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

Written by Nicole Scholz (1st edition),


© 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 covers new medicines and certain medical devices, and would provide the basis for permanent EU-level cooperation in four areas: joint clinical assessments; joint scientific consultations; identification of emerging health technologies; and voluntary cooperation on other aspects of HTA. 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 their participation in the joint work until three years after the rules enter into force, it would become mandatory for all after the sixth year.

Stakeholders have broadly welcomed the proposal, with the medical devices industry reportedly being more sceptical. The legislative process is in its early stages. In the Council, the Working Party on Pharmaceuticals and Medical Devices is dealing with the file. The Parliament’s Committee on the Environment, Public Health and Food Safety is expected to consider the rapporteur’s draft report in summer 2018.



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

procedure ref.: 2018/0018(COD)

Ordinary legislative procedure (COD) (Parliament and Council on equal footing – formerly ‘co-decision’)

Rapporteur: Soledad Cabezón Ruiz (S&D, Spain)
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)

Next steps expected: Publication of draft report

Stage: Commission proposal


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

  1. where can you check current status of the legislation as of April 2018?


    Posted by rdp (@rdplondon) | April 19, 2018, 01:38
  2. Reblogged this on World4Justice : NOW! Lobby Forum..


    Posted by daveyone1 | March 22, 2018, 22:52


  1. Pingback: Boosting cooperation on health technology assessment [EU Legislation in Progress] | - March 23, 2018

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