Preventing, detecting, and responding to falsified and substandard medicines

Raffaella Ravinetto, Amalia Hasnida and Koen Peeters Grietens

Chapter 25 in Handbook of Pharmaceutical Science and Technology Studies, 2026, pp 399-417 from Edward Elgar Publishing

Abstract: The World Health Assembly definition of substandard and falsified (SF) medical products includes three categories: substandard, which are licensed but fail to meet adequate quality standards; falsified, which are deliberately or fraudulently misrepresented for identity, composition, or source; and unlicensed and unregistered, which skipped evaluation by the competent National Regulatory Authority. They are particularly, but not exclusively, prevalent in low and middle-income countries andare generally detected retrospectively, through research or post-marketing surveillance, except when toxicity clusters cause serious harm or death. But SF medical products are also harmful in less visible ways by compromising cure, triggering antimicrobial resistance, increasing costs, fuelling mistrust in health systems. World Health Organization policy mandates to prevent, detect, and respond to them, through coordinated interventions. Yet, besides internationally agreed-upon approaches, this phenomenon is framed in multiple and different ways in scholarly and practice debates. We describe and unpack these frames, examining their interacting, performative consequences in terms of prevention, detection, and response strategies. We conclude that a lack of coherent framing result in poor coordination of the operational and policy response and might even create a “window of opportunity” for SF medical products. We suggest steps towards an integrated “public health” frame to optimally combat SF medical products.

Keywords: Substandard and falsified medical products; Global health; Medicine quality; Medicine safety; Framing; Performativity (search for similar items in EconPapers)
Date: 2026
ISBN: 9781035338443
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