Care Bill [HL]

Lord Walton of Detchant Excerpts

Wednesday 12th June 2013 Lords Chamber

[Lord Collins of Highbury]

My Lords, in Amendment 58A, in addition to conducting and promoting health and social care research, we are seeking to give the Health Research Authority the ability to encourage this research to be translated into innovative practice.

On Monday, in a debate on amendments to Health Education England, many noble Lords highlighted the need to place research at the centre of what the NHS does. Under the Health and Social Care Act, Labour fully supported placing duties on the Secretary of State, the National Commissioning Board and CCGs to promote research. Indeed, my noble friends Lady Thornton and Lord Hunt supported amendments to the Bill reinforcing the importance of research.

In Monday’s debate, my noble friend Lady Wheeler reminded us of the concerns and frustration at the often painfully slow, complex and bureaucratic process of getting innovation in care and treatment adopted in the NHS. I suspect that the noble Earl shares this concern as in the debate in this House last January he reminded us that it took an estimated 17 years for only 14% of new scientific discoveries to enter day-to-day clinical practice. On Monday, too, my noble friend Lord Turnberg referred to the vision for research in the NHS contained in the recent publication of the Association of Medical Research Charities. In this vision, every patient should be offered the opportunity to be involved in research; all staff should be made aware of the importance of research; and the NHS should conduct high quality research and adopt innovation in healthcare rapidly. The purpose of the amendment is to achieve a joined-up approach in reaching these objectives so that when research is commissioned these principles are absolutely borne in mind. I look forward to hearing the Minister’s response.

With regard to Clause 97 standing part of the Bill, I should like to refer the noble Earl to paragraph 8 of the first report this Session of the Delegated Powers and Regulatory Reform Committee. The committee expressed concern over the Secretary of State’s powers to amend the main functions of the Health Research Authority. If, as suggested, they were needed to meet the obligations of an EU directive, an appropriate amendment could be made by exercising powers under Section 2(2) of the European Communities Act 1972. If that is the case, perhaps the noble Earl could explain why the Secretary of State needs these extra powers.

It is a long time since I completed my British Government A-level. I recall how Henry VIII clauses can give powers to delegated legislation to amend or repeal Acts of Parliament. However, I did a little more recent research and found reference to the 1932 Committee on Ministers’ Powers. One quote from its report is particularly relevant. A member said that, whether good or bad, delegated legislation is inevitable. It is,

“a necessary evil, inevitable … But nevertheless a tendency to be watched with misgiving”.

I look forward to the noble Earl’s further explanation as to why the Department of Health believes that these powers are necessary.

[Lord Walton of Detchant]

My Lords, I rise briefly to express my strong support for Amendment 58A. I used to teach my medical students and my postgraduates by telling them that today’s discoveries in basic medical science bring about tomorrow’s practical developments in patient care. Surely this is what the amendment is about. If I were to be pedantic, I would prefer a change in the wording to:

“The HRA shall also have the function of,”

promoting

“the translation of research into innovative practice”.

That is preferable to simply “encouraging” it. Again, I am happy to support the amendment.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)]

My Lords, this amendment takes us to a subject that is dear to my heart—the translation of research—and I agree very much with the tenor of what the noble Lord, Lord Collins, had to say. The Committee will know that our vision is to improve the health and wealth of the nation through research. The Government are committed to cutting the bureaucracy involved in health and social care research. We want to speed up the initiation and delivery of research so that research findings can benefit people more quickly and improve the UK’s competitiveness in the life sciences. At the same time, research involves a degree of risk, and we need to balance a desire for expediency with appropriate safeguards to protect people who participate or who may participate in research.

Clause 97 sets out the Health Research Authority’s four main functions, which are described in more detail in Clauses 98 to 104. It also sets out the authority’s main objective in performing those functions. The Health Research Authority will have functions in four main areas. These will be, first, functions relating to the co-ordination and standardisation of practice relating to the regulation of health and social care research; secondly, functions relating to research ethics committees; thirdly, functions as a member of the UK Ethics Committee Authority; and, lastly, functions relating to approvals for the exceptional processing of confidential patient information. The Health Research Authority’s main objective in carrying out its functions will be to protect participants, potential participants and the general public by encouraging safe and ethical research, and to promote their interests by facilitating the conduct of such research. This objective has been deliberately framed in a way that ensures that the interests of participants and the public are put first.

As I have said, research sometimes involves a degree of risk, so regulation provides participants, potential participants and the public with assurance that there are appropriate safeguards in which they can be confident. The Health Research Authority will meet the first part of its objective through the regulatory functions that this Bill confers on it relating to the regulation of health research and social care research in order to protect the dignity, rights, safety and well-being of research participants. The second part of the Health Research Authority’s overarching objective is to promote the interests of participants, potential participants and the general public in health research and social care research. The Health Research Authority will promote these interests by facilitating high quality and ethical research. This includes co-operating with others to create a unified approval process for research and to promote consistent and proportionate standards for compliance and inspection. To meet its objective of protecting and promoting participants, potential participants and public interest in research, we would expect the HRA to engage patients and the public in its work. For example, Schedule 7 would give it the power to set up committees or sub-committees which may include people from outside the Health Research Authority.

I turn now to the specifics of Amendment 58A, which seeks to make encouraging the translation of research into innovative practice a function of the Health Research Authority. First, I should like to reassure the noble Lord, Lord Collins, and the Committee that we are fully committed to encouraging the translation of research into practice. The Health and Social Care Act 2012 recognises the need to promote research and the use of research evidence and has created unprecedented powers and duties at all levels to meet that need. When it was passing through your Lordships’ House, we debated the duties that the Act places on the Secretary of State. Noble Lords will remember that the Act places a duty on the Secretary of State to promote the use within the health service of evidence obtained from research when exercising his functions in relation to the health service. The 2012 Act also places equivalent duties on the NHS Commissioning Board, now known as NHS England, and clinical commissioning groups when they are exercising their functions under the 2012 Act.

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[Lord Turnberg]

My Lords, I strongly support my noble friend in Amendments 58B, 58C and 59. This clause is about taking note of the regulation and the regulation of research activities, but not of people who are engaged in research. It is important to involve those who regulate the professions—the General Medical Council, the General Dental Council, the Nursing and Midwifery Council—as well as the nurses. I agree entirely with the statement that the nurses should be included. In saying this I should also mention the pharmacists, who play an important part in research. I have been approached by those involved in pharmacy regulation to indicate that they also have an interest here.

I wish to speak particularly to Amendment 60, which is in my name, and to Amendments 61 and 62. On Amendment 60, I emphasise the important part played by the local R&D committees of NHS trusts, which the noble Lord, Lord Hunt, mentioned. We now have the Health Research Authority, which is doing a really remarkable job in speeding up the process for approval of research by bringing together the different research ethics committees and the special ethical approval for research, using data where patients are no longer able to give consent. It has developed a single portal of entry and a single application, which is having an enormously helpful effect, but there remains one major hurdle in the way of those trying to carry out multicentre clinical trials: the local R&D committees of NHS trusts. Some are good and speedy while others are slow and capricious, and the whole clinical trial is determined by the slowest and most capricious of those who have to give approval.

When the Academy of Medical Sciences reviewed research regulation, it identified the local R&D committees as the most difficult and time-consuming concerned, with delays of almost a year in too many instances, so in Amendment 60 we are trying to give the HRA the responsibility of rationalising and improving the approval processes in R&D committees. If it can get the approval of all trust R&D committees to rely on and accept a single robust assessment, covering all their various concerns, it will not only relieve them of that burden but give them the confidence that the review has been properly performed. It will also speed up the process for researchers. I hope that we can include this message in the Bill at a time when I know that the HRA itself is working hard to achieve it. The amendment is simply intended to offer it the support that it needs for its efforts.

Amendment 61, in the name of the noble Lord, Lord Willis, who unfortunately still cannot be with us, gets at the problem of ensuring that all providers of services for the NHS, including the private sector, should have the same responsibilities for research and innovation as the rest of the NHS. The HRA should have a role in ensuring that they do. It is important that their staff have opportunities to engage in research; certainly, they should be encouraged to introduce innovation into their practice.

Amendment 62 is also in the name of the noble Lord, Lord Willis. We welcome the explicit mention of the responsibilities of NHS trusts in the Bill. However, there is further need to ensure that trusts not only have regard to guidance issued by the HRA but actively comply with such guidance. I would welcome further clarification of how the requirement to have regard to such guidance will be ensured and how trusts’ compliance with such guidance might be strengthened.

[Lord Walton of Detchant]

My Lords, I was uncertain whether to speak on these amendments in the presence of two past presidents of medical royal colleges, the noble Lords, Lord Turnberg and Lord Patel. I feel unable to support Amendment 58B because the medical royal colleges are not regulatory bodies. They are essentially educational bodies. They play a role in producing and monitoring the standards of qualifying examinations for those seeking to be specialists, but they are essentially educational and do not have a regulatory role, although, of course, they play an important part in advising on a whole range of health service issues.

However, I believe it is right that Amendment 58C should be inserted, because the bodies mentioned are regulatory authorities. The General Medical Council, for instance, can play a crucial and important role in disciplining doctors who have been found guilty of fraud and misconduct in medical research. This is very relevant to the qualities and responsibilities of the HRA, and for that reason I believe it right for this amendment to be included in the Bill.

[Baroness Emerton]

I rise to speak to Amendment 59 which includes the Chief Nursing Officer in the list of those participating in the authority. I thank the noble Lord, Lord Hunt, for his words on this point. I have raised the issue of the importance of evidence-based practice and the need for us to be able to develop research within the nursing profession where, to date, it has not been at the forefront of progress. Having the Chief Nursing Officer taking part in the work of the research authority, although perhaps not in its detailed content, will assist in raising the profile of the importance of research. It may well be delegated from the CCGs to the health trusts, where we may see professors of research, which will then encourage research throughout. The nursing profession is the largest single workforce within the NHS. It is important that we promote the idea and development of research by having the Chief Nursing Officer in the list.

While on this subject, it is encouraging to see the list in the Bill. When the Health Bill was introduced, health education was not included and the membership of Health Education England was not clearly set out. Although it does not relate to research, I would like to mention the importance of having an executive nurse on the health education board, because there is an executive doctor, but not an executive nurse. Perhaps I can return to this when we come to Report.

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[Lord Walton of Detchant]

My Lords, it pains me to oppose this amendment because the noble Lords, Lord Willis, Lord Patel and Lord Winston, are people for whom I have the highest possible regard. Each in their own way has made outstanding contributions to issues relating to medicine and science in your Lordships’ House. Almost invariably, we have found ourselves singing the same tune, if perhaps sometimes in slightly different keys. Having said that, however, I am opposed to the amendment because I thought that this battle had been won two years ago. Admittedly, when this Government came into office, they embarked on what they called the “bonfire of the quangos”. A huge number of quangos were abolished, but after careful consideration and an attempt to merge these two bodies, the decision was made that they should continue to function independently.

Let me give my reasons for taking this view. When I came to this House in 1989, my baptism of fire was the Human Fertilisation and Embryology Bill that later became an Act. It was based upon the Warnock report. The function of the Bill was to create a Human Fertilisation and Embryology Authority that would license bodies and scientists working on research into the human embryo up to 14 days after fertilisation with, first, the objective of improving the treatment of infertility and, secondly, of helping in the prevention of inherited diseases. The noble Lord, Lord Winston, and others were among those who were eventually extraordinarily successful in carrying out the procedure known as pre-implantation diagnosis in order to detect embryos which were likely to cause serious human diseases. That was a very important development.

Subsequently, several other amendments were introduced—and I was deeply involved in those debates in your Lordships’ House—so that the licence could allow people to embark on research with these objectives and to address the important and crucial issue of carrying out research into the treatment of human disease. That in turn led to the development of the mechanism for creating stem cells for the treatment of human disease. There has been a series of progressive amendments that have been fully debated in your Lordships’ House. Now we are faced with the very exciting prospect, following an extensive period of consultation, whereby embryos can be created by pronuclear transfer derived from women who are likely to pass on devastating mitochondrial genetic mutations to all of their children of both sexes. The consultation is now complete and we can look with hope towards the prospect of the regulations to allow those embryos to be implanted being introduced into your Lordships’ House. This is a crucial development. I agree entirely with certain things that the noble Lord, Lord Winston, has said—the Human Fertilisation and Embryology Authority has not functioned as effectively as it might. However, his criticisms were largely concerned not with the potential merger but with the actual performance of the body as an authority.

I was also heavily involved in the debates in your Lordships’ House on the formation of the Human Tissue Authority. This body arose as a result of the so-called Alder Hey scandal where a huge number of human brains and other organs were kept in the hospital without the permission of the families. Of course, it was not recognised in many debates at the time that certain members of the medical profession held a widespread, ill-founded belief that once permission was given by a family for a post mortem examination it was proper to retain organs. That belief was partly based on the fact that to establish a diagnosis after a post mortem examination it is essential that certain organs are fixed in formalin before they can be studied and before the diagnosis can be confirmed. This is crucial. As a result of the so-called Alder Hey scandal the Human Tissue Authority was established. It has the authority to license anatomy departments to handle human organs and pathology departments to study human samples, both full organs and biopsy specimens. It has the authority to license organs being used for transplantation purposes and many similar functions. These departments in universities and hospitals are licensed by the HTA.

The function of these two bodies is entirely different and I do not believe that it is sensible—even in the attempt to create another quango which brings together two quangos—to merge them. The new body would undoubtedly have to create two sub-committees, one to look at human fertilisation and embryology and another to look at the issues of human tissue and the retention of it. I therefore do not support this amendment.

[Lord Patel]

I disagree with my noble, respected and even revered friend Lord Walton of Detchant. He fundamentally fails to understand this amendment. It does not remove the research functions of the Human Fertilisation and Embryology Authority. I have spoken strongly in the past about embryo research, including cell nuclear transfer and mitochondrial research. It is the authority that has held up for so long the progress in mitochondrial research. We should have been doing something about it at least 18 months ago. This amendment does not remove that function, nor does it remove the functions of the Human Tissue Authority, but by amalgamating these functions we can better promote research. The authority and functions of the Human Fertilisation and Embryology Authority—and now we are entering into a science debate, which is not the purpose of the Bill—stop once it gives a licence to do specific research on an embryo. Once the embryonic stem cells are created it has no authority over how those cells are used. Once the cells are used to create a tissue for research it does not have any authority, but the Human Tissue Authority may do. By amalgamating the two you are co-ordinating this research function and maybe improving it. I hope that my noble and revered friend accepts that explanation.

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[The Lord Bishop of Chester]

My Lords, as St Paul once said, I speak as a fool. However, is there not a difference between stem cells that are alive in that sense and a fertilised egg that is alive in a different sense?

[Lord Walton of Detchant]

I intended to say, but did not, that the two different bodies’ areas of authority collide when you deal with stem cells, because they are derived from embryo research but then become cells that are used for tissue research and transplantation and so on. That is where they collide. That does not necessarily mean that it is crucial to merge the two authorities.

[Lord Warner]

My Lords, at the risk of lowering the tone even further, perhaps I may just take us back and slightly challenge the noble Lord, Lord Walton, which I do not normally do. I also took the Human Tissue Act through this House. I am well seized of the circumstances that we faced then. At the time, I was bombarded by the research community with their concerns about setting up that body and whether it would be another obstacle to research. They recognised that this country had to do something in legislation in terms of the EU directive on human tissue. We were caught between a rock and a hard place. We had to do something about the EU directive; we had all the concerns about what had happened in Liverpool; but we were also conscious that we needed to ensure that we did not put another set of barriers in the way of medical research.

When we were considering the merger of the Human Tissue Authority and the HFEA we were very strongly of the view—which is very similar to what the noble Lord, Lord Patel, has said—that there was not a great deal of difference between the nature, if I may put it that way, of the matter being used for research under the aegis of those two regulatory bodies. In some cases, human tissues were themselves living cells being used for research, and we did not regard that as fundamentally a different type of matter from the one that is regulated for research purposes by the HFEA. I cannot even brag of an O-level in science—“Shame on you, Warner”, says Michael Gove. But in my lay view we had a situation where the advice we got from the scientists was that having two bodies was likely to be a greater impediment. There was a case on savings grounds—back-office services etc; the kind of issues that the noble Lord, Lord Willis, mentioned in his letter to the Times—but there was also a science argument for putting the two bodies together.