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Government position on regenerative medicine regulatory simplification is good news for researchers, says expert

Out-Law News | 04 Oct 2013 | 4:34 pm | 2 min. read

The Government's response to a critical Parliamentary report on the UK policy in relation to regenerative medicine takes an encouraging position on potential simplification of the regulatory landscape, an expert has said.

Life sciences expert Louise Fullwood of Pinsent Masons, the law firm behind Out-Law.com, said that the proposed development of a single point of contact for queries in relation to the "labyrinthine" existing regulatory framework would be a "useful" development for researchers and companies, assuming that it is properly resourced.

"One of the practical problems for researchers, as noted in the original report, is the division of regulatory responsibility between a number of different bodies," she said. "It is therefore good to see that the very first recommendation in this response is an attempt to help researchers through the maze in the short term - with an objective of regulatory simplification in the longer term."

The House of Lords Science and Technology Committee published the results of its work on regenerative medicine in July. Alongside its recommendations for longer term simplification of the UK regulatory landscape, it called on the Health Research Authority (HRA) to develop a "single point of contact" to help those working in the sector obtain information and advice. The HRA is the NHS body responsible for research.

In its response to the Committee (21-page / 480KB PDF), the Government acknowledged the need for regulatory support and guidance beyond the email queries line and online decision tools criticised in the report. It said that the HRA planned to improve its existing tools in conjunction with other regulators, including the creation of a single queries line.

"The HRA is committed to developing, improving and building upon [its] existing tools and will work with research regulators and other organisations providing guidance and advice to improve consistency and reduce unnecessary duplication in information provided by regulators," the Government said in its response.

"This will include developing a single queries line, and redevelopment of the HRA website to provide a source of consolidated information on requirements for research, and make information easier to find. The HRA are also testing whether the early provision of advice to applicants improves rate and time to Research Ethics Committee (REC) approval," the response said.

The Government also plans to establish a Regenerative Medicine Expert Group, which will be tasked with developing a "regenerative medicine delivery readiness strategy and action plan", it said. Part of its work would also be monitoring the impact of regulation on the development of regenerative medicine. This group would be backed by the Department of Health and made up of representatives from the NHS, regulators, industry, researchers, patient representatives and the National Institute for Health and Care Excellence (NICE).

However, the Government will not at this stage commission an "independent advisory group", as recommended by the Committee, to develop a new, "designed-for-purpose regulatory system", it said.

The HRA is one of a number of bodies with some responsibility for the regulation and governance of medical research in the UK. The use of human tissue is licensed and regulated by the Human Tissue Authority, unless such material is derived from human embryos, in which case the Human Fertilisation and Embryology Authority also licences and regulates activity. 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.

In its response, the Government confirmed its commitment to regenerative medicine as one of the UK's "Eight Great Technologies", due to its "huge opportunities for technological advance" and potential economic benefits.

"The UK retains a strong position in Europe and globally in the science and commercial translation of regenerative medicine," the response said. "The quality of our work in research and academia is world class, supported by a strict but enabling legislative and regulatory framework that is helping innovation to flourish."