Rockville, Md. (Vocus) October 27, 2009
With substandard and counterfeit versions of medicines intended to treat life-threatening diseases such as malaria, HIV/AIDS and tuberculosis posing a growing threat throughout the developing world, the U.S. Agency for International Development (USAID) and the U.S. Pharmacopeial Convention (USP) will expand their joint efforts to combat this menace by launching a new program over the next five years.
The Promoting the Quality of Medicines (PQM) Program, a $ 35 million cooperative agreement, will serve as a primary mechanism to help assure the quality, safety and efficacy of medicines that are essential to USAID’s priority health programs. USAID is a U.S. government agency that provides economic, development and humanitarian assistance around the world in support of the foreign policy goals of the United States. USP is a nonprofit scientific organization that develops globally recognized standards for the quality of medicines.
Building on a multi-year USAID-USP partnership in this arena that assists health officials and others in 28 countries around the world, the program will increase work to address the significant public health challenge posed by substandard and counterfeit medicines. According to the U.S.-based Center for Medicines in the Public Interest, counterfeit drug sales alone will reach $ 75 billion globally in 2010, an increase of more than 90 percent from 2005. Various factors contribute to the growth of substandard and counterfeit medicines, including the globalization of trade and weak regulatory capacity in developing countries.
“Substandard and counterfeit medicines represent a threat to public health worldwide but pose a particular problem in developing countries, where lack of financial, technical and other resources make it difficult to protect the drug supply chains,” said Gloria Steele, USAID acting assistant administrator for global health. “Such medicines have the potential to undermine decades of investments in public health. Without good quality, safe medicines to treat diseases such as HIV/AIDS, malaria and tuberculosis, the impact of other health initiatives may be weakened. The PQM Program focuses on this critical aspect of combating these diseases.”
“The lives of patients are put in serious jeopardy when they take substandard or counterfeit drugs,” said Roger L. Williams, M.D., chief executive officer of USP. “Such ‘medicines’ have health as well as economic implications. Moreover, substandard medicines contribute to the development of drug-resistant strains of infectious diseases. Such strains are a leading challenge in the fight against malaria, HIV/AIDS and tuberculosis.”
The program will help ensure the quality, safety and efficacy of medicines by: working with countries to strengthen their medicines regulatory bodies, which are responsible for protecting the supply chains; increasing the supply of good-quality medicines, which often are not available, with shortages giving health facilities no choice but to use medicines that may not have undergone rigorous quality control; combating the availability of counterfeit and substandard medicines through testing programs and other means; and conducting global advocacy to raise awareness of the dangers of substandard and counterfeit drugs.
The PQM Program builds on the work of USAID and USP over the past decade through a predecessor program, the Drug Quality and Information (DQI) Program. Like DQI, the PQM Program will be managed by Patrick Lukulay, Ph.D., partnering with USAID’s Office of Health, Infectious Diseases, and Nutrition, under the direction of Anthony Boni. Highlights of the DQI Program’s work include: