The CMA marks a structural shift in EU life science policy, introducing new definitions, supply obligations, disclosure requirements and procurement mechanisms that will directly impact pricing, manufacturing strategy and governance frameworks. It signals a move from crisis-driven coordination towards a permanent resilience regime, embedding supply security and transparency as enforceable regulatory objectives.
This session will dissect this important new legislative framework, addressing its key aims, uncertainties and implications for your company.
- What will constitute a critical medicine?
- How will the Act work in practice?
-How will the responsibility for its implementation be divided between the Commission and Member States?
- What incentives or other support will companies receive for diversifying their supply chains towards Europe and participating in Strategic Partnerships?
- How will the new public and collaborative procurement initiative influence pricing dynamics?
- How will supply continuity obligations for critical medicines be enforced? Where is the litigation risk, and what is the scope for force majeure?
- What supply chain information will need to be disclosed/reported? What steps will be taken to protect commercially sensitive information?
- How will the Act interplay with the EU HTA Regulations and other legislative frameworks?