Addressing medicine shortages in the EU

Author (Corporate)
Series Details COM (2023) 672
Publication Date 24/10/2023
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Communication adopted by the European Commission on 24 October 2023, setting out actions to better prevent and mitigate critical medicine shortages in the European Union (EU).

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Continued availability of medicines is seen as essential, as shortages put the health and wellbeing of citizens at risk. The EU's supply chains dependencies have become increasingly exposed and concerns have arisen as regards the risk that economic dependency could be weaponised. It has also heightened awareness of the risk of medicine shortfalls.

The need of a fresh approach to better tackle medicines shortages was highlighted by the European Council in June 2023. This feeds into a broader strategic agenda of putting in place a concerted approach to boost the EU's resilience and sustainable competitiveness through diversification and risk management in the spirit of open strategic autonomy. The EU has a relevant pharmaceutical sector, and it is particularly strong in the research and development of innovative medicines. However, the landscape for pharmaceutical manufacturing has evolved over the decades.

The delocalisation of the manufacturing of Active Pharmaceutical Ingredients (API) to a limited number of locations outside the EU has accentuated concerns about security of supply inside the EU. Addressing vulnerabilities in the supply chain of critical medicines is seen as key to enhance resilience of EU healthcare systems. The EU market for medicines remains fragmented. The organisation of healthcare systems is a national competence of Member States: this allows decisions closer to the patient, but also brings major divergences in both pricing and patient access. Better and closer coordination between national authorities opens the door to a more efficient and effective supply of medicines throughout the EU.

This Communication builds on work already underway in developing a European Health Union and sets out set steps the EU can take to make a difference in the availability of medicines to patients across the EU. It covers both generic and innovative medicines, as well as their ingredients. It put forwards a set of short-term and longer-term actions to address shortages of medicines and enhance their security of supply in the EU, by providing predictability and a comprehensive and coordinated approach with stakeholders at EU and global level. The key goals are to prevent or mitigate critical shortages at EU level and to assure a particular focus on the most critical medicines for which security of supply needs to be assured in the EU at all times, in normal times, and in times of crisis.

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Commentary and Analysis
ING Think: Article, 10/10/2023: The EU’s endless drug shortage, its fragile supply chains and the bizarre crab connection
Standing Committee of European Doctors (CPME): News, 18/10/2023: European Doctors urge immediate action on medicine shortages for autumn and winter season
European Federation of Pharmaceutical Industries and Associations (EFPIA): EFPIA statement on the European Commission's Communication on addressing medicine shortages in the EU (26 October 2023)
Pinsent Masons: Out-Law News, 31/10/2023: Risk of medicines shortages addressed in fresh EU initiatives
European Pharmaceutical Review (EPR), 02/11/2023: Mitigating medicines shortages in Europe
Van Bael & Bellis (VBB): Insights, 02/11/2023: European Commission Adopts Plan to Tackle Medicine Shortages in EU

Politico, 05/10/2023: Sweden’s winter drug stockpiling plan risks backfiring
Euronews, 10/10/2023: 'Trying to find solutions’: Worsening drugs shortage is leaving pharmacists and patients in the dark
Bloomberg, 24/10/2023: EU Seeks to Share Critical Medicines During Winter Shortages
Reuters, 25/10/2023: EU sets up new mechanisms to stave off medicine shortages
EurActiv, 08/11/2023: Belgium’s EU presidency to ‘firmly’ focus on critical medicine shortages

European Commission: Priorities 2019-2024: European Health Union
EU European Medicines Agency (EMA): Human Regulatory: Medicine shortages and availability issues
European Commission: Press Release, 24/10/2023: Commission steps up actions to address critical shortages of medicines and strengthen security of supply in the EU
European Commission: Questions and answers: Addressing Medicine Shortages in the EU (24 October 2023)

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