Laia Pibernat-Mir and Cristina Moreno (English Translation)

Laia Pibernat-Mir and Cristina Moreno (English Translation)

 

Lead Author: Laia Pibernat-Mir
Additional Author: Cristina Moreno
Organizations: Farmacèutics Mundi Catalunya and Medical Anthropology Research Center, Universitat Rovira i Virgili
Country: Spain

Abstract

Universal access to essential medicines represents one of the clearest contemporary challenges to the exercise of the right to health due to the limitations that linking the development and marketing of the drug with the private sector entail. Often, medicine ends up being a hijacked right, only within reach for those who can pay. In the framework proposed by the 2030 Sustainable Development Goals, there is an obvious need to open the discussion about plausible solutions to achieve this right to health within the legal framework of innovation, development and distribution of medicines and health. We argue from the academic and the activist areas that this has to be a transdisciplinary discussion.

Medical Anthropology Research Centre (MARC) of Universitat Rovira i Virgili and Farmacèutics Mundi Catalunya, are proposing the International Conference “Medicines and Culture” as a space and environment to promote a discussion that incorporates players from multiple sectors, which includes the spheres of academia, politics and civil society, which gives cause for the creation of alliances and dialog that can cut through contradictions between various laws, public health policies and the social realities of the subjects in a global manner. Beyond the meeting days, the “Medicines and Culture” Conference is planned as a source of publications, information and various communication tools with which to disseminate the most prominent messages and most relevant aspects and conclusions of the conference. This proposal requests support, on the one hand, to strengthen the presence of academic and activist experts on the international level in order to involve in the dialog the principal players in the global discussion, and on the other, to develop effective communication tools for the subsequent dissemination.

Submission

In the contemporary world, medicine holds a central position in public institutional agendas and international development agendas, and in the daily management of the processes of health, disease, care and prevention. Increasing institutional resolve to reduce the gap in access to medicines between populations is clear, however, it constantly represents one of the most prominent contemporary challenges to the exercise of the guarantee of the right to health. Linking the development, innovation and marketing of drugs with the private sector of large pharmaceutical corporations oftentimes transforms medicine into a hijacked right that is only within reach of those who can pay. In this framework, the role of the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) must be stressed, which takes into account inconsistencies between international trade standards and the Universal Declaration of Human Rights. To it is added that despite having ratified the international charter of human rights, most of the signatory states, which have obligations, often do not develop public joint financing policies that guarantee access to essential treatments for disadvantaged populations.1

 

The Universal Declaration of Human Rights drafted and signed in 1948 by all member states of the United Nations Organization recognizes in Article 25 the right to enjoy the highest level of health. Since then, one has observed the transectorial importance of guaranteeing said right, in order to guarantee fulfillment and enjoyment of the remaining universal human rights, as well as succeeding in the fight against poverty, in support of sustainable and equitable development of all human societies. In 1966, the detailed definition of the exercise of the right to health was drafted, as appears in Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). In 2000, the rapporteur committee added Comment No. 14, which develops the normative substance of the right, the obligations associated with it and measures required for its compliance. The Availability, Accessibility, Acceptability and Quality normative framework for compliance with the right to health, which is recognized in Comment No. 14 of the ICESCR proves to be highly applicable in the context of universal access to essential medicines.


Following the in-depth discussion at the 2015 Social Forum concerning access to medicines, we consider this an entirely appropriate time to continue to promote both dialog with respect to this question, and the pertinent changes that can help adapt and improve the consistency of national and supranational policies and legislation that concern access to medicines so that they have a positive impact on global health. Year after year, revision after revision, there are increasingly more arguments that emphasize the role of social determinants in access to health and essential medicines. In late 2015, the Sustainable Development Goals were signed, explicitly clarifying as well as designating a place for this discussion within the Post-2015 Development Agenda: the importance of promoting research and development of medicines and providing universal access to affordable essential medicines, as agreed in the Doha Declaration and with the flexibilities stipulated in the TRIPS.

 

In this current context, both academic communities and organized civil society (nongovernmental organizations), as the parties responsible for the right to health, must promote this right and specifically promote equitable access to essential medicines for the populations of the Global South whose right to health is systematically violated at this time. That is, we have the duty of playing a prominent role in condemning the lack of guarantee of the right, and defending and promoting civil and academic initiatives that offer responsible alternatives, as well as strategies with political impact to push our states and parastatal bodies to exercise their role as holders of obligations.

Given the response to the gap in access to medicines, and its link to the social determiners of health, on November 14, 15 and 16, 2016, the 2nd  Conference of the Medical Anthropology Research Centre (MARC-URV) called “Medicines and Culture” will take place in Tarragona. The Conference is organized within the framework of the project “GenereM Salut Global” research, education and social transformation to promote women’s right to health” coordinated by Farmacèutics Mundi Catalunya with the collaboration of MARC and the Department of Anthropology, Philosophy and Social Labor of Universitat Rovira i Virgili (Tarragona, Spain).

The principal objective of the “Medicines and Culture” Conference is to promote interdisciplinary research of access to medicines in the globalized world, focusing primarily on the socio-cultural determinants and lack of access policies, as well as the creation of meeting and dialog spaces between the different social players involved. There are plans to discuss these aspects at the Conference, from the excellent opportunities that applied anthropology and social sciences can contribute, and under an interdisciplinary perspective, in order to understand the contemporary processes that contribute to difficulties in equitable access to medicines, and therefore, to health. From the socio-cultural perspective of this field of research, medicine is considered an object and a symbol; so that the chain of production, distribution, sale, prescription, use and consumption of medicines is influenced by these two dimensions: the material and the symbolic. All of these issues are the foundation of the Conference and the invitation to reflect on the contemporary challenges and dilemmas that the use of medicines in the globalized world entails.

Participation is open to researchers from a variety of academic disciplines who conduct interdisciplinary and/or transdisciplinary work on the aspects indicated, as well as members of organized civil society and/or user groups and/or activists who defend the right to health, and defend equitable access to essential medicines specifically. They are all invited to collaborate in the Conference days by presenting communications concerning relationships between medicines and cultures in their broadest sense, thereby contributing to the creation of knowledge and a discussion on the relationship between drugs and human behavior, and as a result, inevitable   socio-cultural behavior in the context of global access to medicine.

We recognize the immense benefits that creating these discussions on the use and access to medicine in a transdisciplinary manner can bring, and not only in the academic framework. The collaboration between Farmacèutics Mundi Catalunya and the Medical Anthropology Research Centre (MARC-URV) as it is shows the coordination between both fields of research and discussion in the same context: civil and academic.

In this framework of promoting critical and informed citizens with respect to infringement of the right to health, at the same time as it aims and is oriented toward [its] condemnation and the creation of processes guaranteeing the right, the project has the following objectives:

• To learn and inform about the structural causes that provoke inequalities, specifically those related to socio-cultural and political structures that lead to infringement of the right to health in the Global South, more specifically with respect to the lack of access to essential medicines.

• To broaden understanding and social awareness of the joint responsibility we have as citizens of the Global North in these inequalities and infringement of the right to health in the Global South.

• To create areas for participation, dialog, involvement and alliance for the joint defense of violated rights, with and for various social groups with a key role in the process of social transformation: the university and national and international academic community and civil society organizations of both the North and Global South.

• To disseminate among the general citizens the principal discussions and conclusions carried out in the transdisciplinary participation areas, expanding the fundamental messages of awareness and impact with respect to the current situation of access to essential medicines in the world, and more specifically in the Global South.

Through all this, support for this project will mean encouraging the meeting of players from the North and the Global South with the explicit push indicated above of the participation of players from both academia and organized civil society from the Global South, who could not through their own means attend or participate in the Conference. In this respect, in order to maximize the diversity of the participation and facilitate the involvement of international players, we propose inviting 10 players from Asia, Africa, America and Europe. To cover the costs, economic assistance is requested from the United Nations High-Level Panel on Access to Medicines. The estimated costs are presented below:


The Conference will be developed around six themes: (1) History of the medicine-culture relationship and appropriation of drugs and their dominance from the Hippocratic Doctrine to the present. (2) Determinants and socio-cultural consequences of access to medicines, considering the entire cycle of the medication (from production to consumption). (3) Race relations as a determining and/or differential factor for access to medicines, and consequently, health. (4) Activism and Medicines: The role of NGOs, civil society and social and grassroots movements for the agenda of access to essential medicines as a basic human right. (5) The role of legislation and intellectual property: free trade agreements, patents, generic medicines and the political economy of medicine. (6) Bioethics and pharmacological research: experiments, responsible use of medicines, protocols for research with humans and animals. The main questions to be addressed can be consulted on the Conference website.


The call for proposals is open not only to summaries for oral presentations, but also to photography samples, audiovisual compositions and posters. Similarly, other exhibition proposals will be evaluated as well as the presentation of workshops. The Conference will also accept a parallel sample of films focusing on the social role of medicines “Medicines in Film” and in which documentaries produced by Farmamundi will be viewed, and all audiovisual proposals received by the organizing scientific committee may be included. With this, the objective is to open dialog between different sectors of society and allow this to be presented in different formats, thereby opening the meeting to the integration of different languages, knowledge and communication, which enrich the discussion and debate to the fullest.

 

Following the Conference, strategies have been planned for disclosing the discussions in order to extend the communication that occurred there beyond the persons and organizations that participated in the meeting. It is thereby intended to bring the questions addressed to public, national and international debate, at the same time as carrying out actions with political impact that pressure signatory states to fulfill their role as holders of obligations with respect to the right to health and specifically compliance with the guarantee of equitable access essential medicines as the fundamental way of exercising this right. In this line of action, the following were planned: (1) Joint publication by Farmamundi and MARC-URV of a digital publication that will compile the most outstanding talks and discussions, which may include complementary items of experts who could not participate directly in the Conference and whose contributions complement and enrich the discussions held. (2) Production of video capsule summaries with the most outstanding talks and/or discussions as well as interviews of Conference participants. (3) Creation of an animated video and its dissemination through a viral company via social networks that shows in a concise and attractive manner the main messages condemning infringement of the right to health and the defense and promotion of universal access to essential medicines, according to the conclusions of the discussions held at the Conference.

The project underway has planned the cost of the first of the activities (digital publication). In order to carry out activities (2) and (3), support is requested from the UN High-Level Panel on Access to Medicines to cover the following estimates:

 

As parties responsible for the right to health of the populations of the Global South for whom it is not guaranteed, MARC-URV and Farmamundi are involved in a process of integrating policies to improve access to medicines. We believe that support from the UN High-Level Panel on Access to Medicines could make this an outstanding opportunity to create alliances, build and/or strengthen networks for research, communication, information and activism on the international level to defend the right to health in general, and defend universal access to essential medicines in particular, thereby strengthening the performance of the Post-2015 Agenda with respect to Goal 3 of the Sustainable Development Goals (“Ensuring a healthy life and promoting the well-being of all ages”). Finally, the discussion and materials arising in the context of the Conference enriches and strengthens the discussion with respect to new and yet to be established proposals and solutions of interest to the members of the UN High-Level Panel on Access to Medicines. The budget requested in this contribution proposal is summarized below.

Tables in original language for clarity

Bibliography and References

Costa Chaves, G., Fogaça Vieira, M, and Reis, R. (2008) Access to medicines and Intellectual Property in Brazil: reflections and strategies of civil society. International Journal on Human Rights 163
Ford, N. (2004) Patents, access to medicines and the role of non-governmental organisations. Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 1(2): 137-145
Hoen E., Berger, J., Calmi, A. and Moon, S. (2001) Driving a decade of change: HIV/AIDS, patents and access to medicines for all. Journal of the International Aids Society 14:15
Illingworth, P. (2006) The power of pills: social, ethical and legal issues in drug development, marketing and pricing. London: Pluto Press
Méndez, M. (2000) The face and effects of medicines: a socio-cultural analysis. Revista Venezolana de Sociología y Antropología; 10(29):513-538
Pogge, T. (2008) Access to medicines. Public Health Ethics 1(2): 73-82
Reynolds Whyte, S., van der Geest, S., Hardon, A. (2002) Social Lives of Medicines. Cambridge University Press
Sampat, B.N. (2009) Academic patents and Access to medicines in developing countries. American Journal of Public Health 99(1): 9-17
UN (1948). Universal Declaration of Human Rights. May be consulted at: http://www.un.org/es/documents/udhr/
UN (1966) International Covenant on Economic, Social and Cultural Rights (ICESCR). Available at: http://www.ohchr.org/SP/ProfessionalInterest/Pages/CESCR.aspx
UN (2000) General Comment No. 14 Article 12 of the Covenant on Economic, Social and Cultural Rights.
UN Summit (2015) Sustainable Development Goals. May be consulted at: http://www.who.int/mediacentre/events/meetings/2015/un-sustainable-development-summit/en/
UN (2015) Access to medicines in the context of the right to health. May be consulted at: http://www.ohchr.org/Documents/Issues/SForum/SForum2015/OHCHR_2015-Access_medicines_ES_WEB.pdf
WHO (2008) Human rights, health and strategies to reduce poverty. Series of publications on health and human rights, No. 5. Available at: http://www.ohchr.org/Documents/Publications/HHR_PovertyReductionsStrategies_WHO_SP.pdf
WHO (2008) Rectifying inequalities in a generation. Available at: http://apps.who.int/iris/bitstream/10665/44084/1/9789243563701_spa.pdf
WTO (1994) Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS). May be consulted at: http://www.wto.org
WTO (2001) Doha Declaration, relative to the Agreement on TRIPS and public health. May be consulted at: http://www.wto.org


 International Federation of Pharmaceutical Manufacturers and Associations_A

International Federation of Pharmaceutical Manufacturers and Associations_A

Submission: The value of intellectual property for access to medicines

On behalf of: 
European Federation of Pharmaceutical Industries and Associations
International Federation of Pharmaceutical Manufacturers and Associations
Pharmaceutical Research & Manufacturers of America
Japan Pharmaceutical Manufacturers Association

Click here to read the submission from the International Federation of Pharmaceutical Manufacturers and Associations (A)

International Federation of Pharmaceutical Manufacturers and Associations_B

International Federation of Pharmaceutical Manufacturers and Associations_B

Submission: Pharmaceutical industry perspectives on access to medicines – overcoming barriers to access

On behalf of: 
European Federation of Pharmaceutical Industries and Associations
International Federation of Pharmaceutical Manufacturers and Associations
Pharmaceutical Research & Manufacturers of America
Japan Pharmaceutical Manufacturers Association

Click here to read the submission from the International Federation of Pharmaceutical Manufacturers and Associations (B)

International Federation of Pharmaceutical Manufacturers and Associations_C

International Federation of Pharmaceutical Manufacturers and Associations_C

Submission: Pharmaceutical industry perspectives on solutions that work to create access to medicines

On behalf of: 
European Federation of Pharmaceutical Industries and Associations
International Federation of Pharmaceutical Manufacturers and Associations
Pharmaceutical Research & Manufacturers of America
Japan Pharmaceutical Manufacturers Association

Click here to read the submission from the International Federation of Pharmaceutical Manufacturers and Associations (C)

SANGEETA SHAHSIKANT, Third World Network

SANGEETA SHAHSIKANT, Third World Network

Lead Author: Sangeeta Shahsikant
Additional Author: Gopakumar Kapoori
Organization: Third World Network
Country: India

Abstract

Access to health technologies is widely recognized to be a central aspect to achieving the right to health. The link between access to health technologies and the use of TRIPS flexibilities is well established. Human rights obligations require States to incorporate TRIPS flexibilities into their national laws and to utilize such flexibilities to protect the right to health. Against this background, technical assistance (TA) provided to countries on their TRIPS obligations and flexibilities available to promote access to health technologies as well as on utilization of such flexibilities becomes critical. Inappropriate technical assistance can adversely impact on the fulfillment of the right to health. The World Intellectual Property Organization (WIPO) is a major provider of IP-related technical assistance, spending millions of dollars on such assistance. However since fees received through its various IP registration systems fund it, there is a serious issue of conflicts of interest. There are significant concerns over WIPO’s technical assistance especially its pro-IP orientation at the expense of wider development concerns and public interest. Of particular concern is WIPO’s understanding of
“flexibilities” and its technical assistance on flexibilities. This contribution highlights some of the concerns with regard to WIPO’s technical assistance activities including its approach to “flexibilities”.  It also makes specific recommendations aimed at examining further the appropriateness of WIPO’s technical assistance from a public health perspectives as well as instituting specific reforms that will ensure independent and accountable mechanisms for delivery of technical assistance that is coherent with and supportive of efforts to achieve SDGs and realize the right to health.

Submission

Access to health technologies is widely recognized to be a core component of the right to the highest attainable standard of health1. The link between access to health technologies and use of TRIPS flexibilities is well established.2 Key public health related flexibilities include transition periods for least developed countries (LDCs), application of strict patentability criteria to avoid patents being granted for trivial inventions and prevent patent “evergreening”; compulsory and government use licenses, international exhaustion rules, which facilitate parallel importation; patent opposition and revocation procedures, exceptions to patents such as research and bolar exception.3

Human rights obligations require states to incorporate TRIPS flexibilities into their national laws and to utilize such flexibilities to protect the right to health. For example the Special Rapporteur in the field of cultural rights has concluded that “States have a positive obligation to provide for a robust and flexible system of patent exclusions, exceptions and flexibilities based on domestic circumstances, including through the establishment of compulsory and government use licences when needed”4 while the Special Rapporteur on Health has recommended that “From a right to health perspective, developing countries and LDCs should be enabled to use TRIPS flexibilities.”5

Against this background, technical assistance (TA) provided to countries on their TRIPS obligations and flexibilities available to promote access to health technologies as well as on utilization of such flexibilities becomes critical. Inappropriate technical assistance has a direct impact on the fulfillment of the right to health.

The World Intellectual Property Organization (WIPO), a specialized agency of the UN administers a number of international IP treaties in the area of patents, trademarks, industrial designs6 . WIPO is, entirely self-funded by fees obtained from users of the international registration systems through the Patent Cooperation Treaty (PCT), Madrid and Hague System. In the 2014/15 biennium 77% of its income came from patent filing fees through the PCT system.7 For the 2016/2017 biennium income is projected to be 756.3 million swiss francs budget. The overall surplus for the 2014/15 biennium is estimated at 80 million Swiss francs.8

WIPO is the primary institution providing IP-related TA to developing countries and LDCs.9 The financial resources WIPO devotes to TA has grown over time, both in absolute terms and as a share of WIPO’s overall budget as its income increased.10 For the 2016/2017 biennium, WIPO boasts that it will spend 21% of its budget (approx. 707 million swiss francs) for capacity building and development cooperation11 This amount is supplemented with member state funding.12 Over the years, significant concerns have been raised over WIPO’s pro-IP orientation at the expense of wider development concerns and public interest.13 Concerns that WIPO does not adequately reflect the broader development goals of the UN led to the launch of “WIPO’s Development Agenda” in 2004.

A group of 14 member states14 known as “Group of Friends of Development” (GFOD) pointed to the multiple UN related initiatives, that “have all placed development at the heart of their concerns and actions” and stressed the need for WIPO to bring “the development dimension into all its discussions and activities”.15 It further states: “Experience demonstrates that WIPO has concentrated its efforts in 3 the diffusion of standardized approaches to IP policies that assume, from an uncritical standpoint, that development follows suit as intellectual property rights protection is strengthened.”16

The GFOD was also extremely critical of WIPO’s TA stressing in providing such assistance:
• IP is often be seen as an objective in itself while barely addressing broader policy concerns
such as access to technological goods;
• Tendency to over-emphasize the benefits of IP while giving very little attention to the
limitations, actual costs and to different levels of development;
• TA is focused on the implementation and enforcement of obligations and not on the use of inbuilt rights and flexibilities in international treaties;
• Little independent evaluation of the TA provided by WIPO, including to determine the impact and effectiveness of the assistance.

In 2007, the DA initiative culminated in adoption of 45 recommendations17 which call inter alia for WIPO’s TA to be “development-oriented”, “demand-driven and transparent, taking into account the priorities and the special needs of developing countries, especially LDCs, as well as the different levels of development of Member States” and that WIPO “shall make available advice to developing countries and LDCs, on the implementation and operation of the rights and obligations and the understanding and use of flexibilities contained in the TRIPS Agreement”.

In 2011, as part of the DA, for the first time ever, an independent external review of WIPO’s technical assistance was undertaken providing a rare insight into WIPO’s technical assistance. Some of the findings and observations of Review were as follows:
• WIPO staff and activities lacked a development orientation, including a clear understanding of the overall purpose of WIPO’s TA activities.
• There is a lack of detailed information, transparency and appropriate accountability mechanisms for WIPO’s TA activities;
• The culture of collaboration, public engagement and openness to different perspectives on the IP system necessary for improved development-orientation is not yet institutionalized within WIPO. Staff interviewed by the Experts continued to view WIPO as the “guardian of the international IP system”, and interpret the DA narrowly.
• Analysis of the 2010/11 Program and Budget revealed that WIPO’s TA activities do not properly reflect issues that are of priority to developing countries. It is more focused on assimilating developing countries into the IP system and few activities clearly contributed to the use of TRIPs flexibilities; promoting access to medicines; the promotion of competition; reducing the knowledge gap including making practical use of various exemptions or policy options that would improve access to foreign technologies; establish and use mechanisms that could improve balance in national IP systems, such as those related to pre- and post-opposition to patents.
• The Experts’ efforts to evaluate the development orientation of WIPO’s legislative advice was thwarted by the confidentiality of WIPO’s country-specific legislative advice. However, based on available evidence, the Experts found an orientation towards promoting accession to WIPO administered international treaties and limited practical and proactive advice on how to use TRIPS flexibilities.4
• While some countries did receive advice on the implementation of IP provisions in bilateral FTAs, WIPO did not provide assistance in examining the possible development impacts of these.
• Over-reliance on external consultants with a lack of ability to properly supervise the quality or orientation of consultants’ work;
• There was greater evidence of WIPO’s engagement with IP right-holders, their associations and private sector IP experts than with civil society actors (e.g., consumer rights, public health, or public interest lawyers), research institutes and universities.
• WIPO’s TA on development of national IP strategies/plans were deficient in ensuring a
development-oriented IP system in terms of the overarching legal, institutional and regulatory
framework, highlighting public policy considerations; incorporating explicitly actions for reducing the knowledge gap between developed and developing countries including flexibilities that a country should explore or on reducing the costs for developing countries.
• Some IP strategies/plans were pushing countries to implement IP provisions in bilateral free trade agreements, although such TRIPS-plus provisions are widely criticized for failing to properly balance the development interests of countries. There was a lack of specific attention and advice on how to maximize available policy space or use of flexibilities.
• In some cases, the IP strategies reviewed related more to the strategy of an IP office than of a country more broadly. The Review found considerable confusion about how an IP strategy should seek to address, link to, or be embedded within, broader public policy strategies in areas such a science and technology, public health etc.
• Lack of transparency about the content of WIPO legislative assistance hampered verification of WIPO claims that its assistance is oriented to national development interests.
• Lack of framework instruments to guide the details of advice on the substantive issues that arise in the course of providing legislative assistance.
• WIPO bundles legislative assistance on the many categories of IP and enforcement in one draft Act, motivated by the objective of putting in place a full spectrum of IP laws.18 This approach obscures the complex legal issues and development and sectoral implications of the proposed provisions, many of which warrant serious national debate and in-depth consideration prior to adoption. Limited resources and capacity meant that governments are unlikely to have the capacity to ensure adequate reflection of all categories of IP law simultaneously. Thus countries adopt the law without proper understanding of the content of the proposed law or its development implications. For LDCs, such an approach obfuscates the ability of countries to take advantage of LDC transition periods under TRIPS.
• WIPO received high ratings on its support to countries to ratify and implement WIPO treaties, but poorer ratings on efforts to advice on the use of flexibilities in international treaties and tailoring of advice to national priorities.
• The External Review also found WIPO assistance on certain other IP-related regulatory issues (e.g. control of anti-competitive abuse of IP, advise on patentability guidelines) was generally rated poorly by the survey undertaken.19
• Neither WIPO nor the beneficiary countries systematically gather or analyse data on the
implications of different legislative options on development goals, thus it is unclear on what
grounds WIPO staff recommended certain legal options over others.
• The Experts review of WIPO documents, (.e.g. brochures and web-site pages) revealed a focus on promoting the IP system.5
• The External Review through its public consultation process received two concrete examples (one for developing country and one for LDC) of TRIPS-plus advice on several key issues, such as patent term extension, data exclusivity, exhaustion of rights and compulsory licensing.
Following the Review a group of developing countries submitted a detailed proposal (CDIP/9/1620) aimed at improving transparency and accountability. However limited progress has been made due to resistance from the WIPO Secretariat and developed countries.

In 2012, 100 NGOs wrote to Francis Gurry, DG of WIPO objecting to the holding of the Africa IP summit on anti-counterfeiting in partnership with US, France and Japan and sponsored by the private sector21 that clearly have a strong stake in a pro-IP protection and enforcement agenda. The NGO letter argued that the event lacked a development and public interest dimension as critical issues such as access to medicines and use of TRIPS flexibilities are disregarded22.

Further according to the Secretariat, “... flexibilities can operate either downward or upward, i.e. they may permit measures that reduce or limit the rights conferred; or measures that raise the level of protection above the minimum standards established by the TRIPS Agreement.”23 This means that the Secretariat considers TRIPS-plus obligations such as criminal sanctions for patent infringement24 patent term extension as “flexibilities”. This understanding of flexibilities is completely contrary to the common understanding of “flexibilities” including by UN agencies (e.g. UNDP, UNAIDS, WHO) which is about enhancing policy space by removing the IP barrier.25 Unlike WIPO these agencies also caution against adoption of TRIPS plus measures for its impact on access to medicines.26

The evidence provided above makes clear that in providing TA, WIPO’s orientation remains mainly about protecting and enforcing IP. This is not surprising given that fees from IP applicants fund WIPO.

However this raises issues of conflicts of interests. How can WIPO that is heavily dependent on fees received from IP applicants, also provide objective technical assistance including advice on flexibilities that may affect the right holders?

The lack of transparency and independent accountability mechanisms with regard to WIPO’s technical assistance is a concern.

WIPO’s understanding of “flexibilities” is another huge concern as it would suggest that WIPO may be endorsing and/or advocating TRIPS plus provisions in its technical assistance that will hinder access to health technologies. For example a review of patent laws in LDCs revealed remarkable similarities in the language, sequence of provisions and emphasis on far higher protection of IP than is required in LDCs and it appears that several LDCs have worked off standard formats. The review recommends that WIPO's technical assistance to these countries should be publicly scrutinized to determine if such standard formats emanated from WIPO or elsewhere.27

Given the importance of the use of TRIPS flexibilities to promote access to affordable health
technologies, and fulfill the right to health, flawed technical assistance can have devastating
consequences.

RECOMMENDATIONS
6
1. Commission an independent in-depth review of WIPO’s assistance on legislation and policy
advice to assess the suitability of the assistance for the particular countries from a development and public health perspective. The Review should include an in-depth examination of the content of draft laws and comments on draft laws provided by WIPO, as well as of the content of seminars/training events on legislative matters and development of national IP strategies. It should also review WIPO’s assistance on TRIPS flexibilities, to assess the nature and scope of WIPO’s assistance, its adequacy (relevance, impact and effectiveness), and to recommend ways to improve such assistance.28
2. Develop an independent mechanism (separate from WIPO's norm setting and IP registration
systems) with an independent member state governance structure to implement WIPO’s technical assistance.29 Institute an independent mechanism for systematic monitoring and evaluation of WIPO’s technical assistance.
3. Conduct an assessment of WIPO’s staff and consultants engaged in the delivery of technical
assistance that may have an impact on public health, to assess their competence and orientation and thus suitability to deliver such assistance.
4. Commission experts to develop "guidelines" providing specific detail on how WIPO should
plan and implement more public interest and public health-oriented assistance both in terms of substance and process with a specific focus on ensuring access to affordable health technologies.
5. To ensure that WIPO advises LDCs that they need not implement TRIPS obligations and
should fully utilize the transition periods available to them.
6. To make available on the technical assistance database information on the technical assistance activities such as the objectives, expected and actual outcomes, recipients, participants, donors, experts, consultants, speakers, evaluation reports, and other relevant documentation30 (e.g. programs, presentations, CVs of speakers/experts/consultants, list of participants) that has been agreed in CDIP/3/INF/2 but has yet to be reflected as part of the database.
7. To Revamp the Code of Ethics as proposed in CDIP/9/1631 (Joint Proposal of the Development Agenda Group and the Africa Group).32

IMPACT ON REMEDYING POLICY INCOHERENCE, PUBLIC HEALTH, HUMAN
RIGHTS & IMPLEMENTATION

TRIPS flexibilities are critical for access to affordable health technologies, and thus the realization of the right to health. WIPO is a major provider of IP related technical assistance. Annually it conducts hundreds of TA events. If the assistance of flawed, States will be unable to fulfill their right to health. The abovementioned recommendations are aimed at reviewing WIPO’s TA and introducing mechanisms to ensure WIPO’s TA is coherent with and supportive of (and does not undermine) efforts to achieve SDG targets and realize the right to health.

With regard to implementation, it is important to note that WIPO is bound by the UN-WIPO
Agreement33. Articles 4, 5 and 6 of the Agreement grants the UN specific rights with regard to WIPO.7

This includes requesting information from WIPO, introducing agenda items in relevant WIPO bodies as well as initiating studies and reports with respect to health and to make recommendations on these to WIPO, and for WIPO to report on action taken to comply with the recommendation.

Bibliography and References

CESCR. art. 15(1)(b)-(c). See also Human Rights Council. Access to medicines in the context of the
right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
A/HRC/23/L.10/Rev.1.
http://www.ohchr.org/EN/HRBodies/HRC/RegularSessions/Session23/Pages/ResDecStat.aspx (2013)
and General Comment 14 of the Committee on Economic, Social, and Cultural Rights (CESCR),
http://www.nesri.org/sites/default/files/Right_to_health_Comment_14.pdf.
2 United Nations (2011). “Political Declaration on HIV and AIDS: Intensifying Our Efforts to
Eliminate HIV and AIDS”. UN General Assembly Resolution A/RES/65/277, 8th July 2011. See
http://www.un.org/Depts/dhl/resguide/resins.htm; United Nations (2011). “Political Declaration of the
High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable
Disease”; UN General Assembly Resolution A/66/2 19 September 2011. See
http://www.un.org/Depts/dhl/resguide/resins.htm; United Nations (2012). “The future we want”.
RIO+20 United Nations Conference on Sustainable Development, A/CONF.216/L.1. See
http://www.uncsd2012.org/content/documents/774futurewewant_english.pdf; WHO. (2011), “Global
Strategy and Plan of Action on Public health, Innovation and Intellectual Property”. Adopted in 2008
by Resolution WHA61.21. See
http://www.who.int/phi/publications/Global_Strategy_Plan_Action.pdf?ua=1; WHO, (2013). “Global
Action Plan for the Prevention and Control of Noncommunicable Diseases 2013-2020”. See
http://apps.who.int/iris/bitstream/10665/94384/1/9789241506236_eng.pdf?ua=1.
3 Musungu SF, Oh C. The use of TRIPS flexibilities by developing countries: can they promote access
to medicines? Commission on Intellectual Property Rights, Innovation and Public Health, Study 4C.
Available at http://www.who.int/intellectualproperty/studies/TRIPSFLEXI.pdf; Correa, Carlos M.
2000. Integrating public health concerns into patent legislation in developing countries. Geneva: South
Centre. Available at http://apps.who.int/medicinedocs/pdf/h2963e/h2963e.pdf
4 Statement by Ms. Farida Shaheed, Special Rapporteur in the Field of Cultural Rights at the 70th
session of the General Assembly, October 2015. See
http://www.ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=16918&LangID=E#st
hash.C1e9KaF4.dpuf
5 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, 2009. A/HRC/11/12. See
http://www2.ohchr.org/english/bodies/hrcouncil/docs/11session/A.HRC.11.12_en.pdf
6 A Citizen’s Guide to WIPO, Center for International Environmental Law, see
http://www.ciel.org/Publications/CitizensGuide_WIPO_Oct07.pdf; Musungu, Sisule F., and Graham
Dutfield, “Multilateral Agreement and a TRIPS-plus World: The World Intellectual Property

8
Organization (WIPO),” QUNO and QIAP TRIPS Issue Paper 3, 2003, available at
http://www.iprsonline.org/ictsd/docs/WIPO_Musungu_Dutfield.pdf
7 WIPO’s Program & Budget 2016/2017
8 See the Francis Gurry’s Briefing for Ambassadors at http://www.wipo.int/export/sites/www/aboutwipo/
en/dgo/pdf/ambassadors_briefing_022016.pdf
9 See WIPO’s technical assistance database at http://www.wipo.int/tad/en/. “Many countries rely
heavily or exclusively on WIPO for detailed, technical advice on specific provisions of IP laws and for
putting in place a suite of IP laws.” – see pg. 90 of External Review of WIPO Technical Assistance in
the Area of Cooperation for Development. CDIP/8/INF/1. WIPO at
http://www.wipo.int/meetings/en/details.jsp?meeting_id=22206. See also Deere-Birkbeck, C., “The
Technical Assistance Principles of the WIPO Development Agenda and their Practical
Implementation”, ICTSD at
http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.394.2374&rep=rep1&type=pdf
10 “WIPO’s total estimated contribution to IP-related capacity building in developing countries
between 1996 and 2009 reached over CHF 500 million, more than doubling from an estimated 25 CHF
million in 1996 (approximately 5% of the organization’s budget in that year) to an estimated CHF
118.5 million from the Regular Budget for the 2010/2011 biennium (19.2% of WIPO’s Regular Budget
for that biennium). This growing expenditure on development cooperation activities was possible due
to an increase in WIPO’s income from the Patent Cooperation Treaty (PCT) and Madrid Treaty, which
grew over the same period. Box 1.2 provides an overview of the sources and scale of resources for
WIPO’s development cooperation activities, which for 2008/09 and 2010/11 combine to reach an
estimated grand total of CHF 284.04 million.”, see pg 15 of External Review of WIPO Technical
Assistance in the Area of Cooperation for Development. CDIP/8/INF/1. at
http://www.wipo.int/meetings/en/details.jsp?meeting_id=22206,
11 National Strategies § Regulatory Framework § Technical Infrastructure § Capacity-Building § LDCs
and Appropriate Technology. See the Francis Gurry’s Briefing for Ambassadors at
http://www.wipo.int/export/sites/www/about-wipo/en/dgo/pdf/ambassadors_briefing_022016.pdf
12 In the 2016/2017 biennium it is estimated that approximately 23.3 million swiss francs will be
available through member state funds in trust. See Annex VII of WIPO’s Program & Budget
2016/2017. Funds in Trust are voluntary extra-budgetary contributions by some Member States to
WIPO to support certain development cooperation activities as specified in a Memorandum of
Understanding between the donor country and WIPO.
13 WIPO’s technical assistance has come under criticism from various quarters including independent
bodies such as the U.K Commission on Intellectual Property Rights, which in its report in 2002
characterized WIPO’s technical assistance as too often planned and delivered in isolation from
development goals of developing countries.
14 Argentina, Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, Egypt, Iran, Kenya, Peru, Sierra
Leone, South Africa, Tanzania and Venezuela
15 See “Proposal to Establish a Development Agenda For WIPO: An Elaboration of Issues Raised in
Document WO/GA/31/11) submitted by Brazil on behalf of the Group of Friend of Development
(IIM/1/4) at http://www.wipo.int/edocs/mdocs/mdocs/en/iim_1/iim_1_4.doc. See also “Proposal by
Argentina and Brazil For the Establishment of A Development Agenda for WIPO” (WO/GA/31/11) at
www.wipo.int/edocs/mdocs/govbody/en/wo_ga_31/wo_ga_31_11.pdf
16 See “Proposal to Establish a Development Agenda For WIPO: An Elaboration of Issues Raised in
Document WO/GA/31/11) submitted by Brazil on behalf of the Group of Friend of Development
9
(IIM/1/4) at http://www.wipo.int/edocs/mdocs/mdocs/en/iim_1/iim_1_4.doc. See also “Proposal by
Argentina and Brazil For the Establishment of A Development Agenda for WIPO” (WO/GA/31/11) at
www.wipo.int/edocs/mdocs/govbody/en/wo_ga_31/wo_ga_31_11.pdf
17 See http://www.wipo.int/ip-development/en/agenda/recommendations.html
18 For instance a draft law prepared by WIPO for an LDC viewed by the Experts covered more than 9
categories of IP (i.e. patents, utility model, industrial designs, layout-designs of integrated circuits;
traditional knowledge and handicraft; trademarks, service marks, collective marks, certification signs
and trade name; geographical indications; protection against unfair competition).
19 “…respondents overwhelmingly poorly rated WIPO’s efforts to adapt its legislative advice to
reflect national development priorities in areas such as public health and access to education.
Similarly, WIPO’s assistance to put into practice the IP flexibilities that are included in their national
laws (e.g., through patentability guidelines, advice on issuing a compulsory license; guidelines on
differences between their national patent laws and those of countries which may assist their country in
patent search and examination) was predominantly ranked by respondents in the poor range… WIPO
is not proactive in providing advice on flexibilities and officials do not perceive that they can rely on
WIPO for tailored or pro-development advice.”. See pg. 92, External Review of WIPO Technical
Assistance in the Area of Cooperation for Development. CDIP/8/INF/1. WIPO at
http://www.wipo.int/meetings/en/details.jsp?meeting_id=22206,.
20 Africa Group and Development Agenda Group proposal at
http://www.wipo.int/edocs/mdocs/mdocs/en/cdip_9/cdip_9_16.pdf
21 In particular the International Chamber of Commerce (ICC), Business Action to Stop Counterfeiting
and Piracy (BASCAP), Pfizer, Eli Lilly and Company etc.,
22 NGO Letter to Franci Gurry on Africa IP summit (2012),
http://www.ghwatch.org/sites/www.ghwatch.org/files/AfricaIPSummit2012_0207.pdf; US, WIPO
Training Programme On IP Rights In Africa Comes Under Fire, See http://www.ipwatch.
org/2012/02/12/us-wipo-training-programme-on-ip-rights-in-africa-comes-under-fire/.
23 WIPO, Advice on Flexibilities under the TRIPS Agreement (Emphasis added),
http://www.wipo.int/ip-development/en/legislative_assistance/advice_trips.html
24 See http://www.wipo.int/ip-development/en/agenda/flexibilities/search.jsp and
http://www.wipo.int/ip-development/en/legislative_assistance/advice_trips.html
accessed 28th February 2016.
25 “Using TRIPS flexibilities to improve access to HIV treatment” UNAIDs, UNDP, WHO at
http://www.unaids.org/sites/default/files/media_asset/JC2049_PolicyBrief_TRIPS_en_1.pdf
26 The potential impact of free trade agreements on public health, UNDP, UNAIDS, Issue Brief,
2012, at http://www.unaids.org/sites/default/files/media_asset/JC2349_Issue_Brief_Free-Trade-
Agreements_en_0.pdf; Global Commission on HIV and the Law. 2012. Risks, Rights, and Health.
New York, NY: United Nations Development Programme. Available at
http://www.hivlawcommission.org/resources/report/FinalReport- Risks,Rights&Health-EN.pdf;
WHO Commission Intellectual Property Rights, Innovation and Public Health, see
http://www.who.int/intellectualproperty/en/
27 Kajal Bhardwaj, "Patents and Access to Medicines in Least Developed Countries: Making the Most
of Public Health Safeguards within the WTO framework", December 2015(Forthcoming publication;
Research conducted for the Human Development Fellowship at the Indian Institute of Advanced
Studies, Shimla, India)
10
28 It is worth noting that External Review of WIPO’s technical assistance did not undertake a detailed
review of WIPO’s legislative assistance. Thus the External Review itself recommends (pg. 101)
“WIPO and its Member States should devise a mechanism whereby, without abusing confidentiality
assurances and in consultation with WIPO staff, an in-depth review of legislative assistance could be
conducted by a team of external legal experts, to evaluate its attention to the expressed request of
countries, development priorities, country circumstances and to the full range of flexibilities and
options available to countries, in consultation with WIPO staff. This Review should include an indepth
examination of the content of draft laws and comments on draft laws provided by WIPO, as well
as of the content of seminars on legislative matters.” This recommendation has thus far not been taken
forward in WIPO despite extensive concerns over WIPO’s legislative assistance.
29 This is aimed at addressing the conflicts of interest issue raised above.
30 CDIP/3/INF/2 requires WIPO to make general information on technical assistance activities
available on the technical assistance database: “The data recorded in the system will comprise all
relevant data related to technical assistance activities. It will include details of the activities such as
general information on the activity, who requested the activity, objectives, expected outcomes, budget,
recipients, participants, donors, experts, consultants, speakers, evaluation reports and other relevant
documentation.” However to date inadequate information is being provided. See
www.wipo.int/edocs/mdocs/mdocs/en/cdip_3/cdip_3_inf_2.doc. See also the Evaluation of the
technical assistance database at http://www.wipo.int/edocs/mdocs/mdocs/en/cdip_9/cdip_9_4.pdf
31 Africa Group and Development Agenda Group proposal at
http://www.wipo.int/edocs/mdocs/mdocs/en/cdip_9/cdip_9_16.pdf
32 Paragraph D1 of CDIP/9/16 states:
The Secretariat shall revise the Code of Ethics in Appendix 3 of CDIP/9/14 and present the draft
revised version to the CDIP for its consideration and to the Coordination Committee for endorsement.
The Code of Ethics should be revised to:
• apply it only to WIPO’s staff members with the aim that staff members will be obliged to read and
sign the code of ethics;
• to include a reference to the UN-WIPO Agreement of 1974 in the preambular paragraph and other
relevant sections of the Code (e.g. paragraph on “Loyalty”);
• to include a reference to Development Agenda (DA) recommendations in the preambular
paragraph and other relevant sections of the Code (e.g. paragraph on “Loyalty”);
• to include provisions specifically related to those staff engaged in the provision of development
cooperation activities, which for example highlights the importance of providing technical
assistance according to DA recommendation 1 with only the best interests of the country receiving
technical assistance in view; and requires the Staff to review the DA recommendations.
Paragraph E1 of CDIP/9/16 states: The Secretariat shall prepare a draft Code of Ethics specifically
applicable to all experts/consultants engaged in development cooperation activities, whether engaged
in a paid capacity, with honorarium or expenses covered or on a voluntary basis, with the aim that all
such experts/consultants will be obliged to read and sign the Code of Ethics and a violation of the code
will result in termination of the contract. The Code of Ethics should inter alia:
• stress on principles such as integrity, independence, objectivity, impartiality, respect for human
rights and accountability, with suitable clauses applicable to experts/consultants engaged in
development cooperation activities;
• reflect the DA recommendations and require the experts/consultants to adhere to the DA
recommendations;
11
• address the issue of conflicts of interest including by requiring that the experts/consultants complete
conflict of interest disclosure statements;
• require that professional advice given is both timely and appropriate to the level of development,
needs, interests and priorities of the beneficiary country;
33 See http://www.wipo.int/treaties/en/text.jsp?file_id=305623

Maria Lorena Di Giano and Marcela Fogaça Vieira, REDLAM

Maria Lorena Di Giano and Marcela Fogaça Vieira, REDLAM

Authors: Maria Lorena Di Giano and Marcela Fogaça Vieira
Organization: RedLAM - Red Latino Americana por el Acceso a Medicamentos
Sponsoring Organizations: Associação Brasileira Interdisciplinar de Aids; Grupo de Trabalho sobre Propriedade Intelectual da Rede Brasileira pela Integração dos Povos; Fundación Grupo Efecto Positivo (FGEP); IFARMAl Acción Internacional para la Salud
Country: Argentina, Brazil, Colombia, Peru

Click here to read the submission from Maria Lorena Di Giano and Marcela Fogaça Vieira