Causes of drug shortages in the legal pharmaceutical framework

- Analysis of the European legal pharmaceutical framework which may influence shortages.
- Pricing procedures may influence drug shortages as well as drug unavailability.
- Market withdrawals can be caused by manufacturing/quality requirements.
- The legal framework leaves room for improvement to mitigate drug shortages.

IntroductionDifferent causes of drug shortages can be linked to the pharmaceutical legal framework, such as: parallel trade, quality requirements, economic decisions to suspend or cease production, etc. However until now no in-depth study of the different regulations affecting drug shortages is available. The aim of this paper is to provide an analysis of relevant legal and regulatory measures in the European pharmaceutical framework which influence drug shortages.MethodsDifferent European and national legislations governing human medicinal products were analyzed (e.g. Directive 2001/83/EC and Directive 2011/62/EU), supplemented with literature studies.ResultsFor patented drugs, external price referencing may encompass the largest impact on drug shortages. For generic medicines, internal or external reference pricing, tendering as well as price capping may affect drug shortages. Manufacturing/quality requirements also contribute to drug shortages, since non-compliance leads to recalls. The influence of parallel trade on drug shortages is still rather disputable.ConclusionPrice and quality regulations are both important causes of drug shortages or drug unavailability. It can be concluded that there is room for improvement in the pharmaceutical legal framework within the lines drawn by the EU to mitigate drug shortages.