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Challenges of producing a drug primarily for use in developing countries: microbicides for HIV prevention

Jeremy Nuttall, Karen Douville, Caroline Galbreath, Saul Walker, Pamela Norick and Zeda Rosenberg

Diseases largely confined to the developing world are under-researched in part because of the limited commercial potential for products used in these settings. The need for an alternative model has led to the establishment of product-development partnerships in which the intellectual property and technical expertise of the private sector is combined with both public and private funding to create a not-for-profit drug-development effort. The production of products for developing countries presents many other challenges, including product design, the design and conduct of clinical trials and registration with regulatory agencies. Once they have been registered, there are additional challenges to the marketing and distribution of such products. An overview of these issues is presented within the context of microbicides, which are self-administered vaginal products for the prevention of HIV transmission that, if proven to be efficacious, will represent one of the most promising strategies for combating the HIV/AIDS epidemic.