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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 ...

EU cooperation on health technology assessment

Mad-Daqqa t''Għajn 08-12-2021

During the December plenary session, the European Parliament is expected to vote at second reading on a European Commission proposal to strengthen EU-level cooperation among Member States on assessing health technologies. Improved cooperation would profit national health systems and producers of medicines and medical devices, as approval procedures would be simplified, while also benefiting patients thanks to innovative, safe and effective health technologies becoming available more quickly.

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 ...