• Ethics, epidemiology and access

Ethics, epidemiology and access

This article outlines how microbicides offer the potential for women’s empowerment in HIV prevention. However, it notes that widespread use of these gels could be problematic due to major regulatory and ethical issues. The logistics of ensuring that microbicides work effectively among humans are formidable, as many countries lack the resources needed to carry out such wide-scale trials. The article also highlights the debates surrounding the potential decrease in condom use with microbicide trials and describes various proposals to ensure that this does not happen. Other key issues include: licensing issues concerning combination products, and the huge number of volunteers needed for effective trials.

The authors make a number of recommendations which would help to reduce regulatory barriers. Firstly, international regulatory authorities should evaluate the safety and efficacy of microbicides in developing countries, while developing country National Regulatory Authorities (NRAs) should conduct the risk-benefit analysis. Secondly, links between developing country NRAs should be strengthened to enhance regional, south-south and south-north collaboration for joint reviews. Other recommendations include: transparent NRA decision making to ensure independent assessment; increased donor resources for NRAs, including funding and training, to enhance capacity; and establishing an international advisory group of scientific, clinical and regulatory experts to assist developing country NRAs. [adapted from author]

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