The UK is underprepared for the potential health and economic benefits it could accrue from taking a leading role internationally in developing the field of regenerative medicine, a House of Lords Committee warns.
The government must translate its "warm words" on this issue into action to ensure that the UK does not miss out, says the Lords Science and Technology Committee, in a new report, which also describes the National Institute for Health and Care Excellence (NICE)'s current evaluation process for such treatments as "inappropriate."
The NHS makes the UK a potentially attractive place for international investment in regenerative medicine, but problems in our regulatory arrangements and a lack of coordinated 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, says the report, which calls for changes to ensure investor confidence and clear the route "from bench to bedside" for regenerative therapies.
Research shows that there is likely to be a £44-£54 billion NHS funding gap by 2022, and that management of chronic disease accounts for around 75% of all UK heath costs, the Committee points out. Yet regenerative medicine has the potential to provide innovative treatments for a wide range of chronic diseases such as diabetes and heart disease, and investment in such treatments could be a major benefit to the UK public purse as well as providing health benefits, it adds.
The report makes a number of recommendations, including:
- the Health Research Authority (HRA) should take steps over the next 18 months, with the support of external experts, to streamline the overall regulatory system for regenerative medicine. And in the short term, the HRA 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 (NIHR) should set up a regenerative medicine stream of its clinical research network to assist with design of clinician trials, identifying patients and finding interested clinicians;
- the Department for Business, Innovation and Skills (BIS) should invest in manufacturing facilities to support the scale-up of treatments in mid-to-late-stage clinical development:
- the Department of Health (DH) 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 develop new and innovative treatments. The government should appoint an independent Chair of a group tasked with developing this strategy. The Chair should also drive coordination and maintain momentum in the delivery of regenerative medicine;
- government must explore innovative funding models to further support the field; and
- NICE must review its evaluation processes to ensure that regenerative treatments - which can have high start-up cost but could represent big savings for the NHS in the long run - do not lose out on funding. The current NICE model is "inappropriate," says the Committee.
NICE needs to 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," commented Committee Chair Lord Krebs.
"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," he added.
The Lords' recommendations have been warmly welcomed by the BioIndustry Association (BIA), which said that, "if robustly backed by government, will make the UK a world leader in cell therapy clinical translation and commercialisation."