Commission to step up efforts to address critical medicine shortages and improve security of supply in the EU

On 24 October 2023, the European Commission adopted measures to better prevent and mitigate critical shortages of medicines. For example, last winter's shortage of certain antibiotics showed that coordinated action is needed to prevent a critical shortage of medicines. These actions aim to address supply challenges and improve the resilience of pharmaceutical supply chains in Europe in the long term.

The Commission Communication builds on the ongoing work related to the European Health Union, in particular on the extended mandate of the European Medicines Agency and on the reform of pharmaceutical legislation. 

Measures to prevent a critical shortage of medicines

The European Health Emergency Preparedness and Response Authority (HERA) and the European Medicines Agency (EMA) have identified key antibiotics  (EU Commission 17 July 2023) for which they anticipate the risk of critical shortages this coming winter. Measures have already been taken to ensure the availability of these antibiotics. In addition, other planned measures include:

• 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) This list will be the first step in analysing the supply chain of certain medicines. The analysis will then show where additional measures are needed.
• Regulatory flexibilities. Member States may make use of regulatory exemptions to ensure that medicines reach patients at the right time, including extending shelf-life or the quick authorisation of alternatives The effective use of these flexibility opportunities will be promoted in 2024 through a specific joint action. 
• The Commission will issue EU guidance on procurement of medicines to strengthen security of supply by early 2024.
• EU joint procurement of antibiotics and medicines for respiratory tract infections for next winter.

Securing long-term security of supply

The Commission also intends to set up a Critical Medicines Alliance with all stakeholders to diversify the supply of critical medicines and promote and modernise their production.  The alliance is to be operational at the beginning of 2024. Its work will focus on certain critical medicines with the highest risk of shortages and impact on healthcare systems. 

The Commission will also develop a common strategic approach to the storage of medicines in cooperation with Member States in early 2024. This is intended to prevent and alleviate shortages of medicines. 

International cooperation and the genuine integration of the pharmaceutical industry are key to ensuring access to medicines in Europe and elsewhere in the world. The Commission now intends to set up a network of international partners to improve supply chain resilience. Strategic partnerships will be established with non-EU countries for the production of critical medicines.  

European Commission press release 24 October 2023