HEAL UoS

DH Consultation on the futures of the HFEA and HTA

In 2012, Reproduction on July 2, 2012 at 9:00 am

The Department of Health launched today a consultation on the future of two key regulators, the Human Fertilisation and Embryology Authority and the Human Tissue Authority as part of the Coalition Government’s plan to cut the number of arm’s-length bodies and reduce bureaucracy announced in Liberating the NHS: Report of the arm’s-length bodies review (2010). The Public Bodies Act 2011 provided powers to transfer the functions of the HFEA and HTAto other bodies, but not to abolish them. Substantive change to the terms of the regulatory framework would require further legislation. The consultation runs until 28 September.

The logic of streamlining is that providers of health care are subjected to overlapping licensing/registration and inspectorate regimes that might be better co-ordinated, or possibly integrated into a single scheme of regulation under the umbrella of the Care Quality Commission (as in the preferred option). One test of this will be public confidence in the CQC, which has been criticised by the Public Accounts Committee and  seems likely to receive further adverse scrutiny in the report of the Mid Staffordshire NHS Foundation Trust Public Inquiry in the Autumn.

The research approval functions in relation to embryo research may no longer need to be separated out from the wider system of research ethics committees, supported by the Health Research Authority, as under the Human Tissue Act 2004 where the HTA licenses tissue storage but specific projects are approved by RECs. The preferred option in the consultation adopts this approach.

The consultation does not address the policy making functions of the two authorities. One important historical role of the HFEA has been to develop principled approaches to difficult ethical issues raised by assisted reproductive technologies. Work under way includes a national donation strategy, chaired by Professor Sheila Maclean, and work on public consultation on the use of techniques to prevent mitochondrial disease. It is not clear where such deliberative engagement and policy work will fit into the new regulatory landscape. Parliamentarians have expressed concern over the ‘democratic deficit’ in leaving such considerations to non-elected groups but this consultation document does not set out the thinking on the best way to resolve them in the future.

Jonathan Montgomery is Chair of the Health Research Authority but the views expressed here are personal only.

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  1. […] We look forward to reading the outcome of the consultation in 2013. Previous blog posts on this area can be found here, here and (more tangentially) here. […]

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