AIM agrees on position regarding the draft EC regulation on HTA and the Cabezón report
AIM supports the overall objective of the EC proposal on HTA and calls upon the Council of the European Union and the European Parliament to ensure a compromise text that will bring EU collaboration in the field of HTA further.
- AIM would only be able to support an obligatory system for joint clinical assessments (as described in article 8 of the proposal) if:
- more clarity is created in the regulation about the timing of joint clinical assessments,
- the methodological framework to be used is described in the regulation,
- the transparency of assessment outcomes and the data used is ensured
- Member States have the possibility to do context-specific additional clinical assessments
- Decision maker involvement in HTA is crucial. The regulation should foresee in consultation mechanisms between the coordination group and pricing and reimbursement authorities and payers
Click here for the Position of AIM on the Euroepan Commission’s proposal for a regulation on health technology assessment and the European Parliament ENVI committee draft report on the same proposal.