Legal uncertainty - the gray area around substandard medicines: where public health meets law

Eugenia Olliaro, Piero Olliaro, Calvin W.L. Ho, Raffaella Ravinetto

Research output: Contribution to journalReview ArticleResearchpeer-review

5 Citations (Scopus)


A vicious circle links lack of equitable access to health to the supply of poor-quality medicines, which amount to one-tenth of medicines available in low- and middle-income countries. The WHO introduced a new, public health-focused definition of substandard and falsified (SF) medicines, which offers opportunities for governments to broaden the scope of interventions to combat poor-quality medicines. At the same time, translating it into legal and regulatory measures may be challenging because this definition is not free of ambiguity (in that, there is a gray area between intentionally falsified and unintentional substandard medicines), and some countries may not have appropriate regulatory mechanisms/jurisdictions in place. The focus of the article is to consider what a public health-informed legal and regulatory environment could look like in light ofWHO'sSFdefinition and propose appropriatemeasures to put it into effect.We present a "legal leversmatrix" that may assist legislators and policymakers evaluate the adequacy of measures (i.e., criminal, civil, and administrative mechanisms) to address the problem of poor-quality medicines, particularly in terms of their configuration. In addition, this matrix underscores the importance of fostering dialogue between medical/public health and the legal/regulatory communities and to develop alternative/complementary solutions, including regulatory strengthening and nonpunitive actions. Substandard and falsified medicines arise from the interplay between societies, economies, and behaviors: Effective regulation is necessary to disincentivize the production and/or supply of SFmedicines,whereas health systems should strive to provide affordablemedicines to all levels of society.

Original languageEnglish
Pages (from-to)262-267
Number of pages6
JournalAmerican Journal of Tropical Medicine and Hygiene
Issue number2
Publication statusPublished - 2020
Externally publishedYes

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