he much-discussed EU-wide legislative framework on health technology assessment (HTA) will finally be implemented in 2025, explains EUnetHTA Chair Niklas Hedberg. He outlines the need for this framework given the sheer influx of new products and the limited capabilities of individual countries and why the intervening two years will be exceptionally busy for all stakeholders as they work to adapt to a unified system with new requirements. Hedberg ends with a rallying cry to not let minor details derail the rollout of this important new legislation which has been two decades in the making and has had the support of both governments and private companies.
Q: The European Union (EU)-wide health technology assessment (HTA) regulation has been passed. Can you begin by explaining the fundamentals of this regulation and how it differs from what has gone before?
A: The EU now has a legislative framework for cooperation on HTA. This framework has been voluntary and under construction since 2006 and has taken several forms, including joint actions under the EUnetHTA initiative. EUnetHTA Joint Action 3 was the final joint action, and the European Commission (EC) instead established a service contract, which was made available for tenders. Several partners from EUnetHTA Joint Action 3 came together under the EUnetHTA 2021 banner and won the contract, meaning that we are now a service contractor. However, we try to work very inclusively with as many as possible of the previous EUnetHTA partners, especially national and regional governmental agencies. The service contract has numerous deliverables all based around providing suggestions to the EC that can be used to decide the form of the future HTA system.
Read European Union legal summary of this Regulation.
Learn more about EUnetHTA tools and models for HTA cooperation.