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

Abstract

The WHO estimates that on average, 10.5% of the medicines in low- and middle-income countries (LMICs) are of poor quality,1 failing to meet standards for amounts of active ingredients(s), impurities, bioavailability, sterility, stability, packaging, etc.2,3 They threaten the welfare of individuals and societies, undermine health systems, and challenge the achievement of universal health coverage (UHC), which requires equitable access to quality-assured medicines.4–6 Collectively, poor-quality medicines are now called “substandard and falsified (SF)” medical products (Table 1) as per a 2017 World Health Assembly (WHA) resolution.7 “Falsified” implies intent of deceiving, whereas “substandard” medicines are authorized, but noncompliant with quality standards. This is a welcomed improvement over the previous complex and disputed “working definition” of “substandard/spurious/falsely-labelled/falsified/counterfeit medical products,” as it squarely focuses on public health. It now needs to be translated into action in countries to prevent, correct, compensate for, and, where necessary, sanction wrongdoings.