Senate Briefing: Improving Antimalarial Drug Quality in Africa
Sep 29, 2008
From Africa Fighting Malaria
Africa Fighting Malaria (AFM) arranged a briefing on Capitol Hill hosted by the US Senate Committee on Foreign Relations. The topic was Improving Antimalarial Drug Quality in Africa, focusing on AFM's recent study showing 35% of antimalarial drugs in six major African cities are substandard.
Richard Tren, Director of AFM, was first to speak, followed by Dr. Bernard Nahlen, Deputy Coordinator of the U.S. President's Malaria Initiative.
Mr. Tren's presentation focused on the difference between substandard and counterfeit drugs, both of which are prevalent throughout the developing world. Counterfeits are deliberately and fraudulently mislabeled, while substandard drugs may be legitimately produced but poorly stored or transported, too old, or improperly produced, and as a result are of low quality. The threat to public health, however, is the same: bad medicine can hurt or kill in the short term and drive drug resistance in the long term. AFM's study did not attempt to determine whether the large proportion of substandard drugs found were counterfeit, but this is something that public agencies should address going forward.
Download Mr. Tren's Presentation here
Dr. Nahlen's presentation summarized progress achieved through the President's Malaria Initiative (PMI), a $1.2 billion initiative over five years to scale up interventions and build in-country capacity to control malaria. 11.5 million ACT treatments and over two million rapid diagnostic tests have been procured through the PMI. In addition, 20,000 health workers have been trained on malaria case management with new technologies. All PMI drug procurements comply with applicable statutes and regulations. Drugs with FDA or stringent regulatory authority approval status are preferred, if recommended and available. Most antimalarial drugs do not meet these criteria, so the PMI reviews each drug procurement request on a case by case basis to assess the evidence for quality. Dr. Nahlen emphasized that no compromise should be made on quality in order to lower costs when effective drugs are available.
Download Dr. Nahlen's Presentation here
The presentations were followed by a question and answer session where members of various Senate offices and the malaria advocacy community engaged the speakers in a discussion. Mr. Tren was asked to give an overview of the proposed global ACT subsidy known as the Affordable Medicines Facility for malaria (AMFm). Both Dr. Nahlen and Mr. Tren expressed their support for innovative approaches to increase access to ACTs and drive monotherapies and substandard drugs out of the market. However, more research is needed to ensure that the AMFm is the right mechanism to accomplish this.
Dr. Nahlen explained the need to strengthen drug regulatory agencies in African countries, both by equipping them with the tools to adequately monitor drug imports and by providing the necessary legal support to sanction or prosecute offenders. Dr. Nahlen also stressed that without access to safe and effective drugs, malaria can kill a person very quickly. Given this, Dr. Nahlen argued against a wide-range of antimalarial drugs designed to increase competition and in favor of a limited list of drugs of known quality and authorized by a stringent regulatory agency or granted WHO prequalification status.