Members' Research Service By / March 22, 2018

Boosting cooperation on health technology assessment [EU Legislation in Progress]

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.

© vege / Fotolia

Written by Laurence Amand-Eeckhout (5th edition, updated on 10.2.2022),

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.

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 22 June 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. The Council formally adopted its first-reading position on 9 November 2021. On 30 November 2021, ENVI adopted its recommendation for second reading, which is to be debated and voted during the December plenary session. The regulation, once adopted, will start to apply three years after its entry into force.

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: Timo Wölken (S&D, Germany) 2018/0018(COD)
Shadow rapporteurs: Nathalie Colin-Oesterlé (EPP, France)
Joanna Kopcińska (ECR, Poland)
Michèle Rivasi (Greens/EFA, France)
Ordinary legislative procedure (COD) (Parliament and Council on equal footing – formerly ‘co-decision’)
Next steps expected: Second-reading vote in plenary


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