East Africa Seeks Streamlined Drug Oversight to Ease Access
By Innocent Anguyo
Region is one of the world’s poorest, afflicted with diseases
Drugmakers say EMA-like approach speeds product reviews
The East African Community Medicines Registration Harmonization program allows Bayer AG, Merck KGaA, and rivals to speed products to market, while easing patients’ access to new medicines. Drugmakers would like to see the scope of the project, which started in 2012, widened to more countries.
(Bloomberg) — Modeled on the European Medicines Agency, the program is designed to slice through red tape in a region of 160 million people grappling with high rates of malaria, HIV, and other infectious diseases. East Africa is often slow to gain the benefit of new drugs, devices and diagnostics that are readily available in the rest of the world, said Peter Hotez, dean of Baylor College of Medicine’s National School of Tropical Medicine in Houston.
People in the region need “access to food, water, shelter, and essential medicines, and they also deserve access to innovation,” he said in a telephone interview. “And this is an important step.”
The program streamlines regulatory procedures across the seven authorities in Kenya, Tanzania, Uganda, Rwanda, Burundi and South Sudan. In certain cases, the regional structure has cut the time needed to get marketing authorization from more than two years to less than nine months, project manager John Patrick Mwesigye said.
The group approach “reduces redundant assessment steps and streamlines a complex procedure,” said Anja von Treskow, a Roche spokeswoman. “We are hopeful that several other areas, such as broadening the product list, single dossier submission process, post-approval changes and regulations on biologics, pharmaco-vigilance and medical devices will be included.”
Cheap generic copies of branded drugs are also often stalled by regulatory reviews, Daniela Bagozzi, a spokeswoman for the World Health Organization’s Essential Medicines and Health Products division said. Drugs account for as much as 60 percent of health spending in poor countries, and the EAC pilot program has already shown that it can help understaffed agencies get these generic versions registered and available.
“It’s been really speeding up their capacity to get drugs on the market that are going to save lives,” she said.
Founded in 1995, the EMA assesses the effectiveness and quality of drugs across Europe, and has made efforts to collaborate with the U.S. Food and Drug Administration in some areas, spreading the cost of its operations over numerous countries. Small, poor countries face insurmountable challenges to replicate those efforts on their own, Hotez said.
“No single African country is going to have the capacity of an FDA or EMA, so consolidation makes that possible,” Hotez said.
Novartis has supported the regional effort, providing input on guidelines and insights from working with other government agencies, said Rob Kowalski, the Swiss-based drugmaker’s global head of regulatory affairs. The company is hoping for a payoff in faster, more efficient product assessments.
“Key to bringing EAC to full strength and scale will be ensuring medicines are reviewed within a predictable time scale,” he said, “with member countries completing the final registration step without unnecessary replication.”
The proposed regional agency would operate as an independent institution providing oversight of essential medicines, and wouldn’t replace their national regulatory authorities. Maturation into an official agency will take about another two years, Mwesigye said.