Legal Uncertainty-The Gray Area around Substandard Medicines: Where Public Health Meets Law

Am J Trop Med Hyg. 2020 Feb;102(2):262-267. doi: 10.4269/ajtmh.19-0645.


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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

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


  • Counterfeit Drugs
  • Pharmaceutical Preparations
  • Substandard Drugs