The European Commission wants to improve cooperation among member states on health technology assessment (HTA). It is preparing to present a proposal for a regulation on 31 January which pools clinical assessments. The draft text, which has been seen by EUROPE, makes provision for a three-year transition period.
Health technologies comprise medicines, medical devices (including in vitro diagnostics) and other instruments based on illness prevention technology, diagnosis and medical care treatment. Evaluation of these technologies seeks to provide member states with a scientific analysis to help them reach decisions on prices and reimbursement.
Evaluations and consultations. The current version of the text suggests putting in place joint clinical assessments and scientific consultations, identifying emerging health technologies and encouraging voluntary cooperation.
The flagship proposal relates to joint evaluation of medicines subject to marketing authorisation procedure and of certain medical and in vitro devices. “The proposal establishes a requirement for mandatory use of the joint clinical assessment report and no repetition of the assessment in member states’ overall HTA processes”, the text says. It states that the conclusions of the assessments – which will have to be approved by a coordination group assisted by a network of stakeholders – should be limited to analysis of the relative effects of the technologies and to the degree of certainty of the relative effects based on available evidence.
At the same time, the proposal also allows for health technology designers to ask for a joint scientific consultation with a view to obtaining preliminary advice. It also proposes that the coordination group should oversee an annual study identifying emerging health technologies. Lastly, it allows those member states which wish to go further and to join forces voluntarily to assess health technologies other than the medical products and devices covered by mandatory assessment.
Voluntary v mandatory. At the present time, the European Union has no regulatory measures on HTA. Since 2010, it has simply organised joint action, known as EUnetHTA, in which member states participate on a voluntary basis. The third edition of the EUnetHTA will conclude in 2020.
In general terms, the large member states, like France and Germany, are against EU-level regulatory action, taking the view that HTA is a matter of national competence and closely related to the specific nature of the respective markets. In the face of this reluctance, the Commission suggests phasing in the provisions of the regulation over two periods of three years: the first three-year period prior to the date of application would allow the time to draft the secondary legislation necessary and the second three-year period subsequent to the date of application (or “transitional phase”) would delay the introduction of mandatory participation in assessments and use of reports. Given that the Commission hopes that the regulation will be adopted in the course of 2018, this would take the proposal to 2024 (or even 2025).
The draft text states that member states electing to become involved before the end of the transition phase will not be allowed to withdraw. Member states preferring to take advantage of the transitional period will not be required to use the results of the joint assessments but will have to comply with Community rules on conducting clinical assessments. Once the transitional phase has come to an end, member states will still be able to have recourse to the “safeguard clause” for reasons of protection of public health within their territory.
The text includes a review clause on the scope of the joint clinical assessments and on the organisational framework five years at most after the date of application of the regulation. (Original version in French by Sophie Petitjean)