WHO Assembly analysis

1 July 2003. Related: Treatment access.

Brook K Baker, Health GAP

Now that the dust has settled at the 56th World Health Assembly (WHA), it might be useful to analyse what if any progress is likely at the World Health Organisation (WHO) in the battle against HIV/AIDS. Others may certainly have things to add (or to disagree with), but here’s my take on the Assembly.

A full commitment to three million by 2005

The most promising outcome of the Assembly was the statement by the newly elected Director-General, JW Lee, that he “committed” the WHO to achieving the Barcelona goal of “three by five”, or three million people living with HIV/AIDS in developing countries put onto antiretroviral treatment by the end of 2005.

Although the written version of his prepared remarks were less direct (“I will ensure that WHO provides leadership toward the bold “three-by-five” target”), his speech, by my memory anyway, was more concrete. This goal, of course, cannot be reached without adequate financing, a matter of some desperation at this point given the near bankruptcy of the Global Fund.

However, it also cannot be reached unless there is a sea change in the planning process whereby developing countries get “technical assistance” on utilising all existing programmatic capacity on HIV/AIDS treatment, care, and prevention and further technical assistance on capacity building within the health care sector. (It is interesting to note that in the passed resolution, the World Health Assembly backed away from “endorsing” the three-by-five goal and instead is “bearing it in mind” the weak will and scepticism of some European countries.)

In its report on “WHO’s contribution to the follow-up of the United Nations General Assembly special session on HIV/AIDS,” the Secretariat stated that:

“WHO is working with an international coalition of partners to draft and implement a plan of action for extending access to ARV treatments to three million people by 2005. The plan will include technical assistance and information sharing to guide countries in implementing national treatment programmes.” (Paragraph 16.)

Health GAP and other activists at the WHA urged the Director General to issue this plan as soon as possible, hopefully by the September United Nations review of the UNGASS (United Nations General Assembly Special Session on HIV/AIDS) Declaration of Commitment. Despite the value of a global plan, however, the real test of the WHO’s newfound commitment to three-by-five will be the technical assistance it provides on the ground in individual countries to national health ministries and other stakeholders. As many know, Health GAP considers the lack of technical assistance concerning scale-up and capacity building to be a key obstacle to the realisation of universal access to treatment by 2010 (50% coverage by 2005 and an additional 10% each year thereafter). Fortunately, the Director General is committed to bringing in new staff that will collaborate with health ministries and others to customise scale-up and capacity building plans to local circumstances. This will be challenging work, but the Secretariat actually envisions much less work in Geneva and much more work in country, calling this initiative a “commitment to results at the country level.” In support of this approach, the Assembly, in its Resolution on a Global Health Sector Strategy for HIV/AIDS, passed a provision which requests that the Director-General “support, mobilise, and facilitate efforts of Member States and other concerned parties” to achieve the three-by-five goal.

Funding the Global Fund and technical assistance to Country Coordinating Mechanisms – mixed success

Health GAP, Act Up Paris, and other Fund-The-Fund allies had a goal of getting the Assembly to endorse a dues-based commitment to full funding of the Global Fund to Fight AIDS, TB and Malaria, but activists were not successful in getting explicit language to that effect. Instead, there is a veiled reference in the final HIV/AIDS resolution: Member States are exhorted, as a matter of urgency, “to take all necessary steps, including the mobilisation of resources, to fulfil their obligation under the [UNGASS Declaration of Commitment].”

Since the UNGASS Declaration had acknowledged the need for funding levels of $7-10 billion for HIV/AIDS alone by 2005, and since those numbers have been expanding, based on more precise calculations and on the inclusion of capacity building goals and coverage of TB and malaria (eg WHO Commission on Macroeconomics and Health), the context of this statement is clear – the global fight against HIV/AIDS is still grossly underfunded, particularly at the Global Fund which has virtually no resources to commit to an estimated $1.6 billion of new, high quality proposals expected in round three (due date 31 May).

Another way to energise the Global Fund and to demonstrate the extent of unmet need and capacity is for developing countries to become bolder in submitting robust treatment proposals to the Global Fund whereby they request scale-up and capacity building in a much more dynamic way. Countries have been discouraged from doing so so far because of persistent underfunding of the Global Fund, first by the US and then by other rich donors. When subtle messages weren’t enough, donor representatives forced countries like Malawi to reduce the scale of their treatment proposals. And, of course, developing countries face their own crises of political commitment to AIDS treatment, especially given the uncertain sustainability of treatment programs initiated with Global Fund dollars.

To try to counteract this downward cycle of reduced expectations and suppressed demand, Health GAP and others have been trying to force the Global Fund to clarify that well-rounded proposals should ordinarily include robust treatment plans. Health GAP has also urged that developing countries’ Country Coordinating Mechanisms (CCMs) received technical assistance on crafting high quality treatment-focused proposals. Thus, in addition to providing technical assistance on capacity utilisation and expansion, the WHO’s AIDS Strategy Resolution also addresses helping CCMs file robust proposals to the Global Fund. Health GAP had urged the Secretariat to be proactive in providing technical assistance to CCMs, but the conservative politics at the Assembly resulted in a resolution that conditions technical assistance on countries asking for it. Hopefully the message will get out to countries that they can’t not ask.

Pre-qualification

Health GAP, Health Action International (HAI) and others at the Assembly argued that the WHO’s drug pre-qualification system should be strengthened and extended.

Unfortunately, there was no formal resolution on the Medicines Policy and activists were unsuccessful in getting a statement on pre-qualification squeezed into the AIDS Strategy Resolution. Nonetheless, the importance of enhancing the pre-qualification process, of adding resources, and of providing more pro-active assistance regarding registration of generics, including those with fixed dose combination, was discussed informally with the secretariat and was raised from the floor during the medicines policy debate. However, this programme, critical to the fast-track registration of generic ARVs in developing countries, is crucial and its progress should be carefully monitored.

Access to medicines – prioritising health over intellectual property

The last major issue at the WHA, from a treatment access perspective, was the “Report by the secretariat on intellectual property rights (IPR), innovation, and public health.” As Jamie Love has already reported, this was a pretty disappointing document both with respect to product innovation and with respect to access to medicines. Fortunately, Brazil and other developing countries became active at the Assembly, with constructive intervention from NGOs, in developing a resolution for submission to the General Assembly. The US badly miscalculated its hand and submitted a truly brutal proposal that championed the expansion of intellectual property rights as the only mechanism for spurring innovation. The US went so far as to ignore the adoption of the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health, and thus was condemned publicly and privately for its IPR hubris.

In the end, the resolution that passed: (1) reaffirmed “that public health interests are paramount in both pharmaceutical and health policies,” (2) urged Members states “to consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in [TRIPS],” (3) urged Member states to “maintain efforts aimed at reaching, within the WTO and before the fifth WTO Ministerial Conference, a consensus solution for paragraph six of the Doha Declaration, with a view to meeting the needs of the developing countries,” (4) requesting the Director-General to support member states in the exchange and transfer of technology, especially with respect to antiretrovirals and other medicines to control tuberculosis, malaria, and other major health problems, and (5) to cooperate with member states, at their request, in monitoring and analysing the pharmaceutical and public health implication of relevant international agreements, including trade agreements.

In this regard, it is also useful to note that China succeeded in inserting two access to medicines provisions in the AIDS Strategy Resolution: (1) reaffirming that public health is paramount in both pharmaceutical and health policies and recognising difficulties developing countries have utilising compulsory licenses and, when necessary, using flexibilities in TRIPS to access medicines against HIV/AIDS and (2) urging the Director-General to mobilise support of actions taken by countries with an AIDS epidemic to obtain affordable and accessible drugs to combat HIV/AIDS.

With respect to IPR issues, the IP and AIDS Strategy Resolutions as passed contained three major deficits. First, the Resolutions did not directly encourage the Director-General to continue to intervene in WTO negotiations from a pro-public health perspective, especially concerning the desirability of utilising an Article 30 solution for the production-for-export problem. Given the rambling attack by the US from the floor about the WHO’s intervention to the TRIPS Council on 17 September 2002, it is obvious how important such interventions might be in crystalising the best response to paragraph six problems. Second, the resolutions did not directly address the obligation of the WHO to monitor bilateral and regional trade agreements and to provide technical assistance to developing member states about avoiding TRIPS- and Doha-plus intellectual property protections. This issue is referenced in paragraph 19 of the secretariat’s IP Report where it acknowledges that bilateral and regional trade agreements frequently fail to reflect the need for special treatment for health-related products. Finally, Health GAP and other activists had requested that the WHO provide technical assistance to developing countries concerning revision of their intellectual property laws to make maximum use of the flexibility in the TRIPS Agreement and in the Doha Declaration. At present, WIPO and USAID provide “Trojan-horse” technical assistance that is strongly biased towards enhanced, TRIPS-plus IP protection. To counteract this disabling assistance, the WHO should beef-up its capacity to provide concrete technical assistance on national IP reform (including roll-back of premature TRIPS compliance or of TRIPS-plus legislation) and on strategies for issuing compulsory licenses on essential AIDS medicines.

Obviously, the intellectual property debate is the most highly political and contentious area of policy for the WHO in its battle against the AIDS pandemic. No one would gladly get in a fight with the US and with Big Pharma on these issues because they fight long and dirty to maximise pharmaceutical hegemony for patent holders. However, activists will need to continue to place pressure on the WHO to assist people living with HIV/AIDS in their long struggle to access affordable medicines, which increasingly means accessing low cost, quality generics, whether produced locally or imported. Intellectual property is at the centre of this conundrum, and it must continue to be addressed by the WHO and others.