Out-Law News 3 min. read

Streamlined regulation would be welcome but Government clearly supports regenerative medicines research, say experts

A Parliamentary committee is right to highlight that a complex regulatory regime for regenerative medicine is a barrier to the success of the industry in the UK, but criticisms about the Government's backing of researchers are wide of the mark, two experts have said.

Earlier this week the House of Lords' Science and Technology Committee published a report in which it said that the UK is "currently underprepared to realise the full potential of regenerative medicine"

Among the criticisms the Committee raised was with the regulatory regime that applies in the UK to regenerative medicines and with the level of Government funding to help the industry grow.

Life sciences transactions lawyer Allistair Booth of Pinsent Masons, the law firm behind Out-Law.com, said that the Government had demonstrated its commitment to the growth of regenerative medicines research in the UK.

"Regenerative medicines is one of the next big areas for medical research," Booth said. "The Government has put together centres of excellence around cutting edge technology with the idea of combining research and catapulting it forward. The Cell Therapy Catapult is one of the centres set to benefit from the Chancellor's decision to ring fence £185 million for scientific research in his recent Spending Review." 

"Through, for example, the Cell Therapy Catapult and the government funding of that Catapult, small regenerative medicine research companies can get access to equipment, expertise and the other resources that would most likely otherwise be beyond their reach," he said. "The reality is that, while a number of early stage venture funds have been created in the last few years – and that is a very welcome development – there is still a shortage of early stage investment capital to assist these companies to take forward such cutting edge innovation."

"Through its investment in the various Catapults and the BioMedical Catalyst fund the UK Government is providing vital, meaningful and very welcome support to innovative life sciences companies to move forward their research to the point where it can attract further investment or partnering opportunities," said Booth.

In its report, the Science and Technology Committee said it was concerned that the Cell Therapy Catapult was "seeking to achieve too much, too quickly, given the level of funding" available to it. The Cell Therapy Catapult, set up in 2012, had an initial budget of approximately £70m to be spread over five years, but the Committee said that it should prioritise "developing investable propositions and building connections" before sharing its expertise.

The Committee also said that "innovative funding models" should be explored to help support the development of regenerative medicines research. It said the models would likely rely on the Government matching funds pledged or providing a form of guarantee to investments and that the Government should "put their money where their mouth is".

The Committee also called for action to help reduce regulatory barriers to the development of the regenerative medicines research in the UK. It said that the Health Research Authority (HRA) must "simplify the regulatory route so that the development of regenerative medicine, and other innovative therapies, is not hindered". A new independent advisory group should be set up to assist the HRA in helping "focus and clarify the functions of regulators".

Life sciences expert Louise Fullwood of Pinsent Masons said she agreed with the Committee's view that the existing regulatory framework was 'labyrinthine'.

"One of the practical problems for researchers is the division of regulatory responsibility between a number of different bodies," Fullwood said. "For example, the Human Tissue Authority licences and regulates use of human tissue. Where such material is derived from human embryos then the Human Fertilisation and Embryology Authority also licences and regulates activity. Specific submissions to research ethics committees and central NHS R&D office, if the research is NHS based, is also required."

"The Gene Therapy Advisor Committee has a further oversight role, as, potentially,  do a range of other agencies including the Health and Safety Executive, the Care Quality Commission, the Integrated Research Approval System and local research ethics committees. Although the UK Stem Cell Toolkit is a helpful start in working through the labyrinth, in our experience there are still points of conflict and ambiguity between guidance issued by these different sources," she said.

Recent developments have highlighted the potential for regenerative medicines. In February the Independent reported that clinical trials were set to start to test whether multiple sclerosis could be treated using patient stem cells. In March the UCL Hospitals
Biomedical Research Centre revealed that the world’s first clinical trial of a voice box transplant based on stem cells had received £2.8m worth of funding.

In May the BBC reported that five people who became seriously disabled after suffering strokes had shown signs of recovery following the injection of stem cells into the damaged part of their brains.

Earlier this week Nature magazine also reported that scientists had successfully managed to restore the liver functions of mice by using human stem cells

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