• EU Parliament draft report suggests changes to Critical Medicines Act.
• Proposed changes aim to enhance EU pharmaceutical competitiveness.
• Medicines for Europe highlights gaps in current Act proposals.
The EU Critical Medicines Act draft report proposes changes to enhance pharmaceutical competitiveness and supply security within the European Union. The European Parliament’s SANT Committee emphasizes the need for greater control over medicine provisions to strengthen the security of supply. The draft report, led by Rapporteur Tomislav Sokol, recommends broadening the definition of critical medicinal products and those of common interest. This includes making the Investments Chapter applicable to these categories, alongside critical medicines.
Medicines for Europe, a generics industry body, points out that the current Act fails to address half of the medicines listed by not mandating pricing and reimbursement within national plans. This omission could impact the security of medicine supply. The report also builds on the European Commission’s proposal to improve EU stockpiling and coordination of contingency stocks. It suggests stricter solidarity requirements, regulatory flexibility, and regular reporting by EU Member States.
In May, Medicines for Europe urged the EU to restructure its production capacity for essential off-patent medicines. They advocate for securing funds for critical medicines in the upcoming EU budget and implementing state aid reforms for critical medicines and active pharmaceutical ingredient (API) production. The draft report also advises that environmental and chemical legislation should not unintentionally affect critical medicine availability.
The report strengthens support for manufacturing through regulatory, administrative, and technical assistance, including a one-stop-shop for strategic project designation and funding. It also calls for international partnerships by requiring the Commission to assess health security provisions in free trade agreements. For more details on the EU’s regulatory landscape, visit the European Pharmaceutical Review. Additionally, explore our section on Drug Approvals for related updates.