Lotti Rutter, TREATMENT ACTION CAMPAIGN_B

Lotti Rutter, TREATMENT ACTION CAMPAIGN_B

Lead Author: Lotti Rutter
Organization: Treatment Action Campaign
Country: South Africa

Abstract

The 2001 Doha Declaration affirmed that the provisions of the TRIPS agreement do not prevent governments from taking the necessary policy and legal measures to achieve the right to health. The Doha Declaration explicitly states that the TRIPS agreement should be interpreted in a way that promotes access to medicines for all, and that countries are within their rights to take certain measures to limit intellectual property rights (TRIPS flexibilities) when public health interests demand it to enable access to affordable medicines.

In reality though, many countries have yet to implement such measures effectively, fully or at all. The balance between commercial and public health interests (as intended by TRIPS and the subsequent Doha Declaration) has not been redressed. Some national patent laws have only been moderately amended since the adoption of TRIPS to comply with the 20-year patent requirement and still hark back to pre-independence laws

Instead of being provided with support to comply fully with TRIPS by implementing these measures, WTO members face fierce pressure against such efforts. The World Intellectual Property Office (WIPO) offers “assistance” to ensure commercial interests are promoted. Industry purports the unsubstantiated claims that the medical innovation system will collapse and countries will see disinvestment and weakening economies if public health safeguards are enacted. Countries such as the US and those within the European Union – who benefit from a strict global IP regime – “punish” countries attempting to use safeguards with threats of disinvestment, or through mechanisms such as the 301 Watch List. Moreover, developing countries are often pressured into signing trade agreements that require even stricter TRIPS plus measures that restrict access to medicines even further.

This submission calls for all WTO members to fully implement and utilise TRIPS flexibilities and for the United Nations to provide effective guidance and technical assistance in support of such implementation and utilisation. It also calls on the panel to consider the implications of, and to comment on the consequences of, the United States 301 Watch List and other forms of trade pressure.

Submission

Introduction and statement of the problem:

In 2001, WTO members adopted the Doha Declaration that clarified the ambiguities arising in the TRIPS Agreement. In response to evidence that strict intellectual property (IP) protection negatively impacts upon access to affordable medicines, the Doha Declaration re-affirmed the right of WTO members to protect public health through the full use of the safeguards outlined in TRIPS (TRIPS flexibilities). It states that "the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health". [1]

In reality though, many countries have yet to implement such measures effectively, fully or at all. The balance between commercial and public health interests (as intended by TRIPS and the subsequent Doha Declaration) has not been redressed. Some national patent laws have only been moderately amended since the adoption of TRIPS to comply with the 20-year patent requirement.

Where developing countries do attempt to utilise these legitimate and legal safeguards, they are regularly subjected to outside pressure, whether multilaterally from WTO and WIPO or bilaterally from developed countries. The impetus for policy change over patent regimes thus typically comes from abroad rather than from domestic policy objectives.

It is principally for this reason that a number of developing countries have failed to take advantage of the flexibilities allowed within the TRIPS agreement and have not implemented crucial safeguards into their national patent systems for pharmaceutical and health technologies. Rather, many developing countries have been forced to implement TRIPS plus measures through trade agreements, investment agreements, or international initiatives. This leads to unnecessary and avoidable barriers to access to medicines.

1. Government pressure against use of TRIPS flexibilities

1.1. US Special 301 Watch List

While many of the examples in section 2 (below) involve pressure from the pharmaceutical industry, this pressure is typically backed up by pressure from the United States government in the form of the United States Trade Representative (USTR). While we believe the USTR mostly to exert power behind the scenes and in direct negotiations, it also exerts public pressure on countries using its 301 Watch List.

One study showed that the USTR has typically cited countries on the Watch List for issuing compulsory licenses or developing compulsory licensing plans, and expressed concern on behalf of the US government [2]. “Sometimes the criticism is direct; other times the references are oblique or pledges to monitor the situation. But in each case the mere reference is important; a bullying tactic that tends to serve as a warning to all countries against using health rights.” [3]

In 2012 India issued a compulsory license for sorafenib, a treatment for kidney and liver cancer. Even though the compulsory license was TRIPS compliant, it was nevertheless mentioned in the USTR’s 301 Watch List. The local working provision cited by USTR was only one of several grounds on which India issued its license, the others being affordable price and public needs, and any one of these grounds would have sufficed under Indian law as well as under TRIPS.

In 2012, Indonesia authorised government use of patents for seven HIV/AIDS medicines [4]. As Maybarduk points out “The authorizations are TRIPS compliant, set a critical precedent for global health and could save thousands of lives. Unfortunately, Indonesia made a strange submission to USTR citing an unspecified “mistake in procedure” when issuing the licenses.” The USTR pounced on this noted it in the 301 Watch List – thus sending a clear signal to other countries considering similar compulsory licenses.

Similar examples of USTR trade pressure through the 301 Watch List have been identified in relation to the TRIPS compliant use of compulsory licenses in Thailand, Ecuador and Brazil. (Sources provided in the references section.)
 
1.2. Wider US pressure

Cables released on Wikileaks between the US embassy in Ecuador and the US Department of State showed the United States, multinational pharmaceutical companies, and three Ministers within the government shared information and worked to undermine an emerging policy in Ecuador. The policy aimed to improve access to medicines and support public health programs through a protocol that would reduce medicine costs - including through the establishment of a compulsory licensing mechanism [6].  


2. CASE STUDIES:

1.1. The PMA case:

South Africa is a good example of the phenomenon of failing to take advantage of TRIPS flexibilities. Because of this, the country’s patent regime has a significant adverse impact on the affordability and accessibility of medicines for people living in South Africa. Levels of pressure against the country have been unprecedented.

In 1997 President Nelson Mandela attempted to include into the Medicines Act provisions for parallel importation, provisions encouraging generic substitution of off patent medicines, and a transparent pricing mechanism [7]. Despite this being signed into law, there was an intense backlash from the Pharmaceutical Manufacturers Association (PMA) who, representing 39 pharmaceutical companies, initiated legal action against the South African government that continued until 2001. The trial was delayed for three years, during which time the Act did not go into effect and access to medicine was severely impeded. The case was only dropped following national and international outcry and the prospect of dying AIDS patients testifying in court.

Not only did the South African government feel pressure from industry, in addition following the ratification of amendments to the Act, the United States Trade Representative (USTR) placed South Africa on the 301 Watch List [8]. Inclusion on this list signifies that the US perceived South Africa had created trade barriers for the US and could therefore be subject to trade sanctions. 

Ironically, although the government had vigorously defended these legal measures, which it has built into its amended Medicines Act, the pressures exerted by both the US Government and pharmaceutical companies have made it reluctant to use them [9].

In addition, the severe pressure that the South African government faced in the PMA case has had a chilling effect on the government’s willingness to undertake further law reform. As a result, South Africa has not amended its patent laws subsequent to the Doha Declaration, even though it is and was at the epicenter of the HIV/AIDS epidemic.

2.2. National intellectual property law reform:

In September 2013, the South African Department of Trade and Industry (“the dti”) released the Draft National Policy on Intellectual Property [10]. The draft policy outlined provisions to include TRIPS flexibilities into national law to ensure a better balance between commercial interests and public health rights. However, 16 years later, history is repeating and the South African government is again facing significant bilateral and industry pressure against this process.

Following the release of the draft policy, 25 pharmaceutical companies under the umbrella organisation IPASA (Innovative Pharmaceuticals Association of South Africa), were revealed to be plotting the finance of a scheme to delay the finalisation of this policy. Despite attempting to distance themselves from the “Pharmagate” plot, leaked documents [11] illustrated that both IPASA and US-based industry body PhRMA (the Pharmaceutical Researchers and Manufacturers of America) actively selected a “high calibre consultancy group” – PAE – to subvert the South African intellectual property law reform process by financing a covert US $600,000 campaign and that IPASA’s intellectual property committee was ready to proceed with the proposed plot with “urgency” [12].

The South African Minister of Health, Dr Aaron Motsoaledi, said the campaign sought to restrict access to crucial drugs and called the plot tantamount to “genocide” [13]. South African and other country statements at the Executive Board meeting of the World Health Organization reiterated that IP reform in South Africa would “promote competition and ensure the levelling of the playing field.” [14] One week after the “Pharmagate” scandal, pharmaceutical company Roche quit, and Novo Nordisk temporarily left the IPASA association [15]. 

Furthermore, in mid-2015, the American Chamber of Commerce in South Africa (AmCham) made a submission to the Office of the United States Trade Representative explicitly requesting that South Africa’s eligibility for ongoing inclusion in the African Growth and Opportunities Act (AGOA) should be dependent on the country abandoning certain intellectual property law reforms to protect health.

The argument is contained in a submission [16] to the Office of the United States Trade Representative (USTR), and echoes a 2013 AmCham submission [17] to South Africa’s Department of Trade and Industry (DTI) on the country’s Draft IP Policy.

Prominent AmCham members include some of the pharmaceutical companies behind the 2014 Pharmagate scandal. Pharmaceutical companies implicated in Pharmagate and belonging to AmCham include Abbott Laboratories SA, AbbVie, Bristol-Myers Squibb, Eli Lilly SA, MSD and Pfizer.

While there is no clear evidence the US government is linking AGOA eligibility to halting IP reform, the AmCham submission to the USTR makes it clear that AmCham members are lobbying the U.S. government to exert such pressure. AmCham’s submission shows no recognition of South Africa’s need for affordable medicines to address its severe disease burden of HIV, TB, and non-communicable diseases. The Treatment Action Campaign, MSF, SECTION27 and the Stop Stockouts Project made a submission [18] to the USTR, which countered the AmCham submission to the USTR on South Africa’s eligibility for AGOA. However, while we continue to await the final IP Policy, it remains unknown if trade concessions have been made.

This pressure is not isolated to South Africa but highlights the significant disincentive to amend patent laws in the public interest. Many other countries have also suffered immense pressure for attempting to utilise public health safeguards.

2.3. India vs Novartis:

In 2006, pharmaceutical company Novartis filed complaints against the Indian government challenging the refusal of the patent controller to grant a patent on the beta-crystalline form of its anticancer drug, imatinib mesylate, as well as the validity of section 3(d) of the Indian Patent Act that provided one of several grounds for rejecting its patent application. The case and subsequent appeals continued until 2012. During this time immense pressure was put on the Indian government to grant the patent. Novartis continually threatened to withdraw all manufacturing plants from India if the patent was not granted. Conversely, after losing the case at the Supreme Court, Novartis eventually expanded operations in India. Novartis claimed that this patent was necessary to recoup the development costs of imatinib mesylate. However, research shows that by the most generous estimate, Novartis’ outlay on R&D for imatinib was US $96 million, with the company contributing only 10% of early research costs. Yet in 2012, sales of imatinib generated US $4.7 billion globally – ensuring Novartis realised a return on their investment once every 13 days [19].


2.2. US-Jordan FTA

Before Jordan joined the WTO, the USTR had listed Jordan on its Special 301 Watch List for failure to adequately protect US intellectual property rights [20]. Following accession to the WTO and the signing of the US-Jordan free trade agreement (that introduced a harsh framework of TRIPS-plus measures) in 2001, medicine prices in Jordan have increased by 20%. One study found that of 103 medicines registered & launched since 2001 that currently have no patent protection in Jordan, at least 79% have no competition from a generic equivalent as a consequence of data exclusivity [21].

Data exclusivity is a TRIPS-plus measure that creates a new system of monopoly power, separate from patents, by blocking the registration and marketing approval of generic medicines for five or more years, even when no patent exists.

In addition, the study found that “additional expenditures for medicines with no generic competitor, as a result of enforcement of data exclusivity by multinational drug companies, were between $6.3m and $22.04m” [22]. Furthermore, “patients in Jordan pay from two to ten times more for some new medicines compared with patients in Egypt, where new medicines are manufactured locally through licensing agreements and partnerships” and “where there are no TRIPS-plus barriers.” [23]

When negotiating TRIPS, developed countries promised developing countries that the implementation and expansion of intellectual property protection would result in greater foreign direct investment which would stimulate economic growth. However, despite assertions made by the USTR since the US-Jordan FTA was signed nearly no foreign direct investment (FDI) has been brought by multinational pharmaceutical companies. Moreover “the only FDI into Jordan by multinational drug companies has been to expand scientific offices, which use aggressive sales tactics to ensure that expensive patented medicines are used instead of inexpensive generics.” [24]


3. Impact on remedying policy incoherence:

While the TRIPS agreement, as clarified in the Doha Declaration, enables countries to take steps to ensure better access to medicines, these enabling provisions are often not used because of trade pressure. This creates incoherence between what is technically possible and what is politically possible. While countries are legally allowed to implement TRIPS flexibilities in domestic laws, they are prevented from doing so through trade pressure.

Greater legal and technical assistance from the United Nations, through its various agencies, could potentially make it easier for countries to implement TRIPS flexibilities. In addition, there is potentially great value in the panel recognising and being openly critical of United States 301 Watch List and its chilling impact on countries seeking to protect the health of their people.


4. Impact on public health:

Reduced trade pressure regarding the implementation of TRIPS flexibilities would enable countries to better shape their domestic laws in ways that allows them to protect access to medicines and public health. At present though, countries are forced to make trade-offs between protecting access to medicines and preferable access to agricultural export markets, for example.


5. Impact on human rights:

By fully implementing TRIPS flexibilities countries will be able to increase access to medicines – thereby better protecting the right to health. The right to health is a basic human right that is recognised in various legal systems and in various international agreements.


6. Implementation:

Significantly increased and improved implementation of TRIPS flexibilities in domestic legal systems could be achieved through a combination of reduced trade pressure and increased technical assistance from the United Nations and its agencies.

Providing increased technical assistance, through for example the World Intellectual Property Organization (WIPO), is both possible and feasible. The main obstacle however to appropriate technical assistance would be a potential lack of political will within WIPO and opposition from member states such as the United States – who have essentially been campaigning against this kind of intervention through its 301 Watch List.

Whether a significant reduction in trade pressure is possible is less clear. However, we consider there to be a moral obligation on concerned people in positions of power to go on the record about the harmful impacts of excessive trade pressure and mechanisms such as the 301 Watch List. We also believe that the United Nations must offer a more far-sighted and morally sound view than the views expressed by industry lobbyists and governments who do the bidding of industry lobbyists.

7. Conclusion:

While flexibilities exist under TRIPS that can be used to better balance the right to health with the interests of pharmaceutical companies, many of these flexibilities are not implemented in national laws, and where they are implemented, they are often not fully utilised in the public interest.

The two reasons for this lack of implementation and use of pro-public health legal flexibilities are (a) Trade pressure from rich developed countries, in the form of mechanisms such as the United States’ 301 Watch List, and (b) a lack of support from bodies such as WIPO and the WHO to ensure countries implement and use the available flexibilities in international law.

Both these issues must be addressed – firstly in relation to TRIPS flexibilities, but also in regard to any new/future IP frameworks or mechanisms the panel may deem feasible. A key lesson from TRIPS is that good mechanisms are of limited use if their effective implementation can be prevented through trade pressure.

In conclusion we make the following recommendations:

1.      For all WTO members to fully implement TRIPS flexibilities in order to better balance the right to health with the private interests of pharmaceutical companies.

2.      For the UN, WHO and WIPO to provide guidance and to support WTO members in developing and fully implementing and utilising TRIPS flexibilities. (In this regard we fully support Professor Brook Baker’s submission to the High-Level Panel in relation to Compulsory Licensing.)

3.      For the panel to consider and pronounce on the impact of trade pressure on the implementation of TRIPS flexibilities.

4.      For the panel to consider and pronounce on the impact of the United States 301 Watch List on WTO members seeking to implement and use TRIPS-sanctioned legal flexibilities.

Bibliography and References

1. <In response to evidence that strict intellectual property (IP) protection negatively impacts upon access to affordable medicines, the Doha Declaration re-affirmed the right of WTO members to protect public health through the full use of the safeguards outlined in TRIPS (TRIPS flexibilities).> Doha Declaration, 2001. Available here: http://www.who.int/medicines/areas/policy/doha_declaration/en/

2. <With the exception of Canada’s 2007 export arrangement with Rwanda, every recent pharmaceutical compulsory license or major compulsory licensing policy – at least, of which USTR is aware, and so far as I can tell — has been referenced in the 301 Report. (I had to go back to 2004/2005 to find exceptions, in the case of Indonesian and Malaysian government use licenses for AIDS.)> Maybarduk, May 2013. “US Government Special 301 “Watchlist” and Developing Country Use of Compulsory Licenses for Healthcare”. Available at: http://infojustice.org/archives/29493

3. Ibid.

4. See: http://www.citizen.org/actions-indonesia.

5. See Indonesia’s submission at page 7: http://www.regulations.gov/#!documentDetail;D=USTR-2012-0022-0071.  (The document also oddly states that licenses were issued on nine products.) Indonesia’s submission opened a door for USTR criticism.

6. Public Citizen, 2011. “Leaked Cables Show U.S. Tried, Failed to Organize Against Ecuador Compulsory Licensing”. Available at: http://www.citizen.org/leaked-cables-show-US-tried-failed-to-organize-against-ecuador-compulsory-licensing

7. South Africa’s Medicines and Related Substances Control Amendment Act. Available at: http://www.gov.za/sites/www.gov.za/files/b72b-97_0.pdf

8. Flynn, S. 2010. “Special 301 of the Trade Act of 1974 and Global Access to Medicine”.
Available at: http://infojustice.org/download/gcongress/ipandhumanrights/Flynn%20-%20Speical%20301%20and%20Global%20Access%20to%20Medicine.pdf

9. TAC, 2011. “10 years of TAC”. Available at: http://www.tac.org.za/files/10yearbook/files/tac%2010%20year%20draft5.pdf

10. The Department of Trade and Industry, September 2013. Draft National Policy on Intellectual Property. Available at: http://ip-unit.org/wp-content/uploads/2013/09/DRAFT-IP-POLICY.pdf

11. KEI, January 2014. “New leaked Merck missive reveals deep drug, medical device company opposition to South African patent reforms”. Available at: http://keionline.org/node/1908

12. Ibid.

13. Mail & Guardian, January 2014. “Motsoaledi: big pharma’s satanic plot is genocide.” Available at: http://mg.co.za/article/2014-01-16-motsoaledi-big-pharmas-satanic-plot-is-genocide

14. IP-Watch, January 2014. “WHO Chief: No Government Should Be Intimidated For Doing “Right Thing” In Public Health”. Available at: http://www.ip-watch.org/2014/01/24/who-director-general-no-government-should-be-intimidated-by-interested-parties/

15. Business Day Live, February 2014. “IPASA axes committee in wake of patents row.” Available at: http://www.bdlive.co.za/business/healthcare/2014/02/07/ipasa-axes-committee-in-wake-of-patents-row

16. AmCham, 2015. “Submission on the Out of Cycle Review of South Africa’s Eligibility for Benefits.” http://www.msfaccess.org/sites/default/files/MSF_assets/IP/Docs/IP_SouthAfrica_AmCham_SA_-_AGOA_-_Submission_on_the_Out-of-Cycle_Review_of_South_Africa_Eligibility_for_Benefits-2015-ENG.pdf

17. AmCham, 2013. “COMMENTS ON SOUTH AFRICA’S DRAFT NATIONAL POLICY ON INTELLECTUAL PROPERTY.” Available at: http://www.msfaccess.org/sites/default/files/MSF_assets/IP/Docs/IP-SouthAfrica_US-chamber-submission-on-draft-national-ip-policy_2015-ENG.pdf

18. Submission of TAC, MSF, SECTION27, Stop Stockouts Project, 2015. Available at: http://www.msfaccess.org/sites/default/files/MSF_assets/IP/Docs/IP_SouthAfrica_Submission-TACS27MSFSSO-regarding-SouthAfrica-AGOA-OCR-2015-ENG.pdf

19. Love. J. (2013). ‘R&D costs for Gleevec’. Knowledge Ecology International. Available at: http://www.keionline.org/node/1697

20. Abbott, 2012 “Access To Medicines And Intellectual Property In Jordan”. Available at: http://www.ip-watch.org/2012/07/23/access-to-medicines-and-intellectual-property-in-jordan/

21. Oxfam, 2007. “All costs, no benefits: How TRIPS-plus intellectual property rules in the US-Jordan FTA affect access to medicines”

22. Ibid.

23. Ibid.

24. Ibid.

Kevin Outterson, BOSTON UNIVERSITY SCHOOL OF LAW

Kevin Outterson, BOSTON UNIVERSITY SCHOOL OF LAW

Lead Author: Kevin Outterson
Organization: Boston University School of Law
Country: USA

ABSTRACT

Due to antibiotic resistance, patients could lose access to the most important class of drugs in human history. But while resistance is a serious issue, equally troubling is the unwarranted death of 455,000 children each year from susceptible bacteria that could be treated with existing generic antibiotics. Antibiotics suffer from three simultaneous crises: access, conservation, and innovation. Solutions proposed include antibiotic delinkage, paying for antibiotic innovation based on value, not volume of sales.

Submission 

1. Impact on remedying policy incoherence
A number of initiatives are underway to address the crisis of antibiotic resistance. Some focus on innovation – creating new antibiotics to replace those lost to resistance (Chatham House 2015, AMR Review 2015a). Others focus on conservation - reducing the need for antibiotics through infection control, vaccines, clean food and water, and antibiotic stewardship (US National Action Plan 2015). Access to antibiotics is a third area that is important but frequently overlooked. More than 455,000 children under 5 die from susceptible bacteria that could be treated with existing drugs (Laxminarayan 2016).
The first policy incoherence is that all three of these goals – access, conservation, & innovation – undermine the others and therefore must be pursued in a coordinated fashion.

Second, antibiotic resistance spans both human and animal health. Many emerging infectious diseases have zoonotic origins and low-value use of antibiotics in agriculture drives resistance, but antibiotics also play an important role in animal health in the food supply. Any solution will require tradeoffs and coordination between these two sectors (AMR Review 2015b).
2. Impact on public health
In high-income countries, significant declines in infectious disease mortality pre-dated the introduction of antibiotics. Most of the declines in that period can be attributed to public health interventions, including clean water, clean food, infection control, and environmental control of waste. Nevertheless, the introduction of antibiotics was a signal event in the battle against infectious disease: antibiotics are perhaps the single most valuable drug class in human history. Much of modern medicine depends on it (Teillant 2015).
In many low- and middle-income countries, investment in public health infrastructure lags, resulting in a much higher burden of infectious disease. In these settings, antibiotics perform an additional function: compensating for the weaknesses in public health infrastructure (Laxminarayan 2015).
Therefore, preserving antibiotic effectiveness is a foundation for medical care, population health, and as a key interim tool while public health infrastructure is being improved around the world. Knowing that antibiotics are at risk should prompt additional investments in public health.
3. Impact on human rights
The unwarranted death of 455,000 children under five is a major violation of human rights.
4. Implementation
Conservation & Access: Solutions to the antibiotic access crisis do not require waiting for a new drug to arrive; existing treatments are effective. Nor are patents a major barrier; most of these drugs are off patent. In addition, the WHO Global Action Plan serves as a model for conservation and access efforts. Most of this foundational work is completed; we can focus on implementation immediately, although much work remains in coordination between human and agricultural uses.
Innovation: Despite our best efforts on conservation, new drugs will eventually be required, but they must be brought to the market with guaranteed global access and with incentives in place to support conservation. Access, conservation and innovation must be simultaneously addressed, across both human medicine and agriculture.
Political and civil society mobilization on antibiotic resistance has never been higher. Many stakeholder are currently involved – and more every day – including efforts at IMI/DRIVE-AB, BARDA, PACCARB, AMR Review, Chatham House, Center for Global Development, World Bank, European Investment Bank, Medical Research Council, G7, G20, WHO, DNDi, CDC, ECDC, NIH, Longitude Prize, ReACT, CDDEP, Wellcome Trust, Pew Charitable Trusts, the Bill & Melinda Gates Foundation, and others. Some key points about this process:
First, antibiotics suffer from a particular form of neglect, which is quite different from Chagas, human African trypanosomiasis, Ebola and other neglected diseases. Most diseases treated by antibiotics are globally prevalent. High-income markets, if properly functioning, should be sufficient to drive innovation. If so, some of the goals of the High-Level Panel might be met by articulating and supporting delinkage innovation reforms already in various stages of development (KEI/MSF 2016, AMR Review 2015a, DRIVE-AB 2016, Chatham House 2015, Love 2009, CEWG 2012), with the proviso that leadership is required to ensure that the fruits of that innovation are fully available at generic costs of production to low-income populations.
Second, for antibiotics in particular, coordination with diagnostics and vaccines are key. Most antibiotics are taken in a cloud of diagnostic uncertainty, which leads to significant waste and clinical failure. The best infection is the one that did not occur due to vaccination. The MSF Fair Shot campaign and the Longitude Prize should be amongst the most important near-term policy objectives for any global effort against resistant bacteria.
Third, the High-Level Panel should call for a global antibacterial threat assessment, building on the recent US CDC effort (CDC 2013) (and the ECDC effort currently underway), but with the world in mind. This threat assessment can be used to set research priorities, but more importantly it should guide priority setting at other research institutions like NIH and Wellcome Trust. Governments will increase funding for basic research on bacteria in the next few years. University labs are eager to get to work. A global threat assessment could help focus more than a billion dollars in research efforts over the next decade.

Fourth, the High-Level Panel can help design a sustainable financing mechanism for antibiotic-resistant bacteria. Three models include revisions to the flawed priority review voucher system (Outterson & McDonnell 2016), contractual funding for big science such as CERN and the International Space Station (DRIVE-AB 2016), and an antibiotic user fee (Hollis & Ziana 2013, 2014; Outterson & Hollis 2016). Resistance is a battle fought over decades; bacterial evolution will not resign the field. Our efforts must be similarly relentless and sustainable.
 

Bibliography and References

AMR Review. Securing new drugs for future generations: the pipeline of antibiotics. May 2015.
AMR Review. Antimicrobials in agriculture and the environment: reducing unnecessary use and waste. Dec. 2015.
CDC. Antimicrobial resistance threats in the United States, 2013.
Chatham House (Clift C, Gopinathan U, Morel C, Outterson K, Rottingen JA, So AD, eds.). Towards a new global business model for antibiotics: delinking revenues from sales. May 2015.
Consultative Expert Working Group on Research and Development. Research and development to meet health needs in developing countries: Strengthening global financing and coordination. Geneva, Switzerland: World Health Organization; 2012.
Driving Re-investment in Antibiotics and Advocating for Their Responsible Use (DRIVE-AB). Research project funded by the Innovative Medicines Initiative. Interim report will be discussed at a policy meeting in Amsterdam on June 1-3, 2016.
Hoffman SJ, Outterson K. What will it take to address the global threat of antibiotic resistance? J Law Med Ethics. 2015;43(Supp 2):6-11.
Hollis A, Ziana A. Preserving antibiotics, rationally. New Engl J Med. 2013;369(26):2474-2476.
Hollis A, Ziana A. The path of least resistance: paying for antibiotics in non-human uses. Health Policy 2014;118:264-270.
Knowledge Ecology International, Médecins Sans Frontières/Doctors Without Borders, et al. Joint submission to UN High-Level Panel on Access to Medicines (pending, Feb. 2016).
Laxminarayan R. Economics of antibiotic resistance. Presentation at the Latsis Symposium. July 2015, at slides 4-6 (adapted from Armstrong, Conn, et al. 1999).
Laxminarayan R, Matsoso P, Pant S, Brower C, Rottingen JA, Klugman K, Davies S. Access to effective antimicrobials: a worldwide challenge. Lancet 2016; 387: 168–75.
Love J, Hubbard T. Prizes for innovation of new medicines and vaccines. Ann Health Law. 2009;18(2):155–86, 8 p.
Outterson K, McDonnell A. Transferable regulatory exclusivities for antibiotic innovation: design issues for antibiotic vouchers. Health Aff. 2016 (in press).
Outterson K, Hollis A. Antibiotic user fees as a global funding mechanism. Informal discussion paper for WHO brainstorming session (1 Feb. 2016).
Teillant A, et al. Potential burden of antibiotic resistance on surgery and cancer chemotherapy antibiotic prophylaxis in the USA: a literature review and modeling study. Lancet Infect Dis. 2015;15(12):1429-1437.
US National Action Plan on Combatting Antibiotic-Resistant Bacteria. March 2015.

NATALIE GINSBERG, Multidisciplinary Association of Psychedelic Studies

NATALIE GINSBERG, Multidisciplinary Association of Psychedelic Studies

Lead Author: Natalie Ginsberg
Additional Authors: Ismail Ali
Organization: Multidisciplinary Association of Psychedelic Studies
Country: USA

ABSTRACT

This contribution re-introduces a 1985 recommendation by the WHO Expert Committee that was never followed: to “urge countries” to support and conduct therapeutic research with 3,4-methylenedioxymethamphetamine, otherwise known as MDMA. Despite extensive clinical research supporting MDMA’s safety, low potential for abuse, and demonstrated medical benefits, MDMA has remained in Schedule I since it was criminalized in 1985. This policy incoherence has been a significant obstacle to making MDMA - a medicine with tremendous potential to improve public health by treating trauma - more accessible. Specifically, bureaucratic, funding and stigma-related barriers tied to MDMA’s Schedule I placement blunt research. However, privately-funded clinical MDMA-assisted psychotherapy trials show incredible promise in treating Post-Traumatic Stress Disorder (PTSD). PTSD is a dangerously under-diagnosed psychosocial disorder that afflicts individuals, communities, and without effective intervention, generations to come. Promoting MDMA-assisted psychotherapy for PTSD would advance the human right to physical and mental health, and improve public health, by encouraging States to actualize their commitment to the treatment of mental health disorders like PTSD. In a world pockmarked with violence, the ability to heal from trauma is absolutely essential to developing a more peaceful world, and research indicates MDMA is the most promising tool for treating PTSD.

Submission 

Our contribution re-introduces a 1985 recommendation by the World Health Organization (WHO) Expert Committee on Drug Dependence that was never followed: “urge countries” to conduct therapeutic research with 3,4-methylenedioxymethamphetamine, known as MDMA. MDMA possesses tremendous potential to improve public health by healing trauma. Specifically, clinical MDMA-assisted psychotherapy trials show incredible promise in treating Post-Traumatic Stress Disorder (PTSD).

1. Policy Incoherence
The Multidisciplinary Association for Psychedelic Studies (MAPS) was founded thirty years ago with the goal of increasing access to a specific medicine, MDMA, in response to the codification of a dangerous policy incoherence. In 1985, MDMA was listed as a Schedule I substance - a substance defined as possessing no medical use and high abuse potential - by both the United States Drug Enforcement Agency and in the United Nations Convention on Psychotropic Substances, despite a complete lack of relevant scientific research supporting those claims. In fact, research over the past thirty years has only proved to undermine MDMA’s home in Schedule I.
The chairman of the WHO Expert Committee on Drug Dependence at the time of MDMA’s scheduling, Dr. Paul Grof, “felt that the decision on the recommendation should be deferred awaiting, in particular, the data on the substance’s potential therapeutic usefulness and that at this time international control is not warranted [emphasis added].” [1] The only scientific evidence referenced by the committee was the research on a different but related compound, MDA, administered to rats in frequent and high doses. At the time of MDMA’s scheduling, the WHO’s 22nd report of the Expert Committee on Drug Dependence even stated: “No data are available concerning [MDMA’s] clinical abuse liability, nature and magnitude of associated public health or social problems.” [2] Though MDMA had been administered therapeutically for over a decade at the time of its criminalization in 1985, the Expert Committee on Drug Dependence determined that there was inadequate research supporting MDMA’s therapeutic use. However, the Committee was impressed by the non-clinical reports. The Technical Report Series from the WHO Expert Committee on Drug Dependence (1985) reads:
It should be noted that the Expert Committee held extensive discussions concerning the reported therapeutic usefulness of 3,4-methylenedioxymeethamphetine [MDMA.] While the Expert Committee found the reports intriguing, it felt that the [limited, existing] studies [at the time] lacked the appropriate methodological design necessary to ascertain the reliability of the observations. There was, however, sufficient interest expressed to recommend that investigations be encouraged to follow up these preliminary findings. To that end, the Expert Committee urged countries to use the provisions of Article 7 of the Convention on Psychotropic Substances to facilitate research on this interesting substance. [3]
The WHO and CND have since failed to promote MDMA research. MAPS, a privately-funded non-profit research organization, has conducted the only medical research attempting to evaluate the therapeutic benefit of MDMA. So far, results from MAPS’ Phase II [4] research have been incredibly promising for the treatment of chronic, treatment-resistant Post-Traumatic Stress Disorder (PTSD); in fact, the Phase II research indicates that MDMA-assisted therapy dramatically outperforms current methods of PTSD treatment. Phase I clinical trials have also demonstrated that MDMA can be administered safely in pre-screened subjects, [5] undermining any justification for MDMA’s placement in Schedule I. Research only demonstrates the egregiously incoherent current policy governing MDMA access, and demands further research to expedite access to MDMA as a tool for treating trauma.

2. Public Health
According to the World Health Organization (WHO), Post-Traumatic Stress Disorder (PTSD) afflicted approximately 3.6% of the world’s population in 2012 alone [6]. PTSD develops in response to a wide range of traumatic life experiences, including: violence, rape, natural disasters, poverty and racism [7]. PTSD is also widely under-diagnosed [8], even in hospitals where people are privileged enough to have access to clinicians capable of diagnosing them. [9] PTSD shares high comorbidity rates with addiction, suicidality, and other psychological and physical illnesses [10]. PTSD therefore can have devastating impacts on those close to the individual suffering. Family members have been shown to experience secondary trauma[11]; they also dedicate significant time and resources to caring for a loved one with severe mental illness. Unfortunately, PTSD can wreak the most damaging effects on the children of those suffering, and even on generations to come. Described as intergenerational trauma, “there is now considerable evidence that the effects of trauma experiences are often transmitted across generations, affecting the children and grandchildren of those that were initially victimized,” [12]. Thus, an individual suffering from PTSD endangers a community: effective PTSD interventions must be a public health priority.
Currently, treatments for PTSD are incredibly costly, ineffective, and sometimes deadly. The only currently approved medications for PTSD are Zoloft and Paxil, both SSRIs which fail to help approximately half of their users, and only partially help to decrease PTSD symptoms in others [13]. By contrast, 83% of MAPS’ Pilot Study participants suffering from chronic, treatment-resistant PTSD no longer qualified for PTSD after participating in MDMA-assisted therapy [14]. MAPS’ other research, including a long-term follow up[15], demonstrate similar results, but the scope of our research is still limited, (in part by having no choice but to rely on private donors.)
We applaud the WHO’s recommendation in contrast to the American Psychiatric Association guidelines that antidepressants are “not recommended as a first-line treatment for adults because of the small effect size of these drugs for the treatment of PTSD,” [16] however WHO offers limited alternative treatments. Due to ineffective treatment modalities for PTSD, treatment costs skyrocket: medical systems are forced to pay for treatment for long periods of illness, and over the span of years often pay for a variety of ineffective medicine and treatment. Further, as PTSD impacts families and generations to come, the cost of PTSD treatment extends beyond the individual. The incredibly promising results from MDMA-assisted psychotherapy research for PTSD demand the expansion of therapeutic research with MDMA for PTSD, to address one of our world’s most urgent public health needs.

3. Advancing Human Rights
MDMA-assisted psychotherapy for PTSD advances specific iterations of the human right to health. Article 12 of the International Covenant on Economic, Social and Cultural Rights recognizes “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” including “(c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases.” The relationship between PTSD and its comorbidity with other psychological illnesses, as described above, is well documented and endemic to both specific occupations and populations, as well as to entire regions that experience violent conflict. It is impossible to secure the “highest attainable standard of physical and mental health” of those populations and those regions without treating PTSD. Thus, support for MDMA-assisted psychotherapy for PTSD falls directly within the purview of Article 12.
Elaborating on Article 12, the Committee on Economic, Social, and Cultural Rights in General Comment No. 14 (2000) (“Comment 14”) stated that the aforementioned right to physical and mental health “must be understood as a right to the enjoyment of a variety of facilities, goods, services and conditions necessary for the realization of the highest attainable standard of health.” However, in many countries, the right to effective mental health care “facilities, goods, [and] services” is limited due to multiple factors like inadequate training, subpar facilities, unaffordability, or discrimination. Indeed, according to OHCHR:
[Mental] disabilities are often neither diagnosed nor treated or accommodated for, and their significance is generally overlooked. Adequate policies, programmes, laws and resources are lacking… mental health care, including essential medication such as psychotropic drugs, is inaccessible or unaffordable to many.” [17]
In the case of MDMA for PTSD, however, access is not limited by these factors; rather, it is primarily limited by its Schedule I placement and the subsequent reluctance of States to support research. Though research with Schedule I substances is possible, significant bureaucratic and stigma-related barriers exist that actively discourage research. Proof of Schedule I’s successful deterrence is the dearth of MDMA research in the wake of the Committee’s 1985 recommendation, despite the thriving community of MDMA therapists and researchers before its criminalization.
Promoting MDMA-assisted psychotherapy for PTSD would advance the right to physical and mental health by encouraging States to actualize their commitment to the treatment of mental health disorders like PTSD. More concretely, the State obligations to respect, protect, and fulfill the right to right to physical and mental health apply to making MDMA research accessible for people with PTSD. The obligation to respect the right to health requires States to refrain from denying access to MDMA-assisted psychotherapy to persons suffering from PTSD by stifling research. The obligation to protect includes the duties of States to adopt legislation that protects and encourages research and access to mental-health-related services like MDMA-assisted psychotherapy. The obligation to fulfill requires States to recognize the right to mental health in national legal systems, including legislative implementation - like State support for MDMA research - that enable and assist individuals and communities to enjoy the right to mental health.
Finally, States that continue to engage in and perpetuate violent conflict that has measured and demonstrated psychosocial effects on the populations that come into contact with that conflict, including but not limited to PTSD, have an obligation to provide access to essential medicine – like MDMA – that can help them heal [18].


5. Potential Limitations
Comment 14 acknowledges limitations of fundamental rights based on issues of public health. For instance, criminal limitations of the right to mental health resources like MDMA-assisted psychotherapy may be based on and justified by the perceived danger of allowing legal access to a drug like MDMA that has been stigmatized by its use in popular culture. However, “The Committee... [emphasized] that the Covenant’s limitation clause... is primarily intended to protect the rights of individuals rather than to permit the imposition of limitations by States.” Further, “restrictions must be in accordance with the law, including international human rights standards, compatible with the nature of the rights protected by the Covenant, in the interest of legitimate aims pursued, and strictly necessary for the promotion of the general welfare in a democratic society,” and must be “proportional,” [Comment 14]. The continued State-level prohibition and criminalization of MDMA may be in accordance with present international law, but as demonstrated above, it is not aligned with international human rights standards, it is incompatible with rights protected by Article 12, and extensive research has shown that it is not necessary for the promotion of the general welfare.

MAPS’ current MDMA-assisted psychotherapy model features two co-therapists and one participant. However, MAPS recently received approval for a pilot study administering MDMA-assisted therapy to a couple impacted by PTSD. Individual treatments limit MDMA-therapy’s reach. Group-therapy models should be researched, to further increase MDMA’s therapeutic access.

4. Implementation
To bring this contribution to its expected results of promoting therapeutic research with MDMA and thereby increasing access to MDMA, the following political and institutional steps need to be taken:
1. The Secretary-General’s High-Level Panel on Access to Medicines must echo the recommendations made by WHO’s Expert Committee on Drug Dependence in 1985 and urge States to support therapeutic research of MDMA. States and WHO should be encouraged to fund urgent MDMA research for the treatment of PTSD.
2. To facilitate research and remedy policy incoherence, MDMA must be removed from Schedule I of the UN Convention on Psychotropic Substances, in accordance with relevant scientific research concerning MDMA, not a related but different substance.

Bibliography and References 

[1] WHO Expert Committee on Drug Dependence, Twenty-second Report, Technical Report Series 729 (1985).
[2] WHO Expert Committee on Drug Dependence, Twenty-second Report, Technical Report Series 729 (1985).
[3] WHO Expert Committee on Drug Dependence, Twenty-second Report, Technical Report Series 729 (1985).
[4] Mithoefer MC, Wagner TM, Mithoefer AT, Jerome L, Doblin R. The safety and efficacy of ±3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. J Psychopharmacol 2011;25:439-52.
[5] Kolbrich EA, Goodwin RS, Gorelick DA, Hayes RJ, Stein EA, Huestis MA. Plasma pharmacokinetics of 3,4-methylenedioxymethamphetamine after controlled oral administration to young adults. The Drug Monitor. 2008;30:320–332.
[6] WHO Media Centre: WHO Releases Guidance on Mental Health Care After Trauma (Aug. 6, 2013). Found at: http://www.who.int/mediacentre/news/releases/2013/trauma_mental_health_20130806/en/.
[7] Carter, R. T. Racism and Psychological and Emotional Injury: Recognizing and Assessing Race-Based Traumatic Stress. The
Counseling Psychologist, 35(1),
13-105, 2007
[8] Wimalawansa, SJ. Post-traumatic stress disorder: An under-diagnosed and under-treated entity. Comprehensive Research Journal of Medicine and Medical Science, 1(1): 1-12, 2013.
[9] Zimmerman M, Mattia JI. Is posttraumatic stress disorder underdiagnosed in
routine clinical settings? J. Nerv. Ment. Dis. 1999 Jul;187(7):420-8.
[10] Brady KT, Killeen TK, Brewerton T, Lucerini S. Comorbidity of psychiatric disorders and
posttraumatic stress disorder. J Clin
Psychiatry. 2000;61 Suppl. 7:22-32. Review. Found at: http://www.ncbi.nlm.nih.gov/pubmed/10795606.
[11] Galovski, Tara; Lyons, Judith A. Psychological sequelae of combat violence: A review of the impact of PTSD on the veteran's family and possible interventions. Aggression and Violent Behavior, Vol 9(5), Aug 2004, 477-501.
[12] Bombay, Amy, MSc; Matheson, Kim, PhD; Anisman, Hymie, PhD. Intergenerational Trauma: Convergence of Multiple Processes among
First Nations peoples in Canada. Journal
of Aboriginal Health 5.3 (Nov 2009): 6-47.
[13] SSRIs for PTSD: Just How Effective Are They? The Carlat Psychiatry Report. Vol. 2, No. 4. April, 2004.
[14] Mithoefer MC, Wagner TM, Mithoefer AT, Jerome L, Doblin R. The safety and efficacy of ±3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. J Psychopharmacol. 2011;25:439-52.
[15] Mithoefer MC, et. al. Durability of improvement in
post-traumatic stress disorder symptoms and absence of harmful effects or drug
dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a
prospective long-term follow-up study. J Psychopharmacol. 2013 Jan;27(1):28-39. Found at: http://www.ncbi.nlm.nih.gov/pubmed/23172889.
[16] Wietse A. Tol, PhD; Corrado Barbui, MD; Mark van Ommeren, PhD. Management of Acute Stress, PTSD, and Bereavement. JAMA. 2013;310(5):477-478. Found at: http://jama.jamanetwork.com/article.aspx?articleid=1724282.
[17] Office of the High Commissioner for Human Rights, Fact Sheet 31, Found at: http://ohchr.org/Documents/Publications/Factsheet31.pdf.
[18] Indeed, Comment 14 states: “Since the adoption of the two International Covenants in 1966 the world health situation has changed dramatically and the notion of health has undergone substantial changes and has also widened in scope. More determinants of health are being taken into consideration, such as resource distribution and gender differences. A wider definition of health also takes into account such socially-related concerns as violence and armed conflict.”

James Love_C

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

ABSTRACT 

This submission highlights a particular set of policy options that can be used as part of a progressive implementation of delinkage. In short, we consider the expansion of subsidies for clinical trials tied to policies to reduce the costs of products, either directly through lower prices or by shortening the terms of exclusive rights, or some combination of the two options. The basic idea is that if governments collectively reduce the costs of R&D inputs, they can also reduce the size of incentives to induce investments in such R&D inputs.

Submission 

The grant of temporary monopolies is widely used as an incentive to induce investments in R&D for the development of new drugs, vaccines, diagnostic devices and other products. These monopolies are associated with high prices, access barriers and unequal access, as well as a number of other shortcomings, and are also ineffective at inducing investments in the advance of basic science, projects where the prospects of commercialization of low-end drugs for tropical neglected diseases, to mention a few well known areas of market failures.

In order to achieve greater and more equal access to medicines, prices have to be lower. Many groups are asking that policy makers delink R&D costs from product prices. We have examined various delinkage strategies in a series of papers [see: Additional references on KEI’s work on delinkage]. Many policy makers are warming up to the notion of delinkage, but find the challenges of setting up radically new financing mechanisms a daunting challenge.

This submission highlights a particular set of policy options that can be used as part of a progressive implementation of delinkage. In short, we consider the expansion of subsidies for clinical trials tied to policies to reduce the costs of products, either directly through lower prices or by shortening the terms of exclusive rights, or some combination of the two options. The basic idea is that if governments collectively reduce the costs of R&D inputs, they can also reduce the size of incentives to induce investments in such R&D inputs.

This suggestion takes as its point of departure the U.S. Orphan Drug Tax Credit (ODTC) program. [2] The ODTC provides for a tax credit that directly reduces a company’s tax liability by 50 percent of the qualifying costs of trials on “certain drugs for rare diseases or conditions.” Since the creation of the tax credit in 1983, the credit has been available every year, except for 1995 through 1997. The statutes and regulations that set out the rules for the credit have changed over time, gradually expanding the number of products and trials that qualify for the credit, and liberalizing the carryforward provisions, which has been a benefit to smaller companies with no current profits. The credit is an important subsidy for clinical trials, but only for for-profit entities that file income tax returns. The U.S. Internal Revenue Service publishes some data on the use of the credit, but nothing that can be attributed to a specific trial or company.

Over time, the Orphan Drug Tax Credit has become an under-recognized government subsidy for R&D. In 2015, the FDA approved a record 45 novel drugs. Of the 45, 21 qualified as Orphan Drugs (47 percent of all approvals), and were eligible for the tax credit. [1] For cancer drugs, the role of the ODTC is even more important. From 2014 to 2015, 80 percent of all new cancer drugs qualified as Orphan products.


There are several important aspects of the ODTC.

-There is no transparency of the amount of the subsidy for specific drugs or specific trials.
-The ODTC only subsidizes for-profit entities, and does not provide a benefit to universities or non-profit drug developers, like DNDi, engaged in drug development.
-Non-US firms that sell products in the United States can and do claim the credits.
-U.S. taxpayers pay for the ODTC. No foreign country pays for this R&D subsidy.

The proposal is this: A group of governments could agree, collectively, to expand the current 50 percent ODTC to a higher level of subsidy, say 75 percent, and extend the subsidy to a larger set of drugs and trials. For this to happen, the subsidy would be paid for by a larger set of governments, perhaps lowering the costs for the United States and having other countries share more of the costs of the subsidies.

Why would governments want to consider this? Because at the same time, the governments could either lower expected reimbursements or shorten the effective term of the monopoly, perhaps by eliminating some sui generis regulatory monopolies and patent extensions, or issuing compulsory licenses before the full term of the patent.

The combination of expanding subsidies on clinical trials and reducing prices (and profits) from the monopoly protects innovation and patients simultaneously, and it can eliminate the stigma and negative consequences of lowering drug prices on innovation.

Implementation

The proposal provides a concrete method of progressively delinking R&D costs from drug prices, using well known and familiar policy interventions.

Policy makers should have more transparency of the use of the ODTC for specific drugs and trials.

Policy makers would have to consider and model the costs and impact of deeper and more widely available subsidies for R&D inputs, including in scenarios where prices are lower, or monopolies are shorter.


Impact on Policy Coherence

The key to policy coherence is to protect both access and innovation. This proposal illustrates that this can be done using well known and familiar policy interventions.

Impact on Access

The lower prices obtained through the intervention will expand and make access more fair.

Bibliography and References 

[1] 2016. “2015 Novel Drugs Summary,” Center for Drug Evaluation and Research, U.S. Food and Drug Administration, January. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm474696.htm

[2] 26 CFR 1.28-1 - Credit for clinical testing expenses for certain drugs for rare diseases or conditions.

Additional references on KEI’s work on delinkage

James Love, An Economic Perspective On Delinking The Cost Of R&D From The Price Of Medicines. UNITAID Discussion Paper. World Health Organization. 2016.

2014. James Love, Alternatives to the Patent System that are used to Support R&D Efforts, Including both Push and Pull Mechanisms, with a Special Focus on Innovation-Inducement Prizes and Open Source Development Models, World Intellectual Property Organization, CDIP/14/INF/12, September 19.

2014. Narmeen Haider, Aidan Hollis, James Love. "Delinkage Proposals and the Measurement of Health Benefits." Whittier Law Review, Volume 25, Number 3, Spring 2014.

2012, James Love. Balancing options for health research and development, Bulletin of the World Health Organization 2012;90:796-796A. doi: 10.2471/BLT.12.113886

2012. Testimony of James Packard Love. "The de-linkage of R&D costs and drug prices through the Prize Fund for HIV/AIDS will cost less, expand access, accelerate and improve innovation, and replace an incentive system that is expensive, inefficient and unsustainable." Hearing before the United States Senate, Committee on Health, Education, Labor and Pensions, Subcommittee on Primary Health and Agency on The High Cost of High Prices for HIV/AIDS Drugs and the Prize Fund Alternative, May 15, 2012, Washington, DC

2012.James Love, Jan Keunen, Evert van Leeuwen en Gert-Jan van der Wilt, Weg met dure, inefficiënte patentensystemen, Het Financieele Dagblad, January 9.

2009. James Love and Tim Hubbard, "Prizes for Innovation of New Medicines and Vaccines," Annals of Health Law, Vol. 18, No 2, pages 155-186, Summer.

Eyes on the Prize: Incentivizing Drug Innovation without Monopolies, Multinational Monitor, MAY/JUN 2009, VOL 30 NO. 3. Robert Weissman interviewed me for the Multinational Monitor.

2009 June 18. The Global Fund to Fight AIDS, Tuberculosis and Malaria, the Special Programme for Research and Training in Tropical Diseases and the right to development. Prepared for the UN Human Rights Council, Working Group on the Right to Development, High Level Task Force on the implementation of the right to development. A/HRC/12/WG.2/TF/CRP.4/Rev.1. This paper, commissioned by the UN Human Rights Council, evaluates the Global Fund and the TDR partnerships, as mechanisms to realize the right to development. Among other things, the discussion of TDR ediscusses the role of Bill and Melinda Gates Foundation in changing the UN role in setting and priorities for tropical disease research, and the challenge of sustainability of treatments provided by the Global Fund.

2008 April 11. James Love. "The Role of Prizes in Developing Low-Cost, Point-of-Care Rapid Diagnostic Tests and Better Drugs for Tuberculosis," MSF expert meeting on IGWG and R&D for tuberculosis. Prepared at the request of MSF, this paper first introduced the concept of the open source dividend as a component of a prize fund.

2008 March 26. James Love. "Prizes, not prices, to stimulate antibiotic R&D.," SciDev.net.

2008. KEI Proposal: A WTO Agreement on the Supply of Knowledge as a Global Public Good .

2007 November 28. James Love and Tim Hubbard. "The Big Idea: Prizes to Stimulate R&D for New Medicines," Chicago-Kent Law Review, Volume 82, Number 3 (2007).The paper, which is based upon proposals first dev

2007 November 12. James Love. "Would cash prizes promote cheap drugs?" The New Scientist.

2006 March. James Love, "Measures to Enhance Access to Medical Technologies, and New Methods of Stimulating Medical R & D, UC Davis Law Review, Volume 40, Issue No. 3 Symposium: Intellectual Property and Social Justice, 679. This paper has two sections. The first concerns several proposals for improving the management of the traditional patent system, including improved statutory grounds for granting compulsory licenses, the use of remuneration guidelines for compulsory licenses, the creation of non-voluntary patent pools for the collective management of intellectual property rights, and three additional proposals for increasing patent transparency, managing standards for granting patents and avoiding unwarranted encroachments on the public domain. The second section of the paper looks at more radical changes in the paradigms to support medical R&D, including the use of medical innovation prizes, competitive intermediaries and a global medical R&D treaty.

2006 May. James Love. Drug development incentives to improve access to essential medicines. Bulletin of the World Health Organization. 84(5).

2006 May. James Love, "A new initiative at the WHO, Prizes rather than prices." Le Monde diplomatique.

2005. James Love and Tim Hubbard, "Paying for Public Goods," in Code: Collaborative Ownership and the Digital Economy. Edited by Rishab Aiyer Ghosh. MIT Press, Cambridge, 2005. (pp. 207 229). The chapter in Code evaluates methods of rewarding the production of knowledge, when the knowledge is available to everyone as a public good. The examples focus on the use of competitive intermediaries to reward producers of recorded music, software and biomedical inventions.

2005. James Love et Tim Hubbard, "Rendre les médicaments abordables : un Traité « R&D + » pour remplacer les « ADPIC + »," Pouvoir Savoir : Le développement face aux biens communs de l'information et à la propriété intellectuelle, Ouvrage collectif Coordonné par Valérie Peugeot, April. Also published in Vecam, April 16, 2008.

2004. Tim Hubbard and James Love, “A New Trade Framework for Global Healthcare R&D,” PloS Biology, February 17, 2004.

2003. A New Trade Framework for Global Healthcare R&D, Access to Medicines and the Financing of Innovations in Health Care, Paper presented at Workshop Hosted by the Program on Science, Technology, and Global Development, The Earth Institute at Columbia University, and the Consumer Project on Technology, Washington D.C. December 4th.

2003. James Love, From TRIPS to RIPS: A better Trade Framework to support Innovation in Medical Technologies, Agence nationale de recherches sur le sida/Institute d' Èconomie publique, Workshop on Economic issues related to access to HIV/AIDS care in developing countries, UniversitÈ de la MÈditerranÈe, Marseille, France, May 27th, 2003.

1997. A Free Trade Area For The Americas. A Consumer Perspective On Proposals As They Relate To Rules Regarding Intellectual Property. Comments for the Working Group On Intellectual Property Rights. Third Trade Ministerial and Americas Business Forum. Belo Horizonte, Brazil. May 13-16, 1997

1996. Comments on Trade and Pharmaceutical Policies: A Perspective from the U.S. Consumer Movement, HAI Seminar: World Trade Organization/GATT, Pharmaceutical Policies and Essential Drugs, October 4, 1996, Bielefeld, Germany.

1994. Pharmaceutical Drugs, Intellectual Property Rights and Public Health: A Consumer Perspective from the United States, Presented at XV Asamblea General de la Asociaión Latinoamericana de Industrias Farmacéuticas San Carlos de Bariloche - Río Negro - Argentina 11 al 13 de mayo de 1994. Remarks delivered on May 12, 1994.

Tahir Amin, INITIATIVE FOR MEDICINES, ACCESS & KNOWLEDGE

Tahir Amin, INITIATIVE FOR MEDICINES, ACCESS & KNOWLEDGE

 

Lead Author: Tahir Amin
Organization: Initiative for Medicines, Access & Knowledge (I-MAK)
Country: USA

Abstract 

There is ample evidence to show that the founding social contract of the patent system, namely to give a period of exclusivity for disclosing and promoting the diffusion of new inventions whilst rewarding and remunerating the investment made so as to encourage R&D, is no longer working in practice. Patenting practices today, including the administrative system, are less and less about invention and more about defensive patenting and maintaining a broken system. This leads to a blockage in the diffusion of knowledge and longer exclusivity periods leading to higher prices. The current patent system is, therefore, less about rewarding inventions, but about rewarding investments. In that respect, the patent system is only working to reward pharmaceutical companies with significant power to control the market place and achieve a disproportionate return on their investment.

This contribution seeks to bring the patent system and related administration standards into the 21st Century, to reflect where drug discovery techniques and pharmaceutical business practices are today rather than what it was 30-40 years ago. It advocates for re-designing patent laws and patentability criteria to be industry specific. Through this re-definition of patent standards, it will also help determine how we as a society attach value to medical patents and what is progress. It also calls for better knowledge diffusion by requiring that inventions that are patented but which are not used within a certain period of time will fall into the public domain. And, in order to have a balanced patent system that deters gaming, such a system would impose a penalty on patent holders whose patents are subsequently invalidated. Finally, in order to achieve such reform there also needs to be change in the fee-based patent administration system that currently incentives patent proliferation and higher grant rates of unmerited patents.

Submission 

The current patent system sits at the heart of the discontent that exists between the rights of inventors, international human rights law, trade laws and public health objectives to increase access to medicines. On the one hand, the originator pharmaceutical and biotech industry claim they need patent exclusivity in order to be incentivised to carry out the R&D to come up with new and useful medical inventions. This exclusivity then allows these companies to recoup their investment by being able to determine how much the market should pay for the patented medicines. On the other, public health and human rights advocates and potential commercial competitors believe the current patent system is not achieving what it was founded to do and is one of the main barriers to increased access.

The founding social contract of the patent system was based on two main components. One is to give a period of exclusivity for disclosing and promoting the diffusion of new inventions. The other is to reward and remunerate the investment made so as to encourage R&D that results in new inventions. However, when we look at patenting practices today and the impact it is having on the cost of health, we have to ask is the current patent system delivering on one of its key founding principles, namely to deliver new inventions?

To borrow the title of an essay by the late and much revered former UK High Court Judge in the Chancery division and patents court, Sir Hugh Laddie, ‘Patents – what’s invention got to do with it?’ (1). Although recognising the need for a patent system to encourage investment, Sir Hugh Laddie acknowledged that most inventions are obvious in light of today’s understanding of how chemicals and genes work and the drug discovery techniques, such as the use combinatorial chemistry and high throughput screening ¬techniques, which make it possible to prepare ten to thousand and even millions of compounds in a single process. Yet we continue to see a proliferation of patents.

Much of this is attributed to the lowering of patent standards over the years and as pointed put above, the law not keeping pace with where we are at in science and drug discovery technologies. It also reflects pharmaceutical company business strategies to extend the life cycle of products by extending patent protection through secondary patents beyond the basic patent term on the initial compound in order to maximise profits and to keep competition away from the market. Ample evidence exists to show these practices at play and how such patenting practices can extend the patent life of a drug for decades and contribute to rising costs (2), (3), (4), (5). And such practices are not limited to more downstream secondary patenting activity. Upstream compounds that are readily given the title of new chemical entities are often a slight change atone or two substitution groups from a previously known compound. This practice, which we term ‘patenting the gaps’ is a practice where companies seek to find the holes between existing patents which would then allow them to get a patent under the current system even though they should technically be deemed non-inventive. As such the current patent system does not incentivise a race to the top in terms of new drug discovery and path-breaking science, but minimal effort for maximum gain. Examples of such compounds include the HIV booster cobicistat, which are essentially ritonavir and the new hepatitis C drug sofosbuvir (6).

The proliferation of patents also hinders the other part of the social contract, the diffusion of knowledge. The excessive patenting, especially where it consists of obvious science, blocks knowledge diffusion. It prevents legitimate research from taking place that could turn useful compounds or science that is sitting idle on a company’s library shelf into a useful treatment.

Bringing the Patent System into the 21st Century

In light of the malaise with the current patent system, this contribution seeks to modernise the current patent system by:

• Re-designing patent laws and patentability criteria to be industry specific. The current one size fits all patentability criteria do not work. Patentability criteria that is specific to the pharmaceutical and biotech industry and which reflect modern drug discovery techniques and business practices need to be designed. There is ample evidence or guidance from case law and legal systems that curb secondary patenting or minor modifications of existing compounds that could guide this re-design.

• In order to encourage more diffusion of knowledge and avoid gridlock of research, this contribution proposes a system whereby inventions that are patented but which are not used within a certain period of time will fall into the public domain. While such a criteria would need to be flushed out further, an example would be if the thousands and/or millions of compounds in a markush type patent claim are not shown to be in use for clinical trials within 3-5 years, such compound claims will be open to be invalidated and fall into the public on the grounds of non-use thereby allowing for open access research to take place.

• In order to have a balanced patent system that deters the current industry gaming and abuses, a new patent system would impose a penalty on patent holders whose patents are subsequently invalidated, say by a patent challenge. Under the current system companies reap billions of dollars of profits whilst imposing a huge burden on public health without any consequence if the patent is eventually revoked.

• Related to the above the threat of retrospective damages should be removed from patent laws. This practice deters the early entry of competitors and significantly favours the patent applicant even before a right is granted.

• In order to achieve the above reform, the current patent administrative system and its incentives need to change. The current fee-based patent system, which help run patent offices, only incentivises the proliferation and rubber stamping of patents. It is well known that examiners are under pressure to grant than refuse in order to keep revenues high. Alternative revenue models are needed to run patent offices that do not incentivise more patenting and poor examination standards. Under a new administrative system there. In addition, practices such as divisional and continuation patents would not be permitted.

This contribution, whilst seeking a re-design of the current patent system and its standards, is also likely to complement other contributions that the High Level Panel may receive. For example, useful discoveries that are not patentable may be funded and brought to market by other contributions.


Impact on Policy Coherence

Only by cleaning up the patent system can there be policy coherence in all the various areas the UN HLP is dealing with. Indeed, only by truly reforming the patent system can other mechanisms like patent pools work. As they stand patent pools only serve to strengthen the current broken patent system, undermine any use of TRIPs flexibilities and hand back power to the pharmaceutical companies.

Impact on Public Health

The impacts would be significant, as we would see a reduction in unnecessary monopoly rights that lead to excessive pricing. It would also remove spending on medicines that do not provide any added health benefits. We would also see more research enabled as knowledge becomes more open rather than being constrained by artificial patents. It would also help re-define how we understand invention and innovation, thereby re-defining how we place value on new medicines.

Impact on Human Rights

The proposed reforms create a balance between human rights and private rights. At present the current system is heavily biased in favour of private interests.

Implementation

Politically this would be a challenging process and there would be fear that it would dis-incentivise funding into new medicines. However, alongside other mechanisms and solutions that are possible, we believe that once established alongside other policies we would see significant developments in drug discovery that are not low-hanging fruit.

Bibliography and References 

1) Sir Hugh Laddie, Patents - what's Invention got to do with it?, Intellectual Property in the New Millenium (2004)
2) Amin et al., Secondary Patenting of Branded Pharmaceuticals: A Case Study of How Patents on Two HIV Drugs Could Be Extended for Decades, Health Affairs (2012)
3) Kapczynski et al; Polymorphs and Prodrugs and Salts (Oh My): An Empirical Analysis of Secondary Pharmaceutical Patents, PLOS (2012)
4) European Comission, Pharmaceuticval Sector Inquiry (2009)
5) Vernaz et, al, Patented Drug Extension Strategies on Healthcare Spending: A Cost Evaluation Analysis, PLOS (June 2013)
6) On file with I-MAK and http://www.i-mak.org/sofosbuvir/

Robert Garcia, THE CITY PROJECT

Lead Author: Robert Garcia
Organization: The City Project
Country: USA

Abstract 

We request that the UN High Level Panel support our proposed reform of the US “Common Rule” on human medical experiments, and hear our presentation, to remedy policy incoherence, promote public health, safeguard human rights, and implement evidence based reforms. The US government is studying revisions now.
1. The Common Rule must make explicit nonconsensual human medical experiments violate domestic and international laws. Ethical prohibitions are not enough to deter violations.
Nonconsensual human medical experiments violate customary international law because the prohibition is specific, universal and obligatory among nations, according to the court in Abdullahi v Pfizer (2d Cir. 2009).
2. The Common Rule must recognize voluntary consent of the human subject is absolutely essential.
The Nuremberg Code formulation must not be watered down. Under the Common Rule, “informed consent” is virtually meaningless.
3. The Common Rule must address special problems of human medical research in developing countries.
While US researchers engage in unethical behavior in developing nations, the Common Rule is virtually silent on this. The Rule provides special protections for pregnant women, children, and prisoners, and must do so for human subjects in developing nations.
4. The Common Rule must provide for treatment and compensation for research-related injury.
Subjects should not bear costs for research-related injuries, as happened in STD experiments in Guatemala and Tuskegee, and meningitis experiments in Nigeria.
5. The US must waive sovereign immunity and other procedural obstacles in human medical experiments.
The US court dismissed the lawsuit by Guatemalan victims because the US has not agreed to be sued: “the Guatemala Study is a deeply troubling chapter in our Nation’s history. Yet . . . this Court is powerless to provide any redress to the plaintiffs.” Garcia Gudiel v Sebelius (D.D.C. 2012). The US must waive procedural obstacles in human medical experiments.

Submission 

This contribution recommends that the UN High Level Panel on Access to Medicines support the proposed reform of US regulations on medical human experiments (“the Common Rule”), and hear this presentation in March 2016. This contribution reflects the proposals of legal, human rights, and civil rights experts, academics, and attorneys.

This contribution remedies policy incoherence, safeguards human rights, promotes public health, and implements evidence based reforms regarding the corrupting influence of financial incentives for medicines, vaccines, diagnostics, and medical devices (‘health technologies’) without proper safeguards.

This contribution:
• reflects, aligns, and demonstrates how it will support attainment of Sustainable Development Goal 3, improving health and wellbeing for all, and Target 7, and the 2030 Agenda for Sustainable Development;
• is evidence-informed and includes references to the principles, literature and models upon which it is based;
• incorporates and demonstrates the link to fundamental human rights and the right to health; and
• indicates the requirements to implement the proposed ideas.

This contribution supports Sustainable Goal 3, improving health and wellbeing for all, and most directly Target 7: “Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.” This Target cannot be achieved on the backs of the victims of human medical experiments without proper safeguards, especially in developing nations. This contribution promotes he 2030 Agenda for Sustainable Development, ensuring that all human beings can fulfill their potential in dignity and equality and in a healthy environment.

In a word, the US Department of Health and Human Services can and should implement these recommendations through its pending study and forthcoming revisions to the Common Rule.

1. The Common Rule must explicitly recognize that nonconsensual human medical experiments violate domestic and international laws.

The United States Court of Appeals for the Second Circuit held that nonconsensual medical experimentation on human beings violates customary international law and is actionable under the Alien Tort Statute because the prohibition is specific, universal, and obligatory among nations around the world. See Abdullahi v Pfizer, 562 F.3d 163 (2d Cir. 2009), cert. denied, 130 S.Ct. 3541 (2010). In Abdullahi, researchers experimented without consent on children with a new antibiotic during an epidemic of bacterial meningitis in Nigeria even though an effective vaccine was available - and left the children without care, causing the deaths of 11 children and leaving many others blind, deaf, paralyzed, or brain damaged. The court relied in part on the Nuremberg Code, which was adopted in 1947 upon the conviction by the US of German doctors for nonconsensual medical experiments. The Common Rule must ensure that the legal as well as the ethical and moral underpinnings of the Rule are made explicit. The responsibilities of individual investigators must be made clear in the Rule. At the present time, institutions at best are generally held responsible.

Three reports by the Guatemalan government cited in the resources section below agree that STD experiments by the US beginning in the 1940s violated international human rights and domestic laws. The Guatemalan presidential commission report concludes that the STD experiments were crimes against humanity and domestic crimes, and that racism and discrimination permeated the experiments. The technical report recognizes at page 96: “Given the applicable laws during that period, all directly responsible committed crimes punishable by law, and its cover up suggests knowledge of criminal responsibility.” The archival report concludes at page 165: “It is evident that people responsible for these experiments took advantage of the conditions and vulnerability of these groups to carry out these practices, which were a crime against humanity and a clear violation of the Nuremberg Code.” The US nevertheless has provided no treatment or compensation to the victims until the present day.
Ethical prohibitions are inadequate to deter crimes against humanity and human rights violations in medical research. The US presidential report acknowledges that the experiments in Guatemala were “ethically impossible” by ethhical standards of the time and today. Yet Dr. John Cutler led the STD experiments in Guatemala, and was later responsible for the Tuskegee experiments that left African American men untreated for syphilis for decades. Cutler nevertheless died a hero at the University of Pittsburgh even after the Tuskegee experiments were exposed. Cutler died without ever disclosing the Guatemala experiments. Sonia Shah has described unethical research in Tuskegee and in developing nations. Prof. Henry Beecher published twenty-two examples of unethical human research.

2. The content of the Common Rule must be strengthened to recognize that voluntary consent of the human subject is absolutely essential.

The voluntary consent of the human subject is essential under the Nuremberg Code. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This is the formulation of the Nuremberg Code and it should not be watered down. Research that poses greater risk to subjects should also receive more oversight and deliberation than less risky research. The Common Rule must reflect these requirements.

As it now stands, the term “informed consent” is virtually meaningless under the Common Rule. As explained by Dr. Marcia Angell, former editor of the New England Journal of Medicine:

“[T]he Common Rule itself needs to be revised, because it is almost devoid of ethical content. Instead, it should deal with difficult substantive issues. These include the “therapeutic misconception” (patients’ belief . . . that the researchers are there to provide them with individual care); the higher likelihood of harms than benefits because experimental treatments are usually no better, and often worse, than current treatments; the trade-off between individual benefits and benefits to science and society; whether the scientific merit of the research should be given weight (as called for in the Nuremberg Code); and whether to limit the move to conduct clinical trials in developing countries where there is almost certainly less oversight. . . . As it now stands, the term ‘informed consent’ is virtually meaningless.”

All federal agencies funding or conducting human subjects research must adopt human subjects regulations that are consistent with the legal and ethical requirements and underpinnings of the Common Rule.

Recommendations of the US Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (2011, updated 2012) generally should be implemented. The present contribution reflects recommendations 3, 6, 9, 11, and 13.

3. The Common Rule must be revised to address the special problems of human medical research in developing countries.

The Common Rule says almost nothing about the special problems of human medical research in developing countries. The imbalance between US researches and subjects arises from economic domination by the US of developing nations, discrimination by US researchers against host subjects based on race, color, national origin, gender, religion, income, and other factors; extreme poverty in many regions; cultural differences between researchers and subjects; and the greater likelihood of corruption involving US researchers and agents in the host nation. Poor study design, lack of informed consent, improper handling of adverse outcomes, distortion of findings, outright lying and forgery, blackmail: the meningitis experiments in the notorious case of Abdullahi v Pfizer, discussed above, illustrates a wide variety of ways that US researchers may engage in unethical behavior to pursue profit for big pharma.

The Guatemalan STD experiments are instructive. The Guatemalan presidential report concludes that racism and discrimination permeated the experiments. There was discrimination by US officials against Guatemalan people, and within Guatemala by elites against lower-class indigenous and non-indigenous people. Discrimination is an aggravating, unacceptable factor for the experiments. The archival report concludes the experiments took advantage of the conditions and vulnerability of these people to carry out these practices.
The Common Rule must be revised to provide special protections in developing nations, as the Rule does now for pregnant women, children and prisoners. For example:

• Institutional review boards must include subjects from the host nation who have no interest in the research, or other disinterested international monitors with relevant multicultural fluency.
• The Rule must provide justifications and operational criteria for legal and ethical site selection, whether international or domestic, taking into consideration whether site selection can respond to the needs of the broader community.
• The consent form, nature of the experiment, risks, and right not to take part must be clear to subjects in light of their own language, dialect, and cultural norms. The consent process should be videotaped, as a signature or mark on a written form may mean nothing to a person who does not read or write.
• Community engagement and respect for cultural differences are applicable to medical research both domestically and abroad. The Common Rule must provide a standardized framework for community engagement. The guidelines of the Joint United Nations Program on HIV/AIDS and the AVAC Good Participatory Practice Guidelines, for example, provide such a framework.
• Reports on medical experiments in developing nations must be published in the language of the host nation, not only in English, for the people of the host nation to understand the matter. Such reports must consider the perspective of the host nation. Reports by the host nation must be published in English. For example, the US report “Ethically Impossible” has been published in English and Spanish. In contrast, the US has published its recommendations report Moral Science only in English; the US should publish it in Spanish, too. Both US reports ignore the reports by the Guatemalan government, only one of which is available in English.

4. The Common Rule must provide for treatment and compensation for research-related injury.

Subjects harmed in the course of human research should not individually bear the costs for harms resulting from that research. The Common Rule must provide for compensation and treatment for research-related injuries like those in Tuskegee, Guatemala, and Nigeria in Abdullahi v Pfizer. Surviving family members should also be made whole for harm incurred, whether direct (e.g., disease transmission) or indirect (e.g., emotional distress, loss of a family member at a younger age) in nature.

5. The US should waive sovereign immunity and other procedural obstacles involving US funded human medical experiments abroad.

The US court threw out the lawsuit by Guatemala STD victims against the US on the grounds that the US has not consented to be sued. The court concluded that “the Guatemala Study is a deeply troubling chapter in our Nation’s history. Yet . . . this Court is powerless to provide any redress to the plaintiffs.” Gudiel Garcia v. Sebelius, 867 F.Supp. 2d 125, 144 (D.D.C. 2012), appeal dismissed, 2013 U.S. App. LEXIS 13873 (D.C. Cir. 2013). The US should waive procedural obstacles including but not limited to sovereign immunity and statutes of limitations involving US funded medical experiments abroad. US courts and international tribunals should provide relief to the victims to prevent the US and US funded researchers from acting with impunity. See Michael A. Rodriguez and Robert García, First, Do No Harm: The US Sexually Transmitted Disease Experiments in Guatemala, American Journal of Public Health (Dec. 2013, Vol. 103, No. 12, pp. 2122-2126), available at www.cityprojectca.org/blog/archives/30389.

6. Background on the human horrors of the Guatemala STD experiments

The discussion of legal and ethical reforms of the Common Rule can obscure the horror of what really happens in human terms. The acts described below in the Guatemala STD experiments are violations of customary international law, human rights violations, and crimes against humanity. They also constitute rape, sodomy, battery, assault, conspiracy to do the same, and conspiracy to cover up these wrongs.

The STD infections were not administered with clinical sterility, a pin prick, or a pill. Here is how one woman, identified only as Berta, died at the hands of the lead investigator, John Cutler, MD:

“Berta was a female patient in the psychiatric hospital. Her age and the illness that brought her to the hospital are unknown. In February 1948, Berta was injected in her left arm with syphilis. A month later, she developed scabies (an itchy skin infection caused by a mite). Several weeks later, [lead investigator Dr. John] Cutler noted that she had also developed red bumps where he had injected her arm, lesions on her arms and legs, and her skin was beginning to waste away from her body. Berta was not treated for syphilis until three months after her injection. Soon after, on August 23, Dr. Cutler wrote that Berta appeared as if she was going to die, but he did not specify why. That same day he put gonorrheal pus from another male subject into both of Berta’s eyes, as well as in her urethra and rectum. He also re-infected her with syphilis. Several days later, Berta’s eyes were filled with pus from the gonorrhea, and she was bleeding from her urethra. On August 27, Berta died.”

Presidential Commission for the Study of Bioethical Issues, “Ethically Impossible:” STD research in Guatemala from 1946-1948 at page 52 (2011).

US funded researchers intentionally infected innocent people with STDs without their knowledge or consent beginning in the 1940s and has left them untreated and uncompensated to the present day. The STD experiments involved at least 5,128 vulnerable people, including children, orphans, child and adult prostitutes, Guatemalan Indians, leprosy patients, mental patients, prisoners, and soldiers. Health officials intentionally infected at least 1,308 of these people with syphilis, gonorrhea, and chancroid, and conducted serology tests on others. The experiments and cover up continued before, during, and after the convictions and executions of German doctors at Nuremberg. Ethical prohibitions have proven inadequate to deter such violations by US researchers and to hold institutions and individuals responsible and accountable.

The City Project and other civil rights and human rights attorneys represent the Catholic Archdiocese of Guatemala in a petition before the Inter-American Commission on Human Rights against the US and the Republic of Guatemala in the STD experiments. The experiments were covered up until Prof. Susan Reverby exposed them while doing research on the Tuskegee syphilis experiments. President Barack Obama apologized to the people of Guatemala in 2011. An apology is not enough for truth and reconciliation without restorative justice. The government of Guatemala has published three reports documenting that the experiments were crimes against humanity that violated international human rights law and domestic laws, and were motivated by discrimination against vulnerable people in Guatemala. The US published two reports documenting that the experiments were unethical by the standards of the day and by contemporary standards. While the US reports are silent on the legality of the experiments, silence on that point is a tacit admission that the experiments did indeed violate international and domestic laws.

Guatemalan victims have filed lawsuit for damages against Johns Hopkins University, the Rockefeller Foundation, Bristol-Myers Squibb Company, and others in US district court in Maryland, case number 1:15 CV 950 MJG (2015). A criminal complaint reportedly has been filed in Guatemala against the former president, vice-president, and attorney general of Guatemala. These matters are not connected to the human rights petition filed by the Archdiocese of Guatemala.

Conclusion

The Common Rule must be revised so that nonconsensual human medical experiments never happen again. With all due respect, the UN High Level Panel on Access to Medicines should support reforms proposed above, and hear the presentation in support in March 2016. The US government can and must implement these recommendations through its pending study and forthcoming revisions to the Common Rule.

Bibliography and References 

Abdullahi v Pfizer, 562 F.3d 163 (2009), cert. denied, 130 S.Ct. 3541 (2010). Available at caselaw.findlaw.com/us-2nd-circuit/1442878.html.

US Department of Health and Human Services, Notice of Proposed Rulemaking for Revisions to the Common Rule to Improve Rules Protecting Human Research Subjects. Changes proposed to ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight. www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html

Marcia Angell, Medical Research on Humans: Making It Ethical, N.Y. Review of Books (Dec. 3, 2015). Available at www.nybooks.com/articles/2015/12/03/medical-research-humans-making-it-ethical/.

The Common Rule, Title 45, Part 46, Subpart A, Code of Federal Regulations, issued by the US Department of Health and Human Services in 1991. The rule is available at www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

Nuremberg Code, paragraph 1, available at www.hhs.gov/ohrp/archive/nurcode.html#; "Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp. 181-182, U.S. Government Printing Office (1949).

George J. Annas and Michael A. Grodin, The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation (1992).

Sonia Shah, The Body Hunters: Testing New Drugs on the World’s Poorest Patients (2006).

Henry K. Beecher, Ethics and Clinical Research, New England Journal of Medicine, Vol. 274, No. 24 (June 16, 1966).

Guatemala STD experiments

Petition by the Human Rights Office of the Archdiocese of Guatemala (ODHAG) against the U.S. and Guatemala for Human Rights Violations and Crimes Against Humanity before the International Commission on Human Rights (2015). Click here for the complete Appendix (17 MB on Dropbox).

Guatemala Presidential Commission Report, Consenting to the Damage: Presidential Commission Report for Elucidation of the Experiments Carried Out on Humans in Guatemala, 1946-48 (2011). The US Department of State provided the English translation to The City Project under the Freedom of Information Act. Síga este enlace para leer el reporte en español, Consentir el Daño: Experimentos Médicos de Estados Unidos en Guatemala, 1946-48 (2011).

US Presidential Commission report, “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948 in English. Síga este enlace para leer “Éticamente Imposible”: Investigación sobre las STD en Guatemala desde 1946 hasta 1948 en español.

US Presidential Commission report, Moral Science: Protecting Participants in Human Subjects Research in English.

Article by UCLA Medical School Prof. Michael Rodriguez, and civil rights and human rights attorney Robert García, in the American Journal of Public Health – First, Do No Harm: US Sexually Transmitted Disease Experiments in Guatemala. Síga este enlace para leer el articulo en español.

Two additional reports explicitly describe the violations of domestic and international law and provide background for the report by the Guatemalan Presidential Commission “Consenting to the Damage” These two reports are published in Spanish and are not available in English, except for the translated excerpts below.

Technical report Experimentos en Seres Humanos: el Caso Guatemala 1946-48 (Abril 2011), by Comisión Técnica, Comisión Presidencial para el Esclarecimiento de los Experimentos en Humanos en Guatemala 1946-48. Click here for the excerpts that discuss domestic and international laws in the technical report in English.

Archival report Investigación archivística sobre experimentos practicados en seres humanos en Guatemala, 1947-1948 (Mayo 2011) by Archivo General de Centro América (AGCA), el Archivo Histórico de la Policía Nacional (AHPN), y la Dirección de los Archivos de la Paz (DAP) de la Secretaría de la Paz. Click here for the excerpts that discuss domestic and international laws in the archival report in English.

Gudiel Garcia v. Sebelius, 867 F.Supp. 2d 125, 144 (D.D.C. 2012), appeal dismissed, 2013 U.S. App. LEXIS 13873. Available at casetext.com/case/garcia-v-sebelius-2.

Estate of Arturo Giron Alvarez, et al., v. Johns Hopkins University, Case: 1:15-cv-00950-MJG, 1:15-cv-1100 MJG (D.C. MD 2015) (second amended complaint). Available at static1.squarespace.com/static/55033401e4b015246a9aeda8/t/565dd1a3e4b00481fade3761/1448991713704/Guatemala+Complaint.pdf.

Tuskegee, Alabama, syphilis experiments

Susan M. Reverby, Examining Tuskegee: The Infamous Syphilis Study and Its Legacy (2013 ed.).

Fred D. Gray, The Tuskegee Syphilis Study (1998).

James H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (1993 ed.).

Nigeria meningitis experiments

Abdullahi v Pfizer, 562 F.3d 163 (2d Cir. 2009), cert. denied, 130 S.Ct. 3541 (2010).

 

Yogesh Pai, NATIONAL LAW UNIVERSITY, DELHI

Lead Author: Yogesh Pai
Organization: National Law University, Delhi
Country: India

Abstract

The broad objective of the High-Level Panel is presumably focused on the impact of international norms that regulate the policy space of Sates to undertake measures for ensuring equitable access to medicines. However, it will be useful if the committee takes in to account how States (especially, the developing countries and the least-developed countries) have, in practice, by including several key provisions in their IP law, facilitated equitable access to medicines. By studying a specific example of India, a developing country notable for being the ‘pharmacy of the world’, this note offers deeper insights on the current situation on access to patented medicines in the light of India’s compliance with international intellectual property, trade norms, human rights obligations and public health. However, in offering these insights based on working of the Indian law, this note does note claim that the Indian approach can be readily imported by other countries without assessing the need and context of ensuring of healthcare to its citizens.

Submission

I welcome the “United Nations Secretary-General’s High-Level Panel on Access to Medicines” for providing me with an opportunity to make submissions on a very pertinent topic. This subject has profound implications in achieving the Sustainable Development Goal # 3 in the broader context of the integrated nature of the 2030 Agenda for Sustainable Development. I take this opportunity to contribute to the Panel’s work by offering my comments on the proposed objective of the High-Level Panel, which is to recommend solutions for “remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” 
It appears from the statement of proposed objective of the High-Level Panel that it has made a priori assumption of an actual ‘misalignment’ or ’policy incoherence’ between the rights of inventors, international human rights law, trade rules and public health in the context of health technologies. It would be useful if the High-Level panel discusses these assumptions in greater detail and invite public comments on the same before proceeding to examine how such policy incoherence, if any, can be actually resolved. The proposed objective appears to raise definitive conclusions, which ideally should have been assessed by way of detailed studies and by evaluating actual experiences grounded in empirical evidence. Such a priori assumptions lead to few unintended consequences. 
i. It needlessly restricts our approach in adopting an inquiry based on holistic understanding of the nature and content of actual misalignment and/or policy incoherence in ensuring equitable access to medicines, in as much as the proposed objective makes a normative claim;
ii. The proposed objective seems to overlook the work of several UN agencies in the past (viz., 2012 WHO-WTO-WIPO joint study on Promoting Access to Medical Technologies and Innovation) which has pointed that “lack of access to medical technologies is rarely due entirely to a single determinant”;
iii. Importantly, it discounts experiences of different countries in how they have sought to address issues of intellectual property, trade and public health from a complementary perspective during the last two decades.
The broad objective of the High-Level Panel is presumably focused on the impact of international norms that regulate the policy space of Sates to undertake measures for ensuring equitable access to medicines. However, it will be useful if the committee takes in to account how States (especially, the developing countries and the least-developed countries) have, in practice, by including several key provisions in their IP law, facilitated equitable access to medicines. By studying a specific example of India, a developing country notable for being the ‘pharmacy of the world’, I wish to offer deeper insights on the current situation on access to patented medicines in the light of India’s compliance with international intellectual property, trade norms, human rights obligations and public health. However, in offering these insights based on working of the Indian law, this brief note does note claim that the Indian approach can be readily imported by other countries without assessing the need and context of ensuring of healthcare to its citizens. 
India largely achieved self-sufficiency in medicines by way of a combination of policy instruments that facilitated strong local generic production. The withdrawal of product patents for pharmaceuticals between 1972 -2005 was one among these policy instruments that helped Indian generic companies to produce generic copies of patented drugs by focussing on achieving efficiency in process and scale. It led to a diverse matrix of capabilities in the Indian pharmaceutical sector. However, in order to ensure supply quality drugs and in compliance with stringent USFDA regulatory standards, only the 584 firms are able to meet the requirements as of 2015. Over a period of two decades since the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the Indian pharmaceutical industry has witnessed consolidation. At the same time, the advent of the product patent system since 2005 has led to a new scenario both in terms of challenges to India’s generic industry and in ensuring equitable access to medicines. It has led to a general assumption that patent owning firms would be able to charge prices way beyond what is generally considered as “reasonably affordable” for Indian patient population. 
Recent studies, however, have estimated that “a molecule receiving a patent experienced an average price increase of just 3-6 percent with larger increases for more recently developed molecules and for those produced by just one firm when the patent system began.” The study further notes that “the presence of substitute goods should moderate the pricing power of firms receiving patent protection”. Hence text book cases of pharmaceutical patents serving as strict monopolies that lead to significant increase in prices must be understood with appropriate caveats and caution in the Indian context. This is not to deny that there could be a steady or significant price increase in specific cases in the future depending on the nature of the drug, nature of the technology, disease burden, market size, domestic capabilities, barriers to market entry, drug regulatory challenges, availability of closer substitutes etc... However, to assume that patents in medical technologies, and particularly pharmaceutical patents, are always overpriced, or that there are no mechanisms to deal with the issues of pricing of patented drugs, which has led to policy incoherence is a mistaken assumption. There are several provisions in Indian law that places significant constraint on the continued ability of patent owning pharmaceutical firms to engage in drug pricing beyond what is considered as reasonably affordable. These provisions have significantly benefited the Indian generic industry and patient population at large. In fact, it is quite possible that the very threat of onerous regulation may have significant impact on the behaviour of pharmaceutical firms in exploiting their patents in a way inimical to public interest.
Pharmaceutical firms worldwide are a major source of innovative drugs. It has been noted in several studies that the path dependency of pharmaceutical firms on the patent system is significantly higher when compared to other sectors. However, the way in which patents are exploited in the marketplace may raise barriers for innovation and access. The TRIPS Agreement recognizes that the ‘right to exclude’ may raise barriers to access and allows a host of flexibilities, general understood in terms of liability rules. They take the form of Article 30, Article 31, Article 44 and Article 40 (read with Article 8). Currently, the moratorium on non-violation complaints effectively allows every WTO member to adopt measures to protect public health that are not specifically barred by the TRIPS Agreement (e.g. price control of patented drugs). It is important that these flexibilities are maintained when countries accede to higher standards of intellectual property through bilateral/plurilateral free-trade and investment agreement.
India stands out in her approach to the treatment of pharmaceutical patents in several important ways. A detailed examination of India’s Patents Act, 1970, reveals that not only has India taken recourse to several post-grant flexibilities (liability rules) enshrined in TRIPS Agreement, it has also provided a host of exceptions which flatly restrict a wide variety of patentable subject-matter within the protective gear of patent law. It would be useful for the Panel to highlight the continued utility of some of these exceptions, most of which are subject matter exclusions permitted in Article 27 of the TRIPS Agreement. India has remarkably emerged as one of the few countries which have been able to implement the criteria of “therapeutic efficacy” in determining legal standards of patentability for a large class of incrementally modified pharmaceutical inventions. The Indian Supreme Court has approved of such an approach in the popular case involving Novartis v. Union of India (2013). However, it is a matter of fact that this particular provision has been mostly used in combination with other requirements of patentability (viz., novelty, inventive step and industrial application). Although this provision is designed to contain ‘ever-greening’, it has opened up early entry of generic drugs in the Indian market. While Section 3(d) of the Indian patent law has become a cause célèbre, it is yet to been how it plays out as an administratively manageable standard in terms of offering bright-line rules for patentability of pharmaceuticals.  
Similarly, India’s approach towards balancing patent rights and public interest is not divorced from procedural fairness. India is among the few countries which allow both pre-grant and post-grant opposition. These provisions provide broad standing for interested parties, including public health groups. It has led to streamlining of patent litigation where patents which do not muster the strength of patentability and patent-eligibility can be opposed at an early stage at the Indian patent office, without resort to proceedings in the courts and tribunals. Since the patent system is designed to achieve efficiency by aligning it to the incentives of competitors to challenge patents, such additional avenues indeed help to weed out questionable patents. This improves the public notice function of the patent system and facilitates early entry of generic drugs. Importantly, Indian patent law limits injunctive relief (but on payment of reasonable royalties) in cases involving infringement of mailbox patents where substantial investments were made prior to the publication of these applications. This may be one among the several reasons for the availability competing substitutes for mailbox patented drugs in India. 
Taking advantage of limited exceptions outlined in Article 30 of the TRIPS Agreement, the Indian patent law provides a regulatory review exception, research exemption and limited exceptions for importation and use of patented products for and on behalf of the Government for the purposes of its own use, including use in hospitals notified by the Government in case of any medicine. Of course, there is much to be desired in terms of the actual scope of these provisions owing to lack of judicial guidance. However, these provisions definitely point towards India’s concern for providing access to patented technologies. India’s patent law distinctly provides for international exhaustion.
Similarly, India has not only used the threat of compulsory licences to force firms to engage in voluntary licences and price discrimination, it has been actually able to successfully grant a compulsory licence to bring down prices and to induce local working in line with the conditions prescribed in Article 31 of the TRIPS Agreement. These provisions offer a wide latitude for any person interested (with a capacity to exploit the compulsory licence by local manufacturing) to apply for a compulsory licence anytime after three years from the grant of a patent. So far India has granted one compulsory licence on Bayer’s anti-cancer drug Nexavar (sorafenib). Notwithstanding the presence of an infringing product of sorafenib marketed by India’s generic major Cipla at a competitive price, the Indian courts proceeded to confirm the grant of the compulsory licence. It defined the conduct of infringing competitors as irrelevant to the question of whether or not Bayer had complied with her ‘obligations’ under law to meet reasonable requirements of the public with respect to the patented invention, engage in territorial working of the patented invention, and made it available at a reasonably affordable price. This decision, which has been confirmed by India’s highest court, has far reaching implications on patent holders’ ability to charge unreasonable prices since it has treated grounds for compulsory licensing as amounting to legal obligations on the part of the patent holder in ensuring equitable access.
Perhaps, this is one among the reasons that has led to a host of pro-access measures by certain sections of the patent owing pharmaceutical firms in India by way of differential pricing and non-exclusive licensing. Apart from its positive impact on affordable access to medicines, these voluntary measures undertaken by pharmaceutical firms not only bring new competitive synergies in the market, but are responsible for building sustainable local capacities. Some firms also engage in patient assistance programmes in ensuring access. However, beyond such anecdotes, further empirical studies outlining the actual impact of such voluntary measures will provide evidence into the practices of pharmaceutical firms in providing affordable access to drugs.
Importantly, along with the availability of broad based grounds for third party compulsory licences, Indian patent law has provisions to invoke compulsory licences in cases of national emergency, circumstances of extreme urgency and public non-commercial use. While there is wide latitude in terms of the actual scope of these provisions, India’s attempt to invoke these provisions is at a preliminary stage. Although India’s Ministry of Health is been seized of the matter since 2013, it has offered little guidance on the class of drugs which could fall within the scope of these provisions. Other provisions involving compulsory licences specifically take into account certain situations outlined in the context of Article 31 relating to compulsory cross-licensing of blocking patents, and export compulsory licences articulated in Article 31 bis of the TRIPS Agreement. Furthermore, there is an ongoing stalemate on the question of adopting a price control model for patented drugs in India, a model which is currently being used to regulate prices of generic drugs. Indian law complements measures that LDCs could take in using current transitions period in TRIPS, including the para 6 mechanism in ensuring equitable access to medicines. 
Increasingly, it is noted that there is a strong regulatory turn in ensuring affordable access to drugs beyond questions of data exclusivity. Sustainable production of Bio-drugs (including off-patented biologics) highlights pertinent questions on potential barriers to access created by technical barriers and strong drug regulation. Unlike small molecules, which involves chemical based drugs, ‘biosimilars’ or ‘follow-on-biologics’ raise complex technical and regulatory questions in balancing quality with equitable access. Unless optimally designed, regulatory standards potentially exclude competitors from the market. Although India has limited capacity in the production of bio-drugs, some firms are making attempts to break the barriers by experimenting new business models to synergise and overcome technical and regulatory barriers. However, litigation in these areas shows that regulation can be formidable a challenge to early entry of biosimilars.  
It is important to note that not all measures, which are termed as “TRIPS-plus” have their genesis in international intellectual property agreements. There is evidence in the Indian context that some of the provisions in her patent law that move beyond the common minimum standards of the TRIPS Agreement were unilaterally designed. They specifically relate to enforcement of patents. In fact, Bilateral Investment Protection Agreement (BIPA) that constrains the regulatory space on several intellectual property issues was liberally signed by India without recourse to its implications on intellectual property standards. India’s recent Model BIT is an example of unilateralism where it has agreed to expose its patent law standards to the test of TRIPS consistency in the context of investor-state arbitration. The reason for legislating such provisions may be have been due to pressure from diverse stakeholders and the continued relevance of intellectual property as a policy instrument to attract foreign direct investment. This is despite recent attempts to restrict regulatory power of States by way of designing TRIPS-plus standards in the Transpacific Partnership Agreement (TPP), to which India is not a party.
The above is notwithstanding the existence of systemic issues of drug innovation and access that move beyond pure questions of misalignment or policy incoherence between international intellectual property norms and other international obligations to ensure equitable access. Such systemic issues are widely noted in the area of neglected tropical diseases. There is evident market-failure in the ability of the patent system to offer enough incentives in the absence of a viable commercial market for neglected diseases. Different policy options have been articulated to delinking R&D costs from product pricing. India’s open source drug discovery (OSDD) programme of the CSIR in the area of anti-tuberculosis drugs is an attempt worth studying in greater detail to understand the advantages and pitfalls of such a model. The existence of structural bottlenecks in developing and least-developed countries also contributes to raising barriers to equitable access to medicines. Higher budgetary allocation by States may have positive outcomes on healthcare and in ensuring equitable access. Wide-spread popularity of health insurance schemes can signal positive outcomes for access to medicines.  

One significant issue that has not been addressed by policy makers is in relation to the risk shared by universities and publicly funded research institutes in bringing out valuable inventions and its consequent implications on pricing of such drugs. The High Level Panel must build on the work undertaken by the WHO in implementing the Global Strategy and Plan of Action (GSPOA) adopted by the World Health Assembly in 2008. It is doubtful if international IP norms stand in the way of such alternative measures to address systemic issues in healthcare since these measures exist outside the scope of formal IP protection. There are no major studies that have directly proven the link between international IP protection and non-availability of addition measures to address systemic issues in medical innovation and to ensure equitable access. Exhaustive studies grounded in empirical evidence are highly recommended as part of the work of the High-Level Panel. 

I request the committee to take note of India’s experiences in designing her intellectual property laws in line with her attempts to comply with international intellectual property law, international human rights obligations, trade rules and public health in the context of health technologies. I believe that such measures are a step ahead in the direction of achieving the health and well-being related goals of the 2030 Agenda for Sustainable Development.
 

Jean Lanjouw, The Introduction of Pharmaceutical Product Patents in India: Heartless Exploitation of the Poor and the Suffering? National Bureau of Economic Research (NBER), Working Paper 6366 (1998)
See, http://www.ibef.org/exports/pharmaceutical-exports-from-india.aspx (last accessed 26th February 2016)
See, http://www.business-standard.com/content/b2b-pharma/what-s-driving-mergers-and-acquisitions-in-pharma-industry-115092900554_1.html (last accessed 28th February 2016)
Duggan, Mark, Craig Garthwaite, and Aparajita Goyal. 2016. "The Market Impacts of Pharmaceutical Product Patents in Developing Countries: Evidence from India." American Economic Review, 106(1): 99-135.
Ibid.
Reichman & Hasenzahl, Non-Voluntary Licensing of Patent Inventions: Historical Perspective, Legal Framework Under TRIPS and An Overview of the Practice in Canada and the United States of America, ICTSD (2003) available at: http://www.ictsd.org/downloads/2008/06/cs_reichman_hasenzahl.pdf (describes the experiences of Brazil in using the threat of compulsory licensing to bring down the prices of ARV drugs)
Hall, Bronwyn H., Patents and Patent Policy (Winter 2007). Oxford Review of Economic Policy, Vol. 23, Issue 4, pp. 568-587, 2007. Available at SSRN: http://ssrn.com/abstract=1151148
Grosse Ruse-Khan, Henning, The International Law Relation between TRIPS and Subsequent TRIPS-Plus Free Trade Agreements: Towards Safeguarding TRIPS Flexibilities? (May 19, 2011). Journal of Intellectual Property Law, Vol. 18, No. 2, p. 1, 2011.
Available at SSRN: http://ssrn.com/abstract=1849204
Section 3(d), Indian Patents Act, 1970.
CIVIL APPEAL Nos. 2706-2716 OF 2013 available at: http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212
Sampat and Shadlen TRIPS Implementation and Secondary Pharmaceutical Patenting in Brazil and India, Studies in Comparative International Development, June 2015, Volume 50, Issue 2, pp 228-257


It is particularly regarding concerns of producing data on therapeutic efficacy through research data at the time of making a patent application. See, http://spicyip.com/2015/09/patent-office-rejects-tofacitinib-patent-application-an-analysis-part-ii.html (last accessed 26th February 2016)
Section 25, Patents Act, 1970
11A(7) proviso, Patents Act, 1970
Section 107A(a), Patents Act, 1970
Section 47, Patents Act, 1970
Section 47, Patents Act, 1970
Section 47, Patents Act, 1970
Section 107A(b). This is notwithstanding its broad contours that potentially includes infringing imports. For discussion, see Yogesh Pai, The Hermeneutics of Patent Exhaustion Doctrine in India, in Caboli & Lee ed.Research Handbook on Intellectual Property Exhaustion and Parallel Imports (forthcoming June 2016)
Natco v. Bayer (2012) Compulsory Licensing Application 1 of 2011. Available at: http://www.ipindia.nic.in/iponew/compulsory_license_12032012.pdf (last accessed 26th February 2016)
Section 84(1), Patent Act, 1970. This three year rule for cooling-off in unduly broad since no provisions of TRIPS Agreement or the Paris Convention on Industrial Property have it as a requirement for issuing compulsory licence on all grounds (except working).
WRIT PETITION NO.1323 OF 2013 available at: http://indiankanoon.org/doc/28519340/ The Supreme Court refused to intervene in the decision of the appellate court. See, http://www.lawyerscollective.org/updates/supreme-court-says-no-to-bayer-upholds-compulsory-license-on-nexavar.html (last accessed 26th February 2016)
See, price discrimination for Solvadi: http://timesofindia.indiatimes.com/india/New-Hepatitis-C-drug-99-cheaper-in-India/articleshow/39719323.cms
http://www.livemint.com/Home-Page/f0R9060osU7bENFNwlnx5O/Compulsory-licences-may-spur-more-voluntary-licensing-deals.html (last accessed 26th February 2016)
See, Gauri Pathak, Patient Assistance Programs for Oncology in India: How PAPs can influence physician support and increase market penetration for pharmas, (2014) available at: http://www.kantarhealth.com/docs/white-papers/patient-assistance-programs-for-oncology-in-india (last accessed 26th February 2016)
Section 92, Patents Act, 1970
http://pib.nic.in/newsite/PrintRelease.aspx?relid=113719 (last accessed 26th February 2016)
Section 91 and 92A of Patents Act, 1970
http://www.pharmabiz.com/ArticleDetails.aspx?aid=90974&sid=3 (last accessed 26th February 2016)
Dinesh Thakur, A new class of drugs is here – but India is dangerously inept at dealing with them (2015) available at: http://scroll.in/article/754277/a-new-class-of-drugs-is-here-but-india-is-dangerously-inept-at-dealing-with-them (last accessed 26th February 2016)
A S Rathore, Biosimilars in India, Journal of Proteomics
Volume 127, Part A, 8 September 2015, Pages 71–72
Roche v. Mylan/Biocon. Available at: http://spicyip.com/2014/02/roche-sues-biocon-and-mylan-over-biosimilar-version-of-herceptindelhi-hc-grants-injunction.html (last accessed 26th February 2016)
Intellectual Property Rights (imported goods) Enforcement Rules (2007) covers patents as part of provisions on border measures. http://www.cbec.gov.in/htdocs-cbec/customs/cs-act/formatted-htmls/ipr-enforcementrules (last accessed 26th February 2016)
Prabhash Ranjan, India Seeks Protection With New Model Bilateral Investment Treaty, The Wire (2016) available at: http://thewire.in/2016/02/26/india-seeks-protection-with-new-model-bilateral-investment-treaty-22423/ (last accessed 26th February 2016)
Patrice Trouiller et. al., Drug development for neglected diseases: a deficient market and a public-health policy failure, The Lancet, Volume 359, Issue 9324, 22 June 2002, Pages 2188–2194
James Love, De-linking R&D costs from product prices, KEI (2011) http://www.who.int/phi/news/phi_cewg_1stmeet_10_KEI_submission_en.pdf
http://www.osdd.net/ (last accessed 26th February 2016)
India’s healthcare budget is disproportionately low. It spends 1.2% of the GDP on health. Available at: http://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/indias-disproportionately-tiny-health-budget-a-national-security-concern/articleshow/49603121.cms
India has planned mega insurance schemes with affordable premium. See, http://timesofindia.indiatimes.com/india/Coming-soon-Mother-of-all-health-schemes/articleshow/51002587.cms (last accessed 26th February 2016)
Sampat and Licthenberg, What Are The Respective Roles Of The Public And Private Sectors In Pharmaceutical Innovation?, Health Aff February 2011 vol. 30 no. 2 332-339

Elizabeth Omondi, CANCER AFRICA

Lead Author: Elizabeth Omondi
Organization: Cancer Africa
Country: USA

Abstract 

Access to Medicines: Working to Give Patients the Gift of Time
This submission seeks to put forth the importance of ensuring that whilst addressing the access of medicine to all globally that its equally essential to recognize the importance of the supply and administering of the medicines to the patients. This includes addressing the need for informed policy, skilled workforce and infrastructure that will render the treatment and medicines to the patients.

Submission 

International human rights law in general and the right to health as provided in various international conventions is the most commonly mentioned basis for a right to access to medicine.Though there is no regulatory provisions that explicitly provide for the right to access medicine nevertheless the right to health embodies the need to ensure the provision of health care that is available, accessible, acceptable and of reasonably good quality. It is to that end in seeking to uphold the right to health as envisioned in the conventions that the supply and administering of medicine to the patients be a requisite.
Solutions for the access to medicine will have to be holistic. Majority of the developing countries do not have reliable information as to their local health workforce and infrastructure. Given the complexity of the new emerging diseases in the developing countries it is imperative that resource deficient nations are able to reliably identify their capabilities by having comprehensive information on their health resources. In addition, to ensure there is constant and reliable oversight and accountability. Even if medicine is made accessible and there is no infrastructure and skilled personnel to administer the medicines it would thus be an exercise in futility. For example myself as a cancer patient diagnosed with chronic lymphocytic leukemia and a hematological blood disorder red cell aplasia, these diseases are essentially complicated and so is the treatment. Managing and developing a treatment plan of such a complex case requires skill. It is one thing to make medicines available and accessible but also important that there is skilled knowledge on how to use these medicines appropriately for the intended purpose. The risks could be fatally detrimental to the patient in cases where the medicines are administered incorrectly.
At a stage where health care infrastructure and the human resource capacity is nascent and not sufficient in many developing countries should provide a conducive platform upon which to develop mechanisms that will provide effective and efficient oversight to the integrity of the health products available and services rendered. At the moment even with the limited health care resources available it is beyond surprising how data on local health resources is poorly mismanaged. For example Cancer Africa is currently developing a database on local cancer care resources to include skilled personnel such as oncologists and pathologists and cancer treatment centers that are available in Africa. In one instance data on currently licensed oncologists in the publicly available master register of licensed physicians in one country did not match the data that was sent to us by the officials of the national medical practitioners licensing board to corroborate our independent search. Follow up on our findings has yielded no response. Countries have local institutions that are mandated by law to provide oversight on their health care workforce, treatment, training and research facilities. However this information is not easily available and in some countries the data is not dependable as aforementioned. A starting point would be for a working group to be established regionally that will address and develop a matrix for which to take stock of the skilled workforce and infrastructure locally available and be able to identify the capacity gaps that will in turn inform policy. This in turn will also uphold the third Sustainable Development Goal. 

Bibliography and References 

Human Rights and the WTO: The Case of Patents and Access to Medicines

Holger Hestermeyer Print publication date: 2008 Print ISBN-13: 9780199552177 Published to Oxford Scholarship Online: January 2009

Cancer Care in Africa: An Overview of Resources Daniela Cristina Stefan

Journal of Global Oncology Oct 2015:30-36; published online on September 23, 2015

Olatundun Lawal, PUBLIC HEALTH PROMOTION ALLIANCE

Olatundun Lawal, PUBLIC HEALTH PROMOTION ALLIANCE

Lead Author: Olatundun Lawal
Additional Authors: Ademola Adelekan, Adetona Motunrayo, Philomena Omoregie
Organizations: Public Health Promotion Alliance
Country: Nigeria

Abstract

The effect is that the overall patent incidence is low and yet access to needed medicines has remained unattainable. Pharmaceutical patents therefore do not necessarily create monopoly pricing power beyond the patentee’s exclusive rights for that limited period of time. This is further reinforced by the fact that the patent is to an extent limited due to the therapeutic competition during the life of the patent and generic competition after the expiry of the patent. However, with respect to mid or low income vis-à-vis high income developing countries, it has been shown that patent ‘does not have a measurable impact on real or normal prices of existing drugs’.

In Nigeria, compared with other West African countries, a huge percentage of patents granted by the Patent Registry belong to foreigners. Nigeria has not leveraged on the existing international instruments either through Article 31 of TRIPS Agreement as expanded under Doha or the Patent and Designs Act both of which allow the use of patent by government or compulsory licensing to address the dire health challenges in the country. The National Health Bill is a quantum leap in terms of defining the new health policy direction that guarantees access to medicines, among the wider objectives of national health care delivery system. That guarantee in the Bill can be further strengthened with the incorporation of specific provision for use of patents by government authority in order to ensure urgent supplies of medicines in extreme cases of emergency. This will also bring it in line with that provision in the Patent Act as well as international best practice. Establishment of a national drug policy as a common framework to solve problems in pharmaceuticals and establishment and implementation of the national health equipment policy for Nigeria are therefore recommended for addressing the problem

Submission

Background
Amir Attaran’s study on the patent status of 319 of WHO Essential Medicine List (EML) drugs in sub-Saharan African countries, including the mid-income developing countries, covering a population of over 4.6 billion people with the majority living in developing countries found only 17 essential drugs were patented. The effect is that the overall patent incidence is low and yet access to needed medicines has remained unattainable [1]. Consequently, Professor Attaran drew the conclusion that “patents cannot cause essential drugs to be inaccessible in many developing countries because they do not exist 98.6% of the time” in those countries with the exception of South Africa, because of its market structure.

In the 2001 Survey of patents on 15 anti-retroviral drugs in 53 African countries, it was also found that “these anti-retroviral drugs are patented in few African countries.
. . and that in countries where anti-retroviral drugs patent exist, generally only a small subset of anti-retroviral drugs are patented”[2]. Furthermore, in countries with high HIV prevalence on patents many anti-retroviral do not exist or are not enforced [3]. That statistics would appear to cast a shadow of doubt on the affirmation that patent is responsible for lack of access to medicines. The same analogy appears to hold in the terms of patent structure itself having regard to the nominal life of the patent, which is 20 years, but in practice does not exist beyond 10 years particularly in relation to pharmaceuticals considering the long years of research and development process in its actual working. In that regard, pharmaceutical products may have its patent expire only about 8 years after it is marketed after which generic competitors can enter the
market and engage in price competition, which usually results in lower prices, even lower with multiple generic competitors producing competing versions of the drugs.

From that perspective, pharmaceutical patents therefore do not necessarily create monopoly pricing power beyond the patentee’s exclusive rights for that limited period of time. This is further reinforced by the fact that the patent is to an extent limited due to the therapeutic competition during the life of the patent and generic competition after the expiry of the patent.

However, with respect to mid or low income vis-à-vis high income developing countries, it has been shown that patent ‘does not have a measurable impact on real or normal prices of existing drugs’. A 1998 study reviewed the prices of eight drugs in six different therapeutic classes across nine different countries, including countries with and without patent protection, the authors concluded that price movements of branded pharmaceutical product are generally not affected by changes in patent laws’ [4].

In Nigeria, compared with other West African countries, a huge percentage of patents granted by the Patent Registry belong to foreigners. The 1999 – 2002 data shows that of the 2,544 patents issued, 1,458 are foreign and 986 are to local applicants in which case some of the local grants are made under license from foreign owners [5]. Nigeria has not leveraged on the existing international instruments either through Article 31 of TRIPS Agreement as expanded under Doha or the Patent and Designs Act both of which allow the use of patent by government or compulsory licensing to address the dire health challenges in the country.

TRIPS, Public Health and the Global Debate
The test of TRIPS’ regime for the protection of pharmaceutical patents in the context of promoting public health needs lies in the balance between maintaining a steady patent protection in order to spur the need for research and development on the one hand and a regime of public health which requires accessibility for pharmaceuticals at affordable prices for the wanting population. That test has continued to stretch the ability and the legitimacy of the TRIPS Agreement as a veritable instrument evidencing the global consensus for intellectual property and sustainable development including the ability of developing countries in particular to address their public health needs through a multilateral IP regime. The global debacle became more intense barely a decade into the TRIPS Agreement at the 4th WTO Ministerial Conference in November 2001 in Doha, Qatar. Resulting from intensive negotiations initiated in the TRIPS Council by the African Group, the now famous Doha Declaration sought to clarify the relationship between TRIPS and public health. The Doha Declaration therefore was the product of the discontent among developing countries against the TRIPS Agreement and the feeling that the Agreement constituted an ‘obstacle to development’ and in particular the pursuit of public health policies by developing countries [6]. The discontent borders on the obstacle created by a twenty-year long patent regime for patent holders which, as alleged, is responsible for the absence of affordable medicines needed to combat communicable diseases in developing and African countries. Access to medicines particularly for HIV/AIDS pandemic that is ravaging the most productive population in these countries had become a grave concern to governments.

Public health conditions
Public health conditions have had the history of engaging national attention in a number of ways depicted in various government actions and programmes such as Roll Back Malaria or the establishment of specialized institutions targeted at specific area of special needs, such as the National Action Committee Against AIDS (NACA) in the wake of the HIV/AIDS pandemic or NAFDAC to regulate the use of foods and drugs. Nigeria has been ranked fourth in the world’s tuberculosis prevalence table and second in Africa, recording annual incidence of 311 cases per 160,000 population. Tuberculosis is reported as the leading cause of death among HIV infected people in Africa and that 1/3 of the 40 million people living with HIV/AIDS worldwide are co-infected with TB [7]. India and Nigeria recorded the most cases of polio between 2000 and 2005 with about 2,971 reported cases. Over this period there were 2120 reported cases in Nigeria alone. The large scale internationally financed polio immunization programme for children between 0-5 years, provided the vaccines, which at some point was rejected in some parts of the country, has since 2006 nipped the epidemic in the bud. Nigeria confirmed the swine flu epidemic that first hit Mexico before spreading to the USA in 2008.

Addressing barrier Preventing access to medicines
It is significant to note that the solution to this problem does not lie alone with isolating the so called patent factor in addressing access to medicines, rather it lies in confronting the challenges brought about by the combination of other socio-economic, infrastructural, cultural and political factors that constitutes barrier to access, the discussion of which is not within the scope of this paper [8]. As a developing country, Nigeria is faced with multi-faceted challenges; economic, political and technological which has negative effect on the provision of a sustainable healthcare delivery. Suffice to say that meeting some of those challenges involves building local pharmaceutical production and supply capacity in order to obviate the necessity of invoking the patent law measures to address this critical public health situation. Even at that, the official use is available as an extra-ordinary measure where public health infrastructure is stretched to the limits. The National Health Bill is a quantum leap in terms of defining the new health policy direction that guarantees access to medicines, among the wider objectives of national health care delivery system. That guarantee in the Bill can be further strengthened with the incorporation of specific provision for use of patents by government authority in order to ensure urgent supplies of medicines in extreme cases of emergency. This will also bring it in line with that provision in the Patent Act as well as international best practice.

Implementation strategies for addressing the problem
Establishment of a national drug policy as a common framework to solve problems in pharmaceuticals

Experience in many countries has shown that the complicated and interdependent problems associated with quality and use of essential drugs can best be addressed within a common framework, as piecemeal approaches can leave important problems unsolved and often fail. In addition, the different policy objectives are sometimes contradictory, and so are the interests of some of the stakeholders. On the basis of this experience, WHO recommends that all countries formulate and implement a comprehensive national drug policy (NDP). A national drug policy is a commitment to a goal and a guide for action. It expresses and prioritizes the medium- to long-term goals set by the government for the pharmaceutical sector, and identifies the main strategies for attaining them. It provides a framework within which the activities of the pharmaceutical sector can be coordinated.

A functional national drug policy is needed in Nigeria for the following reasons: (i) to present a formal record of values, aspirations, aims, decisions and medium- to long-term government commitments; (ii) to define the national goals and objectives for the pharmaceutical sector, and set priorities; (iii) to identify the strategies needed to meet those objectives, and identify the various actors responsible for implementing the main components of the policy; (iv)to create a forum for national discussions on these issues. The drug policy should be able to accomplish the following:

(a). Establish norms and standards: Set, validate, monitor, promote and support implementation of international norms and standards to promote the quality of medical products, and ethical, evidence based policy options and advocacy.

(b). Procurement: Encourage reliable procurement to combat counterfeit and substandard medical products, and to promote good governance and transparency in procurement and medicine pricing.

(b). Access and use: Promote equitable access, rational use of and adherence to quality products, through providing technical and policy support to health authorities, professional networks, consumer organizations and other stakeholders.

(c). Quality and safety: Monitor the quality and safety of medical products, by generating, analysing and disseminating signals on access, quality, effectiveness, safety and use.

(d). New products: Stimulate development, testing and use of new products, standards and policy guidelines, emphasizing a public health approach to innovation, and on adapting successful interventions, with a focus on essential medicines that are missing for children and for neglected diseases.

Establishment and Implementation of the National Health Equipment Policy for Nigeria
The implementation of the National Health Equipment Policy for Nigeria should be by legislation, which should include the establishment of a regulatory body. To ensure success, the strategies should take into account, expressed fears and needs of all interest groups. This should be followed by the drawing up of regulations for carrying out the provisions of the law. The strategies are to be considered under the following:
a. Inventory of Medical Equipment: Although a large proportion of medical devices are not functioning in most health care setting in Nigeria, the exact number, brand and location are not known. Therefore the first step is to take inventory of all the medical equipment in a given health care facility.

b. Standardization of Medical Devices: This strategy is expected to solve the existing problem of a wide variety of equipment models imported from a number of countries, which made maintenance difficult. Foreign manufacturers/suppliers with representatives in Nigeria should be preferred.

c. Selection of Medical Devices (Technical Specification): Selection of medical devices should be based on the disease pattern in the country, their suitability for tropical environments and the staff available to operate them.

d. Procurement System: The procurement process should be properly planned and managed. This is because equipment supply has to be coordinated with the construction of a new facility or the modification of an existing one for proper installation.

e. Regulatory System and Registration of Medical Devices: The Body should regulate medical devices either by direct government involvement, third party certification or a combination of both methods.

f. Human Resource Development (Training & Re-training): The Body should be responsible for funding the Training Centres, development of the curricula in conjunction with Federal Ministry of Education. The Training Centres should serve a dual purpose that is teaching and conducting repairs of medical devices.

g. Indigenous manufacturing and servicing of Medical Devices: The way out of our present overdependence on foreign technology is to develop local capability for equipment production. Manufacturing of certain categories of medical devices locally within stipulated standards should be promoted and encouraged.

h. Maintenance of Medical Devices: The regulatory body should all promote and encourage a maintenance culture. Health Care Institutions only pay attention to maintenance when there is a major equipment breakdown.

i. Monitoring and Evaluation: The Agency should conduct monitoring and evaluation activities periodically to ensure that the set objectives are achieved.

Bibliography and References

1. Amir Attaran: How Do Patents and Economic Policies Affect Access to Essential Medicines in Developing Countries, Health Affairs, Vol. 23, No. 3, pp.155-66.
2. Amir Attaran & Lee Gillespie-White: Do Patents for AntiRetroviral Drugs Constrain Access to AIDS Treatment in Africa, Journal of the Americas Medical Association, Vol. 286, No. 15, 17 Oct. 2001, p.1886.
3. Eric Noehrenberg: The Realities of TRIPS, Patent & Access to Medicines in Developing Countries cited in The Intellectual Property Debate, Perspectives from Law, Economics & Political Economy, M. Pevez Pugatch (Ed.) at 170, 173. Eric Noehrenberg.
4. Richard Rozek and Ruth Berkontz: ‘The effects of Patent Protection of the Prices of Pharmaceutical Products; is Protection raising the Drug Bill in Developing Countries National Economic Associates, January 1998.
5. Ikechi Mgbeoji: TRIPS & TRIPS – PLUS Impacts in Africa in Intellectual Property, Trade & Development, Strategies to Optimized Economic Development in a TRIPS –PLUS Era, Daniel Gaervais (Ed.) 259, 280.
6. P. Andorran, Medicaments sans Frontiers? Clarification of the Relationship between TRIPS & Public Health resulting from the WTO Doha Ministerial Declaration, J.W. IP, Vol 5, No. 1; January 2002 @ 5.
7. H.S. Aghanwa & Gregory E. Erhabor: Demographic Socio-Economic Factors in Mental Disorders Associated With Tuberculosis in South-West Nigeria, Journal of Psychosomatic Research, Vol. 45, Issue 4, pp. 353-360 (October 1998).
8. Adewole Adedeji: Combating the Scourge of HIV/AIDS in SubSaharan Africa; Beyond Intellectual Property Rights, Vol VI, Issue I (2008)

James Love, KNOWLEDGE ECOLOGY INTERNATIONAL_B

James Love, KNOWLEDGE ECOLOGY INTERNATIONAL_B

Lead Author: James Love
Organizations: 

The organizations and individuals supporting this submission are listed in alphabetical order:

Organizations:
Coalition Plus
Commons Network
European Public Health Alliance (EPHA)
Health Action International (HAI)
Health Gap, USA
Health Poverty Action (HPA)
Incentives for Global Health (IGH)
Innovarte, Chile
KEI Europe
Knowledge Ecology International (KEI)
Mission Salud, Colombia
People’s Health Movement (PHM)
Stop AIDS, UK
Transparency International (TI)
Treatment Action Campaign (TAC), South Africa.
Union for Affordable Cancer Treatment (UACT)
Young Professionals Chronic Disease Network (YPCDN)

Individuals:
Aidan Hollis, Professor of Economics, University of Calgary, Calgary, Canada.
Joel Lexchin MD, Professor Health Policy and Management, York University, Toronto Ontario, Canada.

Members of the European Parliament:
Franziska Maria "Ska" Keller, Member of the European Parliament
Julia Reda, Member of the European Parliament
Sergio Cofferati, Member of the European Parliament

Country: USA

ABSTRACT

The United Nations Secretary-General’s High Level Panel on Access to Medicine (HLP) calls for “evidence-informed” submissions on measures that can promote research and development (R&D) and increased access to medicines, vaccines and diagnostics and related health technologies. This submission addresses the need to improve the transparency of such markets, so that policy makers, patients and other stakeholders have access to better evidence, and to reduce the information asymmetries that currently exist between manufacturers of products and everyone else.

Without transparency, there is no public accountability to ensure that states protect human rights, businesses respect human rights, and victims can pursue adequate judicial and non-judicial remedies. Transparency International defines transparency in the following way:

“Transparency is about shedding light on rules, plans, processes and actions. It is knowing why, how, what, and how much. Transparency ensures that public officials, civil servants, managers, board members and businesspeople act visibly and understandably, and report on their activities. And it means that the general public can hold them to account.”[1]

Key components of the business model of the pharmaceutical industry, including research, development and commercialisation, remain shrouded in secrecy, particularly as regards access to information by patients and the general public. This undermines trust in and accountability of the pharmaceutical industry, and leaves patients vulnerable to human rights violations, including the right to the highest attainable level of health and ultimately the fundamental right to life, and makes it unnecessarily more difficult for society to make the appropriate policies regarding the financing and priority setting of R&D, and product purchases. Given the complexity, size and volume of transactions in the pharmaceutical sector, the lack of transparency creates a range of opportunities to exercise power and influence that can have negative health outcomes and can result in corruption.
 

Submission

The lack of transparency in how the pharmaceutical industry operates has wide-ranging consequences for patients’ access to medicines. Moreover it hinders informed public debate about the current policies used to finance R&D and how well they are suited to ensure robust and cost-effective mechanisms to finance of R&D in areas of global public need, and ensure affordable prices and fair and acceptable access to products.

Since R&D is situated at the beginning of the value chain, the impacts of a lack of transparency can increase in magnitude as they descend down to the individual. Thus lack of transparency will impact regulators who decide on whether a product is safe to enter market, those who will purchase the product, or the health-care professionals who will administer the final product to patients.

This proposal first identifies areas where it is important to expand transparency – and second, proposes measures that UN agencies, governments and partnerships can adopt to progressively increase transparency in markets for drugs, vaccines and diagnostics.

The economics of R&D

There is a pervading opaqueness around funding flows for R&D. Publicly traded companies self-report some information about R&D budgets for investors, but with limited detail, depending upon the relevance of the data to the share price.

Of particular interest are the data on the economics of clinical trials used to establish the safety and efficacy of drugs and vaccines. According to PhRMA’s 2013 annual industry survey, approximately 67 percent of all member R&D outlays were spent on clinical trials.[2]

The companies and organisations involved in undertaking clinical trial have detailed information on the costs of specific trials and rich statistical information on how those costs vary by disease, location, design and size of trials, and on specific products, but this information is not generally available to the public. While smaller companies sometimes report on the costs associated with some specific trials, this is the exception, and much more frequently such outlays are lumped together in aggregate reporting on R&D outlays that are not assigned to a specific drug or vaccine, let alone a specific trial. This allows companies great discretion in making assertions about R&D spending for specific products, and makes it more difficult for anyone but industry insiders to model the risk adjusted costs of R&D, because costs need to be associated with the timing and the phase of development.

The third parties that conduct or help manage trials have been reluctant to share information about trial costs, and governments and many non-profit research organisations have been unwilling or unable to provide the types of information necessary to establish benchmarks that can be used to estimate R&D costs.

Investments in trials and priority setting

Better data on the costs of trials by disease and drug targets are needed to better evaluate and influence the direction of R&D funding, and to ensure there are sufficient resources for areas of priority, including those involving global health needs.

Government funding of R&D

The role of the government in funding or subsidising R&D costs is important, but for the most part, remains very difficult or impossible to assign to specific trials or drugs. For example, the U.S. National Institutes of Health (NIH) has a registry for trials (http://clinicialtrials.gov) and a database for grants (RePORT), but makes no effort to assign the grant money to specific trials. The U.S. Orphan Drug Tax Credit, which provides a subsidy of 50 percent of the costs of qualifying clinical trials, and which was relevant to 80 percent of the new oncology products approved by the U.S. FDA from 2014 to 2015, is only reported by the IRS in highly aggregate numbers that are not assigned to individual companies or individual trials. Cooperative research and development agreements (CRADAs) by government agencies often do not report the value of in-kind research subsidies. Many other governments also provide direct subsidies, regulatory incentives and tax credits for research on specific types of products. Enhanced transparency can enable governments and taxpayers to better coordinate and document the effectiveness of such measures to support research.

Prices and units of goods

Companies provide some detail on the sales of goods to their investors, but often only in terms of the sales revenues, and even then, with limited detail as regards product lines and geographic regions. When sales of a product are significant enough to require separate reporting for investors, the geographic regions are normally highly aggregated. Country level data may be limited to The United States market only, and regions can be defined very broadly, such as “Europe, Middle East and Africa” into a single region, or “the Americas” or “Asia Pacific.” Sales are normally presented in terms of revenue and not by price or units of sales.
Data on units of sales by country is needed to better understand how access varies across borders. Similarly data on prices by country are needed to better evaluate the impact of policies on affordability of products and the related inducements for investments in R&D.

The companies selling the products have this information, and IMS Global Health also has detailed data on both prices and units disaggregated not only by country but with considerable detail within the channels of sales within countries.[3] Countries fail to require disclosure of such data, and furthermore, the Trans-Pacific Partnership (TPP) has a provision which prohibits countries from requiring such data in connection with the regulatory approval to sell products.[4]

Manufacturing costs
The cost of manufacturing drugs, vaccines and diagnostics is often unknown. Companies that claim to sell products at ‘no-profit’ prices are not required to verify such claims, and often does not comport by independent, third party estimates of per gram costs of formulated products. Even as volumes increase (generating economies of scale) companies do not revise their per unit manufacturing costs downwards. Studies carried out by universities and third party experts have provided useful estimates for manufacturing costs, but still do not provide an authoritative accounting of manufacturing costs.

Marketing costs

Industry costs for marketing are often reported to investors, but typically aggregated across all products, and/or aggregated with other costs. In order to assess the true level of spending on marketing, disaggregated data for drug marketing, broken down by country and product, is required.

In some countries and for some companies, there is reporting of payments to doctors[5], in order to better monitor the risks of conflicts of interest and unwanted distortions of medical decision-making, and such reporting should be expanded.

Times-series data on expenditures on direct-to-consumer advertising should be available, disaggregated by product, in order to better assess the impact of such expenditures on rational use of products and health outcomes, including information on both “ask your doctor” about an unnamed drug, and ads that specifically mention a drug by name.


Many new medicines are duplicative, “me too” products that are minor variations of the original medicine and offer no therapeutic advantage over other medicines that are already available[6]. Gaining market share for these medicines has numerous consequences: healthcare professionals may not be able to keep up to date with relevant/current information on each medicine and to compare alternatives; it can contribute to inconsistency in prescribing within the healthcare system; and – crucially for LMICs – when patients switch to products protected by patents that have higher prices, there is less money to spent on other drugs.


Clinical trial data

A lack of public access to data from all clinical trials, including data on trials that fail, reduces access to knowledge that is critical for advances in science, and hinders appropriate scrutiny of trial design and accuracy of reporting which have direct consequences for our knowledge about the safety and efficacy of medicines that are prescribed to patients.

One element of the right to health concerns the right of access to information about the risks and benefits of treatment options, including by patients and prescribers. The secrecy of trials leads to duplication of research, exposing patients to unnecessary risks of harm, including being asked to use the same failed drug.

Drug prices or rewards for innovation

Debates about drug pricing or the appropriate rewards for successful research outcome should be informed by reliable, transparent and detailed data on the costs of R&D inputs (including information of the role of public funding and subsidies), the medical benefits and added therapeutic value of products[7], and the actual access or lack of access to products by patients.

When prices bear no relationship to costs or benefits from products, or when prices are associated with barriers to access, policy makers have a duty to introduce reforms to improve the efficiency and the fairness of the system.

Patent landscape

At present, the patenting of products is surprisingly non-transparent. Concerns about the transparency of patent landscapes are particularly vexing in the areas of biologic products.

Pharmaceutical companies file numerous patent applications relevant to specific medicines and vaccines. These patent applications are often difficult for third parties, and even patent offices, to link to individual medicines. Generics companies, patient groups and government ministries, including drug regulators are often unable to assess whether there are existing applications or granted patents related to specific medicines, and the uncertainty can present a barrier to entry for affordable generics, a fact recognized in the U.S. Affordable Care Act, in the context of biologic drugs.[8]

Some of these concerns can be addressed by requiring patent applicants and patent holders to disclose the international non-proprietary name (INN) of the biopharmaceutical(s) to which the patent relates, and for the WHO or another entity to create public databases of patent filing.

Governments should also create systems to share information about administrative and judicial challenges to patents.

Registration of products

Companies that have invested vast resources developing a medicine will be under considerable pressure to have a product registered for market entry, which is conducive to corruption vulnerabilities. Drug companies’ registration strategies are also often non-transparent. In some cases, companies simply do not register their medicines or confine the registration to a limited number of countries regardless of needs and public health considerations. The lack of information concerning companies’ registration plans leaves medical providers and governments that await registration of new products, unable to take steps to ensure early availability of new medical tools that can save lives, including such steps as working with WHO or other collaborative registration mechanisms, or directly with other regulatory authorities. There should also be a duty and mechanisms to share changes in regulatory status with other regulators.


Licensing of intellectual property rights

In a limited number of cases, the licenses to use patents and other intellectual property rights are made public by the parties, including, for example, the licenses with the Medicines Patent Pool (MPP), or licenses or licensing terms reported in United States Securities and Exchange Commission (SEC) disclosures to investors. However, such disclosures remain the exception. Having more complete information about actual licensing terms would make it easier to evaluate the reasonableness of terms and conditions of licensing, and to avoid anticompetitive practices.

Of particular interest are the contracts involving intellectual property developed by the public sector or by government grants or research contracts to businesses, university programs or other recipients of public or charitable funds. Rarely are the terms and conditions of such license agreements public.

The licensing of intellectual property from publicly funded research is a critical opportunity for governments to ensure that holders of licenses meet critical milestones to ensure timely development (stewardship), provide fair compensation to taxpayers, and ensure affordable access to products.

Adverse events

There is a need for better reporting and sharing of information on adverse events from the use of drugs and vaccines, both to advance science, and to address the prescribers’, patients’ and regulators’ rights to know.

The Periodic Safety Update Reports that manufacturers are required to provide to regulators should be made available. Many countries put their Adverse Drug Report (ADR) databases online for public access and that could become a norm for all countries.

Know-how and technology transfer

Governments should design and implement obligations to disclose the know-how to make drugs, vaccines and diagnostic tests. This is particularly important for biologic drugs, which often remain de facto monopolies or face limited competition long after patents expire. This is an important issue for drugs used to treat rare diseases, where the cost of obtaining manufacturing know-how limits competition, and is associated with extremely high prices of products.

Implementation

This submission proposes two approaches to expand transparency of the pharmaceutical sector.

i. UN led policies to progressively expand the transparency of markets for drugs, vaccines and diagnostic tests

The various UN agencies and partnerships and global entities that work closely with the UN, such as the World Bank, the TDR, the Medicines Patent Pool (MPP), UNITAID and the Global Fund to Fight AIDS, TB and Malaria, and the many product development partnerships (PDPs), should build upon or establish new, coherent programs to expand transparency across the entire pharmaceutical sector.

Such measures should be done through careful collaboration to avoid duplication, to identify relevant strengths of each institution and to ensure that the entire UN system is working towards this common, critical goal.

Some existing initiatives include the following:

-The V3P price reporting database on vaccines at the WHO, which is supported in part by the publication of prices by UNICEF, PAHO and GAVI for their own respective price negotiations.
-The Price and Quality Reporting Mechanism of the Global Fund to Fight AIDS, TB and Malaria, whose scope may be expanded this year through the introduction of the E-marketplace.
-The licensing agreements of the Medicines Patent Pool, all of which are published after having been signed with pharmaceutical companies (and increasingly with universities and product development partnerships).
-The newly launched WHO R&D Observatory, which has been introduced to track existing R&D funding flows for priority diseases, and to identify critical gaps for essential health needs.
-The multiple efforts of the Medicines Patent Pool, UNITAID, WIPO and WHO to develop and issue patent landscapes for new medicines.

New measures which UN agencies may take include the following:

-Development of model legislation to introduce transparency measures that governments can introduce in specific areas. Such model legislation can then be presented and discussed at the national level by agencies through their programmatic and technical links with governments
-The UN initiate a Heads of State political process to introduce normative measures through one or more new agreements on R&D financing and coordination, including initiatives that may be launched this year via the WHO as one of the ‘remaining issues’ under the Consultative Expert Working Group (CEWG)
-Considering the creation of an annual or biannual forum on transparency of markets for drugs, vaccines and diagnostics, to evaluate progress toward the progressive expansion of transparency

Member State Transparency Initiatives

The UN should work with governments, industry, civil society, shareholders and other third parties to launch a new global transparency initiative for the pharmaceutical sector. In 2001, the UK government, in partnership with industry and civil society, launched an Extractive Industries Transparency Initiative (EITI)[9], which sought to improve transparency across the oil, gas and mining sector, including the payments made by such companies to governments in resource rich countries. The EITI has not only succeeded in encouraging a range of oil, gas and mining companies to voluntarily release such payments, but has led to legal obligations in the United States, Canada and European Union for mandatory disclosure of such information. [10]

A similar initiative led by the UN, in partnership with industry, civil society and shareholders, and key governments, can work to slowly accelerate voluntary and mandatory commitments to pharmaceutical sector transparency for the benefit of all – starting first and foremost with millions of patients around the world.

Governments can also avoid measures in trade agreements that limit transparency of information from clinical trials, disclosures of manufacturing know-how, or the reporting of data on drug prices, revenues and other relevant medical or economic information.

Provisions in trade agreements or in national law dealing with trade secrets should provide for robust exceptions to enable sufficient transparency for pharmaceuticals and other medical technologies when the needed disclosures are presumptively in the public interest.

Member states can impose an obligation on manufacturers to reveal information on total antibiotics produced by class.

Governments can link the disclosure of information to the exercise of exclusive rights in patents or data. For example, the United States eliminates injunctions and royalty payments as a remedy for infringement on patents that are not adequately and timely disclosed to biosimilar competitors, and some patent holders who withhold information about potential claims of infringement to standards bodies are likewise not allowed to later enforce such patents against standards.[11]

In closing, we note governments should limit overreaching claims that scientific, manufacturing and economic information be withheld from disclosure on the grounds that it represents confidential business information. One objective of the proposed disclosure requirements is to redefine certain information that is now held as confidential so that it becomes public. The standard should not be whether or not the firm wants the information to confidential, but rather whether the disclosure is in the public interest.

Bibliography and References 

1. Transparency International: http://www.transparency.org/what-is-corruption/#define – consulted on 24/2/16.

2. Pharmaceutical Research and Manufacturers of America, 2013 Biopharmaceutical Research Industry Profile (Washington, DC: PhRMA, July 2013) p. 65: http://www.phrma.org/sites/default/files/pdf/PhRMA%20Profile%202013.pdf – consulted on 24/2/16.

3. Many countries (including LMICs) rely on “external reference pricing” mechanisms to set prices. Unfortunately, this model is completely flawed in a world in which many countries are getting confidential rebates from manufacturers.
4. Chapter 8, Technical Barriers to Trade, Annex A-C Pharmaceuticals, 7bis, and Annex 8-E Medical Devices, paragraph 8. See a discussion of this in “KEI statement on TPP for the January 13, 2016 hearing of the United States International Trade Commission,” Investigation No. TPA­105­001, Trans­Pacific Partnership Agreement: Likely Impact on the U.S. Economy and on Specific Industry Sectors, December 29, 2015.
5. See, for example: Open Payments DataOpenPaymentsData.CMS.gov, and Charles Ornstein, Eric Sagara, "How Much Are Drug Companies Paying Your Doctor? New data released today will promote transparency and help patients know when docs receive money from product makers," Scientific American, September 30, 2014.
6. 72 percent of all medicines put on the European market between Revenue Prescrire, February 2015; 35(376) : 132-136; Revenue Prescrire, February 2015: 25(258) :139-148.
7. Including possibly through more standardized reporting of the evidence supporting health benefit claims.
8. The Biologics Price Competition and Innovation Act (BPCIA) limits the availability of injunctions and damages for infringement when patents are not constructively disclosed to biosimilar competitors.
9. For more information please consult: https://eiti.org/
10. The United States: The Dodd-Frank Act, 2010; Canada: The Extractive Sector Transparency Measures Act, 2014; The European Union: The Accounting Directive, 2013.
11. See footnote 8, and United States Department of Justice and the United States Patent and Trademark Office Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments. January 8, 2013.

Sun Kim, SEOUL NATIONAL UNIVERSITY

Sun Kim, SEOUL NATIONAL UNIVERSITY

Lead Author: Sun Kim
Organization: Graduate School of Public Health, Seoul National University
Country: Republic of Korea

Abstract

The purpose of this contribution is to show that notwithstanding the capitalistic structure hinders access to medicines, the ‘Publicness of Pharmaceutical Production and Supply Regimes (PPPR)’ could ensure access to medicines.

For this purpose, this contribution, first, conceptualized PPPR and measured it among 25 leading countries of pharmaceutical consumption. Second, this contribution identified varieties of PPPR through a typological analysis and examined the historical and institutional contexts of the typical countries of each types. Finally, this contribution examined PPPR configurations which ensure access to medicines through a necessary-sufficient condition analysis. Fuzzy-set Ideal Type Analysis (Fs/ITA) and Fuzzy-set Qualitative Comparative Analysis (Fs/QCA) was used for each analysis.

Submission

The purpose of this contribution is to show that notwithstanding the capitalistic structure hinders access to medicines, the ‘Publicness of Pharmaceutical Production and Supply Regimes (PPPR)’ could ensure access to medicines.

For this purpose, this contribution, first, conceptualized PPPR and measured it among 25 leading countries of pharmaceutical consumption. Second, this contribution identified varieties of PPPR through a typological analysis and examined the historical and institutional contexts of the typical countries of each types. Finally, this contribution examined PPPR configurations which ensure access to medicines through a necessary-sufficient condition analysis. Fuzzy-set Ideal Type Analysis (Fs/ITA) and Fuzzy-set Qualitative Comparative Analysis (Fs/QCA) was used for each analysis.

The ‘Pharmaceutical Production and supply Regimes (PPR)’ include not only actual production and supply, but also policies and managements like financing and regulations which are indispensable for production and supply. It goes beyond the division between ‘pharmaceutical industry’ and ‘public policy’, and catches the fact that formal and informal (regulative and normative/cultural-cognitive) institutions are systematically interwoven. The ‘publicness’ approach focuses on ‘realization of public values’, rather than on ‘fixing market failures or government failures’. One could overcome the tautology of publicness concept by understanding it as a constructive, compositive and dimensional concept, not as equal of ‘the degree of the role of public sector’, and by distinguishing between ideal and real type of publicness.

Because every modern countries are capitalistic, PPPR could be regarded as a contextual condition, which is in the middle of causal pathway from capitalistic structure to access problem. Also, it could be regarded as an another structure and mechanism itself, which could be explained by historical and institutional contexts.

Based on human rights and public interest theory as philosophical bases, and on publicness theory as a conceptual base, PPPR in a broader sense was defined as compositive concept which consists of following elements: ① public values (publicness of social values), ② institutionalized public values (publicness of institutions) and ③ realized public values (publicness of realized outcomes). In a narrower sense, PPPR was understood as limited to institutionalized public values (publicness of institutions).
Here, PPPR as public values (publicness of social values) was defined as “universal and equitable access to medicines and the obligation of states to ensure it”. And PPPR as realized public values (publicness of realized outcomes) was defined as “states’ ensuring of universal and equitable access to medicines and the outcomes of it.”

PPPR as institutionalized public values (publicness of institutions), which refers to PPPR in a narrower sense, was understood with integration of descriptive and normative sense of publicness. In this sense, PPPR integrates ‘influences of political authority (mix and amount)’ and ‘attachment to public values’, and could be identified with configurations of ownership, funding and control dimensions. Each dimensions of PPPR was defined as follows respectively: ① collective organizational publicness of organizations interacting in PPR, ② government financing to PPR and ③ political control to fulfill states’ obligation of ensuring of universal and equitable access to medicines.

Based on hypothetical mechanisms about impacts of PPPR on access to medicines, ownership, funding and control dimensions of PPPR was measured with following indexes respectively: ① existence of State-Owned Pharmaceutical Companies (SOPC), ② public spending as % of total pharmaceutical expenditure and ③ Pharmaceutical Intellectual Property Protection index (PIPP index) and/or Pharmaceutical Research and Manufacturers of America index (PhRMA index).

Based on the concept of ‘access to medicines’, access to medicines was measured in 2 dimensions: ‘access to essential medicines’ and ‘availability as market access’. The former was measured in 2 dimensions with WHO World Health Survey data: ‘universal access to prescribed medicines’ and ‘protection from catastrophic pharmaceutical expenditures’. The latter was measured in 3 dimensions with Danzon & Furukawa (2008) data: ‘availability of generics’, ‘availability of new drugs’ and ‘market access speed of new drugs’.

Results of Fs/ITA and Fs/QCA showed that there are varieties of PPPR notwithstanding capitalistic structure, and these varieties lead to qualitative and quantitative differences in access to medicines. This implies the possibilities and necessities of public structure and mechanism in PPR, rather than capitalistic structure and mechanism. The detailed results of Fs/ITA and Fs/QCA were as follows.:

1) Results of typological analysis (by Fs/ITA)
Based on configurations of three dimensions of publicness, eight ideal types were constructed. The results of fuzzy-set ideal type analysis were as follows: s*p*i type as a case of Thailand, s*~p*i type as a case of Indonesia, ~s*p*i type as a case of South Korea, s*p*~i type as a case of France, s*~p*~i type as a case of Poland, ~s*p*~i type as a case of Germany, and ~s*~p*~i type as a case of US. Different regimes showed different political, economic, social and cultural contexts, including public health, health care system and pharmaceutical industry.

2) Results of necessary-sufficient condition analysis (by Fs/QCA)
Public pharmaceutical expenditure ensures both ‘universal access to prescribed medicines’ and ‘protection from catastrophic pharmaceutical expenditures’, because it reduces out-of-pocket payments and increases affordability of medicines. Under the resource scarcity however, combination of SOPC and control of pharmaceutical Intellectual Property rights (IPR) and price also ensures both ‘universal access to prescribed medicines’ and ‘protection from catastrophic pharmaceutical expenditures’, because it increases both availability and affordability of medicines.

Market-dependent PPR may have a comparative advantage in ensuring availability of medicines, especially in case of new drugs, but it could do so through lots of resources, because of inefficiencies in pharmaceutical spending. Also, it could lead to a problem of access to medicines, like inequality of access to medicines, because it reduces affordability of medicines.

In PPR where SOPC and control of IPR and price are combined, ‘market access speed of new drugs’ is fast in spite of low ‘availability of new drugs’. High ‘availability of new drugs’ inevitably needs lots of resources, and it could lead to inefficiencies in resource allocation, considering the fact that not all new drugs are innovative. Control of IPR and price may lead to low ‘availability of new drugs’, but under the resource scarcity, it is the result of efficient resource allocation, rather than a problem of access to medicines.

Under the resource scarcity, combination of SOPC and control of IPR and price also ensures ‘availability of generics’. It could lead to ensuring affordability of medicines, because generics are inexpensive than new drugs, and even lower the price of new drugs after market entry. SOPC contributes to the ‘availability of generics’ not only through ‘production and supply’, but also through granting motives and authorities for controlling IPR and price.

In high income countries where public spending as percent of total pharmaceutical expenditure is high, both ‘availability of new drugs’ and ‘availability of generics’ are low, in spite of low control of IPR and price. But these countries control pharmaceutical spending (e.g., by health technology assessment), instead of using direct price control. Low availability in this context, is the result of efficient resource allocation, rather than a problem of access to medicine

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Brigitte Tenni, People's Health Movement - Australia

Brigitte Tenni, People's Health Movement - Australia

Lead Author: Brigitte Tenni
Additional Author: Dr Deborah Gleeson- La Trobe University
Organization: People's Health Movement (PHM) - Australia
Country: Australia

Abstract 

SECTION 1. ABSTRACT
In recent years, several developed nations including the United States, Japan and the European Union have pursued bilateral and or multi-lateral free trade agreements that include measures that adversely impact on access to medicines. These include intellectual property measures that are up and beyond what are required by the World Trade Organization’s (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and investor state dispute settlement (ISDS) clauses that can be applied to intellectual property and threaten countries’ sovereign ability to defend decisions with regard to the granting of patents. This submission highlights the need for trade agreements to be consistent with TRIPS and the Sustainable Development Goals in order to preserve and expand access to medicines globally. Currently, FTAs prioritise the rights of inventors over the right to health and access to medicines. This imbalance needs to be redressed.
 

Submission 

SECTION 2- CALL FOR CONTRIBUTIONS

1. IMPACT ON POLICY COHERENCE
The rules that govern and determine the minimum standards of intellectual property (IP) regulation applicable to World Trade Organization (WTO) Member countries are enshrined in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)(1)
This agreement aimed to balance the rights of inventors with human rights and public health objectives. Although TRIPS is often criticised for being a barrier to access to medicines (2), many Free Trade Agreements (FTA) and Economic Partnerships have introduced intellectual property standards that are beyond what is required by TRIPS. These TRIPS plus measures are inconsistent and incongruent with the WHO, UNDP (3) and human rights groups call for equitable access to medicine and undermine global public health efforts. TRIPS plus measures are in opposition with the goals of the 2030 Agenda for Sustainable Development. In particular, Sustainable Development Goal 3 (4), that aims to improve the health and wellbeing for all. Many of the targets of goal 3 are undermined by FTAs, specifically:
Targets
3.8
Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all

3.b
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, 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

FTAs must be consistent with the goals of the SDGs and public health principles and must not seek additional intellectual property privileges beyond what is required by TRIPS.

2. IMPACT ON PUBLIC HEALTH
In recent years, many high income countries such as Japan, the United States, and the EU have pursued bilateral and multi-lateral Free Trade Agreements (FTAs) that contain standards that compromise access to medicines and curtail governments’ ability to legislate to protect public health.(5) FTAs that contain TRIPS plus measures strengthen drug patents and delay the entry of affordable generics. (5) Generic drugs reduce the price of medicines which creates savings for individuals and health care systems. Upon market entry, generics are substantially cheaper than originator medicine and their price continues to fall over time.(6)
US led FTAs include several chapters that impact on access to medicines including the Intellectual Property (IP) chapter, The Transparency chapter and the Investment chapter. These will be discussed in more detail below.

IP chapter
The demands in the intellectual property chapter of FTAs have the potential to strengthen patents and delay the market entry of affordable generic medicine. These demands are beyond what is required by TRIPS and can include but are not limited to:
- The extension of patentability to cover new forms, uses and methods of using an existing product (despite a lack of evidence of any increase benefit, enabling ‘evergreening’ and lengthening patent terms);
- patents for diagnostic, therapeutic and surgical methods, requiring royalties to be paid for diagnostic and treatment procedures;
- patent term extension to allow for delays in the granting of patents and or marketing approval
- the removal of pre- grant opposition (a safeguard that can be used to prevent patents from being granted in error);
- data exclusivity extension – the provision of at least five years of data exclusivity for new medicines and an additional three years for new uses of existing drugs, and longer periods for biologics
- patent linkage- linking generic drug marketing approval to the patent status of the originator drug (7)

These TRIPS plus measures have shown to be detrimental to access to medicines in developing countries. An Oxfam study that examined the effects of TRIPS plus provisions in the US-Jordan FTA on medicine prices found a 20 percent overall increase in medicine prices over a five year period. (8) Guatemala also experienced dramatic price increases after signing the Central America Free Trade Agreement (CAFTA). (9)

A recent study analysed the potential impact of the 2014 US proposals for the recently signed for the Trans Pacific Partnership (TPP) Agreement on access to anti retro viral (ARV) medication for people living with HIV (PLHIV) in Vietnam. This twelve country agreement includes the US, Canada, Mexico, Japan, Australia, New Zealand, Peru, Brunei, Malaysia, Chile and Singapore and Vietnam. The study found that only 30% of eligible PLHIV in Vietnam would have access to ARVs under the US TPP proposal compared with the current 68% of eligible PLHIV receiving ARV. (10)

Transparency Chapter
An annex to the Transparency chapter in the TPP requires signatories to comply with measures relating to pharmaceutical pricing and pharmaceutical reimbursement schemes. As the TPP is often touted as a “21st century regional trade agreement” and a template for future agreements this annex is of concern as it has the potential to derail existing pharmaceutical reimbursement programs and hamper their establishment in countries who are yet to introduce such schemes.

The initial US initial proposal included:
- challenges to therapeutic reference pricing
- arduous levels of disclosure in the name of ‘transparency’ that allow for pharmaceutical company input
- direct to consumer advertising of medicines which has be shown to undermine rational prescribing
- avenues for pharmaceutical companies and manufacturers of medical devices to be a part of decisions regarding listing, pricing and reimbursement;
- review and appeals processes that allowed for challenges to decisions made by independent health experts in regard to pharmaceutical listing and price. (11)

Collectively these clauses curtail a government’s ability to ensure cost effectiveness in the procurement of drug and medical devices.

Investment chapter
Many FTAs now contain an Investor State Dispute Settlement (ISDS) clause that has profound ramifications for access to affordable medicines. This clause allows foreign companies to sue governments over perceived harm to their investment. American pharmaceutical company Eli- Lilly is currently suing the Canadian government under the North America Free Trade Agreement (NAFTA) in response to Canada’s decision to overturn previously granted patents on two medicines, Zyprexa and Strattera on the grounds that they failed to fulfil Canadian criteria for patentability. (12)

TPP’s investment chapter also includes an ISDS clause and defines intellectual property as ‘investment’. (7) This could potentially enable foreign pharmaceutical companies to sue TPP member nations over unfavourable patent decisions. This has dire implications for the price of medicines and can create a ‘chilling effect’ and deterring governments from making decisions that might trigger an ISDS case. (13)

3. IMPACT ON HUMAN RIGHTS
The right to health, enshrined in the Universal Declaration of Human Rights, is undermined by free trade agreements that contain TRIPS plus measures.

Strengthening drug patents results in high prices which create a significant barrier to medicines both for governments and individuals. Groups already disadvantaged are often the most severely impacted by rising costs such as the elderly, those with chronic illness and the poor. Studies show prescription medicine use declines when co-payments increase, especially for those already marginalised.(14)

The UN has already recognised the potential for free trade agreements and IP regimes to run counter to human rights. The 2012 UNDP publication “HIV and the law: Risks, rights and health” recommended
To ensure an effective, sustainable response to HIV that is consistent with human rights obligations:
6.2. High-income countries, including donors such as the United States, European Union, the European Free Trade Association countries (Iceland, Liechtenstein, Norway and Switzerland) and Japan must immediately stop pressuring low- and middle-income countries to adopt or implement TRIPS-plus measures in trade agreements that impede access to life-saving treatment (5)

Additionally, the 2009 Report of the UN Special Rapporteur on the Right to Health specified that
‘Developed countries should not encourage developing countries and LDCs to enter into TRIPS-plus FTAs and should be mindful of actions which may infringe upon the right to health.’ (15)

The 2001 Doha Declaration reaffirms member state’s right to use the flexibilities enshrined in TRIPS including compulsory licensing. It explicitly states that least developed country members have until 1 January 2016 (which has since been extended to 2033) to apply the TRIPS Agreement and therefore do not have to grant pharmaceutical patents until this time. It reiterates member states’ responsibility to protect the right to health.
We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose. (16)

FTAs that contain TRIPS plus measures restrict the use of TRIPS flexibilities and pressure least developed countries to lock in IP regimes not required by TRIPS. This strengthens patent protection which in turn creates and maintains high medicine prices and favours the rights of inventors over the right to health.

4. IMPLEMENTATION
FTAs must ensure that IP demands are compliant and consistent with the TRIPS agreement. Countries should not be pressured to sign on to TRIPS plus measures and least developed countries should not be pressured to provide patent protection for pharmaceuticals until 2033.
To facilitate access to medicines FTAs should not include:
• extension to patent terms delaying the market entry of generic drugs
• extended data protection periods which can compromise the ability to issue compulsory licenses.
• patent linkage
• the patenting of new forms, new uses or new methods of using an existing product;
• patents for diagnostic, therapeutic and surgical methods; and
• restrictions on pre-grant opposition.
• ISDS clauses that allow pharmaceutical companies to challenge patent decisions of sovereign states.
• Include measures that undermine the establishment or the sustainability of pharmaceutical reimbursement schemes
• Low standards for the granting of patents

Currently only select pharmaceutical and other multinational corporations have privileged access to the draft text. (17) FTA negotiations must be transparent and allow for civil society and public input and public scrutiny of the draft text. FTAs must be consistent with the drive to create alternatives to the current patent system such as the WHO Consultative Expert Working Group’s recommendation to establish a Global Health R&D Observatory and the negotiation of a binding treaty on R&D. (18)

Bibliography and References 

SECTION 3
REFERENCES AND BIBLIOGRAPHY
1. World Trade Organization. Trade Related Aspects of Intellectual Property Rights (TRIPS). 1995. https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm
2. Milstien J, Kaddar M. Managing the effect of TRIPS on availability of priority vaccines. Bull World Health Organ. 2006 May;84(5):360-5.
3. UNDP, UNAIDS The potential impact of free trade agreements on public health. Issue Brief, Geneva. May 2012. http://www.unaids.org/en/ media/unaids/contentassets/documents/unaidspublication/2012/JC2349_Issue_Brief_Free-Trade- Agreements_en.pdf
4. United Nations. Sustainable Development Goals. https://sustainabledevelopment.un.org/sdgs
5. United Nations Development Programme Global Commission on HIV and the Law, Risks, Rights, and Health. New York, NY. 2012 http://www.hivlawcommission.org/resources/report/FinalReport- Risks,Rights&Health-EN.pdf,
6. IMS Institute for Healthcare Informatics Price Declines after Branded Medicines Lose Exclusivity in the U.S. January 2016.
7. Department of Foreign Affairs and Trade (DFAT). Trans Pacific Partnership Agreement. FTA text and associated documents. http://dfat.gov.au/trade/agreements/tpp/official-documents/Pages/official-documents.aspx
8. Oxfam International. All Costs, No Benefits: How TRIPS-plus Intellectual Property Rules in the US-Jordan FTA Affect Access to Medicines. Oxfam Briefing Paper. 2007.
9. Shaffer, E.R. and Brenner, J.E. A trade agreement’s impact on access to generic drugs. Health Affairs 2009. 28(5):w957-968.
10. Moir, H.V.J., Tenni, B., Gleeson, D.H., and Lopert, R. Assessing the impact of alternative patent systems on the cost of health care: the TPPA and HIV treatment in Vietnam' paper presented at 5th Asia-Pacific Innovation Conference, University of Technology, Sydney 2014. (http://ssrn.com/abstract=2536254).
11. Trans Pacific Partnership. Transparency Chapter Annex on Transparency and Procedural Fairness for Healthcare Technologies. Leaked draft dated June 22, 2011. http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificTransparency.pdf
12. Eli Lilly and Company v. The Government of Canada, UNCITRAL, ICSID Case No. UNCT/14/2 http://www.italaw.com/cases/1625
13. UNITAID. The Trans-Pacific Partnership Agreement: Implications for Access to Medicines and Public Health. March 2014.
14. Kemp, A. et al. From the city to the bush: increases in patient co-payments for medicines have impacted on medicine use across Australia. Australian Health Review, 37: 4-10; Searles, A., et al. The affordability of prescription medicines in Australia: are copayments and safety net thresholds too high? Australian Health Review, 2013. 37: 32-40.
15. United Nations. 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: Promotion and protection of all human rights, civil, political, economic, social and cultural rights, including the right to development. 2009. Available from: http://www.ifhhro.org/images/stories/ifhhro/documents_UN_special_rapporteur/3_4_1_en.pdf
16. World Trade Organization. Ministerial Declaration on the TRIPS Agreement and Public Health, Doha, November 14, 2001. http://www.wto.org/english/thewto_e/minist_e/ min01_e/mindecl_trips_e.htm
17. Médecins Sans Frontières. Trading Away Health: What to Watch Out for in Free Trade Agreements. Briefing note – MSF Access Campaign – www.msfaccess.org – February 2013. https://www.msfaccess.org/sites/default/files/Access_Briefing_WhattoWatchFTAs_ENG_2013.pdf
18. 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. Geneva: World Health Organization 2012.

Munnazzar Ahmed, SYMBIOSIS LAW SCHOOL

Munnazzar Ahmed, SYMBIOSIS LAW SCHOOL

Lead Author: Munnazzar Ahmed
Organization: Symbiosis Law School
Country: India

Abstract

Issues in Compulsory Licensing: Since Natco v Bayer
Access= Affordability + Availability, the access to medicine is not guaranteed if any of the either is missing. India has been one of the countries among the developing nations, which has ensured the presence of both leading to the positive results. The task is not that easy how it looks as there is role of different stakeholders as well as Government authorities to be played to achieve the above task. To ensure the TRIPS compatibility and to ensure the access of medicines specifically patented in the country is very critical task for the Government authorities as it also leads to the International Relations among the nations involved in the transaction. When India granted its first compulsory license to Natco for drug named Nexaver to cure of liver & kidney cancer, India was under the critical debate for such step. But India has done nothing else but just exercising the flexibilities under Article 31 TRIPS, so he question comes that then what did India do wrong. Now this is not the case Of India alone but of all developing countries and under developed countries. The access of the medicines to developing countries and under developed countries is under the challenge if such provisions are not allowed to exercise under TRIPS. Indian IP regime was highly criticised soon after the grant of first compulsory license granted. But it is evident through 2 cases where the applications for the compulsory license has been rejected too by the India Patent office because not due to pressure from developed nations but only that they couldn’t comply with requirements. Research intends to enlighten the panel about these developments in India so limelight the fair practice of IP in Indian Jurisdiction.

Submission

Issues in Compulsory Licensing & Access to Medicine: Since Natco v Bayer
Munnazzar Ahmed

Introduction
The meaning of the words Accessibility of patented drugs has a very limited scope under the India Patent regime. It is directly proportional to the cost and the in numbers available in the market or affordability and availability of the medicine. Now this we cannot say is uniform for all the medicines but is applicable to only life saving drugs, for example a medicine used to cure wrinkles cannot be brought under the purview of such medicines, which are life savings.
On March 9, 2012 P.H. Kurien, Controller, Patent & Trademark office, Mumbai issued the first compulsory license to Natco, a Hyderabad based generic medicine manufacturing company for the drug named Nexavar, which was manufactured by Bayer, a German pharmaceutical company. The Controller was satisfied that the conditions under Section 84(1) are eligible in the current case to grant for the compulsory license. Soon after this order there was huge criticism about the India’s IP regime and also India was included in the US priority list. Since then the Indian IP regime is under huge debate among the developed nations and also been the party to the complaint by US in WTO. Now the question arose that time that India abused its rights under TRIPS but India only exercised the right of having flexibility under Article 31 TRIPS in the respective National Legislation. The biggest achievement under the order was that the cost of the drug was brought down from almost 3 Lakh to only 8 thousand required for one month of treatment. No doubt the object of the decision was to benefit the masses in comparison to the individual interest following utilitarian approach.

Impact of Compulsory Licensing
The very impact that could be guessed just after the decision was the lowering of the process of the drugs similar to Nexavar in nature to escape the grant of compulsory license on them too. It was very much evident that many companies brought the rates of the medicine to a low rate and also an active role of Department of Industry & policy in bringing the price of such drugs in control. The very second impact was also visualized that there will be more cases of compulsory licensing by different other generic companies against the different companies having patent over such medicines in India. It happened too. Soon after the order and pendency of the case by Intellectual Appellate Board a new application for the grant of compulsory was filed by BDR Pharmaceutical International Ltd for the drug DASATINIB manufactured and sold by Bristol Mayers. BDR Pharmaceutical stated that the price of each tablet sold by patentee is INR 2761, which will further will be calculated, as INR 1,65,680/- for 60 tablets for 1 month as tables is required to be taken twice a day as per the prescription. BDR pharmaceutical further claimed to sell the same medicine for INR 8100 for 1 moth of treatment.

Researcher just wants to focus on the facts that the objective of policies adopted by developing countries in dealing Intellectual Property is to maintain a balance between the interests of the stakeholders and consumers. Lessons have been learned that until such balance is not achieved it will act as hindrance to developments on any nation which is the prime objective of millennium goals by UN.

Bibliography and References

All the content is authors own analysis with experience in the relevant subject matter