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The Regenerative Medicine Expert Group: Watchmen watching watchmen?

14 October 2013
By Julian Hitchcock
Lawford Davies Denoon
Appeared in BioNews 726

Since the Coalition came to power, we've grown used to its backing of science and technology. So, when the Government published its response to the House of Lords Science and Technology Committee Inquiry into Regenerative Medicine last week, there was barely a murmur from the sector as recommendation after recommendation was endorsed and translated into action.

In their introduction to the response, David Willetts and Earl Howe reasserted the Government's commitment to the UK's 'Eight Great Technologies' identified for serious commitment, of which regenerative medicine is one, illustrating it with an impressive list of government translation projects - all, you will note, existing initiatives (1).

Approving the Committee's recognition of the NHS's potential as a unique biomedical resource, Government approbation was almost audible. When it referred to the Committee's plea for regulatory simplification, it approached a purr. Agreeing in particular with the Committee's view that the regenerative medicine sector cannot grow without a clear pathway from development to NHS delivery, the Government's response is to set up a new group, the Regenerative Medicine Expert Group (RMEG), 'to develop an NHS regenerative medicine delivery readiness strategy action plan'. RMEG's remit will also include 'a role to monitor the effect of regulation on the development of regenerative medicines in the UK'.

Given the Committee's report that the regulatory environment is 'overly complex and repetitive' (para 59), administered by 'the second highest number of competent authorities… covering medicines, medical devices, organ transplantation, tissues and cells, reproduction and blood in the EU' (para 61) and marked by 'significant overlap between the functions of regulators' (para 60), it may be wondered why a committee-cutting government would wish to add yet another institution?

The answer lies in the Committee's recommendation that an independent advisory group assist the Health Research Authority (HRA) 'to focus and clarify the functions of regulators' giving 'special consideration to reducing the overall number of regulators' (para 73). Its report had found 'a lack of coordination between regulators and, in some cases, inconsistency in advice' (para 60) and been particularly 'disappointed by the disparity in regulators' attitudes: the EMA, HFEA, HRA and HTA all acknowledged that there was room for improvement, whilst the MHRA was more focussed on what it was already doing'.

It described the statement of Sir Kent Woods, the MHRA's Chief Executive (that 'the regulation is complex, but the science and technology are complex') as 'overly simplistic'. 'Regulation must be robust and fit for purpose, but that does not justify the complex regulatory environment in the UK. Although there has been some progress, it is clear that there is still considerable room for improvement' (para 71), it said. Despite the existence of on-line tools, the Committee reported evidence that 'it is very difficult for [academics and new companies] to find someone to give them the guidance to take them through the regime'.

All for streamlining, the Government emphasises that it 'does not believe there is a need an additional advisory group on regulation' and cites its endorsement of the proposal in the McCracken report that regulation of tissue for applications aimed at developing regenerative medicine products be transferred from the HTA to the MHRA. Rather, the RMEG is a response to concerns that regulators do not routinely talk with one another: 'Bringing together the regulators with those developing regenerative medicines from academia and industry through the membership of the group will allow any regulatory concerns to be raised and addressed'. And it will be quite a throng that gathers in the Department of Health, comprising not only regulators, but members of NHS England, NICE, industry, researchers, patient representatives, NHSBT, SNBTS and the Cell Therapy Catapult Centre.

This is certainly overdue, but one might ask whether there is something missing. Regulators are authorities on the content of technical laws, but their application of those laws is not immaculate and is susceptible to judicial review. By way of example, the requirement to obtain a marketing authorisation for an advanced therapy medicinal product only applies where there is an intention to place that product on the European market (not a regulatory question), yet regulators may simply assume that a patient's own cells should be regulated as medicinal products placed on the market even if they never leave the operating suite.

Similarly regulators may declare, as a matter of scientific authority, what the 'essential function' of particular cells are (for example, according to the EMA's Committee for Advanced Therapies, fat is a 'natural filler') with no coherent jurisprudence whatsoever, even though that determination may be critical to whether the delivery of the cells requires a licence or not.

Bringing regulators together to hear bellyaches about the differential application of the hospital use exemption in Europe or the phoneyness or virtue of the HFEA's embryonic stem cell deposit rule is not enough: they and other members of the RMEG need to be respectfully reminded of their limitations. One of these is the very limited scope for movement. Virtually the entirety of the regulation of regenerative medicine is European. Indeed, the central body of the law, the Advanced Therapy Medicinal Products Regulation applies directly in the UK and all other EU Member States: whatever RMEG may recommend, it can only be reformed at the EU level.

In large part, the job of the RMEG must be to ascertain how to deploy the minimum number of regulators to administer the same body of law more effectively for the benefit of UK academics, businesses and clinicians. It may be wondered, therefore, why a body which the Committee had proposed should be independent and to breathe down the regulators' necks, should engage those very regulators to do so.  Lawyers are apt to reflect at such moments, 'quis custodiet ipsos custodes': who watches the watchman?

The House of Lords Science and Technology Committee, perhaps? Although their Lordships will find much to welcome in the Government's response, they will surely watch the effectiveness of its RMEG very closely. In its Report the Committee recommended 'that the group make proposals 18 months from its establishment' (para 73), adding darkly, 'We will revisit this aspect of the inquiry to ensure that progress has been made'.

SOURCES & REFERENCES
1) See the £180 million Biomedical Catalyst; the £9 million per annum spent on translational regenerative medicine research at Biomedical Research Centres and Units established in leading NHS and University partnerships; the £25 million UK Regenerative Medicine Platform established within BBSRC, EPSRC and MRC to address scientific and technical challenges associated with translating discovery into clinical application; and the Cell Therapy Catapult Centre.
|  4 June 2020
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