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News announcement29 April 2024Health Emergency Preparedness and Response Authority2 min read

HERA launches the Critical Medicines Alliance to tackle shortages of critical medicines

In a concerted effort to combat shortages of critical medicines, HERA, in collaboration with the Belgian Presidency of the Council of the EU, has officially launched the Critical Medicines Alliance. The announcement was made during the informal EPSCO Council meeting of health ministers, marking a significant stride towards fortifying the European Health Union.

A unified front against medicine shortages

Announced by the Commission in October 2023, the Alliance complements as an industrial arm the proposed reform of the EU pharmaceutical legislation and responds directly to the demands of over 23 Member States for greater strategic autonomy in the sector.

The Alliance aims to unite national authorities, industry stakeholders, healthcare organisations, civil society representatives, the European Commission, and EU agencies. Together, they will strategise and implement measures to identify, prevent, and manage shortages of critical medicines effectively.

With over 250 registered members, the Alliance has already garnered substantial support since its inception. Its primary objectives include enhancing supply security, ensuring medicine availability, and reducing dependencies within the EU's supply chain.

Ensuring supply reliability

To achieve these goals, the Alliance will focus on developing strategic recommendations to address and mitigate shortages. This includes analysing factors such as reliance on a limited number of external suppliers, diversification opportunities, and production capacities. These recommendations will result in a multi-year Strategic Plan, outlining milestones and deadlines for implementation.

Moreover, the Alliance will identify potential 'pipeline investment projects' to bolster manufacturing within the EU, with an emphasis on securing EU and national funding. Market incentives, such as capacity reservation contracts and joint procurement, will also be explored to reinforce the supply of critical medicines.

Recognising the global nature of supply chains, the Alliance will foster collaboration and partnerships among its members. This inclusive approach may extend to EU neighbourhood countries, fostering diversification and resilience in critical medicine supply chains.

A five-year plan for sustainable medicine supplies

Looking ahead, the Alliance is set to operate for five years, with the first set of recommendations expected to be published by the end of 2024 as part of its Strategic Action Plan. While the initial call for expressions of interest has closed, the Alliance remains open to new members at all stages of its operation.

The initiative comes in response to recent shortages of critical medicines, underscoring the urgent need for a more secure and resilient supply chain across the EU. The Commission's ongoing analysis of supply chain vulnerabilities will further inform the Alliance's mandate, ensuring a comprehensive approach to safeguarding medicine supplies for European citizens.

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Publication date
29 April 2024
Author
Health Emergency Preparedness and Response Authority