Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on health technology assessment and amending Directive 2011/24/EU

1. Health technology assessment (HTA) is the systematic evaluation of properties, effects, and/or impacts of a health technology (for example a drug, a medical device, etc). It is a multidisciplinary process to evaluate the social, economic, organisational and ethical issues of a health intervention or health technology.

2. HTAs are carried out in England by the National Institute for Health and Care Excellence (NICE), in Scotland by the Scottish Medicines Consortium (SMC), in Wales by the All Wales Medicines Strategy Group (AWMSC), in Northern Ireland by the Department of Health, Social Services and Public Safety (DHSSPS).

3. In England, commissioners are legally required to fund drugs and treatments positively appraised by NICE through its technology appraisal and highly specialised technologies programmes. In Wales, all health boards and trusts are required to fund all positive recommendations made by NICE and the AWMSG. In Scotland, where the SMC accept a medicine for routine use in the NHS, Health Boards are expected to make it, or its equivalent, available. Where NICE-approved technologies are endorsed by the DHSSPS Department of Health (Northern Ireland) for implementation in the Northern Ireland, they are expected to made available to patients within specified timeframes; there are separate arrangements for drugs recommended by the SMC in Northern Ireland.

Topic  Health 
Department  Health 
Council Reference  5844/18 
COM Reference  COM(18)51 
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Associated file(s)


  1. 11 April 2018 O'Shaughnessy-Cash - 129 KB - pdf
  2. 2 July 2018 O'Shaughnessy-Boswell - 47 KB - pdf
  3. 2 July 2018 O'Shaughnessy-Cash - 51 KB - pdf
  4. 29 March 2018 O'Shaughnessy-Boswell - 54 KB - pdf
  5. 5844/18 - 690 KB - pdf
  6. 5844/18 + Add 1 - 3 MB - pdf
  7. 5844/18 + Add 2 - 426 KB - pdf
  8. EM 5844/18 - 452 KB - pdf

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