GHTC Welcomes Positive Opinion from European Medicines Agency on First Long-acting Vaginal Ring to Protect Women Against HIV

Statement from Jamie Bay Nishi, Director, Global Health Technologies Coalition (GHTC)

Today, the European Medicines Agency (EMA) adopted a positive opinion under Article 58 for use of the monthly dapivirine ring by cisgender women ages 18 and older in developing countries—a move that we at the Global Health Technologies Coalition (GHTC) applaud as a major milestone for women’s HIV prevention efforts. 

We urgently need new and better technologies to tackle HIV/AIDS, which is the leading cause of death globally for women ages 15-44 and one of the biggest threats to women’s health and well-being. Today’s decision represents significant progress for a tool that has been shown to not only reduce women’s risk of HIV, but one that finally could offer them a discreet, women-centered option that they can use on their own terms.

Today’s outcome is a testament to the critical role of US government investments in global health research and development (R&D). Developed by the nonprofit International Partnership for Microbicides (IPM), a GHTC member organization, the ring received crucial funding for nearly two decades from numerous donors, including the US Agency for International Development (USAID), in partnership with the US President’s Plan for Emergency AIDS Relief (PEPFAR), and in-kind support from the National Institutes of Health (NIH). These investments ensured late-stage clinical trials and ongoing follow-up studies, and, pending future regulatory approvals, will enable IPM to introduce the ring in countries in sub-Saharan Africa.

With its potential to transform lives in sub-Saharan Africa, the ring illustrates yet another example of the impressive return on U.S. investments in global health R&D. Yet this is not the end game. Bringing this devastating epidemic under control will require an expanded toolbox of next-generation prevention and treatment products, such as long-acting injectable antiretroviral drugs, multipurpose prevention tools and vaccines. And most importantly, it will mean ongoing, sustained investments in the U.S. government agencies that have made these lifesaving innovations possible.