US accused of blocking generics AIDS drug plan

pharmafile | April 5, 2004 | News story | |   

Aid agencies are claiming that plans to provide antiretroviral treatment for millions of people with HIV are being undermined by the US, because of its objections to the use of generic drugs.

The WHO's '3 by 5 Initiative' aims to provide the technical and organisational support to provide three million people in poor countries with antiretroviral therapy (ART) by the end of 2005.

However, if money donated by the US has to be spent on more expensive, branded drugs fewer people will receive the life-saving drugs.

Aid agency Medecins Sans Frontieres said the Bush Administration was "more interested in protecting the interests of the pharmaceutical industry than it is in expanding antiretroviral (ARV) treatment to the largest number of people possible.

The agency already provides generic ARV treatment to more than 11,000 people living with HIV/AIDS in over 20 countries in Africa, Asia, Latin America, and Eastern Europe but America's global aids co-ordinator, former Eli Lilly chief executive Randall Tobias, has questioned the safety of generic fixed dose combinations (FDCs) of ARVs, which contain three drugs in a single pill usually taken twice a day.

Mr Tobias' deputy John Lange denied the US was blocking generic use, telling Reuters: "What we are looking to do is not to avoid buying generics but to assure the quality, safety and efficacy of them."

Cipla's Triomune and Ranbaxy's Triviro lack FDA approval but have the backing of the WHO. The three patent holders on each drug in the WHO-listed combination are GlaxoSmithKline, Bristol-Myers Squibb and Boehringer Ingelheim.

The two Indian companies' FDCs have been approved by the WHO under its 'pre-qualification' process to assess their quality, which is supported by UNICEF, the UNAIDS Secretariat, the UN Population Fund and the World Bank.

Mr Lange said it may be difficult to assess whether pre-qualified FDCs controlled the AIDS virus without allowing it to eventually develop resistance to the drugs.

The issue was debated at a US Department of Health and Human Sciences-sponsored conference in Botswana at the end of March, but no conclusions were reached.

President Bush last year announced a five-year, $15 billion global AIDS initiative to provide treatment and care to millions of people in Africa and the Caribbean.

But although the US has started issuing grants to help fight AIDS, it has not yet said whether these can be used to buy the generic FDCs.

Individual pharma companies have made some efforts recently to show their social responsibility, including Bristol-Myers Squibb which recently conceded in a patent dispute with Thai AIDS groups.

The company said the patent for its drug Videx would be "dedicated to the people of Thailand" opening the way for the Thai government to produce its own generic version of the drug.

Meanwhile, Johnson & Johnson announced its decision to donate the rights for a developmental product developed by its Tibotec subsidiary that could help prevent HIV infections in women.

J&J will give a royalty-free licence for TMC120, which was originally developed as an AIDS drug, to the International Partnership for Microbicides (IPM), a non-profit group set up to help develop products that can prevent Aids infections.

Dubbed 'the invisible condom' microbicides in the form of gels, films, sponges and other products, would be applied topically (such as intravaginally) to help prevent sexual transmission of HIV.

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