Inside EU Health: Critical medicines trilogue; Pharma Package implementation and ePI; Ixchiq
Entrenched positions likely to mark second critical medicines trilogue; long and winding road to Pharma Package implementation - electronic product information implementation roadmap; EMA updates safety information on chikungunya vaccine
Entrenched positions to mark second critical medicines trilogue
Negotiations between the European Parliament and the Council on the Critical Medicines Act will intensify during their second trilogue. While the Cypriot Presidency described talks as “constructive,” diplomats say there is “little appetite for flexibility” among member states.
Several governments believe Parliament’s amendments go too far, particularly on Chapter III, which defines strategic projects and financing. One diplomat warned that expanding these provisions could “hinder investment” and distract from the act’s core aim: strengthening the supply of critical medicines.
Parliament is pushing for a broader approach, extending the legislation beyond critical medicines to include “medicinal products of common interest.” Although shortages have eased over the last year, the European Medicines Agency warns that conflicts in the Middle East affecting transport routes could still threaten medicine supply chains.
Catherine Feore
Long and winding road to Pharma Package implementation
The EMA Board (12 March) discussed the road to implementation for the Pharma Package agreed in December. The EU will finally sign off on the deal this year, and so begins the long and winding road to implementation.
Secondary legislation
Many of the provisions will have to be elaborated in delegated and implementing acts, where the detailed nuts-and-bolts work will have to be hammered out. This is usually a mixture of items that should not be in the primary legislation or difficult decisions that were ‘kicked down the road’, and where the details are left to national civil servants to squabble over.
Though Parliament does have a powerful veto right over delegated acts, it has rarely been wielded - though some might say this is because it hasn't had to - the implication being that you can speak softly when you carry a big stick.
EMA has put in place a new “EU pharmaceutical legislation implementation governance structure” and nominated leads for different workstreams. There is also a structure for the necessary joint work of the Commission, EMA and national authorities.
Electronic product information implementation roadmap
One of the issues that was problematic during the Pharma negotiations was electronic product information (ePI). The pharma industry was united in its support for ePI, but pharmacies and consumer organisations pushed back on the burden this might place on less tech-savvy users and on pharmacies who might be obliged to offer a printing service.
What emerged was a classic European compromise: a phase-out of paper leaflets in "certain contexts", but when a leaflet is only available electronically, patients have the right to request a printed copy free of charge, ensuring no loss of access for those without digital tools.
EMA presented a draft roadmap for a coordinated roll-out of (ePI) across the EU's regulatory network. In principle, the ePI initiative has many obvious benefits: the timely delivery of up-to-date, accurate, and accessible information on EU medicines to patients and healthcare professionals, but the practicalities remain challenging. EMA will share the roadmap with stakeholders in the coming weeks.
EMA updates safety information on chikungunya vaccine
The European Medicines Agency’s safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), has recommended updating the product information for the chikungunya vaccine Ixchiq to reflect new evidence on the risk of aseptic meningitis.
The review followed a reported case of aseptic meningitis - an inflammation of the membranes surrounding the brain and spinal cord - in a healthy young adult after vaccination.
It is already listed as a possible side effect of Ixchiq, alongside encephalopathy and encephalitis, though its frequency remains unknown, and had only been reported in adults over 65 or those with underlying conditions. PRAC will continue to evaluate safety data as part of a review that concludes in June 2026.