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Africa: Obstacles to AIDS Treatment

AfricaFocus Bulletin
Nov 5, 2004 (041105)
(Reposted from sources cited below)

Editor's Note

There is now a wide international consensus that providing AIDS treatment to all in need of it is essential, along with prevention. But the obstacles are substantial, including lack of resources but also flawed policies and lack of political will. Among particular barriers are the failure to make full use of generic drugs and the policy of user fees that further restricts access.

This AfricaFocus Bulletin contains (1) a strong statement by the Ecumenical Pharmaceutical Network, representing Christian medical associations and hospitals in Africa, which calls on the U.S. government to abandon its policy of insisting on U.S.-approved brand-name drugs in its support for overseas AIDS programs, and (2) an international call from AIDS professionals for a policy of free access to a minimal package of care, including antiretroviral drugs (ARVs) as well as other necessary measures. The "Free by 5" statement requests additional individual and organizational signatures by November 20. To sign on, see the contact information below.

In related actions, the Treatment Action Campaign in South Africa again took the South African government to court yesterday, with a renewed demand for transparency on the government plan to provide AIDS treatment. See http://www.tac.org.za for the TAC statement and other background.

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Update: For several commentaries on the effects of the U.S. election on U.S. policy towards Africa, see the Nov 4 issue of Pambazuka News at http://www.pambazuka.org/index.php?issue=181 The bottom line: more of the same.

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A Statement of the Ecumenical Pharmaceutical Network (EPN) on the President's Emergency Plan for AIDS Relief (PEPFAR)

Moshi, Tanzania, October 7th, 2004

Contact Ecumenical Pharmaceutical Network, Nairobi, Kenya Tel: +254-20-4444832/ 4445020; Fax: +254-20-4445095/4440306 Email: epn@wananchi.com; Website: http://www.epnetwork.org

The Ecumenical Pharmaceutical Network (EPN), comprised of Christian Health Associations and hospitals, non-profit drug supply organisations and church related development agencies, from 22 countries attending our Annual General Meeting held from 5th - 7th October 2004 in Moshi, Tanzania issues this statement on the US President's Emergency Plan for AIDS Relief (PEPFAR).

We recognise and acknowledge that scaling up medical assistance and the care of the men, women and children in our communities who are infected and affected by the scourge of HIV/AIDS, must continue. Therefore, we welcome the initiative and the goals of the US emergency response to provide much needed resources for HIV/AIDS care and support; increase the number of patients under treatment; and, contribute towards the improvement of infrastructure required to fight HIV/AIDS. This gives hope for people living with HIV/AIDS.

However, as a network of health care service providers, we express our deep concern over some aspects of PEPFAR which have been identified as generally applicable, but to varying degrees in individual beneficiary countries:

  1. PEPFAR's insistence on FDA approval for all medicines purchased and the 'buy American' requirement for medicines other than ARVs, causes needless delay in making life-saving drugs available and may be inconsistent with national treatment protocols.
  2. PEPFAR's overwhelming preference for brand-name drugs and the barriers to the use of more affordable generic ARVs and drugs for opportunistic infections raise four major concerns:
    • It introduces a situation where patients are given different brands of the same drug thus creating a multi-cadre patient system in an institution, leading not only to misunderstandings but also a lot of additional work for an already overstretched health staff.
    • It will be difficult for the institutions to continue providing the same treatment at the end of the PEPFAR programme.
    • Using drugs approved only by the FDA may kill the local industries and threaten the sustainability of the already existing drug supply chains. This is particularly true of drugs against opportunistic infections, which are produced locally at affordable prices.
    • Use of expensive branded products, where equally good but cheaper alternatives are available, is not a cost effective use of resources.
  3. In some cases, PEPFAR disregards national drug regulations and local supply chain management systems, which could damage national health systems, especially the pharmaceutical sector.
  4. Treatment requires a lifetime commitment, yet there is currently no long-term strategy to provide a continuance of care at the end of the programme. The high level of donor control and little or no country or local ownership further undermines the sustainability of health care and other services.
  5. In its current form, the implementation of PEPFAR promotes extensive use of US skills and capacities (personnel and institutions) to the detriment of available local expertise with greater understanding of the issues in their local contexts.
  6. There is excessive delay caused by the inherent bureaucracy and conflicting operational rules and regulations. Cumbersome and time consuming documentation requirements; complicated procurement procedures for drugs and other needed items and restrictive expenditure regulations, frustrate and undermine the efforts of institutions trying to implement PEPFAR.
  7. The implementation of PEPFAR is predominantly unilateral, undermining other international efforts such as the '3 ones' (one co-ordination, one strategy and one monitoring/evaluation) and the UN Prequalification Project managed by WHO.

In light of the above, we make the following recommendations:

  1. PEPFAR should remove the restrictions of its funds to purchase only medicines approved by the FDA and the 'buy American' clause and instead allow the purchase of nationally approved medicines, generics or brand-name drugs, and antiretrovirals pre-qualified by the WHO.
  2. PEPFAR should address fears of local drug management and supply institutions that they will be harmed by PEPFAR, and commit to strengthen and improve local structures and systems.
  3. PEPFAR should hold extensive consultations with local partners in all areas of the programmes including policy formulation, planning, design, preparation of terms of reference and actual project implementation.
  4. PEPFAR should regularly meet with community constituted advisory and oversight bodies comprised of people living with HIV/AIDS, FBO's involved in medical delivery, and health care experts among others.
  5. Immediate discussions should start between PEPFAR, other donors, governments and implementing partners on the sustainability of services beyond 2008.
  6. PEPFAR should actively identify and involve local experts resident in the partner countries for the effective implementation of activities.
  7. PEPFAR should dialogue with local implementing partners with a view of recognising and accepting available and relevant local data or data collection systems and the simplification of documentation requirements.
  8. PEPFAR should co-ordinate more effectively with existing international HIV/AIDS programmes including the Global Fund and the WHO '3 x 5' to ease implementation and avoid duplication at local level.

We the members of EPN, in the spirit of goodwill and solidarity, further affirm that the fight against HIV/AIDS deserves concerted effort from all partners to ensure sustainability, effective use of resources, expanded local capacity, empowerment of people living with HIV/AIDS and provision of treatment for as many people as possible. In view of the above, we commit ourselves to play our part in making sure that the PEPFAR programme is implemented to the best interest of those served, the implementing partners and the funding agency.

This statement has been signed on behalf of Ecumenical Pharmaceutical Network.

Mr. Albert Petersen, Chair EPN Board

Dr. Eva M A Ombaka, Coordinator EPN


Free by 5: International Sign-on Statement in Support of Free AIDS Treatment

From: Gorik Ooms, MSF-Belgium gorik@tiscali.be

Dear friends,

HIV/AIDS treatment including anti-retroviral therapy is increasingly available throughout the developing world. However, the drugs and associated laboratory tests are rarely provided for free. Most people living with HIV will die simply because they cannot afford the contribution which is sought from them.

There is evidence that user-fees for AIDS treatment are barriers to equity, efficiency and quality of treatment programs. They threaten the possibility of scaling up these programs.

We believe that, for human rights, public health and economic reasons, there should be free access for all to a comprehensive minimum medical package, including ARVs.

Faced with the emergency and gravity of the situation, people from HEARD, IRD, MSF-Belgium and others have developed the 'Free by Five' declaration to emphasize the necessity of free treatment.

The ultimate objectives of the Free by 5 Declaration are:

a.. to provide economic and public health evidence that could help inform the decisions of policy makers and governments on the issue of free treatment;

b.. to urge UNAIDS, WHO, the Global Fund, the World Bank, PEPFAR and other donors to adopt guidelines and actively promote the principle and implementation of free treatment;

c.. to assist activists and others in their advocacy efforts to obtain free treatment.

We are asking for your commitment to the principle of free HIV/AIDS treatment. Please sign the "Free by 5" Declaration.

If you wish to sign the declaration please:

1.. Send an email to Sabrina Lee (Freeby5@hotmail.com) before the November 20th deadline;

2.. State your name, position, organization and contact details;

3.. Indicate whether you sign on behalf of your organization or as an individual.

The first signatories of the declaration include: Stephen Lewis, UN Special Envoy for HIV/AIDS in Africa; Alice Desclaux, M.D., Professor of Anthropology and Director of Research Center on Culture, Health and Societies (CReCSS), University Paul C‚zanne, Aix-Marseille, France; Helene Rossert-Blavier, Director of Aides (France), Vice-President of the Global Fund to fight AIDS, Tuberculosis and Malaria; Gorik Ooms, Executive Director, MSFBelgium; Bernard Taverne, Anthropologist, M.D., Institut de Recherche pour le Developpement, Dakar, Senegal; Alan Whiteside, Professor and Director of Health Economics and HIV/AIDS Research Division (HEARD), University of KwaZulu-Natal, Durban, South Africa; and Nicoli Nattras, Professor of Economics and Director of Centre for Social Science Research, University of Cape Town, South Africa;

Signatories will be updated regularly on the website http://www.heard.org.za where the declaration is available in English and in French. The declaration will be launched at a series of events at the end of November 2004.

We look forward to receiving your support,

Gorik


Free by 5

Economists', public health experts' and policy makers' declaration on free treatment for HIV/AIDS

[Excerpts from statement. For full statement, including footnotes and answers to counter-arguments, visit http://www.heard.org.za]

We, economists, public health experts and policy makers involved in the fight against AIDS are committed to scaling up access to healthcare, including ARVs, for HIV positive people with the objective of universal access. We consider it a rational economic decision and an absolute priority.

We believe that a prerequisite for ensuring that treatment programs are scaled up, equitable and efficient, and provide quality care, is to implement universally free access to a minimum medical package, including ARVs, through the public healthcare system.

We believe that the treatment package should include HIV tests, prophylaxis and treatment of opportunistic infections, all laboratory and associated examinations, consultation and hospitalisation fees, and ARVs.

We argue that WHO, UNAIDS, the governments of resource-poor countries and international donors, among them the Global Fund, the World Bank, PEPFAR and bilateral cooperation agencies, must adopt and actively promote the principle of universal free access to treatment (including ARVs) and contribute to its implementation.

We urge that additional resources be mobilized through long-term commitments. These should come mainly from donor funding, with the contribution of other stakeholders. Governments in resource-poor settings should engage in an appropriate allocation of domestic resources to show commitment to achieving this goal.

We are committed to promoting the principle of free treatment, and to contributing to its implementation. Otherwise, the idea of universal access will remain a dream.

Introduction

There is consensus on the necessity of providing healthcare in general, and ARV programs in particular, for HIV positive people in resource-poor settings.

In June 2001, the United Nations General Assembly Special Session on HIV/AIDS unanimously adopted a Declaration of Commitment recognizing that: "effective prevention, care and treatment will require behavioural changes and increased availability of and non-discriminatory access to (...) drugs, including anti-retroviral therapy, diagnostics and related technologies".

...

Treatment is justified on economic grounds and for human rights reasons. If we fail to provide it, societies face catastrophe.

...

The goal set by WHO is to have 3 million people on treatment by the end of 2005. There are, of course, major concerns around the scaling up of access to treatment. What it will cost, who will do it and how it will be done are still being debated, and we have much to learn. How can these programs improve the uptake? How can they reach the most vulnerable and poor populations? How can they achieve a high level of adherence to ARV treatments in order to avoid resistance?

We are faced with many uncertainties but we also have some evidence. This declaration sets out a principle we all should subscribe to and apply: the principle of a comprehensive minimum package of treatment provided free to all the people living with HIV/AIDS.

...

The current situation: many patients are being asked to pay for their treatment. ... in the vast majority of resource-poor countries, access to treatment is not free.

In Senegal, ARVs, CD4 counts and viral load tests are free, but other laboratory exams required to initiate therapy have to be paid for and are a major obstacle to access to ARVs. Laboratory exams and drugs for opportunistic infections are not free either. People who would qualify for free drugs cannot afford the tests to obtain them and may die of opportunistic infections despite the fact they have free access to ARVs.

In other countries ART is heavily subsidized, but a monthly contribution is sought from patients: in Burkina Faso patients are expected to contribute 8,000 FCFA per month (12 euros); in Cameroon the current cost for the patient is between 15,000 and 28,000 FCFA (between 23 and 43 euros)[11]; and Niger, in its proposal presented to the Global Fund, will have a range of contributions from 8 000 FCFA (12 euros) to 75,000 FCFA (114 euros) according to the patient's income.

The cost of drugs for opportunistic infections, laboratory exams, consultations and hospitalisation fees must be added to these contributions.

A study in Senegal assessed the cost to patients and found that those on ARV treatment had to pay an average of 5,200 FCFA per month (7,9 euros)[12], i.e. 95 euros per year for their medical expenses additional to the cost of ARVs. ...

These examples give an idea, however imprecise, of the burden of medical expenses on the patients' and their families' finances.

Why do we need free treatment?

There is evidence that user fees in healthcare pose a wide variety of problems, which will worsen in the case of HIV. Therefore, there are many reasons for the provision of free HIV/AIDS treatment: among them are public health and ethical arguments.

Uptake

In order to reach a large number of people, most of them living below the poverty line, and to achieve the 3 x 5 goal, treatment will have to be free. It is unrealistic to believe that treatment programs can be scaled up otherwise. Free treatment is a prerequisite for the achievement of universal access.

Equity

Research shows that even when the contribution sought from the patient for ARVs is small, some are excluded because they cannot afford it. Therefore, providing free treatment will help poor people to have access.

We are fully aware that giving free access to HIV treatments will not be sufficient to achieve equity in these programs, and far more needs to be done. In particular, the needs of the most vulnerable groups must be addressed. But providing treatment free of charge is a necessary condition for the achievement of equity.

Efficiency

Research in Senegal shows the main reason patients were not adherent was that financial problems led to treatment interruptions. In Kenya, patients have discontinued ARV treatment due to lack of money. Adherence must be high in order to avoid resistance and ensure long-term benefit for the patient. Providing treatment for free will contribute to adherence.

Moreover, free treatment is the best way to reduce demand for antiretroviral drugs on the informal market, misuse and consequent viral resistance and to minimize the number of people lost to follow up. Finally, paying for care causes delays in health seeking when, ideally, HIV patients should come at the early stage of illness to optimize the outcome of treatment. Providing treatment for free will contribute to adherence and efficiency at the individual and population level.

...

The poor are the majority

In resource-poor settings the poorest are not a minority! In Senegal, 60% of the population lives below the poverty line; in Botswana, it is 50,1% of the population, in China 47,3%, in India 79,9%, in Ivory Coast 49,4%, in Nigeria 90,8%, and in Uganda 96,4%. If the vast majority of the population is eligible to free treatment, what is the rationale for exemptions that will be costly to put in place and administer?
...

Exemptions or waivers systems are not cost-effective

Finally, the process of defining who gets free treatment and who will not is a resource-consuming process. It takes time, money and personnel, and the amount of money collected is usually not worth it. ...

For all these reasons we believe that treatment should be provided free of charge to all people living with HIV and AIDS, regardless of their socio-economic status.

What is to be made free?

If treatment is to be free then more than drugs are needed. The question of what is to be made free is a big issue, and needs further research, reflection, and international guidelines. At this stage, we propose a minimum package that should be made available free through the public healthcare system.

This should include:

  • HIV tests
  • Consultations with medical staff
  • Laboratory examinations (according to WHO medical guidelines or to national medical guidelines if they are more extensive)
  • Hospitalisation
  • Treatment of common opportunistic infections
  • Prophylactic treatment
  • ARVs

...

Who will pay for it?

The total cost of providing treatment through the 3 by 5 initiative alone ranges from $5.4 to $6.4 billion for the two years 2004 and 2005. UNAIDS estimates that the amount of money needed for treatment and care in 2005 is $3.8 billion, and this will increase to $6.7 billion in 2007. The amounts at stake will not change if free treatment is implemented.

Patients' contributions are marginal in the overall cost of programs because their ability to pay is very limited in a context of generalized poverty. Therefore the implementation of free treatment will not dramatically change the level of contributions asked of other stakeholders (donors, governments, etc).

Financing the response to HIV/AIDS is an enormous challenge, but it will not be heightened by the provision of free treatment.

We note with great concern that the funding gap involved in providing a comprehensive package of care through the 3 by 5 initiative was over $2.5 billion for 2004-2005 as of December 2003, and will increase in the years to come. Therefore we urge international donors, and other stakeholders to fund the minimum package through long-term commitments.

We further expect resource-poor countries to make the appropriate contribution. In April 2001, African leaders meeting in Abuja committed themselves to allocating 15% of their public expenditure to health. ...African leaders have endorsed these policy statements and must ensure they are implemented.

All stakeholders have the responsibility to work in partnership to ensure the provision of free treatment.

...


AfricaFocus Bulletin is an independent electronic publication providing reposted commentary and analysis on African issues, with a particular focus on U.S. and international policies. AfricaFocus Bulletin is edited by William Minter.

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