Friday, October 17, 2008

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

11 comments:

Sean Flynn said...

We invite your comments on this draft NGO resolution on human rights and access to medicines that will be presented for adoption at the NGO Forum preceding the 44th Ordinary Session of the African Commission in Abuja, Nigeria from the 10th-24th of November. The NGO meeting will be November 7-9th, and we will be presenting the resolution to the Forum on November 8th.

This resolution arises out a partnership between PIJIP and the Human Rights Clinic at American University and the University of Pretoria’s Centre on Human Rights to develop human rights strategies to promote access to medicines in Africa.

Through this public blog, we invite you to submit any comments on the resolution in the reply section of the blog. We will be finalizing the draft the week of October 27, and ask that you review the draft before then if you are able.

We will also be asking for NGO endorsements of the final document, which you can submit to me directly or post to the blog any time before November 5.

Please feel free to distribute this widely among interested advocates.

Thank you,

Sean Flynn
Patrick Eba
Meetali Jain
Project Directors

Yousuf Vawda said...

Congratulations on a very comprehensive draft. My only complaint is that it is rather long, although I can see the wisdom of specifying as much detail as possible to avoid the problem of conflicting interpretations at the implementation stage. Having said that, I would propose a few small additions:
1. Under State obligations, recognizing/fulfil/3c/national health strategy: perhaps a reference to a national drug policy – always a useful policy tool to enhance access.
2. Preamble, considering international instruments: add Convention on the Rights of the Child.
3. I agree with the comment that there should be a conclusion. As the text of the resolution already contains the ‘demands’ (sorry, requests!) on states, perhaps an inspirational concluding sentiment like ‘Africa can/must rise to the challenge’?

Andy Gray said...

Firstly, a question of strategy: given the target audience for the Resolution, is the choice of mostly American and European instruments under the preambulatory section "Drawing inspiration" necessary? Might this not distract from the more powerful, universal instruments? Are there elements in any of these that are particularly important, and if so, can these be listed separately?

Then, some minor issues of detail:

1. Under State Obligations, the first "call" - point 1 - shoukd this not read "This duty includes measures to make currently existing essential medicines available within their borders as well as ...", as no obligation should exist to make ALL existing medicines available?

2. Point 2d is confusing - should this read ".. and to regulate the dissemination of untruthful, biased and inaccurate information that misrepresents the safety, efficacy or quality of medicines in a manner that may harm individuals and public health systems."?

3. Point 4 - can this be reworded to make it clear that States are under an obligation to provide for an effective regulatory system that ensures that only medicines that have met appropriate standards of safety, efficacy and quality are available? That allows for various options, from sovereign systems to reciprocity arrangements with acceptable regulatory authorities, but does not place the obligation unfairly on the persons responsible for administration of medicines, at the point of care.

4. Under State Obligations, the second "recognition" - why only in relation to "infectious diseases"? Surely appropriate, essential medical technologies are important in other diseases as well.

5. Point 2a - should "best available medicines" be replaced with "essential medicines"?

6. Point 2b - should "minimum treatment guidelines" be replaced with "standard treatment guidelines"?

7. Point 3e - should the terms "administration" be replaced with "safe use" or "quality use"? The traditional term would have been "rational use", but that is slowly being replaced.

Throughout, replacing "needed medicines" with "essential medicines" may also be of use, as the term is widely understood and entrenches the right of the State to exercise reasonable and informed rationing of scarce resources.

Caroline said...

The following are comments made by Professor Brook Baker of Northeastern University School of Law. They are included here to facilitate further discussion and additional comments.

1. Preamble, Clause 2: Replace "whose full enjoyment is a pre-requisite for the enjoyment of the right to health" with "whose full enjoyment can not be achieved in the absence of realisation of the right to health"

2. After Findings, Clause 3: Insert a clause saying, "Concerned as well by the widespread availability of substandard and counterfeit medicines that threaten the lives and well-being of patients;"

3. Findings, Clause 9: Insert "of good quality" after "medicines"

4. After Findings, Clause 9: Insert a clause saying, "Recognizing that high prices of medicine can occur because of high prices from manufacturers, because of tariffs, customs fees, and value-added and sales taxes, and because of high mark-ups at the wholesale and retail level;"

5. Delete Access to Medicines as a Human Right, Clause 2

6. After Access to Medicines, Clause 7: Insert TWO clauses saying, "Recognizing that the medicines play a critical role in the right to health not only with respect to the treatment of disease but with respect to its prevention as well;" & "Recognizing the importance of medicines in palliative care and in the prevention of unnecessary pain and suffering;"

7. After Access to Medicines as a Human Right, Clause 8: Insert the previously deleted Clause 2.

8. State Obligations, Clause 1, Section 4: Add "safety, efficacy, and" before "quality"

9. State Obligations, Clause 2, Section 1.a.: Add "internal and external migrant workers, rural populations," after "undocumented immigrants" & "children" after "women"

10. State Obligations, Clause 2, Section 2.c: Add "in both the public and private sector" after "medicines"

11. State Obligations, Clause 2, Section 3.b.: Replace "the unreasonably high costs for access" with "unreasonably high costs that restrict access"

12. State Obligations, Clause 2, Section 3.e: Add "and patients" after "public health professionals"

13. State Obligations, Clause 2, Section 3.f.: Comment (in reference to "drug regulatory decisions") -- "This right of access can cut both ways. In S. Africa, when a right of regulatory and oversight was proposed for Manto, health advocates resisted strongly. We want drug regulatory decisions made reliably on the best possible scientific information."

14. State Obligations, Clause 2, Section 3.g.: Comment -- Not sure this is the right word (in reference to "operational"). "I would separate this into two demands: (1) States should adopt legislation and regulatory reforms that give them to right to exercise any and all TRIPS flexibilities including standards for patentability, exclusions and exceptions, compulsory licenses and government use (including Aug. 30 System), parallel importation, early working, etc. and (2) State should use such flexibilities to increase access to affordable medicines."

15. After State Obligations, Clause 2, Section 3.h.: Insert FOUR clauses saying, "States increase access to information about the patent status of medicines by requiring patent holders to file all relevant patent information for each patented medicine with a publicly accessible, internet searchable data base; and likewise increased publicly available access to internet searchable information on the registration status of medicines" & "States must enact legislation to accelerate access to essential life saving medicines by expediting the regulatory review and registration of such medicines, for example by reliance on the fact that the medicine has been prequalified by the WHO Prequalification Programme or been approved for marketing by a stringent drug regulatory agency;" & "States must enact legislation that incentivizes both originator and generic drug companies to register their medicines for use;" & "States must work together with regional partners on drug regulatory standards and on procedures for drug registration and pharmocovigilence to ensure safety and quality of medicines throughout the distribution system;"

16. After Involvement of Other Entities, Clause 3: Insert a clause saying, "Charges the Working Group on Economic, Social and Cultural Rights with the responsibility for increasing regional cooperations on drug regulatory standards and processes that ensure the efficacy, safety, and quality of medicines;"

Blackbecks said...

Kudos for encapsulating the most essential aspects of access to medicines in this draft resolution. It is a promising document on the issue.

Typo: The last paragraph under findings refers to development. Did you perhaps mean developing?

A few points below could be considered if not already implied in the provisions:

Equality: Recognising that equality is a fundamental right underlying all other rights, and that access to medicines is a matter of both formal and substantive equality;

Social determinants of health: Taking into account WHO’s finding that lack of access to health systems which include access to medicines is among the worst causes of poor health and inequalities between and within countries;

Infectious diseases: Noting that research shows that infectious diseases can be treated and only continue to thrive due to poor policies and programs on, inter alia, access to medicines;

Gender: Bearing in mind that relatively women, especially rural women in developing countries suffer poorer health and lesser access to medicines;

Rebecca Amollo,
Socio-Economics Rights Project,
Community Law Centre,
University of the Western Cape

Caroline said...

Preamble, Clause 1: I would delete "as such, States are obligated to take the necessary measures to protect the health of individuals and ensure they have access to medical care when they are sick."

Findings, Clause 1: I’m not sure we need this particular finding, especially since the statistic is over five years old.

Access to Medicines as a Human Right, Clause 3: I think this clause is repetitive of the first clause under “Access to Medicines as a Human Right.” While the first clause defines progressive realization, I think the use of the example of granting access to medicines as one means of acting progressively to achieve full realization is more forceful for purposes of this Resolution and also sufficient explanation. I would delete the first clause.

State Obligations, Clause 2, 2.c: I would delete this clause because it is repeated almost word for word in section 3.b. Because that section illustrates specific duties, I would keep that clause and delete this one.

Caroline said...

These comments come from Professor Amy Kapczynski at Berkeley Law:

This looks great. Would be very cool if you could get it through. a few comments:



The word "property" is missing here: "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." Also, I'm not sure this is entirely true, in fact. I would say that in many countries, no matter how you implement it, TRIPS will raise prices for medicines, with effectively no returns for innovation. That can't be consistent w/ right to health... Maybe instead say "must seek to implement in a manner consistent with..." or "maximally consistent with".



I'm not sure about the "TRIPS-plus" language, because as we all know, TRIPS itself will have the foreseeable result of raising the price of medicines - and don't necessarily want to suggest that its only TRIPS plus that we're worried about. I would therefore revise to something the following:



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 intellectual property rules that may restrict access to generic medicines. (If want to keep a ref to TRIPS plus, then put another sentence like: In particularly, states must not enter into "TRIPS-plus" agreements that will reduce local affordability of medicines.)



Last thing I would say is if possible, would be great to get in some more specific language that a panel in, say a dispute about CLs or article 3(d) could use to find that those actions are consistent w/ TRIPS -- maybe means specifically mentioning limited scope of patentability and efficient CL mechanisms as specific implementations of right to health, or as "measures necessary to protect public health" (using language of Article 7)?

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