Exploring the secretary of state’s new duties towards research in the Lords last night

Posted on November 10, 2011 by

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The Lords were talking health research last night as discussion of the Health & Social Care bill reached clause 5 which details the Secretary of State’s duties towards research. Earl Howe – the health minister leading the bill through the Lords and the minister with responsibility for health research was responding. He said:

  • he will “take a closer look” at the duty on the Secretary of State “to have regard to the need to promote research and the use of research evidence and consider whether this needs to be strengthened.
  • we can expect information on the government’s information strategy including how they plan to create a safe and secure system to allow patient data to be used for research within a month
  • the National Institute of Health Research (NIHR) will retain its own budget and remain under the control of Sally Davies.
  • The government intend to publish draft clauses allowing peers to comment on the detail of their proposals for the Health Research Authority (pre-legislative scrutiny) in the second session of this Parliament, before they produce legislation.

Background

This duty on the secretary of state towards research has not existed before. It was introduced into the bill by the government following the listening exercise back in June and broadly welcomed. It says:

5. The Secretary of State’s duty as to research

After section 1C of the National Health Service Act 2006, insert—

“1D Duty as to research

15“In exercising functions in relation to the health service, the Secretary
of State must have regard to the need to promote—(a) research on matters relevant to the health service, and(b) the use in the health service of evidence obtained from
research.”

Peers had tabled a number of amendments (39, 40, 40A, 41, 41A, 42, 199ZA) to prompt the government into telling us more about how this will work, including the extent of the secretary of state’s duties (39 42), how his success in delivering this will be assessed, his responsibility to ensure high standards of quality research (41A) and to create a safe and secure system enabling the use of patient data for research (40A).

The debate

The list of peers involved in the debate is a roll call of big names in research – Lord Willis (AMRC’s chair), Lord Walton, Lord Warner (former health minister), Lord Turnberg (AMRC’s scientific adviser and chair of the APPG on medical research), Lord Ribeiro (former president of the Royal College of Surgeons), Lord Patel, Baroness Warwick, Lord Rea, Baroness Morgan (chief executive of Breast Cancer Campaign), Baroness Emerton, Lord Darzi (former health minister and active researcher), Baroness Finlay. Lord Kakkar (vice-chair of the APPG on medical research), Lord Hunt of Kings Heath.

The peers spoke a lot of the advances in research, the successful work of the Medical Research Council and the National Institute for Health Research – praising the government’s investment in them. But they pushed the government to give them some answers.

How will the duty of the secretary of state actually be carried out? What will be the extent of it? How will it be assessed and and who will assess it? How and to whom will it be reported?

As Lord Warner put it:

…we need more flesh on the bone that gives some comfort to the idea that the Secretary of State, whoever he or she is, will actually take an interest and pursue some other aspects around the duty of promote R&D.

How do we ensure the Secretary of State takes his duty to support research seriously? Amendment 39 and 199ZA explore this – both change the duty on the Secretary of State and Clinical Commissioning Groups from the rather vague “have regard to the need to promote” research and the use of research evidence to simply “promote”.

The original wording requires the secretary of state/groups to bear in mind the importance of research when exercising any of their functions and consider how the exercise of these functions might in itself promote research or how it might influence the promotion of research by others.

Earl Howe took on board this concern that “have regard to the need to promote” may not capture the importance of the secretary of state being directly responsible for promoting research saying:

I have reflected on these two amendments and I can tell noble Lords that I sympathise with the arguments behind them. Of course, I fully recognise the importance of ensuring that research is promoted within the health service. Therefore, I now give a commitment, following this debate, to undertake a closer consideration of this duty.

Earl Howe also outlined other measure being taken to build embed into the system.

  • The recent proposals for how the NHS Commissioning Board will look emphasise that it should support ” a culture which promotes research an innovation”.
  • The initial document outlining what clinical commissioning groups will look like Developing Clinical Commissioning Groups: Towards Authorisation expects them to demonstrate how they will promote research.

What will success look like for the Secretary of State? Peers pushed for information on how the secretary of state’s performance in delivering his duty will be accessed, asking what benchmarks will be used to see whether his duty has been executed successfully.

Will we continue to evaluate the contribution that NHS research makes to GDP? How will the NHS research duty play in to the research assessment exercise that is undertaken in higher education? Could that be used to show how effective partnerships work in the NHS, because it is often those partnerships between NHS trust and academic institutions which are so important? What could Monitor or the Care Quality Commission do to help us understand the contribution that research has made to improving outcomes in various settings? Will we have an impact rating for NHS foundation trusts relating to their promotion of R&D? Will we be considering the number of patients in clinical trials as a measure-that is something that many people are worried about at the moment? Should we be looking at the number of clinical fellows or clinical professors in surgery?What will success look like for the Secretary of State? I have heard talk that a research tariff is being developed; that has been referred to in correspondence. I would be grateful if the noble Earl could explain whether it is and what the consultation process might be. There has been a suggestion that a diagram or an organigram might help us here when looking at how the funding streams might work. We had a meeting with Dame Sally Davies when that was on the agenda. We have been reassured that funding will work in the same way as in the past. I am not sure whether it can, so I should be grateful if the Minister could reassure us on how that would work and perhaps produce a diagram for us.

This wasn’t directly answered in the debate.

What research will the secretary of state be responsible for? The  duty on the secretary of state to consider research covers all “research on matters relevant to the health service” This is very broad without much clarity over what it captures so peers pushed the government for a clearer definition of this, clarifying whether it includes a duty on the Secretary of State to promote research in public health (i.e. when deciding how to protect the public from pandemics or other national health threats) or whether this falls outside their responsibility. (amendment 41)

Earl Howe confirmed this does cover public health, defining “the health service”:

The duty on the Secretary of State, the board and clinical commissioning groups to have regard to the need to promote research applies to “the health service”. That phrase encompasses both the NHS and public health services, and therefore the duties already apply to public health.

There are concerns over the impact of abolishing the Health Protection Agency and establishing Public Health England will have on the agency’s staff – particularly whether staff will still be able to apply to external bodies (including charities) for funding as they are now. Lord Willis got an answer to a question about this yesterday but this did not entirely satisfy peers’ concerns over this.

Will the Secretary of State ensure staff have the relevant training and support to engage with research and new technologies? The government have committed to introducing a further duty on the secretary of state to ensure an effective system for education and training within the health service. Earl Howe confirmed that an “effective” system includes giving the NHS workforce the support they need to engage with research.

What levers will there be in the system to encourage people to engage with research? Earl Howe committed to respond further in writing but mentioned some of the initiatives underway as part of the Plan for Growth including establishing the Health Research Authority to streamline the process of doing research.

Concern over the future of the National Institute for Health Research and its research budget. This is the research arm of the Department of Health and is currently headed up by Dame Sally Davies who is also the Chief Medical Officer. It has a ringfenced budget of  around £1billion per year (actually just this week Adam Afriyie asked a question in the Commons which helpfully gives the budget for past years and the projected budget up to 2014-15).  There was concern that changes in the Bill could see the NIHR as effectively part of the NHS Commissioning Board with its budget subsumed into the broader NHS commissioning budget, not ringfenced for research. Amendment 42 requiring the Secretary of State to “ensure robust arrangements for safeguarding the funding of research” attempted to probe this and push for reassurance that the budget would remain protected. Baroness Warwick also took this opportunity to call for confirmation that there would be clear responsibility over which body should cover the treatment costs incurred for patients taking part in research funding by the government or research charity partner organisations.

Earl Howe answered these concerns confirming that the budget will remain where it is rather than being transferred to the NHS Commissioning Board. And Sally Davies will remain in charge of NIHR and its budget.

He added:

The Government have signalled their clear and strong support for research by increasing the research budget of the Department of Health in real terms over the current spending review period.

But as Lord Willis noted at the end, he didn’t confirm that it would continue to be ring-fenced.

How can we make sure it is possible to use clinical information about patients for research purposes? Amendment 40A would add another duty on the Secretary of state, to have regard to the need to promote “the use of information derived from patients for research purposes while taking full account of the confidentiality of such information”. Basically, to drive forward the development of a safe and secure system for researchers and patients which would enable the huge resource of patient data collected by the NHS to be used for research. Work is afoot in this area and has been for some time – the government recently held a consultation on the information revolution, their plans to improve the management of information across the NHS (see our response here) – but there is concern that we aren’t progressing towards a workable system very quickly. There was also mention of the new challenges faced by our data system – as we move closer to developing stratified medicines – medicines personalised to you on the basis of your genetics – researchers need more access to genetic data to get to a point where they can deliver these new treatments to patients. As Lord Darzi put it:

Having a single patient record, if we have the right informatics, the right genotype and phenotype, we can drive innovation in that very important field, which will completely transform not just healthcare but the way that we deliver healthcare in future.

Earl Howe responded mentioning the information revolution consultation. The government is in the process of developing an information strategy and we can expect something “within a month”

We are using the responses that we received to the consultation, together with the findings of the NHS Future Forum, to develop an information strategy for health and social care in England. This will highlight how increased transparency and greater access to information supports improvements in care and research. It is the major work stream. I can reassure the noble Lord that we value the use of patient information where confidentiality is appropriately protected as a source of research and that we are looking at ways to embed its use in our information strategy.

Now the Secretary of State has a duty towards research, will  that extend to ensuring it is conducted properly without fraud or poor conduct – i.e. has integrity?

Amendment 41A explored this. The Commons Science & Technology Committee recently conducted an inquiry looking at peer review. Following this, one of the recommendations they made was that:

Oversight of research integrity in the UK is in need of revision. The current situation is unsatisfactory. We are concerned that the UK does not seem to have an oversight body for research integrity that provides ‘advice and support to research employers and assurance to research funders’, across all disciplines

The government responded saying that they did not think there should be a new research integrity agency or an equivalent, but, instead, a “Research Integrity Concordat”, which brought together universities and bodies involved with research and which the Government would oversee. This amendment was pushing for the government to give more detail on how they were progressing with the concordat and ensuring this would cover research in the NHS. Earl Howe promised to write to Lord Willis after the debate with an update on progress with the concordat.

But while answering he did mention something interesting about the Health Research Authority which, as a regulator of health research, will ensure the high ethical standard of all research in the NHS. This is being established as an interim special health authority for now, with primary legislation to establish it through an act of parliament planned for the next session of parliament. There is lots of concern about what this will look like and how it will work. In the debate Earl Howe committed to publish draft clauses outlining what it will look like for pre-legislative scrutiny in the next session of parliament – basically more opportunity for it to be discussed before the government makes a final legislative proposal in the form of a new bill.  He didn’t confirm when the government would plan to introduce the final bill – from previous discussion we understood they would aim to do this in the next session of parliament but introducing a stage of pre-legislative scrutiny may slow this process down.

This evening, I am able to give a new commitment to my noble friend. I am happy to tell him that we intend to publish the draft clauses on research for pre-legislative scrutiny in the second Session of this Parliament. That scrutiny will enable my noble friend and other noble Lords to comment on the detail of our proposals for the Health Research Authority and, in turn, enable us to ensure that future legislation is fit for purpose. I hope my noble friend will welcome that pledge.

There are probing amendments tabled to find out more about the government’s plans for the Health Research Authority which should come up for debate in the next few weeks.

What next?

There are further amendments down exploring the duty on the GP Commissioning Groups and NHS commissioning board towards research – they’ll come up in the next few sessions.

And then just after clause 57 there will be discussion of the government’s plans for the Health Research Authority.

The next day scheduled for the Lords to debate the health & social care bill is Monday 14 November.