Maurits Lugard, partner at Sidley Austin’s Life Sciences practice, and Anna-Shari Melin, associate at Sidley Austin write about the measures being put into place to prevent and manage medicinal product shortages in the EU.
Medicine
EU regulators and industry have begun in earnest to focus on how to prevent and manage medicinal product shortages. Stakeholders have come together to assess the root causes of and potential solutions for such shortages and have proposed strategies. The European Medicines Agency (EMA) Draft Reflection paper on Good Manufacturing Practice (GMP) and Marketing Authorisation Holders (MAHs) of January 14, 2020 (the Draft GMP Reflection Paper), has devoted an entire chapter to the maintenance of supply of medicinal products. And EU regulators have highlighted the fact that medicinal product shortage prevention is one of their key priorities in 2020 (and informs the broader discussion of medicinal product pricing). In light of these developments, MAH should consider now conducting a careful review of their shortage management procedures.
Stakeholder onitiatives to identify root causes of shortages
The European Federation of Pharmaceutical Industries and Associations (EFPIA) recently published a Policy Proposal to Minimise Medicine Supply Shortages in Europe, calling, in particular, for the use of the repositories being set up in the context of the Falsified Medicines Directive as additional intelligence about the root causes and drivers of shortages.