Today, the European Commission adopted an Implementing Regulation that sets out the rules for the management of conflicts of interest of those involved in joint clinical assessments and joint scientific consultations under the Health Technology Assessment (HTA) Regulation.
These rules aim to ensure that EU-level assessments of new health technologies are conducted in an independent, impartial and transparent manner, free from conflicts of interest.
In particular, the rules provide an assessment framework for exclusions from and limitations to participation in the joint work on HTA, based on the declared interests.
These rules will apply to all parties taking part in joint clinical assessments and joint scientific consultations, including representatives in the Member State Coordination Group and its subgroups, the appointed assessors, co-assessors and patients, clinical experts and other relevant experts involved in these joint procedures.
The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the Regulation. This is the third of six acts which must be adopted before 12 January 2025, the date of application of the HTA Regulation. The first implementing act was adopted by the European Commission on 23 May 2024 and the second implementing act on 18 October 2024.
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