The European Commission’s draft for a Critical Medicines Act (CMA): Disruptive Changes in Public Procurement?

Introduction

On March 11, 2025, the European Commission introduced the Critical Medicines Act (CMA), a legislative proposal that significantly impacts public procurement for essential medicinal products.  The CMA was drafted to address persistent difficulties ensuring a stable supply of essential medicines, to mitigate risks to patient welfare, and lessen burdens on healthcare systems, highlighting the need for robust manufacturing, improved commercial practices, and a more competitive industry. It is therefore part of the European Union’s efforts to improve availability and supply of critical medicines in the EU.

“Medicinal Products of Common Interest”: A new Category of Critical Medicines

In this respect, and regardless of patent status, the CMA’s scope is significantly wider than that of existing regulations aimed at addressing supply shortages of medicines. It not only applies to essential medicinal products, as listed on the Union list of critical medicines (UCLM), but also includes “Medicinal Products of Common Interest (MPCI)”, a new category of critical medicines:

The UCLM has been developed by the European Medicines Agency (EMA) in cooperation with the European Commission and the Heads of Medicines Agencies (HMA). Currently, this list includes over 270 active substances, covering treatments for various illnesses such as infections, cardiovascular diseases, mental health conditions, and cancer.

“Medicinal Products of Common Interest”, however, refers to medicinal products not listed in the ULCM. Here, the decisive criterion, as defined in Article 3 (5) of the draft regulation, is that the product in question is either not available or not available in sufficient quantities in three or more Member States, resulting in a supply shortage. The definition also includes an additional criterion: the lack of availability or accessibility must be caused by an insufficient “functioning of the market” in the affected Member States.

Transformative Impact: How the CMA Rewrites the Rules of Public Procurement

The end of the price-only award criterion?

The proposal fundamentally challenges contracting authorities across Member States to evolve beyond price-centric procurement models when sourcing critical medicines. This significant shift includes:

• Mandatory use of MEAT (Most Economically Advantageous Tender) criteria that consider supply security and availability, moving away from lowest-cost procurement practices that have contributed to supply chain vulnerabilities
• Specific procurement requirements that must include
  • Stockholding obligations
  • A number of diversified suppliers
  • State-of-the-art monitoring of supply chains
  • Transparency to the contracting authority
  • Contract performance clauses on timely delivery
  • Measures in case of non-timely delivery
• EU Manufacturing Preference: For critical medicinal products with confirmed supply chain vulnerabilities or a high dependency on limited third countries, contracting authorities must (where justified) apply procurement requirements that favor suppliers who manufacture a significant proportion of these products in the EU. This preference must comply with the EU's international commitments. Similar requirements may apply to medicinal products of common interest when justified by market analysis and public health considerations.

Collaborative and Joint Procurement

Under the CMA, Articles 21 to 24 outline key measures for public procurement of medicinal products.

• Commission facilitated Member States’ cross-border procurement: Upon the request of three or more Member States, the Commission may act as facilitator for the requesting Member States’ cross-border procurement. The Commission's role involves providing secretarial and logistical support, facilitating communication, and offering advice on procurement rules, but it is not liable for any breaches of procurement laws by Member States.
• Commission procurement on behalf of or in the name of Member States: This allows the Commission to procure medicinal products on behalf of or in the name of Member States when requested by nine or more Member States. This is applicable to critical medicinal products or those of common interest, provided the procurement improves security of supply and availability. The Commission assesses the request's utility, necessity, and proportionality, ensuring it does not constitute discrimination or trade distortion.
• Joint Procurement: This details joint procurement procedures involving the Commission and at least nine Member States. This can be initiated by Member States or the Commission and is aimed at improving supply security and availability of critical medicinal products. The Commission evaluates whether such procurement could lead to discrimination or competition distortion.
• Finally, the participating Member States are required to share relevant information and resources with the Commission. An agreement between Member States and the Commission will define the practical arrangements, liabilities, and decision-making processes for these procurement procedures.

Looking Forward: Implications and Implementation Timeline

The Commission has fast-tracked the CMA to address supply chain vulnerabilities in the interest of public health. With implementation within reach, it is clear that the European medicine landscape will undergo considerable transformation. Companies that prepare for these regulatory changes may gain advantages, while those slower to adapt may face challenges. It remains to be seen in what way and to what extent the transition in the public procurement framework will shape the European medicine landscape.