The Heads of Health Technology Assessment Agencies Group (HAG) warmly welcomes the adoption by the European Commission, in October 2024, of two critical implementing regulations concerning the rules for cooperation with the European Medicines Agency (EMA) for joint productions under the Health Technology Assessment (HTA) Regulation, as well as the management of conflicts of interest. These regulations, developed in close collaboration with the Health Technology Assessment Committee, comprising representatives from EU Member States, represent a significant milestone in the full implementation of EU Regulation 2021/2282 on HTA.
On 18 October 2024, the European Commission adopted an Implementing Regulation that sets out the rules for cooperation with the European Medicines Agency in the joint work carried out under the Health Technology Assessment (HTA) Regulation. adopts rules for cooperation with the European Medicines Agency. Among other, these rules define the information to be shared: for planning and forecasting of joint clinical assessments and joint scientific consultations; for identifying patients, clinical experts and other relevant experts to be involved in these joint procedures; and on general scientific and technical matters related to health technology assessment. The HAG recognise that the “implementing regulation on cooperation with EMA is (…) crucial, as it will enable effective and seamless communication.“
The 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 was adopted by the European Comission on 25 October 2024. These rules aim to ensure that EU-level assessments of new health technologies are conducted in an independent, impartial and transparent manner. In the view of the HAG these rules “foster public trust and reinforce confidence in the outcomes of joint scientific consultation and joint clinical assessment, which are essential for the credibility of the European HTA system“.
Find more about the Implementation of the Regulation on health technology assessment here
