Global Policy Forum

By Alison Langley

A United Nations plan to provide three million HIV-infected patients in Africa with anti-retroviral drugs by 2005 is in danger of collapsing owing to lack of funds, UN and World Health Organisation officials said. Some countries, particularly the United States, are balking at supporting the project, Aids workers say, partly because the plan intends to use a form of medicine called fixed-dose combination antiretroviral drugs whose use is opposed by large pharmaceutical companies.

Only $2.3 billion has been secured for the $5.5bn WHO project, dubbed 'Three by Five' because it hopes to provide drugs to three million people by 2005. Only the UK, Sweden and Spain have provided money to date, officials said.

'If Three by Five fails, as it surely will without the dollars, then there are no excuses left, no rationalisations to hide behind. There will only be the mass graves of the betrayed,' said Stephen Lewis, the UN Secretary-General's special envoy for HIV/Aids in Africa.

The WHO urgently needs $200m in the next few months to upgrade health systems' infrastructures in 14 African states, Lewis said.

Aids activists say money isn't forthcoming because of WHO support of the use of combination medicines. Called fixed-dose medicines, these drugs combine two or more active ingredients in one pill, thereby reducing the number of tablets an AIDS patient must swallow each day.

Fixed-dose drugs are also cheaper. Taking two fixed-dose combination pills a day for a year costs $140 per patient, compared to about $600 per year for six pills per day. A fixed-dose combination pill 'has completely revolutionised people's lives', said Ellen 'T Hoes, director of Mí¨decins Sans Frontiéres' Access to Essential Medicines programme.

The US, by far the largest donor with a $15bn plan launched last year, has been reluctant to endorse the fixed-dose combination pills, saying they are not yet convinced the medicines are safe.

In order to make the combination drugs, generic manufacturers use active ingredients that were discovered by different pharmaceutical companies and are under patent in wealthy countries.

'We need to have principles - standards by which the purchase decisions can be made,' said Randall Tobias, the US Global Aids coordinator, in recent testimony before the US Congress. Ambassador Tobias is the retired chairman of Eli Lilly, one of the world's biggest pharmaceutical concerns.

WHO and Aids workers say the principles and guidelines are already in place because the medicines must meet extensive guidelines by the World Health Organisation before being approved for use.

The US is sponsoring a two-day conference starting on 29 March in Botswana to discuss the principles of regulation of these generic medicines.

The fixed-dose pills approved for use by the World Health Organisation are produced by three generic drug makers in India, which does not yet recognise patent laws. Exceptions to the patent system allow local manufacturers in poor countries to produce life-saving generic medicines and export them only under certain limited circumstances to other poor nations.

This means Indian manufacturers will agree to sell their wares in the 14 poorest African nations. Mí¨diciens Sans Frontiére's 'T Hoen believes the US stance is not motivated by safety. 'The US's position is to buy drugs only approved by the (Federal Drug Administration),' she said. 'The fixed dose can't be approved by the FDA because of patent problems, not because of their safety or efficacy.'