An EU-wide approach to HTA:an irrelevant development or an opportunity not to be missed?

An EU-wide cooperation on HTA has been proposed recently by the European Commission, focusing on relative effectiveness assessment (REA) for pharmaceuticals and medical devices. While a good step in the right direction, this collaborative HTA framework needs to be more explicit and pragmatic about clinical value definition, what constitutes quality of evidence, how is real world evidence handled, whether the same assessment requirements will apply for medical devices as they do for pharmaceuticals, and how to safeguard consistency in REA interpretation. If demand- rather than supply-driven, this initiative can deliver wider benefits: Europe can improve its power in global drug design and development, while Member States will have at their disposal more resources to assess performance of interventions in their healthcare systems.