Final Draft Resolution: Right to Access Needed Medicines

PIJIP/University of Pretoria Centre for Human Rights/International Human Rights Legal Clinic (Washington College of Law at American University)
November 4, 2008

We invite your comments on the final draft resolution on human rights and access to medicines in Africa, which will be presented for consideration to the NGO Forum meeting in Abuja (Nigeria) November 8, 2008, on the occasion of the 44th Ordinary Session of the African Commission on Human and Peoples’ Rights (African Commission). The resolution requests the African Commission to adopt a resolution recognizing the human right to access to needed medicines and clarifying the duties imposed by the right.

The resolution is a product of the Access to Medicines and Human Rights Initiative, a collaboration of the University of Pretoria Centre for Human Rights and American University Washington College of Law Program on Information Justice and Intellectual Property and International Human Rights Legal Clinic, supported by the Open Society Institute. More information on the Initiative is available at http://www.wcl.american.edu/pijip/go/humanrights

 


FINAL DRAFT RESOLUTION: RIGHT TO ACCESS NEEDED MEDICINES

 

The NGO Forum meeting in Abuja (Nigeria) on the occasion of the 44th Ordinary Session of the African Commission on Human and Peoples’ Rights (African Commission),


Reaffirming that Article 16 of the African Charter on Human and Peoples’ Rights guarantees that every individual shall have the right to enjoy the best attainable state of physical and mental health and that States are obliged to ensure that everyone has access to medical care, and that Article 4 guarantees every person the right to respect for his or her life;

Recalling that a fundamental objective of the African Union is to work toward the eradication of preventable diseases and the promotion of good health on the continent;

Considering the regional human rights instruments expanding upon the rights to health and life, including the African Charter on the Rights and Welfare of the Child, the Pretoria Declaration on Economic, Social and Cultural Rights in Africa, the Protocol to the African Charter on Human and People’s Rights on the Rights of Women in Africa, the OAU Convention Governing the Specific Aspects of Refugee Problems in Africa;

Recalling the decisions of the African Commission on the right to health notably Free Legal Assistance Group and Others v. Zaire, Purohit and Moore v. The Gambia and Social and Economic Rights Action Center, Center for Economic and Social Rights v. Nigeria which reaffirmed the obligation on States Parties to respect, protect, promote and fulfill the right to health;

Considering international instruments that enshrine the right to the enjoyment of the highest attainable standard of health, including the Universal Declaration of Human Rights; the International Covenant on Economic, Social and Cultural Rights; International Covenant on Civil and Political Rights; the Convention for the Elimination of All Forms of Discrimination Against Women; the Convention on the Rights of the Child; United Nations (U.N.) Declaration on the Rights of Indigenous Peoples (2007); the U.N. General Assembly’s Declaration of Commitment to HIV/AIDS (2001); and the U.N. Commission on Human Rights Resolution on Access to Medication in the context of Pandemics such as HIV/AIDS (2003); among others;

Drawing inspiration from the jurisprudence of national and other regional human rights systems that recognize the rights to access needed medicines as components of the rights to health and life;

Recalling the commitments made by African States in the Abuja Declaration and Plan of Action on HIV/AIDS, Tuberculosis and Other Related Infectious Diseases (2001), the Maseru Declaration on HIV/AIDS (2003) and the Brazzaville Commitment on Scaling Up Towards Universal Access to HIV and AIDS Prevention, Treatment, Care and Support in Africa (2006);

Alarmed that an estimated 10.7 million people died in Africa from communicable diseases, non-communicable diseases, and injuries in 2002 and that essential medicines were available in only 38% of all public and private health care facilities in Africa between 2001 and 2007;

Welcoming the commitment of African heads of State at the Abuja Special Summit in April 2001 to allocate at least 15% of their national budgets for improvement of the health sector to help address the HIV/AIDS pandemic;

Recognizing that intellectual property norms being globalized through the WTO Agreement on Trade Related Aspects of Intellectual Property (TRIPS), bilateral trade agreements and other means are contributing to (1) higher prices and reduced supplies of many needed medicines that are under patent in an increasing number of countries, and (2) a concentration of research and development expenditures on “profitable” diseases that affect major population in richer countries, compounding the problems with developing new treatments for so-called “neglected diseases” that predominantly affect poor people;

Recognizing that the WHO has explained that promoting access to medicines requires a holistic programme of action, including to promote the rational selection and use of medicines of good quality, affordable prices, sustainable financing and reliable health and supply systems;

Stressing that the right to health is not confined to a right to health care but rather embraces a wide range of socio-economic factors that promote conditions in which people can lead a healthy life, including all the underlying determinants of health;

Reiterating the finding of the African Commission that the right to life is the fulcrum of all other rights, including the right to health and that the conditions for leading a healthy and dignified life are necessary to respect and protect the right to life;

Recognizing that the equitable access to needed medicines and other medical devices and products for treatment as well as for prevention and palliative care is a necessary condition for leading a healthy and dignified life, and therefore is necessary for the promotion of the rights to life and health in the African Charter;

Reaffirming the finding of the African Commission in Purohit and Moore v. The Gambia that in accordance with the right to health, States party to the African Charter have the obligation “to take concrete and targeted steps, while taking full advantage of its available resources, to ensure that the right to health is fully realised in all its aspects without discrimination of any kind;”


Calls upon the African Commission to adopt a resolution:

1. Expressly recognizing the right to access needed medicines as a human right and clarifying the nature and content of state obligations regarding these rights;
2. Calling upon member States to recognize the full scope of the right to access needed medicines, including:
a. The availability in sufficient quantities of existing and future innovations in medicines and medical technologies needed to promote the right to the enjoyment of the highest attainable level of health for all in society;

b. The accessibility of needed drugs to everyone within the jurisdiction of the State without discrimination, including

i. Non-discrimination in access to medicines;

ii. Physical accessibility of needed medicines within the reach of all marginalized sections of the population, including refugees, women, children, older persons, persons with disabilities, incarcerated persons, members of rural communities, migrant workers, sex workers, sexual minorities and persons living with HIV;

iii. Economic accessibility (affordability) of needed medicines to all such that payment and pricing systems, including systems of public or private insurance, are based on the principle of equity pricing so that poorer or more needy households are not disproportionately burdened with medicine expenses;

iv. Information accessibility, including the right to seek, receive and impart truthful and accurate information about the availability and efficacy of medicines, and to regulate the dissemination of untruthful, biased and inaccurate information;

c. The acceptability of medicine supplies in the country, being respectful of medical ethics and the cultures of populations being served;

d. The quality of medicine supplies through systems ensuring that available medicines are safe, effective and scientifically, culturally and medically appropriate;

3. Clarifying the duties that the right to access needed medicines imposes on States, including:
a. To respect the right to access medicines by refraining from measures that negatively affect access to needed medicines, including by refraining from:

i. denying or limiting equal access to medicines for marginalized individuals in society;

ii. prohibiting or impeding the use of traditional medicines and healing practices that are scientifically sound and medically appropriate;

iii. interfering with the provision of humanitarian aid that facilitates the proliferation of necessary medicine during natural disasters or other national emergencies;

iv. implementing intellectual property policies with respect to pharmaceutical products that do not take full advantage of all flexibilities built into the TRIPS Agreement that can be used to protect access to affordable medicines;

v. entering into trade or other international agreements that do not contain sufficient flexibility to prevent increased prices or reduced access to needed medicines in society, including agreements that impose “TRIPS-plus” intellectual property rules for pharmaceuticals;

b. To protect the right to access needed medicines from actions by third parties through regulatory systems that:

i. ensure that only medicines that have met evidence-based and scientifically appropriate standards for quality, safety and efficacy are available, including through regional systems for drug registration and pharmocovigilence;

ii. promote the use of medicines according to the best available evidence, including through establishment and regular review and updating of standard treatment guidelines by independent professional bodies that are free of any undue influence;

iii. prevent unreasonably high prices for needed medicines in both the public and private sectors;

iv. ensure that medical practitioners and patients have ready access to truthful and complete information on the safety and efficacy of medicines, including through measures to ensure that those selling, advertising or distributing medicines are prohibited from distributing biased, untruthful or misleading information or exerting a corrupting influence through gifts, payments or other means;

v. interpret and enforce competition, intellectual property, consumer protection and other laws to promote access to medicines;

c. To fulfill the right to access medicines by adopting all necessary and appropriate positive measures to the maximum of its available resources to promote, provide, and facilitate access to needed medicines, including:

i. immediately meeting the minimum core obligations of ensuring non-discriminatory availability and affordability throughout the country of essential medicines as defined by the country’s essential medicines list and the WHO Action Programme on Essential Drugs;

ii. immediately creating a national medicine strategy and plan of action; developing monitoring systems, indicators and benchmarks to ensure compliance with its (1) immediate obligations to make essential drugs universally available now, and (2) progressive obligations to improve access to a broadened definition of needed medicines over time;

iii. promoting meaningful participation by affected individuals and groups in decisions that affect access to medicines, including drug regulatory and pricing decisions and decisions to grant or revoke patents on pharmaceuticals;

iv. creating systems in which patent information and registration status for medicines is readily and publicly accessible;

v. expediting the regulatory review and registration of needed medicines, such as through the use of the WHO Prequalification Programme or approval for marketing by a stringent drug regulatory agency, and creating incentives for companies to register needed medicines expeditiously;

vi. individually and together with other States and non-governmental entities, developing and implementing research and development programmes and systems that ensure that needed medicines are developed to address diseases and conditions that are neglected by traditional patent-based incentive systems;

4. Charging the Working Group on Economic, Social and Cultural Rights to assume the responsibility of further defining state obligations related to the right to access medicines within its principles and guidelines and to develop model monitoring and assessment guidelines for States.

 

Done in Abuja, Federal Republic of Nigeria.

 

 

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