New strategy for uptake of regenerative medicine

A new report sets out a pathway for the UK to build on scientific excellence in regenerative medicine and accelerate transfer into clinical use.

Background

Regenerative medicine: a UK pathway is a report from the Regenerative Medicine Expert Group (RMEG) that makes recommendations to underpin adoption and spread of emerging treatments in healthcare.

Regenerative medicine is an umbrella term used to refer to therapeutic methods to repair, regenerate or replace human cells, tissues or organs. This includes stem-cell medicine and cell-based therapies, new forms of tissue engineering, and gene therapy.

The new report seeks not only to speed the uptake of patient-ready techniques from academic and commercial sources within the National Health Service (NHS), but also to position the UK as a global leader in both the science base and healthcare applications of regenerative medicine.

The RMEG was established following a 2013 House of Lords Science and Technology Committee report on regenerative medicine, which called for such a group to monitor government progress in this important area.

Advice for the MHRA

The new report welcomes the creation of the MHRA Innovation Office to streamline regulatory advice for regenerative medicine. It proposes that the Department for Environment, Food and Rural Affairs (Defra) and the Health and Safety Executive (HSE) should be involved in providing advice on clinical research involving gene therapy products, genetically modified micro-organisms and genetically modified organisms (GMOs), including steps to ensure that UK requirements are comparable and proportionate with respect to EU requirements.

The MRHA is urged to press for EU-wide consensus on classification of products that currently sit between cellular therapies regulated under the EU Tissues and Cells Directive, and those regulated as medicines under the Advanced Therapy Medicinal Products Regulations. It also says that the MHRA should seek EU review of regulatory cost structures and development of ‘a risk-based model for point of care devices and/or relatively simple preparation steps’.

Actions for the NHS

Focusing on the NHS, the report calls for NHS England, the NIHR and their regional equivalents to examine funding mechanisms for excess treatment costs for cell therapy trials, so that costs do not hamper early clinical uptake of the technologies. It also highlights the importance of evaluation and commissioning, praising the National Institute for Health and Care Excellence (NICE) for plans to develop suitable technology appraisals for regenerative medicine products and calling for clear, accessible and advice and guidance, especially for small and medium sized companies.

To embed that new regenerative medicine products in the NHS, the RMEG recommend that NHS England, the Department for Business, Innovation and Skills and the Department of Health should work together to develop Cell Therapy Centres of Excellence to support clinical trials infrastructure and NHS delivery. It is suggested that existing UK blood and tissue services should partner with the Cell Therapy Catapult and others to support such centres.

The need for health professional and translational researcher education and training is emphasised, alongside the need for standardised data collection and a comprehensive shared database including healthcare outcomes, to support ongoing research. Finally, the establishment of a Ministerial Group for regenerative medicine is suggested, akin to the Ministerial Medical Technology Strategy Group and Ministerial Industry Strategy Group.

Response and perspective

Life Sciences Minister George Freeman welcomed the report, but did not favour the creation of a Ministerial Group, preferring a high-level stakeholder group of the relevant bodies plus ‘representation from industry, health and research’ to oversee implementation of the proposed strategy. It is to be hoped that patient views would also play a part; not all of us will need gene therapy, but many more could potentially benefit from advances in cell and tissue therapies.

The value of the NHS in providing an ideal test bed for clinical trials and transfer of scientific ideas and innovations into actual healthcare tools is increasingly recognised. The Academy of Medical Sciences (AMS) first highlighted this in a 2010 report, Reaping the rewards: a vision for UK medical science, and the current UK Government has taken on board a similar agenda, using science to underpin health and wealth generation. Last year NHS England chief executive Simon Stevens announced plans to harness medical innovations in the NHS and position it as a world-leader in genomics and personalised medicine. Regenerative medicine would sit well alongside these plans.