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Invited Commentary
Global Health
August 10, 2018

Prevalence of Substandard and Falsified Essential Medicines: Still an Incomplete Picture

Author Affiliations
  • 1Division of Infectious Diseases and Global Public Health, Department of Anesthesiology, School of Medicine, University of California, San Diego
  • 2Global Health Policy Institute, San Diego, California
  • 3World Health Organization Collaborating Centre for Governance, Transparency and Accountability in the Pharmaceutical Sector, University of Toronto, Toronto, Ontario, Canada
JAMA Netw Open. 2018;1(4):e181685. doi:10.1001/jamanetworkopen.2018.1685

In a press release reporting updates from the recent 71st World Health Assembly of the World Health Organization (WHO), member state delegates called special attention to development of a 5-year roadmap aimed at improving access to safe, effective, and affordable medicines and vaccines, a health target contained in the United Nations’ Sustainable Development Goals.1 The WHO also highlighted one of the key impediments of progress toward this target, the increasing numbers of substandard and falsified medicines (SF medicines) that undermine global health, social and economic progress, and human development.

Despite growing attention from a number of international organizations, including the WHO, the United Nations Office of Drugs and Crime, Interpol, and the World Customs Organization, the problem of falsified (ie, medical products deliberately and fraudulently misrepresenting their identity, composition, or source) and substandard (ie, authorized medical products that fail to meet their quality standards or specifications) medicines is not a recent phenomenon.2 In fact, as early as 1988, the World Health Assembly called for international action against the illicit trade in “counterfeit” medicines (a term WHO has abandoned, as it refers to a violation of intellectual property).2 More than 3 decades later, definitions have changed, resolutions have been adopted, reports have been issued, and new initiatives have been announced, but there remains a scarcity of empirical data on the actual prevalence, key characteristics, and economic impact of SF medicines.

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