Microbicides — products such as gels or creams that can prevent the spread of sexually transmitted diseases — potentially offer a new and effective means of protection against HIV infection. This would be important for women, particularly in developing nations, who may lack the influence to persuade their partners to use a condom.
But microbicide developers are faced with many regulatory hurdles, say Paul M. Coplan and his colleagues in an article in this week's Science. In particular, they argue that developing countries' national regulatory authorities (NRAs) — charged with authorising the sale of new drugs — often lack the resources to assess such novel products.
These NRAs rely on the US and European authorities to issue recommendations, ignoring the fact that their populations would not use microbicides in the same way as Americans and Europeans. The researchers suggest five measures to help overcome regulatory hurdles to the introduction of microbicides in developing countries.
Reference: Science 304, 1911 (2004)