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Post Event Summary
The trade in substandard and falsified pharmaceuticals is one of the most serious and overlooked public health problems facing developing countries today. The National Institute of Health's Guarvika Nayyar opened a conference at AEI on Tuesday by presenting new data that suggests falsified drugs are frighteningly common in developing countries. AEI's Roger Bate reinforced the point with his own research, emphasizing how difficult it is to gather data on the prevalence of substandard drugs because of resistance from drug producers.
The confluence of weak regulatory standards, lack of expertise in pharmaceutical production, inadequate enforcement and shortage of resources undermine safe drug markets, argued Patrick Lukulay of US Pharmacopeia. Leveraging international funds to scale up effective programs, increasing funds for enforcement measures and naming and shaming poor-quality drug producers would help, said the World Bank's Andreas Seiter.
But international efforts to improve drug quality are not always effective. Richard Tren of Africa Fighting Malaria highlighted the failures of the Global Fund's AMFm program, recounting how drug diversion and inept production and distribution caused serious drug shortages. Furthermore, Bernard Nahlen of USAID pointed out, malaria is over-diagnosed, leading international programs to focus disproportionately on treatment. Amir Attaran of the University of Ottawa concluded that these myriad problems can only be addressed through a comprehensive legal framework that creates global criminal penalties for pharmaceutical counterfeiting.
Emerging markets are plagued by substandard and counterfeit medicines. A new study finds that up to a third of antimalarial drugs in emerging markets do not work, and though less data exist on other types of medicines, it is likely that other anti-infectives are equally shoddy. Many of these poor-quality products are counterfeits made by criminal organizations, but some are made by legal producers who endanger patients' lives and increase drug resistance by cutting corners to minimize their production costs. Even well-known producers may fail to maintain consistent quality for every batch. An expert panel will explore initiatives to actively combat poor-quality drugs and discuss what remains to be done.
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Amir Attaran, an associate professor at the University of Ottawa, Canada, focuses on researching health, development and human security in poor countries including foreign aid, medical technology and international human rights law. His articles have appeared in the leading journals of both the legal and biomedical professions as well as major news sources, and his recent book discusses access to medicines in developing countries. Attaran has also been a policy adviser to numerous non-governmental organizations, the United Nations, governments and corporations. Currently, he is an editorial consultant to The Lancet, the world’s leading medical journal, and is on the editorial writing team of the Canadian Medical Association Journal.
Roger Bate is the Legatum Fellow in Global Prosperity at AEI and a founder and director of Africa Fighting Malaria. He researches international health policy with a special interest in counterfeit medicines and malaria control. Bate’s writings have appeared in, among others, The Wall Street Journal, The Financial Times, The Lancet, PLoS One, the Malaria Journal and the British Medical Journal. He also regularly contributes to AEI's Health Policy Outlook series. Bate conducted extensive research on the public health consequences of the counterfeit drug trade in India and numerous African countries. His latest book is entitled “Phake: The Deadly World of Falsified and Substandard Medicines” (AEI Press, May 2012). He is the author or editor of 14 other books including “Making a Killing: The Deadly Implications of the Counterfeit Drug Trade” (AEI Press, May 2008) as well as two dozen peer reviewed journal articles and hundreds of newspaper articles. He writes extensively on topics such as endemic diseases in developing countries (malaria, HIV/AIDS); access and innovation in pharmaceuticals; taxes and tariffs; water policy; and international health agreements. He was the founder of the Frédéric Bastiat Prize for Journalism and is a fellow at the Institute of Economic Affairs in London.
Patrick Lukulay, M.D., is currently the vice president of the Global Health Impact Programs at the United States Pharmacopeial Convention (USP), overseeing all grant-funded programs that provide technical assistance to developing countries. He is also director of the Promoting the Quality of Medicines Program, a five-year, $35-million cooperative agreement implemented by USP and supported by the U.S. Agency for International Development. In that capacity, Dr. Lukulay helps strengthen the pharmaceutical quality assurance and quality systems in 35 countries worldwide. Lukulay worked in the pharmaceutical industry for a combined 12 years as a senior principal scientist for Wyeth and Pfizer. He has also authored several articles on separation science, spectroscopy and medicines quality. He serves on the Institute of Medicine’s committee on counterfeit drugs and frequently speaks at national and international conferences.
Bernard Nahlen, M.D., is deputy coordinator of the U.S. president’s Malaria Initiative. Dr. Nahlen joined the U.S. Centers for Disease Control and Prevention (CDC) in 1986 as an epidemic intelligence service officer assigned to the Malaria Branch. He later served as deputy director of the Los Angeles County AIDS Epidemiology Program. Dr. Nahlen’s commitment to malaria prevention and control subsequently took him to Kenya in 1992 when he was director of the CDC field research station in collaboration with the Kenya Medical Research Institute. In 2000, he was seconded from the CDC Malaria Branch as senior technical adviser to the new World Health Organization (WHO) Roll Back Malaria (RBM) initiative. At WHO, he led the Monitoring and Evaluation team as well as the Malaria in Pregnancy team. He serves as the first chair of the RBM Monitoring and Evaluation Reference Group and oversaw the production of the “Africa Malaria Report 2003” and the “World Malaria Report 2005.” From 2005 to 2006, Dr. Nahlen was seconded to the Global Fund to Fight AIDS, Tuberculosis and Malaria as a senior adviser in the Performance Evaluation and Policy unit. He has authored or co-authored more than 150 articles related to malaria prevention and control.
Gaurvika Nayyar is a research associate at the Fogarty International Center at the National Institutes of Health. She was previously an epidemiology and management fellow at the National Institute of Communicable Diseases in India serving on government outbreak response teams during the Chikungunya epidemic in 2008. Gaurvika’s research interests lie in infectious disease epidemiology, drug resistance, international drug regulation, delivery systems and vaccine policy. Most recently, she has been working to gather evidence and understand the public health impact of poor-quality antimalarials in Southeast Asia and sub-Sahran Africa. Her review in The Lancet highlights that poor-quality antimalarial drugs lead to drug resistance and inadequate treatment, which pose an urgent threat to vulnerable populations and jeopardize progress and investments in combating malaria.
Andreas Seiter, M.D., is a senior health specialist and expert in pharmaceutical policy and management at the World Bank’s Health, Nutrition and Population Anchor. He joined the World Bank in January 2004 and is responsible for analytical and advisory work in all areas of pharmaceutical policy, such as regulation, governance, quality assurance, financing, purchasing, supply chain and rational use. He has been working with World Bank teams, policymakers and experts on the client side in several countries in Africa, Eastern Europe, the Middle East, Latin America and South Asia. In 2010, he published the book “A Practical Approach to Pharmaceutical Policy.” Andreas, a German national, is a physician by training and practiced medicine before joining the pharmaceutical private sector in 1984. He held various positions in medical operations, product management, communications and stakeholder relations in the industry before joining the World Bank.
Richard Tren is the co-founder and executive director of Africa Fighting Malaria (AFM), a health advocacy group based in South Africa and Washington, D.C. Since 2000, Tren and his colleagues at AFM have been advocates for transparent, accountable and effective malaria control programs. Tren has published widely on malaria control and treatment, including papers in peer-reviewed literature and popular press. In 2010, he co-authored, with Donald Roberts, “The Excellent Powder, DDT's Political and Scientific History,” and he has authored or co-authored chapters of several other books. Tren is from South Africa and lives in Washington, D.C.