After decades of voluntary cooperation, the new legislative proposal (https://ec.europa.eu/health) suggests a common regulatory framework within the EU. Hopefully, this will prove to be a leap forward for evidence-based health care.
The foundation is already there. The international HTA community has had a long-standing goal of sharing robust evidence, and there have been three consecutive Joint Actions on HTA at the EU level. Collaboration within the union was further spurred by the Cross-border Healthcare Directive (2011/24/EU).
The new proposal is that the EU Member States work together in four main areas:
- Joint clinical assessments of the most innovative and potentially impactful health technologies – alongside the central marketing authorisation procedure (for medicinal products) or some time after the conformity assessment (for medical devices)
- Joint scientific consultations at which developers of a health technology can seek advice from HTA authorities concerning the type of data and evidence that are likely to be required
- Identification of emerging health technologies to help ensure that important innovations are identified early
- Voluntary cooperation in non-pharmacological and non-device HTA areas, such as assessment of surgical procedures or the financial aspects of health technologies
According to the proposal, the joint effort should be coordinated by a team of representatives from national HTA authorities and bodies in EU Member States. In order to avoid duplication and discrepancies, joint clinical assessments should not be repeated at the national level. However, Member States would be responsible for supplementing joint assessments with non-clinical evaluations of the financial, social, and ethical aspects of health technology. Each State will also evaluate the overall added value of such technologies and make decisions, such as pricing and reimbursement policies, for their healthcare systems.
The role of the European Commission would be twofold: 1. to provide scientific and logistic support for meetings and to facilitate cooperation with other EU organisations, such as the European Medicines Agency, for joint scientific consultations, etc, and 2. to make sure that the coordinating team works independently and transparently.
The proposal will be discussed by the European Parliament and the Council of Ministers with the aim of adoption by 2019. It can become applicable three years later, followed by an additional three-year phase-in period.
As evident in assessments, any theoretically promising health intervention may help or harm in practice. The same thing holds true for regulatory frameworks once they are put to the test. We would be wise to ensure that this one will work as intended.
Ragnar Levi, Editor