1 February 2022 - On Dec 15, 2021, the EU adopted a new regulation to harmonise health technology assessment of new medicines across the European Union.

Currently, after marketing authorisation, manufacturers must apply to individual countries and health technology assessment agencies before new medicines can be reimbursed and broadly accessible. However, health technology assessment agencies have separate procedures, varying evidentiary standards, and ultimately might yield different conclusions.

This has implications for access to cancer medicines across the EU, with potential delays arising from parallel and duplicative manufacturer submissions, non-submission to some countries, and varying timing for national health technology assessment review.

Read The Lancet Oncology article