The details of research changes in the health bill..

Posted on June 27, 2011 by

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I snuck out of the office last week (to go on a brilliant course) and am just catching up with the health bill… and just in time as it’s heading back into committee tomorrow.

After their brief response to the future forum on 14 June which promised some very good things for research, the government published all the detail of what they plan to do on Monday. This basically reiterates the tasters we had on 14 June but with a little more detail of how it is going to be done and where it all fits together.

What does it say about health research?

The interesting bit for research comes on page 26, as in the response on the 14 confirming:

  •  Placing a duty to promote research on the Secretary of State and the new clinical commissioning groups (what before today were called “GP commissioning consortia”)
  • ensuring treatment costs for patients who are taking part in research (sometimes known as Excess Treatment Costs) are covered
  • embedding a culture of research and innovation
  • and establishing Public Health England independently from the Department of Health so it can provide independent advice on public health issues.

Research and Innovation

3.85 The forum’s report also emphasises the important role of commissioners in supporting research and innovation. We agree that research and innovation (by academia, charities, business and the NHS) are vital to the continuous improvement of quality in the NHS. The NHS should drive innovation both in healthcare and across the wider economy, and high quality research will be essential to this.

3.86 As this chapter shows, expert advice from clinicians and other professionals is a core part of the evidence on which the NHS Commissioning Board and clinical commissioning groups should base their plans. But to achieve the best outcomes for patients, the latest clinical research and innovations must also be fed into the design and provision of local services. We will therefore ensure that a culture of research and innovation is embedded in the arrangements for the new NHS Commissioning Board and Public Health England.

3.87. In particular, we will make sure that the systems and processes for commissioning used by the NHS Commissioning Boards and clinical commissioning groups ensure that research is promoted, supported and funded by the NHS. This will include the tariff, commissioning guidance and the processes for authorising and supporting development of clinical commissioning groups. We will also ensure that the systems and processes developed and used by Public Health England fully promote the conduct of research and use of research evidence.

After saying that they will ensure that a culture of research and innovation is embedded, this is a bit more detail of the mechanisms  the government will use to change the culture. Getting these right will be crucial and it good to see they say again that they will ensure that the processes developed work. But this where we’ll  need to get involved as they are developed to help make sure they do work.

3.88. The Bill requires the NHS Commissioning Board to promote innovation in the provision of health services and to take full account of the need to promote research and the use of the evidence that research provides. The Forum’s report recommends that clinical commissioning groups should be placed under the same duties, and also that commissioners fund the treatment costs of patients who are taking part in research.

3.89. We agree. Clinical commissioning groups’ legal duties should reflect their key role in making sure that, at a local level, the need for good research, innovation and a strong evidence basis for clinical decisions is paramount. We will therefore amend the bill to create a new duty for clinical commissioning to promote research and innovation and the use of research evidence, in line with the current duty on the NHS Commissioning Board. We will also make sure that clinical commissioning groups and the NHS Commissioning Board ensure that treatments costs for patients who are taking part in research funded by Government and Research Charity partner organisations are funded through normal arrangements for commissioning patient care, as set out in guidance (HSG(97)32).

3.90. As mentioned in Chapter 2, we also intend to amend the Bill to create a new duty for the Secretary of State to promote research, to reflect the important strategic role of government , together with the Department’s ongoing responsibility for research and development policy and for the National Institute of Health Research.

This is an interesting bit – placing a duty on the Secretary of State to promote research really emphasises the strategic role the government plans in research and development policy, making strategic decisions over its direction. This is really important because research is cross-cutting and doesn’t produce instant results. It requires long-term investment in the right places to get long-term benefits for patients – by understanding their conditions better and developing new treatments – so it needs a long-term, strategic approach.

The government will communicate its expectations and requirements for the NHS to the NHS commissioning board through a mandate laid out by the Secretary of State. The mandate will be set for a three-year period, with an annual review.

The revised plans for Public Health England are on page 37.

Enhancing the autonomy of public health advice

4.34. We are proposing a new approach to public health, to ensure that preventative services are given the priority they need. This will be led nationally by a new public health service, Public Health England, which will integrate and streamline existing health improvement and protection bodies and functions.

4.35. We originally proposed that Public Health England should be a core part of the Department of Health. However, there have been concerns that this could risk undermining the independence of expert advice. We have announced that we intend to establish Public Health England as an executive agency of the Department of Health, subject to completing the normal government approval processes for establishing new bodies. This will ensure that expert and scientific advice is independent, while at the same time integrating policy and action to allow a more joined-up approach to health protection and emergency planning.

4.36. We will make further announcements in the government response to the consultation on the Public Health White Paper, and we will continue to work closely with stakeholders on key issues, such as how best to ensure the continued independence of Directors of Public Health and the level of support they will need from Public Health England and other sources.

Throughout the response there is detail on how they intend to achieve this. For example, making sure that evidence and advice are sought and listened to:

3.30. We will therefore table amendments to the Bill to strengthen the existing duties on the NHS Commissioning Board and clinical commissioning groups to secure professional advice and ensure this advice is from a full range of health professionals where relevant. For example commissioners will need to work with public health experts and in line with public health guidance.

New groups called ‘local clinical senates’ hosted by the NHS Commissioning Board will be established. These will be made up of a range of professionals giving advice and expert support for the design of services  (3.21) and professional advice will be sought through these.

Using patient data for medical research

Page 24 and 25 (3.75) touches on information and the upcoming information strategy. There was a consultation on this a while back which we responded to and we’re expecting the government to respond soon. This report comes back to this in more detail on some of the tricky issues around storing and accessing patient information on page 39

Protecting the confidentiality of patient information

4.51. In response to these concerns, and to ensure patients can be completely confident and clear about how we will use their information we will therefore use our forthcoming information strategy to set out how information will be collected, used and protected to improve our understanding of disease and outcomes while ensuring that patient confidentiality is completely protected.

4.52. We also heard concerns , from the BMA in particular, that the provisions in the Bill for the Information Centre are too broad in relation to patient identifiable information. Our intention is neither to undermine the existing legal position and practice, nor give the information Centre new broad powers that appear to put patient confidentiality at risk. We will therefore consider further how to amend the Bill to protect patient confidentiality in a way that supports our plans to drive quality improvement through greater access to information; and to promote high quality research.

For research there is huge potential if we can develop a system where researchers can safely and securely access patients’ medical records for research – giving researchers access to masses of information about conditions to understand them better. The Ipsos MORI poll we recently commissioned underlined considerable public support for a system where this can happen safely, 80% of those polled would like to consider allowing a researcher confidential access to their medical records. Developing a clear framework protecting both patients and researchers and enabling the safe use of this information is vital.

And there’s a chapter on the NHS workforce (chapter 6) – training and developing the people with the skills the NHS needs which is something we’re worried about too because if research is going to happen, we need people there who have the skill to do research. The government is planning further consultation with an aim to publishing more detail in the autumn.

And on the timetable for all this change – The future forum raised concerns about the pace of change and in response, there is a revised timetable on page 60.

What now?

The changed parts of the bill are now back in committee stage in the commons – first day tomorrow (28 June) and scheduled to finish by 14 July. You can submit evidence to this committee until 14 July.

The government has tabled amendments here and here.

Once committee stage is complete, the bill will move as normal to report stage and third reading in the commons and then head to the lords to be debated.

Posted in: Policy