New agreements aim to make lowest-priced AIDS drugs and diagnostics available to hundreds of thousands of patients throughout the developing world

On April 6th, 2004, the Global Fund, World Bank, UNICEF, Clinton Foundation announced an agreement to make lowest priced AIDS drugs and diagnostics available to hundreds of thousands of patients through the developing world. The WHO welcomes agreements and initiatives to make medicines and diagnostics affordable and available to developing countries and is partnering with these organisations and governments around the world to help countries treat 3 million people with antiretroviral medicines by 2005.

The agreement should pave the way for countries supported by the Global Fund, the World Bank and UNICEF to gain access to drug and diagnostic prices negotiated by the Clinton Foundation. Countries will be required to provide guarantees of payment to conduct long term tenders and to ensure the security of drug distribution. The Global Fund, World Bank and UNICEF will support their funding recipients in complying with these terms as consistent with their policies and existing practices.

The drugs in the agreements announced today include individual formulations and two and three drug fixed dose combinations which have been pre-qualified by the World Health Organization to assure quality and efficacy.

Countries most in need of life saving ARV and other drugs often do not have the regulatory capacity to ensure the safety and quality of medicines from different suppliers around the world. As the international organisation responsible for global health, the WHO helps countries access safe quality drugs through its prequalification process. Companies wishing to have a product prequalified voluntarily submit a dossier to WHO. The submissions are then assessed by an expert panel comprised of regulatory experts from among 28 of the world's leading national regulatory agencies, including experts from Europe, Canada and Australia. The panel experts serve in a personal capacity, not on behalf of the regulatory agencies in their country of origin.

Once medicines are prequalified by WHO, WHO and UNICEF make random batch checks on the quality of the drugs distributed. This is also standard procedure for regulatory authorities around the world.

As part of a global consultation with partners to increase access to treatment, WHO works with partners around the world and last week participated in a consultation on technical principles for fixed dose combination drug products in Botswana bringing together the US dept of Health and Human Services (DHHS) and the Southern African Development Community (SADC), UNAIDS and WHO.

WHO is committed to working with partners and governments around the world to scale up treatment in line with the UNAIDS so called "three ones framework" which calls for one national AIDS coordinating authority, one national AIDS plan, and one national monitoring and evaluation system.

The WHO and UNAIDS estimate that out of the 6 million people around the world who currently need AIDS treatment, only 400,000 have access to the life-prolonging ARV therapy. Every year 3 million people die in developing countries for lack of access to treatment.

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