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Boosting cooperation on health technology assessment

15-04-2019

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 have broadly welcomed the proposal. National parliaments, however, are divided in their appreciation of it. The Council has not yet agreed its position; technical discussions continue. Parliament's Committee on the Environment, Public Health and Food Safety adopted its report on 13 September 2018, and the report was voted in plenary on 3 October. However, with interinstitutional trilogue negotiations unable to start, on the Council side, Parliament adopted its final position at first reading on 14 February 2019.

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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