Care Bill [HL]

Lord Patel Excerpts

Wednesday 12th June 2013 Lords Chamber

[Baroness Cumberlege]

My Lords, I strongly support the amendment tabled by the noble Baroness, Lady Emerton, and am very interested in what the noble Lord, Lord MacKenzie, said. It seems that, over the years, nursing has been the poor relation when it comes to promoting the medical profession. Both are so important, and they have to work together. If the Francis report tells us anything, it is that we need to ensure that both are of a very high quality.

I asked the Royal College of Nursing today to give me some examples of research that nurses are doing. I will not try the patience of the Committee by going through them, but it gave me three extremely good examples which undoubtedly improve the quality of patients’ experiences and recovery rates. This work is going on, but it really should be of a higher profile. It should be applauded and used. I appreciate very much what the noble Lord, Lord Hunt, said about lists, which are a trap that I remember falling into on occasions when I was a Minister. I suspect that the noble Earl will tell us that we want to have it both ways: sometimes we want things in regulations because that is more flexible and at other times we want them in the Bill. This is something of a dilemma, but if the medical profession is in the Bill, nursing certainly should be as well.

I also strongly support Amendment 60, in the name of the noble Lord, Lord Turnberg. I was very interested to read about the delays that occur through not getting together all the different organisations that are going to be involved in a single trial. According to Kidney Research UK, the time taken in one trail to receive R&D permission varied from around five weeks to 29 weeks. A study of stroke survivors took between one week and 35 weeks to receive permission from the NHS trusts involved. The time taken between submission of site-specific information and NHS approval ranged from five weeks to 50 weeks for a multi-centre trial comparing two types of emergency intervention for ruptured aortic aneurysm. This is totally unacceptable. Those who are promoting the research, and are the leaders in it, must get so frustrated when the bureaucracy will not allow them to go ahead. We need good research. It makes a huge improvement to patients’ lives, especially, of course, when it is translated to the patient in the bed, as it were. Anything that we can do to speed this up and to put pressure on to ensure that the time lags are not as long as this would be very much welcomed.

[Lord Patel]

My Lords, I rise to support Amendments 59, 60, 61 and 62, to which I have put my name. It was very clever of the noble Lord, Lord Hunt of Kings Heath, to have an amendment about the medical royal colleges lead to a discussion on value-based pricing and the cancer drugs fund. I am tempted to have that debate because it may be much more interesting; it is an issue that we should debate at some stage. In responding to the previous amendment, the noble Earl highlighted the Government’s strong backing for life sciences. When we talk about value-based pricing, we must consider how we could reimburse cell-based therapy, which is not drug therapy, at what stage in the development of cell-based therapy reimbursement should kick in and what value would be put on different stages. That would be a good debate to have.

Moving on from that, I strongly support the amendment tabled by the noble Baroness, Lady Emerton, on the inclusion of the Chief Nursing Officer. I also support her in asking why Health Education England does not have a nurse education director. If the nursing workforce is the largest health workforce in the NHS and does not have a nurse education directive, something is missing and needs to be replaced.

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Moved by

[Lord Patel]

64: After Clause 104, insert the following new Clause—
“Human Tissue and Embryo Authority
(1) There shall be a body corporate called the Human Tissue and Embryo Authority.
(2) The Authority shall consist of—
(a) a chairman and deputy chairman, and(b) such number of other members as the Secretary of State appoints.(3) The Authority shall keep proper accounts and proper records in relation to the accounts and shall prepare for each accounting year a statement of accounts.
(4) The annual statement of accounts shall comply with any direction given by the Secretary of State, with the approval of the Treasury, as to the information to be contained in the statement, the way in which the information is to be presented or the methods and principles according to which the statement is to be prepared.
(5) Not later than five months after the end of an accounting year, the Authority shall send a copy of the statement of accounts for that year to the Secretary of State and to the Comptroller and Auditor General.
(6) The Comptroller and Auditor General shall examine, certify and report on every statement of accounts received by him under subsection (5) and shall lay a copy of the statement and of his report before each House of Parliament.
(7) The Secretary of State and the Comptroller and Auditor General may inspect any records relating to the accounts.
(8) In this section “accounting year” means the period beginning with the day when the Authority is established and ending with the following 31st March, or any later period of twelve months ending with the 31st March; and Schedule 1 to this Act (which deals with the membership of the Authority, etc) shall have effect.
(9) The Authority shall prepare—
(a) a report for the period beginning with the 1st August preceding the day when the Authority is established (or if that date is a 1st August, beginning with that date) and ending with the next 31st March, and(b) a report for each succeeding period of 12 months ending with 31st March.(10) The Authority shall send each report to the Secretary of State as soon as practicable after the end of the period for which it is prepared.
(11) A report prepared under subsection (9) for any period shall deal with the activities of the Authority in the period and the activities the Authority proposes to undertake in the succeeding period of twelve months.
(12) The Secretary of State shall lay before each House of Parliament a copy of every report received by him under subsection (10).
(13) The following provisions of the Human Fertilisation and Embryology Act 1990 are repealed—
(a) sections 5 to 10, and(b) section 11(1)(a) and (aa).(14) Save for the provision in subsection (13), references in the Human Fertilisation and Embryology Act 1990 to “the Authority” shall be taken to be references to the Human Tissue and Embryo Authority.
(15) The Care Quality Commission may grant the following licences—
(a) licences under paragraph 1 of Schedule 2 to the Human Fertilisation and Embryology Act 1990 authorising activities in the course of providing treatment services,(b) licences under paragraph 1A of that Schedule authorising activities in the course of providing non-medical fertility services.(16) Sections 12, 13 and 13A of, and paragraph 4 of Schedule 2 to, the Human Fertilisation and Embryology Act 1990 have effect in the case of all licences granted under subsection (15) as they would do for licences granted under that Act.
(17) Section 13 of the Human Tissue Act 2004 is repealed.
(18) Save for the provision in subsection (17), references in the Human Tissue Act 2004 to “the Authority” shall be taken to be references to the Human Tissue and Embryo Authority.
(19) In Schedule 5 (power to modify or transfer functions) to the Public Bodies Act 2011 omit—
(a) the entry for the Human Fertilisation and Embryology Authority, and(b) the entry for the Human Tissue Authority.”

[Lord Patel]

My Lords, I rise to speak to this amendment in the name of the noble Lord, Lord Willis of Knaresborough, with some trepidation. It is not because I do not strongly support his amendment, but because I hope that I can do justice to it with the kind of passion that he would have demonstrated when presenting the argument if he had been here. However, I have no doubt that while resting in his bed, he has probably turned on BBC Parliament and is watching to see that I do the task adequately.

I think the reason why the noble Lord, Lord Willis, has demonstrated such passion is because he recognises that there is a need to reduce bureaucracy. Too many regulatory bodies mean more bureaucracy. To give an example, we have the second-highest number of competent authorities in the EU. Joint highest are Poland, Romania and Italy. However, on top of that, we have more regulatory authorities—over a dozen—than any other EU country. I see noble Lords look rather surprised, but I believe that to be true.

One issue is reducing unnecessary regulatory bodies. Another issue is reducing bureaucracy. The third issue is reducing duplication. The Human Fertilisation and Embryology Authority’s key role is to improve clinical services related to patients with fertility problems. The key reason that the authority was set up, following the birth of Louise Brown, was to reduce public anxiety about in vitro fertilisation. No such public anxiety now exists related to in vitro fertilisation.

Further functions were added to that authority in terms of embryo research. There may still be a need for that, but a reducing one. To give an example, we have enough clinical grade embryonic stem cell lines to last us a century and supply the world. I think the derivation of more embryonic stem cell lines is probably unlikely, unless there is some kind of major breakthrough. Research on embryos and embryonic stem cell lines is also now slightly superseded by induced pluripotent cells, dendritic cells and adult cells. However, I agree that there might still be a need for some embryo research and that function needs to remain.

The duplication is likely because the CQC will have a licensing role for those trusts that provide clinical services in infertility. Of course, I accept that the majority of infertility services relating to in vitro fertilisation—and I have no doubt that the noble Lord, Lord Winston, who is listening to me carefully, will correct me wherever I go wrong—are in the independent sector. Unless that service is provided for an NHS patient, the CQC does not have a role, and there must be a way of overcoming that. If we do not overcome that, the services provided within the NHS will run the risk of duplication of effort by the Human Fertilisation and Embryology Authority and the CQC.

There is also a fourth argument, and that is the reduction of cost. The noble Lord, Lord Willis, wrote a letter to the Times asking why all these regulatory authorities have a whole army of communication officers. What do they communicate? Why do they need so many? The noble Lord referred to the cost, and there are also other back office costs that are increased unless we reduce the number of regulatory authorities. His proposal is that there should be a reduction and that a body called the Human Tissue and Embryo Authority should be established rather than the HTA and the HFEA. The noble Lord lists where the changes would be required in their functions and in subsection (15) sets out the role of the Care Quality Commission to streamline all these efforts and reduce costs.

It is interesting that initially, in an attempt to reduce the number of quangos, the Government in the Health and Social Care Act decided that the HFEA and the HTA, with other quangos, would be abolished. Now, with the high profile of patient safety, we wonder whether some of the others should have been abolished. If I remember correctly, we debated the HFEA and the HTA during the passage of the Health and Social Care Bill and, in fact, we had a Division on it.

However, the Government decided to go to consultation, and I understand that Justin McCracken has been commissioned to review the operating functions of the HFEA and the HTA to see how they might deliver greater efficiencies. I think that this amendment, in the name of the noble Lord, Lord Willis of Knaresborough, would deliver those efficiencies, and I should be interested to know whether the Minister agrees that this would be a better way forward in dealing with the Human Tissue Authority and the Human Fertilisation and Embryology Authority. I beg to move.

[Lord Warner]

My Lords, I rise because I gave an assurance to the noble Lord, Lord Willis, that I would speak on this amendment as I have form, as they say, in this area.

Ten or so years ago, when one person accused me of being rather like Vlad the Impaler and we were slaughtering, as well as merging, a number of quangos, two of the candidates for merger were the Human Tissue Authority and the HFEA. Much of the argument for doing that was very similar to the argument that the noble Lord, Lord Patel, has advanced, although I did not know as much then as I know now about the number of bodies that we had compared with other countries regulating in this area. However, I assure the Committee that we had a lot more in 2003-04. Therefore, there is a case for this merger, and it has been made.

By backing away from this merger in the face of the arguments that were put forward, I ceased to be Vlad the Impaler and became Warner the Wimp. To their credit, this Government decided to have another go, but they seemed to get themselves in roughly the same position as Warner the Wimp and withdrew. Really, they withdrew because at the end of the day the savings were—certainly so far as I was concerned—not significant compared with some of the other savings that could be made. However, we have grown to appreciate more the importance of health research and the role of the life sciences in our economy, and I think that there is still a case for going the extra mile, when you can, to streamline the regulatory system in this area.

I hope that the Government will look sympathetically on this amendment, even if they do not want to accept it in its present form. I hope that some of us speaking out on this in the review will give the Government some courage to be a bit braver than they were, and than I was, in the past. Therefore, I support the spirit and the ideas behind this amendment.

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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.

[The Lord Bishop of Chester]

My Lords, having listened to these distinguished doctors taking different points of view on this subject, I fear that I might lower the tone of the debate. However, I think that my money is with the noble Lord, Lord Walton of Detchant. There is a world of difference morally between research carried out on tissue taken from a dead body and research taking place on living tissue which has the potential to be a human being in one way or another. People will argue about when life begins and those arguments can be very sensitive and very divisive. That is why there is separate legislation on research and on therapeutic techniques involving eggs fertilised outside the womb. Whether one likes it or not, if you put together the Human Tissue Authority and the HFEA you will create an impression that you are just dealing with dead matter or whatever, just a lump of cells. That is the impression that will certainly be given psychologically, even if in practice one could construct the unified authority in a way that had the two legs.

It may well be that one needs to revisit this area. The noble Lord, Lord Winston, speaks with such authority that I am very reluctant to take a different view. However, he seemed almost to be arguing for greater regulation rather than no regulation. I would be very reluctant to see a free market in implanting more than two embryos into women in this country, for example. The 14-day rule, which may be an irritant to researchers, was fought over and discussed at great length. To those of us who have quite a few reservations in this area, that is at least a line in the sand. I think that this area needs to be considered on its own merits and, notwithstanding the arguments quite rightly put by the noble Lord, Lord Patel, I am with the noble Lord, Lord Walton.

[Lord Patel]

Stem cells are not dead cells: they are immortal cell lines, such as the HeLa cells on which scientists have been doing research for decades. These cells were taken in 1951 from a woman called Henrietta Lacks—that is why they are called HeLa cells—and they are still alive. Most cancer research is done, and many drugs produced, using HeLa cells. They are immortal, living cells.

[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?

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[Lord Patel]

I thank the Minister for his comments. Of course, I feel satisfied that the matter has been fully explored. No doubt the noble Lord, Lord Willis of Knaresborough, will take note of all the comments made. I thank all the other noble Lords who took part in the debate. I say to the noble Baroness, Lady Thornton, that I look forward to the day when her party brings forward an amendment again to burn the quangos, including the HTA and the HFEA. I look forward to the Minister then being on my side and arguing the point. Until then, I beg leave to withdraw the amendment.

Amendment 64 withdrawn.