The European Commission’s proposal for the Critical Medicines Act aims to improve EU manufacturing capacity for critical medicines through strategic projects. Public procurement is the tool chosen to encourage reliable supply chains, also through collaborative procurement among EU countries. International partnerships may help reduce dependence on a single or limited number of suppliers.
EFPIA reacted to the proposal asking for more clarity on identifying circumstances where collaborative procurement options would improve access beyond existing national pricing and reimbursement pathways. The Act would also need to respond effectively to fragmented national contingency stock requirements. Systematic impact assessments evaluating the extent of the legislation on food, chemicals, and the environment would also be useful to assess how they affect the security of supply of critical medicines.
EuropaBio welcomed the recognition of biomanufacturing as a solution to strengthen the EU’s autonomy and supply security, highlighting also the lack of a proper impact assessment. Medicines for Europe asked for a real procurement reform, including MEAT criteria and multi-winner tendering, an investment partnership between the EU, Member States and the industry, and more EU solidarity on strategic EU reserves and national stockpiling mandates.