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EU Critical Medicines Alliance Strategic Report

Date
March 27, 2025
Category

EU Regulations

Description

The Critical Medicines Alliance was launched in April 2024 and brings together stakeholders from health professions, industry and civil society and representatives from Member States. On 28 February 2025 they published a 47-page Strategic Report to put forward strategic recommendations to the Commission, Member States and the Alliance’s stakeholders on actions and measures that could be implemented to support the strengthening of Critical Medicines manufacturing in the EU and to ensure strategic partnerships with non-EU countries to strengthen the supply chain of Critical Medicines

In this report the Alliance identifies the following key industrial challenges that impact the supply of medicines to the EU:

  1. Overreliance on a limited number of geographical locations for the provision of API and raw materials, which is of high importance for both generics and originators,
  2. Erosion of the EU manufacturing base, starting upstream of the supply chain as well as for marketing authorisation holders - especially for generics (90% of the Critical Medicines list), but also for innovative medicines,
  3. Clear market consolidation which encourages single supplier sourcing inside and outside of the EU,
  4. Lack of competitiveness and investment in the European API industry as well as in the generics industry,
  5. Trend towards a fragmentation of the industrial value chain, with a clear separation between upstream activities producers (intermediates and API producers) and high-value downstream activities producers (formulation and packaging).

The report then makes the following recommendations:

  1. Assess vulnerabilities in the industrial supply chains of Critical Medicines.
  2. Strengthening European manufacturing of Critical Medicines by investing in EU strategic projects.
  3. Ensuring the security of supply of Critical Medicines through updated contingency stocks and procurement strategies
  4. Fostering a level-playing-field for Critical Medicines production.
  5. Enhancing the resilience of the EU’s pharmaceutical supply chain through identification and assessment of alternative countries/regions for establishing partnerships.
  6. Routes to establish and expand international solidarity cooperation.

The report can be found at https://health.ec.europa.eu/do...