Commission launches alliance to address shortages of critical medicines

In another move to tackle medicines shortages faced across the EU, the European Health Emergency Preparedness and Response Authority (HERA) launched a Critical Medicines Alliance, an advisory group, on Tuesday (16 January).

The Critical Medicines Alliance aims to strengthen cooperation between the Commission, national governments, local and regional authorities, health professionals, industry, civil society and other stakeholders to identify challenges, actions and potential policy solutions.

Last winter, the EU faced suddenly increased shortages of important medicines, such as certain antibiotics, critical to ensuring public health. According to the Commission, this was due to a rise in demand, low production capacity, shortages of raw materials, and issues throughout the supply chain, as laid out in their October communication.

“It marks the beginning of a concerted push to bolster and modernise the production of critical medicines in the EU and diversify international supply chains,” said EU Health Commissioner Stella Kyriakides in a statement.

“The Alliance will help to change the way we produce and procure medicines and ultimately reinforce our security of supply,” Kyriakides added, calling the alliance “a new industrial pillar of our strong European Health Union”.

According to the Commission, the alliance will explore how to diversify global supply chains, boost Europe’s capacity to produce and innovate, develop a common strategic approach to medicines stockpiling in the EU, and help leverage and align EU and national funding to implement solutions to medicines shortages.

Along with the launch on Tuesday, the Commission also announced that interested parties should get in touch to become a member.

The alliance will start its work in the spring and last for five years. According to the plan, its first recommendations will be published by Autumn 2024.

EU's first list of critical medicines and other key measures to tackle shortages

The European Medicines Agency (EMA) will publish the first critical medicines list next week, as part of the EU’s strategy aimed at avoiding shortages, which also foresees other measures like stockpiling and diversifying the supply chain. 

Strong focus on shortages and security

In December, the European Commission, the heads of medicines agencies in the EU and the European Medicines Agency (EMA) jointly published the first EU list of critical medicines, which will be updated once a year.

On it are more than 200 active substances of medicines for human use critical for healthcare systems in the EU/EEA. To make the list, these medicines must meet a number of criteria, including being critical in more than one-third of the countries and essential in guaranteeing a high level of public health protection.

Shortages of critical medicines are also high on the Belgian Presidency’s agenda over the next months.

According to Belgian health minister Frank Vandenbroucke, who elaborated on the plans at the EPSCO Council on 30 November, the ongoing negotiations for a revision of the EU pharmaceutical legislation should give member states a head start on dealing with medicine shortages.

This should happen by starting with chapter 10 of the revision’s proposed regulation “Availability and security of supply of medicinal products”. This would make it possible to “more or less know where the Council position is heading before we start implementing nationally”, Vandenbroucke told his fellow EU health ministers. Just like EU health ministers, the EU Parliament is also still to form their mandate.

Closely linked to the medicines shortages is the need to ensure that the EU has sufficient access to the ingredients needed to produce medicines. Industry numbers show that 56% of active pharmaceutical ingredients come from India and China.

On this basis, a potential Critical Medicines Act has also been discussed. According to Kyriakides at the EPSCO Council in November, the Critical Medicines Alliance would be a first stage of looking into a potential Critical Medicines Act.

[Edited by Giedrė Peseckytė/Nathalie Weatherald]

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