Last week, the European Parliament’s health committee adopted its report on the Critical Medicines Act (CMA). The measure passed with 27 votes in favour, one against and eight abstentions. But while MEP’s hail it as a breakthrough, the pharma industry says the plan risks drifting away from its original goal.
The European Parliament has taken a major step toward strengthening Europe’s supply of critical medicines. Lawmakers want to reduce Europe’s dependence on third countries. They also want to address recurring shortages, which increasingly expose weaknesses in EU manufacturing.
More than half of all reported medicine shortages in the EU stem from manufacturing problems. These include shortages of active pharmaceutical ingredients. The report by the SANT committee backs the creation of EU-based “strategic projects” to manufacture critical medicines and key components. MEPs want these projects to create, modernise or expand production capacity inside the EU. They also want the Commission to issue guidelines on how it will assess them. Lawmakers say this will give investors legal certainty.
The report urges both the EU and member states to prioritise funding for these projects. This includes regional and cohesion funds. MEPs also call for a dedicated Critical Medicines Security Fund under the EU’s next long-term budget, the Multiannual Financial Framework (MFF).
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Diversified supply
The committee also proposes changes to public procurement rules. Contracting authorities should be able to award contracts to multiple suppliers for the same product. MEPs say this would reduce dependency on single manufacturers and spread production across the EU. Public buyers should also favour suppliers that manufacture a significant share of critical medicines in Europe.
The report highlights voluntary collaborative procurement between member states. It points in particular to rare disease medicines, antimicrobials and other high-cost or specialised treatments. MEPs want stronger coordination of national stockpiles of critical medicines. They propose an EU-level mechanism to align contingency planning. As a last resort, the Commission could decide to redistribute medicines between countries during severe shortages.
Rapporteur Tomislav Sokol (EPP/HRV) called the vote a turning point. “Today’s vote is a defining moment for Europe’s health security,” Sokol said. “We are tackling persistent shortages and reducing our dependence on a limited number of external suppliers.”
Scope creep?
“The report sets out the strategic projects, collaborative procurement, and incentives needed to boost EU pharmaceutical manufacturing,” he added. “It would bring us closer to a resilient, independent, and patient-centric pharmaceutical ecosystem.”
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) reacted sharply to the committee’s amendments. The group said the adopted text marks “a troubling shift away from the act’s original purpose: addressing shortages of critical medicines”. EUCOPE criticised the expansion of the CMA’s scope to include orphan medicinal products (OMPs) under the category of “medicinal products of common interest” (MPCI).
It would bring us closer to a resilient, independent, and patient-centric pharmaceutical ecosystem. — MEP Tomislav Sokol
Instead of focusing on medicines most affected by supply disruptions, the report “dilutes the scope,” EUCOPE said. It warned that the move risks creating new obligations and uncertainty for companies developing rare disease treatments. “Placing OMPs, and other innovative products, at the centre of the CMA confuses two fundamentally different problems: supply disruptions and access,” the group said.
Concerns over procurement
EUCOPE argued that extending shortage-related obligations to OMPs will not improve patient access. Instead, it could deter non-EU developers and burden EU-based small and mid-sized companies.
EUCOPE acknowledged some positive elements in the SANT report. These include clearer criteria for strategic projects, better administrative support and stronger use of multi-winner procurement. The group also welcomed support for EU-based manufacturing.
However, EUCOPE warned against unintended effects on globally integrated supply chains, including plasma-derived medicinal products. The group also raised concerns about collaborative procurement.“It is essential that collaborative procurement remains strictly voluntary for both Member States and marketing authorisation holders,” EUCOPE said.
The organisation called for safeguards. These include minimum binding volumes, regulatory flexibility, protection of confidential pricing and limits on follow-up negotiations. EUCOPE also warned that unclear definitions, including MPCI and “functioning of the market”, could destabilise access and undermine competitiveness.
Access barriers remain
EUCOPE stressed that joint procurement will not fix access delays. “Collaborative procurement mechanisms do not address the root causes of access delays, which remain at national level,” the group said. Instead, EUCOPE urged EU institutions to use existing tools. These include the Transparency Directive and the Cross-Border Healthcare Directive.
EUCOPE Secretary General Alexander Natz singled out the inclusion of orphan medicines as a core problem. “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,” Mr Natz said.
We regret the inclusion of OMPs under the definition of medicinal products of common interest. — Alexander Natz, Secretary General EUCOPE
“We regret the inclusion of OMPs under the definition of medicinal products of common interest,” he added. “The proposed measures will not solve the fundamental barriers to patient access, mostly related to national competences,” the Secretary General said. “Increasing regulatory and market access requirements, and introducing collaborative procurement mechanisms, will discourage non-EU companies from entering the European market.”
Next steps
Mr Natz also questioned the shortage rationale. “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,” he said.
Parliament plans to adopt its final position during the January 2026 plenary session. Negotiations with EU governments would then begin.
The Commission first proposed the Critical Medicines Act in March 2025. It aimed to strengthen supply security and address market failures. Whether the final law can deliver resilience without undermining access or innovation remains an open question.
