On 11 March, the European Commission has proposed the Critical Medicines Act, a new Regulation to improve the availability of critical medicines in the EU. The proposal aims to protect human health by incentivizing 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.
The elements of the Critical Medicines Act include:
- Strategic Projects will create, increase or modernize 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.
More information HERE
