UK must not miss out on Regenerative Medicine potential

• Committee Report: Regenerative medicine (HTML)
• Committee Report: Regenerative medicine (PDF)
• Inquiry: Regenerative Medicine
• House of Lords Science and Technology Committee

The Committee’s report, Regenerative Medicine, delivers a stark warning that whilst the NHS makes the UK a potentially attractive place for international investment in regenerative medicine, problems in our regulatory arrangements and a lack of co-ordinated leadership on the issue is holding back the chance to deliver improvements to the quality of people’s lives and generate significant economic benefits for the UK. The Committee call for changes to ensure investor confidence and clear the route from ‘bench to bedside’ for regenerative therapies.

The Committee point to research that indicates that there is likely to be a £44bn to £54bn NHS funding gap by 2022 and that management of chronic disease accounts for around 75% of all UK health costs. The report highlights that regenerative medicine has the potential to provide innovative treatments for a wide range of chronic diseases such as diabetes and heart disease, and says that investment in such treatments could be a major benefit to the UK public purse as well as providing health benefits. 

In order to ensure the UK is able to translate scientific knowledge into clinical practice and ensure its status as a world leader in regenerative medicine, the Committee make a number of recommendations including:

• The Health Research Authority should take steps over the next 18 months, with the support of external experts, to streamline the overall regulatory system for regenerative medicine. In the short term it should provide more support to help researchers navigate the ‘labyrinthine’ regulatory system. Researchers need more than a web based service.
• The National Institute for Health Research should set up a regenerative medicine stream of its clinical research network to assist with design of clinical trials, identifying patients and finding interested clinicians.
• The Department for Business, Innovation and Skills should invest in manufacturing facilities to support the scale-up of treatments in mid to late stage clinical development.
• The Department of Health should develop a strategy to ensure the NHS is ready to provide regenerative treatments. The NHS must move from reacting to regenerative medicines to a ‘state of preparedness’ to deliver new and innovative treatments. The Government should appoint an independent Chair of a group tasked with developing this strategy. The Chair should also drive co-ordination and maintain momentum in the delivery of regenerative medicine.
• Government must explore innovative funding models to further support the field.
• The National Institute for Health and Care Excellence (NICE) must review its evaluation process to ensure that regenerative treatments, which can have a high start-up cost but could represent big savings for the NHS in the long run, do not lose out on funding. The Committee say the current NICE model is ‘inappropriate’.

Commenting Lord Krebs, Chairman of the House of Lords Science and Technology Committee, said:

“Regenerative medicine has the potential to be good for public health and the health of the UK economy but we must take steps now to ensure we realise that potential.

“In the NHS the UK has a strong resource for ensuring we are an attractive place to develop innovative regenerative treatments and we have real expertise in research in this area. However, in order to benefit from that, we need the Health Research Authority to up the pace of its review of the regulatory environment to ensure that we are not placing overly onerous burdens on research in this area.

“We also need a co-ordinated approach so that we can translate the successful research that we have in the UK into medical results. Investors need to see the route from bench to bedside.  We are calling on the Government to appoint an independent Chair to oversee regenerative medicine policy in the NHS. NICE must also review its evaluation processes to ensure the long term benefits of investment in regenerative medicine, including potentially reduced NHS costs further down the line, are given appropriate weight in an area where the start up costs can be significant. As we state in the report, the current NICE model is inappropriate.

“Although some media coverage of regenerative medicine sensationalises the immediate prospects for health breakthroughs, regenerative medicine does have the potential to can make a real contribution to improving public health. In particular it may offer new approaches to tackling the chronic health conditions that are predicted to lead to huge NHS funding shortfalls over the next decade. Other countries are taking decisive action to streamline processes and support this field – the UK could and should be a world leader in regenerative medicine. We need leadership and investment now to ensure that this opportunity is not missed.”