Partnership venture apace for faster access to safe paediatric HIV drugs
A new public-private partnership between the Government of Guyana and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) is likely to see safe paediatric Human Immunodeficiency Virus (HIV) medications being made available to Guyana at a faster rate.
According to a statement issued by the United States Embassy yesterday, US Global AIDS Coordinator, Ambassador Eric Goosby announced the public-private partnership between the local Government and PEPFAR. This venture, according to the statement, will see the drugs being made available to Guyana swiftly by expediting the drug registration process.
It was revealed that through the Pre-approval Access for HIV/AIDS Therapies (PaATH) mechanism, the Government of Guyana will grant provisional approval to paediatric HIV medicines approved by the US Food and Drug Administration within the US Department of Health and Human Services. These antiretroviral drugs the statement said will then be available for purchase and use in Guyana while they await full approval through Central Government’s drug approval process.
In most countries, drug registration can be a long process. While the US Government has taken steps to “fast track” approval for antiretroviral drugs through the US 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.
It was also revealed that limited infrastructure in partner countries can prove to be barriers for 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 paediatric antiretroviral treatment is further complicated by the fact that there are fewer formulations of antiretroviral drugs for children than there are for adults,” the statement added.
In Guyana, an estimated 18,000 people are living with HIV, and approximately six percent of these HIV infections are in children. Recognising the impact of HIV/AIDS in Guyana, the Government of Guyana has embraced the PaATH to further the in-country 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.
In addition, it was noted that 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 US Government, the pharmaceutical industry, and non-government organisations to promote scientific and technical discussions on solutions for paediatric HIV treatment, formulations and access.
The partnership includes the US Government, Bristol-Myers Squibb, Gilead Sciences, Inc., and the Partnership for Supply Chain Management.