Access to Medicines in the Context of the Right to Health

©UN Photo/Albert González Farran

Access to Medicines in the context of the Right to Health

Access to Medicines in the context of the Right to Health Summary The present report contains a summary of discussions and recommendations of the 2015 Social Forum. In accordance with Human Rights Council resolution 26/28, the Forum was held in Geneva from 18 to 20 February 2015, and focused on access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, including best practices in that regard. © point-of-views.ch © point-of-views.ch Contents paragraphs page

I. Introduction 1–3 4

II. Opening of the Social Forum 4–6 5

III. Summary of proceedings 7–58 7

A. Keynote speakers and general statements 7–10 7

B. Overview of access to medicines in the context of the right to health 11–15 9

C. Improving health delivery systems in challenging contexts 16–20 10

D. Access to medicines for women and children 21–25 12

E. Intellectual property rights and access to medicines 26–30 13

F. Lessons learned and emerging challenges in the global response to AIDS 31–35 15

G. Patient-centred approaches to access to medicines 36–41 16

H. Breakout discussion groups and plenary discussion 42–43 18

I. Innovative approaches to promoting access to medicines 44–49 19

J. Good practices in promoting access to medicines (round table) 50–58 20

IV. Conclusions and recommendations 59–74 26

A. Conclusions 60–66 26

B. Recommendations 67–74 27

The full report with the annexes and other supporting documents is available at http://www.ohchr.org/EN/Issues/Poverty/SForum/Pages/SForum2015.aspx Access to Medicines in the context of the Right to Health

considered access to medicines in the context of the I. Introduction right of everyone to the enjoyment of the highest 1. The Human Rights Council, in its resolution attainable standard of physical and mental health, 6/13, preserved the Social Forum as a unique including best practices in that regard. The President space for interactive dialogue between the United of the Council appointed Faisal bin Abdulla al- Nations human rights machinery and a variety of Henzab, Ambassador and Permanent Representative relevant stakeholders, underlining the importance of Qatar to the United Nations Ofﬁce at Geneva, as of coordinated efforts at the national, regional the Chairperson-Rapporteur of the Forum. and international levels for the promotion of social 3. The programme of work2 was prepared under cohesion based on the principles of social justice, the guidance of the Chairperson, with inputs from equity and solidarity; to address the social dimension relevant stakeholders. Pursuant to Human Rights and challenges of globalization; and issues linked Council resolution 26/28, paragraph 8, background with the national and international environment reports made available by the Ofﬁce of the United required for the promotion of the enjoyment of all Nations High Commissioner for Human Rights human rights by all.1 (OHCHR) informed the discussions (A/HRC/23/42, 2. In accordance with Human Rights Council A/HRC/17/43 and A/HRC/11/12). The present resolution 26/28, the Social Forum was held report contains a summary of the proceedings as in Geneva from 18 to 20 February 2015 and well as conclusions and recommendations.

1 For further details on the Social Forum, see www.ohchr.org/ 2 Available from www.ohchr.org/Documents/Issues/SForum/ EN/issues/poverty/sforum/pages/sforumindex.aspx. SForum2015/PoW.pdf.

4 © point-of-views.ch advocated that the agenda be underpinned by II. Opening of the Social human rights law, which obliged States to respect, Forum protect and fulfil the right to health. The International Covenant on Economic, Social and Cultural Rights 4. In his opening remarks, the Chairperson- required States to take steps, to the maximum of Rapporteur of the Social Forum called on their available resources, towards realization of the participants to identify and promote concrete, right to health, prohibited retrogressive measures, progressive and action-oriented approaches to and required immediate fulfilment of minimum improve access to medicines. Noting the particular core obligations. According to the Committee on significance of that issue to the State and people Economic, Social and Cultural Rights, access to of Qatar, he advocated greater international medicines was a core obligation. Medicines must be cooperation to guarantee access to medicines, which affordable, acceptable, accessible, of good quality, was critical for health, well-being and development and made available without discrimination. Yet, for all and a matter of social justice. Therefore 2 billion men, women and children had no access inequities, including high costs borne by patients to essential medicines. Ms. Connors called on the in many low and middle-income countries, must be international community to take immediate steps to eliminated. To that end, the international community rectify that tragedy, including by building production should support innovation and local production, use capacity in developing countries, allowing access of flexibilities under the Agreement on Trade-Related to generic drugs and enhancing research and Aspects of Intellectual Property Rights (TRIPS), policy development relating to treatment for neglected coherence among human rights obligations and diseases. international trade and investment regimes, and 6. Joachim Rücker, President of the Human Rights active engagement of all stakeholders, including the Council, affirmed his support for the Social Forum as private sector, to save the lives of millions who do a subsidiary body of the Council, bringing together not have access to medicines. multiple stakeholders including Member States, civil 5. Jane Connors, Director of the Research and society and others. The Forum provided a unique Right to Development Division, OHCHR, described space enabling constructive engagement to discuss access to medicines as a critical and timely issue, practical solutions to real life problems including at particularly in the light of the emerging post-2015 the grass-roots level. He called for immediate action development agenda. OHCHR had consistently to strengthen health systems, establish universal

5 Access to Medicines in the context of the Right to Health

BILLION PEOPLE

NO A VE CCE HA SS

TO ESSENTIAL MEDICINES

World Health Organization, Medicines strategy: countries at the core, 2004-2007 (Geneva, WHO, 2004)

6 health coverage and ensure access to safe and rural setting. She advocated a holistic approach to efficacious medicines. Recent tragedies, like the health-care delivery by improving access to clinics Ebola outbreak in West Africa, illustrated the need (roads and infrastructure), training medical personnel for immediate measures to strengthen health systems and building health facilities. The Foundation also with rights-based solutions that affirmed peoples’ developed the skills of grass-roots communities. dignity and ensured their well-being. In moving The Hawa Abdi Village that had grown around forward, including on access to medicines in the the clinic represented a bastion of security and post-2015 development agenda, respect for human community. While international non-governmental rights must be the ultimate foundation upon which organizations contributed to programmes, their roles rested the legitimacy of the actions of governments, were often temporary, leaving a vacuum following international institutions and corporations. their departure. Support was required to establish a functioning public health system, including through training community health workers and improved 3 III. Summary of proceedings use of technology. Mobile phones, for example, could facilitate communication between patients A. KEYNOTE SPEAKERS AND GENERAL STATEMENTS and health personnel, where physical access was 7. Deqo Mohamed, Chief Executive Officer of the difficult. A renewed focus on sustaining access to Dr. Hawa Abdi Foundation in Somalia, described medicines was needed, including by empowering its work. With limited resources, it had provided people through education designed to promote their health care to over a million people in a war-torn, independence. 8. Jorge Bermudez, Vice-President of Health Production and Innovation, Fundação Oswaldo 3 Statements and presentations made available to the Secretariat are available from www.ohchr.org/EN/Issues/ Cruz, Ministry of Health, Brazil, discussed the impact Poverty/SForum/Pages/StatementSForum2015.aspx. of international trade agreements on access to

World Health Organization, Medicines strategy: countries at the core, 2004-2007 (Geneva, WHO, 2004)

7 © UN Photo/Tobin Jones © UN Photo/Tobin Access to Medicines in the context of the Right to Health © ILO/M. Crozet

8 © ILO/M. Crozet

medicines and the need to integrate right to health States highlighted measures at the national level considerations in negotiations. The TRIPS Agreement for ensuring access to medicines. They emphasized should not impede the realization of the right to that health concerns must prevail over intellectual health. In its negotiations, Brazil advocated measures property rights and commercial interests and called to uphold the right to health. It had explicitly for flexibility in the TRIPS Agreement. Other issues embraced that right in its domestic laws and raised included: quality of medicines; production policies, including by guaranteeing universal access of generics; supporting local capacity; inequality to health care and linking health and development. between States and the resulting impact on access; Brazil had used public-private partnerships to mental health; overprescription; international reduce medicine costs and develop local expertise. cooperation; public-private partnerships; benefits of It had also employed price regulation, essential healthy populations to development; links between medicines lists and other domestic policies. Those health costs and poverty; investment and innovation; efforts had resulted in substantially lower prices for mobilizing resources to combat disease in antiretroviral therapies. Nevertheless, affordability developing countries; medication for children; youth remained a major problem. He called for national, participation in relevant discussions; black markets; regional and global action to address the human health-care laws and policies. rights implications of the intellectual property regime, including expansion of TRIPS flexibilities, B. OVERVIEW OF ACCESS TO MEDICINES IN THE increased use of voluntary licensing mechanisms and CONTEXT OF THE RIGHT TO HEALTH international support to promote progress towards 11. Martin Khor, Executive Director of the trade agreements that improved access. South Centre, described access to medicines as 9. Stephen Lewis, Co-Director of AIDS- a cornerstone of the enjoyment of the rights to Free World, discussed affordability and the health and life. Key barriers included investment responsibilities of pharmaceutical companies. treaties and regional agreements limiting TRIPS He decried a system that allowed companies to flexibilities, reduced government revenues owing to charge tens of thousands of dollars for treatment economic situations, and conditions that prevented with a production cost of only around 100 dollars, the establishment and continued functioning of wherein companies intensively lobbied governments generic companies. To address those challenges, to protect the status quo. Emphatic that balance he suggested: (a) promoting the use of TRIPS sheets must not be prioritized over human lives, flexibilities; (b) renewing TRIPS exceptions for least Mr. Lewis recalled the recommendation of the Global developed countries for as long as they retained that Commission on HIV and the Law to convene a status; (c) permitting TRIPS exceptions for middle- neutral high-level body to develop a new intellectual income countries; (d) amending investment treaties property regime for pharmaceutical products, that threatened the right to health; (e) eliminating and to place a moratorium on patent protection TRIPS-plus provisions and other clauses in free- of medicines in future free-trade agreements. He trade agreements that might jeopardize access proposed five steps to increase access to medicines: to medicines and the right to health; (f) protecting (a) use the proposed sustainable development goals, public health services even in times of economic especially goal 3.8, to put pressure on governments; crisis; (g) building capacity to produce generic (b) litigate against pharmaceutical companies; medicines; (h) promoting universal access to (c) integrate right to health considerations in trade newly developed medicines; (i) prioritizing negotiations; (d) form alliances to raise awareness development of medicines for drug-resistant diseases; of cost and accessibility issues; (e) support OHCHR (j) promoting publicly funded and shared research in its efforts to encourage governments to fund and development; (k) providing financial and health care. technological assistance to developing countries. 10. In the general statements segment, 12. Zafar Mirza, Coordinator, Public Health, representatives of Brazil, Chile, China, Colombia, Innovation and Intellectual Property, Department of Cuba, India, Pakistan, South Africa, Sri Lanka, Essential Medicines and Health Products, World Thailand, the Bolivarian Republic of Venezuela, Health Organization (WHO), presented an overview the Holy See, the Ariel Foundation International of the WHO work on access to medicines which and Autistic Minority International intervened. was one of its six leadership priorities. Access to

9 Access to Medicines in the context of the Right to Health

medicines could be rendered sustainable in the 15. In response, the Special Rapporteur on the context of universal health coverage and functioning right of everyone to the enjoyment of the highest health systems. It was an unequivocal part of the attainable standard of health observed that there human right to health and a complex issue involving were many lessons to learn from the Ebola crisis. He multiple stakeholders, determinants and perspectives. called for improved response systems, mobilization WHO strived to promote universal access to safe, of additional resources, and improved health systems effective and high quality medicines that were and infrastructure to prevent crises. Dr. Mirza prescribed and used rationally, and monitored clarified the fact that the challenges in access to by appropriate regulatory mechanisms. Access patented and generic drugs were the same, but to existing medicines (generic and patent) should that the high prices of patented drugs posed an be improved and research and development for additional challenge. He suggested a broader new essential medicines should focus on improving approach going beyond a focus on patented drugs health outcomes, not only returns on investment. The and market failures, to also recognize failures in medical needs of the most vulnerable must be met. public policy. Speaking on behalf of Mr. Khor, Litigation on the right to health promoted access to Germán Velásquez, Special Adviser for Health and medicines. Development at the South Centre, suggested that WHO employ article 19 of its Constitution to make 13. Dainius Pūras, Special Rapporteur on the right binding decisions and deliver justice in access to of everyone to the enjoyment of the highest attainable medicines. standard of health, denounced widespread and crippling inequalities in access to health services C. IMPROVING HEALTH DELIVERY SYSTEMS IN and medicines that had left 2 billion people without CHALLENGING CONTEXTS access to the health products they needed. Ill health was both a cause and consequence of poverty and 16. Abdul Majeed Siddiqi, Head of Mission, access to medicines was a particularly pertinent HealthNet TPO, Afghanistan, discussed mental problem in the developing world. States must ensure health treatment in fragile States. In Afghanistan, the that medicines were affordable and accessible on work of HealthNet TPO since 2000 had included a non-discriminatory basis. That required improved efforts to integrate mental health services in the procurement and distribution globally, especially in health systems of 15 provinces on the basis of developing countries. Research and development in fact-finding, education and training, and policy medicines for neglected diseases must be improved. advocacy. However, approximately half the Afghan Although States had the primary responsibility for population suffered from mental health problems, ensuring access to medicines, including through compared with 20 per cent in other developing domestic health policies, intellectual property laws countries, and only 2 per cent sought treatment. and donor country policies could also have major Additional challenges in Afghanistan included: impacts. He discussed problems of medicine overuse stigmatization of mental health patients; unequal and misuse especially in relation to mental illness. integration of mental health services in primary and Prescription of medicines, particularly psychotropic secondary health care; lack of quality referral health medicines, should be part of a holistic approach to care, funding and prioritization by the Government treatment. and donors; staff capacity, supply of medicines in health facilities, quality of medicines and 14. During the interactive dialogue, representatives compliance. of India, the Indian Council of South America, the International Association for Hospice and Palliative 17. Msgr. Robert J. Vitillo, Head, Caritas Care and Rencontre africaine pour la défense des Internationalis, Geneva, while acknowledging the droits de l’homme took the floor. The speakers role of States, pointed to the complementary role in highlighted issues such as lack of access to effective health crises of various stakeholders including faith- pain relief medicines, the slow response to the Ebola based organizations. Following the Ebola outbreak, crisis, the failure of the intellectual property regime while governments and international organizations to protect traditional knowledge from exploitation by struggled to respond, organizations like Caritas had pharmaceutical companies, and differences between acted immediately at the local, national, regional challenges relating to access to patented and and international levels. They strengthened and generic drugs. maintained support provided by local Catholic

10 health services and mobilized international neglected in challenging contexts, for example, volunteers, working with local communities. Faith- Ebola treatment units had no facilities designed based organizations were particularly well placed for childbirth. However, increased cooperation to ensure that human dignity was upheld in all between governments, international medical teams circumstances, and to provide local communities and non-governmental organizations working with material, pastoral and spiritual support that with local communities could support better health complemented medical support from health-service outcomes. Mr. Daher noted that many health- providers. care professionals in Gaza had not received their

18. Mahmoud Daher, Head, WHO Gaza sub- office for the occupied Palestinian territories, explained how since 1967 military occupation had GAZA impeded development in the region, weakening all over the past aspects of development for 4.2 million Palestinians and adversely affecting health systems. In Gaza, 30 YEARS multiple external and internal factors had caused chronic shortages in essential medicines averaging 30 per cent over the past five years, and, averaging -30% 50 per cent in disposable medical supplies. ESSENTIAL MEDICINES Unreliable fuel supplies and inadequate equipment and financial resources also posed obstacles to health services delivery, especially in Gaza. He noted that the Palestinian health sector would continue to suffer until the structural causes of those deficiencies were addressed and barriers were -50% removed to control over resources and planning, to DISPOSABLE MEDICAL SUPPLIES economic and educational opportunities and to self- determination.

19. During the interactive dialogue, interventions salaries for over a year, causing serious strains on were made by representatives of the Congo, the system. Dr. Siddiqi stated that donors adopted Associazione Comunità Papa Giovanni XXIII, the different approaches, but that there had been some China Medical Association, Health Innovation in recent success in streamlining and improving the Practice, New Generation Ishaka, the People’s effectiveness of international assistance to improve Health Movement, and by Dr. Bermudez and access to essential medicines in challenging contexts. Raffaela Schiavon, General Director, Ipas Mexico. Panellists agreed on the need for pharmaceutical Suggestions included: (a) the international companies, governments and the international community must guarantee access to essential drugs community to improve responsiveness to crises and and protect and support health-care professionals ensure the realization of human rights. even in challenging contexts and people in vulnerable situations including women, must have access to medicines; (b) renew the focus on direct actions to improve health systems, including in rural areas, and to train medical personnel and support staff; (c) build trust between communities and health workers; (d) effectively coordinate international responses to health challenges; (e) base long- term, sustainable approaches to improve access to medicines, on data and not politics. 20. In his concluding remarks, Msgr. Vitillo observed that maternal health care was often

11 Access to Medicines in the context of the Right to Health

D. ACCESS TO MEDICINES FOR WOMEN AND CHILDREN 21. Dr. Schiavon stated that ensuring access to, and consistent procurement of, reproductive and neonatal health commodities was essential to WORLDWIDE ensuring human rights including the rights to health and life. Although maternal mortality rates had dropped signiﬁcantly since 1990, 289,000 women had still died from causes relating to maternity in 2013, and there were signiﬁcant disparities in mortality rates between regions. Worldwide + 41 per cent of pregnancies were unwanted, and most of them were due to non-use or underuse of CONTRACEPTIVES contraceptives. Lower contraceptive use correlated with higher rates of abortion. Reducing unintended pregnancies could avert 60 per cent of maternal deaths and 57 per cent of child deaths. Although access to contraceptives had increased, inequities remained both within and between States. Diverse -57% challenges and barriers prevented equal access to CHILD DEATHS potentially life-saving drugs for women, including ideological opposition to certain medications, such as emergency contraception and misoprostol (oral oxytocic) recommended for a variety of obstetric -60% uses. She advocated evidence-based guidelines and MATERNAL DEATHS policies to promote access to medicines for sexual and reproductive health. 22. Tarek Meguid, Associate Professor, State (Brazil, China, India, the Russian Federation and University of Zanzibar, asserted that lack of access South Africa), noting their efforts to reach reduction to medicines constituted a grave human rights targets in child mortality. While many affordable and violation, particularly in maternal and child health. accessible medicines had been developed, effective Quoting Mahmoud Fathalla, he said that women intervention was often inadequate owing to the lack were not dying from a lack of technical capacity. of paediatric formulations and other factors. Despite They were dying because they were poor, powerless positive steps, only 4.1 per cent of medicines and pregnant, and the international community had in China were reserved for children, according yet to make the decision that their lives were worth to a survey of medicines used in paediatrics in saving. He described inadequate facilities which 15 hospitals. Dr. Zhang suggested that an appeal had an air of veterinary medicine about them, and be launched to raise global awareness of the need stressed that the lives and dignity of poor women for all States to have an essential medicine list for and children must be protected. Women must be children. She called for States to learn from each given the space to empower themselves so that they other’s good practices, including advances by BRICS can take control of their own lives. Dr. Meguid called countries, like the essential medicine list for children for the creation of physical, economic and social in China, India and South Africa. spaces for women to give them agency and enable 24. In the ensuing discussion, the speakers were them to be the drivers of change. That required Dr. Mohamed and representatives of OHCHR, immediate action. Associazione Comunità Papa Giovanni XXIII, Autistic 23. Lingli Zhang, Professor and Director of Minority International, the Center for Reproductive Pharmacy, West China Second University Hospital, Rights and the People’s Health Movement. They Sichuan University, described efforts to improve discussed governmental duties to ensure access children’s access to medicines in the BRICS countries to information on contraceptive services on a

12 non-discriminatory basis; access to medicines for E. INTELLECTUAL PROPERTY RIGHTS AND ACCESS pregnant women living with food insecurity, and TO MEDICINES for autistic women and children; and the potential 26. Lisa Forman, Assistant Professor, Dalla Lana of education in reducing infant mortality. War and School of Public Health, University of Toronto, migration disproportionately affected women, described access to medicines as one of the most mothers and children. In such cases, special health explicit examples of how economics and trade rules policies should be implemented and drugs made conflicted with human rights, including the rights to available in durable forms that did not require life, health and development. She focused on how refrigeration. intellectual property rights had an impact on drugs, 25. Dr. Meguid stated that poor conditions were illustrated by the increase in drug prices in Malaysia the standard for people who lived with inadequate of 28 per cent per year between 1996 and 2005 medical facilities. Since they had no agency in following the implementation of TRIPS. Over 2 billion relation to their health needs that would enable people still lacked access to essential medicines, with accountability, they did not complain. Health drug pricing remaining a key obstacle to access. facilities were understaffed and their personnel She called on the United Nations to support the worked in unacceptable conditions. Health workers use of compulsory licensing as a proven means of became both victims and perpetrators of human reducing prices and realizing State duties under the rights abuses. Consequently, they would continue right to health. States should be held to account in to deliver inferior health services until they and the universal periodic review process for imposing their patients were empowered. Dr. Schiavon TRIPS-plus provisions in free trade agreements concluded that inequity in access to contraceptives as a violation of the right to health. Ms. Forman and some other medicines was global, and often suggested that TRIPS flexibilities were an insufficient an ideological issue. Dr. Zhang called for change solution to pricing concerns, referring to the Global in mindsets on access to medicines and stressed the Commission on HIV and the Law’s recommendation importance of an effective health policy. that the Secretary-General create a new body to

13 © UN Photo/Ron Haviv/VII Access to Medicines in the context of the Right to Health © ILO/M. Crozet

recommend a new intellectual property rights regime (WTO), highlighted the intersection of health, for drugs. trade and intellectual property rights. The Doha Declaration on the TRIPS Agreement and Public 27. Thamara Romero, Legal Officer, Intellectual Health was a major milestone in understanding Property Unit, United Nations Conference on Trade those intersections, recognizing the importance and Development (UNCTAD) discussed UNCTAD of intellectual property in the development of new work on access to medicines. The UNCTAD mandate medicines while acknowledging possible effects in that area was based on the 2012 Doha Mandate on pricing — a basis for international policy (TD/500/Add.1, para. 65 (j)), and its assurance discussions seeking to implement practically an of the supply of essential medicines. UNCTAD had appropriate balance between promoting access and observed an increased need to diversify and expand innovation. He recommended greater international pharmaceutical production. In the future India might cooperation to fulfil the right to health, required no longer be considered the “pharmacy of the for sustainable development. He outlined three world”. Expanding local production could result in broad areas for future work: (a) elucidation of rules, improved access. She referred to a high court case data and industry developments; (b) coordination in Peru in which an individual’s right to health had of operations and system-wide coherence; been upheld, regardless of whether the Government (c) implementation and action. Drawing on the had assigned adequate financial resources to study by WTO, the World Intellectual Property the health sector. She called for increased use Organization and WHO, Promoting Access to of TRIPS flexibilities. She argued that, if properly Medical Technologies and Innovation, he noted implemented, human rights and intellectual property widespread recognition of the need to strengthen were not necessarily contradictory. However, it was national health systems and to develop innovative necessary to create awareness among policymakers procurement solutions within existing legal and and judges on the application of TRIPs flexibilities to policy frameworks. enhance access to medicines. 29. During the interactive dialogue, comments 28. Antony Taubman, Director, Intellectual were made by representatives of Colombia, India, Property Division, World Trade Organization Mexico, the Colombian Commission of Jurists,

14 Knowledge Ecology International, the People’s so left behind were from vulnerable social groups Health Movement-Safe Observer International, Third including the poor, sex workers, drug users and World Network, Universities Allied for Essential lesbian, gay, transgender, transsexual and intersex Medicines, as well as by Dr. Bermudez, Dr. Schiavon persons. He argued that patients should not be mere and Regina Kamoga, Executive Director, Community statistics. In the Asia Pacific region, almost 40 per Health and Information Network, Uganda. They cent of people infected with HIV/AIDS were not discussed the following: South-South cooperation; receiving treatment. Depression and mental illness patent monopolies; TRIPs-plus provisions in free were highly prevalent amongst people with HIV trade agreements; the fundamental unfairness but they often went untreated as well. In national of intellectual property regimes, particularly for legislatures APN+ had strongly advocated that middle income countries; definition of “essential people living with HIV had the right to have access medicines”; alternatives to TRIPS; the role of to treatment. APN+ also worked to extend treatment WTO; contribution of universities to innovation and and community support to the most vulnerable. development of medicines; barriers to research and 32. Alma de Leon, Regional Director, International development; antibiotic resistance and the challenge Treatment Preparedness Coalition, Latin America from intellectual property regimes that hampered and the Caribbean, explained that many medicines the supply of effective antibiotics; the positive role available in the developed world were not available of TRIPs in spurring innovation; the need for more in Latin America. Children often had little access compulsory licensing in developing countries. to treatment, which might, however, be reduced 30. In her closing remarks, Ms. Forman referred or eliminated when they became adults for lack to the responsibilities of States in ensuring access of the third line of drugs, which were inaccessible to all medicines, not only essential medicines, and in some countries because of their high price. The asserted that the current system of TRIPs exceptions new development goals must accelerate universal and flexibilities was inequitable. The Optional coverage and eliminate gaps in access to medicines. Protocol to the Convention on Economic, Social Universal health care would only become a reality and Cultural Rights, which had entered into force if the people’s demands were met and if human on 5 May 2013, established a legally binding rights prevailed over intellectual property rights. She petitions procedure, an important mechanism for called on the international community to break down interpretation and enforcement of the right to health. barriers to access and pursue international trade and Mr. Taubman reiterated the importance of policy investment laws that permitted access to affordable coherence across legal and policy regimes. He medicines. The commendable efforts of community called for intellectual property experts to develop movements in exerting pressure to reduce prices must a stronger understanding of public health issues, be redoubled to enhance progress towards access to and for health practitioners and policymakers to affordable medicines for all. gain a practical understanding of TRIPS flexibilities. 33. Tenu Avafia, Policy Adviser, HIV, Health and Ms. Romero noted that different countries had Development Practice, Bureau for Development different needs, but that analyses of national legal Policy, United Nations Development Programme, strategies were helpful in implementing the TRIPS cited the report of the Global Commission on HIV agreement and its flexibilities. Improved local and the Law which called for changes in legal production capacity facilitated access to medicines. systems. That could prevent up to 900,000 new F. LESSONS LEARNED AND EMERGING HIV infections by 2030. The Joint United Nations CHALLENGES IN THE GLOBAL RESPONSE Programme on HIV/AIDS had set several targets TO AIDS in that regard including: halving the number of countries with punitive laws and practices 31. Martin Choo, Asia Pacific Network of around HIV transmission; creating an environment People Living with HIV/AIDS (APN+), stressed which safeguarded dignity, health and justice; the importance of equitable access and effective and developing action-oriented, evidence-based treatment. He asserted that access to treatment was recommendations for effective AIDS responses that a human right, treatment made patients feel human, promoted and protected the human rights of people and effective treatment was a public good. However, living with and most vulnerable to HIV. The report patients were being left behind, and many of those emphasized that application of the current patent

15 Access to Medicines in the context of the Right to Health

regime to medicines was a recent development. G. PATIENT-CENTRED APPROACHES TO ACCESS TO Furthermore, States had historically had the right MEDICINES to license patented inventions compulsorily when 36. Ms. Kamoga called for a people-centred needed. The TRIPS Agreement posed a barrier to approach to access to medicines that took into access to medicines. It benefited patent-holders at account cultural and demographic differences to the expense of people living with HIV. The report extend appropriate and effective health care to recommended that the Secretary-General examine rural and urban populations alike. Rural populations proposals for a new multilateral regime to promote faced particular difficulties in reaching medical innovation and increase access, that developed centres and were more likely to experience lack countries stop pushing TRIPS-plus agreements, that of access to medicines owing to shortages. She developing countries use TRIPS flexibilities, and that explained that Uganda had both formal and least developed countries be indefinitely exempted informal medical systems. People who lacked access from TRIPS. to formal systems must rely on private health care 34. During the dialogue, there were interventions and pay three to five times more for medicines than from representatives of the Bolivarian Republic those with formal coverage. Innovative approaches of Venezuela, the China Medical Association, were essential to ensure access to medicines and Health Innovation in Practice and Zomi Community save lives. Civil society organizations had led the USA, as well as from Amit Sengupta, Associate way by extending medical services to rural areas, Coordinator, People’s Health Movement, India, promoting community drug distribution programmes and Dr. Bermudez. They called for urgent action that pooled transportation costs and providing social to change an intellectual property regime that support and education for patients. Unfortunately, continued to be a barrier to access to medicines. many national governments in developing countries © UN Photo/M. Perret The achievements of the AIDS movement had not lacked the political will to take action to protect their been adequately translated into improved access citizens. They must act immediately to ensure access to all medicines for all. Continued activism would to affordable, high quality and safe medicines support access to medicines for HIV/AIDS treatment and promote further investment in research and and States must act to improve their local production development. of drugs, eradicate stigmatization of persons living 37. Dimitry Borisov, Executive Director, Equal with HIV/AIDS and ensure that domestic laws and Right to Life, Russian Federation, asserted that all policies promoted, protected and fulfilled people’s persons had an equal right to life. Therefore, access right to health. to medical care for all categories of patients must be 35. In conclusion, panellists emphasized the ensured. Unfortunately, in the Russian Federation, need to eliminate stigma and discrimination there were plans to reduce spending on health against persons living with HIV/AIDS. Mr. Choo care from 3.6 per cent to 2.8 per cent of gross called for increased support from international domestic product, placing a direct threat to access to organizations, improved mental health care and medicines. Beyond resources, there were structural strategic, interlinked, community-based partnerships barriers to access including inadequate transparency to support and care for persons living with HIV/ in decision-making processes, insufficient collection AIDS. Ms. de Leon advocated increased attention of data, and a gap between legislative policies and to key populations and an end to senseless deaths their financing and execution. Those problems were caused by stigmatization of persons living with HIV/ clearly evident in cancer treatment. The inadequate AIDS. Mr. Avafia stressed the importance of strong treatment of cancer patients substantially affected legal systems in protecting patient confidentiality mortality rates and those problems were reflective and reducing stigma. He observed that current of the health system of the Russian Federation as a drug prices were not sustainable even in developed whole. Equal Right to Life promoted a patient-centred countries and that they affected persons suffering approach and advocated fulfilment of State health- from all diseases. He argued for policy coherence to care commitments and intersectoral collaboration. reconcile human rights obligations and international 38. Noel Hayman, Clinical Director, Inala trade and investment laws. Indigenous Health Service, Australia, described his efforts to extend health care to aboriginal

communities, in which life expectancy was 17 years demanding fulﬁlment of their rights. In India, there less than for other Australians. He emphasized the was a history of common people uniting to bring importance of quality research and good data to about transformative change. Access to medicines ascertain the origins of health outcome disparities. had always been an issue for popular mobilization Research revealed that few indigenous peoples had by the masses. Civil society organizations in access to and used primary health-care systems. India campaigned against large pharmaceutical Results of a focus group demonstrated that many companies and put pressure on the Government aboriginal Australians were not accessing available to introduce measures that would allow generic health services because of cultural differences pharmaceutical and local production to thrive. making them feel unwelcome. By actions to bridge Consequently, drug prices in India were 10 per cent those cultural differences, including employment of or less than global prices, and Indian generics aboriginals in health systems, cultural awareness helped reduce the cost of antiretrovirals by more strategies and educational outreach, the health than 40 times. However, the implementation of TRIPS service had greatly expanded its reach. The key in India posed a threat both for India and importing was to understand and acknowledge the culture and States. He called for global solidarity and collective community. To further close the health coverage gap action to address that threat, preserve the generic for indigenous peoples, the private sector, national industry of India, resist pressure to adopt TRIPS-plus and local governments, medical practitioners and agreements and improve access to medicines for all. communities must continue to collaborate to address 40. During the interactive dialogue, there were their speciﬁc medical needs effectively. By so doing, interventions from Dr. Mohamed and Dr. Schiavon, the health service had improved access to affordable representatives of Panama, the United States of medicines. America, WHO, the International Association for 39. Dr. Sengupta stated that people working Hospice and Palliative Care, Maloca Internationale, together had the power to change health systems by Third World Network and the Union for International

17 Access to Medicines in the context of the Right to Health

Cancer Control. Issues included the following: that substandard drugs posed a real challenge, access to opioids and palliative care; patenting particularly in Uganda which lacked appropriate and criminalization of traditional medicines; cancer regulatory and enforcement mechanisms. She treatment; use and standardization of essential advocated a rights-based approach to access medicine lists; acquisition, receipt, distribution and to medicines that empowered communities and storage of medicines; impact of changing political individuals and employed effective, evidence-based regimes on health systems; procurement of medicines policies. and treatment of patients in resource-constrained settings; balancing between ensuring drug quality H. BREAKOUT DISCUSSION GROUPS AND PLENARY and safety and preventing overregulation and DISCUSSION regulatory capture. 42. All participants were invited to join one of 41. In his concluding remarks, Dr. Sengupta stated three breakout discussion groups. Each focused that, although safety was a valid and important on a key issue relating to access to medicines concern, the current debate around it had political in the context of the right to health. Group one, elements that could not be ignored. Decisions and facilitated by Dr. Velásquez, addressed intellectual policies affecting health care must not lose sight property regimes and access to medicines. Group of the ultimate objective of fulfilling the people’s two, facilitated by Nhan T. Tran, Manager, right to health. Dr. Hayman agreed that safety, Implementation Research Platform, Alliance for particularly for use of opiates, was an important Health Policy and Systems Research, WHO, focused concern. He emphasized the responsibilities of all on health systems strengthening, capacity-building, governments in guaranteeing access to medicines. community engagement and empowerment. Group Mr. Borisov described how the transition from the three, facilitated by Dr. Sengupta, discussed Soviet public health system to the current public/ financing access to medicines and universal health private health system had had a negative impact coverage. In those groups, participants focused on on access to health care in the Russian Federation. identifying concrete solutions and good practices for Currently, thousands lacked adequate cancer care overcoming barriers to access to medicines. because of coverage gaps and insufficient financing 43. During the plenary discussion which followed, for legislative mandates, exacerbated by lack of the main findings of the groups were presented transparency in decision-making. Ms. Kamoga stated by a rapporteur nominated by each group. All © UNFPA/A. Cullen © UNFPA/A.

18 participants were given an opportunity to respond implementation of TRIPs which had an impact on and present proposals for the conclusions and their ability to procure medicines. The Fund sought recommendations of the Social Forum. Those who to improve access by underserved populations took the floor were representatives of Ecuador, worldwide by reducing market fragmentation to Panama, Ariel Foundation International, Knowledge capitalize on collective negotiating power including Ecology International, Third World Network and through the use of electronic marketplaces and Universities Allied for Essential Medicines, as well exchanges. Its strategies directly integrated human as Ms. Forman, Dr. Meguid, Dr. Sengupta and rights considerations, focused on procurement for Damiano de Felice, Strategic Adviser to the Chief impact, leveraged new technologies for innovation Executive Officer, Access to Medicine Foundation. and supply chain management, and promoted A synthesis of the proposals emerging from the market access and continuity of supply. The Fund breakout and plenary discussions is reflected in the sought to increase investment in programmes that conclusions and recommendations of the present addressed human rights barriers to accessing health report. services and withdraw support from programmes that infringed upon human rights. I. INNOVATIVE APPROACHES TO PROMOTING ACCESS TO MEDICINES 46. Rohit Malpani, Access to Medicines Campaign Director of Policy and Analysis, Médecins Sans 44. Geoff Adlide, Director of Advocacy and Public Frontières, described the Access Campaign, Policy at Gavi, the Vaccine Alliance, explained the which responded to doctors’ frustration regarding innovative efforts of Gavi to shape vaccine markets the availability, affordability and suitability of with a view to promoting access. Gavi was a public- medicines. It sought to address basic market failures private partnership focused on saving children’s of the patent system, under which research and lives and promoting human health through improved development costs were to be recouped through access to immunization in poor countries. It sought monopolies leading to high-priced products. There to address inequities in access to vaccines through was no incentive for research and development innovative approaches to access, governance, for the poor nor for expanding their access. The monitoring and vaccine markets. It supported Campaign called for delinking product prices vaccine purchases by low-income countries through from research and development costs. Its 3P pooling domestic and regional purchasing power project, “push, pull, pool”, aimed to combine push and donor contributions to minimize costs. Gavi also funding, pull funding and the pooling of intellectual promoted competition and sought to balance supply property rights to promote innovative research and demand to ensure continuous supplies of the and development for new, effective tuberculosis vaccines required. It tried to improve vaccination drug regimens and affordable access to quality delivery including with regard to thermostability, medicines for all. In multidrug-resistant tuberculosis, presentation and packaging, combinations, safety the 3P project incentivized collaborative, early-stage and efficiency. Timely, transparent and accurate research through patent pooling and pull and push market information for manufacturers and States was funding. By securing public funding for prizes and essential to its work to promote sustainable access to clinical trials, ensuring an open and collaborative vaccines for all. model, it promoted the collaborative development 45. Nana Boohene, Procurement and Supply of drug regimens through patent pooling. The Specialist, Global Fund to Fight AIDS, Tuberculosis Campaign was seeking to promote a model of and Malaria, and Hye-Young Lim, Human Rights research and development that delinked its cost from Adviser at the Global Fund, presented the Fund’s the final product price and ensured that research work to promote access to medicines. A rapidly and development for tuberculosis was carried out evolving global health landscape required innovative in a manner that delivered effective, short-course, approaches to increasing access to essential affordable tuberculosis regimens for all. health commodities. The Global Fund operated 47. Lena Kähler, Researcher, Human Rights and in 140 countries and adaptability was integral Development, Danish Institute for Human Rights, to maximizing its impact. When States reached a national human rights institution mandated to middle-income status, they lost access to certain promote and protect human rights in Denmark and benefits in international assistance and delayed abroad, introduced the Institute’s efforts to develop

19 Access to Medicines in the context of the Right to Health

indicators for accessibility, availability, acceptability vaccinations through governments; responded to and quality in the context of the right to health. The requests from governments; worked to reduce prices lack of consensus on the interpretation of economic, and emphasized transparency in its operations. Mr. social and cultural rights constituted an obstacle to its Malpani decried continued mispricing of vaccines, work. By developing a generally applicable toolbox called for rendering access to medicines sustainable on right to health indicators, it hoped to promote and reiterated that middle-income countries faced realization of the right to health locally and globally. substantial challenges in improving access. The Institute had identified as core obligations the availability of essential medicines, prevention, J. GOOD PRACTICES IN PROMOTING ACCESS TO treatment and control of epidemic and endemic MEDICINES (ROUND TABLE) diseases, immunization against major infectious 50. Mr. de Felice described the Access to diseases, and reproductive, maternal and child Medicine Index, a ranking of the world’s 20 largest health care. research-based pharmaceutical companies on 48. During the discussion, there were interventions the basis of what they did to facilitate access to from representatives of Brazil, Chile, the China medicine in developing countries. He noted that Medical Association, the Colombian Commission there was hope, that there were good practices, of Jurists, Third World Network, Universities and that the Index, by drawing attention to Allied for Essential Medicines, as well as from Dr. corporate behaviour, could influence businesses to Sengupta, Dr. Mohamed and Dr. Meguid. Some exercise greater responsibility. The Index compared speakers described efforts to impede production corporations on the basis of their performance of low-cost generic pharmaceuticals as crimes over time with regard to multiple factors, including against humanity. Others called on the Human but not confined to governance, pricing, patents, Rights Council and special procedures mandate local stakeholder engagement, capacity-building holders to focus on access to medicines. They and donations. Although progress was uneven, the supported a holistic, people-centred and community- Index indicated that the pharmaceutical industry had driven approach to health. That would include stepped up its efforts to improve access to medicine innovative efforts to address neglected diseases, in developing countries. A competitive environment like multiple drug-resistant tuberculosis, that that not only held pharmaceutical companies disproportionately impacted on the poorest and most accountable when required, but also recognized vulnerable, and to promote improved governance their efforts and accomplishments, would help mechanisms, particularly for regulatory oversight advance access to medicines. and accountability of multinational corporations. 51. Sathyanarayanan Doraiswamy, Senior The question was raised as to whether or not efforts Reproductive Health/HIV Coordinator, Office of the to promote access had gone far enough to seek United Nations High Commissioner for Refugees alternatives to market-based approaches. (UNHCR), described UNHCR work to ensure access 49. In their concluding remarks, the panellists for refugees and other persons of concern. When supported further integration of human rights people were forcibly displaced across national considerations in access to medicines. Ms. Lim borders, they became refugees, often with limited stressed the need to integrate human rights principles access to health care in countries of asylum. UNHCR throughout procurement processes. She noted that efforts to promote health care for refugees were the concept of middle-income countries was an guided by its global strategy for public health and artificial one and that access to medicines should its guidelines on essential medicines and medical not be dictated by the economic status of a country supplies. Those addressed the needs of persons but by the needs of people, and that the Global in differing phases and contexts including acute Fund to Fight AIDS, Tuberculosis and Malaria was emergencies, protracted displacement and in their supporting the strengthening of health systems pursuit for durable solutions. The two main models in a number of countries. Citing the work of the for providing health care were direct integration in Committee on Economic, Social and Cultural Rights, national systems of host States and integration to Ms. Kähler asserted that the right to health required the maximum extent possible combined with support access to all medicines not only essential medicines. from UNHCR and non-governmental organizations. Mr. Adlide clarified that Gavi only supplied UNHCR pursued various methods to promote

20 © UN Photo/Evan Schneider access, including: provision of emergency health translation of technical human rights language into kits, collaboration with national AIDS programmes business language. to support antiretroviral treatment, research 53. James Love, Director, Knowledge Ecology programmes and partnerships with the private sector. International, recommended drastic changes to While those provided short-term solutions, the only existing models of research and development and long-term sustainable solution was total integration intellectual property rights. The prevailing system into national health systems. had failed to promote access and was fundamentally 52. Soraya Ramoul, Director, Access to Health, unfair. It created patent monopolies, vesting power Novo Nordisk, described the company’s efforts to and profits in private hands. Corporate lobbying promote access to medicines for the treatment of to protect those interests contributed to regulatory diabetes. Many people with diabetes resided in arbitrage and perpetuation of the status quo. That low and middle-income countries. Novo Nordisk system valued profits over human well-being and provided half of the insulin worldwide. It employed failed to achieve its stated objective of promoting differential pricing policies so that patients in innovation, particularly in research and development developing countries paid one quarter of the price for treatment of diseases that disproportionately paid in developed countries. However, access was impacted the poor and the vulnerable. He argued for not simply a matter of affordability. It also required changes to the intellectual property regime, improved strong health delivery systems including sufficient incentives for underfunded areas of research and and adequately trained medical personnel. Local development, mobilization of innovative sources prices might differ from initial purchasing prices of finance, increased scrutiny by the Human because of supply chain problems, price mark- Rights Council, particularly in applying the right ups, import duties and taxes. Further efforts were to development in relation to intellectual property needed to ensure that prices offered to patients rights, and innovative approaches to research and were affordable and also sustainable from a development. Mr. Love advocated deep, radical and business perspective. Better implementation of the transformative reforms that would delink research right to health in the private sector context required and development costs from product prices along

with the elimination of product monopolies, in of new commodities, often by leveraging its favour of other financing mechanisms, including purchasing power to negotiate with manufacturers combination of research grants, contracts and other for the supply of quality-assured health products subsidies and delinked financial incentives, including at lower prices or by enabling generic, low-cost robust funding of large innovation inducement prizes production of medicines. for HIV/AIDS and cancer as well. 56. Hans Rietveld, Director, Market Access and 54. Esteban Burrone, Head of Policy, Medicines Capacity-Building, Malaria Initiative, Novartis Patent Pool, described the evolution and work of Pharma AG, introduced the Novartis Malaria that initiative. WHO first proposed the idea of a Initiative. The latter had been involved in providing patent pool in 2008 as part of its global strategy low-cost, life-saving treatment for malaria patients, a on public health and innovation. After a feasibility disease which had been taking the life of one child study by the International Drug Purchase Facility every 60 seconds for the past 15 years. It pursued (UNITAID) (“Innovative financing to shape markets multiple strategies to combat malaria including for HIV/AIDS, malaria and tuberculosis”), which research and development of new treatment options, was welcomed by the Human Rights Council at its capacity-building, improving access and provision of fifteenth session, the Medicines Patent Pool was set treatment. Since 2001, the Initiative had delivered up to promote access to medicines for HIV treatment more than 700 million treatments without profit to through resource pooling and voluntary licensing. 65 malaria endemic countries. It had developed Since 2010, that entity had negotiated licences paediatric tablets that were dissolvable in liquid for for 11 antiretrovirals with five patent-holders. It babies and children and an improved formulation worked with 10 generic manufacturers through for adults. The Power of One campaign treated one 53 sublicensing agreements to improve access to child for every dollar raised. Its partnership with the antiretrovirals in low and middle-income countries fund-raising organization Malaria No More had where up to 94 per cent of people living with HIV rallied public support and funds for 3 million malaria resided. Patent pool licences had been recognized treatments in Zambia. The Initiative sought simple for their public health orientation, transparency and and innovative solutions to complex problems. For flexibility. Within four and a half years, the Pool example, it had utilized mobile phones to monitor had contributed to opening up the market for first drug supplies in Africa and head off stock-outs, and and second line antiretrovirals. It was exploring published and distributed education materials on expansion to cover tuberculosis and hepatitis C. malaria prevention and treatment. However, much remained to be done including on development of 55. Smiljka de Lussigny, HIV Programme new treatment for drug-resistant malaria and on Manager, UNITAID, discussed that initiative’s focus strengthening health systems. on innovative access to medicines. UNITAID used innovative financing, a major portion of which 57. During the interactive dialogue, the following came from a levy on air tickets, for greater access took the floor: representatives of Brazil, Indonesia, to treatments and diagnostics for HIV, malaria and the International Association for Hospice and tuberculosis in low-income countries. It focused on Palliative Care, New Generation Ishaka, Safe maximizing available resources for the promotion Observer International, Rencontre Africaine pour of access by mobilizing resources and promoting la défense des droits de l’homme, Third World their effective use. Affordability posed a substantial Network, Universities Allied for Essential Medicines; barrier to access, particularly when States lacked Drs. Sengupta, Bermudez, Schiavon and Zhang; appropriate national policies, access to affordable Ms. Forman. Many speakers called for a rights- and quality generic medicines and/or financial based health paradigm to replace market-oriented resources. New, effective treatment for hepatitis C solutions, and related actions from the Human was largely inaccessible to many patients owing to Rights Council. They recommended increasing prohibitive costs. UNITAID intervened by providing attention to the medical needs of children, corporate funding to organizations working to demonstrate the responsibility, equitable access to medicines, and impact, cost-effectiveness and utility of new treatment reduction of regulatory barriers to access, including and diagnostic tools and to develop the evidence TRIPs and TRIPs-plus provisions, research and needed to inform health policy and normative development of treatments for neglected tropical guidance. It also helped to improve the affordability diseases, access to pain medication, and the use of

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tariffs to safeguard local manufacturing capacity. access to medicines. Mr. de Felice explained the Several speakers called on States to promote access methodology of the Access to Medicine Index and without discrimination, to put people first, and to suggested additional research into neglected tropical refrain from exerting political pressure to increase diseases. He supported initiatives to promote sharing patent protections at the expense of access to and enhanced access to intellectual property like medicines. They called on the Secretariat to issue the Medicines Patent Pool. Citing positive impacts strong recommendations on intellectual property of the Patent Pool, Mr. Burrone appealed for rights, regulatory measures, and equal access to greater risk-taking and policy experimentation. He health care and sexual and reproductive health. highlighted the need to maintain drug quality while Reiterating that access to medicines was a matter regulatory barriers were rationalized to promote of life and death, they demanded that States and access. Mr. Love lamented a system which excluded the private sector take immediate action to remove the majority, and the lack of access to cancer barriers to access to medicines. medication. He proposed fundamental changes to promote innovation in the least harmful manner, and 58. In response, Mr. Rietveld clarified that he to delink drug prices from research and development spoke for the Novartis Malaria Initiative, and costs. Ms. de Lussigny referred to the obligation to not Novartis as a whole. The Initiative worked promote access and use limited resources to benefit because the non-profit business model and the as many people as possible. She recommended scale of the problem had allowed Novartis and addressing the issue of regulatory barriers to the partners to combine their approaches into a importation of life-saving medicines and emphasized sustainable effort to promote access to life-saving the important role of generic competition in reducing medicines. Ms. Ramoul urged governments, health- prices. Dr. Doraiswamy supported a greater focus on care professionals, activists and industry to avoid neglected populations and their rights. finger-pointing and instead collaborate to promote © ILO/M. Crozet

IV. Conclusions and ACCESS TO recommendations 59. In closing the Social Forum, the Chairperson MEDICINES assured all the participants of the continued commitment of Qatar to global health. He informed them of the World Innovation Summit for Health which had held its annual session in Qatar in February 2015. The Summit had brought together health leaders from over 80 countries to share the latest research, ideas and health innovations that QUALITY OF LIFE had the potential to revolutionize the future of global LIFE WITH DIGNITY health care. A. CONCLUSIONS SOCIAL JUSTICE 60. Several common themes emerged from the 2015 Social Forum. Not only is access to medicines HUMAN RIGHTS a matter of life and death; it also enhances the quality of life; and it is key to a life with dignity. Yet, 2 billion men, women and children have no access to essential medicines. Intellectual property laws, lack of ﬁnances, weak health systems, poverty, inequality and discrimination, among other factors, contribute to lack of access to medicines. 61. Access to medicines involves public health, social justice and international human rights obligations. The International Covenant on Economic, Social and Cultural Rights requires States to take steps, to the maximum of their available resources, to progressively realize the right to health, prohibit retrogressive measures and requires them to immediately fulﬁl their minimum core obligations. It also calls for international cooperation. Access to medicines is a core obligation. Medicines must be affordable, acceptable, accessible, of good quality, and made available without discrimination. 62. Access to medicines is a complex and multidimensional issue calling for holistic solutions. Measures must be put in place to improve supply chains, address the underlying social determinants of health, promote policy coherence premised on the primacy of human rights over international trade, investment and intellectual property regimes and to ensure that health delivery systems are appropriate to those they serve. Inequities must be eliminated, including high costs borne by patients in many low and middle-income countries. 63. People’s agency and empowerment should be improved to enhance access to medicines especially

26 for the poor. Procedural safeguards like participation established and access to medicines ensured. That and access to information must be upheld. Evidence- included building production capacity in developing based guidelines and policies to promote access to countries, allowing access to generic drugs, appropriate health-care services for women would enhancing research and development into treatment help realize their right to health, and an increase in for neglected diseases and implementing effective paediatric formulations would strengthen access for procurement, distribution, price and quality control children. Addressing stigma and discrimination and systems. Urgent steps to improve access to maternal ensuring equitable access and effective treatment and child health would help prevent maternal would help realize the rights of people living and infant mortality. The international community with HIV. must aim for universal access in the post-2015 development agenda, which should also include 64. Resource constraints cannot be an excuse mental health. for failing to meet health needs. Reasons for disparities in health outcomes across States of similar 68. All stakeholders should explore ways of socioeconomic status must be understood and mobilizing new and innovative means of financing addressed. Experience shows that publicly funded development and increasing resources available for health systems are the best way to ensure equitable health. Possibilities included imposition of a financial access to health care. Access can be improved transaction tax, debt cancellation, resource pooling through innovative financing mechanisms; enabling and tax reforms. International financial institutions public policies; more health workers; technical must allow States sufficient policy space to pursue support; better health data, administrators, transport health objectives and States should make efforts to and delivery; improved supply chains, local utilize existing resources more effectively including production and health education; and other means. by leveraging their political and purchasing power Holistic, people-centred and community-driven to negotiate reduced prices and voluntary licensing. policies and active local involvement help strengthen 69. TRIPS flexibilities and compulsory licensing health systems. should be used to their fullest and resort to political 65. Access to medicines is one of the most explicit pressure to undermine those tools or impose examples of how economics and trade rules conflict TRIPS-plus provisions in trade agreements must be with human rights, including the rights to life, regarded as a violation of human rights obligations, health and development. All are entitled to enjoy calling for accountability in the universal periodic the benefits of scientific progress and traditional review. The legally binding petitions procedure knowledge must be protected. Pharmaceutical under the Optional Protocol to the Convention on companies must comply with their human rights Economic, Social and Cultural Rights provided a responsibilities and ethical obligations. Several means for interpretation and enforcement of the right initiatives and good practices, including by those to health. companies, point to steps in that direction. New 70. Intellectual property laws required models of research and development must address transformative changes to ensure that the benefits needs, not simply manage markets and profits. of scientific progress were enjoyed by all. 66. Effective health policies, including the Recommendations included alternatives to market- development of essential medicines lists, could based approaches and reforms to delink research improve access. States must live up to their individual and development costs from product prices. The and collective commitments and adopt a human recommendations of the report of the Global rights-based approach to access to all medicines, not Commission on HIV and the Law, particularly the call only essential medicines. International solidarity and for the United Nations to establish a commission to collective action could support access for all. examine and propose alternatives to TRIPS, needed follow-up action. In the meantime, implementing B. RECOMMENDATIONS TRIPS must be suspended, where it impeded access 67. Participants recommended urgent and to medicines for the poor. immediate action, at the local, national, regional 71. Participants called for a new and legally and international levels. Health systems needed binding treaty on research and development of to be strengthened, universal health coverage medicines that would promote innovation and

27 Access to Medicines in the context of the Right to Health

equitable access. University research should be enterprises, and the Human Rights Council should perceived as public research for everyone’s benefit act to ensure their implementation. and not patented without proper safeguards to 74. The Human Rights Council and the ensure access to resulting medicines. The Committee international human rights machinery must remain on Economic, Social and Cultural Rights should seized of the issue. Participants recommended consider adopting a general comment on the right to integration of a universal periodic review of enjoy the benefits of scientific progress. the right to health and access to medicines that 72. All stakeholders should collaborate to is evidence-based and promotes transparency enhance health systems. Participants proposed a and accountability. They called on the Council holistic approach to health systems that enhanced to commission a compilation of good practices equitable access, improved training of health in promoting access to medicines. The and administrative personnel, employed culturally recommendations of the Social Forum must be taken appropriate delivery systems, involved engagement up by the Council and acted upon. with local communities and provided health and education outreach. 73. Participants recommended improved governance mechanisms, particularly for the regulatory oversight and accountability of multinational corporations. Pharmaceutical companies had responsibilities as articulated in the 2008 report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of health (A/63/263) containing the Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines. States, pharmaceutical companies, the Working Group on the issue of human rights and transnational corporations and other business

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