NHS: Clinical Commissioning Groups’ Funding of Treatment

Lord Walton of Detchant Excerpts

Tuesday 12th November 2013 Lords Chamber

[Lord Walton of Detchant (CB)]

My Lords, does the Minister accept that, largely as a result of new developments in molecular biology, a number of highly effective but also very expensive so-called orphan and ultra-orphan drugs are coming on stream for the treatment of patients with rare diseases? If these drugs are approved by the rare disease advisory group of NHS England and by NICE, will it then be incumbent on clinical commissioning groups to agree to their being prescribed for NHS patients?

[Earl Howe]

My Lords, the system is very clear. If NICE recommends under its technology appraisal that a drug should be made available, the funding will automatically follow.

NHS: London

Lord Walton of Detchant Excerpts

Wednesday 30th October 2013 Lords Chamber

[Earl Howe]

To answer the last point, it is clear from the IRP report that its authors believe that this is a comprehensive set of proposals which will stand the test of time in north-west London. It is a very thorough set of proposals which takes into account every aspect of healthcare provision. On maternity and paediatrics, I can tell the noble Lord that under these proposals there will be more obstetric consultants on duty 24/7 in labour wards. As he will know better than anyone, that, of course, is designed to reduce the number of complications during birth and to ensure one-to-one midwifery care for women during labour. Consultants in other specialties such as paediatrics will be on duty, as I mentioned, for 12 to 16 hours a day, seven days a week, providing much better cover than at present.

It was very striking in the IRP report that the first point made by the noble Lord, Lord Winston, did not elude the panel. The panel concluded that the pragmatic and explicit approach used by the NHS reflected the clarity of the aim to improve quality outcomes by implementing life-saving standards through the establishment of major hospitals. The report referred to the economic realities of the NHS and the urgency of making progress in the light of known risks to the sustainability of emergency services such as the abilities of staff, A&E and emergency surgery rotas, and the desire to minimise the negative impact on access of concentrating services. That was shorthand—as the noble Lord will see if he reads the rest of the report—for saying that the desirability of concentrating expertise in centres of excellence is a clear imperative for the quality of care that patients receive. As regards surgical experience, I think that if my noble friend Lord Ribeiro were here, he would confirm that that is absolutely the direction of travel, but that we must ensure that surgical expertise is built on a sufficient number of hours and cases for the quality of care to be maintained. That is exactly what underlies this whole set of proposals.

[Lord Walton of Detchant (CB)]

My Lords, since the relevant professional bodies, not least the British Medical Association, have decided that they wish to support a move towards the provision of all acute and relevant services in the NHS for a full seven-day period, it is inevitable that there will be major reconfiguration of services not just in north-west London but in many other parts of the country. This will involve the concentration of specialist services in fewer hospitals and could even result in the closure of some smaller hospitals. However, that is not immediately relevant. The point I will make is that it is good to know that the clinical commissioning groups and the local hospital trusts have all supported this proposed reconfiguration.

However, I must ask the Minister a couple of questions. First, is he satisfied that the five A&E departments into which all accident and emergency services are to be concentrated, with four others closing, have the capacity to provide facilities for all the relevant staff and to deal with the increased number of patients who will go through those five hospitals? That is point number one, which is crucial.

Secondly, is the Minister satisfied that this concentration of services, with the new 800 posts in the community to which he referred, can be carried out within the existing financial constraints? Have these changes been costed? As the Minister knows, under the so-called Nicholson challenge, the NHS is required to make substantial savings across the country over the next year or so, and it is crucial that he can reassure the House that the necessary money will be available to provide this reconfiguration, which is clearly in the best interests of patients and their communities.

[Earl Howe]

My Lords, the noble Lord raises the important question of capacity. The key point is that none of these changes will be implemented until such time as commissioners and the relevant providers are satisfied that the necessary capacity exists. That is a key point. Secondly, on the costing and the financial aspects of the proposals, the way in which we will be able to spend more money on front-line care and better-quality facilities is by spending less on duplicated facilities, underperforming services, and badly designed and out-of-date buildings, which cost a lot to maintain. Therefore, as part of this package, there will be new custom-built hospitals at Ealing and Charing Cross, costing about £80 million each, designed to deliver the specific services needed in those respective communities. That will be part of the way in which the money released will be invested for the betterment of patients in the area over future years.

NHS: Health and Social Care Act 2012

Lord Walton of Detchant Excerpts

Wednesday 9th October 2013 Lords Chamber

[Earl Howe]

My Lords, that has already happened to an extent, not least under the previous Government, who made sure that the nascent social enterprises that were formed out of transforming community services were set up on a sustainable basis. However, we have built into the 2012 Act a provision which prevents active discrimination in favour of one sector or another, so government help specifically for a particular sector is, I am afraid, not legally possible.

[Lord Walton of Detchant (CB)]

Is the noble Earl satisfied that the commissioning processes under NHS England relating to the commissioning of highly specialised services will take full account of the important necessity of concentrating these highly specialised services in a smaller number of major centres? Is he also satisfied that the interests of the Rare Disease Consortium under the Rare Diseases Advisory Group of NHS England will be fully recognised in the processes to which he is referring?

[Earl Howe]

I can give the noble Lord an absolute assurance on both those counts.

NHS: Children’s Congenital Heart Services

Lord Walton of Detchant Excerpts

Tuesday 23rd July 2013 Lords Chamber

[Earl Howe]

My Lords, the first point to emphasise to my noble friend is that the new review is the responsibility of NHS England. It is not a piece of work that Ministers are in charge of. NHS England’s advice to me is that it is too soon to describe what the exact process will be. However, I can say that NHS England is developing a process that is, in its words, “rigorous, transparent and inclusive”, particularly in the use of evidence and data. As I have said, there will be opportunities for all stakeholders to participate in the review—including, importantly, the current providers of children’s congenital heart services.

[Lord Walton of Detchant]

My Lords, can the Minister give any estimate of how long this saga is likely to smoulder on? By all national and international comparisons, the unit at the Freeman Hospital in Newcastle upon Tyne has proved to be absolutely outstanding, and awaiting the outcome of this lengthy process is delaying a number of important and significant developments. Can the Minister give us any assurance about how long this will take?

[Earl Howe]

My Lords, my right honourable friend the Secretary of State wrote to NHS England as soon as the IRP’s report was published to say that it will need to work with all interested parties to ensure that progress on its new review of congenital heart services is made as quickly as possible. NHS England’s aim is that by June 2014 it will have developed, tested and revised a proposition for the review and undertaken work to identify a preferred approach to implementation.

Medical Litigation: Impact on Medical Innovation

Lord Walton of Detchant Excerpts

Monday 15th July 2013 Lords Chamber

[Earl Howe]

There is indeed a danger that if the information that is published has not been carefully scrutinised to make sure that it is balanced and reflects faithfully the performance of the individual surgeon or the surgical team. I share the noble Lord’s concern that we should not just release information that has not been carefully examined in that sense, but there is a value, I suggest, to patients and clinicians themselves to have benchmarking metrics against which to judge performance.

[Lord Walton of Detchant]

My Lords, does the Minister agree that there is a longstanding Bolam judgment—which to the best of my knowledge is still active—to the effect that, in the management of a particular patient, a doctor is not negligent if he or she has acted in accordance with the views of a group of informed medical opinion? It does not have to be the majority medical opinion so long as the individual has acted in accordance with the views of a well recognised group of other doctors.

[Earl Howe]

I agree with the noble Lord, subject to one qualification, which was the judgment in Bolitho, which held that a doctor may be negligent even if there is a body of medical opinion in his favour.

Health: Prescription Drugs

Lord Walton of Detchant Excerpts

Thursday 11th July 2013 Lords Chamber

[Earl Howe]

My Lords, I am sure that the noble Earl will be encouraged to know that a lot of work is going on in this area. The Centre for Pharmacy Postgraduate Education, the Royal College of General Practitioners, Public Health England and others are developing information and educational materials and training on addiction to medicines for GPs and other healthcare professionals. In fact, the Royal College of General Practitioners published a consensus statement in January in which a wide range of professional organisations signed up to tackling this serious issue. I know that the Board of Science of the British Medical Association has also discussed it. I hope that the noble Earl will be encouraged that there is genuine activity in this area.

[Lord Walton of Detchant]

My Lords, many years ago when I was chairman of the General Medical Council’s education committee before I became its president, I received in the course of two months 32 letters each demanding that the special interest groups that wrote to me should have their conditions and concerns included in the undergraduate medical curriculum. Does the Minister accept that the range of medical knowledge is now so vast that basic medical education over five or six years does no more than simply enable graduates in medicine to benefit from postgraduate or vocational training having acquired skills and knowledge in principle which will help them to do that? Can he assure us that this extremely important matter raised by my noble friend now figures in postgraduate training of doctors, and not least in the mandatory vocational training programme of three years which must be undertaken by all intending general practitioners?

[Earl Howe]

I do, of course, agree with the noble Lord. I am sure that we have to be realistic about the extent to which every GP can be fully informed about this area. I can only say that it has risen in prominence in recent years, not least thanks to the efforts of the noble Earl. There is growing concern that this particular cohort of patients has been poorly served in the past and that is why the extent to which these drugs are being prescribed has diminished significantly over recent years.

NHS: Mid-Staffordshire NHS Trust

Lord Walton of Detchant Excerpts

Monday 24th June 2013 Lords Chamber

[Earl Howe]

I agree with the noble Lord’s general point that it is important to avoid oversensationalising or exaggerating a situation. I am not aware that official NHS spokesmen have been guilty of that in either of the two cases that he refers to. If there is cause for concern about any aspect of the NHS, it is surely right that that concern is made public. The important thing is for those public statements to be balanced and authoritative. That will be one major advantage of having as Chief Inspector of Hospitals a professional who is as widely respected as Professor Sir Mike Richards.

[Lord Walton of Detchant]

My Lords, is the Minister aware that, many years ago, the General Medical Council imposed on registered medical practitioners an obligation to report any serious deficiencies in practice or other serious failings which they observed on the part of medical colleagues? It was a kind of medical whistleblowers’ charter. Bearing in mind what happened not only in Staffs but in Furness hospital in Cumbria, is it not time for a similar formal obligation to be imposed on executives and managers in the NHS and in relevant bodies such as the Care Quality Commission?

[Earl Howe]

My Lords, the noble Lord raises a very current issue. As he will remember, we have introduced a contractual duty to raise concerns. We have issued guidance to NHS organisations on that subject. We have also strengthened the NHS constitution to support staff in the NHS and in social care on how to raise concerns. There is a free helpline to enable them to do that. We are considering in the context of the Care Bill the whole issue of the duty of candour. I feel sure that the noble Lord will make a valid contribution to that debate.

Health: Children's Heart Services

Lord Walton of Detchant Excerpts

Wednesday 12th June 2013 Lords Chamber

[Lord Walton of Detchant]

My Lords—

[Baroness Northover]

My Lords, I remind noble Lords that these should be brief interventions. We have only had two thus far and we are seven minutes in. I suggest we hear the Bishop, then from these Benches and we try to get around.

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[Earl Howe]

The noble Lord makes another very good point, and Recommendation 3 of the IRP report focuses on that very issue. It says:

“Before further considering options for change, the detailed work on the clinical model and associated service standards for the whole pathway of care must be completed to demonstrate the benefits for patients and how services will be delivered across each network”.

Therefore, that point has been explicitly recognised.

[Lord Walton of Detchant]

My Lords, the noble Earl has explained with his customary clarity the reasons for this further delay. However, surely he would agree that, in the ultimate, the decision that is eventually reached must be based on quality of service and quality of outcomes. This must surely be the guiding principle throughout. I fully appreciate the concerns expressed by the people surrounding the units that were originally marked for closure, but I have to express a personal avuncular interest in Freeman Hospital in Newcastle, which, according to all international comparisons, is producing results in paediatric and adult heart surgery that stand comparison with the best cardiac centres in the world. I know that this further delay is going to cause concern and further damage morale in that unit. I only hope that in the long term it does not have any effect on the efficiency of the service. Let us hope that this review is concluded as quickly as possible.

[Earl Howe]

My Lords, I pay tribute to the work done in Newcastle in this extremely complex area of surgery. The noble Lord knows that hospital better than anyone in this House, and I understand the disappointment felt in Newcastle about this decision. Nevertheless, I would slightly qualify the comment that he made at the beginning. Although I agree that the decision must depend on outcomes and the quality of care, it must also bear in mind the sustainability of the service into the future. While we can recognise good care when we see it now, we must be sure that the service is capable of being sustained on that level into the future.

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.

Health: Degenerative Brain Diseases

Lord Walton of Detchant Excerpts

Wednesday 5th June 2013 Lords Chamber

[Earl Howe]

I endorse entirely the noble Lord’s ambition in this area. It is an extremely important area of tissue donation and contributes enormously to our understanding, particularly of neurodegenerative diseases. The network of brain banks I referred to has already begun work on its donation strategy, encouraging new donors to sign up for brain donation. Its plan is to target well characterised individuals, for example those in clinical cohorts, as, once donated, the tissue has lots of associated clinical information from life, which is highly useful to researchers. I know that a lot of the major charities are involved in promoting brain donation.

[Lord Walton of Detchant]

My Lords, does the Minister recognise that, partly as a result of such donations but also as a result of major developments in genomic medicine, the individual genes responsible for a substantial number of degenerative brain diseases have now been identified; the missing or abnormal gene product has been found and, as a result, new treatments are coming on stream? Does he therefore agree that the rare disease advisory group now established under NHS England should be in a position to recommend, in collaboration with NICE, the prescription under the NHS of these so-called orphan or ultra-orphan drugs which are proving to be so effective in some of these conditions and which are now coming on stream in an increasing number?

[Earl Howe]

My Lords, we are clear that there needs to be a mechanism to assess the clinical and cost-effectiveness of new drugs, particularly those designed to treat rare and very rare conditions. NICE will indeed be the body charged with doing that. It is devising a process by which it can do so that is quite distinct from its normal technology assessment methodology. As the noble Lord will appreciate, the drugs concerned here are of a different kind and order of cost from those which NICE normally assesses. The noble Lord is quite right that that is the broad process which will be adopted.