More research in the Lords yesterday – and amendments tabled for the next debate

Posted on October 13, 2011 by

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The Lords finished their first big debate of the health bill yesterday. The headlines this morning are focused on the voting down of a couple of amendments against the bill… but in the midst of the debate ahead of those, there were a few interesting mentions of research and a positive response from the minister emphasising his recognition of the need to support research.

Background

The bill’s passage through the Lords is a great opportunity for the government to make further changes to the bill or make commitments during the debates to take things forward. We’re hoping to push them to consider some of our big concerns about the impact of the bill on research, and also explore some of the opportunities this bill presents to improve the environment for research in the NHS.

In the course of the debates, we’d like more detail on how the government will take steps to:

  • Provide further detail of how the commitments to promote research and innovation will be delivered
  • Develop effective mechanisms to deliver research locally
  • Establish streamlined and robust regulation and governance of health research
  • Integrate meaningful patient and public involvement in research
  • Enable the safe and secure use of patient data for research
  • Develop the health research workforce
  • Support innovation in the NHS

Read our briefing outlining these issues here – this is the briefing we have shared with peers ahead of this debate.

Mentions of research yesterday

Baroness Finlay of Llandaff, who is a professor of palliative medicine, focused on the need for the NHS to constantly change and evolve to provide better care – including supporting and taking up research and innovations. She touched on the need to strengthen the duty to facilitate research in the bill.

The duty to facilitate research must be strengthened in the Bill. Research drives up quality of care as well as contributing a financial benefit to the UK; when money is tight we need research more than ever. Change and innovation are essential for our health services to keep abreast of improved outcomes, to promote independence and to meet patient need. Change and innovation are driven by research. That is why universities and hospitals need to integrate more, not less.

Lord Patel, who is a member of the Medical Research Council and the Academy of Medical Sciences, echoed Phil Willis’s speech yesterday, emphasising the importance of establishing the health research authority to streamline the regulation of health research in the UK and strengthening the duty on healthcare providers to support research.

Yesterday’s best advice to the noble Earl, as it was put, came from the noble Lord, Lord Willis of Knaresborough. Later I shall have another piece of best advice for today. However, the noble Lord, Lord Willis, was right to say that establishing the health research authority is crucial. I also hope that the Bill will provide stronger support for a duty on all healthcare providers to be involved in promoting clinical research. I will therefore support the amendments tabled by the noble Lord, Lord Willis.

He also touched on the importance of medical training – to produce an NHS workforce who can provide good care and do research:

My noble friend Lord Walton of Detchant expressed strongly the need for the UK to be recognised internationally for good medical training. The Bill’s proposals on the role of health education in England and of the regulator of medical education and training, the General Medical Council, cause confusion. Nothing should be done to change national training programmes. I hope that my noble friend Lord Walton will bring forward amendments that others will be able to support.

Earl Howe, the health minister who will be leading this bill through the lords who is also the department of health minister with responsibility for research and innovation, responded to some of these issues as he summed up. He indicated that the government is receptive to measures to support research:

The future of both education and training, and research, were raised by a number of speakers. The noble Lord, Lord Walton, and my noble friend Lord Willis spoke passionately about the benefits of research. The noble Baroness, Lady Masham, and my noble friend Lord Ribeiro spoke equally passionately about innovation. As Minister responsible for research and innovation, I fully share this passion and I hope that I can reassure noble Lords that we are taking all necessary steps to ensure that we act quickly on taking forward the report of the Academy of Medical Royal Colleges, including future legislation.

He mentions “future legislation” here. The government is planning a second Health & Social Care Bill in the next session of Parliament to establish the Health Research Authority in primary legislation (it is currently being set up through statutory instrument as a special health authority) and also to bring forward changes to education and training.

Such legislation will also take forward the future arrangements for education and training but I can confirm to the House that we will table a new duty for the Secretary of State with regard to education and training in time for Committee. In addition, as both issues have attracted so much interest, I will ensure that new fact sheets on both topics are produced by officials in the Department of Health and made available prior to Committee. Again, my door is open to noble Lords to discuss any or all those issues.

The new duty on the Secretary of State with regard to education and training was one of the commitments the government made back in June. in response to the listening exercise.

What next?

The next debate is commitee stage starting on Tuesday 25 October. The bill will be scrutinised clause by clause which will take some time. Amendments are now being tabled and will continue to be up until and as committee stage goes forward. You can see the amendments tabled yesterday here.

This includes one mentioned by Lord Willis on Tuesday which several other peers indicated their support for in their speeches. This proposes a new clause establishing the Health Research Authority in this bill. This is a probing amendment which when debated will push the government to give more detail about their plans for the Health Research Authority and how it will function. At the moment we know they plan to establish it but have limited detail on how much it will deliver the functions recommended by the Academy of Medical Sciences when they reviewed how to improve the regulation of health research in the UK (background on their review here).

LORD WILLIS OF KNARESBOROUGH

LORD PATEL

LORD KAKKAR

LORD WARNER

Insert the following new Clause—

“The Health Research Authority

(1) There shall be a body corporate called the Health Research Authority (referred to as “the HRA”).

(2) The Secretary of State shall make all necessary regulations to establish the HRA within 12 months of the Act receiving Royal Assent.

(3) The HRA shall manage a co-ordinated process for all aspects of the approval of health research involving human participants or their data, including—

(a) the provision of ethics committee opinions and other approvals,

(b) with the National Institute for Health Research and NHS Trusts, delivering a consistent, efficient process for obtaining permission for research carried out under the scope of the Research Governance Framework for Health and Social Care (referred to as “NHS R&D permissions”),

(c) with the Medicines and Healthcare Products Regulatory Authority, improving the regulation of clinical trials of medicinal products, and

(d) other such functions as may be specified in regulations including those currently being undertaken by organisations which will cease to function following the implementation of future legislation.

(4) The HRA shall have the following general functions—

(a) providing general oversight and guidance as it considers appropriate in relation to activities within its remit,

(b) publishing annual metrics and indicators on all research approvals within its remit,

(c) working with relevant bodies across England, Wales, Scotland and Northern Ireland to address differences in practice and legislation, and providing supporting guidance or codes of practice that apply across the UK,

(d) superintending compliance with requirements imposed by legislation relevant to its remit,

(e) monitoring developments relating to activities within its remit, and

(f) facilitating and promoting health research involving human participants or their data.

(5) The HRA must carry out its functions effectively, efficiently and economically.

(6) In carrying out its functions, the HRA must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed).

(7) The Special Health Authority known as the Health Research Agency is abolished and its functions transferred to the HRA.”

We’ll be producing more detailed briefing to support the peers in their debates soon. And the All Party Parliamentary Group on Medical Research are planning a briefing focused on research and the bill ahead of committee stage to give peers the opportunity to speak directly to researchers about their concerns ahead of the next debate.

Posted in: Policy