Conclusions and recommendations
Research and commercialisation
1.Regenerative medicine provides a unique approach to treating diseases and disorders by providing the body itself with the means to repair, replace, restore and regenerate damaged or diseased cells, tissues and organs. Its continual development depends crucially on a strong foundation of basic scientific research. The next Government should work with UK Research & Innovation to achieve a balance of investment in both basic scientific research and the translational research that it underpins, and to identify any research gaps in the light of the significant changes in the regenerative medicine sector over recent years. (Paragraph 18)
2.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, effective and safe therapies are made available to patients. The MHRA have taken forward the Regenerative Medicine Expert Group’s recommendations on providing a central focal point for regulatory advice, but there is more to be done. (Paragraph 25)
3.The next Government should review how regulatory ‘hospital exemptions’ are used for Advanced Therapy Medicinal Products across the UK, to assess how EU ATMP regulations might be adapted for the UK post-Brexit in order to reflect our own perspectives on the optimal balance between safety and accelerated access to cutting-edge technologies. (Paragraph 26)
4.The UK life sciences sector is a pioneer in the clinical development of new regenerative medicine therapies and well placed to create new high-tech high-value manufacturing businesses around these advanced therapies. Regenerative medicine researchers, however, need manufacturing support for ‘translating’ their work, and the Cell and Gene Therapy Catapult is working to bridge the gap between ‘translational’ research and commercialisation. The Catapult should nevertheless extend its support more widely, to make it available to both experienced and new innovators in the regenerative medicine sector. (Paragraph 33)
Adoption in the NHS
5.Having a universal NHS for all patients provides a receptive environment for the development and adoption of innovative and scientific advances in regenerative medicine. The next Government should nevertheless work with NHS England and Clinical Commissioning Groups to create the appropriate financial incentives to stimulate regenerative medicine research and innovation within the NHS, which will encourage more clinicians to become more involved in research. The next Government should also support work by NHS England and NICE to deliver a ‘fast track’ appraisal system for emerging regenerative medicine therapies. (Paragraph 51)
6.The next Government should also work with the biotech sector and with NHS England and NICE to agree new reimbursement payment models which take greater account of the value of regenerative medicine therapies that offer cures, reduce healthcare costs and make treatments available earlier to patients. (Paragraph 52)
7.The Regenerative Medicine Expert Group provided recommendations to Government to develop an NHS regenerative medicine strategy to deliver innovative treatments. While the Government has responded and made progress through investment in further research and in setting up the Cell and Gene Therapy Catapult, there is still more work to be done. A strategy is needed that covers the entire value chain—academic research, commercial development and clinical application—if the UK is to respond to the challenges of our healthcare system as well as facilitate economic growth. (Paragraph 56)
8.NHS England needs to take a lead on regenerative medicine by including it explicitly in its Personalised Medicine strategy. This would send a strong signal to the sector of the NHS’s commitment and willingness to adopt new and emerging therapies. (Paragraph 57)
9.The next Government should work with UK Research & Innovation, industry, academic researchers and the health sector to develop a strategy for Advanced Therapies, which should include regenerative medicine and cell therapies. The strategy 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. (Paragraph 58)
28 April 2017