Nairobi — Humanitarian organisations and Aids activists are opposed to what they see as an attempt by the United States to scuttle a World Health Organisation effort to provide drugs to three million patients in developing countries.
They say a meeting organised by the US Department of Health and Human Sciences in Gaborone, Botswana, which ends today, is a forum to reinforce US reluctance to support the WHO scheme. The two-day conference is on Fixed-Dose Combination (FDC) Drug Products.
The US opposition is based on the scheme's reliance on fixed-dose combination of anti-retrovirals (ARVs), which it says infringe on patent law in some wealthy nations.
The US is also critical of the effectiveness of FDCs, and WHO's pre-qualification scheme.
The pharmaceutical industry has been urging the White House to undermine the WHO initiative, which has taken care of the concerns about the drugs' safety by inspecting and making a list of approved generics.
Aids activists argue that the US stance has been influenced by resistance from pharmaceutical companies, which disapprove of the drugs sale, because they are made from patented ingredients.
The activists and treatment providers believe the Gaborone meeting has been organised to question WHO's approval process, by drawing in experts from the pharmaceutical industry to claim that the scheme, which is supported by top-notch public health experts, is inadequate and unsafe.
In an open letter to the US Government, organisers MSF South Africa, MSF-USA and the Campaign for Access to Essential Medicines have sought a clarification on the objectives of the conference.
Dr Ellen Hoen, Dr Eric Goemaere and Dr Kris Torgeson criticise the US Global Aids coordinator, Mr Randall Tobias, who has persistently questioned the quality of generic ARVs, undermined international quality standards set by the WHO, and concluded that providers of ARV treatment in developing countries may be endangering their patients' lives.
"We question what this meeting will add to the processes that are already underway and whether it will in any way contribute to the urgent task of expanding access to affordable essential medicines for Aids and other illnesses," the letter said.
The most affordable ARVs produced, including FDCs, are produced by generic companies based in developing countries.
However recent public statements by the US administration, regarding generic medicines seem to "indicate a troubling lack of support for WHO prequalified generics, including FDCs", they say.
The letter is copied to the other co-sponsors of the conference - the United Nations Joint Programme of HIV/Aids (Unaids), Southern African Development Community (SADC) and WHO.
Dr Paul Zeitz, the executive director of the Global Aids Alliance, also took issue with a Bush Aids initiative report, saying: "It's remarkable how little new there is in this document and how vague it is on some of the most critical issues."
"For an issue the administration repeatedly says is on a par with terrorism in significance, the narrow country focus and the lack of specificity is quite disturbing," he said.
The availability of FDCs of ARV pills containing two or three Aids drugs in one tablet has dramatically improved the ability of treatment programmes in poor countries.
MSF is providing anti-retroviral therapy to more than 11,000 Aids patients in more than 20 countries in Africa, Asia, Latin America, and Eastern Europe, and expects the total number of patients on ARVs to reach 25,000 in 25 countries by the end of the year.
Over 50 per cent of the patients and over 70 per cent of those newly enrolled are starting treatment using WHO-recommended triple FDCs.
Because FDCs promote adherence, decrease the risk of resistance, and facilitate stock and procurement management, MSF says they are widely recognised as being a key element in efforts to scale up ARV treatment in developing countries.
The 3-by-5 Initiative was created to help three million Aids patients in the developing world to get anti-retroviral therapy by the year 2005.
Fixed-dose combinations are cheaper and easier to take than the existing Aids treatment protocol. Taking two fixed-dose combination pills a day for a year costs $140 (Sh10,640 ) per patient, compared to about $600 (Sh45,600) per year for the normal regimen of six pills per day.
Previous excuses used to deny patients in poor countries access to ARVs centred around two common arguments: that poor people could not adhere to complex treatment regimens and would improperly take the drugs (leading to drug-resistant forms of HIV) and that the infrastructure in poor countries is insufficient to support complex Aids care.
After a year's delay in funding, US President George Bush's administration unveiled a parallel five-year $15 billion global initiative to combat the global Aids epidemic, but failed to provide details of its policies on generic medication and how it will coordinate with the Global Fund, which is active in 121 countries.
Mr Tobias discussed the initiative's future strategy, but fell short of mentioning how current US trade policies may undermine the ability of developing countries - those in urgent need of medicine - to expand access to ARVs.
Although anti-retroviral therapy for Aids is more affordable and has been proven to be efficient even in poor settings, only 400,000 out of 6 million people in need have access to this life-prolonging treatment.

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