1921
image of Legal Uncertainty—The Gray Area around Substandard Medicines: Where Public Health Meets Law
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

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.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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http://instance.metastore.ingenta.com/content/journals/10.4269/ajtmh.19-0645
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  • Received : 30 Aug 2019
  • Accepted : 22 Oct 2019
  • Published online : 18 Nov 2019
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