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Faulkner Gateways RM published Mar2016.pdf (545.35 kB)

Opening the gateways to market and adoption of regenerative medicine? The UK case in context

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journal contribution
posted on 2023-06-09, 01:19 authored by Alex Faulkner
Regenerative 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 Medicine

ISSN

1746-0751

Publisher

Future Medicine

Issue

3

Volume

11

Page range

321-330

Department affiliated with

  • International Relations Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2016-05-20

First Open Access (FOA) Date

2016-05-20

First Compliant Deposit (FCD) Date

2016-05-20

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