Written by Nicole Scholz (4th edition, updated on 15.7.2021),

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 broadly welcomed the Commission proposal. National parliaments, however, are divided in their appreciation of it. The provisional agreement, applauded by some stakeholders, has been criticised by the pharmaceutical industry, in particular, for its lack of ambition.

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 24 March 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. Council and then Parliament are expected to formally adopt it in the coming months.

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