Substandard medicines contribute to morbidity, mortality, and drug resistance and, despite efforts to raise quality, are a problem in many countries. Academics have proposed a treaty on drug quality to accelerate quality improvement.
“This could be negotiated incrementally, starting from the agreement by all parties that poor quality medicines are unacceptable, with emphasis on reaching a consensus on the contentious points, such as definitions and terms”, researchers wrote in PLoS Medicine.
Public health-oriented definitions are needed, the academics wrote, to improve quality and protect the trade in generics. “Counterfeit medicines should be defined in terms of harm to health, with punishments appropriate for the injury or killing of patients”, the researchers wrote.
With definitions of key terms in place the treaty could “facilitate transnational jurisdiction over widespread, systematic counterfeiting as a crime against humanity”, the academics wrote.
The treaty could also cut the frequency of substandard drugs through “positive legal powers and a financial mechanism to facilitate good quality manufacturing and access to affordable high quality medicines”.
Tensions between defence of commercial interests and public health have hindered efforts to stop substandard drugs, the academics wrote, and these differences must be overcome to help patients.
The researchers wrote: “We strongly suggest that those concerned with medicine quality and access put the recent controversies behind them and work positively towards agreement on definitions and a treaty to facilitate access to good quality essential medicines and medical products”.