The European Health Emergency Response and Preparedness Authority (HERA), in collaboration with the Belgian Presidency of the Council of the EU, launched, in Brussels on Wednesday 24 April, the Critical Medicines Alliance.
The Alliance brings together national authorities, industry, healthcare organisations, civil society representatives, the Commission and EU agencies to identify the best measures to address and avoid shortages of critical medicines (see EUROPE 13329/4).
First announced by the Commission in October 2023, the Alliance will focus on industrial policy and complement the Commission’s proposed reform of EU pharmaceutical legislation. This is a direct response to the call from over 23 Member States for greater strategic autonomy in the sector.
Following an open Call for expressions of interest launched on 16 January, the Alliance now has some 250 registered members, including ministries or governmental agencies representing Member States, companies or organisations as industry representatives, and non-governmental organisations.
The Alliance will work to enhance security of supply, strengthen the availability of medicines and reduce EU supply chain dependencies. Discussions within the Alliance will help the Commission to identify innovative ‘pipeline investment projects’ that could benefit from European 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 security of supply of critical medicines.
“We are increasingly faced with shortages of medicines, sometimes very critical medicines”, Frank Vandenbroucke, Belgium’s Minister of Health, told the media. He pointed out that in 2023, Belgium and 22 other countries called for immediate action against shortages of medicines, including “much more effective solidarity in Europe, even on a voluntary basis, without the need for a new legal framework”.
A voluntary solidarity mechanism is in place to enable Member States to support each other in the event of a shortage, said the Commissioner for Health, Stella Kyriakides.
The Commission has conducted a pilot analysis of the vulnerabilities of the supply chain of a first set of representative critical medicines that are part of the EU list.
“This gives a good starting point for the Alliance to explore strategies to strengthen Europe’s production capacity and look into innovative manufacturing technologies”, said the Commissioner. In addition, the Commission will look at ways to diversify the sources of supply of critical medicines. The Alliance will support the development of a set of industrial instruments to address these challenges, added Ms Kyriakides. This could include “joint procurement, capacity reservation contracts (...), or funding opportunities for strategic projects or strategic partnerships with third countries”.
One of the first deliverables of this Alliance will be the joint development of a Strategic Plan by the end of the year, with concrete and actionable recommendations. (Original version in French by Lionel Changeur)