EU Faces Ongoing Challenge in Seeking a Solution
The European Union (EU) is facing a significant challenge with critical medicine shortages, as reported by various member states. In the past two years, record levels of medication shortages have been documented across EU countries, with 136 critical shortages recorded from January 2022 to October 2024.
The European Medicines Agency (EMA) has been working to mitigate these shortages, but lacks the necessary data due to often incomplete and late notifications from the industry. The industry's obligation to ensure supply continuity is not effectively enforced, leading to severe shortages of some critical medicines.
The fragmentation of the EU's single pharmaceutical market hinders the free circulation and availability of these essential medicines, and access to them is not equal for all. Medication shortages can affect all categories of medicines, including innovative patented medicines, non-patented generics, and vaccines.
The European Commission has identified vulnerabilities in the supply chain, with a significant portion of production of antibiotics and painkillers being outsourced to Asia. The continuous supply of medicines is the responsibility of the industry, but without adequate legal framework and timely communication of usable information, the system needs to be improved to prevent and mitigate severe medicine shortages.
The European Court of Auditors has highlighted the need for an improved system to manage critical medication shortages. The establishment of the first EU-wide list of critical medicines is a significant step forward, but nothing has yet ensured their availability.
The lack of coordination among member states has also been a contributing factor to the exacerbation of shortages. Some countries have started stockpiling medicines without coordination, which may have worsened the situation in some cases.
The EMA is not empowered to assist EU countries outside of a health crisis, and the European Commission has not effectively tackled cross-border trade barriers, making it difficult for medicine redistribution to alleviate shortages.
The consequences of these shortages can be serious for patients, compromising public health and costing a lot to doctors, pharmacies, and the countries concerned. The EU countries with the highest number of critical medicine shortages between January 2022 and October 2024 are Germany, France, and Italy.
It is clear that a more coordinated and regulated approach is needed to address the issue of critical medicine shortages in the EU. The lack of data, ineffective enforcement, and fragmentation of the pharmaceutical market are obstacles that must be overcome to ensure the continuous supply of essential medicines to all EU citizens.
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