Liberal Democrat peer Phil Willis, former head of the Commons Science and Technology Committee, has condemned government plans to merge the research regulation functions of the Human Fertilisation and Embryology Authority and the Human Tissue Authority.
The Department of Health said on 26 July that the coalition intends to abolish the agencies and create a single body for medical research regulation, also absorbing the National Research Ethics Service. The Care Quality Commission and the Information Centre for Health and Social would take on other functions of the agencies.
Tory health secretary Andrew Lansley said that, subject to Parliamentary approval, eight or ten of his department’s 18 ‘arm’s-length bodies’ would be cut, saving more than £180 million by 2014-15.
But a joint Lords and Commons committee on the Human Tissue and Embryos Bill, chaired by Willis, has already considered and rejected a proposal to merge the bodies—in 2007. “We went through this in huge detail,” Willis told Research Fortnight. “There was a total agreement of the joint committee: regulating tissue and embryos are separate functions. The idea that you have a single focus for what are distinct functions would be a retrograde step."
The Department of Health said on 26 July that the coalition intends to abolish the agencies and create a single body for medical research regulation, also absorbing the National Research Ethics Service. The Care Quality Commission and the Information Centre for Health and Social would take on other functions of the agencies.
Tory health secretary Andrew Lansley said that, subject to Parliamentary approval, eight or ten of his department’s 18 ‘arm’s-length bodies’ would be cut, saving more than £180 million by 2014-15.
But a joint Lords and Commons committee on the Human Tissue and Embryos Bill, chaired by Willis, has already considered and rejected a proposal to merge the bodies—in 2007. “We went through this in huge detail,” Willis told Research Fortnight. “There was a total agreement of the joint committee: regulating tissue and embryos are separate functions. The idea that you have a single focus for what are distinct functions would be a retrograde step."
The 2007 committee included former HFEA head Ruth Deech, fertility specialist Robert Winston and Conservative peer Charles Jenkin, head of the Foundation for Science and Technology. Evidence received from groups including researchers, patients and religious bodies, was “overwhelmingly against” setting up the joint agency, said the committee.
A spokeswoman for the Department of Health said that the new move was about streamlining, not reducing the functions of either organisation. “The review looked at whether or not the type of work still needs to be carried out nationally and at arm’s length from the department. And [in this case] there’s a recognition that the work they do is so important we want to bring it closer.” The spokeswoman said the measure would also maximise the efficiency of back-office functions such as human resources and estates.
According to the department, there is a “strong argument” for rationalising medical research regulation. It would create “greater strategic coherence around research by placing responsibility for these different aspects of medical research regulation within one arm’s-length body that would perform a stand-alone technical function as a research regulator”.
But Willis suggests that the proposal has not been given enough thought. “It’s hugely disappointing that, in an area where successive governments have to command the widest range of support for regulatory proposals, this should be slipped through in what appears to be little more than a cost-cutting matter,” he says.
The government’s proposal is subject to consideration of practicalities and legal implications. It also awaits the results of a review of medical research regulation by the Academy of Medical Sciences, which began under the last government. A spokesman for the AMS said it had not previously been asked to consider a single agency—this would be new to the review, which is scheduled to conclude by the end of the year.
Separating the functions of the HFEA into research regulation and IVF treatment would be “disastrous”, adds Willis. “I would be fundamentally opposed to the idea that you could simply hive off elements of the HFEA into the Care [Quality] Commission, which has, to put it mildly, a somewhat problematic reputation,” he says.
The strength of the present arrangement was its support from both clinicians and researchers, as well a wide range of patient interest groups, he says. “In order to maintain that as a world-class regulatory authority, you really do need to have research and clinical application linked,” says Willis.
One criticism of the 2007 proposal was that a single agency would struggle to deal with the complex issues covered by regulation. “The HTA is essentially concerned entirely with the policing of consent, important but quite trivial in a deep philosophical sense,” said Martin Bobrow, then chairman of an AMS committee on inter-species embryos. “The HFEA with its remit to look at all aspects of embryology deals with a much wider, more complex range of issues.”
The current system “has served the public, patients and licensed centres well”, according to HFEA chairwoman Lisa Jardine. “Our task now is to deliver the organisational change that the government has decided on and to ensure the continuity of the very high standard of regulation that the sector deserves and expects,” she said in a statement.
The government also plans to scrap the Health Protection Agency, whose functions include responding to pandemic outbreaks and carrying out chemical, viral and radiological research. Its role would be absorbed by the department as part of a new ‘public health service’.
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