Summary
Regenerative medicine has enormous potential, offering treatments for diseases and disorders by providing the body itself with the means to repair, replace, restore and regenerate damaged or diseased cells, tissues and organs. The UK has considerable strengths in this field, underpinned by world-class research. Its continual development depends crucially, however, on an appropriate balance between basic scientific research and the translational research that it underpins.
It is important that the regulatory environment for regenerative medicine remains flexible to accommodate new and diverse approaches while also maintaining robust review processes to ensure that the most promising therapies are made available to patients. The next Government should review how regulatory ‘hospital exemptions’ are used for Advanced Therapy Medicinal Products (ATMPs) and how EU ATMP regulations might be adapted for the UK post-Brexit to reflect our own perspectives on the optimal balance between safety and accelerated access to cutting-edge technologies.
Having a universal NHS provides a receptive environment for the development and adoption of innovative and scientific advances in regenerative medicine, but the next Government should work with the NHS to: create the appropriate financial incentives to further stimulate regenerative medicine research and innovation; deliver a ‘fast track’ appraisal system for emerging therapies; and agree new reimbursement payment models which take greater account of the value of regenerative medicine therapies.
The next Government should work with UK Research & Innovation (UKRI), industry and researchers to develop a strategy for advanced therapies that covers the entire regenerative medicine value-chain specifically—from academic research, to commercial development and clinical application—and the NHS’s Personalised Medicine strategy should explicitly include regenerative medicine and cell therapies. These strategies should be aligned to the Government’s response to the Accelerated Access Review and the strategic objectives outlined in the Government’s Industrial Strategy Green Paper.
28 April 2017