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

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.