Folding discrete agencies such as the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) into a single regulator under the UK Department of Health would be “a step in the right direction towards streamlining the regulatory review processes and creating a more coherent and robust framework with clarity of responsibilities for research regulation and governance”, argues the BioIndustry Association (BIA).

The BIA was responding to the Cabinet Office’s formal announcement of its plans to overhaul 481 non-departmental public and other bodies, of which 192 will be scrapped altogether, have their functions absorbed into central government, be devolved to local government or be moved out of the government infrastructure.

As was flagged in a leak to the BBC last month, 30 health quangos will be affected by this process, which the government intends to implement through a Public Bodies Bill and other measures.

A total of 40 Department of Health bodies are included in the reform proposals. According to the DoH, the future of nine of these – including the HFEA and the HTA – was already determined by its Arm’s Length Body Review in July.
In general, the reforms will take effect from 2012, the Department says, adding: “Changes to previously announced Arm’s Length Bodies may take longer, but all are expected to be in place by 2013/14”.

Transfer functions

As the Cabinet Office list of proposed reforms explains, the aim is to abolish the HFEA and the HTA by the end of the current Parliament and transfer their functions “to other regulators”.

The fate of other health quangos is mixed: for example, the Human Genetics Commission would be reconstituted as a Department of Health Committee of Experts, while the Commission on Human Medicines would be retained on grounds of impartiality.

In August the Academy of Medical Sciences (AMS) launched a second call for evidence in its review of the regulation and governance of medical research in the UK, specifically to consider the possibility of bringing all aspects of medical research under a single regulatory umbrella.

This idea had been floated in the report on the future of arm’s-length bodies published under the new Conservative-Liberal coalition government by the Department of Health in July. The report noted that a number of different arm’s-length bodies in the UK had responsibility for different aspects of research regulation, including granting permissions.

There was a “strong argument” for rationalising this set-up and “creating 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”, it suggested.

Pointing out that the regulatory activities of the HFEA and the HTA were within the scope of the AMS review, the DoH said there could – subject to the outcome of the review – be  “significant advantage in consolidating these functions” into a single regulatory body.

The report further proposed that the future of the National Research Ethics Service (NRES), the umbrella body for ethics committees in the UK’s National Health Service, should be considered as part of the AMS review of research regulation, “with a view to moving this function into a single research regulatory body”.

Move to the MHRA?

The final deadline for comments on the AMS review was 14 September 2010.

The BIA’s submission, the association notes, highlighted “the important role of the Medicines and Healthcare products Regulatory Agency in the area of clinical trials in the UK and Europe and that it would be appropriate for the MHRA to take on the regulatory functions of the HTA in respect of research and the human application sector as well as the HFEA licensing function relating to stem cell research along with the role of the Steering Committee for the UK Stem Cell Bank”.

Such a move, the BIA believes, “would bring the UK in line with many EU countries, which compete with the UK to attract inward investments in life sciences”. A single, UK-wide research regulator could also benefit smaller companies by providing “a more efficient, transparent and predictable regime”, the association suggests.

At the same time, the BIA argues, ethical and scientific/regulatory reviews of medical research “should continue to be performed by separate and distinctive bodies”. The NRES - not mentioned in the DoH list of arm's-length body reforms - “is well managed and is performing an efficient independent review of research through the NHS Research Ethics Committees”, it comments.