DRAFT RESOLUTION ON THE RIGHT TO MEDICINES

DRAFT RESOLUTION ON THE RIGHT TO MEDICINES

The African Commission on Human and Peoples’ Rights,

Preamble

Reaffirming that 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 as such, States are obliged to take the necessary measures to protect the health of individuals and ensure they have access to medical care when they are sick, under Article 16.

Noting that the African Charter on Human and Peoples’ Rights entitles every human being with the respect for his or her life and personal integrity under Article 4, and that the right to life is a fundamental human right, whose full enjoyment is a pre-requisite for the enjoyment of the right to health;

Considering the legal instruments of the Commission 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, and the Constitutive Act of the African Union;

Recalling the commitments made by African States at the Abuja Call for Accelerated Action Towards Universal Access to HIV and AIDS, Tuberculosis and Malaria Services in Africa; the Brazzaville Commitment on Scaling Up Towards Universal Access to HIV and AIDS Prevention, Treatment, Care and Support in Africa; and the Maseru Declaration on HIV/AIDS;

Considering international human rights instruments that enshrine the rights to health and life, 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 U.N. General Assembly’s Declaration of Commitment to HIV/AIDS; and the United Nations (U.N.) Commission on Human Rights Resolution on Access to Medication in the context of Pandemics such as HIV/AIDS;

Drawing inspiration from other regional human rights instruments that also enshrine the rights to health and life, including the American Declaration of the Rights and Duties of Man; the American Convention on Human Rights; the Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social, and Cultural Rights “Protocol of San Salvador,” the European Convention for the Protection of Human Rights and Fundamental Freedoms;

Recognizing that members of the World Trade Organization (WTO) may implement global intellectual rules in a manner consistent with the rights to health and life;

Welcoming the decision of the World Health Organization (WHO) Intergovernmental Working Group to explore alternative research and development systems that focus resources on the most needed health problems;

Findings

Alarmed that, according to the WHO, an estimated 10.7 million people died in Africa from communicable diseases, non-communicable diseases, and injuries in 2002;

Recognizing further that half of the population in the poorest parts of Africa lack access to medicines to prevent and treat disease;

Deeply concerned that essential medicines were available in only 38% of all public and private health care facilities in Africa between 2001 and 2007;

Considering that marginalized populations, particularly refugees, women, children, the elderly, persons with disabilities, incarcerated persons, members of rural communities, migrant workers, sex workers, and sexual minorities, bear a disproportionate burden of the lack of access to medicines, which significantly exacerbates their vulnerability;

Reaffirming that the Millennium Development Goals of working together with pharmaceutical companies to provide access to affordable essential drugs in developing countries, improving maternal and child health, and halting and beginning to reverse the spread of HIV/AIDS, malaria and other major diseases by 2015 depends on the improvement of access to medicines;

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;

Recalling also the marked improvements of developing countries in Africa and around the world, in reversing the spread of infectious diseases through a display of political will and effective implementation and monitoring of sound prevention and treatment programs;

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, including in countries that have historically provided affordable supplies of medicines to the developing world, 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, affordable prices, sustainable financing and reliable health and supply systems;

Recognizing that in development countries a lack of affordability of medicines can be a particularly insurmountable barrier to access because substantial populations rely exclusively on private financing of medicines;

Access to Medicines as a Human Right

Recognizing that the duty to progressively realize the right to health imposes “an obligation to move as expeditiously and effectively as possible” towards its full realization;

Stressing that the right to health is not confined to the 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, and extends to the underlying determinants of health, such as the access to medicines;

Recalling that the U.N. Commission on Human Rights has explained that “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;”

Recognizing that the equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy, affordability, and their scientifically sound and cost-effective use are essential to achieving the highest attainable standard of health;

Recognizing that the right to enjoy the benefits of scientific progress and its applications requires access to medicines;

Recognizing that access to medicines constitutes an integral part of living a dignified life and that the denial or withholding by a State of medicines essential to protecting or prolonging life poses a threat to the right to life;

Recognizing that the U.N. Commission on Human Rights has stated emphatically that “access to essential medicines is a human right.”

Affirms that the African Charter recognizes a specific right to access to needed medicines that is integral to the realization of the rights to health and to life;

State obligations

Calls Upon States to adopt policies that progressively realize the right to access to medicines, in accordance with international, regional, and domestic law, by ensuring:

1. The availability in sufficient quantities of medicines and medical technologies needed to promote the highest attainable level of health for all in society. This duty includes measures to make currently existing medicines available within their borders as well as to invest in research and development systems to help create new medicines needed to address health problems that are currently neglected by the dominant systems of incentives for innovation;
   
   
2. The accessibility of needed drugs to everyone within the jurisdiction of the state party without discrimination. Accessibility has four components:
   
   
   1. Non-discrimination in access to medicines;
      
      
   2. Physical accessibility of needed medicines within the reach of all marginalized sections of the population, including people living in rural areas, people with disabilities and others who are not able to access transportation, people in the custody of the government or housed in refugee or transitional housing for displaced people;
      
      
   3. Economic accessibility (affordability) of 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;
      
      
   4. 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 that misrepresents the availability of efficacy of information in a manner that may harm individuals and public health systems.
   
   
   
3. The acceptability of medicines supplies in the country, being respectful of medical ethics and the cultures of populations being served;
   
   
4. The quality of medicines used, including that all medicines be proved to be scientifically and medically appropriate and of good quality before being administered to individuals.

Recognizing that in order to achieve these goals, states must identify good practices for the operationalization of the right to health, and thus the right to access to medicines, at the community, national and international levels by accepting and carrying out their human rights obligations:

1. To respect the right to access medicines by refraining from adopting measures that would deny or limit the access of all persons to preventive, curative or palliative medicines and medical technologies used to treat disease;
   
   
   1. States must refrain from denying or limiting equal access to medicines for marginalized individuals in society, including but not limited to prisoners or detainees, minorities, asylum seekers, undocumented immigrants, institutionalized persons, women, sexual minorities, sex workers;
      
      
   2. States must refrain from prohibiting or impeding the use of traditional medicines and healing practices that are scientifically sound and medically appropriate;
      
      
   3. States may not interfere with the provision of humanitarian aid that facilitates the proliferation of necessary medicine during natural disasters or other national emergencies;
      
      
   4. States must not enter into trade or other international agreements the foreseeable result of which will be to raise prices of and reduce access to needed medicines in society, including agreements that impose “TRIPS-plus” intellectual property rules that may restrict access to generic medicines;
      
   
   
2. To protect the right to access medicines by adopting legislation and/or other measures that preserve access to preventive, curative or palliative medicines and medical technologies used to treat infectious diseases and by ensuring that third parties do not obstruct the enjoyment of the right to health,
   
   
   
   1. States must put in place and enforce legal and regulatory frameworks that prevent third parties from limiting access to medicines through irrational pricing policies, the distribution of unsafe medicines, the spreading of untruthful or misleading information about medicines and other practices that threaten rights to access the best available medicines for their needs;
      
      
   2. States must promote the use of medicines according to the best available evidence through the establishment and regular review and updating of minimum treatment guidelines by professional bodies that are free of any undue influence by third parties, such as pharmaceutical marketers;
      
      
   3. States have a duty to prevent unreasonably high costs for access to needed medicines;
      
      
   4. States must ensure that privatization of the health sector and trade agreements to which the State commits do not constitute a threat to the availability, accessibility, acceptability and quality of health facilities, goods and services;
      
      
   5. States must ensure that medical practitioners and those selling, advertising or distributing medicines meet appropriate standards of education, skill and ethical codes of conduct, including by ensuring that information about medicines is based on the best available evidence and is free of biased, untruthful or misleading information and is not tainted by gifts, payments, kick backs or other practices that may give marketers an undue and corrupting influence over those in the health system responsible for administering medicines;
      
   
   
3. To fulfill the right to access medicines by adopting all necessary and appropriate positive measures to the maximum of its available resources, and by promoting, providing, and facilitating effective access to preventive, curative or palliative medicines and medical technologies, with the necessary regulation and enforcement to ensure their safety, efficacy, and quality;
   
   
   
   1. States must immediately meet the minimum core obligations of ensuring the universal availability and affordability throughout the country and to every person or group of essential medicines, as defined by the country’s essential medicines list and the WHO Action Programme on Essential Drugs;
      
      
   2. States must prevent the unreasonably high costs for access to essential medicines, which can be accomplished through the exchange of price information, price competition and price negotiation with public procurement and insurance schemes, price controls, reduced duties and taxes and improved distribution efficiency, reduced distribution and dispensing costs, and reduced marketing expenses;
      
      
   3. States must discharge their immediate obligations of creating a national public health strategy and plan of action for the progressive realization of the right to access medicines so that access steadily increases;
      
      
   4. States must develop 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,;
      
      
   5. States must promote and ensure access to information regarding the administration of medicines to allow public health professionals to make informed decisions;
      
      
   6. States must promote meaningful participation, including through access to information and resources to participate through knowledgeable representatives, by affected individuals and groups in decisions that affect access to medicines, including in drug regulatory decisions, decisions to grant or revoke patents on pharmaceuticals and in medicine price decision-making processes;
      
      
   7. States must take advantage of the operational flexibilities built into the TRIPS Agreement in order to promote and protect the right to access medicines, such as the incorporation of compulsory licenses, the facilitation of parallel imports, the promotion of relaxing import duties, and establishing reasonable pricing norms for medicines where available and applicable to ensure the availability of medicines and technologies at affordable prices for treatment, care, and prevention of epidemic, endemic, occupational and other diseases;
      
      
   8. States must use utilize their law making, interpretation and implementation powers to promote the right to access to medicines, including by interpreting ambiguous provisions in trade agreements, competition, intellectual property and other laws to promote the right to access needed medicines;
      
      
   9. States must, individually and together with other developed and developing countries, work to design and implement 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;
      
      
   10. States must actively promote and facilitate innovation, research, and development of new medicines and medical technologies through, including but not limited to providing direct funding for the promotion of public research, providing incentives to the private sector through tax credits, patents, or other mechanisms that reward innovation, and encouraging technology transfer between developed and developing countries.
       

Involvement of other entities

Charges the Working Group on Economic, Social and Cultural Rights with the responsibility of defining state obligations related to the right to access medicines within its principles and guidelines;

Calls upon the Working Group on Economic, Social and Cultural Rights to adopt within its principles and guidelines a mandate to investigate, monitor, and implement access to medicines in state parties to the African Charter;

Delegates to the Working Group on Economic, Social and Cultural Rights the responsibility to establish structural, process and outcome indicators for monitoring and assessing the right to access to needed medicines in each member State of the African Union;

Requests the African Union to provide the Working Group on Economic and Social Rights with all the support and assistance necessary to implement this mandate;

Calls upon civil society to transmit reports on violations of the right to medicines and impediments in achieving this mandate;

Conclusion