The European Commission published a Communication adopting a set of actions to better prevent and mitigate critical medicine shortages in the EU. Recent critical shortages, including of certain antibiotics last winter, show that continued coordinated action is needed to address supply challenges and to make Europe’s medicine supply chains more resilient in the long run.
The key goals of the Communication are to prevent and mitigate critical shortages at EU level. It puts a particular focus on the most critical medicines, for which security of supply in the EU must be ensured at all times.
This Communication builds on the work under the European Health Union, notably the reinforced mandate of the European Medicines Agency and the recently published pharmaceutical reform. It follows a strong call by Member States at the 2023 June European Council, confirmed in Granada in October 2023, and from the European Parliament. In particular, it focuses on:
- The launch of a European Voluntary Solidarity Mechanism for medicines (October 2023): the mechanism flags a Member State’ needs for a given medicine to other Member States, that can respond by redistributing medicines from their available stock.
- A Union list of critical medicines (available by the end of 2023): Once established, this list will be the first step to analyse the supply chain of selected medicines by April 2024. This analysis will then show where additional measures are needed.
- Regulatory flexibilities: Member States can use regulatory exemptions to allow medicines to reach patients in a timely manner, including extending shelf-life or the quick authorisation of alternatives. There will be a dedicated Joint Action in 2024 to promote effective use of these flexibilities.
- EU guidance on procurement of medicines to strengthen security of supply issued by the Commission by early 2024.
- EU joint procurement for next winter for antibiotics and treatments for respiratory viruses.
This Communication complements the pharmaceutical reform by further boosting the anticipation and operationalisation of some of the measures proposed in the reform, while acknowledging that additional policy tools, including industrial policy, can support the important objective of ensuring security of supply of critical medicines in the EU.