Brussels – Europe and its paradoxes: when faced with “structural” problems—which are then crisis contexts—it stalls, when faced with new problems, it accelerates. So, while for defence there is an insistence on the need to create a single market that does not exist (and which, it must be said, since we are talking about products not for private individuals but for governments, it is also logical that it should not exist), for pharmaceuticals the single market, which does exist, is not freed of those barriers that produce the shortages of medicines that the EU now periodically has to face, and which curb the European competitiveness. A topic, the latter, at the heart of the Connact event scheduled for tomorrow (18 September).
The European Court of Auditors, in its special report on the subject, holds the European Commission accountable for its failures. It is true, remember the Luxembourg auditors, that health and sanitation remain national competences, but at the same time the Community executive “has the responsibility to ensure the proper functioning of the single market, which allows the free movement of goods within the EU.” Medicines are goods, and ensuring their free movement “is a basic condition for their availability.” Precisely because of national competences in this area, “EU action in this area is based on the single market for security of supply.” Here, however, little has been done.
“Medicines shortages can have severe consequences for patients, compromise public health and result in high costs for doctors, pharmacies, and countries alike,” warns Klaus Heiner Lehne, member of the Court of Auditors responsible for investigation and publication. “The EU needs an effective remedy for critical shortcomings and must address them at their root, also as a matter of European strategic autonomy.”
By 2028, according to the recommendations produced by the Luxembourg auditors, the European Commission should therefore proceed to remove the still existing obstacles and barriers, fostering the coordination that is currently lacking. “Action is needed,” insists Lehne. “It is time to create a system to respond to shortcomings; it is also a question related to the strategic autonomy of the EU.”
Yes, the EU to date is not as autonomous as it should be. It is too dependent on foreign countries for the production and supply of a wide range of medicines, for both general and specific use. Lehne cites anaesthetics and oncology drugs as products on which Europe relies on foreign countries, but also “for painkillers such as ibuprofen and paracetamol, the EU is heavily dependent on Asia,” warns the ECA member. This exposes the twelve-star bloc to risks, besides being in contrast to and almost in disregard of a social situation that sees the EU with an elderly population, eager therefore for cures, especially in Italy.
https://www.eunews.it/en/2025/03/10/not-just-defence-eu-countries-ask-von-der-leyen-for-new-resources-for-critical-drug-shortage/
A system that is still too national, and therefore fragmented, needs to be relaunched from a European perspective. The Commission has taken measures and initiatives, but “in a limited and tardy manner,” the head of studies emphasises. There is certainly a political aspect behind this. “In the Critical Medicines Act, there could have been something more, but the competence is national and therefore limitations could secure approval” from the states, Lehne argues. This reluctance to disturb governments, however, means that “there is still no effective system for dealing with critical shortages,” the ECA criticises.
Shortages of medicines have long been a recurring problem across the EU, with non-availability peaking in 2023 and 2024 and affecting as many as 136 different medicines between January 2022 and October 2024. The problem has been observed everywhere, and yet countries are working in isolation, with no communication between them, introducing national stockpiles that end up creating new barriers and obstacles to the free movement of goods that are useful for health and healthcare.
“Remember the antibiotic shortages in December 2023 and
those due to COVID? These situations have not disappeared,” warns Lehne. Who anticipates: “For winter and the ‘seasonal illnesses’ of 2025, I would not expect a different situation from last year. No more dramatic, but I expect shortages again this year.”
To solve this, “missing medicines must be reported on time. Still, beyond that, a single European database is needed”, urges the EU Court of Auditors. Hence, the call for the EU Commission to take action by the end of 2027 to ensure that shortages of centrally authorised medicines are reported to the European Medicines Agency (EMA) in a timely manner, as well as to provide for appropriate measures to resume the continuous supply of medicines in the event of critical shortages. Also, by the end of 2027, the EMA should operate a single database of medicinal products and a unified communication platform, consolidating and ensuring the interoperability of existing and planned databases in this regard.
English version by the Translation Service of Withub
