LEEM Quality Control Program
Counterfeit and substandard medicines are a major threat to health in developing countries, many of which lack the technical resources to identify inferior quality medicines. To help alleviate this situation, the association representing the R&D pharmaceutical industry in France, Les Entreprises du Medicament (LEEM), started a program in 2006 to allow developing countries to send samples of suspect medicines to France for analysis. To ensure impartiality, the LEEM pays for samples to be analyzed by an independent expert body, the Central Humanitaire Medico Pharmaceutique (CHMP). The program focuses on francophone countries in Africa and is primarily addressed to health ministries, national medicine authorities and state purchasing centers. To date, samples have been provided by Burundi, Chad, Comoros, Congo, Egypt, Gabon, Guinea, Guinea Bissau, Madagascar, Mauritania and Togo. Samples submitted for evaluation must be either antiretrovirals or medicines purchased on the street. In period 2007-08, a total of 116 samples were analyzed; and the results showed that a non-conformity rate of 22%, up from 18% for the 2006-07 period. The 2009-10 exercise is not yet complete, but for the 58 samples analyzed in 2009, the ratio of non-conforming products had increased to 43%. The biggest categories of medicines submitted for analysis are antimalarials, followed by anti-inflammatories, anti-fever medications and pain killers.