This past 31 January, the European Commission presented a proposal to boost cooperation among EU Member States in assessing health technologies, including medications and certain medical devices.
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:
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
Medical and Social Science & Practice The SBU newsletter presents and disseminates the results of the SBU reports, describes ongoing projects at the agency, informs about assessment projects at sister organisations, and promotes interest in scientific assessments and critical reviews of methods in health care and social services.