In-depth: The Treatment Era: ART in Africa
AFRICA: Show us the money!
AIDS activists have pushed for better access to generics and lower prices for brandname drugs
JOHANNESBURG, 6 December 2004 (IRIN In-Depth) - Protest emails flowed fast and furious in mid-November when AIDS activists at a meeting in Arusha, Tanzania, lobbied against a US-led drive to delay a new round of grants by the Global Fund to Fight AIDS, Tuberculosis and Malaria.
The United States, the largest contributor to the three-year-old Fund, raised concerns about its efficiency and accountability, the absorptive capacity of recipient countries and grants to rogue regimes like North Korea.
A compromise was reached in Arusha and a delayed new $1 billion round will take place next year. But the problem showcased the uncertainty under which the Fund operates, and the myriad AIDS-related activities it finances from Albania to Zimbabwe.
During four proposal rounds since its inception, the Global Fund has approved up to US $3 billion in grants to 128 countries - falling short of raising the $10 billion a year it set out to raise three years ago.
Meanwhile, the US Congress has set the US contribution to the Fund for 2005 at US $350 million, or $200 million less than in 2004. Activists read this as proof of Washington's "go-it-alone" approach to AIDS, eschewing multilateral institutions in favour of George Bush's President's Emergency Plan for AIDS Relief (PEPFAR), launched in 2003.
The controversial five-year $15 billion PEPFAR programme funds treatment, prevention, orphan and palliative care in 15 developing countries. (Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam and Zambia).
BRANDS VERSUS GENERICS
Its two most contentious issues are the preference for expensive brandname antiretrovirals (ARVs) instead of cheaper generic drugs, and abstinence and fidelity over condoms in prevention. Critics charge that PEPFAR protects the interests of big US-based pharmaceutical companies and the agenda of the Christian religious right.
Before the Arusha meeting, the Ecumenical Pharmaceutical Network (EPN), which represents Christian hospitals and charities in 22 developing countries, criticised PEPFAR's choice of brandname drugs for antiretroviral therapy (ART).
The health services of developing countries normally use generic drugs to treat AIDS. Adding branded ARVs creates a two-tier, multidrug regime system, which complicates procurement and supply lines, while burdening health professionals and community health workers, who have to administer different drug regimes, sometimes to patients in the same family.
Generic treatment uses a 3-in-1 fixed-dose combination pill taken once a day. Branded ART consists of several pills a day, which can complicate adherence and encourage pill sharing among family members, said EPN.
PEPFAR will not use generic ARVs that are not approved by the US Food and Drug Administration (FDA) - not even those approved by the World Health Organisation (WHO). Critics argue that the FDA is not the global arbiter of drug quality, and should reinforce WHO's stringent qualification process instead of shunning it.
Conceding the point, the FDA is fast-tracking approval of 3-in-1 generic medication for 2005. However, the US-based pressure group, Health Gap, says the FDA process is "a bottomless pit of enhanced approval criteria aimed at shutting out generics from approval", that will give drug companies time to develop 3-in-1 brand-name pills.
Earlier this year, generic ARVs got a boost with the release of results from the world's first open clinical study on the safety and effectiveness of a 3-in-1 pill, conducted in Cameroon by Medecins Sans Frontieres-Switzerland and the French agency for research on HIV/AIDS, in which Triomune, a drug produced by Indian manufacturer CIPLA performed as well as brand medicines.
After six months, 80 percent of patients, formerly at stage IV of AIDS (where the body's immune system has been incapacitated by the virus), had undetectable viral loads. "We know from our direct field experience that these generic fixed-dose-combinations are prolonging lives," said an MSF statement.
While the price of ARVs has fallen dramatically over the last few years - from $15,000 a year to $185 in South Africa - PEPFAR pays premium prices for its medicines. The Wall Street Journal reported in October that PEPFAR was paying more than twice as much for AIDS drugs than the World Bank or the Global Fund - the two other main funding sources for ART. Paying double the price equals treating half the patients, say critics.
It is the fall in drug prices that has brought what Dr Eric Goemare of MSF calls "a seismic shift" in the ability and willingness of governments to treat their citizens.
SHIFTING STRATEGY
Reacting to criticism, in May 2004 PEPFAR pledged to harmonise its AIDS work with other donors and governments. Ambassador Randall Tobias, head of the US Office of the Global AIDS Coordinator, promised "to respect local government decisions as to how to manage their HIV/AIDS programmes".
One example is Mozambique: it provides only generic ARVs and wants to stay that way. A multiplicity of drug regimes would further burden the rundown health infrastructure and scarce health professionals in one of the world's poorest countries.
"We can't have parallel systems and duplication of efforts in drug procurement, pharmacy, computerisation, monitoring and training," said Dr Mouzinho Saidi of Mozambique's National Programme to Fight HIV/AIDS. "Just think: patients and their doctors would be confined to the place where a certain ART is available."
The Mozambican government argued that PEPFAR should support the national strategy and not impose another. "We had long, tough, high-level negotiations but, eventually, we reached consensus," Saidi told PlusNews.
PEPFAR agreed to fund the non-pharmaceutical parts of ART, to expand ART sites, train health workers, improve labs, and ensure blood safety. It will also provide branded second-line ARVs (for patients with resistance to generic first-line ones) and paediatric ARVs, the two most expensive drug items.
PEPFAR's commitment to Mozambique for 2004 is $25.5 million, including funds for prevention, counselling, mother-to-child transmission, orphans and home-based care.
The EPN has recommended that PEPFAR coordinate more effectively with existing HIV/AIDS programmes. As the number of funding sources has grown, so has recognition of the need for harmonisation and streamlining of donor procedures to enable better utilisation of grants.
The so-called "three ones" - one national AIDS action plan, one national coordinating strategy, one monitoring system - are key to preventing duplication and identifying bottlenecks to aid flows, according to UNAIDS.
But the Global Fund has also been recognised as more than a funding mechanism. "The Fund is rewriting the rules on delivering assistance. It tries to marry the best of all other instruments: an emergency spirit, recipient-owned programmes, and participatory processes," Mabel van Orange, managing director of the Brussels-based Open Society Institute, said at the Bangkok AIDS conference.
Among the criticisms of PEPFAR is that it diverts potential financing from the Global Fund. "Donor governments need to view the Global Fund in the same way that they view their other national priorities, like contributions to international peacekeeping, or investments in domestic school systems," the International Council of AIDS Service Organisations said in a report released earlier this year.
[Resources: "Stepping Back from the Edge: The Pursuit of Antiretroviral Therapy in Botswana, South Africa and Uganda", (UNAIDS), 2003 - www.dec.org
"Assessment of First Year Efforts of the Global Fund to Fight AIDS, TB and Malaria", United States General Accounting Office - www.gao.gov
"A Comparative Analysis of the Financing of HIV/AIDS Programmes in Botswana, Lesotho, Mozambique, South Africa, Swaziland and Zimbabwe", 2003 - www.synergyaids.com]