The European Commission‘s Health Emergency Preparedness and Response Authority (HERA), working with the Belgian Presidency of the Council of the EU, has launched the Critical Medicines Alliance at the margins of the informal EPSCO Council meeting of health ministers, as part of the actions to build a strong European Health Union.
The Alliance brings together national authorities, industry, healthcare 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 the EU’s pharmaceutical legislation as proposed by the Commission. It is a direct response to the call of more than 23 Member States for more strategic autonomy in the sector.
Following an open Call for expression of interest launched on 16 January 2024, the Alliance has now some 250 registered members, including ministries of governmental agencies representing Member States, companies or organizations as industry representatives, and non-governmental organizations.
Key strategic actions of the Alliance
Set up as an inclusive and transparent consultative mechanism for key stakeholders, the Alliance will:
- work to enhance the security of supply;
- strengthen the availability of medicines;
- reduce EU supply chain dependencies.
This will ultimately contribute to a more resilient and sustainable pharmaceutical industry in Europe and more secure medicine supplies for citizens.
To strengthen the security of supply, the Alliance will develop strategic recommendations to address and avoid shortages. Key factors being analyzed include an over-dependency on a limited number of external suppliers, limited diversification possibilities, and limited production capacities. This will build on the Commission’s vulnerability analysis of supply chain bottlenecks of critical medicines on the Union list of critical medicines. The recommendations will form together a multi-year ‘Strategic Plan’, containing milestones and corresponding deadlines for their implementation.
Discussions in the Alliance will help the Commission to identify innovative ‘pipeline investment projects’, which could benefit from EU and national funding to strengthen manufacturing in the EU.
The Alliance will also look at how market incentives, such as the possibility to expand the use of capacity reservation contracts and joint procurement can be used to enhance the security of the supply of critical medicines.
The Alliance will take a holistic view of the supply chain, and its members can identify new synergies to work with each other more effectively, including creating new partnerships. Given the global nature of the supply chain and the strong interest expressed by, for example, several partners from the Western Balkans, as well as EU neighborhood countries, to participate in the Alliance, these new partnerships could bring the diversification of the supply chain of critical medicines.