INTELLECTUAL PROPERTY: WHO-WIPO-WTO BOOK

Annex I. Overview of international key stakeholders

Chapter I describes the trend, notably over the past decade, towards the expression of a more diverse range of views and perspectives in policy discussions about public health, intellectual property (IP) and trade, and also in debates about the issue of access and innovation relating to medical technologies such as pharmaceuticals. This study acknowledges the inputs of many stakeholders and their essential contribution to a necessarily multidisciplinary and pluralistic set of policy discussions. Annex I is not exhaustive. It contains information on a selection of some of the most active participants in the policy discussions about public health, IP and trade, other than the WHO, WIPO and the WTO. The first section covers international organizations and the second section introduces other stakeholders such as public health advocates and industry representatives. These are listed in alphabetical order. This annex does not contain information on many important practical initiatives, as these are covered in the main body of the study.

The descriptions of the mandates, roles and priorities of the organizations listed in Annex I are based on, and summarized from, material provided and published by these organizations. The descriptions cannot be attributed to the WHO, WIPO or the WTO. Readers are encouraged to contact the organizations for authoritative and up-todate information on any of the programmes and other activities described in this study.

International organizations

Global Fund to Fight AIDS, Tuberculosis and Malaria

Created in 2002, the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) is a public-private partnership and international financing institution dedicated to attracting and disbursing additional resources to prevent and treat HIV/AIDS, tuberculosis (TB) and malaria. The Global Fund’s model is based on the concepts of country ownership and performance-based funding, with recipients of its funding implementing their own programmes based on their priorities, on the condition that verifiable results are achieved.

The Global Fund urges recipients of its funding to adhere to good procurement practices, including competitive purchasing from qualified manufacturers and suppliers. It encourages them to apply national laws and applicable international obligations in the field of IP, including the flexibilities contained in the TRIPS Agreement and interpreted in the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration), in a manner that achieves the lowest possible price for products of assured quality.

The Global Fund encourages recipients who face challenges on the procurement and supply of health products, including challenges in relation to the management of issues related to intellectual property rights (IPRs), to obtain the requisite technical assistance and support as part of the Global Fund grant.

The Global Fund maintains a public web-based Price and Quality Reporting (PQR) system which tracks procurement transactions for key health products purchased by its recipients.

¹ It aims to promote transparency on pricing, monitor compliance with the Global Fund’s Quality Assurance Policy and enable recipients to make informed procurement decisions.

Website: www.theglobalfund.org

Contact:   The Global Fund to Fight AIDS,
                 Tuberculosis and Malaria
                 Chemin de Blandonnet 8
                 1214 Vernier Geneva, Switzerland
                 Tel: +41 58 791 1700
                 Fax: +41 58 791 1701

United Nations Human Rights Council and Office of the United Nations High Commissioner for Human Rights

The United Nations Human Rights Council (HRC), a subsidiary body of the United Nations General Assembly, is responsible for promoting universal respect for the protection of all human rights and fundamental freedoms for all. The HRC was established by the United Nations General Assembly to replace the former Commission on Human Rights.² The Office of the United Nations High Commissioner for Human Rights (OHCHR) provides substantive and technical support to the HRC in all areas of its work, including its regular and special sessions and the meetings of its subsidiary bodies.

Special Rapporteurs are appointed by the HRC to address either specific country situations or thematic issues in all parts of the world. The OHCHR provides them with personnel, policy, research and logistical support for the discharge of their mandates. Special Rapporteurs operate within their respective mandates through different means and activities.³ These include monitoring the situation of the right to health throughout the world, as well as presenting annual and thematic reports to the HRC and interim reports to the United Nations General Assembly. During his tenure (2002-2008), the first Special Rapporteur, Mr Paul Hunt, regularly analysed the issue of access to medicines as a component of the right to the highest attainable standard of health. In 2008, he published Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines.⁴ His successor closely examined the relationship between the right to health, specifically with regard to access to medicines, and IPRs in his 2009 report to the HRC.⁵ Making use of the flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and avoiding higher IP standards in free trade agreements (FTAs) than provided by the TRIPS Agreement are among the actions recommended by the Special Rapporteur. Following his 2011 report on expert consultation on access to medicines,⁶ the HRC mandated the Special Rapporteur to explore existing challenges with regard to access to medicines in the context of the right to health, ways to overcome these challenges, and good practices.⁷

The Intergovernmental open-ended Working Group on the Right to Development and the High-Level Task Force on the implementation of the right to development also examined and reported on their findings with respect to trade issues from a human rights perspective, including Target E of Millennium Development Goal (MDG) 8, which concerns providing access to affordable medicines in developing countries.⁸

The Committee on Economic, Social and Cultural Rights (CESCR), established under the International Covenant on Economic, Social and Cultural Rights (ICESCR), has also considered the right to health and IPRs. Like the considerations underlying the broader debate on the appropriate balance in the IP system as it relates to public health, the need to strike an adequate balance between the various rights guaranteed in the Covenant is also recognized.⁹

Website: www.ohchr.org

Contact: Office of the UN High Commissioner for
                 Human Rights (OHCHR)
                 Palais Wilson
                 Rue des Pâquis 52
                 CH-1201 Geneva, Switzerland
                 Tel: +41 22 917 9220

South Centre

The South Centre is an intergovernmental organization comprising 52 developing countries. Based in Geneva, it was established to provide policy advice to developing countries and to contribute to south-wide collaboration in promoting common interests and coordinated participation by developing countries in international forums dealing with South–South and North–South matters.

The three main activities undertaken by the South Centre are: research and policy analysis; policy advice; and capacity-building and training. The Centre has developed a strong reputation for working consistently on issues related to IP, innovation and access to pharmaceutical products. In its day-to-day operations, it uses an interdisciplinary approach, and relies on a team of experienced experts in various fields, including law, economics, development studies, political science and international relations.

The provision of policy advice is the main activity undertaken by the South Centre in order to meet its objective of assisting developing country governments in decision-making with respect to standard-setting and rule-making in so far as these relate to IP and access to pharmaceutical products. The Centre provides analysis of the main international treaties and ongoing international negotiations, as well as advice on regional and national processes, such as the negotiation of FTAs and their implications for public health – in particular the issue of access to pharmaceutical products. It also provides training for pharmaceutical patent examiners.

In line with its work in the field of IP and access to pharmaceutical products, the South Centre has published a number of books, research papers and policy briefs.

Website: www.southcentre.org

Contact: South Centre
                 CP 228
                 1211 Geneva 19
                 Switzerland
                 Tel: +41 22 791 8050
                 Fax. +41 22 798 8531
                 e-mail: [email protected]

Joint United Nations Programme on HIV/AIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) is an innovative partnership which provides global inspiration and leadership towards the achievement of universal access to (HIV) prevention, treatment, care and support. Two political declarations on HIV/AIDS, adopted by the United Nations General Assembly in 2001 and 2006, established the framework for a global response to the epidemic. In 2011, the General Assembly adopted a third Declaration which commits member states to a set of ambitions targets, including ensuring that 15 million people living with HIV have access to treatment by 2015, and halving new HIV infections. In the absence of a vaccine, and given the need for ever simpler and more tolerable antiretroviral (ARV) medicines, UNAIDS calls for continued and increased investments in research and development (R&D).

UNAIDS fully supports the use of flexibilities contained in the TRIPS Agreement and clarified by the Doha Declaration by developing countries. Such flexibilities are critical to enable countries to expand access to HIV treatment and are central to the 2010 UNAIDS Treatment 2.0 initiative, which aims to accelerate access to cheaper, more effective and tolerable drug combinations and diagnostics. In March 2011, UNAIDS, the WHO and the United Nations Development Programme (UNDP), produced a policy brief which reviewed available trade-related aspects of intellectual property rights (TRIPS) flexibilities and urged countries to make use of such flexibilities where appropriate, in order to obtain access to affordable generic ARV medicines, including through local production, where feasible.¹⁰ In its capacity as an observer, UNAIDS has been monitoring TRIPS Council discussions in so far as these relate to IP and public health since 2002.

UNAIDS is also fully committed to the recently launched Medicines Patent Pool, an innovative mechanism for managing IPRs, in the hope that this mechanism will help to advance its Treatment 2.0 initiative.

Website: www.unaids.org

Contact:   UNAIDS Secretariat
                 Avenue Appia 20
                 CH-1211 Geneva 27
                 Switzerland
                 Tel: +41 22 791 3666
                 Fax: +41 22 791 4187

United Nations Conference on Trade and Development

The United Nations Conference on Trade and Development (UNCTAD) has undertaken a number of activities related to trade and health, in particular in the area of IPRs. Since 2001, the UNCTAD IP programme has been running a major project which aims to address concerns voiced by developing countries with respect to the implementation of the TRIPS Agreement and new developments in the area of IPRs. One of the key results of this programme was the publication in 2005 of the Resource Book on TRIPS and Development in conjunction with the International Centre for Trade and Sustainable Development (ICTSD). The Resource Book, conceived as a practical guide to the TRIPS Agreement, provides detailed analysis of each of its provisions, aimed at a sound understanding of WTO members’ rights and obligations. It is designed to help negotiators and policy-makers engage in informed participation in negotiations and decision-making processes. It is also designed to assist national authorities in the implementation and adoption of policies on IPRs.¹¹ UNCTAD and the ICTSD have also worked on the so-called “Development Dimension of Intellectual Property Reports”, with the objective of assisting developing countries, for example, Cambodia and Uganda, in integrating IP issues into their overall development goals.¹²

In 2005, UNCTAD was mandated to engage in work specifically related to the local manufacturing and supply of pharmaceutical products.¹³ The overall objective of UNCTAD is to assist developing countries to establish domestic IP regimes that will facilitate increased access to affordable medicines and, where feasible, to support the creation of local or regional pharmaceutical production and supply capacities, including in cooperation with investors. Among a range of programme activities, UNCTAD has produced a series of comprehensive publications, including Using Intellectual Property Rights to Stimulate Pharmaceutical Production in Developing Countries: A Reference Guide¹⁴ and Investment in Pharmaceutical Production in the Least Developed Countries: A Guide for Policy Makers and Investment Promotion Agencies.¹⁵ It has also provided training courses on TRIPS flexibilities for local pharmaceutical production. The work of UNCTAD in the field of medical products is complemented by a series of case studies focusing on examples of technology transfer for pharmaceutical production and access to medicines in selected developing and least-developed countries.¹⁶ This activity is part of a larger project, which is based on the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI), which includes UNCTAD as one of the stakeholders. The project, conducted in partnership with the WHO and the ICTSD, examines possibilities to improve access to medicines in developing countries by identifying the main challenges and obstacles to local pharmaceutical production and related technology transfer in selected developing countries.

Website: www.unctad.org

Contact: UNCTAD
      Palais des Nations
      Avenue de la Paix 8-14
      1211 Geneva 10 Switzerland
      Tel: +41 22 917 1234
      Fax: +41 22 917 0057

United Nations Development Programme

The United Nations Development Programme (UNDP) is the UN global development network and is represented in 177 countries around the world. In cooperation with a broad range of stakeholders, the UNDP helps countries to create knowledge and share experience and resources in order to find solutions to global and national development challenges to achieve positive social change and to realize the MDGs.

In order to reduce costs and increase access to HIV treatment and treatment of co-infections, as well as access to relevant technologies, the UNDP advocates the implementation and use of the public health-related flexibilities contained in the TRIPS Agreement. In furtherance of this objective, the UNDP provides technical and policy support to countries which are engaged in reviewing legislation with a view to incorporating TRIPS flexibilities into such legislation. It also provides support to countries involved in WTO accession negotiations or FTA negotiations, in particular where such negotiations may have IP-related implications. The UNDP also analyses and disseminates knowledge on the experience of countries in utilizing the TRIPS flexibilities to reduce cost and increase access to essential medicines. For example, in 2010, the UNDP published the Good Practice Guide: Improving Access to Treatment with Flexibilities in TRIPS. In early 2011, the UNDP, UNAIDS and the WHO released a joint policy brief on using the TRIPS flexibilities to increase access to HIV treatment.¹⁷

The UNDP has been supportive of the Doha Declaration and has advocated for the simplification of national laws in order to remove obstacles that prevent the effective use of the 30 August decision, and also in order to give effect to the Paragraph 6 System.

Website: www.undp.org

Contact:   UNDP Headquarters
                 One United Nations Plaza
                 New York, NY 10017
                 USA
                 Tel: +1 212 906 5000
                 Fax: +1 212 906 5001

United Nations Children’s Fund

Created in 1946 and formerly known as the United Nations International Children’s Emergency Fund, UNICEF is the key advocate for children within the UN system. UNICEF is the world’s leading procurement agency of vaccines for children. It works in partnership with national governments, donor agencies and other organizations to obtain quality pharmaceutical products at reasonable prices. UNICEF is also committed to improving access to treatment for children affected by HIV/AIDS.

In order to ensure the safety and efficacy of medicines, UNICEF has a quality assurance system for purchasing medicines. This is based on the principles of the WHO Model Quality Assurance System for Procurement Agencies.¹⁸ As part of the system, pre-qualification of suppliers based on the WHO Good Manufacturing Practice Guidelines is required, documentation provided by suppliers is assessed, products are evaluated, and visits to manufacturing sites are organized. When purchasing medical products, UNICEF is mindful of the need to take into account patents and other IPRs, as they apply to the products concerned, in accordance with the international and national legal framework. Where appropriate, UNICEF fully supports the use of TRIPS flexibilities as clarified by the Doha Declaration. The UNICEF Supply Division therefore reviews the patent and regulatory status of individual products in order to find the best supply solutions for each country. To ensure that IP issues do not impede UNICEF procurement efforts, and in line with paragraph 7 of the Doha Declaration, least-developed country (LDC) WTO members must provide a certification of nonrecognition and non-enforceability of patents and test data in the pharmaceutical sector. Developing countries, on the other hand, must state which TRIPS-compliant measures have been taken, or are intended, to authorize generic medicines in their respective domestic markets.

UNICEF is committed to working with manufacturers to increase the affordability of quality medicines. It contributes to the publication of prices for HIV/AIDS medicines through the WHO Global Price Reporting Mechanism.¹⁹ Prior to 2011, UNICEF had a practice of publishing only the average prices paid for vaccines. In 2011, in an attempt to increase transparency and thus stimulate competition, UNICEF decided to systematically publish details of prices paid to individual producers.²⁰ This measure is expected to lead to lower prices for vaccines needed in developing countries, and will enable purchasers to procure vaccines at reasonable prices from quality sources.

Website: www.unicef.org

Contact: UNICEF House
                 3 United Nations Plaza
                 New York, New York 10017
                 USA
                 Tel: +1 212 326 7000
                 e-mail: www.unicef.org/about/contact_ contactusform.php

UNITAID

Created in 2006, UNITAID is an international drug purchase facility. The objective of this facility is to scale up access to prevention and treatment products for HIV/ AIDS, TB and malaria in developing countries. In order to achieve this, prices are negotiated, often in cooperation with relevant partners (such as the Clinton Foundation and Stop TB), for already existing forms of medication and by bulk purchasing and pooled procurement. UNITAID also encourages follow-on innovation, so as to ensure that medicines are available in formulations and combinations that are best suited to target populations and treatment conditions in developing countries.

UNITAID raises money through a combination of taxes on airline tickets and long-term government funding. It does not administer the distribution of drugs. Rather, it provides the necessary resources to facilitate the purchase of needed drugs by other organizations. As a consequence, its activities are mainly focused on the identification of current needs by potential recipients, on the negotiation of long-term contracts with pharmaceutical companies, and the maintenance of relations with major stakeholders in the field. In cases where it is appropriate to achieve competition and price reductions, UNITAID supports the use by countries of compulsory licensing under the framework of the Doha Declaration. UNITAID was the main driving force behind the proposal that patent holders be asked to share their IPRs in a pool which would then make licences available to other producers, thus facilitating the production of affordable generic medicines and the development of adapted formulations. This process ultimately led to the establishment of the Medicines Patent Pool.

Website: www.unitaid.eu

Contact: World Health Organization
                 UNITAID
                 Avenue Appia 20
                 CH-1211 Geneva 27
                 Switzerland
                 Tel: +41 22 791 5503
                 Fax: +41 22 791 4890
                 e-mail: [email protected]

The World Bank

While recognizing the importance of innovation for improving health care, the World Bank is also cognizant of the financial strain that high-priced innovative technologies place on health systems and citizens in all countries.

Incentivizing innovation through IP protection has been shown to be effective in sustaining funding for innovators of products with significant commercial potential. In order to encourage innovation that benefits the poor, and also in order to make new technologies affordable for them, alternative innovation models as well as options for segmentation of product markets need to be explored.

The World Bank’s key role in the health sector is to assist countries in building stronger health systems, including sustainable mechanisms for financing. As part of that role, the World Bank staff and consultants have published a number of articles and guides designed to assist countries in navigating the complexities of IP rules, for example in procuring medicines for HIV/AIDS. Going forward, it will be important to broaden the discussion beyond the issues surrounding IP protection and to explore alternative incentive models for innovators and public-private partnerships. In addition, it will be important to ensure the implementation of contractual arrangements that improve access to new technologies for commercially marginalized groups without undermining the sustainability of health financing.

Website: www.worldbank.org

                 Contact: The World Bank
                 1818 H Street, NW
                 Washington, DC 20433
                 USA
                 Tel: +1 202 473 1000
                 Fax: +1 202 477 6391

Other international key stakeholders

Bill & Melinda Gates Foundation

The Global Health Program of the Bill & Melinda Gates Foundation harnesses advances in science and technology to save lives in poor countries. It focuses on the health problems that have a major impact in developing countries but get too little attention and funding. Where proven tools exist, the Global Health Program supports sustainable ways to improve their delivery. Where such tools do not exist, it invests in R&D of new interventions, such as vaccines, drugs, and diagnostics. Most of the work of the Global Health Program is done through grants to partners in priority areas of focus, with extensive input from external experts and from the Program’s Global Health advisory panel.

The Global Health Program’s work in the field of infectious diseases focuses on developing ways to fight and prevent enteric and diarrhoeal diseases, HIV/ AIDS, malaria, pneumonia, TB, and neglected and other infectious diseases. It also works on integrated health solutions for family planning, nutrition, maternal, neonatal and child health, tobacco control and vaccine-preventable diseases.

The Bill & Melinda Gates Foundation’s three cross-cutting programmes include:

Discovery: closing gaps in knowledge and science and creating critical platform technologies in areas where current tools are lacking.
Delivery: implementing and scaling up proven approaches by identifying and proactively addressing the obstacles that typically lie in the path of adoption and uptake.
Policy and Advocacy: promoting more and better resources, effective policies, and greater visibility of global health, so as to effectively address the foundation’s priority health targets.

Website: www.gatesfoundation.org/global-health/

Contact: Bill & Melinda Gates Foundation
                 PO Box 23350
                 Seattle, WA 98102
                 Tel: +1 206 709 3100
                 e-mail: [email protected]

Clinton Health Access Initiative

In 2002, the Clinton Health Access Initiative (CHAI) began as the Clinton HIV/AIDS Initiative to address the HIV/ AIDS crisis in the developing world and strengthen health systems there. On 1 January 2010, the CHAI became a separate non-profit organization.

The CHAI currently operates four programme areas: HIV/AIDS; Health Systems; Maternal and Child Health; and Access to Medicines. Through these programmes, the CHAI is saving lives in low- and middle-income countries (LMICs) by helping people gain access to essential medicines and health services. The CHAI works closely with governments and other partners to improve the management and organization of in-country health systems and global commodity markets while addressing key health systems barriers. The CHAI does not implement stand-alone programmes; neither does it create parallel health systems. Rather, at the invitation of individual governments, it works to strengthen and sustain their capacity to provide long-term health care to their citizens.

The CHAI negotiates price reductions for drugs and diagnostics and it also works to increase the quality of these commodities. It reports that more than 70 countries can now avail of lower drug prices as a result of the CHAI’s work with pharmaceutical companies. Moreover, some 3.9 million people – representing almost 70 per cent of people being treated for HIV/AIDS globally – have benefited from lower prices for HIV/AIDS medicines The CHAI has helped countries save more than US$ 1 billion by reducing the price of some drugs by 60 per cent to 90 per cent between 2008 and 2011.

Website: www.clintonhealthaccess.org

Contact: Clinton Health Access Initiative
                 383 Dorchester Avenue
                 Suite 400
                 Boston, MA 02127
                 USA
                 e-mail: [email protected]

The COHRED Group

The COHRED Group is an international non-governmental organization (NGO) established following the merger in March 2011 of the Council on Health Research for Development (COHRED) with the Global Forum for Health Research.

The COHRED Group believes that research and innovation are key drivers for development and the improvement of people’s health. Sustainable development in LMICs is only possible where governments recognize the importance of fostering an environment where research and innovation are valued and can prosper.

COHRED was established in 1993, and has focused on strengthening the governance, management and systems of LMICs to use research, science and technology and innovation to improve health, equity and development. The Global Forum for Heath Research has provided a key focal point for debate on the role of research in the improvement of health in LMICs, organizing 13 global meetings between 1997 and 2010 alone.

The COHRED Group is actively engaged in discussions around the interaction between public health, IP and trade. Key examples include:

Strengthening pharmaceutical innovation in Africa: in partnership with the New Partnership for African Development (NEPAD) and the African Union, the COHRED Group is developing a framework through which LMIC governments can understand the benefits of pharmaceutical innovation, and design effective national innovation strategies.²¹
Supporting the implementation of the GSPA-PHI: in collaboration with the WHO , the COHRED Group is developing a monitoring and evaluation platform to track global progress towards achieving the GSPAPHI indicators.²²
The Global Forum for Health Research: Forum 2012 marks the first in a new series of Global Forum for Health Research meetings. It focused on moving “beyond aid” – achieving health, equity and development through research and innovation. This will include looking at important framework conditions, such as IP.²³

Website: www.cohred.org

Contact: COHRED group
                 Route des Morillons 1-6
                 1211 Geneva
                 PO Box 2100
                 Switzerland
                 Tel: +41 22 591 8900
                 e-mail: [email protected]

Drugs for Neglected Diseases initiative

The Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit R&D organization.²⁴ It was established in 2003 by Médecins Sans Frontières, the Indian Council for Medical Research, the Oswaldo Cruz Foundation in Brazil, the Kenya Medical Research Institute, the Ministry of Health of Malaysia, and the Pasteur Institute in France, with the Special Programme for Research and Training in Tropical Diseases (WHO-TDR) as a permanent observer. It aims at bridging gaps in existing R&D in essential drugs for neglected diseases through collaboration with public and private sector entities.²⁵ For this purpose, it identifies significant unmet medical needs, R&D opportunities such as candidate compounds and improved formulations to address these needs, possible organizations to partner with in the R&D process, as well as adequate funding sources. DNDi is dedicated to developing new, .field-adapted treatments for neglected tropical diseases, such as African sleeping sickness, Chagas disease and visceral leishmaniasis.²⁶ Malaria was also an early focus of DNDi, and new R&D programmes for pediatric HIV²⁷ and specific helminth infections²⁸ were added in 2011. Thus far, DNDi has delivered five new treatments that are safe, effective, field-adapted and affordable.²⁹

DNDi regards drug research as a public good that should, primarily lead to the advancement of health. As such, DNDi’s mission is also to make research outputs available through open access scientific databases in order to further facilitate and stimulate neglected diseases R&D. In 2011, DNDi published more than 20 pre-clinical datasets related to fexinidazole (a clinical candidate for the treatment of human African trypanosomiasis) on the Public Library of Science-Neglected Tropical Diseases (PLoSNTD) website. DNDi also provided raw data to WIPO Re:Search.

DNDi’s approach to IP is characterized by two major guiding principles: (i) to ensure that drugs developed by DNDi are affordable and that access is equitable for patients who need them; (ii) to develop these drugs as public goods whenever possible.³⁰ Negotiations regarding ownership of patents and licensing terms are therefore made on a case-by-case basis in order to guarantee the best possible conditions for patients. Depending on the status of any IP that predates DNDi partnership agreements, the IP generated in collaboration with DNDi may be individually or jointly owned by DNDi and/or its partners. If DNDi does not own the IP, it secures non-exclusive, sub-licensable, royalty-free licences on the pre-existing IP and the newly-generated IP, in order to retain control of the outcome of the joint research in the field of neglected diseases. Such non-exclusive licences provide DNDi with the freedom to coordinate R&D and manufacturing activities globally with third parties on a sustainable basis, should any partner discontinue its collaboration with DNDi.

Website: www.dndi.org

Contact: DNDi
                 Chemin Louis-Dunant 15
                 1202 Geneva
                 Switzerland
                 Tel: +41 22 906 9230
                 e-mail: [email protected]

Health Action International

Health Action International (HAI) is a Dutch civil society NGO, with a coordinating office (HAI Global) in Amsterdam and partner regional offices in Africa (Nairobi), Asia-Pacific (Penang), Latin America (Lima) and Europe (Amsterdam). Recognized globally for its medicines policy expertise, it is a non-profit, independent, worldwide network of over 270 members, including consumer groups, public interest NGOs, health care providers, academics, media and individuals in more than 70 countries. Due to the HAI’s work on access to essential medicines, including price, affordability, availability, quality, safety, efficacy and the rational use of medicines, it is in a position to make a valuable contribution to the trade, health and innovation debate.

The HAI Medicines, Access Trade & Health (MATH) programme was established in 2008 and is coordinated by HAI Europe. The programme has both facilitated and strengthened a global expert civil society dialogue on trade and health issues between the five HAI regions. An analysis of EU and US trade policy and the global importance of IP protection and enforcement suggest that civil society organizations such as the HAI should play a bigger role in international trade negotiations.

The HAI also works towards the exploration and implementation of new models of innovation, engaging in discussions at the WHO and at regional and national levels. Together with other organisations, the HAI has been supporting the exploration of an essential health and biomedical R&D treaty, in order to ensure needs-driven and accessible innovation.

Website: www.haiweb.org

Contact: HAI Global
     Overtoom 60/II
     1054 HK Amsterdam
     The Netherlands
     Tel: +31 20 683 3684
     Fax: +31 20 685 5002
     e-mail: [email protected]

International Centre for Trade and Sustainable Development

Founded in Geneva in September 1996, the International Centre for Trade and Sustainable Development (ICTSD) aims to influence the international trade system such that it advances the goal of sustainable development. The ICTSD promotes the use and management of knowledge and technology conducive to sustainable development, in the context of balanced and development-oriented IP regimes. Its programme activities focus on: facilitating pro-development and pro-competitive outcomes in international IP and trade negotiations; helping to implement IP norms that balance private rights and public interests; maximizing incentives for innovation, creativity and technology transfer to developing countries; and promoting greater integration between IP, technology transfer, foreign direct investment and competition policies. The IPRsonline.org internet portal offers a useful source of information regarding further resources, documents and news on IPRs and sustainable development.³¹

More specifically, in the context of the relationship between IPRs and public health, the ICTSD cooperates closely with key stakeholders, in particular UNCTAD and the WHO. Relevant activities have focused on identifying options for the use of public health-related TRIPS flexibilities by developing countries. Such activities have included: publication of the Resource Book on TRIPS and Development,³² a comprehensive guide to the TRIPS Agreement from a development and public policy perspective which was co-published with UNCTAD; guidelines for the examination of pharmaceutical patents to support the development of a public health perspective through improved transparency and efficiency of patentability examination of pharmaceutical inventions, which was co-published with UNCTAD and the WHO³³; and a policy guide on public health-related TRIPS-plus provisions in bilateral trade agreements for negotiators and implementers in the WHO Eastern Mediterranean region, co-published with the WHO Regional Office for the Eastern Mediterranean.³⁴ Technology transfer, including as a means to support local production of pharmaceuticals in developing countries, has also been dealt with comprehensively by the ICTSD, in particular in the context of a joint project with the WHO and UNCTAD.³⁵ In addition, the ICTSD has undertaken extensive policy-oriented research on a variety of issues relevant to the relationship between IPRs and public health, such as an analysis of IP technical assistance and capacity-building, as well as an analysis of bilateral and regional trade agreements. In this regard, it has commissioned and published two major country studies on the impact of TRIPS-plus standards in FTAs on the prices of medicines in Central America.

Website: www.ictsd.org

Contact: ICTSD
     International Environment House 2
     Chemin de Balexert 7
     1219 Châtelaine
     Geneva
     Switzerland
     Tel: +41 22 917 8492
     e-mail: [email protected]

International Federation of Pharmaceutical Manufacturers & Associations

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) was founded in 1968 as a global, non-profit NGO representing the research-based pharmaceutical industry, including the biotechnology and vaccine sectors. The primary role of the IFPMA is to represent its members’ views in dialogue with intergovernmental organizations, with diplomatic missions of national governments and with specialized NGOs. The IFPMA participates in meetings organized by international organizations, such as the WHO and WIPO. It also participates in technical cooperation activities organized by the WTO.

The mission of the IFPMA is to advocate policies that encourage discovery of, and access to, life-saving and life-enhancing medicines to improve the health of people everywhere. To fulfill its mission, the IFPMA follows a number of guiding principles, including encouraging a global policy environment that is conducive to medicines innovation, both therapeutic and preventive, for the benefit of people around the world. For this purpose, effective IP systems in both developed and emerging developing countries, supported by sound regulatory processes and health care financing, are regarded as a key enabling factor to encourage innovation and manage the resulting IPRs. IFPMA member companies and associations also cooperate closely with country authorities to combat counterfeit medicines. The promotion of high standards of manufacturing practices and quality assurance for pharmaceutical products is another key IFPMA objective.

A number of IFPMA-sponsored projects provide detailed information on the research-based pharmaceutical industry’s activities, with a special focus on global public health. The IFPMA Developing World Health Partnerships Directory lists the research-based pharmaceutical industry’s long-term partnership programmes aimed at helping to achieve the MDGs and improve other aspects of global health. The directory is searchable by country, by disease, by programme type and by partner organization.³⁶ Dedicated events and public health-related material on the IFPMA website provide, among others, information relating to clinical trials, vaccines, biotech medicines and ethical marketing.

Website: www.ifpma.org

Contact: IFPMA
     Chemin Louis-Dunant 15
     PO BOX 195
     1211 Geneva 20
     Switzerland
     Tel: +41 22 338 3200
     Fax: +41 22 338 3299
     e-mail: [email protected]

International Generic Pharmaceutical Alliance

The International Generic Pharmaceutical Alliance (IGPA) is an informal network of five national/regional associations of generic medicines manufacturers from Canada (CGPA), Europe (EGA), USA (GPhA), Japan (JGA) and South Africa (NAPM), with three observer associations. The IGPA represents the generic industry in relations with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the WTO, WIPO, the WHO and other international organizations. The IGPA Science Committee has worked with various international institutions to encourage the adoption of high quality standards for generic medicines, including the application of good manufacturing practices (GMP) standards and bioequivalence studies. The IGPA Intellectual Property Committee is responsible for reviewing relevant IP issues and formulating positions. One of the objectives of the IGPA is to promote affordable access to high-quality medicines, including biosimilars. In line with this objective, it provides guidance on regulatory matters relating to the registration and marketing of generic medicines. It also supports policies that cultivate both innovation and competition in pharmaceutical markets.

The IGPA advocates a balanced approach to IP, taking into account different national health care priorities and IP systems, as well as the flexibilities provided in the TRIPS Agreement. Unwarranted periods of IP protection prevent the dissemination of established knowledge in the public domain and hinder the progress of technology.

It has expressed strong concerns about the evergreening of patents and has advised countries to resist the inclusion of TRIPS-plus provisions in FTAs. Further, the IGPA contends that the Paragraph 6 System is cumbersome, and is lacking any practical applicability. It supports the flexibilities provided in the exception clause in Article 30 of the TRIPS Agreement, which it views as being applicable to situations identified in paragraph 6 of the Doha Declaration. In addition, because of its strong interest in the production of quality medicines, the IGPA has lent its support to the implementation of strict and effective controls of production and trade in medicines, in order to avoid the proliferation of counterfeit versions of both originator and generic products.

Website: http://198.170.119.137/igpa.htm

Contact: For IGPA Members and Contact information

see the website above.

Knowledge Ecology International

Knowledge Ecology International (KEI) is a not-for-profit NGO that searches for better outcomes, including new solutions, to the management of knowledge resources. The KEI focuses on the human rights dimension of IP and innovation policy, and the protection of consumer interests.

Since the 1990s, the KEI (formerly known as the Consumer Project on Technology) has been involved in discussions about norms and practices relating to IP and innovation. Issues addressed in these discussions have included the following: the role of public sector R&D; the use of compulsory licences; the control of anti-competitive practices; the collective management of IPRs (including the UNITAID-sponsored Medicines Patent Pool); the exhaustion of rights and other limitations and exceptions to patent rights (including those relevant to the enforcement of rights in Part III of the TRIPS Agreement); pricing of medical technologies; the global trade framework for both IP and medicine pricing.

The KEI has been very active in efforts to explore alternative incentive systems for R&D that delink R&D incentives from medicine prices, such as through the use of prize funds, the implementation of the “open source dividend”, the consideration of a medical R&D treaty (a public health paradigm to support global funding of R&D), and a new WTO agreement on the supply of public goods.

Website: www.keionline.org

Contact: Knowledge Ecology International
     1621 Connecticut Ave, NW, Suite 500
     Washington, DC 20009
     USA
     Tel: +1 202 332 2670
     e-mail: [email protected]

     Route des Morillons 1
     1211 Geneva 2
     Switzerland
     Tel: +41 22 791 6727
     e-mail: [email protected]

Medicines Patent Pool Foundation

Established in 2010 with the support of UNITAID, the Medicines Patent Pool (“the Pool”) aims to improve the health of people living in LMICs by increasing access to quality, safe, efficacious, appropriate and affordable ARV medicines, with a special focus on HIV/AIDS. For this purpose, the Pool negotiates with patent holders – companies, researchers, universities and governments – to share their IP. The Pool makes licences available on a non-exclusive and non-discriminatory basis to other producers. The easier availability of needed licences will result in facilitating the production of affordable generic medicines and the development of adapted formulations of HIV/AIDS medicines, such as heat-stable or pediatric formulations, which are needed in target countries.

The Pool is a voluntary mechanism. It operates within the current IP framework and provides a collaborative platform for all parties involved. In this way, patent holders receive royalties for sharing their patents; generic drug manufacturers obtain access to broader markets; and, most importantly, people living with HIV/AIDS will have expanded access to affordable, appropriate medicines.

The Pool has amassed a large database of patent information related to critical medicines for the treatment of HIV/AIDS and. It has decided to make this information publicly available, so that others can benefit from it and add to it. The database contains information on the patent status of selected ARVs in a large number of LMICs. It is searchable by country/region and by medicine.

Website: www.medicinespatentpool.org

Contact: Medicines Patent Pool
                 Route de Ferney 150
                 P.O. Box 2100
                 1211 Geneva 2
                 Tel: +41 22 791 6304
                 e-mail: [email protected]

Médecins Sans Frontières

Médecins Sans Frontières (MSF) is an international, independent, medical humanitarian organization that delivers emergency aid to people affected by armed conflict, epidemics, natural disasters and exclusion from health care. It was founded in 1971 and currently works in more than 60 countries, providing high-quality care to those in need.

MSF’s actions are guided by medical ethics and the principles of neutrality and impartiality. Since it was founded, it has been an active advocate for improved medical treatments and protocols. It has drawn attention to neglected health crises as well as to challenges of the aid system.

In 1999, MSF established the Campaign for Access to Essential Medicines as a response to the growing frustration of MSF volunteers who were experiencing difficulties in providing treatment for patients because the medicines and diagnostic tools they needed were unavailable, unaffordable or unsuitable. The objective of the campaign is to improve access to existing medical technologies (medicines, diagnostics and vaccines) and to stimulate the development of new medical tools that have, or could have, a major impact on morbidity and mortality. As part of this campaign, MSF has encouraged countries to make use of flexibilities in international trade rules to facilitate access to patented medicines. Along with a number of other organizations, MSF played an important advocacy role in the lead-up to the Doha Declaration.

The current key priority areas of the campaign include improving: the availability and affordability of HIV and TB treatment options; promoting the change to improved treatment guidelines for severe malaria; improving the quality of food aid to meet the nutritional needs of growing children; and campaigning for improved, more affordable, more suitable versions of existing vaccines and the development of new vaccines to address the needs of developing countries. In addition, MSF advocates for fundamental changes to the framework for stimulating medical innovations, so that it is driven by health needs rather than by profits. For this purpose, it supports delinking R&D costs from the price of the resulting medical innovation. MSF regularly publishes a guide to the prices of ARVs entitled Untangling the Web of Antiretroviral Price Reductions. It includes information on the evolution in price for each ARV over time, charting the difference between the originator price and the prices available from generic producers for developing countries.³⁷

MSF has been very active in the discussions on the seizure of medicines in transit in the European Union to developing countries for alleged patent infringement. In addition, it has repeatedly urged pharmaceutical companies to participate in the Medicines Patent Pool.

Website: www.msfaccess.org

Contact: MSF Campaign for Access to Essential
     Medicines
     Rue de Lausanne 78
     Mailbox 116
     1211 Genève 21
     Switzerland
     Tel: +41 22 849 8405
     Fax: +41 22 849 8404
     e-mail: [email protected]

Oxfam

Oxfam is an international confederation of 17 organizations working together in 90 countries and with partners and allies around the world to find lasting solutions to poverty and injustice. It believes that all people should have access to health services, including HIV services, free at the point of use. This includes meeting needs for water and sanitation and hygiene promotion (WASH) in crises, supporting rights holders to campaign for the provision of essential services, and holding governments to account to meet the needs of people in poverty.

Oxfam has worked with other civil society organizations to ensure that IP rules do not create barriers to access to affordable medicines. It has called for new approaches to innovation to stimulate innovation for medicines, vaccines and diagnostics for diseases that disproportionately affect poor people in developing countries. In addition, it has called for increased innovation and access to medicines through engagement in key multilateral, rules-setting bodies – especially the WTO and the WHO. It has engaged with other organizations on this issue – in particular organizations that purchase significant quantities of medicines and vaccines on behalf of LMICs. Oxfam thus works with a number of global institutions involved in health, in particular the World Bank, the GAVI Alliance, the Global Fund, UNITAID and the WHO. Through research and advocacy at global and national levels, it seeks to influence the policies and practices of these institutions, so that they ensure improved access to health care and medicines for poor people

Oxfam works with civil society organizations around the world to ensure that governments fully respect key safeguards and flexibilities in the TRIPS Agreement and the Doha Declaration. This involves lobbying developed countries – the European Union and the United States in particular – to not introduce TRIPS-plus rules through bilateral and regional trade agreements, including, but not limited to, the Anti-Counterfeiting Trade Agreement, and to not punish developing countries that make legal use of TRIPS safeguards and flexibilities to promote and protect public health. Oxfam also lobbies developing countries to not introduce TRIPS-plus rules that will undermine efforts to improve access to medicines. It encourages LMICs to incorporate safeguards and flexibilities into national legislation and to utilize these safeguards to ensure affordable medicine prices.

Oxfam lobbies multinational pharmaceutical companies, and their shareholders, to encourage these companies to adopt changes to their business models. Such changes would see access to medicines placed at the heart of their business models. Additionally, major companies would be benchmarked on their approaches to IP, pricing and R&D.

Website: www.oxfam.org/en/campaigns/healtheducation/health

Contact: Oxfam International Secretariat
                 266 Banbury Road
                 Oxford OX2 7DL
                 United Kingdom
                 Tel: +44 1865 339 100
                 Fax: +44 1865 339 101

Third World Network

The Third World Network (TWN) is an independent nonprofit international NGO involved in issues relating to development, developing countries and North–South affairs. It aims to deepen the understanding of the development dilemmas and challenges facing developing countries and to contribute to policy changes in pursuit of just, equitable and ecologically sustainable development. It also works to bring about a greater articulation of the needs and rights of peoples in the South.

A key focus of the work of the TWN work is on IP and public health, particularly with regard to access to medicines. The objective is to ensure that IP rules and standards do not undermine public health and, in particular, do not undermine access to affordable medicines in developing countries. For this purpose, the TWN carries out research, engages in advocacy and provides technical assistance and support for capacity-building, aimed at enhancing the use of TRIPS flexibilities in developing countries in order to protect public health.

The TWN broadly represents developing countries’ interests and perspectives at international forums and conferences, in discussions with UN agencies, and also in discussions with WIPO, the WHO and the WTO. The TWN actively monitors international negotiations on IP and public health that take place in the WTO, WIPO and the WHO.

Website: www.twnside.org.sg

Contact: Third World Network - International
                 Secretariat
                 131 Jalan Macalister
                 10400 Penang
                 Malaysia
                 Tel: +60 4 226 6728/226 6159
                 Fax: +60 4 226 4505
                 Rue de Lausanne 36
                 1201 Geneva
                 Switzerland
                 Tel: +41 22 908 3550
                 Fax: +41 22 908 3551

See www.theglobalfund.org/en/procurement/pqr/. back to text

General Assembly resolution A/RES/60/251 of 3 April 2006. back to text

Particularly relevant for this study is the mandate of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health (right to health), which was established by the Commission on Human Rights in April 2002 by Resolution 2002/31. back to text

UN document A/63/263, Annex. back to text

UN document A/HRC/11/12. back to text

UN document A/HRC/17/43. back to text

UN document A/HRC/RES/17/14. back to text

For the final reports of the high-level task force on the implementation of the right to development, see UN documents A/HRC/15/WG.2/TF/2 and Add. 1 and 2. back to text

See “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” (Article 12) and General Comment 14 as well as “the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author” (Article 15.1(c)) and General Comment 17. back to text

See www.unaids.org/en/media/unaids/ contentassets/documents/unaidspublication/2011/ JC2049_PolicyBrief_TRIPS_en.pdf. back to text

See www.iprsonline.org/unctadictsd/ResourceBookIndex.htm. back to text

For Uganda, see www.unctad.org/en/docs/ diaepcb200913_en.pdf. back to text

See UN document TD/B/COM.2/L.22 and www.unctad.org/Templates/Page.asp?intItemID=4567&lang=1. back to text

See www.unctad.org/en/docs/diaepcb2009d19_en.pdf. back to text

See www.unctad.org/templates/Download.asp?docid=14956& lang=1&intItemID=2068. back to text

See http://unctad.org/en/PublicationsLibrary/ diaepcb2011d7_en.pdf. back to text

See www.unaids.org/en/media/unaids/ contentassets/documents/unaidspublication/2011/ JC2049_PolicyBrief_TRIPS_en.pdf. back to text

See www.who.int/medicines/publications/ ModelQualityAssurance.pdf. back to text

See www.who.int/hiv/amds/gprm/en/ back to text

Available at www.unicef.org/supply/index_57476.html. back to text

See www.cohred.org/pharmainnovation. back to text