Health GAP Briefing Paper
www.globaltreatmentaccess.org | www.healthgap.org

I. Where is the plan for treating 3 million people with HIV by 2005?

The World Health Organization has a mandate to devise a concrete, ambitious plan for responding to the HIV/AIDS pandemic. WHO has asserted that the world can and should treat 3 million people living with HIV in developing countries with antiretrovirals (ARVs) by 2005, but to date it has provided little vision, no credible framework, and insufficient technical assistance to achieve this goal.

At minimum the world's premiere public health institution has an obligation to create a "global roadmap" for scaling up access to comprehensive HIV/AIDS treatment, care, and prevention, aiming for universal access by 2010.

Implementing a "global roadmap" is only possible if WHO mobilizes forces and creates an action plan for providing expert technical assistance so that poor countries can map achievable targets to utilize and scale-up under-resourced capacity as quickly as possible. The WHO should continue to provide cost estimates for comprehensive scale-up, to provide a funding mandate for donor nations to fulfill their promises to equitably fund the Millennium Development Goals, the goals articulated in the UNGASS Declaration of Commitment, and the Global Fund to Fight AIDS, TB, and Malaria (Global Fund). Moreover, the WHO should provide competent technical assistance for the dynamic escalation of ARV treatment proposals to the Global Fund and should endorse an equitable funding framework for donor contributions to the Global Fund and to other global AIDS initiatives. Finally the WHO should enhance its drug pre-qualification efforts and take a firmer public stand on the priority of the right to health and access to medicines over intellectual property rights.

II. Articulate a Vision and Plan for Universal Coverage of HIV/AIDS Treatment by 2010:

At the XIV International AIDS Conference in Barcelona (2002), the WHO has set an initial, attainable goal of treating 3 million people with anti-retroviral (ARV) therapy by the end of 2005. This figure represents 50% of people living with HIV/AIDS in clinical need of ARVs who would ordinarily die within two years in the absence of ARV therapy. However, WHO has provided no vision beyond 2005 for the continual scale-up of the number and percentage of people in clinical need who should be treated if the world devoted sufficient resources. Therefore, we call on the WHO to set a goal of treating an additional 10% of people living with AIDS each year until by 2010 the goal of 100% universal coverage is reached. That gives the WHO and the world at large seven long years to plan and then implement robust and comprehensive programs for treatment, care, and prevention.

III. Provide Technical Assistance for National Treatment Plans:

To reach these progressive and achievable goals, the WHO is responsible for providing collaborative technical assistance to developing countries to accurately assess existing health care capacity. Although WHO is currently assessing recipient countries' absorptive capacity for the Global Fund, WHO needs to dramatically expand its technical assistance so that each poor and middle income country can create a National AIDS Program that steadily expands public health sector capacity with the goal of providing universal HIV/AIDS treatment by 2010. This technical assistance should be driven by country demand, but, on the other hand, the WHO should offer a template of technical assistance subject matter to help guide the collaboration. In addition to amassing a team of TA experts in Geneva, the WHO should plan for secondment of such experts to national health departments as they plan and implement treatment plans. The components of technical assistance for a national treatment plan will be varied, but they include at a minimum:

A. Testing, prevention, and treatment

* Plan for dramatic-scale up of voluntary counseling and testing (VCT) through site selection, training of counselors (lay and professional), utilization of low-cost quick tests, record keeping, and referral to prevention counseling, support groups, and treatment programs as appropriate. It is expected that VCT can expand from its existing base in MTCT programs to a coordinated national network of VCT facilities.

* Address stigma reduction, treatment literacy, and treatment advocacy by and for people living HIV/AIDS since the success of VCT scale-up will depend on a dynamic program of treatment preparedness. Language appropriate treatment literature and education programs should prepared and widely distributed with the goal of creating community-based support for treatment, care, and prevention efforts.

* Develop simplified treatment protocols appropriate to local circumstances in resource poor settings relying in substantial measure on new WHO Guidelines. In addition to proposing a comprehensible array of first-line therapies, favoring fixed-dose combination therapies as appropriate, treatment protocols should address clinical assessment and blood test protocols for initiation of ARV therapy and for monitoring side effects and viral resistance. Protocols should also address treatment of opportunistic infections and prophylactic treatment with cotrimoxazole, isoniazid, and other appropriate medicines. As WHO Guidelines are field-tested, they should be regularly updated.

* Plan for coordination with the private sector, which should bear its fair share for the treatment of its workforce and dependants; plan for continuity of care.

B. Strengthening national health infrastructure and human resources:

* Plan for building additional health care facilities, for training health care workers, and for training trainers.

* Plan for the survival, retention, and expansion of health sector workforce. In addition to prioritizing ARV treatment for health care workers, countries should address salary inequities that divert health workers to the private sector and that encourage emigration. Recruitment of health care workers from HIV-impacted nations should be declared unlawful.

* Plan for health sector budget allocations sufficient to pay national share of improvements to public health sector, including appropriate raises for public health care workers if necessary to ensure retention. Plan for budgeting and fiscal management of funds received from the Global Fund and from bilateral donors.

C. Developing a national medicines and procurement policy:

* Plan for procurement of lowest-cost, quality medicines including:

- Local production of generic medicines pursuant to compulsory licenses or otherwise, assuming sufficient and efficient production capacity
- Importation of generic medicines where no patents are on file or where a compulsory license has been issued, enabled by legislative reform simplifying issuance of compulsory licenses for local production or importation pursuant to maximal flexibilities in the TRIPS Agreement and the Doha Declaration
- Bulk procurement by international, regional, or local entities based on competitive and transparent bidding
- Least developing countries should not endorce pharamceeutical patents at least until 2016 (As specified in the Doha Declaration on TRIPS and Public Health).
- Utilization of parallel importation, enabled by legislative reform permitting international exhaustion if necessary

* Establish and/or update a National Essential Drug List to include ARVs and OI medicines

* Fast track registration of AIDS medicines based on WHO Pre-Qualification

* Provide for quality assurance and spot-checking of drug supplies.

* Establish a strong distribution system with safeguards against diversion and spoilage and with safeguards against price-gouging by intermediate distributors.

* Eliminate taxes and tariffs on imported AIDS medicines

D. Human rights and social support:

* Plan a human rights agenda clarifying that the right to health is fundamental and that people living with HIV/AIDS should not be subjected to any form of discrimination.

* Plan for regular consultations with people living with HIV/AIDS for program input and for monitoring program effectiveness.

* Plan for social subsidies to people living with HIV/AIDS.

* Plan for orphan care.

* Plan to meet nutritional needs of people living with HIV/AIDS.

IV. Provide Technical Assistance for Proposals to the Global Fund:

The WHO is well suited to provide technical assistance to poor and middle-income countries with respect to drafting robust treatment proposals to the Global Fund. At present, many recipient countries have been discouraged from submitting proposals for dramatically increased treatment because of donor countries' efforts to under-fund the Global Fund and to discourage large-scale treatment plans. WHO should play a pivotal role in catalyzing treatment scale-up proposals to the Global Fund at the same time that they help poor countries frame and implement their national treatment plans.

V. Endorse an Equitable Donations Framework:

The WHO should endorse the principle that donor nations are obligated to provide funding for the global AIDS agenda pursuant to an equitable donations framework. Basically, each country should agree to pay its fair share based on its proportion of the global economy. However, poor countries with struggling economies, high debt burdens, and fiscal austerity measures will find it difficult to pay even their small share, except perhaps by their efforts to enhance public health sector capacity and to improve national systems for program delivery. Thus, donor countries might also need to enhance their equitable share somewhat to make up for the fiscal limitations of poor countries.

VI. Enhance Drug Pre-Qualification Process:

The WHO made an important contribution to the realization of global treatment goals by having initiated the drug pre-qualification process. However, the WHO needs to become more proactive in assisting generic drug producers in their registration and pre-qualification efforts and in expediting the pre-qualification process. The pre-qualification process in particular can play a crucial role in the development of fixed dose combinations of ARV's that presently do not exist. Achieving increased efficiency will require additional expert resources and monetary commitments. The WHO should also pre-qualify procurement agencies.

VII. Challenge intellectual property rights that impede public health and access to medicines: implementation of the Doha Declaration on the TRIPS Agreement and Public Health:

The WHO should increase its advocacy for measures that prioritize public health and access to medicines over intellectual property protection. In particular, the WHO should use its expertise to overcome quickly the impasse at the WTO regarding compulsory licensing for countries with insufficient or inefficient domestic pharmaceutical manufacturing capacity in a manner that prioritizes public health and not commercial interests. The WHO should evaluate and respond to the likely public health impact of new and emerging regional and bilateral trade agreements containing ÒTRIPS-plusÓ provisions. Finally, the WHO should provide countries with technical assistance in developing and amending national intellectual property policy to prioritize public health and access to medicines and to make maximum use of the flexibility the Doha Declaration permits. This resource will help offset technical assistance currently being provided by WIPO (World Intellectual Property Organisation) that supports countries' s of strong intellectual property protection, no matter the impact on health and access to medicines.

Health GAP calls on the WHO to use its observer status at the upcoming TRIPS Council (3-4 June) to support a solution to the Òparagraph 6Ó problem that is economically viable, is not restricted in disease scope, and that poor countries can use quickly and easily.