Proposal for a regulation on health technology assessment in Europe – opinions of policy makers, payers and academics from the field of HTA

ABSTRACT

Introduction: In January 2018 the European Commission published a Proposal for a Regulation on Health Technology Assessment (HTA): ‘Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU’. A number of stakeholders, including some Member States, welcomed this initiative as it was considered to improve collaboration, reduce duplication and improve efficiency. There were however a number of concerns including its legal basis, the establishment of a single managing authority, the preservation of national jurisdiction over HTA decision-making and the voluntary/mandatory uptake of joint assessments by Member States. Areas covered: This paper presents the consolidated views and considerations on the original Proposal as set by the European Commission of a number of policy makers, payers, experts from pricing and reimbursement authorities and academics from across Europe. Expert commentary: The Proposal has since been extensively discussed at Council and while good progress has been achieved, there are still divergent positions. The European Parliament gave a number of recommendations for amendments. If the Proposal is approved, it is important that a balanced, improved outcome is achieved for all stakeholders. If not approved, the extensive contribution and progress attained should be sustained and preserved, and the best alternative solutions found.

KEYWORDS:

• EUnetHTA
• joint collaboration on HTA
• cross border agreements
• Member States
• European legislation

Declaration of interest

Most of the authors are employed by government or non-governmental organisations or bodies which have activities in the field of pricing and reimbursement in their countries. All the authors have no other conflicts of interest to declare.

Reviewer Disclosures

A reviewer on this manuscript has disclosed their employing institution is partner in EUnetHTA. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.