Critical Medicines Act Plans to Improve Supply Chain

On 11 Mar. 2025, the European Commission (EC) proposed the Critical Medicines Act, setting out a plan to improve medicine procurement, provide subsidies for drug production, and improve supply chains to reduce the risk of drug shortages (1). The European Union (EU) relies heavily on medical supplies outside the EU, particularly India and China (2). The COVID-19 pandemic exposed significant vulnerabilities in the EU’s pharmaceutical supply chain.

Shortage of critical medicines

Access to medicines varies considerably from Member State to Member State. According to a recent survey conducted by the EU4Health programme-funded Joint Action of Member States on shortages (CHESSMEN), over 50% of reported shortages in 2022 and 2023 were caused by manufacturing issues, in particular, shortages in APIs (see Table I [3–4]).

The European Medicines Agency (EMA) regularly updates its list of critical medicines to ensure it can take proactive measures to avoid medicine shortages (5). It has set up the European Shortages Monitoring Platform (ESMP) to gather information about medicine availability, supply, and demand to prevent, detect, and manage human medicine shortages in the EU and European Economic Area (EEA). As per Regulation (EU) 2022/123, a ‘shortage’ is defined as “a situation in which the supply of a medicinal product that is authorized and placed on the market in a Member State […] does not meet the demand for that medicinal product […] at a national level, whatever the cause” (6). However, there is currently no harmonized definition on the EU level for a potential shortage.

Recommendations from the Critical Medicines Alliance

In January 2024, the EC launched the Critical Medicines Alliance (CMA) to “identify challenges resulting from vulnerabilities and the most appropriate actions and instruments to address the vulnerabilities in the supply chains of critical medicines, with the primary public health goal of reducing the risk of shortages of those critical medicines” (7). In February 2025, the Alliance published its Strategic Report laying out a set of recommendations (8).

Aims of the Critical Medicines Act

The Critical Medicines Act aims to address the issues raised by:

• strengthening Europe’s manufacturing capacity
• diversifying supply chains
• reducing the EU’s dependencies
• incentivising resilience
• leveraging demand.

The EC’s proposal aims to overhaul procurement rules allowing EU Member States to prioritize the security of supply based not only on price but on additional criteria including stockholding obligations, the number of diversified suppliers, monitoring of supply chains, transparency, and performance clauses. Where appropriate, preference will be given to suppliers that manufacture a significant proportion of critical products in Europe and EU Member States or the EC may undertake joint procurement of critical medicines (2).

EU countries can provide financial support for ‘strategic projects’ to improve and expand the EU’s manufacturing capabilities of critical medicines, APIs, or starting materials. These funds are not available for non-critical medicines. EU funding will be accessible through the Strategic Technologies for Europe Platform (9).

A Critical Medicines Coordination Group, composed of representatives from each Member State, will be established to provide information on manufacturing capabilities, identify strategic projects for state support, and pinpoint areas of vulnerability in the supply chains (2).

Future outlook

Given the turbulent geopolitical landscape, it is paramount that the EU has access to a stable and reliable supply chain for essential medicines. The Critical Medicine Act complements the revised pharmaceutical legislation and will help the EU to improve its preparedness and resilience, strengthen its overall security, and increase the EU’s competitiveness within the global pharmaceutical arena (10). 

References

1. EC. Proposal for a Critical Medicines Act. EC.europa.eu. 11 Mar. 2025
2. O’Neill, R. EU Plans to Boost Medicines Manufacturing in Drug Shortages Bill. Politico.eu. 11 Mar. 2025
3. CHESSMEN. Identifying the Root Causes of Observed Shortages of Medicines. 2024
4. EMA. Union List of Critical Medicines. ema.europa.eu. 14 Feb. 2025.
5. EMA. Regulation (EU) 2022/123. ema.europa.eu 25 Jan. 2022.
6. EMA. European Shortages Monitoring Platform (ESMP) Frequently Asked Questions (FAQs). ema.europa.eu. 7 Mar. 2025.
7. EC. Critical Medicines Alliance. EC.europa.eu. January 2024.
8. CMA. Strategic Report of the Critical Medicines Alliance. EC.europa.eu 28 Feb. 2025.
9. EU. Strategic Technologies for Europe Platform (STEP). EC.europa.eu. Accessed Mar. 2025.
10. EC. Reform of the EU Pharmaceutical Legislation. EC.europa.eu. 26 Apr 2023.

About the author

Cheryl Barton, PhD, is founder and director of PharmaVision, Pharmavision.co.uk.

Article details

Pharmaceutical Technology® Europe
Vol. 37, No. 3
April 2025
Pages: 6–7

Citation

When referring to this article, please cite it as Barton, C. Critical Medicines Act Plans to Improve Supply Chain. Pharmaceutical Technology Europe 2025 37 (3).