Belgium looks to get a head start on potential medicine shortages

Despite the short and long-term initiatives already in the pipeline, health ministers are eager to further expedite action on medicines shortages and secure an open strategic autonomy on health.

One of the key tasks for Belgium ahead of its EU Council presidency starting 1 January is to address medicine shortages – through the proposed EU pharmaceutical legislation – as soon as possible, Belgian health minister Frank Vandenbroucke told the EPSCO Council on Thursday (30 November).

Cracking open the negotiations with chapter 10 of the revision’s proposed regulation 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.

The ministers called for more urgency to deal with the problem of medicines shortages across the continent following last winter’s critical increase, which, according to the European Commission, was due to a surge in demand, insufficient production capacity, shortages of raw materials, distribution problems, labour disruptions and natural disasters.

Negotiations on the revision of the EU pharmaceutical legislation, proposed by the Commission in April, still have a long way to go, with Council and Parliament still working on their positions. On top of that, the revision holds many thorny issues, meaning the road towards an interinstitutional agreement could drag on. In the meantime, additional action to deal with the critical medicine shortages is necessary, EU Health Commissioner Stella Kyriakides said at the meeting.

“It will take time to go through all the processes [of the pharmaceutical reform negotiations]. This is why we came out with specific short and medium-term steps to address medicine shortages in the EU in the coming years until we get the pharmaceutical reform through,” said Kyriakides.

In October, the European Commission published a communication with a set of actions aiming to prevent and mitigate critical medicine shortages.

This included certain elements from the proposed pharmaceutical revision such as earlier notification of shortages by companies, shortage prevention plans for all medicines, and increased information for sharing medicine shortages at the EU level.

The actions include the launch of a European Voluntary Solidarity Mechanism for medicines, a list of critical medicines by the end of 2023, regulatory flexibilities and EU guidance on public procurement.

While health ministers generally supported the Commission’s initiatives, they stressed the urgency of overcoming the shortages and the vast majority argued for further action.

Dutch health minister Ernst Kuipers said that “the proposals are, for understandable reasons, still quite generic” and that he was looking forward to more specific proposals.

Others, such as Ireland and Germany, urged mindfulness to avoid duplications in the many actions.

Towards a critical medicines act

Closely linked to the medicines shortages is the need to ensure that the EU has sufficient access to the ingredients needed to produce medicines.

Following the COVID-19 pandemic, the vulnerability of supply chains of medicines began to raise increasing concern.

Numbers from the industry show that the production of active pharmaceutical ingredients within Europe is in steep decline, increasing dependence on other regions. They show that 56% of these ingredients come from India and China.

In May, Belgium, with the support of 18 other member states, argued for the need to create a Critical Medicines Act (CMA) to reduce dependencies on critical medicines and raw ingredients, following the example of the Chips Act and the recently agreed-upon Critical Raw Materials Act.

According to Kyriakides, the Critical Medicines Alliance – a public-private partnership announced in October as “an industrial policy pillar to our European Health Union” – will be set up in early 2024 as a first stage of looking into a potential CMA.

Under this constellation, a vulnerability assessment of the supply chains for key critical medicines will be made.

“So we will be looking at actions to address these vulnerabilities, for example, public procurement, boosting and manufacturing capacity for strategic projects, and coordinating stockpiles of medicines at EU level,” Kyriakides said.

“This alliance is a new way for public authorities in the EU to work together in order to find practical solutions to ensure security of supply for medicines. And with this work, we are also paving the way for a possible future Critical Medicines Act, which is in the making,” she added, with a number of countries asking for the work on a CMA to be sped up.

[Edited by Giedrė Peseckytė/Nathalie Weatherald]

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