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Boosting cooperation on health technology assessment

15-07-2021

The European Commission has proposed a regulation on health technology assessment (HTA). HTA is a research-based tool that supports decision-making in healthcare by assessing the added value of a given health technology compared to others. The proposal would provide the basis for permanent EU-level cooperation in four areas. Member States would still be responsible for assessing the non-clinical (economic, ethical, social, etc.) aspects of health technology, and for pricing and reimbursement. While ...

The European Commission has proposed a regulation on health technology assessment (HTA). HTA is a research-based tool that supports decision-making in healthcare by assessing the added value of a given health technology compared to others. The proposal would provide the basis for permanent EU-level cooperation in four areas. Member States would still be responsible for assessing the non-clinical (economic, ethical, social, etc.) aspects of health technology, and for pricing and reimbursement. While Member States could choose to delay participation in the joint work until three years after the rules enter into force, it would become mandatory after six years. Stakeholders broadly welcomed the Commission proposal. National parliaments, however, are divided in their appreciation of it. The provisional agreement, applauded by some stakeholders, has been criticised by the pharmaceutical industry, in particular, for its lack of ambition. The European Parliament adopted its final position at first reading on 14 February 2019. In the Council, work was carried out under seven consecutive presidencies. On 24 March 2021, the co-legislators reached a provisional agreement in interinstitutional trilogue negotiations. The Council's Permanent Representatives Committee endorsed the provisional agreement on 30 June 2021. Parliament's ENVI committee voted in favour of the text on 13 July 2021. Council and then Parliament are expected to formally adopt it in the coming months. Fourth edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure.

Strengthening EU cooperation on health technology assessment

18-06-2018

The impact assessment (IA) accompanying the Commission proposal on strengthening EU cooperation on Health Technology Assessment clearly defines the problem, as well as the general and specific objectives. However, the IA does not appear to have succeeded in presenting a very convincing range of options. The analysis of impacts focuses on the economic dimension, which is consistent with the manner in which the problems have been defined. In light of the reported concentration of SMEs in the medical ...

The impact assessment (IA) accompanying the Commission proposal on strengthening EU cooperation on Health Technology Assessment clearly defines the problem, as well as the general and specific objectives. However, the IA does not appear to have succeeded in presenting a very convincing range of options. The analysis of impacts focuses on the economic dimension, which is consistent with the manner in which the problems have been defined. In light of the reported concentration of SMEs in the medical technologies sector (95 %), more emphasis could have been put on analysing the impacts of the retained options on them. The stakeholders' views have been illustrated in a satisfactory way. The evidence included or referenced in the IA is copious and up to date. The IA appears to have addressed most of the RSB's recommendations. Finally, the legislative proposal appears to be consistent with the analysis carried out in the IA.

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