Proposed changes to regulation of research announced today

Posted on July 26, 2010 by

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The government has published proposals today to change the Department of Health’s arm’s-length bodies. This includes changes to the research regulators to create one research regulator, combining the research functions of several arm’s-length bodies including the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) so they will cease to exist as separate bodies. The exact form these changes will take is dependent on the Academy of Medical Sciences ongoing review of the regulation of medical research and a process of consultation with stakeholders by the government. The changes will also need to be agreed by Parliament.

Key documents

The government report announcing the proposed changes to the Department of Health’s arm’s-length bodies, Liberating the NHS: Report of the arms-length bodies review.

This follows chapter 5 of the health white paper (published on 12 July) which stated that the government would set out in detail their plans to reduce bureaucracy and improve efficiency. Today’s report gives some of this detail.

The government intends to engage with stakeholders around the implementation of the changes outlined in this report. To achieve the proposed changes, they will have to be agreed by parliament.

The proposed changes are laid out on p13 and summarised in Annex A beginning on p35:

3.3 The assessment of our arm’s-length bodies means that, subject to Parliamentary approval:

• six of our arm’s-length bodies have a clear future as arm’s-length bodies, albeit operating in the most cost effective and efficient way: Monitor, the Care Quality Commission, the National Institute for Health and Clinical Excellence, the Medicines & Healthcare products Regulatory Agency, the Health and Social Care Information Centre and NHS Blood & Transplant;

• the functions of two of our arm’s-length bodies will be transferred to other organisations to achieve greater synergies where appropriate: the Human Fertilisation and Embryology Authority and the Human Tissue Authority. Further work is required to examine in greater detail the practicalities involved and we propose that they remain as independent arm’s-length bodies in the short term, with the aim that their functions will be transferred by the end of the current Parliament;

• two of our arm’s-length bodies will be abolished as statutory organisations and their functions will be transferred to the Secretary of State as part of the new Public Health Service: the Health Protection Agency and the National Treatment Agency;

• there are four of our arm’s-length bodies which we propose to abolish from the sector; the Alcohol Education Research Council, the Appointments Commission, the National Patient Safety Agency and NHS Institute for Innovation and Improvement.

• one of our arm’s-length bodies will be moved out of the sector to operate on a full-cost recovery basis: the Council for Healthcare Regulatory Excellence;

• one of our arm’s-length bodies will have its function transferred to an existing professional regulator: the General Social Care Council;

• two of our arm’s-length bodies will be subject to a commercial review by industry experts to identify potential opportunities for greater efficiency through outsourcing, divestment and contestability and/or employee ownership: NHS Litigation Authority and NHS Business Services Authority.

The proposal is to reduce these down to four regulators (p15)

3.10 So in future, we propose to have:

• one quality regulator;

• one economic regulator;

• one medicines and devices regulator; and

• one research regulator.

Page 18 gives a bit more detail on the role of the new research regulator – how it is formed is very dependent on the outcomes of the Academy of Medical Sciences ongoing review of the regulation of medical research which was begun by the previous government in March 2010.

A new research regulator

3.21 We have asked the Academy of Medical Sciences to conduct an independent review of the regulation and governance of medical research which is expected to report in autumn 2010. Currently a number of different arm’s-length bodies have responsibility for different aspects of research regulation, including giving permissions. There is a strong argument for rationalising this 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. This 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.

3.22 In the light of the Academy of Medical Sciences review, we will consider legislation affecting medical research, and the bureaucracy that flows from it, and bring forward plans for radical simplification.

Human Tissue Authority

Changes to the Human Tissue Authority will be considered in the light of the Academy of Medical Sciences review of regulation and examination of the legislative implications. As it is highly complex, the timescale for this will be quite long so the government do not intend to legislate for this in the Health Bill planned this autumn. (p19)

Human Fertilisation and Embryology Authority

Proposed changes to the Human Fertilisation and Embryology Authority are laid out on pp20-21

3.30 Notwithstanding this, there are clear synergies between some of the functions performed by the Human Fertilisation and Embryology Authority, the Human Tissue Authority and the Care Quality Commission, and there is significant read across to the potential scope of a new research regulator. There are therefore opportunities to rationalise some of the Human Fertilisation and Embryology Authority’s functions that would lead to a different organisational solution for the future. As with the Human Tissue Authority, the Human Fertilisation and Embryology Authority research licensing function is subject to the wider review by the Academy of Medical Science on research and governance regulation, due to report in the autumn. Moving this function to a new research regulator, to achieve the benefits described above, reduces the justification for the Human Embryology and Fertilisation Authority to continue as a separate regulator, and opens the way for its remaining functions relating to the regulation of fertility clinics to be transferred to the Care Quality Commission.

The future of the National Research Ethics Service will also be dependent on the outcome of the Academy’s review.

3.63 The National Research Ethics Service helps protect the interests of patients and research participants in clinical trials and facilitates and promotes ethical research. It includes recognising and authorising Research Ethics Committees, which approve individual research applications. We propose that the future of the National Research Ethics Service is considered as part of the wider Academy of Medical Science’s review of research regulation with a view to moving this function into a single research regulatory body.

And on the future of the Alcohol Education and Research Council (p23)

3.45 The Alcohol Education and Research Council was established as an Executive Non-Departmental Public Body via the Licensing (Alcohol Education and Research) Act 1981. The Alcohol Education and Research Council has charitable status and administers a fund of around £8m to support research into the prevention of alcohol-related harm. The Department does not provide funding for this arm’s-length body. Overall, the organisation does not satisfy the criteria for Department of Health arm’s-length bodies. We intend to remove this organisation from our arm’s-length bodies sector while seeking to maximise opportunities for the organisation to contribute to the development of the evidence base for effective policy across Government to reduce harm from alcohol misuse. We will engage with the Alcohol Education and Research Council on the options.

Implementation of these changes

The report states that implementation of the proposals will be completed by 2014 in line with the wider system changes.

Annex C (p43) lays out the proposed implementation timetable

Legislation will be required:

Many of the changes outlined in this document will require primary and secondary legislation. The Queen’s speech included a major Health Bill and a Public Bodies Bill for the first legislative programme. The Government will introduce these bills this autumn and the changes, where appropriate, will be enacted through one of these bills: our intention is that the majority of changes will be in place during 2012/13.

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