Europe makes progress in its bid to tackle medicine shortages

European legislation to strengthen medicine supply in the region has passed a key milestone, after the European Parliament’s SANT Committee adopted the draft version of the Critical Medicines Act (CMA).

It brings the EU closer to agreeing a framework for the crucial area, aiming to strengthen availability of critical medicines in the EU, and follows an initial proposal for the Act (CMA) issued by the Commission in March.

Rapporteur Tomislav Sokol, said: “The report sets out the strategic projects, collaborative procurement, and incentives needed to boost EU pharmaceutical manufacturing, while ensuring fair access to essential medicines like antibiotics, insulin, and pain treatments. It would bring us closer to a resilient, independent, and patient-centric pharmaceutical ecosystem that delivers stability and better care across the EU.”

While the parliament vote constituted a more consistent, risk-based contingency stock rules, The European Federation of Pharmaceutical Industries and Associations (EFPIA) cautioned that other elements of the compromise such as; an overly broad definition of “medicinal products of common interest”, the scope and thresholds around the joint/collaborative procurement framework and local-content measures introduced without robust impact assessment risk undermining the CMA’s core logic.

Nathalie Moll, Director General, EFPIA, said: “Europe needs a CMA that works rather than one that tries to address everything. Our region’s resilience will not be strengthened by layering interventions across the entire pool of medicines, but from targeted, evidence-based measures that reflect how pharmaceutical supply chains actually operate.

“To deliver secure supply, Europe must focus on real risks, use the right tools and remain a competitive environment for manufacturing and innovation.” 

Medicines for Europe viewed the EU vote as positive progress, with its Director General, Adrian van den Hoven asserting: “The European Parliament has demonstrated that is has truly learned the lessons from Covid-19 by adopting clear policies to strengthen critical medicines supplies and to reduce medicine shortages. This is the way forward for EU health security.”

Adoption of the EU Parliament’s position is anticipated in January 2026, with EU government negotiations expected to follow.

Progress on adoption of the EU Biotech Act

Alongside the CMA, the European Commission has also proposed a Biotech Act to tackle global competition, insufficient funding, regulatory bottlenecks and barriers to innovation for the region’s companies.

EFPIA Director General Nathalie Moll stated the move is “an important moment for Europe’s life sciences sector” because it helps to improve the EU’s R&D competitiveness by strengthening coordination across authorities to biotech innovation.  

One element of the Biotech Act includes shortening clinical trial approval timelines to 75 days, increasing the Europe’s attractive for innovative or time-critical trials.

EFPIA and Vaccines Europe noted that increasing IP protection through a targeted extension of the supplementary protection certificates (SPCs) scheme is also an important tool to boost Europe’s attractiveness for pharmaceutical R&D.

However, EFPIA’s Director General illustrated concern that its effectiveness “may be limited by restricting it to an overly small subset of products or geographical conditions on manufacturing”.

Both industry bodies also advised against ‘manufactured in the EU’ being set a criterion for IP protection of medicinal products, as this would prevent differentiation between EU-manufactured and imported products.   

Medicines for Europe called for policymakers to recalibrate the competitiveness measures, shifting focus away from additional IP extensions “which have always promised but never delivered on R&D in Europe”.