What does the right to health offer Peruvian actors working on medicines access?

1. What does the right to health offer Peruvian actors working on medicines access? Dr. Lisa Forman Comparative Program in Health and Society University of Toronto Canadian Institutes of Health Research, University of Toronto Comparative Program on Health Research and Care-Peru Workshop on Rights-Based Policy Options for Accessing Medicines in Peru, 20-21 July 2009

2. Objectives 1. Assess impact of TRIPS & patents on medicines 2. Explore right to health in international law 3. Analyze rights-based strategies

3. 1. The Problem - Limited Access to Medicines • 2 billion people—1/3 global population—lack regular access • In Peru, 1/3 population lack access to essential medicines, including for diabetes, hypertension, schizophrenia, AIDS and cancer

4. Medicines Access in Peru • Access barriers include price, physical access, availability and quality (Meta, 2008) • Public procurement in Peru depends on price (HAI, 2007) • Some treatments are unaffordable • Less availability of originator brands, more generics Source: WHO (2004) 4

5. Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) • 20 year exclusive patents for pharmaceuticals • Exceptions and limitations • compulsory licensing (article 31) • parallel imports (article 6) • exclude inventions to protect life or health (article 27.1) • limited exceptions (article 30) • anti-competitive measures (article 40)

6. TRIPS-Plus Pressures and Rules • Unilateral Trade Sanctions • Korea, Mexico, Chile, Thailand, Indonesia, Bolivia, Columbia, Ecuador, Peru, Venezuela, India, Argentina, Brazil, Taiwan • Corporate Litigation • Kenya, Uganda, Ghana, Thailand, Brazil, China, South Africa • Free Trade Agreements • Extend monopoly periods • Limit TRIPS flexibilities 6

7. Public Health Impact of FTA • Extend monopoly periods beyond twenty years • Limit market entry for generics • Limit compulsory licensing • Prohibit parallel imports • Raise prices

8. Peru’s FTA with TRIPS-plus • US-FTA • European Free Trade Association • Impacts price, generic availability (as Peru’s assessment of US-FTA showed) 8

9. 2. The right to health • The right to health requires a greater priority to be given to medicines • What are implications for access and trade rules? 9

10. International and Regional Instruments with Right to Health 1946 – Constitution of the World Health Organization 1948 – Universal Declaration of Human Rights 1961 – European Social Charter 1965 – Convention on Elimination of Racial Discrimination 1966 – Covenant on Economic Social and Cultural Rights 1979 – Convention on Elimination of Discrimination against Women 1981 – African Charter of Human and People’s Rights 1988 – American Protocol of San Salvador 1989 – Convention on the Rights of the Child 1990 – Cairo Declaration on Human Rights in Islam 2002 – Convention on the Protection of the Rights of Migrants Workers 10

11. Peru’s International, Regional and National Commitments to the Right to Health 1965 – Convention on Elimination of Racial Discrimination 1966 – Covenant on Economic Social and Cultural Rights 1979 – Convention on Elimination of Discrimination against Women 1988 – American Protocol of San Salvador 1989 – Convention on the Rights of the Child 2002 – Convention on the Protection of the Rights of Migrants Workers 1993 – Constitution of Peru (articles 7, 9,11) 1997 – General Health Law 2009 – Universal Health Insurance Law (articles 4.1 and 5) 11

12. International and Domestic Rights Supplement Each other Growing list of successful cases claiming access to medicines as a human right Consistent variables are ratification of Social Rights Covenant and constitutional entrenchment of health right (Hogerzeil et al, 2006) 12

13. ICESCR, Article 12 1. State parties recognize everyone’s right to the enjoyment of the highest attainable standard of physical and mental health 2. Steps to be taken include a. reducing still birth and infant mortality and for children’s healthy development b. improving environmental and industrial hygiene c. preventing, treating and controlling epidemic, endemic, occupational and other disease d. creating conditions to assure to all medical services and attention in sickness

14. General Comment 14 – Scope, Content and Duties • Right to health includes adequate health care and underlying determinants of health • Inclusive right interdependent with other rights

15. Essential Elements of the Right to Health • Availability -sufficient quantities • Accessibility - non-discriminatory, physical, economic and informational • Acceptability -medically, ethically and culturally appropriate • Quality - Good quality goods and services

16. Right to Health Obligations • Minimum core obligations not subject to resource constraints • Duty to progressively realize right to health • Duties to • respect (don’t obstruct) • protect (regulate corporations) • fulfil (provide)

17. Duties relevant to medicines • Minimum core obligation to provide essential medicines • Duty to progressively realize access to available, accessible and good quality medicines

18. Duties relevant to trade • Take right to health obligations into account when entering bilateral or multilateral agreements • Ensure international agreements don’t adversely impact right to health

19. Access to medicines as a human right April 2001 Commission on Human Rights, Access to Medication in the Context of Pandemics such as HIV/AIDS June 2001 Intellectual Property Rights and Human Rights: Report of the Secretary-General The Impact of TRIPS on Human Rights–Report of High Commissioner August 2001 Intellectual Property Rights and Human Rights Dec 2001 Committee on Economic, Social and Rights, Human Rights and Intellectual Property July 2002 OHCHR and UNAIDS, Revised Guideline 6 on Access to Prevention, Treatment, Care and Support 19

20. Commission on Human Rights, 2001 Access to medication in the context of pandemics such as HIV/AIDS is one fundamental element for achieving progressively the full realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health

21. Commission on Human Rights (2001) continued Calls on states to refrain from taking measures that would deny or limit equal access to pharmaceuticals to treat pandemics such as HIV/AIDS Calls on states to ensure that their actions as members of international organizations take due account of the [right to health] and support public health policies which promote broad access to safe, effective and affordable pharmaceuticals

22. General Comment 17 (2005) • Intellectual property rights are not equivalent to human rights • State parties should ensure that intellectual property rights do not impede core obligations under rights to food, health and education • State parties have a duty to prevent unreasonably high costs for access to essential medicines

23. Implications for trade • States should use TRIPS flexibilities to realize the right to health (UN 2001) • States imposing/implementing TRIPS-plus rules in FTA may be violating the right to health

24. Concern about impact of TRIPS-plus rules on right to health • Committee on Economic Social and Cultural Rights Concluding Observations • Ecuador, 2004 • Committee on the Rights of the Child Concluding Observations • Thailand, 2006 • Nicaragua, 2005 • Philippines, 2005 • El Salvador, 2004

25. What does this mean for social and political actors in Peru?

26. 3. Rights-based strategies to access medicines • Litigation • Rights-based law & policy • Participatory advocacy • Impact assessment

27. a. Rights-based Litigation Growing cases globally challenging government and companies South Africa – NGOs use constitutional right to health to sue Minister of Health, results in national MTCT policy Thailand – NGOs successfully invalidate AIDS patent Court recognizes that “medicine is essential for human life” and “the treatment of life and health transcends the importance of any other property”

28. b. Rights-based policy approach • Policy based on participation, non-discrimination and accountability • Adopts right to health standards • Essential elements (AAAQ) • State duties (core, respect, protect, fulfill)

29. Conceptual Framework Applied Adapted from Hunt and MacNaughton, 2006 29

30. Applying Duties to Policy 30

31. Rights-based medicines policy in Peru • MoH, DIGIMED duties to ensure available, affordable, accessible and good quality medicines • Implications for • Financing • Procurement • Distribution • Registration • Marketing

32. Rights-based policy beyond the health sector • Trade, financing and patent departments duties regarding • Health care financing • TRIPS flexibilities • FTA negotiations • Patent law and policy

33. c. Participatory Advocacy • Care Peru and Forasalud’s Health Rights Program • Training • Capacity building • Policy dialogue • Results: policy input, governmental representation, Ministry of Health mobilization on health rights and responsibilities (Frisancho (2008), Frisancho and Goulden (2008) 33

34. d. Impact assessment • Right to health standards used to reform trade-related patent law and policy • Reduce restrictive impact on access to medicines • Peru’s impact assessment is key example • Method will be presented tomorrow

35. Questions for the Workshop • How can the right to health assist Peruvianpolicy and social action? • What are the challenges and opportunities to using it? • What can Peru offer the world in terms of case-study?

36. Acknowledgements Research funded by Canadian Institutes of Health Research Comparative Program on Health and Society, University of Toronto Research Assistance – Jennifer Simpson For further information Email:lisa.forman@utoronto.ca 36

37. US-Southern African Customs Union From Free Trade to Trade Investment and Development Cooperation Agreement • 2002-4 negotiations with Southern African Customs Union (SACU) - Botswana, Lesotho, Namibia, South Africa and Swaziland • Civil society protests over intellectual property rights provisions stall negotiations • Negotiations resume as ‘Trade, Investment and Development Cooperation Agreement’ • Unclear that it includes TRIPS-plus intellectual property rights