UK plans to abolish several health regulatory agencies
This article was originally published in RAJ Devices
The UK government plans to cut the number of health-related agency bodies from 18 to between just eight and ten, as part of an exercise to streamline the organisations and deliver savings of over £180m (US$279 million) by 2014-151,2.
Its move follows the publication of a Department of Health review that proposes scrapping or merging several health-related arm's-length bodies (ALBs). The review does not propose changing the status of the Medicines and Healthcare products Regulatory Agency, but says the agency would be expected to "undertake its regulatory duties in the most cost-effective way". Among the ALBs likely to be affected are the Human Tissue Authority, the Human Fertilisation and Embryology Authority, the National Patient Safety Agency and the NHS Institute for Innovation and Improvement.
MHRA retained; HTA, HFEA to transfer functions
The DoH review assessed whether the work of the 18 ALBs remains essential nationally and whether work is being duplicated or could be carried out by a different body.
Upon reviewing the MHRA's functions, it found that the agency satisfies the government's test for ALBs to remain in the sector. As the MHRA is largely self-funding through the fees it charges, the review did not result in any proposals to change the MHRA's status or to transfer its functions to another body.
The report, however, raises the question of whether the MHRA can take up some of the functions of the HTA in respect of licensing establishments working with tissues and cells for human application. The HTA regulates the removal, storage and use of human tissues and organs.
The review recommends that the HTA be retained as a separate ALB for the time being, "with the aim of transferring its functions by the end of the current Parliament". A similar recommendation has been issued with respect to the HFEA, which regulates human embryo storage, research and assisted reproduction treatment. In the meantime, the government will examine the practicalities and legal implications of how to divide the HTA's and HFEA's functions.
The review also recommends abolishing the National Patient Safety Agency, which promotes patient safety and manages the National Clinical Assessment Service and the National Research Ethics Service. In addition, it proposes that the NHS Institute for Innovation and Improvement (which supports the National Health Service by spreading new ways of working, new technology and leadership), be removed from the ALB sector.
As for the National Institute for Health and Clinical Excellence, the country's health technology assessment body, the review recommends that it be retained. It says that NICE should be put on a firmer statutory footing through new provisions in a Health Bill that was proposed earlier this year and that would secure NICE's independence and core functions, and extend its remit to social care.
New research regulator soon?
The DoH review refers to future plans by the government to carry out major changes to medical research regulation and governance. In March, the government asked the Academy of Medical Sciences to conduct an independent review on this matter and a report is expected later this year3.
Currently, a number of ALBs are responsible for different aspects of research regulation, including giving permissions. The report puts forth a strong argument for rationalising this and creating greater strategic coherence by placing responsibility for these different aspects of medical research regulation within one ALB that would perform a stand-alone technical function as a research regulator.
This, it says, would streamline the process of gaining permission to undertake medical research, making it more attractive to universities and health institutions. Moreover, there is potential for a single research regulator to have wider cross-government reach.
In light of the academy's review, the government will "consider legislation affecting medical research, and the bureaucracy that flows from it, and bring forward plans for radical simplification", the review said.
Next steps
As for the next steps, subject to parliamentary approval, organisations that are no longer needed will be removed from the sector, with essential work moved to other bodies. Many of the changes outlined will require primary and secondary legislation.
The Queen's May 2010 speech included the Health Bill4 and a Public Bodies Bill for the government's first legislative programme. The government will introduce these bills later this year and changes to the ALBs, where appropriate, will be enacted through one of these bills. Most of the changes are expected to be in place during 2012-13.
The government believes that over the years, the health ALB sector has grown to a point where overlap between organisations and duplication of effort have produced a needless "bureaucratic web". Through the new proposed measures, the government says it has acted decisively to ensure that the ALB sector remains fit for purpose, is affordable, promotes greater value for money and is more efficient.
References
1. DoH press release, 26 July 2010, www.dh.gov.uk/en/MediaCentre/Pressreleases/DH_117844
2. DoH Liberating the NHS: Report of the arm’s-length bodies review, 26 July 2010,
3. Academy of Medical Sciences, Project Details: Review of the regulation and governance of medical research, Site accessed 27 July 2010, www.acmedsci.ac.uk/p47prid80.html
4. Queen's Speech – Health Bill, 25 May 2010, www.number10.gov.uk/queens-speech/2010/05/queens-speech-health-bill-50617