The Portuguese Presidency of the Council of the EU is continuing its efforts to reach a general approach on the draft regulation on health technology assessment.
On Tuesday 16 February, it submitted a new draft compromise proposal to Member States which removes the idea of explicitly providing for penalties for violations committed by health technology developers (Article 34a).
The draft regulation on health technology assessment, known as ‘HTA’, has been under discussion for almost three years now. It proposes that clinical evaluations carried out by the Member States be pooled to determine the added value of a medicinal product or certain medical devices and thus help them to determine their specific position on pricing and reimbursement (see EUROPE 11951/6).
The Portuguese Presidency is working hard to achieve a common approach by the EU Council on 16 March. It has submitted a new draft compromise, of which EUROPE has received a copy, which takes up the main lines of the German proposal (see EUROPE 12649/4).
The main novelty is the deletion of Article 34a, which requires Member States to define “effective, proportionate and dissuasive” penalties that would apply to health technology developers who do not comply with the Regulation, “including their failure to provide information, data, analysis and other evidence”.
The draft compromise specifies that the first joint assessment will apply to oncology treatments using “new active substances”. It adds that the Commission will have to select, by means of an implementing act, the medical devices and in vitro medical devices eligible for a common evaluation on the basis of one of the following criteria: - unmet medical needs; - new therapeutic class; - major potential impact; - embedded software using artificial intelligence, machine learning or algorithms. It also reintroduces throughout the text the reference to “in vitro” medical devices.
Link to the compromise dated 16 February: http://bit.ly/37rhtuJ (Original version in French by Sophie Petitjean)