US-Conference on Fixed-Dose Combination (FDC) Drug Products in Botswana March 29-30, 2004: The US challenge to the WHO drug pre qualification scheme, risk depriving poor patients from basic treatment

Oxfam, March 26, 2004

Treatment programmes which save the lives of HIV/AIDS patients are under threat from the hostility of the major pharmaceutical companies towards generic drug production in developing countries. The WHO 3X5 strategy plans to treat 3 million HIV people by the year 2005 and the Global Fund is already financing treatment programmes in many countries. The US HIV/AIDS emergency plan also aims to scale up treatment in 24 countries.

Such programmes depend on using quality medicines at the lowest price and on using fixed dose combinations of AIDS medicines (FDCs), which enhance patients=92 compliance and decrease the chances of developing resistance. The price of relevant brand name drugs ($562) is more than three times the price of the WHO=92s recommended generic FDC ($ 140). But the US government, under the influence of major pharmaceutical companies is now attempting to undermine the validity of the WHO pre-qualification scheme, which vets and approves the quality of medicines including cheap generic versions of patented medicines legally produced in countries such as India and China. If successful, the US challenge would prevent treatment programmes from using the cheaper generic medicines and thus deprive poor patients of simple FDCs treatment.

The forthcoming US-sponsored conference in Botswana on FDCs risks confusing developing countries who are already implementing treatment programmes using FDCs, and may dissuade them from using such medicines approved by the WHO pre-qualification scheme. This could have drastic consequences for prescribers and patients, requiring them to change to different drug regimes.

Many of the Indian companies vetted by the WHO are already approved by the US Food and Drug Administration (FDA) to sell medicines for the US market. Cipla, the producer of the basic FDC, has been approved by the FDA since 1985. The company sells it Active Pharmaceutical Ingredients to US-based producers. American patients are already using Flutamide, a Cipla product for the treatment of cancer.

WHO is mandated to support developing countries to ensure access to essential medicines. The Pre-qualification Scheme has been set up to ensure that procurement is based on assured quality, including of generic drugs and FDCs and is successfully doing that. There are three reasons why WHO should be supported to continue pre-qualification.

The major pharmaceutical companies and the US government must now recognise the crucial role of generic medicines in public health. Oxfam urges the US government to stop concentrating on enhancing profits of US companies and focus instead on the real issue of treating patients. If the US money is used to purchase only FDA approved drugs, it would make it much more difficult for countries to manage multiple treatment schemes and to monitor resistance. All donors, including the US, should strengthen WHO to undertake its core normative functions, including pre-qualification. At the end of the day pharma and generics should work together to provide life saving medicines for HIV patients in developing countries.

Dr. Mohga Kamal Smith
Health policy advisor
Tel + 44 (0) 1865 312290
Mobile +44 (0) 777 62 55 884

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