The UN health agency (WHO) has reached an agreement with the United States that should expand the number of drugs available for use in HIV/AIDS treatment programmes in poor countries.
The US Food and Drug Administration (FDA) and the World Health Organisation have agreed to share confidential testing data on anti-AIDS drugs destined for global aid projects, said Hans Hogerzeil, director of medicines, policy and standards at the WHO.
– The WHO is extremely pleased with the agreement and decision that has been reached. We are very eager to cooperate with the FDA. This makes it easier for us to extend our list, Hogerzeil added Monday.
The Geneva-based WHOs current “pre-qualification” scheme is the cornerstone of attempts to supply more affordable life-saving drugs to tackle HIV/AIDS in developing countries where they are most needed by governments and aid agencies.
The scheme, a supplementary evaluation for generic and brand-name drugs use, was approved by WHO member states last year.
But US authorities had been reticent about the scheme amid fears that it could shortcut stricter national regulatory approval.
WHO pre-qualification does not replace national regulatory approval. However, the single endorsement by the global health agency effectively allows an anti-AIDS drug to be used in several developing countries.
Hogerzeil said the deal should also allow the FDA to bolster supplies for its own fast track approval scheme for medicines that can be used in President George W. Bushs 15-billion-dollar (90 mia. DKR) AIDS fund.
Fast-tracked FDA drugs can only be used outside the United States.
Some developing countries – including Ethiopia, Kenya and Tanzania – had been reluctant to accept the medicines without the WHOs seal of approval, Hogerzeil said.
The streamlined WHO system was introduced following controversy over attempts by poor countries and aid agencies to seek cheaper anti-retroviral drugs to treat millions of HIV/AIDS patients.
The WHO admitted earlier this year that it was unlikely to meet its target of treating three million poor people with anti-AIDS drugs by the end of 2005.
About one million people in developing and transitional countries were receiving anti-retroviral therapy (ART), compared with 400.000 in December 2003 when the “Three by Five” initiative was launched.
Kilde: The Push Journal
