Medicines utilized for addressing long-term health issues known as chronic conditions.
The European Union (EU) has been grappling with record high shortages of medicinal products in 2023 and 2024, a challenge that continues to pose serious implications for patients, public health, and healthcare costs.
The root causes of these shortages are still in their early stages of being addressed. The method of providing healthcare is the responsibility of individual EU member states, who are also the main producers of medicinal products within the EU. However, vulnerability in supply chains, particularly for antibiotics and painkillers, has been identified as a key factor contributing to these shortages.
The European Commission has taken note of this issue and has created the first EU-wide list of critically important medicinal products. Yet, current measures have not ensured their availability, and information on medicinal product shortages remains insufficient for proactive measures.
The single market for medicinal products in the EU is fragmented, limiting their free flow and availability and contributing to unequal access. This fragmentation, coupled with the fact that most medicinal products are registered at the national level, with differences in packaging and cross-border trade obstacles that have not been sufficiently resolved, further complicates the situation.
In 2022-2024, EU countries reported 136 cases of critical shortages. To address this, many EU countries have started building up their stocks of medicinal products. However, this could potentially exacerbate shortages in other EU countries due to a lack of coordination.
The European Medicines Agency (EMA) has been instrumental in mitigating the impact of these shortages. Yet, the EMA lacks sufficient data to systematically support the management of emerging medicinal product shortages, and it lacks the mandate to assist EU member states outside of health crises.
The Commission has taken initial steps towards changing EU legal provisions to improve the system. However, auditors warn that even changed legal provisions may not resolve all problematic areas. The lack of a robust system to address critical shortages of medicinal products remains a significant concern.
Critical shortages of medicinal products can affect all categories, including innovative patented medicines, non-patented generics, and vaccines. The lack of these essential products poses a significant threat to public health and incurs high costs.
The EU needs an effective system to address critical medicinal product shortages and must address its root causes. The Commission's efforts to address these main causes are facing challenges, including the pharmaceutical industry's inability to ensure stable supplies.
The total expenditures of EU countries on healthcare amounted to 1.648 billion EUR in 2022, with healthcare expenditures ranging from 5.5% to 12.6% of their GDP. Despite these significant investments, auditors found critically low stocks of some medicinal products, underscoring the need for a more comprehensive approach to addressing medicinal product shortages.
The European Court of Auditors highlighted the persisting problems in their latest report, emphasising the urgent need for action. A robust system to address critical shortages of medicinal products is still lacking in the EU, and it is crucial that steps are taken to ensure the availability of these essential products for all EU citizens.
