Draft Resolution on the Right to Medicines

DRAFT RESOLUTION ON THE RIGHT TO MEDICINES
The African Commission on Human and Peoples’ Rights,

[Originally posted on: PIJIP Blog ]

Preamble

Reaffirmingthat the African Charter on Human and Peoples’ Rights guarantees thatevery individual shall have the right to enjoy the best attainablestate of physical and mental health and as such, States are obliged totake the necessary measures to protect the health of individuals andensure they have access to medical care when they are sick, underArticle 16.

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

Consideringthe legal instruments of the Commission expanding upon the rights tohealth and life, including the African Charter on the Rights andWelfare of the Child, the Pretoria Declaration on Economic, Social andCultural Rights in Africa, the Protocol to the African Charter on Humanand People’s Rights on the Rights of Women in Africa, the OAUConvention Governing the Specific Aspects of Refugee Problems inAfrica, and the Constitutive Act of the African Union;

Recallingthe commitments made by African States at the Abuja Call forAccelerated Action Towards Universal Access to HIV and AIDS,Tuberculosis and Malaria Services in Africa; the Brazzaville Commitmenton Scaling Up Towards Universal Access to HIV and AIDS Prevention,Treatment, Care and Support in Africa; and the Maseru Declaration onHIV/AIDS;

Consideringinternational human rights instruments that enshrine the rights tohealth 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 Conventionfor the Elimination of All Forms of Discrimination Against Women; theU.N. General Assembly’s Declaration of Commitment to HIV/AIDS; and theUnited Nations (U.N.) Commission on Human Rights Resolution on Accessto Medication in the context of Pandemics such as HIV/AIDS;

Drawing inspiration fromother regional human rights instruments that also enshrine the rightsto health and life, including the American Declaration of the Rightsand Duties of Man; the American Convention on Human Rights; theAdditional Protocol to the American Convention on Human Rights in theArea of Economic, Social, and Cultural Rights “Protocol of SanSalvador,” the European Convention for the Protection of Human Rightsand Fundamental Freedoms;

Recognizingthat members of the World Trade Organization (WTO) may implement globalintellectual rules in a manner consistent with the rights to health andlife;

Welcoming thedecision of the World Health Organization (WHO) IntergovernmentalWorking Group to explore alternative research and development systemsthat focus resources on the most needed health problems;

Findings

Alarmedthat, according to the WHO, an estimated 10.7 million people died inAfrica from communicable diseases, non-communicable diseases, andinjuries 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 concernedthat essential medicines were available in only 38% of all public andprivate health care facilities in Africa between 2001 and 2007;

Consideringthat marginalized populations, particularly refugees, women, children,the elderly, persons with disabilities, incarcerated persons, membersof rural communities, migrant workers, sex workers, and sexualminorities, bear a disproportionate burden of the lack of access tomedicines, which significantly exacerbates their vulnerability;

Reaffirmingthat the Millennium Development Goals of working together withpharmaceutical companies to provide access to affordable essentialdrugs in developing countries, improving maternal and child health, andhalting and beginning to reverse the spread of HIV/AIDS, malaria andother major diseases by 2015 depends on the improvement of access tomedicines;

Welcomingthe commitment of African heads of State at the Abuja Special Summit inApril 2001 to allocate at least 15% of their national budgets forimprovement of the health sector to help address the HIV/AIDS pandemic;

Recalling alsothe marked improvements of developing countries in Africa and aroundthe world, in reversing the spread of infectious diseases through adisplay of political will and effective implementation and monitoringof sound prevention and treatment programs;

Recognizingthat intellectual property norms being globalized through the WTOAgreement 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 areunder patent in an increasing number of countries, including incountries that have historically provided affordable supplies ofmedicines to the developing world, and (2) a concentration of researchand development expenditures on “profitable” diseases that affect majorpopulation in richer countries, compounding the problems withdeveloping new treatments for so-called “neglected diseases” thatpredominantly affect poor people;

Recognizingthat the WHO has explained that promoting access to medicines requiresa holistic programme of action, including to promote the rationalselection and use of medicines, affordable prices, sustainablefinancing and reliable health and supply systems;

Recognizingthat in development countries a lack of affordability of medicines canbe a particularly insurmountable barrier to access because substantialpopulations rely exclusively on private financing of medicines;

Access to Medicines as a Human Right

Recognizingthat the duty to progressively realize the right to health imposes “anobligation to move as expeditiously and effectively as possible”towards its full realization;

Stressingthat the right to health is not confined to the right to health care,but rather, embraces a wide range of socio-economic factors thatpromote conditions in which people can lead a healthy life, and extendsto the underlying determinants of health, such as the access tomedicines;

Recalling thatthe U.N. Commission on Human Rights has explained that “access tomedication in the context of pandemics, such as HIV/AIDS, is onefundamental element for achieving progressively the full realization ofthe right of everyone to the enjoyment of the highest attainablestandard of physical and mental health;”

Recognizingthat the equitable access to essential medical products, vaccines andtechnologies of assured quality, safety, efficacy, affordability, andtheir scientifically sound and cost-effective use are essential toachieving the highest attainable standard of health;

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

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

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

Affirmsthat the African Charter recognizes a specific right to access toneeded medicines that is integral to the realization of the rights tohealth and to life;

State obligations

Calls UponStates to adopt policies that progressively realize the right to accessto medicines, in accordance with international, regional, and domesticlaw, by ensuring:

  1. The availabilityin sufficient quantities of medicines and medical technologies neededto promote the highest attainable level of health for all in society.This duty includes measures to make currently existing medicinesavailable within their borders as well as to invest in research anddevelopment systems to help create new medicines needed to addresshealth problems that are currently neglected by the dominant systems ofincentives for innovation;
  2. The accessibilityof needed drugs to everyone within the jurisdiction of the state partywithout discrimination. Accessibility has four components:

    1. Non-discrimination in access to medicines;
    2. Physical accessibility of needed medicines within the reach of allmarginalized sections of the population, including people living inrural areas, people with disabilities and others who are not able toaccess transportation, people in the custody of the government orhoused in refugee or transitional housing for displaced people;
    3. Economic accessibility (affordability) of medicines to all such thatpayment and pricing systems, including systems of public or privateinsurance, are based on the principle of equity pricing so that pooreror more needy households are not disproportionately burdened withmedicine expenses;
    4. Information accessibility,including the right to seek, receive and impart truthful and accurateinformation about the availability and efficacy of medicines, and toregulate the dissemination of untruthful, biased and inaccurateinformation that misrepresents the availability of efficacy ofinformation in a manner that may harm individuals and public healthsystems.
  3. The acceptability of medicines supplies in the country, being respectful of medical ethics and the cultures of populations being served;
  4. The qualityof medicines used, including that all medicines be proved to bescientifically and medically appropriate and of good quality beforebeing administered to individuals.
Recognizingthat in order to achieve these goals, states must identify goodpractices for the operationalization of the right to health, and thusthe right to access to medicines, at the community, national andinternational levels by accepting and carrying out their human rightsobligations:
  1. To respect the right to access medicines by refrainingfrom adopting measures that would deny or limit the access of allpersons to preventive, curative or palliative medicines and medicaltechnologies used to treat disease;

    1. Statesmust refrain from denying or limiting equal access to medicines formarginalized individuals in society, including but not limited toprisoners or detainees, minorities, asylum seekers, undocumentedimmigrants, institutionalized persons, women, sexual minorities, sexworkers;
    2. States must refrain from prohibiting orimpeding the use of traditional medicines and healing practices thatare scientifically sound and medically appropriate;
    3. States may not interfere with the provision of humanitarian aid thatfacilitates the proliferation of necessary medicine during naturaldisasters or other national emergencies;
    4. States mustnot enter into trade or other international agreements the foreseeableresult of which will be to raise prices of and reduce access to neededmedicines in society, including agreements that impose “TRIPS-plus”intellectual property rules that may restrict access to genericmedicines;
  2. To protect the right toaccess medicines by adopting legislation and/or other measures thatpreserve access to preventive, curative or palliative medicines andmedical technologies used to treat infectious diseases and by ensuringthat third parties do not obstruct the enjoyment of the right to health,

    1. States must put in place and enforce legal and regulatory frameworksthat prevent third parties from limiting access to medicines throughirrational pricing policies, the distribution of unsafe medicines, thespreading of untruthful or misleading information about medicines andother practices that threaten rights to access the best availablemedicines for their needs;
    2. States must promote the useof medicines according to the best available evidence through theestablishment and regular review and updating of minimum treatmentguidelines by professional bodies that are free of any undue influenceby 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 tradeagreements to which the State commits do not constitute a threat to theavailability, accessibility, acceptability and quality of healthfacilities, goods and services;
    5. States must ensurethat medical practitioners and those selling, advertising ordistributing medicines meet appropriate standards of education, skilland ethical codes of conduct, including by ensuring that informationabout medicines is based on the best available evidence and is free ofbiased, untruthful or misleading information and is not tainted bygifts, payments, kick backs or other practices that may give marketersan undue and corrupting influence over those in the health systemresponsible for administering medicines;
  3. To fulfill the right to access medicines by adopting all necessary and appropriate positive measuresto the maximum of its available resources, and by promoting, providing,and facilitating effective access to preventive, curative or palliativemedicines and medical technologies, with the necessary regulation andenforcement to ensure their safety, efficacy, and quality;

    1. States must immediately meet the minimum core obligations of ensuringthe universal availability and affordability throughout the country andto every person or group of essential medicines, as defined by thecountry’s essential medicines list and the WHO Action Programme onEssential Drugs;
    2. States must prevent the unreasonablyhigh costs for access to essential medicines, which can be accomplishedthrough the exchange of price information, price competition and pricenegotiation with public procurement and insurance schemes, pricecontrols, reduced duties and taxes and improved distributionefficiency, reduced distribution and dispensing costs, and reducedmarketing expenses;
    3. States must discharge theirimmediate obligations of creating a national public health strategy andplan of action for the progressive realization of the right to accessmedicines so that access steadily increases;
    4. Statesmust develop monitoring systems, indicators and benchmarks to ensurecompliance with its (1) immediate obligations to make essential drugsuniversally available now, and (2) progressive obligations to improveaccess to a broadened definition of needed medicines over time,;
    5. States must promote and ensure access to information regarding theadministration of medicines to allow public health professionals tomake informed decisions;
    6. States must promotemeaningful participation, including through access to information andresources to participate through knowledgeable representatives, byaffected individuals and groups in decisions that affect access tomedicines, including in drug regulatory decisions, decisions to grantor revoke patents on pharmaceuticals and in medicine pricedecision-making processes;
    7. States must take advantageof the operational flexibilities built into the TRIPS Agreement inorder to promote and protect the right to access medicines, such as theincorporation of compulsory licenses, the facilitation of parallelimports, the promotion of relaxing import duties, and establishingreasonable pricing norms for medicines where available and applicableto ensure the availability of medicines and technologies at affordableprices for treatment, care, and prevention of epidemic, endemic,occupational and other diseases;
    8. States must useutilize their law making, interpretation and implementation powers topromote the right to access to medicines, including by interpretingambiguous provisions in trade agreements, competition, intellectualproperty and other laws to promote the right to access needed medicines;
    9. States must, individually and together with other developed anddeveloping countries, work to design and implement research anddevelopment programmes and systems that ensure that needed medicinesare developed to address diseases and conditions that are neglected bytraditional patent-based incentive systems;
    10. Statesmust actively promote and facilitate innovation, research, anddevelopment of new medicines and medical technologies through,including but not limited to providing direct funding for the promotionof public research, providing incentives to the private sector throughtax credits, patents, or other mechanisms that reward innovation, andencouraging technology transfer between developed and developingcountries.

Involvement of other entities

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

Calls uponthe Working Group on Economic, Social and Cultural Rights to adoptwithin its principles and guidelines a mandate to investigate, monitor,and implement access to medicines in state parties to the AfricanCharter;

Delegates tothe Working Group on Economic, Social and Cultural Rights theresponsibility to establish structural, process and outcome indicatorsfor monitoring and assessing the right to access to needed medicines ineach member State of the African Union;

Requeststhe African Union to provide the Working Group on Economic and SocialRights with all the support and assistance necessary to implement thismandate;

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

Conclusion


3comments:


Sean Flynnsaid...

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 beforethen 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 Vawdasaid...

Congratulations on a very comprehensive draft. My only complaint isthat it is rather long, although I can see the wisdom of specifying asmuch detail as possible to avoid the problem of conflictinginterpretations at the implementation stage. Having said that, I wouldpropose a few small additions:
1. Under State obligations,recognizing/fulfil/3c/national health strategy: perhaps a reference toa 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 textof the resolution already contains the ‘demands’ (sorry, requests!) onstates, perhaps an inspirational concluding sentiment like ‘Africacan/must rise to the challenge’?

Andy Graysaid...

Firstly, a question of strategy: given the target audience for theResolution, is the choice of mostly American and European instrumentsunder the preambulatory section "Drawing inspiration" necessary? Mightthis not distract from the more powerful, universal instruments? Arethere elements in any of these that are particularly important, and ifso, can these be listed separately?

Then, some minor issues of detail:

1.Under State Obligations, the first "call" - point 1 - shoukd this notread "This duty includes measures to make currently existing essentialmedicines available within their borders as well as ...", as noobligation should exist to make ALL existing medicines available?

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

3. Point4 - can this be reworded to make it clear that States are under anobligation to provide for an effective regulatory system that ensuresthat 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 acceptableregulatory authorities, but does not place the obligation unfairly onthe persons responsible for administration of medicines, at the pointof 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 "safeuse" or "quality use"? The traditional term would have been "rationaluse", but that is slowly being replaced.

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




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

 

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

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

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

4.After Findings, Clause 9: Insert a clause saying, "Recognizing thathigh prices of medicine can occur because of high prices frommanufacturers, because of tariffs, customs fees, and value-added andsales taxes, and because of high mark-ups at the wholesale and retaillevel;"

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 tohealth not only with respect to the treatment of disease but withrespect to its prevention as well;" & "Recognizing the importanceof medicines in palliative care and in the prevention of unnecessarypain 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 externalmigrant 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 unreasonablyhigh costs for access" with "unreasonably high costs that restrictaccess"

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 bothways. In S. Africa, when a right of regulatory and oversight wasproposed for Manto, health advocates resisted strongly. We want drugregulatory decisions made reliably on the best possible scientificinformation."

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) Statesshould adopt legislation and regulatory reforms that give them to rightto exercise any and all TRIPS flexibilities including standards forpatentability, exclusions and exceptions, compulsory licenses andgovernment use (including Aug. 30 System), parallel importation, earlyworking, etc. and (2) State should use such flexibilities to increaseaccess to affordable medicines."

15. After State Obligations,Clause 2, Section 3.h.: Insert FOUR clauses saying, "States increaseaccess to information about the patent status of medicines by requiringpatent holders to file all relevant patent information for eachpatented medicine with a publicly accessible, internet searchable database; and likewise increased publicly available access to internetsearchable information on the registration status of medicines" &"States must enact legislation to accelerate access to essential lifesaving medicines by expediting the regulatory review and registrationof such medicines, for example by reliance on the fact that themedicine has been prequalified by the WHO Prequalification Programme orbeen approved for marketing by a stringent drug regulatory agency;"& "States must enact legislation that incentivizes both originatorand generic drug companies to register their medicines for use;" &"States must work together with regional partners on drug regulatorystandards and on procedures for drug registration and pharmocovigilenceto ensure safety and quality of medicines throughout the distributionsystem;"

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

 

 

 

 

 

 

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