In March 2025, the European Commission proposed a landmark legislative initiative aimed at strengthening the resilience and strategic autonomy of the European Union in the pharmaceutical sector: the Critical Medicines Act (CMA).
The draft regulation aims to improve the availability, supply, and production of critical medicines (as defined in the Union List of Critical Medicines) and medicines of common interest (as defined in Article 3(5) of the draft CMA) within the European Union. This regulation responds to longstanding vulnerabilities in the EU's pharmaceutical supply chain and is part of a broader effort to build a stronger European Health Union.
The draft CMA follows the establishment of the Critical Medicines Alliance in April 2024—a consultative forum bringing together industry, Member States, and EU institutions to collaborate on identifying and solving supply challenges. While the Alliance lays the groundwork for dialogue and coordination, the CMA provides the legislative muscle to implement structural change.
The Act is closely linked to the goals outlined in the Pharmaceutical Strategy for Europe and the Pharmaceutical Package proposed in 2023. It addresses recurring medicine shortages, particularly those affecting essential drugs like antibiotics, oncology treatments, and intensive care products.
As a regulation, the CMA will have direct effect across the EU, eliminating the need for transposition into national law. It seeks to reinforce the strategic autonomy of the Union by identifying and protecting critical medicinal products, enhancing supply chain diversification and transparency, and enabling fast, coordinated responses to disruption risks.
The legislative process is still in its early stages. According to the draft regulation, implementation is expected to begin in 2026, followed by a start-up period lasting until 2027. Full-scale operation is expected to begin in 2027.
Key Provisions of the Critical Medicines Act
The draft CMA suggests several key mechanisms designed to improve the availability and security of supply of medicines in the EU:
Union List of Critical Medicines: The Act mandates the creation of a Union list of critical medicines, developed in cooperation with the European Medicines Agency (EMA). Medicines will be selected based on public health importance, supply chain fragility, and the lack of therapeutic alternatives. These cover a wide range of medicines, from antibiotics and anti-thrombotics to cancer treatments and cardiovascular medicines.
This list will be continuously updated to reflect changes in clinical relevance and market conditions.
Supply Chain Mapping and Risk Identification: Manufacturers and Marketing Authorization Holders (MAHs) of critical medicines will be required to provide granular data on their supply chains. This includes information about active pharmaceutical ingredients (APIs), key starting materials, geographic locations of production, and logistics arrangements.
The goal is to map vulnerabilities—particularly dependencies on third-country suppliers or single manufacturing sites—and allow for better risk management at the EU level.
Strategic Projects and Incentives: To support re-shoring or scaling up production in Europe, the Act provides for the designation of Strategic Projects. These projects may benefit from EU-level funding, fast-track permitting, and eligibility for support under programs like STEP, EU4Health, InvestEU, Horizon Europe (see Guidance on the application of State aid rules in the context of the Critical Medicines Act).
Joint Procurement and Strategic Stockpiling: The CMA builds on lessons from the COVID-19 pandemic by promoting joint procurement mechanisms for critical medicines. Member States will be encouraged to coordinate purchases, enabling better bargaining power and equitable distribution.
Additionally, the Act supports the creation and coordination of strategic stockpiles, ensuring timely availability during crises.
European Medicines Resilience Board (EMRB): To ensure effective governance, the CMA establishes the European Medicines Resilience Board, which will oversee the implementation of the Act, monitor risks, and coordinate actions among Member States and industry. The Board will include representatives from the Commission, Member States, and relevant agencies.
Implications for the Life Sciences and Biotech Sectors
Once it comes into force, the CMA will provide a strategic shift to the European pharmaceutical landscape—placing resilience and security of supply on par with innovation and market access. Here are the main implications for industry:
- Regulatory Compliance and Operational Transparency: Companies involved in manufacturing or distributing critical medicines will be subject to new obligations related to supply chain disclosures and risk assessments. Legal and regulatory teams must prepare for increased reporting duties and potential audits by EU authorities.
- Strategic Incentives for EU-Based Production: The draft CMA sends a clear signal that EU-based manufacturing capacity is a priority. Companies investing in local production or diversifying supply chains away from overreliance on non-EU sources may benefit from incentives and funding, positioning themselves as preferred suppliers in joint procurement schemes.
- New Public-Private Collaboration Models: The Act encourages structured cooperation between regulators and industry. Participation in Strategic Projects or the Critical Medicines Alliance could offer early insights into regulatory expectations and improve the predictability of public procurement opportunities.
- Geopolitical and Supply Chain Realignment: Biotech firms that rely heavily on globalized supply chains—particularly those sourcing APIs or intermediates from China or India—will need to rethink sourcing and manufacturing strategies. The EU is clearly prioritizing “open strategic autonomy,” and companies must adapt to remain competitive.
- Opportunities for Innovators: Manufacturers of medicines that could serve as alternatives to at-risk or outdated products may find new market openings, especially if they offer more secure supply chains or manufacturing advantages within Europe. Biotech firms should monitor the evolving list of critical medicines to anticipate where their pipelines may align with public health priorities.
Conclusion
The draft Critical Medicines Act is a defining moment in the EU’s pharmaceutical policy. It combines proactive risk management with strategic investment to ensure that citizens have access to essential medicines—even in times of crisis or global disruption.
For in-house counsel, regulatory strategists, and business leaders in the life sciences sector, the CMA is more than a compliance exercise—it is a signal of strategic transformation. Preparing now for its requirements and opportunities could offer both competitive advantage and reputational value in an increasingly regulated and politically sensitive landscape.
