EUCOPE response to the SANT report on the Critical Medicines Act

On 15 December 2025, the European Parliament Public Health Committee (SANT) adopted its report on the Critical Medicines Act (CMA). The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) deems that the adopted text marks a troubling shift away from the CMA’s original purpose: addressing shortages of critical medicines.

Instead of focusing on medicines most affected by supply disruptions, the report dilutes the scope to include orphan medicinal products (OMPs) under the definition of “medicinal products of common interest” (MPCI). This move will not solve existing access barriers and risks creating new unnecessary obligations and uncertainty for OMP companies, therefore undermining patient access to innovative rare disease therapies.

The CMA was designed to strengthen resilience against shortages of critical medicines. Placing OMPs, and other innovative products, at the centre of the CMA confuses two fundamentally different problems: supply disruptions and access. Extending measures, and related obligations, that the Commission originally intended only for critical medicines to MPCI will not improve patient access. Instead, it will discourage non-EU developers from entering the European market and create additional regulatory burden on EU-based companies, particularly small and mid-caps, the backbone of rare disease innovation.

EUCOPE acknowledges positive steps regarding proposals for critical medicines. The SANT report clarifies eligibility for strategic projects, promotes adequate administrative support and financial resources, reinforces MEAT criteria and multi-winner approaches in public procurement. Support for EU-based manufacturing is welcome, but it must not penalise companies operating in trusted strategic partners, especially for globally integrated supply chains like plasma-derived medicinal products (PDMPs).

Provisions on collaborative procurements remain concerning. It is essential that collaborative procurement remains strictly voluntary for both Member States and marketing authorisation holders (as stated in recital 32), to preserve flexibility and avoid unintended market distortions. The introduction of safeguards, such as minimum binding quantities, regulatory flexibilities, and restrictions on parallel or subsequent negotiations, would also provide some certainty for marketing authorisation holders, outlining crucial pre-conditions to the use of such mechanisms.

However, these improvements are overshadowed by unclear definitions (notably, MPCI and ‘functioning of the market’), lower thresholds for Commission-led and joint procurement (art. 22-23), and other missing safeguards – including confidential pricing and alignment of participating Member States based on similar economic, population and epidemiological profiles. This could destabilise access and undermine competitiveness, particularly for small and mid-sized companies developing OMPs.

Crucially, collaborative procurement mechanisms do not address the root causes of access delays, which remain at national level. Instead of creating new EU-level structures, EU Institutions should better leverage existing tools such as the Transparency Directive and the Cross-Border Healthcare Directive to improve timely and equitable access for patients.

In preparation of the upcoming European Parliament’s Plenary vote, EUCOPE calls on Members of the European Parliament to urgently:

• Remove obligations for OMPs and other innovative products that risk reducing access and driving developers away.
• Keep CMA measures focused on critical medicines most affected by shortages – primarily generics.
• Ensure public procurement and manufacturing measures strengthen resilience without fragmenting the single market or global supply chains.

The EU needs a CMA that delivers supply resilience without sacrificing patient access or competitiveness. SANT vote falls short of that goal.

Quote from Alexander Natz, EUCOPE Secretary General

“Placing orphan medicinal products (OMPs) at the centre of the Critical Medicines Act (CMA) must not create additional burdens for companies seeking to bring these treatments in the EU. Notably, we regret the inclusion of OMPs under the definition of medicinal products of common interest. The scope of new obligations for medicinal products of common interest under the CMA remains unclear. The proposed measures will not solve the fundamental barriers to patient access, mostly related to national competences. Increasing regulatory and market access requirements – and introducing collaborative procurement mechanisms – will discourage non-EU companies from entering the European market. It will also create additional burdens on EU-based companies. This is particularly concerning given that the CMA proposals are framed as solutions to shortages, despite OMPs having experienced virtually no shortages over the past decades.”