The Commission has proposed a Regulation to improve the availability of critical medicines in the EU. The proposal aims to protect human health by incentivising supply chain diversification and boosting pharmaceutical manufacturing in the EU. This will support the EU’s pharmaceutical sector which is a major contributor to our economy. The Act also aims to improve access to other medicines of common interest, which may not be available in certain markets. This initiative contributes to the European Health Union’s goal of ensuring that EU patients have access to the medicines they need, when they need them.
President von der Leyen announced the Critical Medicines Act in her political guidelines to reduce dependencies and enhance the EU’s resilience, particularly for medicines and active ingredients where there are only few supplying manufacturers or countries. It complements legislative proposals already put forward to address medicine shortages in the EU, notably the pharmaceutical reform.
In recent years, Member States have been confronted with serious medicine shortages and global challenges such as the COVID-19 pandemic and geopolitical tensions clearly exposed significant vulnerabilities in the EU’s pharmaceutical supply chain. Shortages can put patients’ lives at risk and place a significant burden on our healthcare systems. These shortages can be caused by manufacturing problems, supply chain vulnerabilities or global competition for resources. The Critical Medicines Act aims to provide an industrial toolkit to address these problems, by making the EU a market in which producing critical medicines will be more attractive.
The Act will facilitate investments for companies that increase EU manufacturing of critical medicines, while incentivising actions that make supply chains more resilient. It will also offer Member States the possibility to join together to increase their purchasing power.
Key elements of the Critical Medicines Act include:
- Strategic Projects will create, increase or modernise EU manufacturing capacity for critical medicines or their ingredients. These industrial projects may benefit from easier access to funding and fast-tracked administrative, regulatory and scientific support.
- State aid guidance has been published to assist Member States in financially supporting such Strategic Projects.
- Member States can use public procurement to diversify and incentivise the resilience of supply chains. For critical medicines, procurers will have to include a broader set of requirements in their procurement procedures, such as diversified sources of input material and monitoring of supply chains. In case of high dependency on a single or a limited number of countries, they will also have to use procurement requirements that favour critical medicine production in the EU. This will also be possible for other medicines of common interest, when justified.
- The Commission will support collaborative procurement among different Member States at the request of Member States, to address availability and access disparities of critical medicines and other medicines of common interest throughout the EU.
- International partnerships with likeminded countries and regions will be explored, to broaden the supply chain and reduce dependencies on single or limited numbers of suppliers.
For more information
Proposal for a Critical Medicines Act
Questions and answers on the Critical Medicines Act
Factsheet – EU Actions to address medicines shortages
Factsheet – Critical Medicines Act
Source: European Commission | Press corner (https://tinyurl.com/29yc6yma)