EU acts to address shortage of critical medicines

(BRUSSELS) - The European Commission adopted Tuesday a set of actions to better prevent and mitigate critical medicine shortages in the EU, this winter, next winter and beyond.

Following recent critical shortages, including of certain antibiotics last winter, the goals of the Communication are to prevent and mitigate critical shortages at EU level, with particular focus on the most critical medicines, and their security of supply in the EU.

Actions in the Communication include:

• 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.

To diversify supply as well as stimulate and modernise production of critical medicines with all stakeholders, the Commission says it intends to set up a Critical Medicines Alliance to be operational in early 2024. The Critical Medicine Alliance will add an industrial policy pillar to our European Health Union. This will allow national authorities, industry, civil society representatives, the Commission and EU agencies to coordinate action at EU level against the shortages of medicines and to address supply chain vulnerabilities.

The work of the Alliance will focus on a targeted number of critical medicines with the highest risk of shortages and impact on healthcare systems. It will draw from a varied toolbox of policy measures to mitigate risks of shortages and increase supply, including:

• Coordinating public procurement practices at EU level;
• Exploring how to diversify global supply chains through strategic partnerships;
• Boosting Europe's capacity to produce and innovate in the manufacturing of critical medicines and ingredients in coordinated way;
• Developing a common strategic approach to medicines stockpiling in the EU;
• Helping leverage and align EU and national funding.

The Commission is also to launch a dedicated, preparatory study by the end of 2023, paving the way for an impact assessment for a possible 'Critical Medicines Act' in the future.

In the first half of 2024, the Commission will also develop a common strategic approach to medicines stockpiling to prevent and mitigate shortages in cooperation with Member States.

The Commission will establish a network of international partners to address supply chain resilience. Strategic partnerships with third countries for the production of critical medicines will also be set up, reflecting both local demands and needs at the EU and global level.

Communication on tackling medicine shortages in the EU

Factsheet

Medicine Shortages in the EU - guide

Availability of medicines | European Medicines Agency (europa.eu)