LONDON – Problems with the regulatory framework and a lack of coordination is holding back development of regenerative therapies, delaying both health and economic benefits. Changes are needed to give investors confidence and clear the path to commercialization, according to a report on regenerative medicine in the UK, published last week.

Private investors are reluctant to put money into regenerative medicine because of the high risk of failure to translate promising science into reimbursable treatments. The government needs to simplify and clarify the regulatory system, enhance support for clinical trials and back new funding models, according to the report by the House of Lords Science and Technology Committee.

"The UK is underprepared for the potential health and economic benefits it could accrue from taking a leading role internationally in developing in regenerative medicine," said John Krebs, chairman of the committee. "The government must translate its warm words on this issue into action."

The report calls for steps to streamline the overall system of regulation and provide additional services to help navigate what it describes as the "labyrinthine" regulatory system. A researcher or company trying to develop a regenerative medicine in the UK could have to deal with up to eleven different regulators, with significant overlap between their functions.

The committee recommends that the Health Research Authority (HRA) as the body responsible for the oversight of research in the National Health Service (NHS), commissions an independent advisory group made up of national and international experts, to develop a designed-for-purpose regulatory system.

"We acknowledge there is significant value in the expertise of some regulators. But patients, business and the taxpayer deserve a modern, designed-for-purpose, efficient regulatory system rather than one that has evolved in a haphazard, piecemeal way," the report said.

An independent advisory group supporting the HRA will give the authority support in focusing on and clarifying the functions of regulators. This group should give special consideration "to reducing the overall number of regulators," the report recommended.

As CEO of the first company to navigate a fetal stem cell product through to the clinic, Michael Hunt, of Reneuron plc, has experienced the complexities and longeurs of the current regulatory system. He welcomed the recommendations saying, "The potential barriers to commercialization identified in the report are real and important, and we endorse the recommendations proposed in the report to address them."

Alongside reform of the regulatory system, the report called for the formation of a specialized regenerative medicine stream in the NHS Clinical Research Network to assist in the design of clinical trials, help overcome difficulties in identifying patients and to identify clinicians interested in such studies.

In addition, there is a need to scope existing manufacturing capacity and ensure production facilities are in place to support the scale-up of treatments that are in mid- to late-stage clinical development.

It also is necessary to ensure that once regenerative medicine products are approved, patients can get access. This will require the NHS to put in place resources and structures for treating patients and the National Institute for Health and Care Excellence (NICE) to alter its evaluation process to allow for the fact that although they come with a high price tag, regenerative therapies are likely to reduce overall costs in the long run.

NICE must ensure that its evaluation process recognizes the higher initial costs, without compromising its goal of assessing value-for-money in health care. Part of its value-for-money consideration should be that early investment in this field could unlock other treatments with significant economic impact, both in terms of savings to the health system and increased potential work productivity.

"Investors need to see a clear pathway from development to delivery in the NHS if they are to have the confidence to invest in regenerative medicine. It is not sufficient to rely on trail blazing therapies to forge pathways to clinical delivery. The NHS must shift from reacting to regenerative medicine to a state of preparedness to deliver new and innovative treatments," the report said.

To ensure that happens, the Department of Health should establish an expert working group to develop an NHS regenerative medicine delivery readiness strategy and action plan by December 2014, according to the report.

Chris Mason, chair of the UK Bioindustry Association's Cell Therapy and Regenerative Medicine Advisory Committee, welcomed the recommendations. "The committee's comprehensive vision for achieving the streamlining of regulation, innovative funding mechanisms, market pull by the NHS and appropriate reimbursement will give cell therapy and regenerative medicine companies a much needed boost," Mason said.