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In December 2021, the European Commission published a study on medicines shortages in the EU, which had been requested by stakeholders – such as EAHP – the European Parliament and the Council. The study provides an overview of the trends and characteristics of medicines shortages in the EU, their root causes and an evaluation of the legal framework.
Medicines shortages present a significant problem for the quality and continuity of patient care and can also have economic consequences. Though a number of actions have been launched in recent years to address shortages at the EU level, the COVID-19 pandemic has further highlighted the issue of the availability of medicines and the vulnerabilities of supply chains. In relation to the root causes, the study noted that their proper understanding remains substantially challenged by inconsistent and limited reporting. Linked to the legal framework and the two provisions that may help prevent and mitigate medicines shortage it was shown in the study that all Member States have transposed these provisions into national legislation but that they have operationalised them in different ways.
Based on the findings 16 recommendations have been put forward that could address different aspects of the issue of shortages. These solutions collectively cover areas related to the collection and sharing of data and information between parties, supply chain issues, market issues and mitigation strategies. Their implementation will require action by different sets of stakeholders, with some requiring coordination at the level of the European Commission or the EMA whilst others will need to be supported and coordinated by competent authorities or similarly responsible bodies in the
The report will feed into the Commission’s ongoing work on the Pharmaceutical Strategy that seeks to make the European pharmaceutical system more patient-centred, future-proof and crisis-resistant. The Commission aims at presenting a legislative proposal …
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.