The NCPE are a member of the Heads of HTA Agencies (HAG). The HAG is an independent group of 32 European healthcare agencies working together to advance strategic collaboration on HTA. The HAG support the preparation of national systems and capacities for the adoption of the HTA Regulation (website link)
At their meeting at the end of January 2024 the Heads of HTA Agencies issued a statement highlighting areas of particular interest in the revised Pharmaceutical Legislation for the European Union. The HAG stress the importance of the Article 162 of the proposed Regulation that foresees a consultation mechanism with HTA bodies for the development of scientific guidelines related to the unmet medical need definition, comparative clinical trials, and other topics related to evidence generation along the medicine life cycle legislation. It will be particularly important to involve the HTA Coordination Group, responsible for endorsing methodological guidelines and joint clinical work on the relative effectiveness and relative safety of health technologies as per EU Regulation 2021/2282. The HAG identifies challenges with the large number of alternative and accelerated regulatory pathways mentioned in the proposal, which should not increase uncertainties surrounding the added value of some pharmaceuticals. The HAG supports the early approval of new medicinal products that are safe and have demonstrated their added clinical benefit particularly when patients do not have alternative treatment options. The impact of reduced marketing authorization timelines on the processes outlined in the HTA regulation and its implementing acts must be anticipated. The inclusion of Joint Scientific Consultations, already an established process under EU Regulation 2021/2282, is also welcomed and continuation of this joint work is recommended.
https://htahag.eu/wp-content/uploads/2024/02/HAG-short-position-on-EU-Pharma-reform_FINAL.pdf
