Europe remains committed to finding solutions
The European Union (EU) is currently grappling with a significant issue - critical drug shortages that affect all categories of medicines, including innovative drugs, generics, and vaccines. These shortages can have serious consequences for patients, overwhelm public health systems, and pose a significant challenge to doctors, pharmacies, and countries.
The European Medicines Agency (EMA) has been instrumental in mitigating the impact of these shortages. However, the agency lacks sufficient knowledge to prevent them, partly due to pharmaceutical industry representatives providing late and incomplete information. This lack of transparency hinders the development of effective strategies to address the root causes of these shortages.
The EU has proposed changes to its law to tackle these issues, but these changes are unlikely to resolve all problems. For instance, they may not ensure timely reporting of shortages or influence industry actions during critical shortage events. The Commission has also identified supply chain vulnerabilities as a fundamental cause of these shortages, with a significant portion of production for antibiotics and anticancer drugs being shifted to Asia.
The fragmentation of the EU drug market is another contributing factor. This fragmentation hinders the free flow and availability of medicines, making access to them unequal. Significant price differences between countries and limited price transparency also complicate matters.
Efforts to address these causes have encountered challenges, including the pharmaceutical industry's failure to effectively implement the obligation to ensure stable supplies. As a result, improvements are needed in the system of preventing and mitigating critical drug shortages, as it lacks adequate legal frameworks and up-to-date, useful information.
One of the crucial steps forward has been the creation of the first EU list of critically important medicines. However, efforts so far have not ensured their availability, and auditors have noted critical shortages of several drugs on this list. This underscores the need for a more effective solution to tackle critical drug shortages and address their root causes.
In response to these challenges, some EU countries have started stockpiling drugs. However, without coordinating these actions, it could exacerbate shortages elsewhere in the EU. The EU needs a comprehensive strategy to address these issues and strengthen its strategic autonomy.
Recently, record levels of drug shortages were reported in EU countries in 2023 and 2024, with 136 medicines experiencing critical shortages. Unfortunately, specific information about which EU country recorded the highest levels of medication spikes in these years is not currently available.
Drug packaging also differs between countries, and the Commission has not adequately addressed cross-border trade barriers, hindering the redistribution of drugs to combat shortages. These barriers need to be addressed to ensure the free flow of medicines across the EU.
In conclusion, the issue of critical drug shortages in the EU is complex and multifaceted. It requires a coordinated and comprehensive approach to ensure the availability of essential medicines, protect public health, and strengthen the EU's strategic autonomy.
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