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

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.

Identification of Substandard and Falsified Medicines: Influence of Different Tolerance Limits and Use of Authenticity Inquiries

“…These categorizations cannot be free of ambiguity in scientific practice. 12 For example, even when a product has passed visual inspection, chemical analysis, and authenticity inquiries, it may still be falsified if labeling and chemical composition of the authentic product have been imitated very closely. Furthermore, defining criteria by which deliberate/fraudulent intent should be proven will always be a controversial issue.…”

“…Furthermore, defining criteria by which deliberate/fraudulent intent should be proven will always be a controversial issue. 12 And in case of OOS medicines, definitive proof of absence of such intent is virtually impossible.…”

“…The previously cited wording “Substandard medical products: Also called ‘out of specification’…” appears to use the term “substandard” synonymous with the term “out of specification.” This may sometimes cause confusion because, according to the U.S. Food and Drug Administration, out-of-specification (OOS) results include all test results that fall outside the relevant specifications or acceptance criteria, 11 irrespective of the absence or presence of deliberate intent as the reason for noncompliance of the investigated product. Notably, the cited WHO document adds a footnote to its definition of substandard medical products: “When the authorized manufacturer deliberately fails to meet these quality standards or specifications due to misrepresentation of identity, composition, or source, then the medical product should be considered ‘falsified’.” 10 , 12 …”

Exposure of consumers to substandard antibiotics from selected authorised and unauthorised medicine sales outlets in Ghana

“…For example, such a medicine may contain less (or more) active ingredient than the label claim. There may not necessarily be an intention to cheat or an issue of fraud with such occurrences; they may be due to problems with the manufacturing processes or distribution challenges within the supply chain [25] or to accidental errors and negligence [26].…”

Sub-standard or Sub-legal? Distribution, Pharma Dossiers, and Fake-talk in India

“…In early 2020, I had intended to do in-person fieldwork in India to learn what people exporting and distributing pharmaceuticals thought about widespread claims that fake drugs from India were rampant in international markets ( Quet 2021 ; Olliaro et al 2020 ; Nayyar et al 2019 ; Johnston and Holt 2014 ; Newton, Green, and Facundo 2010 ). Unfortunately, the COVID-19 pandemic made it impossible to travel, so I began phoning and using online platforms like WhatsApp to contact traders.…”