European Commission Publishes Study on Medicine Shortages in European Economic Area

• 09/12/2021
• Articles

The European Commission (Commission) published yesterday a study on medicine shortages (Medicine Shortages Study or MSS) which includes an analysis of real-world data culled from national shortage registries of 22 European Economic Area (EEA) countries, a review of the causes for medicine shortages in the European Economic Area, an assessment of the current regulatory framework and a series of possible solutions in the form of 16 policy measures. The MSS, a joint effort of the Ecorys, Milieu Law & Policy Consulting, and Technopolis Group consultancies, will inform the Commission’s Pharmaceutical Strategy (see, Van Bael & Bellis Life Sciences News Alert of 26 November 2020) and may translate into a legislative proposal by the end of 2022.
 
The solutions which the MSS recommends cover a wide range of areas in relation to data collection and sharing; supply chain management; market issues; and mitigation strategies. They are, depending on the subject, directed to the Commission, Member States and the European Medicines Agency. For the life sciences industry some of the envisaged measures will create significant additional burdens, but other measures promise a welcome regulatory relaxation. To be sure, it remains to be seen if and how these measures will become part of the Commission’s proposed regulatory package. In short, they concern: 

• a harmonised EU-wide definition of “medicine shortages”;
• harmonised reporting criteria for shortages;
• financial sanctions on marketing authorisation holders (MAH) for any failure to respect notification requirements and supply responsibilities;
• an EU-wide list of critical medicines and rules to enhance their availability;
• a safety stock of products for medicines of major therapeutic interest;
• transparency obligations with regard to both supply quota systems and wholesaler/trader activity;
• mandatory shortage prevention and mitigation plans for MAHs;
• common principles for national restrictions on intra-EEA trade in medicines;
• greater scope for emergency imports of medicines;
• broader information regarding alternative medicines in shortage databases;
• stakeholder dialogue platforms;
• a widening and diversifying of the group of potential tendering candidates in public procurement procedures;
• reduction of red tape for post-approval changes of marketing authorisations;
• accelerated Mutual Recognition Procedure (MRP);
• a more efficient Repeat Use Procedure which involves the recurrent use of an MRP to secure a marketing authorisation for the same medicine in additional Member States;
• revised packaging and labelling rules that offer more scope for digital leaflets and multi-language packaging and labelling.