The African Union Friday is launching the African Medicines Regulatory Harmonization Program, which among other things, aims to improve access to essential medicines for priority diseases on the continent.
The six countries of the East African Community will be the first ones on the continent to have the same regulations governing the registration, sale, and use of medical drugs. Kenya, Uganda, Tanzania, Rwanda, Burundi and South Sudan are all part of the new regulatory program.
Up until now, companies wishing to register a new drug in Africa had to go through each country’s regulatory authority with their various requirements. Dealing with multiple jurisdictions poses problems, said Chris Lovelace, the World Bank’s senior health adviser for the Africa region.
"The consequence of that is that sometimes companies will just decide to go to the big markets, for example. It is just too much bother to try to get a product registered in a small market with a small demand," he said.
Lovelace thinks harmonizing regulations will have a positive effect on the introduction and use of essential medicines.
"As new products are developed to address malaria, TB, AIDS, and the like, each one needs to be registered in order to be made available to the public," he said. "So, as those new medicines come online, obviously it is in everyone’s interest to see them available as quickly as possible and not caught up with bureaucratic or regulatory procedures.”
Friday’s launch in East Africa marks the debut of a wider African program, initiated at an African Union meeting in February 2009 and supported by the World Bank, the World Health Organization, the Bill and Melinda Gates Foundation, and others.
The launch, held in the Tanzanian town of Arusha, is being hosted by the African Union’s technical body, the NEPAD Agency.
Dr. Jayesh Pandit, head of the Department of Pharmacovigilance in Kenya’s Pharmacy and Poisons Board, said the initiative will bring the region’s countries closer together in what he calls a “win-win situation.”
"This will definitely help us, maybe even if we are looking at buying medicines in bulk," said Pandit. "We will be able to, as a much larger market, negotiate a much [more] favorable price for our countrymen to benefit with the reduction in price."
Pandit believes the program will also help to crack down on fake drugs, a big problem in the region.