EU Member States push for the creation of a “Critical Medicines Act”

5 May 2023

A non-paper published this week by Belgium, with the support of 18 other Member States, is calling for the creation of an EU “Critical Medicines Act”. Taking inspiration from the EU’s Chips Act and Critical Raw Materials Act, the signatories are calling for the establishment of a toolbox that would boost the production of critical medicines, APIs and chemical inputs in the EU. The non-paper, which was published on 2 May, was signed by many of the EU’s big heavyweights including, France, Spain, Germany and Italy.

In the non-paper, Member States argue that the issues around severe medicine shortages are not new, noting that “medicine shortages have increased over the past few years”. According to the OECD for instance, between 2017 and 2019, shortage notification increased by some 60%. The reasons for medicine shortages are very complex. They range from unexpected increases in demand, bottlenecks in the supply chains, regulation and reimbursement policies and manufacturing and quality issues. The reasons for the recent shortages across Europe can be attributed to many of the aforementioned factors, however, another problem for the EU, which the Member States address in the non-paper, is its increasing dependence on imports from a small number of manufacturers and specific regions for medicine supplies. This adds a critical security dimension to this issue. 

Together, the 19 countries have proposed the following points of action:

  • Installing a voluntary solidarity mechanism within the MSSG to temporarily alleviate acute shortages in Member States. This would be used as a last resort. 
  • Establishing a European list of critical medicines whose supply, production and value chains are monitored. This aligns with a measure recently put forward by the Commission under its adoption of the Pharmaceutical Legislation. 
  • Exploring a Critical Medicines Act to “reduce dependencies for critical medicines and ingredients, particularly for products where there are only a few supplying manufacturers or countries”. 

On the proposed Critical Medicines Act, the 19 Member States write that the Act should be seen as a “toolbox of different instruments” that would build on the Critical Raw Materials Act and work, among other things, on the supply of specific ingredients important for the health industry. 

Speaking about the proposal this week, Adviser in the Cabinet of Frank Vandenbroucke, Belgium’s Vice Minister for Social Affairs and Public Health, Gloria Ghéquière explained that greater medicine production is needed in the EU and that through the initiatives outlined in the non-paper, Member States are seeking to identify the products needed and thereafter, work to increase European production.

The non-paper was well received by stakeholders in Brussels this week. Notably, the European Commission has said it welcomes the initiative, while industry representatives, physician representatives and MEPs have equally expressed their support. Medicine shortages is a critical issue, countries have struggled with over recent years, and it is a problem that can have serious implications for patients and the care they receive. Together with the proposals included in the Commission’s recently adopted Pharmaceutical Legislation, it seems a greater EU effort to tackle the issue is underway.