Faulkner Gateways RM published Mar2016.pdf (545.35 kB)
Opening the gateways to market and adoption of regenerative medicine? The UK case in context
journal contribution
posted on 2023-06-09, 01:19 authored by Alex FaulknerRegenerative medicine is a site for opposing forces of gatekeeping and innovation. This applies both to regulation of market entry and to clinical adoption. Key gateways include the EU’s Advanced Therapy Medicinal Products Regulation, technology assessment body NICE and commissioning/service contractor National Health Service England. The paper maps recent gatekeeping flexibilities, describing the range of gateways to market and healthcare adoption seen as alternatives to mainstream routes. The initiatives range from exemptions in pharmaceutical and ATMP regulations, through ‘adaptive pathways’ and ‘risk-based’ approaches, to special designation for promising innovation, value-based assessment and commissioner developments. Future developments are considered in the UK’s ‘accelerated access review’. Caution is urged in assessing the impact of these gateway flexibilities and their market and public health implications.
Funding
Regenerative medicine and its potential for development and diffusion: an analysis of emergent value systems and health service readiness; G1398; ESRC-ECONOMIC & SOCIAL RESEARCH COUNCIL; R15474 - ES/L002779/1
History
Publication status
- Published
File Version
- Published version
Journal
Regenerative MedicineISSN
1746-0751Publisher
Future MedicineExternal DOI
Issue
3Volume
11Page range
321-330Department affiliated with
- International Relations Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2016-05-20First Open Access (FOA) Date
2016-05-20First Compliant Deposit (FCD) Date
2016-05-20Usage metrics
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