EU Commission launches Critical Medicines Alliance to prevent and address critical medicines shortages

Brussels – Today, the European Commission’s Health Emergency Preparedness and Response Authority (HERA), in collaboration with the Belgian Presidency of the Council of the EU, launched the Alliance for Critical Medicines on the sidelines of the informal meeting of the Council of Health Ministers as part of actions to build a strong European Health Union.

The Alliance, a note explains, brings together national authorities, industry, health organizations, civil society representatives, the Commission and EU agencies to identify the best measures to address and avoid shortages of critical medicines.

First announced by the Commission in October 2023, the Alliance will focus on industrial policy and complement the reform of EU pharmaceutical legislation proposed by the Commission. This is a direct response to the more than 23 member states’ call for greater strategic autonomy in the sector. Following an open call for expressions of interest launched on January 16, 2024, the Alliance now has about 250 registered members, including government agency ministries representing member states, companies or organizations such as industry representatives, and nongovernmental organizations. Key Strategic Actions of the Alliance Established as an inclusive and transparent consultative mechanism of key stakeholders, the Alliance will improve supply security, strengthen the availability of medicines, and reduce dependencies in the EU supply chain. This will ultimately contribute to a more resilient and sustainable pharmaceutical industry in Europe and safer supplies of medicines for citizens. To strengthen the security of supply, the Alliance will develop policy recommendations to address and avoid shortages.

Key factors that will be analyzed include over-reliance on a limited number of external suppliers, limited opportunities for diversification, and limited manufacturing capacity. This will be based on the Commission’s vulnerability analysis of bottlenecks in the supply chain of critical medicines on the Union’s list.

The recommendations will be part of a multi-year “Strategic Plan“, which will contain corresponding milestones and timelines for their implementation. Discussions in the Alliance will help the Commission identify innovative “pipeline investment projects” that could benefit from European and national funding to strengthen manufacturing in the EU. The Alliance will also examine how market incentives, such as the possibility of expanding the use of capacity reservation contracts and joint procurement, can be used to improve the security of the supply of critical medicines.

The Alliance will take a holistic view of the supply chain, and its members will be able to identify new synergies to collaborate more effectively, including by creating new partnerships. Given the global nature of the supply chain and the strong interest expressed, for example, by several partners from the Western Balkans and EU neighbouring countries to participate in the Alliance, these new partnerships could lead to diversification of the supply chain for critical medicines.

The Alliance has been launched for five years. Beginning with today’s launch, work will start with the publication of initial recommendations on actions to improve the supply of critical medicines expected by the end of the year. While the first call for expressions of interest has closed, the Alliance remains open to new members at all stages of its operation.