Giuliana Miglierini

The European Commission published on 24 October the Communication detailing actions to prevent and mitigate critical medicine shortages in the EU, starting from this winter. The document is comprehensive of a series of short-term measures, and of mid- and long-term actions to improve the resilience and strategic autonomy of the European pharmaceutical supply chain. The focus of the Communication is on the most critical medicines, for which security of supply must be ensured at all times. The European Health Emergency Preparedness and Response Authority (HERA) and the European Medicines Agency (EMA) have already identified a list of key antibiotics (including specific paediatric formulations) potentially subjected to critical shortages ahead of the winter, and for which measures are already in place to ensure supply. The launch of the new European Voluntary Solidarity Mechanism for medicines by EMA has immediately followed the Communication. Under the MSSG Solidarity Mechanism, member states experiencing difficulties with the availability of critical medicines may ask support to other member states, which may voluntary share their available stocks. A Toolkit containing MSSG recommendations was also published by EMA. The end of the year should see the issuing of the new Union list of critical medicines, which should be followed in 2024 by the analysis of critical supply chains. Several forms of regulatory flexibility were also considered, i.e. regulatory exemptions, extension of shelf-life or the quick authorisation of alternatives. A dedicated Joint Action was announced for 2024 to promote effective use of these flexibilities. A new EU guidance on procurement of medicines to strengthen security of supply should be issued by early 2024, and a EU joint procurement should be activated to manage the 2023 winter season for antibiotics and treatments for respiratory viruses. Other elements of the proposed pharmaceutical reform may be accelerated, where possible.

The second part of the Communication addresses the structural measures identified by the Commission to support the long-term security of supply. A Critical Medicines Alliance should become operative in 2024, with the objective of diversifying supply and modernising production of critical medicines. The Critical Medicine Alliance will represent the industrial policy pillar of the European Health Union, and it will allow for the coordination of actions at EU level against the shortages of medicines and supply chain vulnerabilities. The Alliance will focus on a targeted number of critical medicines with the highest risk of shortages and impact on healthcare systems. Among its objectives are the coordination of public procurement practices at EU level, and how to diversify global supply chains through strategic partnerships. The possibility to expand Europe’s capacity to produce and innovate in the manufacturing of critical medicines and ingredients in coordinated way will be also explored, as well as helping leverage and align EU and national funding. The development by the Commission of a common strategic approach to medicines stockpiling in the EU was announced for the first half of 2024. A dedicated, preparatory study for a possible Critical Medicines Act should be launched by the end of 2023, followed by a impact assessment. At the international level, the Commission aims to establishing a network supporting resilience of supply chains, and strategic partnerships with third countries for the production of critical medicines.