Paediatric HIV medication will soon be available faster in Guyana through the expedition of the country’s drug registration process as a result of a new partnership between the government and the US President’s Emergency Plan for AIDS Relief (PEPFAR), the US State Department said yesterday.
According Ambassador Eric Goosby, US Global AIDS Coordinator, who announced the new partnership, through the Pre-approval Access for HIV/AIDS Therapies (PaATH) mechanism, the Guyana Government will grant provisional approval to paediatric HIV medicines approved by the US Food and Drug Administration within the US Depart-ment 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.
The statement said that in most countries, drug registration can be a long process. It was pointed out that 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.”
And variations from country to country in the drug registration process also result in delays to access, the statement said. “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,” it continued.
Meanwhile, according to the statement, in Guyana, it is estimated that there are some 18,000 people living with HIV, and children account for approximately six per cent of this number. According to the statement, it was in recognition of the impact of HIV/AIDS in Guyana that the Government of Guyana has embraced the PaATH to further the 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 statement said.
The PaATH was developed through a public-private partnership that brings together the US 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 US Government, Bristol-Myers Squibb, Gilead Sciences, Inc., and the Partner-ship for Supply Chain Management.