The EU Parliament and Council have reached a provisional deal on a new regulation that seeks to strengthen the EU’s resilience in addressing ongoing challenges to security of supply of critical medicines in Europe.
The aim of the critical medicines act (CMA) is to tackle shortages of key medicines such as antibiotics, insulin and painkillers by improving security of supply and availability of critical medicines, and medicines of common interest in the EU.
The new rules seek to diversify supply chains of critical medicines, make it easier for EU countries to join forces to procure critical medicines, and strengthen the manufacturing capacity for critical medicines and their active ingredients within the EU.
“Patients should not have to worry about whether critical medicines such as antibiotics will be available at their pharmacy or hospital”, said Cyprus’ Health minister Neophytos Charalambides, for the EU presidency: “With today’s agreement, we are taking practical action to reduce our vulnerabilities, diversify supply chains and strengthen Europe’s capacity to produce critical medicines and their ingredients closer to home.”
Under the agreed Critical Medicines Act:
- Member States will have to diversify and incentivise resilience in the medicine supply chains during public procurement procedures. For critical medicines, procurers will have to support the diversification and reliability of supply sources. In case of a high dependency on a single or a limited number of third countries, the CMA goes further, foreseeing the obligation for contracting authorities to favour “manufacturing in the EU”.
- The creation of Strategic Projects to boost, increase or modernise EU manufacturing capacity for critical medicines or their active substances, through easier access to (Member State and Union) funding as well as fast-tracked administrative support. In addition, projects for manufacturing of orphan medicines will also benefit from faster permitting.
- When Member States require companies to hold contingency stocks, they will have to ensure that this does not negatively affect supply of critical medicines in other countries in the Union. Member States will also have to share up to date information on contingency stocks available for reallocation when a call for solidarity is launched through the Voluntary Solidarity Mechanism.
- Collaborative procurement will be available for Member States to address availability and access disparities of critical medicines, orphan medicines and other medicines of common interest throughout the EU.
- Strategic partnerships with international partners will be explored, to broaden the supply chain and reduce dependencies on single or limited numbers of suppliers.
The political agreement is now subject to formal approval by the European Parliament and the Council.
Proposal for a Critical Medicines Act
Questions and answers on the Critical Medicines Act
