Expediting access to pediatric HIV/AIDS drugs in Guyana; a new public-private partnership

A very interesting announcement from the U.S. Department of State.

The U.S. Government, Government of Guyana, and Pharmaceutical Companies Partner to Expedite the Registration of HIV/AIDS Drugs for Children

Office of the Spokesman
Washington, DC
September 22, 2010

Ambassador Eric Goosby, U.S. Global AIDS Coordinator, announced a new public-private partnership between the Government of Guyana and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) to make safe pediatric HIV medications available faster in Guyana by expediting the country’s drug registration process. Through the Pre-approval Access for HIV/AIDS Therapies (PaATH) mechanism, the Government of Guyana will grant provisional approval to pediatric HIV medicines approved by the U.S. Food and Drug Administration within the U.S. Department of Health and Human Services. These antiretroviral drugs will then be available for purchase and use in Guyana while they await full approval through the Government of Guyana’s drug approval process.

In most countries, drug registration can be a long process. While the U.S. Government has taken steps to “fast track” approval for antiretroviral drugs through the U.S. Food and Drug Administration, slow registration processes and limited infrastructure in partner countries can be barriers to access to antiretroviral treatment and other life-saving drugs. Variations from country to country in the drug registration process also result in delays to access. Access to pediatric antiretroviral treatment is further complicated by the fact that there are fewer formulations of antiretroviral drugs for children than there are for adults.

In Guyana, an estimated 18,000 people are living with HIV, and approximately six percent of these HIV infections are in children. Recognizing the impact of HIV/AIDS in Guyana, the Government of Guyana has embraced the PaATH to further their country’s fight against the virus. Guyana has long been regarded as an innovator and global leader addressing regulatory issues specific to the developing world, particularly in the area of HIV/AIDS. Guyana’s experience with the PaATH will provide best practices and lessons learned for other PEPFAR countries interested in expediting their drug approval process. Based on the success in Guyana, the project will expand to other PEPFAR-supported countries.

The PaATH was developed through a public-private partnership that brings together the U.S. Government, the pharmaceutical industry, and non-government organizations to promote scientific and technical discussions on solutions for pediatric HIV treatment, formulations and access. The partnership includes the U.S. Government, Bristol-Myers Squibb, Gilead Sciences, Inc., and the Partnership for Supply Chain Management.