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 journalA1: Web of Science-article

Abstract

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 of WHO's SF definition and propose appropriate measures to put it into effect. We present a "legal levers matrix" 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 SF medicines, whereas health systems should strive to provide affordable medicines to all levels of society.

Original languageEnglish
JournalAmerican Journal of Tropical Medicine and Hygiene
Volume102
Issue number2
Pages (from-to)262-267
Number of pages6
ISSN0002-9637
DOIs
Publication statusPublished - 2020

Keywords

  • Counterfeit Drugs
  • Developing Countries
  • Humans
  • Legislation, Drug
  • Pharmaceutical Preparations/standards
  • Public Health/standards
  • Substandard Drugs

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