NHS changes; what does it mean for medical research and regulation?

Posted on December 15, 2010 by

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The Department of Health have published a report today outlining more detail of how they propose to change the NHS over the next four years and how they plan to go about it. This includes some more about changes which will be important for medical research, including where it fits in the NHS and how it is regulated. It looks like changes to the regulation of research may be made separately, rather than included in the big health bill planned for the new year.

Background

Back in July the government published a health white paper called Equity and Excellence: Liberating the NHS outlining its plans for the NHS over the next five years (check out this briefing summarising it here). They followed this up with a series of consultations asking people to feed back their views on the proposals. Further details of their plans for public health were published on 30 November – more details here – and they are also asking for views on that.

Published today is the government’s response to all the comments and feedback they got from their consultations, Liberating the NHS: Legislative framework and next steps.

A few consultations are ongoing – particularly one on the information revolution which is particularly of interest to medical research as it looks at patient data – safe, secure and ethical access to which is very important for medical research. Government will respond separately to these in future.

What does it say?

It summarises the themes that came out of the consultation process and all our feedback on the white paper and sets out what the government is planning to do; they have made some revisions in the light of the feedback they got, but:

The consultation process has strengthened both the Government’s belief that these reforms are necessary and our resolve to follow them through. The following chapters, which are based on the structure of the White Paper, set out the next level of detail on how we have decided to put our proposals into practice. (page 16)

It also explains how the government are planning to legislate for and implement these reforms. There is a nice timeline on page 172 laying out the planned transition over the next four years.

Any bits interesting to medical research?

In the section focused on improving healthcare outcomes (chapter 3), the report looks specifically at research (page 46 of the pdf) and restates the government commitment to research as a core function of the NHS

3.46 Supporting and promoting research and development will be a core function of the future Department of Health, and the Government remains committed to providing the right environment for innovation to flourish. The increased funding for health research announced in the recent Spending Review gives us a strong platform to fulfil this ambition.

It goes on to discuss the regulation of research and the need to streamline this to make it easier to do medical research in the UK. It refers to the Academy of Medical Sciences ongoing review of the regulation and governance of medical research in the UK which is due to publish early in the new year. The government already indicated in their review of arms-length bodies published in July that they plan to reorganise the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) to become part of a single research regulator but we are still waiting for further details on how this will look.

Alongside support for the streamlining of regulation which can make it difficult to fund research in the UK, there are lots of concerns among the research community about the impact changes to these regulators may have as they have responsibility for ethically sensitive areas of research and have within them a considerable amount of expertise, ethical review and engage with the public. Check out Bionews for a series of editorials with different experts thoughts on proposed changes to the HFEA.

The government restates here that the result of the Academy’s review of regulation will underpin their plans so we can expect more details on how these changes will be made once the review has reported:

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

Interestingly, in chapter 7 government says these changes and the creation of a new research regulator will not be part of the Health and Social Bill in the new year so we may have a little longer to wait for the details:

7.18 The Bill and related secondary legislation will also rationalise public bodies, including, among others, the abolition of the Appointments Commission and the Office of the Health Professions Adjudicator, the removal from the sector and the change in functions of the Council for Healthcare Regulatory Excellence, abolition following removal from the sector of the Alcohol Education and Research Council and the transfer of functions and abolition of the National Information Governance Board, NHS Institute for Innovation and Improvement, the National Patient Safety Agency and the General Social Care Council. It will deal with changes to the functions of the Care Quality Commission, and the establishment in primary legislation of the two bodies being reestablished,NICE and the Information Centre. The changes to the Human Fertilisation and Embryology Authority and the Human Tissue Authority including the proposed creation of a new research regulator will be dealt with elsewhere, through separate means.

The changes to the National Information Governance Board are also of interest for medical research as they are involved in the regulation of patient data being used for research.

Also on research, in Chapter 4 focused on commissioning, government restates that the new Health Bill will put a duty on the NHS Commissioning Board to promote involvement in research and the use of research evidence.

4.58Another key theme was the importance of demonstrating that the NHS Commissioning Board is responsive to the needs of consortia and ensuring that it holds the confidence of healthcare professionals. It will need to be able to demonstrate good clinical evidence in support of its decisions, maintain effective relationships with the Royal Colleges and other professional bodies, and have strong internal professional leadership. The Bill will put duties on the Board to obtain professional advice in the exercise of its functions (which it could discharge, for example, through employing or otherwise securing the services of national clinical experts) and to promote involvement in research and the use of research evidence.

The National Institute for Health Research has a nice summary of the researchy bits.

What now?

We’re expecting the government to publish a health & social care bill in the new year which will start putting some of these proposals into action.

We’re waiting for the Academy’s review of the regulation and governance of medical research in the UK to report early in the new year and following that to hear from the government how they plan to act on its findings. This is when we should start to find out more about how the proposed new research regulator may look.

Check out Simon Denegri, AMRC Chief Execs’, reflections on what this all means on his blog here.

Posted in: Policy