation is the most straightforward way to bring policy coherence to the areas of law and policy that this high-level panel has been asked to resolve. High prices are the disease that kills policy coherence, and delinkage is the cure. To implement de-linkage globally, there is a need for practical steps to address cross-border obligations to ensure robust and sustainable funding for R&D.

Impact on public health

The two key aspects of the proposal that impact public health are to make R&D funding robust and sustainable, including in areas of priority, and to expand access to products.

De-linkage, which is to be progressively implemented, is the only policy that is consistent with the goal of universal access and the elimination of price-based rationing of drugs. Delinkage is also the best outcome for low-income persons.

Impact on human rights

The Universal Declaration of Human Rights safeguards the human right to health, and has been consistently interpreted to include universal access to medicines. The SDGs encapsulate these commitments under SDG 3, through commitments to universal health coverage, specifically innovation and access to medicines, vaccines and other health technologies.

Current measures to incentivize innovation, which are coupled with higher drug prices, fundamentally obstruct the realization of these basic rights. This is not limited merely to the poorest countries, but especially applies to middle-income countries, where 75 percent of all people living in poverty reside, and to high-income countries, where increasing inequality is both a cause and consequence of the current innovation system, and where there are increasing access barriers and rationing of high-priced medicine.

States are fundamentally unable to meet core responsibilities to satisfy the human right to health, and are implementing policies, laws and practices that deny enjoyment of the right to health. States also operate within a framework of international trade rules that hinder people’s enjoyment of the right to health. Progressive realization of the right to health will require not only re-examining and addressing the shortcomings of existing rules, but also introducing ways to promote R&D and access to health technologies.

Implementation

The need for global and coordinated priority-setting for biomedical R&D, and for some pooling of R&D funding, has growing support, at least for areas where market failure is clear. Incentives that de-link the cost of R&D from prices are being implemented and/or considered not only for neglected diseases, but also to promote innovation for global priorities like antibiotics.

There are several initiatives that are trying to improve the current biomedical R&D system, including ongoing negotiations at the World Health Organization about the implementation of the 2008 Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, the recommendations of the 2012 CEWG Report, the proposed WHO Blueprint for R&D to accelerate the development of new vaccines and treatments for emerging infectious diseases with epidemic potential, as well as the different initiatives being considered to globally coordinate and increase biomedical R&D for antibiotics and vaccines.

Yet these initiatives are partial because they mostly address the needs of developing countries, or only address particular issues such as regulatory strategies to accelerate drug approval or because they mostly deal with a specific subset of diseases or a specific health technology. The ongoing WHO discussions are being led by representatives of Health Ministries, not heads of state, and have difficulties generating the financial resources and political commitment needed.

The UN High-Level Panel has the unprecedented opportunity to start THE process to change the global normative framework that underpins the biomedical R&D system, bringing coherence to the different processes and elevating the decision-making process to a Head-of-State level. It can ensure that there is robust and sustainable funding for R&D, irrespective of drug prices, while also ensuring access and affordability of medicines. Ultimately it will require the recognition that the progressive realization of the right to health requires the progressive implementation of delinkage, backed by high-level political leadership.

Bibliography and References

Report by the Commission on Health Research for Development. Health research: Essential link to equity in development (1990). Available: http://www.cohred.org/downloads/open_arc hive/ComReports_0.pdf

United Nations Framework Convention on Climate Change (UNFCCC 1992). Available: http://unfccc.int/2860.php

Fatal imbalance: the crisis in research and development for drugs for neglected diseases (2001). Drugs for Neglected Diseases Working Group, MSF. Available: https://www.msfaccess.org/our-work/neglected-diseases/article/958

Report of the WHO Commission on Macroeconomics and Health. Investing in health for economic development (2001). Available: http://apps.who.int/iris/bitstream/10665/42435/1/924154550X.pdf

Trouiller P, Olliaro P, Torreele E, Orbinski J, Laing R, et al. (2002) Drug development for neglected diseases: A deficient market and a public-health policy failure. Lancet 359: 2188–2194. Available: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(02)09096-7/fulltext

United Kingdom Commission on Intellectual Property Rights (CIPR) (2002) Integrating intellectual property rights and development policy. Available: http://www.iprcommission.org/graphic/doc uments/final_report.htm

WHO Framework Convention on Tobacco Control (WHO FCTC 2003). Available: http://www.who.int/fctc/about/en

Love J, Hubbard T. (2004) A New Trade Framework for Global Healthcare R&D. PLOS Biology. 2(2): e52. Available: http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.0020052

Medical Research and Development Treaty Proposal (February 2005). Available: http://www.cptech.org/workingdrafts/rndtreaty.html

Dentico N, Ford N (2005) The Courage to Change the Rules: A Proposal for an Essential Health R&D Treaty. PLoS Med 2(2): e14. doi:10.1371/journal.pmed.0020014. Available: http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020014

Request from 162 scientists, public health experts, law professors, economists, Nobel laureates, government officials, members of parliament, NGOs and others asking the WHO Executive Board and the CIPIH to evaluate a proposal for new global medical R&D treaty (2005). Available: http://www.who.int/intellectualproperty/submissions/CPTech.pdf

Report of the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) (2006). Available: http://www.who.int/intellectualproperty/ report/en/index.htm

Faunce T (2006). Toward a Multilateral Treaty on Safety and Cost Effectiveness of Medicines and Medical Devices. WHO Public Hearing on Public Health, Innovation and Intellectual Property. Available: http://globalizationandhealth.biomedcentral.com/articles/10.1186/1744-8603-2-5

Nathan C (2007). Aligning pharmaceutical innovation with medical need. Nature, Vol 13, 304 - 308. Available: http://www.nature.com/nm/journal/v13/n3/full/nm0307-304.html

Ashiya M, Jindal A (2007). Medical Research and Development Treaty: A New R&D Framework, Icfai Journal of Systems Management, Vol. 5, No. 1, pp. 23-31.

WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (2008). World Health Assembly Resolution WHA 61.21. Available: http://www.who.int/gb/ebwha/pdf_files/A6 1/A61_R21-en.pdf.

Proposal for WHO Discussions on a Biomedical R&D Treaty (2009). Submission by governments of Bangladesh, Barbados, Bolivia and Suriname to WHO EWG process. Available: http://www.who.int/phi/Bangladesh_Barbados_Bolivia_Suriname_R_DTreaty.pdf

An Essential Health and Biomedical R&D Treaty (2011). Submission to the WHO CEWG process by Health Action International Global, Initiative for Health & Equity in Society, Knowledge Ecology International, Médecins Sans Frontières, Third World Network (TWN). Available: http://www.who.int/phi/news/phi_1_joint_submission_en.pdf

Report by the WHO Consultative Expert Working Group on Research and Development Financing and Coordination (CEWG) (2012). Research and development to meet health needs in developing countries: Strengthening global financing and coordination. Available: http://www.who.int/phi/cewg_report/en/index.html

Stiglitz J E. (2012). A breakthrough opportunity for global health. Project Syndicate. Available: http://www.project-syndicate.org/commentary/a-breakthrough-opportunity-for-global-health

Moon S, ’t Hoen E. (2012). Medicines for the world: a global R&D treaty could boost innovation and improve the health of the world’s poor – and rich. Scientist; 26. Available: http://www.the-scientist.com/?articles.view/articleNo/32664/title/Medicines%20for%20the%20World

How a global R&D convention could fill the gaps left by today’s medical innovation system. MSF (2012). Available: http://www.msfaccess.org/sites/default/files/MSF_assets/Innovation/Docs/MedInno_Briefing_GlobalConventionRD_ENG_2012Update.pdf

Dickson D. (2012). We need a global treaty on health research for the poor. Available: http://www.scidev.net/en/health/editorials/we-need-a-global-treaty-on-health-research-for-the-poor-1.html

Balasegaram M, Bréchot C, Farrar J, Heymann D, Ganguly N, Khor M, et al. (2015) A Global Biomedical R&D Fund and Mechanism for Innovations of Public Health Importance. PLoS Med 12(5): e1001831. doi:10.1371/journal.pmed.1001831. Available: http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001831

Report from the Chatham House Working Group on New Antibiotic Business Models (2015). Towards a New Global Business Model for Antibiotics: Delinking Revenues from Sales. Available: https://www.chathamhouse.org/publication/towards-new-global-business-model-antibiotics-delinking-revenues-sales

Report by the O’Neill AMR Review (2015): Ensuring new drugs for future generations: the pipeline of antibiotics. Available: http://amr-review.org/sites/default/files/SECURING%20NEW%20DRUGS%20FOR%20FUTURE%20GENERATIONS%20FINAL%20WEB_0.pdf

Jorge Roque, DIFERENCA REAL

Lead Author: Jorge Roque
Organization: Diferenca Real
Country: Portugal

Abstract

Dear Madame Sirs

I am very glad for UN dedicates so much importance to this crucial aspect for our age.

My name is Jorge Roque, from Portugal, lawyer in Human Rights, activist in the Drugs Reform field,even more known for my fight for the Decriminalization of Drugs Use and the collaboration with several international organizations as Encod, or INPUD director, I have being dedicating the majority of my energy analyzing and studying the Pharma control over the international drugs policy.
Somehow I was placed on the first line of this "war", because I started to be contacted by some of the big Pharma Labs to help them entering in Portugal, not by humanitary principles, but because they were trying to use the Drugs Decriminalization place for getting profit with a plant that couldnt be targeted in Patent, the cannabis. For my sad surprise, it was not the problems that illicit drugs produce in society, but in how to make money with it, their great objective. Also the NGOs started to receive much funds for fighting for Harm Reduction Industry, instead of Rights, so I realized that it will not be a "delicate" approach, that will get changes, only a strong posture from UN could produce effective results.

My first job was in the Pharma industry and I saw labs using Patents and sell an equal molecule five times more expensive, so I used these knowledge they gave me. Because the reality is that is not by the expensive costs for investigate a new, effective molecule, the reality is that the pharma industry got out of control and now is just in the hands of cold organizations that only use the argument Life to profit. Othewise a rational distribution of costs through hundreads of universities that are working in the same subject, would reduce at least 90 times the price.
So, we can not trust in an individual option of supporting alone the costs as an excuse for obtaining a super expensive medecine, because the only reason of that choice is to get the Patent and make a fortune alone.

Yes, all of this has to be done, well and it will be done, but the most important, the key for an effective change, it will be the Strategy!
30 years ago my bosses already had the "magical" words: - "its expensive, because millions are needed to get to an effective molecule".
We are never restricted by a legal convention that restricts the access to Life and denies the international cooperation for Peace written in the article 1 nº 3 of UN Chart and according my International Law professor, now Minister of Defense in Portugal (Azeredo Lopes) rules over all international conventions, especially the economics, where the Patent protection allows that the value material get over the value life. 
That is why I present a strategy of controling the Value of Image through a big Media Global Event about the real importance of a medecine with the UN Human Prizes and through a concentrations of all resources in the world to get time and to decrease costs.

A better new World

Jorge Roque

Submission

IMPACT ON POLICY COHERENCE: To what extent does the contribution reduce the incoherence in rules between rights of inventors, international human rights laws, trade rules, and public health objectives? Does it address systems-wide incoherence, or does it address a specific aspect?
It adress all aspects.

This question in formal therms, would be similar as to ask" how banks can offer more loans, by free? "
I mean there is too much money in Pharma industry, there are many material and human resources, but the problem is that there is no interest in reorganizing labs, resources, knowledge, universities, that could decrease the costs of investigation at least 80% and the time of reaching the molecule in more than 90%, but as now the objective is not to reduce the costs, but increase the price, it will never be possible to achieve better prices, if we keep the support to an exclusive profit industry. Also when each lab wants to make its own full research, for getting with the exclusivity of profit, the delay that all this individual policy produces, just makes to grow the demand.

So, when we need a medicine that all Humans can access, first we need to split Health from Business, Life from Greed!

IMPACT ON PUBLIC HEALTH: Explain how the expected results will improve access to health technologies. Explain the significance of the proposal in terms of incentivising innovation to address the health needs of all.

The concentration of all resources will make decrease the costs and time. The Image of being "an Human Star", or a Villan will split the business from the real health necessity and that will increase the search of low prices.

Also the reports that a New Independent Scientific Department from UN will have in defining what is a real necessity in health and priority and what is still not a certain because it is not better than the UN Placebo Test and/or it is not a real necessity, it has not the value, the degree of recognition as an important necessity for Humanity, it will allow that the Health Ministers save money on that product and to use it for other Health Urgent Necessities.

ADVANCING HUMAN RIGHTS: To what extent do the contributions incorporate and demonstrate the link to fundamental human rights and the right to health?

The global information changed so much the world, that the majority of countries dont even want to confront the situation, because if before it was easy a rich country to corrupt and explore any country, now all people react to any abuse if known and global information makes it known and the global knowledge woke up all persons in the globe about how they were explored by fake intentions, the access to medicines or the deny to it creates too much hate. The attempt to offer the access medicines at better prices to all, it will be seen as a great step for Human Kind.
True respect for Human Rights in all planet it is an huge advance!

IMPLEMENTATION: Describe the political, financial and institutional work that would need to be taken to bring the contribution to its expected results. Describe how your contribution advances sustainable health outcomes.
- In Court it will not be hard for a team of expert international lawyers to win, because the Conventions signed under the UN Principles has to obbey to the juridic spirit of the article 1,nº 3 (UN Chart), at least my international law professor (Azeredo Lopes) in many conversations we had about this subject, he always argue that the value Life could never be denied by the value Patrimony and he is now the Ministry of Defense, so the Pharma Labs will have to prove in Court that he is wrong and it will never be based on honesty and justice that the Patent protection will exist free for protect some and make others to suffer.

- Court - Expert Lawyers
Apply the article 1 nº 3 of UN (..international cooperation, solve economic, social problems...) and at least reduce to a few years (5,6) the monopoly of Patent exclusive protection.
This conflict if not "harmonized" will end destroying the Patent value and many countries are already deciding to copy all interesting molecules and the actual fragility of world social peace will not allow an economic restriction to China, India, Brazil, neither Islamic countries, that is why we have a position of: "better one bird in the hand of labs, that all pills at 5 cents"..., this forces UN to have a stronger position, but it will need a great courage and decision in advancing with it!

- Creation of 3 Departments:
1- Division what is Health what is Business- Cosmetic-Placebo?
- Independent Science of Human Life.
-Independent True Science vs Science Dependent of Profit.
Without that, all be useless, ruled without control from a group that will buy law, disease and cure.

2- What is a Human Priority Need and what is an Economic Individual Interest?
-Department of Joyning All Resources from all countries.
- The UN needs a strong true intention to change something, otherwise it will be just a cosmetic business in the hands of criminals that delay and make harder the solutions for health because to control the offer allows to control the demand, so to be player or to be an humanist- In Court it will not be hard for a team of expert international lawyers to win, because the Conventions signed under the UN Principles has to obbey to the juridic spirit of the article 1,nº 3 (UN Chart), at least my international law professor (Azeredo Lopes) in many conversations we had about this subject, he always argue that the value Life could never be denied by the value Patrimony and he is now the Ministry of Defense, so the Pharma Labs will have to prove in Court that he is wrong and it will never be based on honesty and justice that the Patent protection will exist free for protect some and make others to suffer.

3- Human Media Prizes.
The force to conquer such a difficult objective, confronting such a powerful industry could look like a distant uthopy, but if we attack the "Achille`s Heel", the effort is not so huge, so conflictive and with much more eficience could be achieved.
The Health Industry is based on the image of trust, without that people would look to it more and more as the Thalidomide sellers.
The solution for achieve a reorganization for decreasing the prices passes for the "Image Status".
Image of promoting the Human Heroes, or the Villans.
The better way is to create The UN Prizes a big event, a mix of Oscars more Nobel Prize, as the:
UN Best Human 2017! This year goes to dr. Smith creator of a cure to lung cancer. He will not need more than 1, 2 million dollars, because the "Oscar" has a social value of about 200 million dolars.
 

The most expensive medicine 2017. is Minumini from X Lab.
Next year this lab will not want win this "prize" again. Otherwise the Lab will suffer bad image and defined as Anti Humanity Organization.
Suffering the attack to the real" health utility" in other medicines belonging to this Pharma, about 30 to 40% of medicines have the same effect than a placebo, meaning that they are a nothing, just a cost.The risk of loosing the certain for the uncertain profit will open substancially the superior position that the disease business presents with the signed convention of economic patents.
The UN can develop a mark of Placebo, where the scientific studies, made by real scientists, neutral scientists, because nowadays science is ordered and payed to obtain a specific result. All medecines from not Human Friendly Labs would have all their products showed under the real effect compared with the UN Placebo.

* Countries as China, Brazil, India, Indonesia , Islamic countries will not keep being subservients to the west exclusive profit laws. Not even USA will start a war just for defending the money of a few unterprises, specialy because it costs much and would cost much more to their tax payers.
- Human Costs Organization -Analyzing the real global, true costs joyning Universities Investigation, Human Resources share.
The major problem that new discoveries could be obtained is exactly because, the objective of getting the exclusivity stops the share of knowledge and close faster methods if they can not guaratee a patent. The attempts to delay the investigation of other enterprises is current, so to use the price high costs is an attempt to true.

Determination and Defenition of what are Fundamental Medicines for the Human Race and those will be the medicines that will be target of UN priority,
- Giving more space for the Activists and groups that denounce the Human Rights and Health restrictions, it will allow that UN could moderate both extreme positions, but supporting the true global vision reaching all people.
- This Strategy that I present do not needs much more money, because it is about how to use much better the resources we already have.
The UN Prices could be expensive, but it could be supported by television, public health departments, artists that are open for Human Events and other independent donators.
- As last resource, it will need to be given the illicit drugs destribution to the Pharma industry, as they want and that could also solve the criminal drugs problem, but this will be a new debate.

* This Project can be Publicized

References and Bibliography

Charter of the United Nations.

Lisa Forman, DALLA LANA SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF TORONTO

Lead Author: Lisa Forman
Organization: Dalla Lana School of Public Health, University of Toronto
Country: Canada

Abstract

Access to medicines is the lynchpin to realizing a range of human rights, public health and development imperatives. However without strong policy action to increase access to affordable medicines, there is little hope of achieving the Sustainable Development Goals or of realizing the human right to health. Yet access to medicines is a fundamental element of the right to health, and the majority of states are bound by core obligations in this regard. Accordingly states must ensure that this critical human rights, public health and development interest is appropriately prioritized against inadequate resource allocations and competing private or trade interests. In this submission, I explore interpretations in international human rights law regarding state duties towards medicines. I argue that at least two clear duties emerge to support the High Level Panel’s recommendations: (1) the duty to prevent unreasonably high costs for medicines from denying large segments of the population their rights to health and (2) the core obligation to provide essential medicines. Consequently I explore three areas of action implied by these duties: (1) consistent implementation of human rights impact assessment; (2) institutionalizing TRIPS flexibilities in law and policy; (3) making permanent the waiver of TRIPS for least developed countries (LDC), and waiving the application of TRIPS to essential medicines in low and middle-income countries.

Submission

(1) Reducing policy incoherence between human rights and trade
Access to affordable medicine is the lynchpin to realizing a range of human rights, public health and development imperatives: This is why essential medicines are understood as a core obligation of states under the right to health (United Nations 2000); why medicines are recognized as a fundamental building block of health care systems capable of providing universal health coverage (World Health Organization 2010); and why medicines features prominently within Sustainable Development Goal (SDG) 3 on health (United Nations 2015). Yet “essential medicines remain unaffordable and insufficiently available in developing countries” (MDG Gap Task Force 2015, p53). While generic medicine policies are broadly recognized as a key policy intervention to control health budgets and make medicines more affordable (WHO, WIPO and WTO 2012, p156), the policy space that countries have to provide affordable medicines is bound sometimes wholesale by trade rules around intellectual property rights.

The introduction of the Agreement on Trade-Related Intellectual Property Rights (TRIPS) in 1995 conferred unprecedented exclusive rights to pharmaceutical patent holders. The monopolistic pricing that resulted saw sometimes dramatic increases in drug prices, as in Malaysia where drug prices increased by 28 per cent per year between 1996 and 2005 (Smith et al 2009, p689). The use of flexibilities in TRIPS is an important mechanism to ensure that high prices resulting from exclusive patenting rights do not negatively impact public health imperatives. Yet their use continues to attract litigation, drug removals, trade sanctions and economic and diplomatic pressures. At the same time, TRIPS flexibilities are limited and eradicated in free trade agreements, and the global movement of generic medicines through international borders are obstructed under measures to eradicate counterfeit medicines. Global access to affordable medicines is under more not less threat and without for effective action at the international level it is unlikely that the SDGs on health or indeed the right to health will be realized.

Which countries are affected by conflicts between human rights and trade treaties?
The majority of states globally hold duties under the right to health and trade-related intellectual property rights. For example, the International Covenant on Economic, Social and Cultural Rights (ICESCR) had been ratified by 164 states as of 25 February 2016 – approximately two thirds of all states globally (United Nations Treaty Collection 2016). At the same time, 162 states globally are members of the WTO (WTO 2016a). The overlaps between these domains are extensive: at least 133 states that have ratified the ICESCR are also members of the WTO. Yet the overlap is far greater than these figures suggest: WTO members that have not ratified the ICESCR will certainly be bound by health rights in article 24.1 of the Convention on the Rights of the Child, which with 196 ratifications has an effective universality (applicable in almost country save for the USA), albeit that its rights and duties only apply to children. Irrespective of the precise figures the conclusion is clear: most states globally must balance right to health duties with trade-related intellectual property duties, and this has practical implications for how decision-makers at various levels should interpret and implement these duties.

Applying a principle of systemic integration to assure respect for human rights
The imperative to balance duties under competing international legal regimes is addressed in a 2006 International Law Commission (ILC) report exploring the problems created by fragmented legal regimes in international law (ILC 2006). The report emphasizes that no specialized regime, including the WTO, operates outside of international law (ILC 2006, para. 13.a). The report argues for application of the principle of systemic integration so as to link functional areas to a deeper normative idea in international law, so that the “common good of humankind [is] not reducible to the good of any particular institution or regime” (ILC 2006, para. 480, emphasis added). The report argues that two specific areas of international law offer support in this regard: first, the hierarchically superior norms within international law (such as jus cogens/peremptory norms and obligations ergo omnes/duties owed to all), and second, the Vienna Convention on the Law of Treaties (VCLT) which offers customary rules for international treaty interpretation.

I have previously explored the implications of both areas of international law for balancing right to health duties with trade-related intellectual property rights (see Forman 2011). For the purposes of this submission I will restrict my observations to the following:

(1) While current definitions of international law’s hierarchically superior norms (such as peremptory norms and obligations ergo omnes) do not specify the right to health, they do collectively prohibit gross violations of any rights (including health), and place reasonable limits on all human conduct (including trade) to protect human health and life. In any event, access to medicines is explicitly demarcated as a core obligation under the right to health, and this should elevate access to medicines into a hierarchically superior norm within international human rights law. The priority of a right to medicines does not suggest that it automatically ‘trumps’ competing interests. However the prioritized nature of this right provides an important governing principle for the type of balancing mechanisms between public and private interests that the High Level Panel (HLP) should propose accordingly.

(2) The right to health offers an important framework for interpreting intellectual property rights contained in TRIPS and other multilateral and bilateral agreements. That such treaties should be interpreted in this fashion is supported by article 31 of the VCLT, which specifies that treaties must be interpreted in good faith according to the ordinary meaning of treaty terms in their context and in the light of a treaty’s object and purpose (article 31.1). Adjudicators can ascertain treaty context, inter alia from “any relevant rules of international law applicable between the parties” (article 31.3.c). Article 31.3.c thus supports using ICESCR as a relevant rule of international law applicable between state parties in interpreting trade-related intellectual property rights. As such, article 31.3.c is the clearest textual avenue within international law for ensuring ‘systemic integration’ between human rights and trade rules when adjudicative bodies (including the HLP) assess potential conflicts.

(2) International human rights law and access to medicines

International human rights law is increasingly explicit regarding the human rights duties imposed on states by medicines, essential or otherwise, and their implications for other legal duties.

Access to medicines as a core obligation under the right to health
The right to health in article 12 of the ICESCR has been interpreted by the United Nations Committee on Economic, Social and Cultural Rights (CESCR) to place prioritized duties on states regarding essential medicines (United Nations 2000). In General Comment 14 on the Right to the Highest Attainable Standard of Physical and Mental Health, the Committee underscores the importance of state duties towards essential medicines in a number of domains:

First, the Committee indicates that the essential elements of the right to health include ensuring sufficient availability of functioning “public health and health-care facilities, goods and services” including “essential drugs, as defined by the WHO Action Programme on Essential Drugs” (United Nations 2000, para. 12.a).

Second, the Committee locates essential medicines within core obligations under the right to health. In General Comment 14, the Committee indicates that core obligations under the right to health include providing “essential drugs, as from time to time defined under the WHO Action Programme on Essential Drugs” (United Nations 2000, para. 43.d). The Committee is explicit about the significance of a core obligation: While all other duties under the ICESCR are subject to progressive realization within maximum available resources, “a State party cannot, under any circumstances whatsoever, justify its non-compliance with the core obligations set out in paragraph 43 above, which are nonderogable” (United Nations 2000, para. 47).

Whatever the strength of these duties, the implication holds that a state’s core obligations have a temporal and substantive priority over other human rights duties and indeed over duties under other legal regimes.

Balancing core obligations with other legal duties
These implications are made explicit in the Committee’s General Comment No. 17 (United Nations 2005). Here the Committee makes it clear that intellectual property rights are not to be confused with the human right to benefit from the protection of moral or material interests resulting from any scientific production protected in ICESCR article 15.1.c:

“In contrast to human rights, intellectual property rights are generally of a temporary nature, and can be revoked, licensed or assigned to someone else. While under most intellectual property systems, intellectual property rights, often with the exception of moral rights, may be allocated, limited in time and scope, traded, amended and even forfeited, human rights are timeless expressions of fundamental entitlements of the human person” (United Nations 2005, para. 2).

When it comes to balancing duties under other rights in the ICESCR, the CESCR is clear that “private interests of authors should not be unduly favoured and the public interest in enjoying broad access to their productions should be given due consideration” (United Nations 2005, para. 35). More concretely this means that states should ensure that their legal regimes to protect author’s interest “constitute no impediment to their ability to comply with their core obligations” including specifically those under the right to health (United Nations 2005, para. 35). The Committee goes on to emphasize that:

“Ultimately, intellectual property is a social product and has a social function. States parties thus have a duty to prevent unreasonably high costs for access to essential medicines … from undermining the rights of large segments of the population to health …” (United Nations 2005 para. 35, emphasis added).

I believe that this explicit interpretation of a state’s duties to balance core obligations to provide essential medicines and author’s rights provides a crucial foundation for the High Level Panel’s recommendations in this domain.

While CESCR general comments do not constitute binding law, they do constitute authoritative interpretations of the ICESCR. Moreover state consensus on the fundamental nature of duties towards medicines within the right to health is reflected in a series of UN General Assembly resolutions issued since 2001 recognizing that “access to medicines is one of the fundamental elements in achieving progressively the full realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” (United Nations 2013, para. 2; see also, United Nations 2009a, para. 1).

(3) Implementing right to health duties towards medicines

What are the concrete actions that should flow from core obligations to provide essential medicines and duties towards medicines more generally? The analysis above outlines at least two clear duties that should underpin the HLP’s considerations: (1) the duty to prevent unreasonably high costs for medicines from denying large segments of the population their rights to health; and (2) the core obligation to provide essential and other medicines. I suggest that these two duties are the foundation for at least three primary areas of action: (1) consistent implementation of human rights impact assessment (HRIA) before adopting law and policies affecting access to medicines; (2) institutionalizing TRIPS flexibilities in law and policy; and (3) making permanent the waiver of TRIPS for least developed countries (LDC) and waiving TRIPS for essential medicines in low and middle-income countries.

(1) Human rights impact assessment (HRIA)
State duties not to obstruct access to affordable medicines extend to when, how and whether they enter into legal regimes or agreements imposing intellectual property rights. There is very strong support for the contention that states should institutionalize the use of HRIA when entering into and implementing agreements on intellectual property rights:
• In General Comment 14 the Committee is explicit that it is a violation of the right to health to fail “to take into account its legal obligations regarding the right to health when entering into bilateral or multilateral agreements with other States, international organizations and other entities, such as multinational corporations” (United Nations 2000, para. 50).
• In General Comment 17 the Committee specifically argues that when entering agreements on intellectual property rights states should undertake human rights impact assessments before adopting and after implementing such legislation (United Nations 2005, para. 35).
• The Committee and two other treaty-monitoring committees have consistently called on countries to conduct assessments of the effect of international trade rules on the right to health and medicines (UNCESCR 2004, 2006, 2008; UNCEDAW 2006a, 2006b, 2007, UNCRC 2004).
• Olivier De Schutter, the former UN Special Rapporteur on the Right to Food, has argued that HRIA is in fact a human rights legal obligation and that all States should “prepare human rights impact assessment prior to the conclusion of trade and investment agreements” (United Nations 2011, p.5).

Gillian MacNaughton and I have developed an HRIA specifically focused on trade-related intellectual property rights and the right to health that provides a user-friendly framework for such assessments (Forman and MacNaughton forthcoming; see also Forman and MacNaughton 2014; MacNaughton and Forman 2014, and Forman 2012). An HRIA would provide clear evidence of how proposed intellectual property rights would impact drug affordability and access, allowing states to mitigate this impact in a number of ways (such as not adopting the rights and implementing measures to ensure affordability). HRIA are a practical and feasible way to ensure policy coherence between the right to health and intellectual property rights duties, and to ensure that population health is not unduly sacrificed to trade or commercial imperatives.

(2) Institutionalization of TRIPS flexibilities
There is very clear and explicit political support for using TRIPS flexibilities to advance access to affordable medicines:
• The Doha Declaration explicitly endorses the right of WTO members to protect public health and promote access to medicines for all, and to use TRIPS flexibilities to the full to do so (WTO 2001, para. 4).
• Numerous UN General Assembly resolutions urge states to promote access to medicines for all, including through using to the full, TRIPS flexibilities (see for example United Nations 2009b; 2013).
• SDG 3.8 calls on states to achieve universal health coverage that includes access to safe, effective, quality and affordable essential medicines and vaccines for all. SDG 3.b proposes an explicit means of implementation for this goal that states “provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all” (United Nations 2015).

This political consensus underscores the importance of TRIPS flexibilities in realizing the right to medicines not simply as a public health but human rights imperative. This interpretation is strongly supported by Anand Grover’s contention as UN Special Rapporteur on the Right to Health that states hold a right to health duty to use TRIPS flexibilities. Grover argued that duties to protect the right to health extend to ensuring “developing countries and LDCs should review their laws and policies and consider whether they have made full use of TRIPS flexibilities or included TRIPS-plus measures, and if necessary consider amending their laws and policies to make full use of the flexibilities” (United Nations 2009b, para. 97).

Recommendations: The High Level Panel should make strong explicit recommendations that explicitly specify the TRIPS flexibilities in question and that recommend:
(i) That states institutionalize the use of TRIPS flexibilities in domestic law and policy
(ii) That states consistently and effectively use these mechanisms to advance access to affordable medicines
(iii) That TRIPS flexibilities are protected from erosion in free trade and other agreements
(iv) That the imposition of TRIPS plus intellectual property rights that restrict TRIPS flexibilities violate the right to health

(3) Making permanent the LDC waiver from TRIPS and restricting the application of TRIPS to essential medicines in LMIC
TRIPS flexibilities are a necessary but insufficient solution to resolving the way that trade-related intellectual property rights contribute to restricting large segments of the population from accessing affordable medicines. In this regard the HLP could consider two interrelated mechanisms: a permanent waiver of TRIPS’s pharmaceutical patents to LDC and a permanent waiver of the application of TRIPS to essential medicines in low and middle-income countries.

TRIPS originally waived the application of TRIPS in toto to LDC until 2005 (TRIPS, article 66.1). This transition period has been extended twice after requests by the LDC Group, first to 2013 and then to 2021 (WTO 2016b). With regard to medicines, the Doha Declaration asked the TRIPS Council to extend the waiver for LDC to apply TRIPS to pharmaceuticals until 2016 (WTO 2001, para 7). The TRIPS Council approved this request. In November 2015 the TRIPS Council extended the transition period for pharmaceutical patents until 1 January 2033 or when a country ceases to be an LDC if that happens before 2033. The Council also waived obligations regarding mailbox applications and exclusive marketing rights that would otherwise apply to LDC (WTO 2015). This waiver applies only to LDC albeit that it extends to all pharmaceuticals. The 2012 UN Commission on HIV and the Law makes the more ambitious proposal that TRIPS is urgently suspended for essential medicines for low and middle-income countries while the UN Secretary General convenes a new body to recommend a new intellectual property regime for drugs (United Nations 2012, p86-7).

Recommendations: The UN Commission’s proposal underscores the appointment of the High-Level Panel, and should be adopted and expanded in the following ways:
(i) The HLP should recommend that the WTO waiver of TRIPS to LDC to 2021 and the waiver of TRIPS to pharmaceuticals in LDC to 2033 be made permanent.
(ii) The HLP should recommend that this waiver be extended to permanently suspend the application of TRIPS to essential medicines in low and middle-income countries generally.

(4) Potential public health impact and potential negative effects
Two related considerations should underpin the HLP’s considerations: First, expanding access to affordable medicines offers exponential population health benefits. This amplification effect is suggested by how the expansion of antiretrovirals in low and middle-income countries has resulted in significant reductions in AIDS-related morbidity and mortality and major improvements in AIDS prevention (UNAIDS 2015). Second, the proposals made in this submission pose little threat to the current system of innovation that drives the development of new medicines. This conclusion is strongly supported in the 2006 report of the WHO Commission on Intellectual Property, Innovation and Health which held that where “the market has very limited purchasing power, as is the case for diseases affecting millions of poor people in developing countries, patents are not a relevant factor or effective in stimulating R&D and bringing new products to market” (WHO 2006, p34).

Bibliography and References

Agreement on Trade-Related Aspects of Intellectual Property Rights. 1994. Annexure 1C to the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994.

Forman, Lisa. 2011. “An Elementary Consideration of Humanity? Linking Trade-Related Intellectual Property Rights to the Human Right to Health in International Law,” 14:2 Journal of World Intellectual Property 155–175.

Forman, Lisa. 2012. “From TRIPS-Plus to Rights-Plus? Exploring right to health impact assessment of trade-related intellectual property rights through the Thai experience,” (2012) 7:2 Asian Journal of WTO and International Health Law and Policy 347-375.

Forman, Lisa and MacNaughton, Gillian. 2014. “Moving Theory into Practice with Human Rights Impact Assessment of Trade-Related Intellectual Property Rights,” (2014) 7:1 Journal of Human Rights Practice 109-138.

Forman, Lisa and MacNaughton, Gillian. forthcoming. “Lessons Learned: A Framework Methodology for Health and Human Rights Impact Assessment of Intellectual Property Provisions in International Trade Agreements,” Impact Assessment and Project Appraisal.

International Law Commission. 2006. “Fragmentation of International Law: Difficulties Arising from the Diversification and Expansion of International Law: Report of the Study Group of the International Law Commission - Finalized By Martti Koskenniemi,” U.N. Doc. A/CN.4/L.682, 13 April 2006.

MacNaughton, Gillian and Forman, Lisa. 2014. “Human rights and health impact assessment of trade agreements/access to medicines: A Comparative Study of Thailand and Peru,” (2014) Journal of Human Rights 1-25.

Millennium Development Goal Gap Task Force (2014), “Millennium Development Goal 8:The State of the Global Partnership for Development. (United Nations, New York, 2014), p53. Accessed online at:
http://www.un.org/en/development/desa/policy/mdg_gap/mdg_gap2014/2014GAP_FULL_EN.pdf.

Smith, Richard D., Correa, Carlos and Oh, Cecilia. 2009. ‘Trade, TRIPS and Pharmaceuticals,’ Lancet 373.

UNAIDS. 2015. “AIDS by the numbers”, Geneva. Accessed online at:
http://www.unaids.org/sites/default/files/media_asset/AIDS_by_the_numbers_2015_en.pdf

United Nations. 1976. International Covenant on Economic, Social and Cultural Rights 26 December 1966, 993 U.N.T.S. 3, 6, I.L.M. 360 (1967) (entered into force 3 January 1976).

United Nations. 2009a. “Promotion and Protection of all human rights, civil, political, economic, social and cultural rights including the right to development – Resolution adopted by the Human Rights Council on Access to medicines in the context of everyone to the enjoyment of the highest attainable standard of physical and mental health,” UN Doc. A/HRC/RES/12/24, 2 October 2009.

United Nations. 2009b. “Promotion and Protection of all Human Rights, Civil, Political, Economic, Social and Cultural Rights, Including the Right to Development - Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Anand Grover*”, UN Doc. A/HRC/11/12 31 March 2009.

United Nations. 2011. Guiding principles on human rights impact assessments of trade and investment agreements. Report of the Special Rapporteur on the right to food, Geneva. UN Doc. A/HRC/19/59/Add.5.

United Nations. 2013. “Promotion and Protection of all human rights, civil, political, economic, social and cultural rights including the right to development – Resolution adopted by the Human Rights Council on Access to medicines in the context of everyone to the enjoyment of the highest attainable standard of physical and mental health,” UN Doc. A/HRC/23/L/10/Rev.1; 11 June 2013.

United Nations. 2015. “Transforming our world: the 2030 Agenda for Sustainable Development - Resolution adopted by the General Assembly on 25 September 2015.” UN Doc. A/RES/70/1, 21 October 2015.

United Nations Committee on Economic, Social, and Cultural Rights. 1991. “The nature of states parties obligations (art. 2, par. 1): CESCR General comment 3,” 14/12/90, Fifth session 1991.

United Nations Committee on Economic, Social, and Cultural Rights. 2000. General Comment No. 14: The Right to the Highest Attainable Standard of Health. UN Doc E/C.12/2000/4, 11 August 2000.

United Nations Committee on Economic, Social and Cultural Rights. 2004. “Concluding Observations of the Committee on Economic, Social and Cultural Rights: Ecuador,” UN Doc. E/C.12/1/Add.100, 7 June 2004.

United Nations Committee on Economic, Social, and Cultural Rights. 2005. “General Comment No. 17 on the right of everyone to benefit from the protection of the moral and material interest resulting from any scientific, literary or artistic production of which he or she is the author,” UN Doc. E/C.12/GC/17, 12 January 2006.

United Nations Committee on Economic, Social and Cultural Rights. 2006. “Concluding Observations of the Committee on Economic, Social and Cultural Rights: Morocco.”

United Nations Committee on Economic, Social and Cultural Rights. 2008. “Concluding Observations for Costa Rica,” U.N Doc. E/C.12/CRI/CO/4, 4 January 2008.

United Nations Committee on the Elimination of Discrimination against Women. 2006a. “Concluding comments of the Committee on the Elimination of Discrimination against Women: Guatemala,” UN Doc.CEDAW/C/GUA/CO/6, 2 June 2006.

United Nations Committee on the Elimination of Discrimination against Women. 2006b. “Concluding comments of the Committee on the Elimination of Discrimination against Women: Philippines,” UN Doc. CEDAW/C/PHI/CO/6, 25 August 2006.

United Nations Committee on the Elimination of Discrimination against Women. 2007. “Concluding comments of the Committee on the Elimination of Discrimination against Women: Colombia,” UN Doc. CEDAW/C/COL/C0/6, 2 February 2007.

United Nations Committee on the Rights of the Child. 2004. “Consideration of Reports Submitted by States Parties under Article 44 of the Convention - Concluding Observations: El Salvador,” UN Doc. CRC/C/15/Add.232, 4 June 2004.

United Nations Global Commission on HIV and the Law. 2012. “Risk, Rights and the Law,” July 2012. Accessed online at:
http://www.hivlawcommission.org/resources/report/FinalReport-Risks,Rights&Health-EN.pdf

United Nations Treaty Collection. 2016. “Ratifications of the International Covenant on economic, social and cultural rights.” Accessed online at: https://treaties.un.org/Pages/ViewDetails.aspx?src=TREATY&mtdsg_no=IV-3&chapter=4&lang=en

Vienna Convention on the Law of Treaties. 1980. 1155 U.N.T.S. 331, 8 I.L.M. 679, entered into force 27 January 1980.

World Health Organization. 2006. Public Health Innovation and Intellectual Property Rights: Report of the Commission on Intellectual Property Rights, Innovation, and Public Health, Geneva, p. 34.

World Health Organization. 2010. “Monitoring the building blocks of health systems: a handbook of indicators and their measurement strategies,” (Geneva: World Health Organization; 2010). Accessed online at:
http://www.who.int/healthinfo/systems/WHO_MBHSS_2010_full_web.pdf?ua=1

World Health Organization, World Intellectual Property Organization and World Trade Organization. 2012. “Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade.” Accessed online at:
https://www.wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf

World Trade Organization. 2001. Declaration on the TRIPS Agreement and Public Health. (Doha, 9-14 November 2001), WT/MIN(01)/DEC/2, 20 November 2001.

World Trade Organization. 2015. “Extension of the transition period under article 66.1 of the TRIPS Agreement for least developed country members for certain obligations with respect to pharmaceutical products - Decision of the Council for TRIPS of 6 November 2015,” IP/C/73, 6 November 2015.

World Trade Organization. 2016a. ‘Members and observers’, Accessed online at: https://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm

World Trade Organization. 2016b. ‘Responding to least developed countries’ special needs in intellectual property.” Accessed online at:
https://www.wto.org/english/tratop_e/trips_e/ldc_e.htm

William Fisher and Talha Syed, HARVARD LAW SCHOOL

Lead Author: William Fisher and Talha Syed
Organization: Harvard Law School
Country: USA

Abstract

We propose a novel regulatory system that would cause both a reduction of the prices charged by pharmaceutical firms for their existing drugs in developing countries and an increase in the firms’ investment in research and development aimed at creating new drugs for neglected diseases. The heart of our proposal is a requirement that each firm demonstrate compliance, annually, with a “social-responsibility index.” This index would consist of the ratio between (1) the total number of Disability Adjusted Life Years (DALYs) saved as a result of the consumption of the firm’s products during the year and (2) the firm’s global gross revenues during the year. The DALYs used to calculate firms’ ratios would be both tradeable and bankable. Over time, the mandatory ratio would be gradually increased, bringing the overall pattern of pharmaceutical research and sales into closer alignment with global social welfare. Our proposed system would have many advantages, including: capitalizing on the knowledge held by the scientists and executives of the pharmaceutical firms concerning which adjustments of their business practices would most efficiently contribute to alleviation of the global health crisis; rapid responses to the emergence of new technological opportunities or new disease threats; facilitation of reflection and debate concerning our collective moral obligations to address the plight of the global poor; and minimal expenditures of public resources. The principal drawback of the system – the heavy demand for accurate information that it would place upon the institution charged with its administration – could be mitigated through a combination of careful institutional design and augmented pharmacoeconomic research by universities and nongovernmental organizations. Adoption of this system would surely not be simple, but is politically and financially feasible and would address the health needs of the residents of developing countries effectively and efficiently.

Submission

Each year, infectious diseases cause approximately six million deaths in developing countries. Most of those deaths could be prevented if (a) existing vaccines and medicines aimed at infectious diseases were available at affordable prices in developing countries and (b) increased resources were devoted to creating and testing new vaccines and medicines aimed at the diseases in question. We propose a practicable and affordable regulatory system that would advance both of these goals simultaneously.

The system we advocate would work as follows: Each pharmaceutical firm would be required to achieve, each year, a ratio, which we call the social-responsibility index (SRI). The numerator of this index would be the total number of Disability Adjusted Life Years (DALYs) saved as a result of the distribution and consumption of the firm’s products during the year. The denominator would be a measure of the firm’s size, presumptively its global gross revenues during the year.

Such a requirement could be instituted worldwide in either of two ways. First, the U.S. Congress could adopt a statute instituting the requirement as a condition for the right to distribute pharmaceutical products in the United States. Because the U.S. market for drugs constitutes roughly 40% of the global market, few firms, regardless of where they are based, would refuse to comply. Most likely, Congress would delegate responsibility for implementing the system to an administrative agency – either the Food and Drug Administration or a new agency. Alternatively, a new multilateral treaty (or an amendment to an existing treaty) could authorize a global institution to impose such a requirement in all member countries. The most plausible candidate for this role would be the World Health Organization (WHO). Negotiation of the necessary treaty might be facilitated by the World Intellectual Property Organization (WIPO) – in much the way that WIPO recently facilitated the successful negotiation of the Marrakesh Treaty for the Visually Impaired.

The DALYs used to calculate the numerator of each firm’s index would be both tradeable and bankable. Thus, a firm that, in a given year, failed to earn enough DALYs to meet its target could purchase DALYs from a firm that had a surplus. For example, a firm specializing in so-called “lifestyle” products (such as erectile-dysfunction drugs, sales of which are lucrative but result in only modest health benefits) could buy DALYs from a firm specializing in vaccines or drugs efficacious in preventing or treating more serious diseases (such as malaria or dengue). Alternatively, a firm that, in a given year, earned more that enough DALYs to satisfy its obligations, instead of selling the surplus could apply it to the firm’s account for the following year.

Under this regime, each firm would decide how it could most efficiently comply with its obligation. A firm at risk of missing its target would have (at least) the following options:
1) It could reduce the prices charged in developing countries for drugs already in its portfolio, thereby increasing the number of persons able to afford the drugs and earning more DALYs.
2) It could alter the formulations of drugs already in its portfolio so that they could be distributed more easily in developing countries – for example, by making them more heat resistant and thus easier to distribute in areas without reliable “cold chains.”
3) It could increase its investment in research projects that promised to generate drugs with large health benefits (for example, an improved vaccine for tuberculosis or a better pediatric formulation for a particular AIDS drug).
4) It could alter its business-acquisition policies to purchase more small biotechnology companies that had developed products offering large health benefits (for example, one of the many small firms that are currently in the late stages of the development of vaccines for the Zaire strain of the Ebola virus or a similar firm beginning work on Zika).
5) It could collaborate with governments or NGOs in developing countries to improve the distribution systems for the firm’s drugs, thereby getting them into more mouths (for example, by providing financial and technical support for the networks of Community Health Workers already in place in several African and Latin American countries).
6) It could buy DALYs from other firms better positioned to improve public health in one of the ways sketched above.
7) Finally, it could reduce the prices of all of its products, thereby lowering the denominator of its ratio. (For obvious reasons, this is the option the firm is least likely to adopt.)
Some firms would pursue one of these paths exclusively; others would adopt a combination of the approaches. The net result is that more people in developing countries would be able to afford crucial medicines, and more research would be focused on serious diseases that currently get little attention.

The system would be introduced gradually. During the first year of its operation, the responsible administrative agency or global institution would estimate the total number of DALYs saved throughout the world during the preceding year as a result of the consumption of all pharmaceutical products, divide that number by an estimate of the global gross revenues of the pharmaceutical industry, and set the mandatory ratio slightly higher. The announcement of the ratio would prompt firms to begin trading DALYs, along the lines described above. Assuming the agency’s estimates were roughly accurate, the equilibrium price for DALYs during this first year would be very low. In each subsequent year, the agency would increase the ratio. The equilibrium price for DALYs would rise as a result, and the financial pressure on the pharmaceutical industry as a whole to redirect its aggregate energies toward improvements in global health would increase correspondingly.

A system of this sort would have many advantages. Most fundamentally, it would address simultaneously the “access problem” (the inability of poor countries and their residents to afford the drugs they need) and the “incentive problem” (the inadequacy of the financial motivations to develop new drugs for neglected diseases). Most reform proposals address only one of the two causes of the global health crisis and either leave the other dimension untouched or exacerbate it. By contrast, the social-responsibility index would lead to substantial gains on both fronts.

The second major advantage of the regime we propose is that it would capitalize on the informational advantages of the pharmaceutical firms. Their scientists and executives know better than government officials which of the seven paths enumerated above would generate, in a given year, the biggest health benefits for the least cost. By setting a target but not telling the firms how to hit it, our proposed regulatory regime would enable them to use that knowledge. The result would be increased efficiency in alleviation of the global health crisis.

Similar efficiency gains would result from the market in DALYs. The firms best positioned to improve global health would do so – relying partly on funds provided by firms less well situated.

The system we recommend would also prompt firms to respond rapidly both to scientific advances and to changes in the landscape of diseases. When scientific breakthroughs exposed new paths to the creation of efficacious drugs or when new diseases appeared (or old diseases suddenly became more virulent), the firms would alter course immediately. They would not need to wait for government officials to detect the changes and adjust accordingly the regulatory regime or the pattern of government subsidies for research.

Finally, the system would stimulate public discourse concerning the global health crisis as a whole. An indirect effect of the market for DALYs is that it would reveal the price that society as a whole places upon a year of healthy human life. Public discussion of the plight of the poor in developing countries is currently impeded by the difficulty of grasping the scale of the problem and the feasibility of solutions to it. By exposing, simply and accurately, the marginal cost of saving a year of someone’s healthy life, the system would facilitate reflection and debate concerning our collective moral obligations to do more – or less. That debate would help guide the institution that managed the system when determining whether (or how fast) to turn up the SRI dial. More broadly, it would strengthen the global moral community.

The principal disadvantage of our proposed system is that, to operate well, it would require a great deal of information. Some of the data necessary to implement it has already been developed for other purposes. For example, the World Health Organization already collects and publicizes annual mortality and morbidity data broken down by country and disease. And government agencies in Australia, Canada, France, Germany, New Zealand, Sweden, and the United Kingdom have already developed considerable data concerning the relative clinical effectiveness of the various drugs that target each of those diseases. Other data essential to the operation of the system could be provided by the pharmaceutical firms themselves. For example, to demonstrate achievement of the SRI, the firms could be obliged to submit, not just financial information necessary to calculate the denominators of their ratios, but also verified data concerning the distribution (and consumption) of each of their drugs during the preceding year. But, to run system accurately and fairly, the institution managing it would need to supplement these data with additional information. That would be difficult and costly, especially in the first year of its operation. This drawback could, however, be mitigated by asking universities (in particular, faculty in medical schools and schools of pharmacy) and other nongovernmental organizations, to augment their ongoing pharmacoeconomic evaluations of drugs. That such evaluations would not only have global social benefits (of the sorts we have outlined) but would also enhance the ability of individual doctors to prescribe the right treatments for their patients might also prompt foundations to fund increased research of this sort.

The version of the social-responsibility index outlined above is the most straightforward. But modified versions are readily imaginable. Some would advance our goals more precisely than the basic model; others might be more politically palatable. A few of them are described and assessed below.

(a) Safety Valves

One of the advantages of the SRI is that (unlike analogous systems currently used in some countries to curb air pollution) it would not expose either the regulated firms or society at large to serious risks caused by government officials misestimating social benefits and harms. As we have explained, during the first year of its operation, the system would require firms to achieve a ratio only slightly higher than the industry-wide ratio of DALYs saved to global revenues – the calculation of which would be time-consuming but not prone to serious error. In subsequent years, the mandatory ratio would be gradually increased, subjecting firms to slowly strengthening obligations. This incremental approach would pose little danger of forcing firms suddenly to make large – and potentially socially excessive – expenditures to meet their regulatory obligations. As a result, our proposed system would not need a “safety valve” of the sort commonly used to soften the impact of “cap-and-trade” systems for controlling greenhouse gases.

Adding such a valve to our system would, however, be simple. The institution administering the regime would offer to sell each year an unlimited number of (virtual) DALYs at a specified price – a price somewhat higher than the price at which the institution expected DALYs to trade on the private market. If the market price rose above this level, delinquent firms could and would purchase from the government the number of DALYs they needed to hit their targets.

There are two reasons why it might make sense to add this feature. First, the availability of the valve might reduce pharmaceutical firms’ opposition to the adoption of the regime. Second, a beneficial side-effect of the use of the valve would be to provide the responsible institution a source of money that it could use to fund (through grants or prizes) additional research on neglected diseases.

(b) Refining Measures of Health Impacts

In two ways, the mechanism we have outlined for measuring the health benefits secured through the distribution of drugs could be refined. First, the DALY metric, although widely and successfully used to measure health impacts, is imperfect. Because the incentives generated by our proposed system are tied to DALYs, the system would sometimes result in a pattern of pharmaceutical research and development that (although vastly better from the standpoint of social welfare than the current pattern) would fail to align exactly with our moral intuitions. This problem could be avoided (at some cost) by authorizing the institution charged with running the system to develop and apply a new metric that addressed the legitimate criticisms that some philosophers and public-health experts have directed at the DALY scale (for example, that it mistakenly assumes that the suffering caused by a given condition does not vary by country – that being blind in France is no more and no less burdensome than being blind in Ethiopia).

Second, the calculations used to determine the mandatory ratio for a given year could be adjusted to improve the distributional impact of the system. The regime we have outlined thus far employs a purely utilitarian criterion. It measures – and consequently would nudge the pharmaceutical industry toward maximization of – overall human welfare (measured by the values that people place on life and good health). Such an approach has the effect of giving equal weight to drugs designed to alleviate minor ailments that afflict large numbers of people and drugs designed to alleviate serious ailments that afflict small numbers of people. If we wished to tilt the pattern of incentives more toward serious ailments (as we currently do, clumsily, by creating special incentives for “orphan drugs”), we could adjust the way that the numerator of the SRI is calculated. For example, before multiplying the number of DALYs saved per person through the consumption of a given drug by the number of people to whom it had been administered, we could apply an exponential function to the number of DALYs saved per person (and then of course modify the mandatory ratio to maintain the overall pressure the system exerted on the industry). Such an adjustment would accommodate our moral intuition that, if the total misery caused by two diseases is equal, and they are equally susceptible to prevention or cure, more resources should be devoted to research aimed at the disease that causes acute pain to a few people than to the one that merely irritates many people.

(c) Offset Credits

Another possible adjustment of the regime would permit pharmaceutical firms to count, for the purposes of satisfying their obligations, benefits (for which they are responsible) other than those arising out of consumption of their products. To be sure, even the basic form of our model would accommodate a wide range of health benefits. For example, the administration of a vaccine to one person generates a benefit, not just to the person vaccinated, but also to everyone else with whom that person might come into contact. The resultant “positive externality” would certainly be included in the calculation of the DALYs saved through the administration of the vaccine.

But some kinds of health interventions would fall outside the model as we have described it thus far. Suppose, for example, that a pharmaceutical firm developed and deployed an improved technology for monitoring drugs in the distribution chain and thereby detecting (and enabling patients to avoid) counterfeits. The resultant increase in the consumption of authentic versions of the firm’s products would cause a rise in firm’s SRI. But, if the numerator of the fraction included only health benefits attributable to consumption of the firm’s products, the benefits accruing from the concomitant increase in the consumption of other firms’ products made possible by the new technology could not be counted by the innovator firm. Including such ancillary gains from innovations other than the creation of new drugs (analogous to the “offset credits” used in some “cap-and-trade” regulatory systems) would add to the complexity of our proposed regime, but would improve the pattern of incentives it sustained.

(d) Enlisting the Firms

A final possible variation on our plan is procedural, rather than substantive. Instead of imposing a regime of this sort upon reluctant pharmaceutical firms, it might be developed with their assistance and support. The major pharmaceutical firms are currently under considerable pressure to adjust their business practices to address the global health crisis. Some have already voluntarily initiated major programs designed to develop new vaccines and drugs or to lower the prices for their products in developing countries. They are hobbled, however, by the competitive nature of the industry. Under such circumstances, all of the firms could benefit from a regulatory regime that bound them all. Perhaps, recognizing this, the executives of the firms could be persuaded to help build and implement the system.

The obvious danger of this approach is “industry capture”; the resultant regime might serve the firms’ interests more than the interests of the public at large. But the histories of other industries confronting comparable challenges makes clear that, if the government officials participating in the planning process are vigilant, the public interest need not be sacrificed. (A reassuring example is provided by the automobile industry, where most major manufacturers helped craft – and now support – the recent sharp increase in the Corporate Average Fuel Economy standards in the United States.)

Adoption of such an approach would enhance the prospects of a treaty necessary to enable the World Health Organization (or a similar global agency) to implement the system. Many pharmaceutical firms are based in countries other than the United States. For various reasons, both symbolic and practical, they would likely prefer that such a regulatory regime be managed by an institution more attuned to their needs than the government of the United States. If so, their support would increase sharply the likelihood that a treaty giving the WHO the necessary authority could be negotiated in a reasonable period of time.

Bibliography and References

Our submission to the High-level Panel is a distillation of a proposal we advance in Chapter 6 of a forthcoming book: Infection: The Health Crisis in the Developing World and What We Should Do About It (Stanford University Press, forthcoming 2017). The current draft of the book, which includes a more detailed analysis of our proposal, is available at http://cyber.law.harvard.edu/people/tfisher/Infection.htm. The references for each portion of the book can be found at the end of the pertinent chapter. Set forth below is the set of references most germane to our submission to the Panel.

Adler, Matthew D. "QALYs and Policy Evaluation: A New Perspective." Yale Journal of Health Policy, Law and Ethics 6 (2006): 1.

Anand, Sudhir, and Kara Hanson. "Disability-Adjusted Life Years: A Critical Review." Journal of Health Economics 16 (1997): 685-702.

Anand, Sudhir, and Kara Swanson. "DALYs: Efficiency versus Equity." World Development 26, no. 2 (1998): 307-10.

Arnesan, T., and E. Nord. "The Value of DALY Life: Problems with the Ethics and Validity of Disability Adjusted Life Years." British Medical Journal 319 (1999): 1423-25.

Avi-Yonah, Reuven S., and David M. Uhlmann. "Combating Global Climate Change: Why a Carbon Tax Is a Better Response to Global Warming Than Cap and Trade." Stanford Environmental Law Journal 28 (2009): 3.

Cerri, Karin H., Martin Knapp, and Jose-Luis Fernandez. "Decision Making by NICE: Examining the Influences of Evidence, Process and Context." Health Economics, Policy and Law 9 (2014): 119-41.

Commission on Intellectual Property Rights. "Integrating Intellectual Property Rights and Development Policy." 2002.

Cullenward, Danny. "Leakage in California’s Carbon Market: Preliminary Trading Is Consistent with Expected Impact of Regulatory Changes." (2014).

Fisher, William, and Katrina Geddes, “Learning from Ebola: How Drug-Development Policy Could Help Stop Outbreaks of Infectious Diseases” (2015), available at http://cyber.law.harvard.edu/people/tfisher/Learning_from_Ebola.pdf.

Gaffney, Alexander, and Michael Mezher. "Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers." Regulatory Affairs Professional Society (July 2, 2015).

Gamage, David, and Darien Shanske. "Using Taxes to Improve Cap and Trade, Part I: Distribution." State Tax Notes (2015).

Goulder, Lawrence H., and Andrew R. Schein. "Carbon Taxes vs. Cap and Trade: A Critical Review." (2013). http://ssrn.com/abstract=2308219.

Haworth, E.A., R. Booy, L. Stirzaker, S. Wilkes, and A. Battersby. "Is the Cold Chain for Vaccines Maintained in General Practice?" British Medical Journal 307 (1993): 242-44.

Kapczynski, Amy, and Talha Syed. "The Continuum of Excludability and the Limits of Patents." Yale Law Journal 122 (2014): 1900.

Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired or Otherwise Print Disabled, http://www.wipo.int/treaties/en/ip/marrakesh/.

Masur, Jonathan S., and Eric A. Posner. "Toward a Pigouvian State." University of Pennsylvania Law Review 164 (2015): 93.

Murray, Brian C., Richard G. Newell, and William A. Pizer. "Balancing Cost and Emissions Certainty: An Allowance Reserve for Cap-and-Trade." Resources for the Future (2008).

Musungu, Sisule F., and Cecilia Oh. "The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines?" Commission on Intellectual Property Rights, Innovation and Public Health (2005).

New, William. "Negotiators, Stakeholders Tell Tale of WIPO Marrakesh Treaty Negotiation, Look to Implementation." Published electronically September 20, 2013. http://www.ip-watch.org/2013/09/20/negotiators-stakeholders-tell-tale-ofwipo-marrakesh-treaty-negotiation-look-to-implementation/.

Newell, Richard G., and Nathan E. Wilson. "Technology Prizes for Climate Change Mitigation." Resources for the Future (2005).

Outterson, Kevin. "Should Access to Medicines and TRIPS Flexibilities Be Limited to Specific Diseases?" American Journal of Law & Medicine 34 (2008): 317-38.

Parker, Larry. "Climate Change and the EU Emissions Trading Scheme (ETS): Looking to 2020." Congressional Research Service. R41049 (2010).

Reidpath, D.D., P.A. Allotey, A. Kouame, and R.A. Cummins. "Measuring Health in a Vacuum: Examining the Disability Weight of the DALY." Health Policy Plan 18, no. 4 (2003): 351-56.

Sachs, Rachel. "Prizing Reimbursement: Prescription Drug Reimbursement as Innovation Incentive." 2015.

Scherer, F.M., and Jayashree Watal. "Post-TRIPS Options for Access to Patented Medicines in Developing Countries." Journal of International Economic Law 5, no. 4 (2002): 913-39.

Sorenson, Corinna, and Kalipso Chalkidou. "Reflections on the Evolution of Health Technology Assessment in Europe." Health Economics, Policy and Law 7 (2012): 25-45.

Walley, Tom. "Drugs, Money and Society." Journal of Clinical Pharmacology 70, no. 3 (2010): 342-45.

Wara, Michael. "Instrument Choice, Carbon Emissions, and Information." Michigan Journal of Environmental & Administrative Law 4, no. 2 (2015): 261-302.

Wranrik, Dominika. "Healthcare Policy Tools as Determinants of Health-System Efficiency: Evidence from the OECD." Health Economics, Policy and the Law 7 (2012): 197-226.

Yang, Tseming. "An Introduction to California's Greenhouse Gas Emission Trading Program." Journal of Jiangsu University, Social Science

Gabriela Chaves, Sergio Arouca National School of Public Health (English Translation)

Lead Author: Gabriela Chaves
Additional Authors: Adriana Mendoza Ruiz, Angela Esher Moritz, Claudia Garcia Serpa Osorio-de-Castro, Maria Auxiliadora Oliveira, Rondineli Mendes, Vera Lucia Luiza
Organization: Department of Medicines Policy and Pharmaceutical Services, Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation
Country: Brazil

Disclaimer: This proposal does not reflect the views or official position of the National School of Public Health Sergio Arouca, of the Oswaldo Cruz Foundation, of the Ministry of Health of Brazil. It is the position of a group of researchers with experience in public and pharmaceutical health policies, it presents its thoughts on the misalignment between the rights of inventors, international law of human rights, trade rules and public health which prevents innovation of technologies and access to them with the aim of responding to the call of the High Level Panel on access to Medicines Secretary General of the United Nations.

Abstract

The purpose of this abstract is to contribute to the fight against high priced medicines that are currently under monopoly. A “medicine under monopoly” is a product that is owned by and available from only one provider (company) in a given country. Generally, this is because the product is awaiting approval of pending patent applications, or patents have already been awarded in said country. Evidence of various mechanisms and distortions associated with high prices of medicines under monopoly are presented, including significant efforts by numerous parties to overcome this problem. A proposal is made to eliminate the patent barrier for medicines considered to be essential or for those defined by health systems as necessary to meet national health goals. This abstract supports and complements an already published proposal aimed at making the TRIPS Agreement consistent with human rights obligations by revising Articles 27 and 7 thereof. For Article 27, the author of this already published proposal suggests excluding patentable medicines considered essential. She suggests that essential medicines should be defined as those on national lists of essential medicines. We propose adding the following interpretation to the definition of “essential” in Article 27: “Medicines on national lists of essential medicines or those defined by health systems as necessary to meet national health goals.”

Submission

1) DESCRIPTION OF THE PROBLEM (INCOHERENT POLICIES)

This document aims to contribute to the fight against high priced medicines that are currently under monopoly. A “medicine under monopoly” is a product that is owned by and available from only one provider (company) in a given country. Generally this is because the product is awaiting approval of pending patent applications, or patents have already been awarded in said country [1].

Since the TRIPS Agreement of the World Trade Organization (WTO) took effect, an international patent system has formed with special interests in the pharmaceutical sector that have contributed to strengthening the monopoly over medicines, ensuring greater market power for companies to dictate prices.

In a context of patent granted monopolies, medicine prices are justified as a way to recoup the costs of product Research and Development (R&D). In addition to R&D, companies also have other costs such as the cost of producing the medicine [2] and the marketing costs [3].

Today, the primary challenge is: what’s an acceptable limit on product pricing that allows for supposed R&D costs to be recouped while, at the same time, providing an affordable price for those who need the medicine?

Several strategies for regulating the pharmaceuticals market are described in the literature [4,5]. This includes regulating medicine prices and limiting government or insurer expenses. For patented products, instruments are cited such as “Direct Price Control” using external reference pricing (ERP), price negotiation or therapeutic reference pricing (TRP)[5].

Direct control by ERP refers to the definition of “a reimbursement or market price maximum for patented products based on prices of similar medicines in other countries” [4][5]. The option of “price negotiation” in addition to the reference price adopts other strategies to establish the prices of the patented products (Maximum price, cost-plus formulas, price freezing, etc.) [5]. The TRP refers to establishing prices for generic and patented products, the latter’s price depending on the price of generics within a specific therapeutic class [5].

While significant, these regulatory methods can be limited or lack the desired scope in some situations, such as:

(A) Identifying existing international reference prices – Under the TRIPS Agreement, developed and developing countries are supposed to recognize patents, of procedures and products, for the pharmaceutical sector. This means that countries with similar levels of development will have patent applications filed for the same medicines, leading to a trend by companies to set similar or high prices. Additionally, some countries or institutions negotiate prices with companies and do not make them public, making it difficult to get a reference value on the discounts obtained (Scherer, 1996 apud Reis et al 2004) [6]. Price negotiations for countries can apply at different levels when forming domestic prices, i.e. a government price, a price for insurers, wholesale prices (or for wholesale distributors), and end-user prices. An example is the direct control of Lopinavir/ritonavir and other medicines in Colombia [8].

(B) Bargaining power – Negotiating prices of products under monopoly with a government committed to ensuring universal access to medicines puts companies in an advantageous position, since they know the purchase is a sure thing. Aspects that can increase a government’s bargaining power include reliable estimates or knowledge of the production costs, existing international reference prices, the possibility of importing and/or producing locally, as well as adopting strategies to overcome the patent barrier [1,9-11]. When these aspects are absent from negotiation, it is very unlikely a company will feel threatened to reduce its price.

Over the last two decades, Latin American countries have formed important alliances to negotiate prices together (first with ARVs and later cancer drugs) with mixed results. At first, the drops in price were satisfactory, but as products under monopoly increased – despite collective bargaining – the reductions obtained did not meet the predicted reduction levels. Nevertheless, the countries continue to rely on this strategy to cope with the problem [12, 13, 14, 15].

Another mechanism that has been used in the Americas is the PAHO (Pan American Health Organization) Strategic Fund [16]. The combined drug needs defined by the countries allows the PAHO-SF to negotiate a price based on a given volume and sign agreements for a given duration. Significant reductions have been achieved. However, the products under monopoly are the most expensive [17]. In any case, the prices agreed upon are made public. This option allows countries in this region to acquire quality products – that may or may not have been registered locally – and meet international purchase standards and national regulations.

(C) TRP – There exists the risk that all the drugs in a given therapeutic class may be under monopoly and any alternative generic drugs won’t be available in the short term. In the United States, the price for tyrosine-kinase inhibitors was determined based on the first drug in its class, imatinib. In 2001, the introductory price of annual treatment with this product was US $30,000, reaching US $92,000 per treatment per year in 2012. Subsequent introductions of nilotinib and dasatinib were made at a price of US $115,500 and US $ 123,500 [18] per treatment per year, respectively. In Latin American countries, the price for annual treatment with these drugs was, respectively, US $29,000, US $39,000 and US $49,500 in Mexico and US $52,000, US $73,500 and US $80,000 in Argentina [18].

The 20-year term under the TRIPS Agreement, in addition to the TRIPS-plus provisions implemented primarily through the signing of free trade agreements (FTA), have left a series of lessons on the patent system dynamic in the pharmaceutical sector. The first of these is that a medicine under monopoly doesn’t just depend on the grant of a patent, i.e., on the mere existence of patented medicines.

This dynamic has given rise to, what we call, “a bloated patent system.” Situations have arisen as to whether a product is patentable or not, which can grant to the company filing the patent application(s) a marketing period: (a) greater than than the product’s first 20-year patent period; and/or (b) for however long it takes to reach a decision on granting the patent, or not, or on the litigation arising from the patent application(s) filed.

From a drug company’s perspective, the so-called practice of “evergreening” has left its mark on the pharmaceutical sector. This consists of strategies to extend the monopoly of products already on the market (17). In terms of patenting, one of the strategies is to file several patent applications (“Secondary patents”) covering one medicine while incorporating arguments not just for the active ingredient but also for its salts, polymorphs, dosage forms, prodrugs, uses, etc. [19, 20].

In Brazil, there at least 11 pending patent applications for the antiretroviral drug lopinavir/ritonavir. The patent granted for the compound (active ingredient) is valid until 2017. The Ministry of Health replaced the capsule with the tablet because it doesn’t require refrigeration. The company holding the patent for the compound filed a patent application for the “tablet” dosage form. If this patent is awarded, the monopoly will be extended until 2023 [21]. The Brazilian patent office initially refused to award a patent, but the company appealed the decision in court [22].

For the government, through its patent office, there is also the risk that it could take years for the filed patent applications to be examined (unexamined patent application backlog). When the TRIPS Agreement took effect many developing countries had to begin examining patent applications in technological fields that they previously didn’t have to. In Brazil, patent applications can take up to ten years to be examined. Under Brazilian law, this extends the duration of a monopoly beyond 20 years [23, 24].

A company can market its products exclusively for the time its patent applications are pending, either because potential competitors won’t risk entering the market until a decision regarding grant, or not, of the patent(s) is issued or because the customers (government, insurers, etc.) aren’t willing to assume the risk either.

Antiretroviral tenofovir, adopted by the Ministry of Health of Brazil in 2003, was marketed exclusively by Gilead (the patent applicant) until 2010. The company had filed a patent application there for fumarate, a salt. In 2006, the first generic alternative became available internationally [25]. That same year, opposition to granting the patent for fumarate (referred to as an aid to examination) was filed with the National Intellectual Property Institute [Instituto Nacional de Propiedad Intelectual (INPI)] by the Oswaldo Cruz Foundation (Fiocruz) and civil organizations in Brazil [26,27].

The INPI’s ruling denying the patent was handed down in 2009. Learning of the ruling in favor of the public interest, Brazil’s own Ministry of Health stated, “Considering that the patent application submitted to the INPI generates an expectation of monopolistic right, with an impact on the product price…” [28].

Accordingly, it can be concluded that both the patent granted and the “bloated patent system” in the pharmaceutical sector lead companies to increase their chances of setting high drug prices, which aren’t always coherent with recouping the costs of R&D and production.

In addition to the incoherent policies of the current patent and pricing system as it concerns guaranteeing the right to access medicine as a component of a basic human right to health, it’s also worth illustrating the trade-off imbalance caused by granting patents as justification to recoup R&D costs.

One option for regulating drug prices under monopoly is to overcome the patent barrier by making use of the public health safeguards in the TRIPS Agreement [29, 30]. Depending on when they are used, they can be classified as pre- or post-grant safeguards [31, 32]. These have become a legitimate option to fighting high drug prices and have been upheld by countries in different forums of the United Nations System [32, 33, 34]. Although they have been used in specific cases with significant impact on drug price regulation, the resistance of those involved is well known when trying to implement these safeguards.

Systematic use of safeguards has not kept up with the challenge faced by countries when purchasing essential medicines under monopoly. Add to this the continual negotiation and approval process of bilateral and regional FTAs containing TRIPS-plus provisions that limit policy space to adopt safeguards and reinforce market exclusivity for companies, even when products are not protected by patent (Ex. Exclusivity of data to obtain health certificates from health authorities).

There have been estimates on the impact of adopting the TRIPS-plus provisions on the pharmaceutical market and drug costs in Latin American countries (Colombia, Ecuador, Peru, Costa Rica and the Dominican Republic) [36-41].

Thus, establishing an acceptable limit on a drug’s market price while still allowing R&D costs to be recouped is not insignificant. In this sense, policy continues to be inconsistent regarding human rights and the rights of business. The availability of a more systemic solution is fundamental to reaching the international commitment to universal health access, including drug treatment, by 2030.

(2) OPTIONS

To contribute to greater access to medicines under monopoly, the following is proposed: Eliminate the patent barrier to essential medicines or those medicines determined by health systems to be necessary to meet national health goals.

(3) IMPACT ON PUBLIC HEALTH

Eliminating the patent barrier will be an important component to regulating prices, which will correct many of the distortions in the current patent system that (as previously illustrated) allow companies to exclusively market their products in a given country.

It will also help increase government bargaining power vis-à-vis companies in a possible scenario with greater options for reference prices and the availability of imported or locally produced generic alternatives.

(4) IMPLEMENTATION

The author of the proposal presented herein is Dr. Suerie Moon [42], winner of the 2011 Doctors Without Borders contest aimed at answering the question: “Can the TRIPS Agreement be reformed to meet public health needs?”

To make the TRIPS Agreement consistent with human rights obligations, the above author proposed revising Articles 27 and 7 of the Agreement. In this manner, she proposed incorporating the language below, in CAPITAL letters:

“Article 27

Patentable Subject Matter

1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. (5) Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and

and whether products are imported or locally produced.

2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

3. Members may also exclude from patentability:

    (a)    diagnostic, therapeutic and surgical methods for the treatment of humans or animals,  AND ANY MEDICINES MEMBERS DESIGNATE AS ESSENTIAL (NEW LANGUAGE);

    (b)    plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.”

“Article 7

Objectives

    The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare AND TO THE OBSERVANCE OF HUMAN RIGHTS (NEW LANGUAGE) and to a balance of rights and obligations. MEMBERS MUST NOT ENFORCE THE AGREEMENT IN A WAY THAT UNDERMINES THE PROMOTION OR PROTECTION OF HUMAN RIGHTS (NEW LANGUAGE).”

For the purposes of revising the TRIPS Agreement, the author discusses two points in her proposal:

- Defining essential medicines – she proposes they be defined as those on national lists of essential medicines. We propose adding the following interpretation to the definition of “essential” in Article 27 of the Agreement: “Medicines on national lists of essential medicines or those defined by health systems as necessary to meet national health goals.”

- Financing the R&D costs – as a countermeasure to the proposed amendments to the Agreement, standards “on mechanisms through which countries could contribute to R&D“ (p.3) of new medicines – including proposals aimed at developing and signing a global R&D convention – could be negotiated, even though the details of this approach are beyond the scope of the author’s proposal.

Lastly, with regard to the aforementioned proposal to revise the TRIPS Agreement, it is important to note that the countries would also have to revise any FTAs containing any TRIPS-plus provisions incompatible with the Agreement.

Bibliography and References

1. Chaves GC, Hasenclever L, Osorio-de-Castro CGS, Oliveira MA. Strategies for price reduction of HIV medicines under a monopoly situation in Brazil. Rev Saúde Pública [Internet]. 2015 [cited 2016 Feb 15];49. Available from: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102015000100309&lng=en&nrm=iso&tlng=en

2. Pinheiro E, Vasan A, Kim JY, Lee E, Guimier JM, Perriens J. Examining the production costs of antiretroviral drugs. Aids. 2006;20(13):1745–52.

3. Angell M. A verdade sobre os laboratórios farmacêuticos - como somos enganados e o que podemos fazer a respeito. Rio de Janeiro: Record; 2007.

4. Rêgo E. Políticas de Regulação do Mercado de Medicamentos: A Experiência Internacional. Rev BNDES. 2000;7(14):367–400.

5. Sood N, de Vries H, Gutierrez I, Lakdawalla DN, Goldman DP. The Effect Of Regulation On Pharmaceutical Revenues: Experience In Nineteen Countries. Health Aff
(Millwood). 2009 Jan 1;28(1):w125–37.

6. Reis AL de A dos, Bermudez JAZ, Oliveira MA. Effects of the TRIPS Agreement on the Access to Medicines: Considerations for Monitoring Drug Prices. In: Intellectual Property in the Context of the WTO TRIPS Agreement: challenges for public health. Rio de Janeiro: Jorge A. Z. Bermudez, Maria Auxiliadora Oliveira; 2004.

7. República de Colombia. Circular No 6 de 2013. Por la cuál se incorpora el régimen de control directo el medicamento Kaletra el cual contiene los princípios activos lopinavir y ritonavir. Comision Nacional de de Precios de Medicamentos y Dispositivos Medicos. 3 de Octubre de 2013.

8. República de Colombia. Circular No 7 de 2013. Por la cuál se incorporan unos medicamentos al régimen de control directo com fundamento em la metodología de la Circular 3 de octubre de 2013 de la Comision Nacional de Precios de Medicamentos y Dispositivos Medicos y se les fija su precio máximo de venta. Comision Nacional de de Precios de Medicamentos y Dispositivos Medicos. 20 de deciembre de 2013.

9. Nunn AS, Fonseca EM, Bastos FI, Gruskin S, Salomon JA. Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment. PLoS Med. 2007;4(11):e305.

10. Greco DB, Simao M. Brazilian policy of universal access to AIDS treatment: sustainability challenges and perspectives. Aids. 2007;21:S37.

11. Ford N, Wilson D, Chaves GC, Lotrowska M, Kijtiwatchakul K. Sustaining access to antiretroviral therapy in the less-developed world: lessons from Brazil andThailand. Aids. 2007;21:S21–9.

12. Osorio-de-Castro CG, Crisante M, Miranda ES, Oliveira EA, Oliveira MA. Proposed methodology for monitoring antiretroviral drugs price negotiations in Latin America and the Caribbean. Revista Panamericana de Salud Pública. 2009;26(2):137–47.

13. Seoane-Vazquez E, Rodriguez-Monguio R. Negotiating antiretroviral drug prices: the experience of the Andean countries. Health Policy Plan. 2007;22(2):63-72. Epub 2007 Feb 13.

14. Comisca - Consejo de Ministérios de Salud de Centroamerica y República Dominicana. Acta Adjudicación - Negociación conjunta de precios y compra de medicamentos para Centroamerica y República Dominicana - Evento 1 2015 [Internet]. 2015 [cited 2016 Feb 22]. Available from: http://comisca.net/sites/default/files/Acta%20Evento%201-2015.pdf

15. Comisca - Consejo de Ministérios de Salud de Centroamerica y República Dominicana. Resultados Evento Negociación Conjunta 1-2015 [Internet]. 2015 [cited 2016 Feb 22]. Available from: http://comisca.net/sites/default/files/Resultados%20Negociaci%C3%B3n%20Conjunta%20Evento%201-2015%20%281%29.pdf

16. Horst MM de L, Soler O. Fundo Estratégico da Organização Pan-Americana da Saúde: mecanismo facilitador para melhorar o acesso aos medicamentos. 2010 [cited 2016 Feb 26]; Available from: http://iris.paho.org/xmlui/handle/123456789/9579

17. OPS - Organización Panamericana de Salud Pública. Lista de productos y precios de referencia de Fondo Estratégico de OPS [Internet]. 2015 [cited 2016 Feb 22]. Available from: http://www.paho.org/hq/index.php?option=com_content&view=article&id=1042%3Aproduct-list-and-reference-prices-&catid=1159%3Ahss-strategic-fund&Itemid=986&lang=es

18. Experts in Chronic Myeloid Leukemia. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood. 2013 May 30;121(22):4439–42.

19. Kapczynski A, Park C, Sampat B. Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents. Mintzes B, editor. PLoS ONE. 2012 Dec 5;7(12):e49470.

20. Correa C. Guidelines for the examination of pharmaceutical patents: developing a public health perspective [Internet]. ICTSD; 2007 [cited 2015 Mar 16]. Available from: http://newsser.fda.moph.go.th/drug_gpiip/publish/downloads/03%20GEPP.pdf

21. Villardi P. Panorama do status patentário e registro sanitário dos medicamentos antiretrovirais no Brasil - implicações para o acesso e a política industrial no Brasil [Internet]. Associação Brasileira Interdisciplinar de Aids; 2012. Available from: http://www.deolhonaspatentes.org.br/media/file/Publica%C3%A7%C3%B5es/Publica%C3%A7%C3%A3o%20Pedro_Final_23OUT.pdf

22. Instituto Nacional de Propiedad Industrial (INPI). Busca de patentes, número PI 0413882-1 A2. Disponível em www.inpi.gov.br, acesso em 23/02/2016

23. Chaves G, Reis R. Health, Intellectual Property and Innovation Policy: a case study of Brazil. In: Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing. 1a ed. Genebra: South Centre; 2013. p. 337.

24. Câmara dos Deputados, Brasil. A revisão da Lei de Patentes: inovação em prol da competitividade nacional. 1a ed. Edições Câmara; 2013. 658 p.

25. Access Campaign/Medecins Sans Frontières. Untangling the web of antiretroviral price reduction. Genebra: MSF; 2008 p. 87. Report No.: 11a edição.

26. Barroso W. Procedimento de oposição: o caso Tenofovir. In: Propriedade intelectual e políticas públicas para o accesso aos antirretrovirais nos paises do Sul. Rio de Janeiro: ANRS e E-papers; 2013.

27. Veras J. Making Tenofovir Accessible In The Brazilian Public Health System: Patent Conflicts And Generic Production: Making Tenofovir Accessible. Dev World Bioeth. 2014 Aug;14(2):92–100.

28. Brasil, Ministério da Saúde. Declara de interesse público o medicamento anti-retroviral Tenofovir para fins de exame prioritßrio de pedido de patente junto ao Instituto Nacional de Propriedade Industrial - INPI. Portaria MS/GM no 681 de abril de, 2008.

29. Varian H. Microeconomia: princípios básicos. Rio de Janeiro: Editora Campus; 1994.

30. Beall R, Kuhn R. Trends in Compulsory Licensing of Pharmaceuticals Since the Doha Declaration: A Database Analysis. Ford N, editor. PLoS Med. 2012 Jan 10;9(1):e1001154.

31. Chaves GC, Oliveira MA. A proposal for measuring the degree of public health-sensitivity of patent legislation in the context of the WTO TRIPS Agreement. Bull World Health Organ. 2007;85(1):49–56.

32. United Nations Conference on Trade and Development. Using Intellectual Property Rights to Stimulate Pharmaceutical Production in Developing Countries: A Reference Guide [Internet]. New York, Geneva: United Nations; 2011 [cited 2013 Apr 25] p. 193. Available from: http://unctad.org/en/Docs/diaepcb2009d19_en.pdf

33. Joint United Nations Programme on HIV/AIDS - Unaids. Doha+10 trips flexibilities and access to antiretroviral therapy: lessons from the past, opportunities for the future. Geneva: Unaids; 2011. Disponível em: http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/JC2260_DOHA+10TRIPS_en.pdf [citado 2014 jan 20]

34. World Health Organization. How to develop and implement a national drug policy: updates and replaces: guidelines for developing national drug policies, 1988. 2.ed. Geneva; 2013. Disponível em: http://apps.who.int/medicinedocs/pdf/s2283e/s2283e.pdf [citado 2014 jan 15]

35. Brennan, H; Distler, R; Hinman, M; Rogers, A. A Human Rights Approach to Intellectual Property and Access to Medicines. Global Health Justice Partnership Policy Paper 1 September 2013. Yale Law School and Yale School of Public Health. Disponible en http://media.wix.com/ugd/148599_c76ed6f7341fa426bc22f5ccf543ea04.pdf (acceso 22/02/2016)

36. Acción Internacional para la Salud; Ifarma. El impacto del TPP en el acceso a los medicamentos en Chile, Peru y Colombia [Internet]. 2013 [cited 2016 Feb 22]. Available from: http://web.ifarma.org/index.php?option=com_content&view=article&id=73:el-impacto-del-tpp-en-el-acceso-a-los-medicamentos-en-chile-peru-y-colombia

37. Gamba MEC. Intellectual property in the FTA: impacts on pharmaceutical spending and access to medicines in Colombia [Internet]. Misión Salud; IFARMA; 2006 [cited 2016 Feb 22]. Available from: http://web.ifarma.org/images/files/pintelectual/TLC_Colombia_ingles[1].pdf

38. Gamba MEC, Buenaventura FR, Bernate IR. Impacto de los derechos de propiedad intelectual sobre el precio, gasto y acceso a medicamentos en el Ecuador [Internet]. Fundación Ifarma; OPS; 2010 [cited 2016 Feb 22]. Available from: http://web.ifarma.org/images/files/pintelectual/Impacto_de_los_derechos_de_PI-Ecuador_final_diciembre_2010.pdf

39. Gamba MEC, Cornejo EM, Bernate IR. Impacto del acuerdo comercial UE-países de la CAN, sobre el acceso a medicamentos en el Perú [Internet]. AIS-LAC, Fundación IFARMA, Fundación Misión Salud, Health Action International; 2009. Available from: http://web.ifarma.org/index.php?option=com_content&view=article&id=56:impacto-del-acuerdo-comercial-ue-paises-de-la-can-sobre-el-acceso-a-medicamentos-en-el-peru&catid=9:propiedad-intelectual&Itemid=29

40. Hernández-González G; Valverde M. Evaluación del impacto de las disposiciones de Adipc plus em el mercado institucional de Costa Rica. 2009. Cinpe, ICTSD, OPS, PNUD. Disponible en http://web.ifarma.org/images/files/pintelectual/final_31_julio_09.PDF (acceso em 22/02/2016)

41. Rathe M, Minaya RP, Guzmán D, Franco L. Estimación del impacto de nuevos estándares de propiedad intelectual em el precio de los medicamentos em la Republica Dominicana. 2009. Fundación Plenitud, ICTSD, OPS. Disponible en http://web.ifarma.org/images/files/pintelectual/informe_final_1.pdf (acceso en 22/02/2016)

42. Moon, S. Restoring Policy Space: Excluding essential medicines from patentability in TRIPS. MSF Revising TRIPS Ideas Contest Entry. 2011. Disponible en http://www.msfaccess.org/sites/default/files/MSF_assets/Access/Docs/Access_Contest_RestoringPolicySpace_Moon_Eng_2011.pdf (acceso en 21/02/2016)

43. MSF/Access Campaign. Revising TRIPS for Public Health: Can TRIPS be reformed to meet public health needs? Disponible en http://www.msfaccess.org/content/revisingtrips (acceso en 20/02/2016)

Gabriela Chaves (Original Language)

Lead Author: Gabriela Chaves
Additional Authors: Adriana Mendoza Ruiz, Angela Esher Moritz, Claudia Garcia Serpa Osorio-de-Castro, Maria Auxiliadora Oliveira, Rondineli Mendes, Vera Lucia Luiza
Organization: Department of Medicines Policy and Pharmaceutical Services, Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation
Country: Brazil

*Renuncia:  La presente propuesta no refleja la visión o posición oficial de la Escuela Nacional de Salud Pública Sergio Arouca, de la Fundación Oswaldo Cruz del Ministerio de Salud de Brasil. Se trata de la posición de un grupo de investigadores con experiencia en salud pública y políticas farmacéuticas, que presenta sus reflexiones sobre la desalineación entre los derechos de los inventores, el derecho internacional de los derechos humanos, las normas de comercio y la salud pública cuando impide la innovación de las tecnologías y el acceso a éstas con el ánimo de responder al llamado del Panel de Alto Nivel sobre Acceso a los Medicamentos del Secretario General de las Naciones Unidas.

Abstract

El objetivo de este aporte es contribuir al enfrentamiento del problema de los precios elevados de medicamentos que se encuentran en situación de monopolio. Se considera “medicamento en situación de monopolio” aquel producto cuya disponibilidad, en un determinado país, es potestad de apenas un proveedor (empresa). Ello, en general, porque este producto tiene solicitudes de patente presentadas (pendientes de decisión) o patentes concedidas en el país. Se presentan evidencias de diferentes mecanismos y distorsiones relacionadas con los precios elevados de medicamentos en situación de monopolio, incluidos algunos esfuerzos relevantes realizados por distintas partes para superar ese problema. Se propone eliminar la barrera patentaria para medicamentos considerados esenciales o los definidos por los sistemas de salud como prioritarios para alcanzar los objetivos sanitarios nacionales. Este aporte respalda y complementa una propuesta ya publicada con miras a que el Acuerdo sobre los ADPIC se torne consistente con las obligaciones de derechos humanos, mediante la revisión de los artículos 27 y 7 de dicho Acuerdo. Para el artículo 27, la autora de la propuesta publicada sugiere la exclusión de patentabilidad de los medicamentos considerados como esenciales. Sugiere que esenciales sean aquellos medicamentos presentes en las listas nacionales de medicamentos esenciales. Nuestra propuesta es adicionar a la definición de “esenciales” (señalada para el art. 27) la siguiente interpretación: “aquellos presentes en las listas nacionales de medicamentos esenciales o definidos por los sistemas de salud como prioritarios para alcanzar los objetivos sanitarios nacionales”.

Submission

(1) CARACTERIZACIÓN DEL PROBLEMA (INCOHERENCIA DE LAS POLITICAS)

Este documento tiene por objetivo presentar una contribución para el enfrentamiento del problema de los precios elevados de medicamentos que se encuentran en situación de monopolio. Se considera “medicamento en situación de monopolio” aquel producto cuya disponibilidad, en un determinado país, es potestad de apenas un proveedor (empresa). Ello, en general, porque este producto tiene solicitudes de patente presentadas (pendientes de decisión) o patentes concedidas en el país(1).

Desde la entrada en vigor del Acuerdo sobre los ADPIC de la Organización Mundial del Comercio (OMC), se configuró internacionalmente un sistema de patentes con especificidades en el sector farmacéutico que contribuyeron al fortalecimiento de la situación de monopolio de medicamentos, asegurando un mayor poder de mercado para que las empresas definan los precios.

En un contexto de monopolio conferido por la patente, los precios de medicamentos son justificados como la posibilidad de recuperar los costos de Investigación y Desarrollo (I&D) de los productos. Además de los costos en I&D, la empresa también tiene otros costos como el costos de producción del medicamento(2) y los costos de propaganda(3).

El primer desafío hoy es ¿cuál sería el límite aceptable entre el valor del precio practicado que permite recuperar los supuestos costos de I&D y al mismo tiempo garantizar un precio asequible para quienes necesitan medicamentos?

Varias estrategias para regular el mercado farmacéutico son descritas en la literatura(4,5). Entre ellas, la regulación de precios de medicamentos y los límites a gastos de los gobiernos o los aseguradores. Para productos patentados se citan instrumentos como el ‘Control Directo de Precios’ mediante la utilización de precios de referencia externos (ERP- External Reference Pricing), negociación de precios o Precio de Referencia Terapéutico (TRP - Therapeutic Reference Pricing)(5).
El control directo por ERP se refiere a la definición de “un nivel máximo de reembolso o precio de mercado para productos patentados basado en precios de medicamentos similares en otros países” (p.4)(5). La opción de ‘negociación de precios’ además del precio de referencia adopta otras estrategias para establecer los precios de los productos patentados (Precio máximo, fórmulas cost-plus, congelamiento de precios, etc.)(5). El TRP se refiere al establecimiento de precios a productos genéricos y patentados, siendo que el precio del último dependerá del precio de los genéricos dentro de una clase terapéutica específica(5).

Aunque relevantes, esas modalidades de regulación pueden presentar limitaciones o no tener el alcance deseado en algunas situaciones, tales como:

(A) Existencia e identificación de precio de referencia internacional – por el Acuerdo sobre los ADPIC los países desarrollados y en desarrollo son obligados a reconocer patentes, de procedimiento y de producto, para el sector farmacéutico. Ello significa que países con niveles de desarrollo semejantes tendrán solicitudes de patente presentadas para los mismos medicamentos, conllevando una tendencia de las empresas a definir precios semejantes o altos. Adicionalmente, algunos países o instituciones negocian precios con las empresas y no los tornan públicos, dificultando la consecución de valores de referencia con los descuentos obtenidos(Scherer, 1996 apud Reis et al 2004)(6). Las negociaciones de precios de los países pueden aplicarse a diferentes niveles en la formación de precios nacionales, es decir, a precio para el gobierno, precio para los aseguradores, precio al por mayor (o a distribuidores mayoristas), precio al usuario final. Un ejemplo es el control directo de precio de Lopinavir/ritonavir y otros medicamentos en Colombia.(7,8)

(B) Poder de negociación de precios – la negociación de precios de productos en situación de monopolio con un gobierno comprometido en asegurar acceso universal a medicamentos brinda a la empresa una posición ventajosa, pues esta sabe que la compra será realizada obligatoriamente. Aspectos que pueden aumentar el poder de negociación del gobierno en la negociación de precios incluyen el conocimiento o estimaciones confiables del costo de producción, existencia de precios de referencia internacionales, posibilidades de importar y/o producir localmente, así como la adopción de estrategias para enfrentar la barrera patentaría(1,9–11). Cuando esos aspectos no están presentes en la negociación es poco probable que la empresa se sienta amenazada para reducir su precio.
Durante las dos últimas décadas, los países latinoamericanos han realizado importantes alianzas para negociar conjuntamente los precios (iniciando con ARV y luego oncológicos) con resultados diferenciados. Inicialmente, los resultados de reducción de precios fueron satisfactorios, pero con el aumento de los productos en situación de monopolio – a pesar de las negociaciones conjuntas - las reducciones obtenidas no alcanzaron los niveles de reducción previstos. Aun así, los países continúan apostando en esta estrategia para aliviar el problema.(12,13, 14,15)
Otro mecanismo que se viene utilizando en la región de las Américas es el Fondo Estratégico (FE) de la Organización Panamericana de la Salud (OPS)(16). La consolidación de necesidades de medicamentos definidos por los países permite al FE-OPS negociar un precio, a partir de ese volumen, estableciendo acuerdos con duración definida. Importantes reducciones han sido alcanzadas. No obstante, los productos en situación de monopolio son los más caros(17). De todas formas, los precios acordados son tornados públicos. Esta opción permite a los países de la Región adquirir productos de calidad - que pueden o no haber sido registrados localmente – cumpliendo estándares de compra internacional y normas nacionales.

(C) TRP – existe el riesgo de que todos los medicamentos de una determinada clase terapéutica estén en situación de monopolio y que no exista la alternativa de disponibilidad - en el corto plazo - de medicamentos genéricos. En los Estados Unidos, el precio de los medicamentos oncológicos de la clase de los inhibidores de la tirosina quinasa fue definido a partir del precio del primero de su clase, el imatinib. En 2001, el precio de lanzamiento del tratamiento anual con dicho producto fue US$30 mil que llegó a US$92 mil por tratamiento por ano en 2012. Los subsecuentes nilotinib y dasatinib fueron lanzados a US$ 115,5 mil y US$123,5 mil(18) por tratamiento por ano, respectivamente. En países latinoamericanos, los precios de los tratamientos anuales para esos tres medicamentos fueron, respectivamente, de US$ 29 mil, US$ 39 mil y US$ 49,5 en México y de US$ 52mil, US$ 73,5 mil y US$ 80 mil en Argentina(18).

Los 20 años de vigencia del Acuerdo sobre los ADPIC, sumados a la implementación de dispositivos ADPIC-plus principalmente por la firma de Tratados de Libre Comercio (TLC), han dejado una serie de lecciones sobre la dinámica del sistema de patentes en el sector farmacéutico. La primera de ellas es que el monopolio de un medicamento no depende apenas de la concesión de la patente, es decir, de la mera existencia de medicamentos patentados.

Esta dinámica ha provocado lo que denominamos “hipertrofia del sistema de patentes”. Se han generado situaciones de incertidumbre sobre la patentatibilidad, o no, de un producto, que puede asegurar un tiempo de comercialización exclusiva a la empresa que presenta la(s) solicitud(es) de patente(s): (a) mayor que el período de 20 años de vigencia de la primera patente del producto; y/o (b) durante el período que demore la toma de decisión sobre la concesión, o no, de la patente o de las disputas judiciales sobre la(s) solicitud(es) de patente(s) presentadas.

Desde el lado de las empresas, el denominado evergreening es una práctica que marca al sector farmacéutico. Consiste en estrategias para extender el monopolio de productos ya disponibles en el mercado (17). En lo que se refiere a la cuestión patentaria, una de las estrategias es presentar varias solicitudes de patente (“Patentes secundarias”) cubriendo un mismo medicamento, incorporando reivindicaciones no solo para el principio activo sino también para sus sales, polimorfos, formas farmacéuticas, profármacos, uso, etc(19,20).

En Brasil, hay al menos 11 solicitudes de patentes presentadas para el antirretroviral lopinavir/ritonavir. La patente concedida para el compuesto (principio activo) está vigente hasta 2017. El Ministerio de Salud substituyó la cápsula por el comprimido porque este no requiere refrigeración. La empresa detentora de la patente del compuesto presentó la solicitud de patente para la forma farmacéutica ‘comprimido’. Si esta patente se concediera, la situación de monopolio se extendería hasta 2023(21). Inicialmente, la decisión de la Oficina de Patentes de Brasil fue negativa para concesión de patente, pero la empresa apeló la decisión en la instancia judicial(22).

Por el lado del Estado, a través de sus Oficinas de Patentes, también existe el riesgo de que las solicitudes de patente presentadas demoren años en poder ser analizadas (conocido como backlog del examen de patente). Con la entrada en vigor del Acuerdo sobre los ADPIC, muchos países en desarrollo debieron realizar el examen de patente de campos tecnológicos que no contemplaban antes. En el caso de Brasil, las solicitudes de patente presentadas pueden llevar más de diez años para ser analizadas. Según la legislación brasileña, ello extiende la duración de la situación de monopolio más allá de 20 años(23,24).

La empresa puede comercializar de forma exclusiva sus productos durante el periodo en que sus solicitudes de patente presentadas están “pendientes de decisión”, sea porque los competidores potenciales no se arriesgan a entrar en el mercado hasta que la decisión sobre concesión, o no, de la(s) patente(s) sea tomada o porque los compradores (Gobierno, aseguradores, etc.) tampoco están dispuestos a asumir ese riesgo.

El antirretroviral tenofovir, adoptado por el Ministerio de Salud de Brasil en 2003, fue comercializado de forma exclusiva por la empresa Gilead (solicitante de la patente) hasta 2010. La empresa había presentado una solicitud de patente en el país para la sal de fumarato. La primera alternativa de genérico estuvo disponible internacionalmente en 2006(25), en ese mismo año una oposición a la concesión (denominada subsidio al examen) de la patente para la sal de fumarato fue presentada al Instituto Nacional de Propiedad Intelectual (INPI) por la Fundación Oswaldo Cruz (Fiocruz) y grupos de la sociedad civil en Brasil(26,27).

La decisión del INPI de negar la solicitud de patente se dio en 2009. El propio Ministerio de Salud de Brasil, al expedir la declaración de interés público afirmó: “Considerando que la solicitud de patente presentada al INPI genera expectativa de derecho monopólico, con impacto en el precio del producto...”(28).
Por lo expuesto, puede afirmarse que no solo la patente concedida sino también la “hipertrofia del sistema de patentes” en el sector farmacéutico contribuyen a que las empresas aumenten sus posibilidades de practicar precios altos para medicamentos, no siempre coherentes con la recuperación de los costos de I&D y producción.

Además de la incoherencia política del sistema vigente de patentes y de los precios en relación con la garantía del derecho al acceso a medicamentos como componente del derecho humano a la salud, es igualmente oportuno ilustrar el desbalance trade-off de la concesión patentaria como justificación para la recuperación de los costos de I&D.

Una opción para la regulación de precios de medicamentos en situación de monopolio es el enfrentamiento de la barrera patentaria mediante utilización de salvaguardias de protección de la salud pública previstas en el Acuerdo sobre los ADPIC(29,30). Según el momento de aplicación pueden clasificarse como: salvaguardias anteriores o posteriores a la de la concesión de patente (31,32). Estas se convirtieron en opción legítima para enfrentar los precios elevados de medicamentos y han sido reafirmadas por los países en diferentes foros del Sistema de Naciones Unidas (32,33,34). Aunque se han utilizado en casos específicos con efectos importantes en la regulación de precios de medicamentos, también es reconocida la resistencia de los actores al intentar implementarlas.

El uso sistemático de salvaguardias no ha acompañado el ritmo del desafío enfrentado por los países en la compra de medicamentos esenciales en situación de monopolio. A ello se suma el proceso continuo de negociación y aprobación de TLC bilaterales y regionales, contemplando dispositivos ADPIC- plus que restringen el policy space para la adopción de las salvaguardias y refuerzan la exclusividad en el mercado a favor de las empresas, aunque no exista protección patentaria de productos (Ej. Exclusividad de los datos para la obtención de registro sanitario).

Existen estimaciones del impacto de la adopción de dispositivos ADPIC-plus sobre el mercado farmacéutico y los gastos con medicamentos en países latinoamericanos (Colombia, Ecuador, Peru, Costa Rica y República Dominicana) (36-41).

Por tanto, no es trivial establecer el límite aceptable entre el precio practicado de un medicamento que permita recuperar sus supuestos costos de I&D. En este sentido, persiste la incoherencia política entre los derechos comerciales y los derechos humanos. Disponer de una solución más sistémica es fundamental para poder alcanzar en 2030 los compromisos internacionales de acceso universal a la salud, incluido el tratamiento medicamentoso.

(2) OPCIONES
Para contribuir a la ampliación del acceso a medicamentos en situación monopolio se propone:
•Eliminar la barrera patentaria para medicamentos considerados esenciales o los definidos por los sistemas de salud como prioritarios para alcanzar los objetivos sanitarios nacionales.

(3) IMPACTO EN LA SALUD PÚBLICA
La eliminación de la barrera patentaria será un componente importante de la regulación de precios que subsanará diferentes distorsiones del sistema de patentes actual que (como se ilustró previamente) permiten a las empresas comercializar sus productos de forma exclusiva en un país.
Igualmente favorecerá el aumento del poder del gobierno en la negociación de precios de medicamentos con las empresas, en un escenario potencial de mayores opciones de precios de referencia y disponibilidad de alternativas genéricas, importadas o producidas localmente.

(4) IMPLEMENTACIÓN

La propuesta aquí presentada es autoría de la Dr. Suerie Moon (42), vencedora del concurso promovido por Médicos Sin Fronteras en 2011, que procuraba responder esta pregunta: ¿“El Acuerdo sobre los ADPIC necesita ser reformado para atender las necesidades de pública?”

Para que el Acuerdo sobre los ADPIC se torne consistente con las obligaciones de derechos humanos, dicha autora propuso la revisión de los artículos 27 y 7 del Acuerdo. Así, propuso la incorporación del lenguaje presentado a continuación, destacado en letra MAYUSCULA:

“Artículo 27
Materia patentable
Sin perjuicio de lo dispuesto en los párrafos 2 y 3, las patentes podrán obtenerse por todas las invenciones, sean de productos o de procedimientos, en todos los campos de la tecnología, siempre que sean nuevas, entrañen una actividad inventiva y sean susceptibles de aplicación industrial.(5) Sin perjuicio de lo dispuesto en el párrafo 4 del artículo 65, en el párrafo 8 del artículo 70 y en el párrafo 3 del presente artículo, las patentes se podrán obtener y los derechos de patente se podrán gozar sin discriminación por el lugar de la invención, el campo de la tecnología o el hecho de que los productos sean importados o producidos en el país.
2. Los Miembros podrán excluir de la patentabilidad las invenciones cuya explotación comercial en su territorio deba impedirse necesariamente para proteger el orden público o la moralidad, inclusive para proteger la salud o la vida de las personas o de los animales o para preservar los vegetales, o para evitar daños graves al medio ambiente, siempre que esa exclusión no se haga meramente porque la explotación esté prohibida por su legislación.
3. Los Miembros podrán excluir asimismo de la patentabilidad:
a) los métodos de diagnóstico, terapéuticos y quirúrgicos para el tratamiento de personas o animales, Y MEDICAMENTOS QUE LOS MIEMBROS DESIGNEN COMO ESENCIALES (NUEVO LENGUAJE);
b) las plantas y los animales excepto los microorganismos, y los procedimientos esencialmente biológicos para la producción de plantas o animales, que no sean procedimientos no biológicos o microbiológicos. Sin embargo, los Miembros otorgarán protección a todas las obtenciones vegetales mediante patentes, mediante un sistema eficaz sui generis o mediante una combinación de aquéllas y éste. Las disposiciones del presente apartado serán objeto de examen cuatro años después de la entrada en vigor del Acuerdo sobre la OMC.”

“Artículo 7
Objetivos
La protección y la observancia de los derechos de propiedad intelectual deberán contribuir a la promoción de la innovación tecnológica y a la transferencia y difusión de la tecnología, en beneficio recíproco de los productores y de los usuarios de conocimientos tecnológicos y de modo que favorezcan el bienestar social y económico Y EL CUMPLIMIENTO DE LOS DERECHOS HUMANOS (NUEVO LENGUAJE) y el equilibrio de derechos y obligaciones. LOS MIEMBROS NO DEBEN APLICAR EL ACUERDO DE FORMA QUE DEBILITE LA PROMOCIÓN O PROTECCIÓN DE LOS DERECHOS HUMANOS (NUEVO LENGUAJE)”

Para fines de la revisión del Acuerdo sobre los ADPIC, la autora discute dos puntos en su propuesta:

•Definición de medicamentos esenciales – propone que sean aquellos medicamentos presentes en las listas nacionales de medicamentos esenciales. Proponemos adicionar a la definición de “esenciales” en el artículo 27 del Acuerdo la siguiente interpretación: “aquellos presentes en las listas nacionales de medicamentos esenciales o definidos por los sistemas de salud como prioritarios para alcanzar los objetivos sanitarios nacionales”

•Financiamiento de los costos de I&D – en contrapartida a la enmiendas propuestas al Acuerdo, podrían negociarse normas “sobre mecanismos a través de los cuales los países podrían contribuir con la I&D” (p.3) de nuevos medicamentos, incluyendo propuestas con miras al desarrollo y suscripción de una Convención Mundial de I&D, aun cuando el detalle de este abordaje estaba fuera del alcance de la propuesta de la autora.

Finalmente, en relación con la propuesta referida de revisión del Acuerdo sobre los ADPIC, es importante anotar que los países igualmente deberán revisar los TLC que contemplen dispositivos ADPIC-plus que sean incompatibles con dicho Acuerdo.

Renuncia (disclaimer): la presente propuesta no refleja la visión o posición oficial de la Escuela Nacional de Salud Pública Sergio Arouca, de la Fundación Oswaldo Cruz del Ministerio de Salud de Brasil. Se trata de la posición de un grupo de investigadores con experiencia en salud pública y políticas farmacéuticas, que presenta sus reflexiones sobre la desalineación entre los derechos de los inventores, el derecho internacional de los derechos humanos, las normas de comercio y la salud pública cuando impide la innovación de las tecnologías y el acceso a éstas con el ánimo de responder al llamado del Panel de Alto Nivel sobre Acceso a los Medicamentos del Secretario General de las Naciones Unidas.

Bibliography and References

1. Chaves GC, Hasenclever L, Osorio-de-Castro CGS, Oliveira MA. Strategies for price reduction of HIV medicines under a monopoly situation in Brazil. Rev Saúde Pública [Internet]. 2015 [cited 2016 Feb 15];49. Available from: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102015000100309&lng=en&nrm=iso&tlng=en

2. Pinheiro E, Vasan A, Kim JY, Lee E, Guimier JM, Perriens J. Examining the production costs of antiretroviral drugs. Aids. 2006;20(13):1745–52.

3. Angell M. A verdade sobre os laboratórios farmacêuticos - como somos enganados e o que podemos fazer a respeito. Rio de Janeiro: Record; 2007.

4. Rêgo E. Políticas de Regulação do Mercado de Medicamentos: A Experiência Internacional. Rev BNDES. 2000;7(14):367–400.

5. Sood N, de Vries H, Gutierrez I, Lakdawalla DN, Goldman DP. The Effect Of Regulation On Pharmaceutical Revenues: Experience In Nineteen Countries. Health Aff
(Millwood). 2009 Jan 1;28(1):w125–37.

6. Reis AL de A dos, Bermudez JAZ, Oliveira MA. Effects of the TRIPS Agreement on the Access to Medicines: Considerations for Monitoring Drug Prices. In: Intellectual Property in the Context of the WTO TRIPS Agreement: challenges for public health. Rio de Janeiro: Jorge A. Z. Bermudez, Maria Auxiliadora Oliveira; 2004.

7. República de Colombia. Circular No 6 de 2013. Por la cuál se incorpora el régimen de control directo el medicamento Kaletra el cual contiene los princípios activos lopinavir y ritonavir. Comision Nacional de de Precios de Medicamentos y Dispositivos Medicos. 3 de Octubre de 2013.

8. República de Colombia. Circular No 7 de 2013. Por la cuál se incorporan unos medicamentos al régimen de control directo com fundamento em la metodología de la Circular 3 de octubre de 2013 de la Comision Nacional de Precios de Medicamentos y Dispositivos Medicos y se les fija su precio máximo de venta. Comision Nacional de de Precios de Medicamentos y Dispositivos Medicos. 20 de deciembre de 2013.

9. Nunn AS, Fonseca EM, Bastos FI, Gruskin S, Salomon JA. Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment. PLoS Med. 2007;4(11):e305.

10. Greco DB, Simao M. Brazilian policy of universal access to AIDS treatment: sustainability challenges and perspectives. Aids. 2007;21:S37.

11. Ford N, Wilson D, Chaves GC, Lotrowska M, Kijtiwatchakul K. Sustaining access to antiretroviral therapy in the less-developed world: lessons from Brazil andThailand. Aids. 2007;21:S21–9.

12. Osorio-de-Castro CG, Crisante M, Miranda ES, Oliveira EA, Oliveira MA. Proposed methodology for monitoring antiretroviral drugs price negotiations in Latin America and the Caribbean. Revista Panamericana de Salud Pública. 2009;26(2):137–47.

13. Seoane-Vazquez E, Rodriguez-Monguio R. Negotiating antiretroviral drug prices: the experience of the Andean countries. Health Policy Plan. 2007;22(2):63-72. Epub 2007 Feb 13.

14. Comisca - Consejo de Ministérios de Salud de Centroamerica y República Dominicana. Acta Adjudicación - Negociación conjunta de precios y compra de medicamentos para Centroamerica y República Dominicana - Evento 1 2015 [Internet]. 2015 [cited 2016 Feb 22]. Available from: http://comisca.net/sites/default/files/Acta%20Evento%201-2015.pdf

15. Comisca - Consejo de Ministérios de Salud de Centroamerica y República Dominicana. Resultados Evento Negociación Conjunta 1-2015 [Internet]. 2015 [cited 2016 Feb 22]. Available from: http://comisca.net/sites/default/files/Resultados%20Negociaci%C3%B3n%20Conjunta%20Evento%201-2015%20%281%29.pdf

16. Horst MM de L, Soler O. Fundo Estratégico da Organização Pan-Americana da Saúde: mecanismo facilitador para melhorar o acesso aos medicamentos. 2010 [cited 2016 Feb 26]; Available from: http://iris.paho.org/xmlui/handle/123456789/9579

17. OPS - Organización Panamericana de Salud Pública. Lista de productos y precios de referencia de Fondo Estratégico de OPS [Internet]. 2015 [cited 2016 Feb 22]. Available from: http://www.paho.org/hq/index.php?option=com_content&view=article&id=1042%3Aproduct-list-and-reference-prices-&catid=1159%3Ahss-strategic-fund&Itemid=986&lang=es

18. Experts in Chronic Myeloid Leukemia. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood. 2013 May 30;121(22):4439–42.

19. Kapczynski A, Park C, Sampat B. Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents. Mintzes B, editor. PLoS ONE. 2012 Dec 5;7(12):e49470.

20. Correa C. Guidelines for the examination of pharmaceutical patents: developing a public health perspective [Internet]. ICTSD; 2007 [cited 2015 Mar 16]. Available from: http://newsser.fda.moph.go.th/drug_gpiip/publish/downloads/03%20GEPP.pdf

21. Villardi P. Panorama do status patentário e registro sanitário dos medicamentos antiretrovirais no Brasil - implicações para o acesso e a política industrial no Brasil [Internet]. Associação Brasileira Interdisciplinar de Aids; 2012. Available from: http://www.deolhonaspatentes.org.br/media/file/Publica%C3%A7%C3%B5es/Publica%C3%A7%C3%A3o%20Pedro_Final_23OUT.pdf

22. Instituto Nacional de Propiedad Industrial (INPI). Busca de patentes, número PI 0413882-1 A2. Disponível em www.inpi.gov.br, acesso em 23/02/2016

23. Chaves G, Reis R. Health, Intellectual Property and Innovation Policy: a case study of Brazil. In: Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing. 1a ed. Genebra: South Centre; 2013. p. 337.

24. Câmara dos Deputados, Brasil. A revisão da Lei de Patentes: inovação em prol da competitividade nacional. 1a ed. Edições Câmara; 2013. 658 p.

25. Access Campaign/Medecins Sans Frontières. Untangling the web of antiretroviral price reduction. Genebra: MSF; 2008 p. 87. Report No.: 11a edição.

26. Barroso W. Procedimento de oposição: o caso Tenofovir. In: Propriedade intelectual e políticas públicas para o accesso aos antirretrovirais nos paises do Sul. Rio de Janeiro: ANRS e E-papers; 2013.

27. Veras J. Making Tenofovir Accessible In The Brazilian Public Health System: Patent Conflicts And Generic Production: Making Tenofovir Accessible. Dev World Bioeth. 2014 Aug;14(2):92–100.

28. Brasil, Ministério da Saúde. Declara de interesse público o medicamento anti-retroviral Tenofovir para fins de exame prioritßrio de pedido de patente junto ao Instituto Nacional de Propriedade Industrial - INPI. Portaria MS/GM no 681 de abril de, 2008.

29. Varian H. Microeconomia: princípios básicos. Rio de Janeiro: Editora Campus; 1994.

30. Beall R, Kuhn R. Trends in Compulsory Licensing of Pharmaceuticals Since the Doha Declaration: A Database Analysis. Ford N, editor. PLoS Med. 2012 Jan 10;9(1):e1001154.

31. Chaves GC, Oliveira MA. A proposal for measuring the degree of public health-sensitivity of patent legislation in the context of the WTO TRIPS Agreement. Bull World Health Organ. 2007;85(1):49–56.

32. United Nations Conference on Trade and Development. Using Intellectual Property Rights to Stimulate Pharmaceutical Production in Developing Countries: A Reference Guide [Internet]. New York, Geneva: United Nations; 2011 [cited 2013 Apr 25] p. 193. Available from: http://unctad.org/en/Docs/diaepcb2009d19_en.pdf

33. Joint United Nations Programme on HIV/AIDS - Unaids. Doha+10 trips flexibilities and access to antiretroviral therapy: lessons from the past, opportunities for the future. Geneva: Unaids; 2011. Disponível em: http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/JC2260_DOHA+10TRIPS_en.pdf [citado 2014 jan 20]

34. World Health Organization. How to develop and implement a national drug policy: updates and replaces: guidelines for developing national drug policies, 1988. 2.ed. Geneva; 2013. Disponível em: http://apps.who.int/medicinedocs/pdf/s2283e/s2283e.pdf [citado 2014 jan 15]

35. Brennan, H; Distler, R; Hinman, M; Rogers, A. A Human Rights Approach to Intellectual Property and Access to Medicines. Global Health Justice Partnership Policy Paper 1 September 2013. Yale Law School and Yale School of Public Health. Disponible en http://media.wix.com/ugd/148599_c76ed6f7341fa426bc22f5ccf543ea04.pdf (acceso 22/02/2016)

36. Acción Internacional para la Salud; Ifarma. El impacto del TPP en el acceso a los medicamentos en Chile, Peru y Colombia [Internet]. 2013 [cited 2016 Feb 22]. Available from: http://web.ifarma.org/index.php?option=com_content&view=article&id=73:el-impacto-del-tpp-en-el-acceso-a-los-medicamentos-en-chile-peru-y-colombia

37. Gamba MEC. Intellectual property in the FTA: impacts on pharmaceutical spending and access to medicines in Colombia [Internet]. Misión Salud; IFARMA; 2006 [cited 2016 Feb 22]. Available from: http://web.ifarma.org/images/files/pintelectual/TLC_Colombia_ingles[1].pdf

38. Gamba MEC, Buenaventura FR, Bernate IR. Impacto de los derechos de propiedad intelectual sobre el precio, gasto y acceso a medicamentos en el Ecuador [Internet]. Fundación Ifarma; OPS; 2010 [cited 2016 Feb 22]. Available from: http://web.ifarma.org/images/files/pintelectual/Impacto_de_los_derechos_de_PI-Ecuador_final_diciembre_2010.pdf

39. Gamba MEC, Cornejo EM, Bernate IR. Impacto del acuerdo comercial UE-países de la CAN, sobre el acceso a medicamentos en el Perú [Internet]. AIS-LAC, Fundación IFARMA, Fundación Misión Salud, Health Action International; 2009. Available from: http://web.ifarma.org/index.php?option=com_content&view=article&id=56:impacto-del-acuerdo-comercial-ue-paises-de-la-can-sobre-el-acceso-a-medicamentos-en-el-peru&catid=9:propiedad-intelectual&Itemid=29

40. Hernández-González G; Valverde M. Evaluación del impacto de las disposiciones de Adipc plus em el mercado institucional de Costa Rica. 2009. Cinpe, ICTSD, OPS, PNUD. Disponible en http://web.ifarma.org/images/files/pintelectual/final_31_julio_09.PDF (acceso em 22/02/2016)

41. Rathe M, Minaya RP, Guzmán D, Franco L. Estimación del impacto de nuevos estándares de propiedad intelectual em el precio de los medicamentos em la Republica Dominicana. 2009. Fundación Plenitud, ICTSD, OPS. Disponible en http://web.ifarma.org/images/files/pintelectual/informe_final_1.pdf (acceso en 22/02/2016)

42. Moon, S. Restoring Policy Space: Excluding essential medicines from patentability in TRIPS. MSF Revising TRIPS Ideas Contest Entry. 2011. Disponible en http://www.msfaccess.org/sites/default/files/MSF_assets/Access/Docs/Access_Contest_RestoringPolicySpace_Moon_Eng_2011.pdf (acceso en 21/02/2016)

43. MSF/Access Campaign. Revising TRIPS for Public Health: Can TRIPS be reformed to meet public health needs? Disponible en http://www.msfaccess.org/content/revisingtrips (acceso en 20/02/2016)

Jaime Espin, ANDALUSIAN SCHOOL OF PUBLIC HEALTH (English Translation)

Lead Author: Jaime Espin
Organization: Andalusian School of Public Health
Country: Spain

Abstract

Price is an important variable that determines better access to and availability of medicines. A medicine’s price should be determined by variables such as its therapeutic value and its production cost, but in the current system, the international reference pricing mechanism is causing drug prices to be determined by the drug’s price in other countries, which makes it hard for many middle and low income countries to access new drugs.

My contribution proposes a measure that the United Nations Secretary General’s High-Level Panel on Access to Medicines could collaborate on to improve access to medicines in many countries: creating a global drug-pricing database. This database wouldn’t just include the price of drugs in the countries where they’re marketed, it would also contain important variables that affect access to them: whether a drug is reimbursed/financed or not, the therapeutic value compared to competing drugs, sales volumes, what the price would be if we adjust for GDP per capita for purchasing power parity, etc. 

Submission

An imbalance in available information is a key variable that determines whether a market is competitive or not. In the pharmaceutical market, where a large number of drugs are under patent, the lack of competition is evident, which results in access and availability problems in many countries around the world, especially low and middle income countries.

Policies to regulate drug prices aim to improve access, but the lack of transparency in the procedures, in the assessment and in the result make it hard know the final outcome: the price of the drug.

A public drug-pricing database would achieve greater market competition and better access. There have been several international experiences demonstrating that it is possible to implement a database of this nature.

Bibliography and References

Espin J., Rovira J., Olry de Labry A. Review series on pharmaceutical pricing policies and interventions: Working paper 1: External reference pricing. WHO Policy Review 2011.

Kanavos P., Nicod E., Espin J., van den Aardweg S. Short- and Long-Term Effects of Value-Based Pricing vs. External Price Referencing, (European Medicines Information Network –EMINET- 2011). DG Enterprise and Industry. European Commission.

Rovira Forns, Joan; Espin Balbino, Jaime. Acceso, Financiacion y Regulacion Economica de los Medicamentos (En Medicamentos. Entre la Salud y el Mercado). Icaria 2009. [Access, Financing and Economic Regulation of Medicines (In Medicines: Between Health and the Market)]

Jaime Espin (Original Language)

Lead Author: Jaime Espin
Organization: Andalusian School of Public Health
Country: Spain

Abstract

El precio de los medicamentos es una variable importante que determina un mejor acceso y su asequibilidad. Este precio debería venir determinado por variables como su valor terapéutico o su coste de producción, pero en el sistema actual el mecanismo de los precios internacionales de referencia está determinando que el precio de los medicamentos venga determinado por el precio de ese producto en otros país de mundo, lo que hace difícil para muchos países de renta media y baja el acceso a nuevos fármacos.

Mi contribución plantea una acción en la que el Panel de Alto Nivel sobre Acceso a los Medicamentos del Secretario General de las Naciones Unidas puede colaborar para mejorar el acceso a los medicamentos en muchos países: la creación de una base de datos mundial de precios de medicamentos. Esa base de datos no solamente incluiría el precio del medicamento en los países donde el medicamento está comercializado, sino también variables importantes que condicionarían su acceso: si está reembolsado/financiado o no, valor terapéutico con respecto a su comparador, volumen de ventas, cuál sería el precio en otro países si lo ajustamos por PIB per cápita por paridad de poder adquisitivo….

Submission

Las asimetrías de información son una de las variables más importantes que determinan que un mercado no sea competitivo. En el caso del mercado farmacéutico, donde un número importante de medicamentos están bajo patente, la falta de competencia es evidente lo que tiene como resultado problemas de acceso y asequibilidad en muchos países del mundo, especialmente a los de renta media y baja.

Las políticas de regulación de precios de los medicamentos pretende mejorar la accesibilidad, pero la falta de transparencia en los procedimientos, en la evaluación y en el resultado hace difícil saber el resultado final: el precio del medicamento.

Con una base de datos pública de precios de los medicamentos se conseguiría una mayor competencia en el mercado y un mejor acceso. Existen distintas experiencias en el ámbito internacional que avalan que es posible la puesta en marcha de una base de datos con estas características.

Bibliography and References

Espin J, Rovira J, Olry de Labry A. Review series on pharmaceutical pricing policies and interventions: Working paper 1: External reference pricing. WHO Policy Review 2011

Kanavos P, Nicod E, Espin J, van den Aardweg S. Short- and Long-Term Effects of Value-Based Pricing vs. External Price Referencing, (European Medicines Information Network –EMINET- 2011). DG Enterprise and Industry. European Commission

Rovira Forns, Joan; Espín Balbino, Jaime. Acceso, Financiación y Regulación Económica de los Medicamentos (En Medicamentos. Entre la Salud y el Mercado). Icaria 2009

James Freeman, GP2U TELEHEALTH

Lead Author: James Freeman
Additional Author: Dr. Andrew Hill
Organization: GP2U Telehealth, the FixHepC project, and St Stephens AIDS Trust, Chelsea and Westminster Hospital
Country: Australia; UK 

Abstract

Worldwide, public health could be rapidly advanced if a robust system existed to rapidly deploy generic versions of patented medications where the existing legal framework allows it. The experience with HIV has proven the power of generic medication to deliver impressive results, but sadly this experience is not being efficiently duplicated to other globally significant infectious diseases such as Hepatitis B and Hepatitis C.

If we look at the Who Model List of Essential Medicines we can observe the listing of Entecavir (for Hepatitis B) and Sofosbuvir and Daclatasvir (for Hepatitis C). Sadly, if we then look at the WHO List of Prequalified Active Pharmaceutical Ingredients, or the WHO List of Prequalified Medicinal Products, we do not find them available.

While patents present obvious challenges many countries either do not, or are not required under TRIPs to, recognize them, so generics are possible right now. With Entecavir the patents have either been rejected, expired or will expire by Mid 2016 presenting the opportunity to tackle Hepatitis B globally. Sadly the key preparations, such as prequalified APIs and Medications, have not yet been attended to.

The current prequalification process places considerations such as GMP and bioequivalence front and centre. In clinical medicine both doctor and patient are less concerned with provenance, and far more concerned with two pragmatic questions:

If I give this medication, from this manufacturer, to a patient:

• What are the chances of cure? and
• What are the chances of adverse effects?

We assert these two questions can be efficiently answered using the power of the crowd and the cloud through inexpensive distributed patient monitoring – in effect Phase 4 post marketing surveillance of generics already in use.

Proof is the ultimate yardstick.

We have built a prototype of this system and encouraging interim results are to hand.

Submission

Facilitating Proof of Concept Trials for low cost Generic medicines

Background

Worldwide, public health could be rapidly advanced if a robust system existed to rapidly deploy generic versions of patented medications where the existing legal framework allows it. Public health could be further enhanced if innovative new medications could reach the market faster.

“Big Pharma” is a heavily subsidised industry, and as always, subsidies distort markets. In routine business a company develops a product and sells it at a price consumers can afford. If the product is good enough, consumers buy it and not only are the R&D costs recovered, but a handsome profit is returned. Looking to big screen televisions we have not seen any of Sony, Teac or Samsung go out of business because of a competitive market. We have seen high initial prices rapidly fall, with increasing volumes compensating for reduced margins. Both workers and consumers have benefited from this increase in scale.

The key consumers of medications are government and insurers who provide the patient subsidies required to support prices that end users simply cannot afford. While this market distortion should be changed, doing so is complex and will take a great deal of time, so it will not be addressed directly here. Rather we will look at practical ways to deliver results in the short and medium term.

What we need from our pharmaceutical juggernauts is more innovation, and less duplication and ever-greening of existing ideas. Ever-greening refers to the process of extending an existing drugs patent life by submitting a minor change [1]. Unfortunately the current incentives have seen the truly innovative medications like the cholesterol lowering medication Simvastatin followed by no less than 8 “me too” sequels from different Pharma companies – Atorvastatin, Crivastatin, Fluvastatin, Lovastatin, Mevastatin, Pitavastatin, Pravastatin, Rosuvastatin [2,3].

Not only is such duplication a substantial waste of time, energy, and capital resources it also carries real risks – Crivastatin, a medication for which there was no real need, was withdrawn from the market following a number of deaths [4].

On this topic of risk we know that our Pharmaceutical manufacturers are less than 100% transparent with the data they deliver when seeking new drug approvals [5]. Entities like the US FDA simply check what is submitted but do not provide independent validation. The withdrawal of block buster drugs like Vioxx [6] and Avandia [7] after what is estimated at over 100,000 deaths [8] speaks loudly to the need for independent oversight, and this is precisely what we propose, however it is not oversight simply for the sake of it, it is oversight that delivers tangible benefits on a very low cost base by leveraging the power of crowd sourced data and cloud computing.

Recommendation

We propose that WHO set up a body that is independently administered and funded by WHO to provide open access medication monitoring, initially targeted at assessing the clinical efficacy of generic medications, and in the longer term expanding to provide resources useful for investigational Phase 1, 2 and 3 drug trials.

The impact of voluntary submission of generic medications to such a process is not limited to simply proving that that a generic medication works in clinical practice. It also provides a valuable mechanism to independently validate the claims relating to the original medication and might reasonably be expected to reveal issues that have previously not been reported. The knowledge that independent validation of results is likely is a powerful mechanism to ensure transparency.

We have built a prototype of this system and encouraging interim results are to hand in relation to generic versions of the Hepatitis C Direct Acting Antiviral (DAA) medications Sofosbuvir, Ledipasvir and Daclatasvir. If our late breaker abstract [ILC2016-LB-4611] is accepted these results will be presented at the European Association for the Study of the Liver (EASL) conference in April.

The experience with HIV has proven the power of generic medication to deliver impressive results, but sadly this experience is not being efficiently duplicated to other globally significant infectious diseases such as Hepatitis B (HBV) and Hepatitis C (HCV).

If we look to history we can see that the publication in the Lancet in 2004 of a study funded by Médecins Sans Frontières (MSF) and conducted in Cameroon was pivotal in provisioning confidence in HIV generics [9].

We have performed a similar study in Australia targeting HCV, but have leveraged cloud based Internet technology to allow reporting of results remotely from around the country. This study is called REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) [10] and we are hopeful it will have the same impact as the MSF trial in provisioning confidence in generics.

If we look at the Who Model List of Essential Medicines [11] we can observe the listing of Entecavir (for Hepatitis B) and Sofosbuvir, Ledipasvir and Daclatasvir (for Hepatitis C). Sadly, if we then look at the WHO List of Prequalified Active Pharmaceutical Ingredients [12], or the WHO List of Prequalified Medicinal Products [13], we do not find them available.

While patents present obvious challenges many countries either do not [14], or are not required under TRIPs to [15] recognize them, so in many locations generics could be delivering results right now. With Entecavir the patents have either been rejected, expired or will expire by Mid 2016 presenting the opportunity to tackle Hepatitis B globally. It is a matter of concern that key preparations, such as prequalified APIs and Medications, have not yet been attended to.

The current prequalification process places considerations such as GMP and bioequivalence front and centre. In clinical medicine both doctor and patient are less concerned with provenance, and far more concerned with two pragmatic questions:

If I give this medication, from this manufacturer, to a patient:

• What are the chances of cure? and
• What are the chances of adverse effects?

We assert these two questions can be efficiently answered using the power of the crowd and the cloud through inexpensive distributed patient monitoring – in effect Phase 4 post marketing surveillance of generics already in use.

Proof is the ultimate yardstick, and in our view a better way to judge the quality of a restaurant is to taste the food, rather than simply assess the quality of the fit out of the kitchen and assume everything will be all right.

In essence the system we have developed presents users with a single intuitive form to which data can be added. There are structured and unstructured data fields to fill in and a secure file repository where copies of results can be uploaded to validate the accuracy to any additions. Baseline demographics are gathered as part of the registration process, and reporting is real time and completely automated.

For example the overview looks like this:

Summary for EASL
n: 420
SOF+RIBA: 0.7% (3/420)
SOF+LED: 44.8% (188/420)
SOF+LED+RIBA: 4.8% (20/420)
SOF+DAC: 43.6% (183/420)
SOF+DAC+RIBA: 6.2% (26/420)
Naive: 48.3% (203/420)
Cirrhosis: 29.9% (121/420)
Mean Age: 54.3 years
Mean HCV RNA: 6.46 log IU/ml (2897317 IU/ml)
GT1: 63.6% (267/420)
GT2: 5.0% (21/420)
GT3: 28.1% (118/420)
GT4: 2.4% (10/420)
GT5: 0.2% (1/420)
GT6: 0.5% (2/420)

These numbers make this trial of generic medications larger than the majority of those sponsored by industry. It would in fact be the largest trial ever, however we are only tracking about 20% of the patients we know of on generics due to financial resource limitations. The trial has not excluded patients using criteria designed to improve the results so the sample represents something far closer to that which exists in the real world making the results far more relevant to clinicians.

On the subject of the financial requirements for such a system they are remarkably small. We built a rapid prototype leveraging an existing Telehealth platform and have found the unit cost per patient being monitored is approximately $140 to provision 1 labour day chasing down and validating results. This cost would be further reduced if the labour was provisioned in a country where cost are lower than our circa $20 per hour rate.

The beauty of cloud computing is that once the initial development costs have been covered the delivery cost per patient/drug unit is negligible and almost completely limited to labour, most of which is provided free by doctors and patients simply going about the business of treatment.

We estimate that turning our existing single disease focussed prototype into something completely generic could be achieved for under $2 million dollars and it could be done within 6 months. This low cost is because the vast majority of the work has already been done – it is only a small step from Telehealth, which in effect is a system to deliver care remotely, and what is proposed.

The entire project was bootstrapped from an initial seed of $200,000 so these numbers are not fanciful.

Short Term Goals

Worldwide the 5 big ticket causes of infectious disease death are Malaria, TB, HIV, Hepatitis B and Hepatitis C. Millions die annually from these.

Relatively recently effective treatments for Hepatitis B, and outright cure for Hepatitis C, have been invented and put to market. Sadly these treatments are not being deployed on a mass scale due to extremely high prices, so the fact of their invention is having a negligible impact on global health.

Taking the invention of the drug Sofosbuvir as an example we can observe that, although 150,000,000 people worldwide are infected with Hepatitis C, in the 3 years since this drug was approved a mere 613,000 [16] people have been treated with it.

In a tragedy of breathtaking proportions, during this same time period, 1,500,000 people have died due to lack of affordable access to Sofosbuvir. On current trends by the time the patent expires around 20,000,000 people who could have been saved will have perished unnecessarily.

Also looking at Sofosbuvir we can observe that the entire development cost was $325 million through to the end of Phase 2. We know this because the balance sheet of the company that was set up to develop it is public knowledge. The initial investors received a 30 x return for their risk which seems not entirely unreasonable. The 3 x return over the last 2 years on Gilead Sciences $11 billion investment buying the patent seems less reasonable [17], particularly when we look at the impact of the pricing structure on global health.

Hepatitis B is similar in scale, however the patent expiry presents the opportunity to treat everyone, everywhere, and do it now.

Generic medications offer the solution and our goal is to see them clinically validated to provision the confidence to deploy them on mass scale. This can be achieved without the need for legislative changes.

Longer Term Goals

The time taken to bring a new drug to the market has risen from approximately 3 years in 1960 to 12 years at the start of the new millennium [18] The barriers to entry in the realm of new medications are currently so substantial that innovators struggle to find sufficient capital to take a product all the way from concept and invention through to final marketing approval.
There is a staggering untapped capacity for countries such as China and India to drive not only generic drug production, but also new innovation. A major barrier is the path to market and the current cost of clinical trials to validate the utility of a new medication.

It is relatively easy to envision how a system initially used to monitor generic drugs in post marketing surveillance could also be utilised for the pre-marketing trials. This would vastly reduce the barriers to entry for new and innovative manufacturers to the benefit of the entire world.

A major global trend is that medication prices have been increasing far faster than GDP growth [19]. While there is little doubt regulatory changes can address competition will remain an effective tool in the battle to control rising medication prices.

Provisioning generic tools to assist the deployment of generic medications is a simple and actionable step forward and could help restore balance to a distorted market that is currently failing to deliver treatment to the world, even where such treatment exists.

The WHO Constitution enshrines:

“…the highest attainable standard of health as a fundamental right of every human being.”

When Jonas Salk invented polio vaccine he did not patent it. When asked why he said "You can't patent the sun". Humanity as a whole continues to reap the benefits.

While it would be unreasonable to expect such generosity in our modern self centric times, it is entirely possible to regain a middle ground that more equitably balances patent rights, with patient rights.

Bibliography and References

References:

1) New drugs for old http://www.australianprescriber.com/magazine/29/6/148/9
2) List of Statin Medications https://en.wikipedia.org/wiki/Statin
3) Lovastatin and beyond: the history of the HMG-CoA reductase inhibitors http://www.nature.com/nrd/journal/v2/n7/full/nrd1112.html
4) Withdrawal of cerivastatin from the world market http://www.ncbi.nlm.nih.gov/pmc/articles/PMC59524/
5) Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012 http://bmjopen.bmj.com/content/5/11/e009758.full.pdf
6) FDA Public Health Advisory: Safety of Vioxx http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm
7) FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl http://www.fda.gov/Drugs/DrugSafety/ucm255005.htm
8) First do no harm. Improving drug safety through legislation and independent research http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2267386/
9) An advance for HIV/AIDS treatment access in the developing countries http://www.msfaccess.org/resources/press-releases/632
10) Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods (REDEMPTION) https://clinicaltrials.gov/ct2/show/NCT02657694
11) WHO List of Essential Medicines - http://www.who.int/selection_medicines/committees/expert/20/EML_2015_FINAL_amended_AUG2015.pdf
12) WHO List of Prequalified Active Pharmaceutical Ingredients (APIs) - (Updated 19 February 2016) http://apps.who.int/prequal/lists/API/2016/API_PQ-List_V3_19February2016.xlsx
13) WHO List of Prequalified Medicinal Products http://apps.who.int/prequal/ (use a blank search to bring up the entire list)
14) WHO updates patent information on sofosbuvir and ledipasvir for the treatment of Hepatitic C Virus http://www.who.int/phi/implementation/ip_trade/ip_patent_landscapes/en/
15) Agreement on Trade-Related Aspects of Intellectual Property Rights https://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm
16) Gilead's Sovaldi Tied to Slow Heartbeat in Hepatitis C Patients http://www.bloomberg.com/news/articles/2015-11-04/gilead-s-sovaldi-tied-to-slow-heartbeat-in-hepatitis-c-patients
17) The Real Development Cost of Sofosbuvir http://fixhepc.com/blog/item/25-the-real-development-cost-of-sofosbuvir.html
18) Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK http://bmjopen.bmj.com/content/3/2/e002088.full.pdf+html
19) Can the U.S. Afford New Prescription Drugs Headed to the Market? http://www.usnews.com/news/articles/2015/07/28/expensive-prescription-drugs-contribute-to-growth-in-health-care-spending

Kristine Husoy Onarheim, The Lancet Youth Commission on Essential Medicines Policies

Lead Author: Kristine Husoy Onarheim
Additional Authors: Members of the Lancet Youth Commission on Essential Medicines Policies
Organization: The Lancet Youth Commission on Essential Medicines Policies
Country: Norway

Abstract

The Lancet Youth Commission on Essential Medicines Policies (YCEMP) was convened in March 2015 to examine access and promotion policies for Essential Medicines worldwide through a youth lens. YCEMP is comprised of 17 young professionals from 15 different countries, representing every region in the world.

We believe medicines should be available to all who need them, for both individuals and societies to realize their full potential, and to realize the human right to health and the right to science and culture, as recognised in the United Nations International Covenant on Economic, Social and Cultural Rights. This makes sense from both a public health perspective, and an economic perspective.

To achieve this, scientific progress and knowledge should be acknowledged as global public goods. This has significant implications for the current intellectual property and trade system, which places a disproportionate emphasis on the rights of innovators. Although those who develop drugs should benefit from their work, this cannot be at the expense of human lives. We can no longer tolerate a situation wherein the majority of the world does not have the opportunity to benefit from these developments. Indeed, the problems in the current systems restricting access to medicines, such as unaffordability, will increasingly apply to all countries as costs of healthcare continue to rise dramatically, and new drugs are created.

In this submission, we outline specific recommendations for the High Level Panel to consider for Member States. We recommend:
1. To implement research and development (R&D) models that incentivize innovation based on global health need and facilitate access to knowledge; and
2. For Member States to develop and implement legislation mandating transparency of R&D costs and prices associated with pharmaceutical, diagnostics, and vaccine research, development, and production.

Submission

RECOMMENDATION 1
Implementation of R&D models that incentivize innovation based on global health need and facilitate access to knowledge, from basic research to end products, for all in need

Currently, the research and development (R&D) of pharmaceuticals and other medical technologies is a market-based system, where innovation of new treatments is primarily driven by profitability rather than patient need. The majority of medicines are developed for patient populations in high-income countries, rather than those in low- and middle-income countries. This is a paradox, as the major burden of disease affects people in low- and middle income countries (IHME, 2013). By focusing on developing drugs for patients with the ability to pay high prices for drugs, pharmaceutical companies and their investors are ensured high returns on investment (WHO 2012; Røttingen et al. 2013). The current model for R&D incentivizes developers to recoup their investments by the price they set for the medicines product. For these reasons, newly-released drugs are often priced highly, as occurred when antiretroviral drugs were first released, and as has been seen with newer cancer drugs (Abboud et al 2013 ref). Through the patent system, pharmaceutical developers are awarded a monopoly on drugs they develop for up to 20 years, which allow them to determine drug price without reference to competitor activity within the market. Moreover, certain classes of drugs can be awarded extended monopoly period through additional intellectual property rights such as data or market exclusivity.

When patients or governments cannot afford to pay for highly priced drugs, there is little incentive for pharmaceutical companies to invest in R&D to produce drugs for those markets. The lack of financial incentive for R&D based on global health needs has been widely acknowledged (WHO 2006; WHO 2008; WHO 2012; MSF 2015; KEI 2014; HAI 2012; IFPMA 2013). The poor are particularly vulnerable; for example, in relation to the lack of development of new drugs for neglected tropical diseases.
While some argue that a model wherein private companies are adequately compensated such that R&D costs are reimbursed and sufficient profits are garnered is the only one that will incentivize necessary development of new drugs, YCEMP is concerned about the efficiency and effectiveness of the present system. Current monopoly rights of 20 years result in high prices for patients and health systems, with significant implications for resource allocation. Further, privatized knowledge and patented products does not necessarily result in more innovation: in fact, this can delay further developments of ideas, and skew production incentives towards low-risk propositions that add minimal value in respect of health outcomes. Of the medicines currently being developed, 85-90% have little or no added therapeutic value compared to current treatment options (Light and Lexchin 2012).

The goal of R&D should be to produce the most necessary medicines based on global disease burden, with products of such R&D made widely available at affordable prices.
To reach this goal, we recommend the following changes to reform and realign the R&D system:
1. Knowledge should be considered a global public good: We argue that knowledge – from basic scientific research through to development of end products – should be secured as global public goods, not private goods as they are in the current system. Stiglitz (1995) defines a global public good as a good that is not necessarily only both non-rivalrous and non-excludable, as per the traditional definition of Samuelson (1954), but of value worldwide. As a global public good, we envisage knowledge relating to medical R&D being made widely available, which can facilitate development of new drugs for the public. To facilitate this, alternative mechanisms are needed. The important work by the WHO CEWG gives guidance on how this can be ensured through various approaches including open-source collaboration and open access mechanisms; pooling of intellectual property and financing; and global coordination through establishing of a R&D observatory. These recommendations can be acted upon, and can provide incentives that can align and ensure the interests and rights of inventors, international human rights law, trade rules and public health.
2. A delinked R&D system: the costs of innovation and production should be delinked. When R&D is delinked, the end price of the product is unconnected to the development costs (Chatham House, 2015). Through post-registration delinkage, revenues are awarded to the developer of the medicine after successful registration of the product with a stringent regulatory authority such as the FDA or EMA, or ‘prequalification’ through the WHO prequalification programme. If the developer is ensured certain revenues, medicines can be produced and sold at a price close to that of production. In a delinked system, a reward is accrued for the innovative idea itself, rather than the development or production process. Hence, there can be several producers and the price do no longer have to be set with the purpose of recovering R&D expenses. When monopoly rights are removed, this should open up markets for competition between different actors, which generally facilitates sale of medications at lower prices.
3. Global financing mechanisms should be implemented to support R&D according to global health needs
In the current system pharmaceutical companies – and, in turn, payers – bear the burden of cost of development. However, alternative funding mechanisms for drug development must ensure that research to develop new products takes places according to global health need. We envision that, in order to support R&D as a global public good, additional financial incentives are needed. Moreover, as medicines are different from other private goods, public financing is needed.

YCEMP is of the view that, as R&D is a global challenge, countries should share the burden of costs of innovation through shared financing mechanisms: i.e. through global pooled funding. Member States should reach agreement that, through a global R&D treaty, funds can be contributed annually at a rate of 0.01% of GDP that will be used to develop drugs that can be used worldwide (WHO 2012).

While earlier funding mechanisms have focused on illnesses that are almost exclusively poverty-related (e.g. drugs for neglected tropical diseases) we argue that the creation of a global fund for needs-driven R&D should be broader. This is because market failures go beyond tropical diseases; looking into the future, greater investment in drugs to treat NCDs (which increasingly constitute a large proportion of the worldwide disease burden) will be necessary globally, not just in certain regions. Looking towards 2030, financing mechanisms should focus on global health need, and include R&D on all drugs, for all diseases, as the burden of disease in LMICs and HIC are overlapping (WHO 2016). This will also benefit public health care systems that struggle with high prices, which is of importance as countries move towards universal health coverage.

Milestone prizes or other alternative financing mechanisms can be promoted by country governments and other stakeholders to speed up the process for development by offering financial reward for reaching intermediate steps in exchange for the intellectual property rights (WHO, 2012).


RECOMMENDATION 2
Development of legislation across Member States mandating transparency of R&D costs and prices associated with pharmaceutical, diagnostics, and vaccine research, development, and production

High drug prices are contributing to an increasing percentage of individual healthcare-related expenses, particularly in situations where out-of-pocket expenditures towards health care are common, but also in health systems in which reimbursement for medicines is undertaken collectively. The issues of high drug prices is not limited to LMICs alone, as evidenced by reports by IMS Health which estimated that 8.4 million fewer prescriptions in the U.S. been filled in 2014 compared to 2013 due to cost concerns (IMS Institute for Healthcare Informatics, 2014). These concerns around the affordability of pharmaceuticals in all countries will become even greater as new, personalized medicines and other biologics drugs are expected to enter the market (Murugan 2015; PhRMA 2013).

As national health systems move towards their commitment implement universal health care coverage under the Sustainable Development Goals, they are called upon to provide financial risk protection by ensuring affordable access to healthcare services including essential medicines (WHO 2014). To achieve this, States must “expand priority services, include more people and reduce out-of-pocket payments” (Ottersen, 2014). For universal health coverage to be truly realized, health care services and drugs must be wholly or substantially subsidized to ensure financial risk protection for citizens (Ottersen, 2014, WHO 2010)).

Moreover, in deciding how to move towards universal health coverage, countries are also tasked with selecting which services to expand first. It has been suggested that countries base their ranking of highly prioritized services based on criterion related to cost–effectiveness, prioritizing those populations who are worst-off, and financial risk protection (WHO, 2014).

When looking at cost-effectiveness data pertaining to medicines, we argue that these estimates should not be based on manufacturer-set price, which frequently bears no relation to the costs of R&D and production of the medication in question (Henry and Searles, 2012). Indeed, medication prices are frequently determined by what the market will bear, as opposed to considerations for maximising access (The Economist, 2015). Instead, policymakers should consider the actual cost of creation of the medication. In order to do so, production costs data has to be made publicly available. If these data are not available, societies and countries can make uninformed decisions in negotiating the prices of drugs with manufacturers, with implications for patients and health systems. Accordingly, manufacturers should be required to report on the specific cost inputs of R&D of each drug that is sold on the market, through implementation of legislation at the national level mandating cost transparency.

This type of legislation has already been proposed in six states in the U.S. in 2015 and within the White House budget proposal for the Fiscal Year 2017 (Policy and Medicine, 2015; Office of Management and Budget, 2016). The proposals outlined in American bills are very promising and include reporting of production costs including R&D, manufacturing, and regulatory costs as well as the contributions to drug development by public institutions such as government grants. This has to be supplemented with additional cost information towards administration, marketing and advertising. Moreover, the legislation also calls for transparency of prices towards payers including public and private insurers, pharmacies, and others. Finally, the manufacturer must also disclose the profits yielded based on these prices. All of this information is to be reported to the relevant government agency on an annual basis, with provisions to make the information publicly available and to be used to negotiate prices for those drugs found to be major contributors to health budgets.

YCEMP supports the introduction of such legislation. We also recommend having an independent, autonomous body to audit and approve data submitted concerning costs, before publication. This would allow the public and experts to scrutinize the data provided, and allow comparison of the R&D cost to the actual return of investment on each medicine. Furthermore, the pharmaceutical industry must make the marginal cost of producing a product publically available. These statutory mechanisms should apply to all medicines approved for national use, and not only essential medicines. It can take years before newer medicines are added to WHO Model Essential Medicines List and/or national Essential Medicines Lists, often based on concerns around pricing; for this reason, all medicines approved for use by States should therefore be included in the legislation.

National governments would be responsible for introducing and enforcing these bills, supported by institutional and technical bodies holding actors accountable. Further, this new knowledge about production costs should enable policy makers and executives to use this information to negotiate better prices at the country level.

Bibliography and References

References and bibliography

Abboud, C., et al. (2013). "The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts." Blood 121(22): 4439-4442.

Chatham House Report (2015), edited by Charles Clift, Unni Gopinathan, Chantal Morel, Kevin Outterson, John-Arne Røttingen and Anthony So; Towards a New Global Business Model for Antibiotics Delinking Revenues from Sales

The Economist (4 June 2015), Crippling. Available from: http://www.economist.com/blogs/democracyinamerica/2015/06/pharmaceutical-pricing

HAI (2012), Follow up of the CEWG report. WHA66 – Intervention agenda item 17.2. Health Action International. Available from: http://haieurope.org/wp-content/uploads/2013/10/Intervention-Stichting-Health-Action-International-item-17.2.pdf

Henry, D and Searles, A, (2012), “Chapter 9: Pharmaceutical Pricing Policy” in Managing Access to Medicines and Health Technologies. Management Sciences for Health, Arlington, USA. Available from: http://apps.who.int/medicinedocs/documents/s19585en/s19585en.pdf

IFPMA (2013), Statement: Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination. WHO WHA 66, agenda item 17.2. International Federation of Pharmaceutical Manufacturers & Associations. Available from: http://www.ifpma.org/events/statements/browse/2.html [Accessed August 31, 2015].

Institute for Health Metrics and Evaluation (IHME) (2013), The Global Burden of Disease: Generating Evidence, Guiding Policy. University of Washington, USA.

KEI, (2014), World Health Assembly (WHA 67) agrees to create pooled R&D fund, endorses delinkage of R&D costs from product prices. Knowledge Ecology International. Available from: http://keionline.org/node/2015

Light, D.W. & Lexchin, J.R., (2012). Pharmaceutical research and development: what do we get for all that money? BMJ (Clinical research ed.), 345(aug07_1), p.e4348. Available from: http://www.bmj.com/content/345/bmj.e4348 [Accessed April 23, 2015].

MSF, (2015), The urgent need for new tools to prevent, diagnose and treat medical needs in humanitarian emergencies. [Statement: World Humanitarian Summit]. Médecins Sans Frontières. Available from: https://www.worldhumanitariansummit.org/node/504363

Office of Management and Budget (2016). The President’s Budget for Fiscal Year 2017. The White House. Available from: https://www.whitehouse.gov/sites/default/files/omb/budget/fy2017/assets/budget.pdf

Ottersen, T., et al. (2014). Making fair choices on the path to universal health coverage. Bulletin of the World Health Organization, 92(6):389.

Policy and Medicine (2015), New York Introduces Pharmaceutical Cost Transparency Bill. Policy and Medicine. Available from: http://www.policymed.com/2015/05/new-york-introduces-pharmaceutical-cost-transparency-bill.html [Accessed November 13, 2015].

Samuelson, P. (1954), The Pure Theory of Public Expenditure. Review of Economics and Statistics 36 (4): 387-389.

Stiglitz, J (1999), Knowledge as a global public good. In: Kaul I, Grunberg I, Stern MA, editors. Global public goods: international cooperation in the 21st century. New York: Oxford University Press; 1999. Available from: http://web.undp.org/globalpublicgoods/TheBook/globalpublicgoods.pdf

Røttingen, J.-A. et al, (2013), Mapping of available health research and development data: what's there, what's missing, and what role is there for a global observatory? Lancet, 382(9900):1286-1307. Available from: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)61046-6/abstract

WHO (2006), Public Health, innovation and intellectual property rights. Report by the commission on intellectual property rights, innovation and public health, Geneva. Available from: http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf [Accessed August 27, 2015].

WHO (2008), Global strategy and plan of action on public health, innovation and intellectual property. Sixty-first World Health Assembly, 19–24 May 2008, Resolution WHA61.21, Geneva. Available from: http://apps.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf [Accessed August 27, 2015].
WHO (2010), Health systems financing: the path to universal coverage. Available from: http://www.who.int/whr/2010/en/ [Accessed February 28, 2016]

WHO (2012), Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination. The report of the Consultative Expert Working Group on Research and Development: Financing and Coordination, Geneva. Available at: http://www.who.int/phi/CEWG_Report_5_April_2012.pdf?ua=1 [Accessed August 27, 2015].

WHO (2016), Projections of mortality and burden of disease, 2002-2030. From website; http://www.who.int/healthinfo/global_burden_disease/projections2002/en/ [Accessed Februrary 28, 2016]

Dzintars Gotham, THE 8E TASK FORCE

Lead Author: Dzintars Gotham
Additional Authors: Kristine Onarheim and Melissa Barber
Organization: The 8E Task Force
Country: UK; Norway; South Africa

Abstract

In this submission, we look at the Millennium Development Goals (MDG) and new Sustainable Development Goals (SDG) as a tool to improve Access to Medicines. This submission is relevant to the work of the High Level Panel on how progress to meet these overarching goals are measured and monitored. We have looked at 8.E as an example to illustrate measurement and accountability challenges when aiming to meet targets and indicators. In particular, the submission focus on accountability for SDG 3 and the sustainable development agenda. We argue that to be able to evaluate progress, better systems for measurement and accountability is needed as a baseline to evaluate progress towards the SDGs and improved access to medicines, vaccines and diagnostics. The High Level Panel should in its recommendation address the following issues:
1. The UN should affirm that increased data collection efforts will always precede abandonment of a target/indicator;
2. Decisions to change or abandon data collection for, and the reporting of, goals, targets or indicators, should undergo a robustly transparent and accountable process, including consultation of stakeholders such as member states, civil society and academia;
3. Decisions on the absolute and relative (as applicable) levels of resources allocated should be needs-based, rational, accountable, and based in a consultative decision-making process;
4. Additional funding will be needed to support better and appropriate data collection and reporting.

Submission

Background and aim of submission

The High-Level Panel on Access to Medicines (HLP) calls for input to “address the misalignment between the rights of inventors, international human rights law, trade rules and public health where it impedes the innovation of and access to health technologies,” with attention to contributions that can promote health and wellbeing, as outlined in the SDGs, and particularly for SDG 3. This submission is relevant to the work of the HLP in how these global goals are measured and monitored. We looked at Millennium Development Goal (MDG) target 8.E - the target on access to medicines - to illustrate measurement and accountability challenges when aiming to meet targets and indicators. In particular, our submission focuses on accountability for SDG 3. We argue that to be able to evaluate progress towards targets, better systems for measurement and accountability will be needed.

The 2000 Millennium Summit in New York set out an ambitious agenda for poverty reduction. Few imagined that the agenda, and later developed goals, targets, and indicators would be as crucial as we now know.

Global goals have significant influence on the agendas and financing of governments, international organizations, NGOs, the private sector, and civil society.(1) Global goals offer attention and focus, and have real implications for the opportunities and lives of people.

For several years, MDG 8.E was excluded from the yearly MDG reports. In this submission, we would like to draw the attention to shortcomings in the monitoring of the MDG target MDG on access to medicines, and the lack of accountability and transparency that accompanied these shortcomings.

The lessons learnt are highly relevant to new metrics that will be used to monitor progress towards reaching the SDGs.(2)

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Target 8.E

A comment article on the story of MDG target 8E has recently been accepted for publication in The Lancet Global Health.(3)

Target E of Millennium Development Goal 8 was: “In cooperation with pharmaceutical companies, provide access to affordable essential drugs in developing countries”.

Six MDG progress reports, from the 2008 report up until the 2015 report, make no mention of target 8E whatsoever. All other targets, including 8D and 8F, are mentioned and reported on in the reports. Having noticed this in early 2015, we began to make inquiries into the omission from the main MDG progress report. The 2015 MDG progress report, published later that year, once again included 8E - but only as an abrupt note that data in the area was lacking.

While the separate MDG Gap task force has reported on target 8E every year, the data has been very lacking.(4) The data reported by is based on only 26 country surveys conducted over 7 years (as of 2015).(5) For many other targets, data from over a hundred countries is available, owing to significant efforts to scale up the monitoring and reporting of respective indicators.(6)

The Friends of the Chair group recommended that 8E have “special effort [...] put into setting up data collections to provide the information”, or, alternatively, be changed or abandoned, recommending that priority should be given to “established” indicators that are “closely related to existing data collection programmes”.(7)

We find this line of argumentation taken in the 2005 Report of the Friends of the Chair concerning. The Friends of the Chair assert that a) 'established' indicators should be favoured, and that b) the metric 'proportion of the population with access to essential medicines' is not 'established'. The establishment of Goals and targets implies, by definition, that new actions need to be taken to change the status quo. It is not surprising that areas of human wellbeing in which gaps are identified (gaps that are to be filled by reaching a Goal) will also have gaps in knowledge and measurement. In our view, it is very clear that the mandate to continually create and improve relevant metrics and measurement techniques is an inalienable part of the mandate of the targets and Goals themselves. While deficiencies in data availability and measurement techniques for indicator 8.13 should have prompted “special effort [to be] put into setting up data collections to provide the information”, as the Friends of the Chair proposed, it was simply swept under the carpet: after a string of inquiries, we were eventually told by a senior employee at the UN Statistics Division that “[t]he decision not to report on the indicator for target 8E was made by the WHO representatives in the [Inter-Agency Expert Group] [...] A few years ago they decided to focus on HIV/AIDS treatment and stopped reporting on the rest” (email communication, 14 May 2015).

Put in simple terms, when it was found that data for an indicator was not already being collected by non-UN entities (such as governments) without ‘special effort’ being put into it, a small group, without broad consultation or publicly visible discussion, opted to abandon the indicator. As the mandate to strengthen indicators is a part of the mandate to strive towards the Goals, this is tantamount to a semi-clandestine abandonment of part of a mandated development agenda. While we recognise that bodies tasked with technical statistical tasks need some flexibility in order to function (the General Assembly cannot be asked to reach unanimity on every statistical calculation used), we feel that a decision to deprioritise a whole target in favour of a different target under a different Goal clearly lies outside the flexibility needed for technical work.

For the SDGs, we thus recommend that
The UN should affirm that increased data collection efforts will always precede abandonment of a target/indicator;
Decisions to change or abandon data collection for, and the reporting of, indicators, should undergo a robustly transparent and accountable process, including consultation of stakeholders such as member states, civil society, and academia;
Decisions on the absolute and relative (as applicable) levels of investment should be needs-based, rational, accountable, and based in a democratic decision-making process.

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From 8E to the proposed SDG indicators

Indicators analogous to the MDGs’ indicator on access to affordable medicines have been proposed as SDG indicators.

SDG targets and indicators on access to affordable medicines will demand sufficient political investment for robust measurement. In the MDGs, monitoring of access to medicines was done in collaboration between Health Action International - a non-governmental organisation (NGO) -and the WHO. NGOs have historically been key in both reporting and advocating for policy changes in the area of access to medicines. However, it is worth noting that 8E, debatably, is the only target of the MDGs’ 21 targets for which data collection was done chiefly by an NGO. While it is not clear how large a part this fact played in what we argue was the deprioritisation of the target, it comes to our attention that this may reflect an element of lower resource allocation.

We note that progress on other MDG goals and targets such as child and maternal health has received attention. These indicators have been monitored by the UN itself through the WHO, but also by external actors such as the Institute of Health Metrics and Evaluation .(8-9) Further, initiatives such as “Countdown to 2015” has monitored country progress on the MDG targets and indicators as well as coverage levels for maternal, newborn and child health interventions.(10)

For the MDG indicator (8.13) on access to medicines, data reported in 2015 was based on survey data from 26 countries conducted over 7 years - enough data for a global median of very limited representativeness, but nowhere near the amount of data that would be necessary for true country-level comparisons and progress-tracking.(5) Compared to the data that has been collected and analyzed for other health MDGs - such as maternal and child health - the data used for monitoring of 8.13 illustrate that access to medicines needs further attention.

While many of the suggested SDG indicators are relevant for access to medicines, some are of particular relevance. In our view targets 3.8 and 3.b are the targets most directly relevant to access to medicines. The suggested indicators for these targets are:

3.8.1 Coverage of tracer interventions (e.g. child full immunization, antiretroviral therapy, tuberculosis treatment, hypertension treatment, skilled attendant at birth, etc.)
3.8.2 Fraction of the population protected against catastrophic/impoverishing out-of-pocket health expenditure
3.b.1 Proportion of the population with access to affordable medicines and vaccines on a sustainable basis
3.b.2 Total net official development assistance to the medical research and basic health sectors

For indicators 3.8.1 and 3.8.2, it is suggested that data can be based on data already collected by WHO and World Bank. Details are provided on how these can be collected and analyzed, including information numerators to be used and disaggregated data to be collected. We are however concerned regarding the proposed indicators 3.b.1 and 3.b.2. Compared to other indicators for SDG 3, these indicators include noticeably little information on how data should be collected or monitored, and who will held accountable and responsible to collect the data.(11) Considering that the SDGs include 167 targets, as opposed to the MDGs’ 21, we are concerned that this lack of detail early in the SDG process is reflective of the area receiving little attention, and may be a harbinger for future neglect.

Importantly, adequate financing will be needed to support better data to monitor these indicators. From the lessons learnt from tracing the story of target 8E and its indicator 8.13, it is obvious to us the in order to be adequate, financing will need to be significantly increased.

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Conclusion

Decisions regarding target 8.E were made without consultation with relevant stakeholders and without broader acknowledgement. In our view, this undermines the inclusion of access to medicines as a genuine and crucial part of the development agenda. The HLP can highlight the challenges in measurement of globally agreed targets for access to medicines. Better processes in ensuring accountability, and financing of monitoring processes, is key to meeting the SDGs and fulfilling the human right to health.

Bibliography and References

1. Waage J, Banerji R, Campbell O, et al. The millennium development goals: A cross-sectoral analysis and principles for goal setting after 2015: Lancet and London international development centre commission. Lancet 2010; 376: 991– 1023.

2. United Nations Economic and Social Council. Report of the Inter-Agency and Expert Group on Sustainable Development Goal Indicators. 2015. http://undocs.org/E/CN.3/2016/2 (accessed Feb 18, 2016).

3. Gotham D, Onarheim KH, Barber MJ. How the Millennium Development Goals gave up on measuring access to medicines. Lancet Global Health (in press, 2016)

4. United Nations Department of Economic and Social Affairs Development Policy and Analysis Division. MDG Gap Task Force Reports. http://www.un.org/en/development/desa/policy/mdg_gap/mdg_gap_archive.shtml (accessed Feb 18, 2016).

5. United Nations. Millennium Development Goals Reports. http://www.un.org/millenniumgoals/reports.shtml (accessed Feb 18, 2016).

6. United Nations Statistics Division. Data Availability by Series. http://mdgs.un.org/unsd/mdg/DataAvailability.aspx (accessed Feb 18, 2016).

7. United Nations Economic and Social Council. Report of the Friends of the Chair on Millennium Development Goals indicators. 2005. http://undocs.org/E/CN.3/2006/15 (accessed Feb 18, 2016).

8. Kassebaum NJ et al (2014). "Global, regional, and national levels and causes of maternal mortality during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013." The Lancet.

9. Wang H et al (2014). "Global, regional, and national levels of neonatal, infant, and under-5 mortality during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013." Lancet 384(9947): 957-979.

10 Victora CG, Requejo JH, Barros AJD, et al. Countdown to 2015: a decade of tracking progress for maternal, newborn, and child survival. Lancet (London, England) 2015; 6736: 1–11.

11. Inter-agency Expert Group on SDG Indicators. Compilation of Metadata for the Proposed Global Indicators for the Review of the 2030 Agenda for Sustainable Development:
Goal 3 Ensure healthy lives and promote well-being for all at all ages. http://unstats.un.org/sdgs/files/metadata-compilation/Metadata-Goal-3.pdf (accessed Feb 18, 2016).

Damiano de Felice, ACCESS TO MEDICINE FOUNDATION

Lead Author: Damiano de Felice  
Organization: Access to Medicine Foundation
Country: The Netherlands

Abstract

This contribution focuses on the Access to Medicine Index as the most authoritative example of an independent ranking and report that incentivizes pharmaceutical companies to maximise their efforts to improve access to medicine.

As a complement (not a substitute) to other policy and financial initiatives, the Access to Medicine Index offers an incremental solution to the misalignment between the rights of inventors, international human rights law, trade rules and public health because it stimulates pharmaceutical companies (1) to engage in innovative R&D activities targeted toward need and known product gap and (2) to enhance access to their products through responsible and effective strategies in business areas such as pricing and IP management.

The Access to Medicine Index triggers corporate action in several ways:
- It builds multi-stakeholder consensus on what the corporate responsibility to respect human rights means for the pharmaceutical industry (thus providing detailed guidance to companies and clear standards for external accountability)
- It prompts collection and disclosure of corporate information (thus enabling better internal management and stronger external tracking)
- It creates a race to do better by ranking companies one against the other
- It diffuses good practices through publication of reports and direct engagement with companies
- It empowers internal change-makers by raising the visibility of access-to-medicine issues and generating “wake-up” calls in case of low performance
- It unleashes pressure from external stakeholders, such as long-term investors, by providing comparative data on corporate performance

In February 2016, a year-long independent evaluation of the Access to Medicine Index found that the tool “has made commendable contributions towards advancing the engagement of the pharmaceutical industry with the issue of access to medicine”. The Index acted as “a catalyst for accelerating ongoing access-to-medicine activities and as an inspiration for development of new activities.”

Submission

IMPACT ON POLICY COHERENCE

The problem of access to health technologies is complex and multifaceted. Numerous actors, including governments, NGOs, academia, financial institutions and multilateral organisation, must play a role to tackle it. As developers and manufacturers of life-saving products, pharmaceutical companies clearly have crucial responsibilities too.

The Access to Medicine Index is an independent ranking and report of 20 of the world’s largest research-based pharmaceutical companies based on their efforts to improve access to medicine for people living in low and middle income countries. The Index uses a weighted analytical framework of 83 indicators to consistently capture and compare company data across 107 countries (including middle income countries with large inequalities), 50 diseases (10 communicable diseases, 14 non-communicable disease, 17 neglected tropical diseases and 9 maternal and neonatal health conditions), and 8 product types (medicines, microbicides, therapeutic vaccines, preventive vaccines, diagnostics, vector control products, contraceptive methods & devices, platform technologies). The framework is constructed along seven areas of focus: governance, ethics, research and development, pricing, intellectual property management, health system strengthening and product donations.

Funded by the Bill & Melinda Gates Foundation and the UK and Dutch governments, the Index has been published by the Access to Medicine Foundation every two years since 2008. Each Access to Medicine Index is the result of a two-year process known as the ‘Index cycle.’ During the first year of the cycle, the Access to Medicine Foundation embarks in a targeted process of multi-stakeholder consultation to refine and validate the Index methodology. Year two is spent collecting, analysing and verifying data from pharmaceutical companies. When the results are published in a new ranking and report, the Access to Medicine Foundation makes sure that relevant findings reach key internal and external change-makers.

The Access to Medicine Index reduces the incoherence between the financial expectations of investors and the human rights responsibilities of pharmaceutical companies through several, mutually-reinforcing mechanisms of influence.

It is important to emphasize two points before describing these mechanisms of influence.

First, the mechanisms of influence have been recently tested in an independent evaluation of the Access to Medicine Index conducted by Technopolis Group. The evaluation concluded that “the Index can be viewed as a catalyst for accelerating ongoing ATM activities and as an inspiration for development of new activities. Companies’ willingness to concede that the Index is used internally as a tool for learning and strategy formulation, whilst even welcoming greater use of the Index by external stakeholders, speaks to the importance that many companies attribute to the Index. The Access to Medicine Index should therefore be seen as a valuable contributor to change in a complex environment fraught with competing influences.”

Second, the strength of the Access to Medicine Index lies in the fact that, whatever international standards, policy environments or financial incentives, there will always be room for companies to behave more or less responsibly, for business leaders to take access to medicine more or less seriously. The Access to Medicine Index triggers basic processes of transparency, accountability, competition and learning which are particularly helpful to prevent companies from taking advantage of the loopholes and limitations of any other potentially useful interventions (for instance, policy changes to mitigate patent protection and/or push and pull mechanisms to incentivize innovation). In this light, the Index should not be seen as a substitute, but, yes, as a powerful complement of other initiatives.

1) An independent ranking and report builds consensus on “authoritative focal points” and actionable standards

Senior managers, patients, investors, officers of international organizations, activists, etc. often hold diverging views on the responsibilities of pharmaceutical companies in facilitating access to medicine. This is problematic because the pharmaceutical industry lacks concrete guidance on how to best respond to societal pressure. Moreover, external stakeholders cannot hold the industry to account using mutually-agreed-upon standards.

The process of developing the methodology and indicators for the Access to Medicine Index builds consensus on what society expects from pharmaceutical companies. For each successive Index, representatives from relevant stakeholder groups (including investors, NGOs, international organizations, business associations, patient organizations, etc.) are brought to the table in order to improve and validate the methodology. Participation by business representatives also encourages ownership of the problem.

2) An independent ranking and report prompts transparency and enables accountability towards international targets

The accountability processes of most global health and international development targets, such as the Sustainable Development Goals, still mainly focus on government actions and metrics. While there is increasing recognition of the role of the private sectors to achieve these targets, there is almost no mechanisms (for companies and external stakeholders alike) to track corporate progress.

The Access to Medicine Index offers the potential of a multi-stakeholder accountability mechanism for the contribution of pharmaceutical companies to global health and sustainable development targets. For instance, the MDGs Gap Task Force reported the results of the 2012 Access to Medicine Index because it recognized that “[i]t is important to monitor and evaluate what pharmaceutical companies themselves, as the producers and suppliers of medicines, are doing to increase access to their products”.

3) An independent ranking and report triggers positive competition

Companies are “competitive animals”. Yet, they lack financial incentives to compete on in the field of access to medicine.

In addition, behavioural change is most likely when negative consequences (the stick) and positive enticements (the carrot) mutually reinforce each other. However, pharmaceutical companies are confronted with an environment where they are very often said what they have done wrong but almost never praised when they do something right.

The ranking component of the Access to Medicine Index (with its social and media coverage) introduces a positive competitive environment that fuels a corporate race to do better. Moreover, recognition is an important motivator for companies and their employees to drive ongoing efforts further and motivate the development of new activities.

4) An independent ranking and report diffuses best practices

Pharmaceutical companies have few occasions to share their access to medicine initiatives with each other and/or exchange how they integrate access to medicine into their business strategies. This leads companies to continuously “reinvent the wheel” and duplicate initiatives.

The Access to Medicine Index offers a comprehensive overview of what pharmaceutical companies are doing to facilitate access to medicine and allows the diffusion of good practices. By providing companies a better understanding of their own performance and that of their peers, the Index facilitates cross-company learning.

5) An independent ranking and report unleashes pressure from investors

Investors increasingly recognize that access to medicine issues can be material for pharmaceutical companies. To start with, wider access to health technologies is a key component of a novel business model based on reaching new customers in high volume-low price emerging markets. Second, the way in which companies respond to societal pressure is a good proxy for long-term, sustainable management practices. Yet, investors have very little information on the access to medicine performance of pharmaceutical companies.

The Access to Medicine Index enables evidence-based engagement by investors. More than 50 institutional investors have already pledged their support for the Access to Medicine Index by signing our Investor Statement. Together, these institutional investors have more than USD 5 trillion assets under management.

6) An independent ranking and report empowers internal change-makers

Ensuring a coordinated effort towards access to medicine is not an easy task for a large pharmaceutical company. Multinational companies are composed of different units and departments. It is also likely to witness conservative resistance to change practices and adopt innovative approaches.

The Access to Medicine Index supports internal-change makers at all levels of a company. Bottom-up pressure is exerted by employees whose specific mandate is to ensure good performance in access to medicine. Top-down pressure involves senior managers who use Index findings to promote new strategies.

7) An independent ranking and report multiplies the impact of other global health and sustainable development initiatives

Given the complexity of the access-to-medicine challenge, donors rightly support numerous research, policy and financial initiatives. The risk is that these initiatives are not aligned with each other and lead to duplication of efforts.

The Access to Medicine Index is not a substitute but a complement to other initiatives in the global health and sustainable development landscape. For instance, the Index incentivizes private sector participation in public-private partnerships (from product development partnerships to innovative patent pools). Moreover, it stimulates public and private co-developers to integrate pro-access provisions as soon and effectively as possible.

IMPACT ON PUBLIC HEALTH

Any positive change in the behaviour of pharmaceutical companies can affect the life (or death) of thousands of people. The Access to Medicine Index is designed to incentivise pharmaceutical companies to both (1) innovate to address the health needs of all and (2) improve access to health technologies.

With respect to the first point (innovation), the Access to Medicine Index rewards companies that engage in R&D activities which are targeted toward need and toward known product gaps. R&D projects that are demonstrably addressing high-need, non-commercial product gaps will be given extra credit in the scoring process.

Moreover, the Access to Medicine Index incentivizes companies to develop health technologies in partnership with other actors. This is particularly important to leverage the resources and capabilities of a network of public, philanthropic and private-sector partners. The 2014 Access to Medicine Index also found that public partners correlate with greater transparency and access provisions.

With respect to the second point (access), the Access to Medicine Foundation incentivizes companies to adopt a holistic approach that includes, inter alia, the alignment of access-to-medicine objectives with their business plans, the responsible management of their intellectual property, pricing strategies based on needs, capacity-building activities and structured, locally-driven donations programme.

The 2015 Methodology Report offers a useful summary of the specific actions that companies should take in order to meet stakeholders’ expectations. As a way of illustration, the approach to pricing and IP management is described below.

In terms of pricing, there is much debate among stakeholders as to how companies can ensure pharmaceutical products are affordable. As a result, how the Index evaluates company pricing strategies has also evolved over time. In 2012, the Index measured the extent to which companies engaged in differential (tiered) pricing. In 2014 the Index progressed to examining whether companies took ‘ability to pay’ into account when designing pricing strategies.

The 2014 approach yielded new insights. For example, while companies may take socio-economic factors into account when setting pricing practices, they frequently group countries together according to aggregative measures, such as World Bank-defined income level. Stakeholders have strongly voiced the view that the national income level of a country or group of countries is insufficient for establishing whether a company has fully considered the ability of the population to pay. It was felt that companies should take account of differences between countries’ disease burdens, their levels of inequality, their healthcare financing systems, and the ability of different groups to pay, as well as other constraints and variables. The development of a suitable model for evaluating whether pricing strategies are needs-based was required.

The 2016 Index will newly analyse how companies consider socio-economic factors (in addition to income level) in forming their pricing strategies, in order to evaluate the extent to which companies are customising strategies according to the needs and constraints of the population groups they are targeting. This framework will allow for comparability between companies in different disease areas and will set a first, objective baseline for measuring how companies are approaching needs-based pricing.

In terms of IP management, the Index stimulates companies to support a competitive market for pharmaceuticals. This includes managing responsibly the impact of patent monopolies on medicines prices (e.g., by taking steps that support both the market entry of generic medicine manufacturers and the activities of drug procurement agencies) and refraining from anti-competitive activities.

For instance, companies are encouraged to publish patent statuses, publicly agree not to patent, not to enforce patents, and to abandon existing patents in the broadest range of countries, and publicly agree to waive rights to data exclusivity. Moreover, companies are penalized when they do not acknowledge publicly the full range of flexibilities in the Doha Declaration on TRIPS and Public Health aimed at protecting public health, when they engage in lobbying activities intended to restrict these flexibilities, and when they hinder access to affordable medicines through other mechanisms related to trade policy. Finally, companies are rewarded when they seek to engage in licensing where opportunities exist, and when they agree pro-access licensing terms for a wide range of countries, including middle-income countries.

Specifically on to middle-income countries, a clear message was received from stakeholders that companies must be able to demonstrate how they target the needs (through licensing strategies but also through pricing) of the very poor segments of these increasingly wealthy territories. In 2016, the Access to Medicine Index will look more closely at whether companies are prepared to license their products for manufacture and distribution in middle-income countries, and how they achieve this, for example, by agreeing tiered royalties for different country groupings.

ADVANCING HUMAN RIGHTS

According to the United Nations Guiding Principles on Business and Human Rights, business enterprises should respect human rights. This means that they should avoid infringing on the human rights of others and should address adverse human rights impacts with which they are involved. Guiding Principle 14 clarifies that the responsibility of business enterprises to respect human rights applies to all enterprises regardless of their size, sector, operational context, ownership and structure, that is, it applies to all pharmaceutical companies.

An independent ranking and report like the Access to Medicine Index offers crucial information on whether pharmaceutical companies meet this responsibility or not. Indeed, the United Nations Working Group on Business and Human Rights – the expert body in charge of ensuring full implementation of the Guiding Principles – recently acknowledged that the Access to Medicine Index represents one of the most authoritative examples of corporate accountability in the field of measuring business and human rights issues.

The Access to Medicine Index is also in line with the Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines developed by Paul Hunt in 2008 during his mandate as UN Special Rapporteur on the right to health. A comparison between the approach and coverage of the Human Rights Guidelines and the technical areas covered by the Access to Medicine Index corroborates this alignment. The Human Rights Guidelines and the Access to Medicine Index similarly cover issues regarding policy statements, transparency, public policy influence, patents and licencing, pricing and donations.

Specific indicators from the Access to Medicine Index also validate its alignment with basic human rights principles, such as participation and due diligence. For instance, indicator A.III.2. measures whether pharmaceutical companies engages with relevant stakeholders, including universities, industry peers, patient groups, local governments, employees, and local and international non-governmental organisations, with the aim of improving access to medicine. Indicator D.III.2. assesses whether pharmaceutical companies take into consideration needs-based affordability and other relevant socioeconomic factors when making inter-country pricing decisions.

The very idea of benchmarking corporate performance against human rights responsibilities was suggested by Mary Robinson (former UN Commissioner for Human Rights) and Paul Hunt. In 2006, they both suggested to evaluate policies and practices of pharmaceutical companies against a consensus report developed through expert consultation, and make the evaluation public. Anand Grover, Special Rapporteur on the Right to Health from 2008 to 2014, also repeatedly called for stronger accountability mechanisms for pharmaceutical companies under international human rights law.

IMPLEMENTATION

Based in the Netherlands, the Access to Medicine Foundation is a not-for-profit organisation dedicated to addressing the problem of access to medicine worldwide. The work of the Foundation advances sustainable health outcomes because it offers substantial value-for-money.

The annual budget of the Access to Medicine Foundation is about $1.5 million. The annual revenues of the average company included in the Access to Medicine Index is about $30 billion (ratio of 1:20,000!). The annual revenues of all the companies included in the Access to Medicine Index is about $630 billion (ratio of 1:420,000!).

Political and financial support to the Access to Medicine Foundation would ensure robust measurement of company performance and the possibility to expand the scope of the Index, for instance, to new diseases and companies.

With respect to the disease scope, the Access to Medicine Index does not cover cancer. Given that several cancer drugs are high-priced, that access to them is limited, and that the burden of cancer in low-income and middle-income countries is increasing, some stakeholders argued for the inclusion of at least a subset of cancer conditions within the disease scope of the Index. Additional resources would allow to develop a sound measurement system to assess the activities of pharmaceutical companies with respect to access to cancer medicines.

With respect to the company scope, the Access to Medicine Foundation could develop an index and report focusing on generic drug manufacturers in developing countries. While generic drugs are generally perceived as being more accessible for poorer people, these medicines are not available everywhere to everyone. In some developing countries, the availability of low-cost generic medicines in the public sector is just a staggering 30%. As per its standard practice, the Access to Medicine Foundation would develop the final methodology of a potential Access to Generic Medicine Index through a detailed process of multi-stakeholder consultation. The most interesting areas for improving performance of developing country manufacturers are likely to be the following: product manufacturing and adaptation, affordability, availability and quality.

The Access to Medicine Foundation hopes to be invited to present and engage members of the High-Level Panel at one of the two Global Dialogues in March 2016 in order to discuss how to consolidate the achievements of the Access to Medicine Index, increase the impact of its activities and discuss the potential expansion of its scope of coverage.

Bibliography and References

[Because of the format of the online submission, references are listed under pertinent topics. For the sake of conciseness, the list includes two relevant references for each topic – with the exception of the Access to Medicine Index itself.]

On the Access to Medicine Index:
- Access to Medicine Foundation. Full Report: The 2014 Access to Medicine Index. November 2014. http://www.accesstomedicineindex.org/sites/2015.atmindex.org/files/2014_accesstomedicineindex_fullreport_clickablepdf.pdf
- Access to Medicine Foundation. Methodology for the 2016 Access to Medicine Index. November 2015. http://www.accesstomedicineindex.org/sites/2015.atmindex.org/files/2015methodology_2016accesstomedicineindex_accesstomedicinefoundation.pdf
- Access to Medicine Foundation. Methodology for the 2017 Access to Vaccines Index. November 2015. http://www.accesstomedicineindex.org/sites/2015.atmindex.org/files/2015methodology_2017accesstovaccinesindex_accesstomedicinefoundation_0.pdf
- Access to Medicine Foundation. Access to Medicine Index Investor Statement. February 2016. http://www.accesstomedicineindex.org/sites/2015.atmindex.org/files/150526atm_investorsstatement_opm12.pdf
- D J Edwards, D G M Coppens, T L Prasad, L A Rook & J K Iyer. Access to hepatitis C medicines. Bulletin of the World Health Organization. 2015; 93:799-805. DOI: http://dx.doi.org/10.2471/BLT.15.157784
- L Urlings, D G M Coppens, L A Rook & J K Iyer. Access to Maternal Health: Pharmaceutical Companies' Contribution to MDG 5. April 2015. http://www.accesstomedicineindex.org/sites/2015.atmindex.org/files/2015_landscape_study-access_to_maternal_and_reproductive_health-access_to_medicine_foundation.pdf
- H V Hogerzeil, J K Iyer, L Urlings, T Prasad & S Brewer. Is the pharmaceutical industry improving with regard to access to essential medicines? The Lancet Global Health. 2014; 2:139–140. DOI: http://dx.doi.org/10.1016/S2214-109X(13)70159-1
- H V Hogerzeil. Big Pharma and Social Responsibility: the Access to Medicine Index. New Eng J Med. 2013; 369:896–899. DOI: http://dx.doi.org/10.1056/NEJMp1303723

On the impact assessment of the Access to Medicine Index:
- The executive summary of the evaluation study of the Access to Medicine Index will be published on the website of the Access to Medicine Foundation at the beginning of March. http://www.accesstomedicineindex.org/news
- In 2014, the Access to Medicine Foundation convened an independent Reference Group (chaired by Paul Engel, Senior Fellow and former Director at ECDPM) to support the assessment of how, and to what extent, the Access to Medicine Index has contributed to changes in the behaviour and performance of research-based pharmaceutical companies with respect to access to medicine. The responsibilities of the Reference Group included the selection of a third-party assessment agency and the validation of its methodology. In February 2015, the Reference Group selected Technopolis Group to conduct the study. Technopolis Group is a pre-eminent provider of policy advice and support to organisations with a mission to address environmental and societal challenges. Technopolis had already carried out several studies and evaluations of global health-related programmes, projects and organisations, such as the Product Development Partnership Fund of the Dutch Ministry of Foreign Affairs, the European and Developing Countries Clinical Trials Partnership and the ‘Operational Research in Health Project’ in developing countries (jointly funded by the UK Department for International Development, Médicines Sans Frontières and the World Health Organization). The evaluation was primarily based on interviews with representatives from indexed companies, non-indexed companies and external stakeholders. Technopolis conducted in-depth case studies for five indexed companies. Purposive selection on several key characteristics was done to ensure sufficient heterogeneity in the sample. The two most important of these were a company’s relative position in the Index (and the evaluation therein over time), and its geographic representation. Additional company characteristics that were considered were the number of diseases and markets covered that are in scope for the Index, or the presence of company characteristics such as particularly strong performance in one of the Technical Areas of the Index. To provide a theoretical underpinning for the evaluation, Technopolis developed a Theory of Change for the Access to Medicine Index. The Theory of Change included several pathways of influence, covering pressures from both within and outside the companies. The evaluation first assessed whether the Index fulfils basic conditions of relevance, feasibility, acceptability and credibility, which are necessary to activate its potential pathways of influence (such as competition through the ranking, learning through diffusion of good practices, and financial pressure from investors). The study then evaluated the absolute and relative effectiveness of each of these pathways.

On pharmaceutical companies and the Sustainable Development Goals:
- United Nations Global Compact. Post-2015 Agenda and Related Sustainable Development Goals: The Role of Business in Improving Health. UN Global Compact Briefing Series: Issue Paper 4. February 2014. http://www.unprme.org/resource-docs/Post2015HealthIssueBrief.pdf
- GSK & Pfizer. The Central Role of Health in the Post-2015 Sustainable Development Agenda. Business & Health Action Group for Post-2015. 2014. http://www.everywomaneverychild.org/images/Health_in_the_SDGs_v10_6April15_2.pdf

On the Access to Medicine Index and the Sustainable Development Goals:
- MDG Gap Task Force. The Global Partnership for Development: The Challenge We Face. United Nations Department of Economic and Social Affairs. 2013.
- D de Felice & D J Edwards. SDG SERIES: The Access to Medicine Index and Accountability of Pharmaceutical Companies. Health and Human Rights Journal (blog). 23 September 2015. http://www.hhrjournal.org/2015/09/sdg-series-the-access-to-medicine-index-and-accountability-of-pharmaceutical-companies/

On the human rights responsibilities of pharmaceutical companies:
- S Moon. Respecting the right to access to medicines: Implications of the UN Guiding Principles on Business and Human Rights for the pharmaceutical industry. Health and Human Rights. 2013; 15: 32-43. http://www.hhrjournal.org/wp-content/uploads/sites/13/2013/06/Moon-FINAL.pdf
- L Forman & J C Kohler. Access to Medicines as a Human Right: Implications for Pharmaceutical Industry Responsibility. University of Toronto Press. 2012. http://www.utppublishing.com/Access-to-Medicines-as-a-Human-Right-Implications-for-Pharmaceutical-Industry-Responsibility.html

On the Access to Medicine Index and the human rights responsibilities of pharmaceutical companies:
- J Lee & P Hunt. Human Rights Responsibilities of Pharmaceutical Companies in Relation to Access to Medicines. The Journal of Law, Medicine & Ethics. 2012; 40:220-233. DOI: http://dx.doi.org/10.1111/j.1748-720X.2012.00660.x
- United Nations Working Group on Business and Human Rights. Report of the Working Group to the General Assembly on the issue of human rights and transnational corporations and other business enterprises ("Measuring the implementation of the Guiding Principles on Business and Human Rights"). 2015. A/70/216. http://www.un.org/en/ga/search/view_doc.asp?symbol=A/70/216

On pharmaceutical companies and public-private product development partnerships:
- E Ponder & M Moree. Developing new drugs & vaccines for neglected diseases of the poor. The Product Developer Landscape. BIO Ventures for Global Health. 2012. www.bvgh.org/Portals/0/Reports/2012_03_developing_new_drugs_and_vaccines_for_neglected_diseases.pdf
- V Muñoz, F Visentin, D Foray & P Gaulé. Can medical products be developed on a non-profit basis? Exploring product development partnerships for neglected diseases. Science and Public Policy. 2015; 42:315-338. DOI: http://dx.doi.org/10.1093/scipol/scu049

On pharmaceutical companies and equitable pricing strategies:
- Z Kaló, L Annemans & LP Garrison. Differential pricing of new pharmaceuticals in lower income European countries. Expert Rev Pharmacoecon Outcomes Res. 2013; 13:735-41. DOI: http://dx.doi.org/10.1586/14737167.2013.847367
- S Moon, E Jambert, M Childs & T von Schoen-Angerer. A win-win solution?: A critical analysis of tiered pricing to improve access to medicines in developing countries. Globalization and Health. 2011; 7:39-55. DOI: http://dx.doi.org/10.1186/1744-8603-7-39

On pharmaceutical companies and responsible IP management:
- K Cox. The Medicines Patent Pool: Promoting Access and Innovation for Life-Saving Medicines Through Voluntary Licenses. Hastings Science & Technology Law Journal. 2012; 4:293-323. www.hstlj.org/articles/the-medicines-patent-pool-promotingaccess-and-innovation-for-life-saving-medicines-through-voluntarylicenses
- S K Sell. Business and Democracy? Pharmaceutical Firms, Intellectual Property and Developing Countries; in Porter and Ronit (eds.), The Challenges of Global Business Authority: Democratic Renewal, Stalemate or Decay? State University of New York. 2010. http://www.sunypress.edu/p-4983-the-challenges-of-global-busine.aspx

On the importance of building consensus on “authoritative focal points” and actionable standards:
- J G Ruggie. Business and Human Rights: The Evolving International Agenda. The American Journal of International Law. 2007; 101: 819-840. http://www.jstor.org/stable/40006320
- N Jagers. UN Guiding Principles on Business and Human Rights: Making Headway towards Real Corporate Accountability. Neth. Q. Hum. Rts.. 2011; 29:159-177. http://www.corteidh.or.cr/tablas/r26644.pdf

On the power of indicators to trigger human rights compliance:
- G A Sarfaty. Regulating Through Numbers. Virginia Journal of International Law. 2013; 54:97-126. DOI: http://dx.doi.org/10.2202/1565-3404.1033
- S Fukuda-Parr & M Langford. The Turn to Metrics. Nordic Journal of Human Rights. 2012; 30:222-238. http://sakikofukudaparr.net/wp-content/uploads/2013/01/NordicJournalHumanRights.pdf

On the power of rankings to create “virtuous competition”:
- K Davis, A Fisher, B Kingsbury & S E Merry (eds.). Governance by Indicators: Global Power through Quantification and Rankings. Oxford University Press. 2012. https://global.oup.com/academic/product/governance-by-indicators-9780199658244
- M Lee & J Kohler. Benchmarking and Transparency: Incentives for the Pharmaceutical Industry’s Corporate Social Responsibility. Journal of Business Ethics. 2010; 95:641-658. DOI: http://dx.doi.org/10.1007/s10551-010-0444-y

On the importance of learning processes and diffusion of good practices:
- S D VanDeveer & G D Dabelko. It’s Capacity, Stupid: International Assistance and National Implementation. Global Environmental Politics. 2001; 1:18-29. DOI: http://dx.doi.org/10.1162/152638001750336569
- C Deere. The Implementation Game: The TRIPS Agreement and the Global Politics of Intellectual Property Reform in Developing Countries. Oxford University Press. 2008. https://global.oup.com/academic/product/the-implementation-game-9780199550616

On the importance of monitoring progress:
- H Droppert & S Bennett. Corporate social responsibility in global health: an exploratory study of multinational pharmaceutical firms. Globalization and Health. 2015; 11:15-37. DOI: http://dx.doi.org/10.1186/s12992-015-0100-5
- S Gruskin & Z Raad. Are Drug Companies Living Up to Their Human Rights Responsibilities? Moving Toward Assessment. PLoS Med. 2010; 7:e1000310. DOI: http://dx.doi.org/10.1371/journal.pmed.1000310

On the importance of transparency and accountability:
- M N Graham Dukes. Accountability of the pharmaceutical industry. The Lancet. 2002; 360:1682-1684. http://www.sciencedirect.com/science/article/pii/S0140673602115996
- A Grover, B Citro, M Mankad & F Lander. Pharmaceutical Companies and Global Lack of Access to Medicines: Strengthening Accountability under the Right to Health. The Journal of Law, Medicine & Ethics. 2012; 40:234-250. DOI: http://dx.doi.org/10.1111/j.1748-720X.2012.00661.x

On the power of investors in pharmaceutical companies:
- M Clark, T Race & R Parkes. Tropical diseases: Social responsibility, neglected market. Deutsche Bank Markets Research. September 2014. http://www.accesstomedicineindex.org/sites/2015.atmindex.org/files/deutsche_bank_market_research_-_european_pharmacueticals.pdf
- A Ward. Investors join push for more transparency on drug trials. Financial Times. 23 July 2015. http://ow.ly/YQzro