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Health and Social Care Regulatory Bodies

14th May 2007

As part of a wider Whitehall drive to reduce the administrative burden of regulation and inspection, the Department of Health has been reviewing its own arrangements and is currently consulting on plans to streamline the regulation of health and social care. Here we look at where the review has got to, and when changes are likely to happen.

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What are the existing regulatory bodies?

The Department of Health works with, and financially sponsors, a large number of ‘arms length bodies’ (ALBs) which are concerned with patient safety and wellbeing. In 2003/04 there were 38 ALBs, employing 25,000 staff between them, and costing £4.8bn to run. ALBs generally fall into the following categories:

• Regulation – of patient services, professionals and medicines eg Healthcare Commission, Medicine and Healthcare Products Regulatory Agency (MHRA)

• Standard setting – eg National Institute for Health and Clinical Excellence (NICE)

• Protecting public welfare – eg National Patient Safety Agency, Health Protection Agency, Public Health Laboratory Service

• Central services – which achieve economies of scale by providing some functions on a national level eg Blood and transplantation Authority, NHS Litigation Authority, NHS Direct

Before the Departmental Review began, the ALBs involved in regulation were the following:

Figure 1 : Regulatory bodies prior to DH review

Regulation of providers and services

Healthcare Commission

Commission for Social Care Inspection

Mental Health Act Commission

Monitor

Human Fertilisation and Embryology Authority (HFEA)

Human Tissues Authority (HTA)

Regulation of professionals

Council for Healthcare Regulatory Excellence (CHRE - previously Council for the Regulation of Healthcare Professionals)

General Social Care Council

Postgraduate Medical Education and Training Board

Dental Vocational Training Authority

Regulation of Medicines

Medicines and Healthcare Products Regulatory Authority

Why the need to change?

In March 2005, two reports were made to the Treasury (the Hampton Report) and the Prime Ministers office (Better Regulation Taskforce) advising the need to rationalise regulation and inspection across government to reduce the financial burden on the private sector. ‘Regulation – Less is More’ from the Better Regulation Taskforce endorsed the Dutch approach where specific targets to cut administrative costs were set. So began a programme to reduce bureaucracy and cut administrative costs across Whitehall. The Department of Health’s target was set to reduce the £1.2bn regulatory burden on the private sector by 25% (£300m) by March 2010. A further £800m should come from reducing the burden on the public sector.

So what is being proposed?

The Department of Health published the Simplification Plan in December 2006 summarising its intentions to streamline administration and achieve the savings. It plans to reduce the number of ALBs from 38 to just 19, saving a projected £500m by 2007/08 and reducing the head count in these organisations by 25%. By the time the Plan was published, 12 ALBs had already been cut, including NHS Estates and the Retained Organs Commission.

A number of the ALBs directly involved in regulation and inspection joined forces voluntarily in 2006 to agree the Healthcare Inspection Concordat, aimed at better coordinating their various inspection activities across health and social care. But the Department plans to take this one step further. It has identified its seven most ‘burdensome’ regulations, and found that four of them were to do with social care (eg inspection of Care Homes and Domiciliary Care). It is now out to consultation on fundamental changes to the regulation of health and social care which would see the Healthcare Commission merged with the Commission for Social Care Inspection, and the Mental Health Act Commission in 2008 to create a single regulator making sure patients are protected wherever they are in the system. It has, however, stopped short at including Monitor in the merger, and proposes to leave it to regulate NHS Foundation Trusts, taking advice from the Healthcare Commission (or new single regulator) where national care standards are not being met. The new single regulator may therefore end up registering the Foundation Trust as a healthcare provider and inspect it’s compliance with care standards, but the Trust will be authorised and performance monitored by Monitor. And Monitor has been unsuccessful in its bid to become the overall economic regulator for the health service, with SHAs still keeping the watching brief on NHS Trusts’ financial performance.

As well as streamlining the number of regulatory ALBs, savings will be made by them adopting an inspection model more akin to that developed by the Healthcare Commission. This risk-based approach makes heavy use of self assessment, with site inspections being the exception rather than the norm. The Department wants the regulatory bodies to refocus on their roles in licensing/registration, monitoring and enforcing licences, refereeing disputes and adherence to competition rules, and publishing information for the public on the performance of NHS bodies (Monitor providing a good example of this). Price setting under Payment by Results and resource allocation are set to remain part of the Department of Health remit and will not be handed over to any independent regulator, according to the consultation document.

The consolidation of the health and social care regulatory bodies and the new approach to inspection is projected to lead to savings of around £28m alone. The consultation on the proposed changes closed at the end of February, and a summary of responses and action is awaited.

In other areas of regulation, the Department plans to:

• Improve administrative processes to make it quicker to get medicines to market, with the MHRA moving to a more risk-based approach of regulation, saving an estimated £104.4m to the pharmaceutical industry.

• Merge the HFEA and HTA to form the Regulatory Authority for Tissue and Embryos in 2008/09.

• Review non-medical professional regulation. The Council for the Healthcare Regulatory Excellence (CHRE) has already been established as a result of the Bristol Royal Infirmary inquiry, which stressed the need for an overarching organisation to standardise the work of various professional regulatory bodies. The CRHE enforces consistent standards of practice across the nine professional bodies, including the General Medical Council, and Nursing and Midwifery Council. It has already dissolved the Dental Vocational Training Authority.

Latest news

  • A delay in the merger of the Healthcare Commission with other regulatory bodies means that it will have its budget for 2008/09 effectively cut by 17%. It will have to go into next year sharing with the other remaining bodies the single available funding pot which was set aside for the new single regulator in anticipation of it being established and savings from parent organisations being made by then. The Healthcare Commission has said it will continue to focus on the annual healthcheck as its main priority, and will likely have to cut back on the more detailed service review programme it undertakes.

For more information on changes to regulatory bodies, go to:

http://www.dh.gov.uk/PolicyAndGuidance/...chk=zCHWe5
http://www.dh.gov.uk/assetRoot/04/14/11/86/04141186.pdf
http://www.dh.gov.uk/AboutUs/DeliveringHealth...
http://www.concordat.org.uk

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