The European Commission is putting the finishing touches to its draft regulation on Health Technologies Assessments (HTA). According to the information we have received, the draft text seen by EUROPE has only made a few marginal changes (see EUROPE 11942): the Commission is still planning to propose a transition period on 31 January, at the end of which, participation of member states in the assessments will become compulsory.
Health Technologies Assessments, such as those for medicines or medical devices, seek to provide a scientific analysis to member states in an effort to help them make decisions on prices and reimbursement. The European Union does not currently have any compulsory measures on the HTA. Since 2010, it has only organised joint activities known as EUnetHTA, in which the member states participate on a voluntary basis. The third of these will be coming to an end in 2020.
The draft text seen by EUROPE establishes the procedures and structures for cooperation on joint work at a European level. The document for exclusive internal use explains, "The joint work will mainly be through joint health assessments. The use of the reports on joint health assessments at a level of the member state will be compulsory”.
In response, the European Patients' Forum (EPF) indicated that it would strongly support the compulsory integration of the HTA results for all technologies. It argues that this integration is a prerequisite for ensuring equitable access to care for all. EPF General Secretary, Nicola Bedlington, explained that, “What we also would like to see in the Commission’s proposal is mandatory and meaningful involvement of the patient community in the HTA process per se, including the selection of technologies to be assessed”.
The other organisations we contacted include the EFPIA (pharmaceutical industry), MedTech Europe (medical technologies manufacturers) and Emanet (doctors), although they did not provide any response to the questions we put to them. (Original version in French by Sophie Petitjean)