EU list of critical medicines by end of year

The communication builds on measures within the European Health Union, particularly the strengthened powers of the European Medicines Agency and the recently published pharmaceutical reform. It responds to a strong call by member states at the European Council in June 2023 and reaffirmed in Grenada in October 2023, as well as to the European Parliament.

Mitigating critical shortages this winter and beyond

To better prepare for the coming winter, a number of measures have already been taken. For example, the Health Emergency Preparedness and Response Authority and the European Medicines Agency have identified key antibiotics (including some agents for children) for which the risk of critical shortages is anticipated before the onset of winter. Appropriate measures have been taken to ensure the availability of these antibiotics.

However, more needs to be done. Therefore, activities are being intensified by:

• Launch of the European voluntary solidarity mechanism for medicines (October 2023): The mechanism signals a member state's need for a particular drug to another member state, which can respond by making the drug available from its stockpile.
• EU list of critical medicines (to be made available by the end of 2023): The list will be the first step in analyzing the supply chains of selected medicines (due by April 2024). The analysis will identify areas where additional action is needed.
• Regulatory flexibility: member states can use regulatory exemptions so that patients get necessary medicines in a timely manner, including by extending the shelf life of medicines or quickly approving equivalents for the drugs in question. A special joint action will be launched in 2024 to promote the effective use of these flexibilities.
• EU guidelines for purchasing medicines to strengthen security of supply (to be published by the Commission in early 2024).
• A joint EU order of antibiotics and drugs against viruses that cause respiratory diseases for the coming winter.

Member states, the EMA and the Commission have already begun moving toward the proposed pharmaceutical reform to prevent and mitigate the risk of critical shortages. The Commission will continue to work with Member States to advance the various elements of pharmaceutical reform to strengthen security of supply where possible.

Structural measures to support security of supply in the long term

In order to diversify supply and stimulate and modernize the production of critical medicines with the participation of all stakeholders, the Commission intends to establish a Critical Medicines Alliance, which is expected to begin operation in 2024. The Critical Medicines Alliance will establish a pillar of industrial policy within our European Health Union. Such an alliance would enable national authorities, pharmaceutical industry players, civil society representatives, the Commission and EU agencies to coordinate at EU level against drug shortages and address vulnerabilities in supply chains.

The Alliance's work will focus on a specific number of critical medicines where the risk of shortages and the impact on health systems are greatest. The Alliance will use a diverse set of policy measures to mitigate the risk of shortages and increase supply. These measures include, but are not limited to:

• Coordinating procurement practices at the EU level,
• Examining how to diversify global supply chains through strategic partnerships,
• Increasing Europe's manufacturing and innovation capacity for critical drugs and ingredients in a coordinated manner,
• Developing a common strategic approach to stockpiling medicines in the EU,
• Assistance in the use and alignment of EU and national funding.

This could pave the way for the possible adoption of a "critical drugs act." To this end, by the end of 2023. The Commission will initiate a special preparatory study, which will form the basis for an impact assessment.

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

Source: press release