Written by Nicole Scholz (3rd edition, updated on 15.4.2019),

medicine
© vege / Fotolia

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.

Versions

Proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU
Committee responsible: Environment, Public Health and Food Safety (ENVI) COM(2018) 51 of 31.1.2018
Rapporteur: Soledad Cabezón Ruiz (S&D, Spain) 2018/0018(COD)
Shadow rapporteurs: Françoise Grossetête (EPP, France)
Bolesław G. Piecha (ECR, Poland)
Gesine Meissner (ALDE, Germany)
Kateřina Konečná (GUE/NGL, Czech Republic)
Michèle Rivasi (Greens/EFA, France)
Piernicola Pedicini (EFDD, Italy)
Joëlle Mélin (ENF, France)		 Ordinary legislative procedure (COD) (Parliament and Council on equal footing – formerly ‘co-decision’)
Next steps expected: Council general approach