Health technology assessment / Compromise

EESC opinion: Health technology assessment / Compromise

EESC opinion on the Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU

Key points


  • agrees that evidence based processes like Health Technology Assessment (HTA) that is a key driver for socio-economic growth and innovation in the Union can cover both clinical and non-clinical aspects of a health technology and this can be achieved through cooperation between Member States at Union level aiming at a high protection of health for patients and ensuring the smooth functioning of an inclusive Single Market;
  • supports the initiative of introducing increased coordination on HTA’s by submitting one dossier, and endorses a progressive implementation timeline, but it points out the absence of special provisions for SMEs;
  • is concerned about the set timelines of implementation and especially the delayed application of three years and believes that for the benefit of the patients and cost-effectiveness this could be shortened;
  • emphasizes that in order to achieve the promise of digital health and care, of which HTA is part, the involvement of civil society (notably of social economy organisations and patient organisations) is crucial.

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Council of the EU compromise on COM(2018) 51 final – 2018/0018 (COD)