HTA Regulation - European Commission Publishes Implementing Regulation Managing Conflicts of Interest
- 28/10/2024
- News
The European Commission publishes today the third of six Regulations implementing the Regulation on Health Technology Assessment (HTA) (Regulation (EU) 2021/2282 of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU) (see, Van Bael & Bellis Life Sciences News & Insights of 15 December 2021 and Van Bael & Bellis Life Sciences News & Insights of 22 December 2021) (the HTA Regulation).
The third Implementing Regulation sets out rules for the management of conflicts of interest of those involved in joint clinical assessments and joint scientific consultations (Commission Implementing Regulation (EU) 2024/2745 of 25 October 2024 “laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups”; the Third Implementing Regulation – see, attached copy).
The Third Implementing Regulation provides an assessment framework for exclusions from and limitations to participation in the joint work on HTA, based on the declared interests. In so doing, it aims to ensure that HTA assessments are conducted in an independent, impartial and transparent manner, free from conflicts of interest.
The management of conflicts of interest by participants in the assessment of medicines and medical devices has raised concerns over loopholes affecting the impartiality of the assessments. For instance, on 14 March 2024, the Court of Justice of the European Union held that the European Medicines Agency (EMA) had breached the impartiality requirements when examining a marketing authorisation for a medicinal product. EMA was also found to have breached its own internal procedural guidelines (see, Van Bael & Bellis Life Sciences News & Insights of 20 March 2024).
