Policy debate on HTA
The most important topic of discussion was the proposal for a regulation of the European Commission on health technology assessment. The focus of the 28 health ministers’ discussion was on the mandatory application of clinical assessments proposed by the Commission. The aim is to make it mandatory for Member States to participate in joint clinical assessments and then to use the reports as the basis for their national pricing and reimbursement decisions. Member States will no longer be permitted to carry out their own clinical assessments on the technologies covered by the Regulation.
Larger Member States, in particular, were opposed to a mandatory approach. Differences in areas of national decision-making, such as the selection of comparators or the assessment of the patient relevance of endpoints, are too significant. Smaller Member States, on the other hand, welcomed the obligatory nature of the proposal, not least because some of these countries do not have their own HTA.
The Presidency concluded that a voluntary approach met with noticeably greater approval. Despite the differing views between a mandatory approach or a more voluntary approach, there was agreement among Member States that there should be better and more structured cooperation on HTAs and that the Commission proposal should be developed further.
Germany also spoke strongly for deeper but voluntary cooperation. The EU Regulation should not restrict competences for pricing and reimbursing medicinal products. Together with France, Germany has drafted a non-paper with core positions, which are to be included in the technical discussions with other Member States under the Austrian Presidency.
Future of EU health policy
In the lead up to the upcoming European Parliament elections in May 2019, Health Ministers held a policy debate on the future of health in the EU. Member States were in favour of maintaining an independent EU health policy in order to address the specific needs of the healthcare sector. This stance taken by the Health Ministers was also important in the context of the recurring discussions on retaining a separate Directorate-General for Health and Food Safety (DG SANTE).
The Member States highlighted that future cooperation at EU level can be beneficial in areas such as cross-border health threats, European reference networks for the treatment of rare diseases, the fight against antimicrobial resistance, prevention, chronic non-communicable diseases and the digitalisation of healthcare and long-term care. The Ministers stressed that despite strengthened cooperation, competences and proportionality must continue to be respected.