Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Lord Walton of Detchant Excerpts

Tuesday 24th February 2015 Lords Chamber

[Lord Winston]

I am very concerned that the noble Lord, Lord Patel, might get into trouble with the Whip sitting on the Front Bench. I am always in her bad books, and I would not want to allow him to be in her bad books as well.

Let me answer the noble Lord, Lord Alton. It is true that, two years ago, I said that it was unpredictable; of course, these things are unpredictable. In the context in which I was speaking, that was correct. To be fair, however, the noble Lord, Lord Alton, knows that, with the case of Jacques Cohen in New Jersey, 17 babies were born after mitochondrial transfer. Therefore, there has been some other evidence—other than that evidence from China—that suggests that this is not quite as daft as proposed. Added to which, of course, in two years, a huge amount of research has been done by our colleagues in Newcastle. They have been working flat out on a whole range of tests which, I think, have made a very big difference. Since the statement that I made in the House, three different committees have looked at the safety.

Science does not have the truth; we have a version of the truth. We have to interpret what we can as best we can.

I deeply respect the noble Lord, Lord Alton, as he knows very well. We both come from a very strong view about what is the right thing to try to do wherever possible. However, I feel here that, apart from the issue of preserving healthy life, if we decide not to vote for the amendment of the noble Lord, Lord Deben, we are doing something really important. We are expressing our concern—our compassion—as a House for people who are faced with an invidious and horrendous choice.

Under those circumstances, given that this will be a limited procedure affecting very few people, it would be utterly wrong for this House to turn down the democratically elected Chamber and not to support what the Government propose.

[Lord Walton of Detchant (CB)]

My Lords, at the outset, I have to declare two interests. First, I am the honorary life president of Muscular Dystrophy UK, which, along with the Wellcome Trust and other organisations, has been sponsoring and funding some of this research. Secondly, I have to say that I have an avuncular interest in the department in Newcastle upon Tyne, because Professor Douglas Turnbull, who now holds the chair of neurology in that university, holds the chair which I held 32 years ago.

I say just in passing to the noble Lord, Lord Deben, to whom I listened with the greatest possible interest, that he may not remember that I was the neurologist on the Southwood working party, which advised his department on BSE and produced a report which ultimately led to the disappearance of BSE and its human form, Creutzfeldt-Jakob disease, so he does not need to lecture me about the precautionary principle.

There is one sensitive matter which I feel that I must raise at this stage. I am a lifelong member of the Methodist Church, although I at present attend an Anglican church. I know full well that from the very first day that the whole issue of human fertilisation and embryology came before this House, it was bitterly opposed by the Roman Catholic Church. I do not suggest to either the noble Lord, Lord Deben, or my noble friend Lord Alton that their adherence to and strong faith in the Roman Catholic principles has in any way influenced their attitude to the regulations; but at every stage from the first regulations to allow human fertilisation and embryology to take place, they have been bitterly opposed.

I must confess that I did discuss the whole issue of the status of the human embryo with an old friend, the late Cardinal Hume, whose father was a professor of medicine in Newcastle, Sir William Hume, who taught me briefly when I was a medical student in the early 1940s. Cardinal Hume and I discussed the whole issue, and I told him that I simply could not accept what the Roman Catholic Church has now decreed. Many, many years ago, St Thomas Aquinas said that life did not begin until the foetus was capable of independent existence outside the womb. It was a Pope in the 19th century who decreed that life began at the moment that the sperm entered the egg.

I said to Cardinal Hume that I really could not believe that a small bundle of cells carries the same status in society as a mature adult, and that that was something with which I profoundly disagreed. We discussed it and regularly went on to have a powerful exchange of views and then to decide that we could not agree, but then moved on to discuss a matter of much more mutual concern: the fortunes of Newcastle United Football Club. When, in 1980, the city of Newcastle decided to create a number of new honorary freemen to celebrate its 900th anniversary, among them were me as dean of medicine, Cardinal Hume and Jackie Milburn, the former England and Newcastle centre forward. Cardinal Hume said that it was the greatest day of his life: all his life he had been waiting to meet Jackie Milburn.

Francis Report: Update and Response

Lord Walton of Detchant Excerpts

Wednesday 11th February 2015 Lords Chamber

[Earl Howe]

My Lords, it may be that Sir Robert’s recommendations lead to legislative proposals. At the moment, we have no view on that. We want to consult broadly to seek people’s views, not least from all parties in Parliament. If I understand Sir Robert correctly, he was keen to achieve answers to these questions that do not involve legislative change and can be achieved easily, without too much bureaucracy. However, we would certainly wish to leave the door open if legislation is needed. In fact, there is one particular measure that we will endeavour to put through in the current Parliament, as long as we have cross-party support for it.

[Lord Walton of Detchant (CB)]

My Lords, I express the thanks of everyone who has worked in the National Health Service for this extremely important and compelling report. Is the Minister in a position yet to say anything about the terms of reference of those who will be the local whistleblowing guardians, what kind of qualifications they will be expected to hold and who will employ them? I take it that the national whistleblowing guardian is to be employed by the Care Quality Commission. Again, it would be helpful to know the Government’s views about the kind of individual who will be sought to fulfil that appointment.

[Earl Howe]

The noble Lord, as ever, makes a series of very important points. The personal qualities of these guardians need to be considered very carefully. At this early stage, we have made no firm proposals along those lines. As I have indicated, we think that every NHS organisation needs to identify one member of staff to whom other members of staff can speak if they have concerns, particularly if they feel that they are not being listened to. Clearly, the qualities of that local guardian need to be of a kind that inspires trust in the body of employees. As regards the national whistleblowing guardian, that will be a full-time post within the CQC. Again, it will require somebody of stature, sensitivity and trustworthiness so that the system can be seen to be robust.

NHS: Dermatology Services

Lord Walton of Detchant Excerpts

Wednesday 17th December 2014 Lords Chamber

[Earl Howe]

My Lords, the National Institute for Health Research’s clinical research network is currently recruiting patients to more than 60 studies in dermatology. Specifically, it funds a wide range of research on skin cancer. It has awarded £1 million for research on GP and patient interventions to improve early diagnosis of malignant melanoma in primary care. Another NIHR award is on understanding the experiences and support needs of patients with melanoma and their carers, and patients are being recruited to 18 melanoma studies. I will take away my noble friend’s point about administrative costs but clearly any research project carries such costs, which must be covered somehow. Unless the balance is wholly wrong, I do not think we should be worried that some funding goes towards administration.

[Lord Walton of Detchant]

My Lords, it is a truism in medicine that one of the greatest stimuli towards the recruitment of doctors into a particular specialty is the example that they respect from their teachers. Many years ago when I was dean of medicine in Newcastle, the standard of dermatological services in the area was relatively poor. The appointment of a new professor who had a stimulating effect on teaching and recruitment made an immense difference. What are the Government doing to encourage Universities UK to recruit new professors in dermatology?

[Earl Howe]

My Lords, I will have to write to the noble Lord on that issue. I know that there is not an issue in relation to the number of dermatologists serving in the health service. We believe that number to be satisfactory. But as regards the emergence of leaders in the sense that he has described, I shall have to take advice and let him know.

NHS: Five Year Forward View

Lord Walton of Detchant Excerpts

Monday 1st December 2014 Lords Chamber

[Earl Howe]

My Lords, the noble Lord makes a very good point. It is for precisely that reason that we have looked at the mechanism that we have called the Better Care Fund to bring together budgets for health and social care. It will amount in practice to a transfer of funding into social care from the NHS. We are clear that that is the best way in which we can realise the vision that we have set, which is a preventive one for people—in other words, to forestall admissions to hospital.

Local government is feeling the strain—I do not seek to deny that—but so are many other areas of our national life. Up to now, the Better Care Fund aside, we have found an extra £1.1 billion from the NHS budget to bolster local authority budgets, and we are maintaining public health allocations at the same figure as before, so no cuts there. I realise that the strains are considerable and that local authorities are having to find ingenious ways of moving forward, but I am encouraged by the Better Care Fund plans that are coming forward; they look credible and exciting in terms of the quality of care that local authorities are now looking at.

[Lord Walton of Detchant (CB)]

My Lords, it may be thought inappropriate that someone of my age should comment upon what is called a forward view but which is in fact a five-year plan. Having said that, I have listened carefully to the Statement repeated by the Minister with his characteristic lucidity and authority, and although I have heard many five-year plans discussed by Governments of all parties over the past 66 years since the NHS began, I think that there are features of this one that are quite important, not least the crucial importance of integration between medical and social care. Will the additional funding that the Minister announced be capable of introducing and maintaining a seven-day week in the NHS, in the community and in the hospitals, which has been long awaited? That is a very important point.

I welcome what the Minister said about developments in the training of healthcare professionals; that is a crucial point at this stage in NHS development. I also welcome what he said about developments in biomedicine. In what way are the Government going to be able to handle the many new orphan and ultra-orphan drugs that are now coming on stream for the treatment of rare diseases, as a result of research in the NHS, which are going to be extremely costly? Is this going to be handled by NICE or do the Government have any specific plans regarding that problem?

Health: Pneumococcal Disease

Lord Walton of Detchant Excerpts

Monday 3rd November 2014 Lords Chamber

[Earl Howe]

My noble friend is right to highlight the burden of disease caused by pneumonia in particular in the elderly. As I said in my Answer, what happened at the October meeting of the JVCI was an agreement that a pneumococcal sub-committee should be formed to fully consider the latest evidence on adult pneumococcal vaccination, including the evolving epidemiology of pneumococcal disease in the UK following the introduction of the conjugate vaccine into the childhood vaccination programme. In addition, the review will consider the latest data on the use of the conjugate vaccine in adults. This was discussed at the October meeting, the minutes of which are due to be published next week.

[Lord Walton of Detchant (CB)]

My Lords, as a young doctor, I saw many cases of pneumococcal meningitis in childhood. This disease caused about a 15% mortality, and 25% of those who recovered were left with serious disabilities such as blindness, deafness and other forms of abnormality. The disease in adults is much less devastating. Vaccination in children has been enormously successful in almost completely eradicating pneumococcal meningitis. Pneumonia in elderly adults, caused by the pneumococcus, is a very serious disease. May we express the hope that the committee will come up with very positive recommendations for a wider vaccination programme with a different group of vaccines for adults?

[Earl Howe]

My Lords, the noble Lord summarised the position extremely well. I share his hope that we will see an outcome from the sub-committee’s work in which everyone can take satisfaction. He is right that rates of pneumococcal disease in children have fallen dramatically, but it is interesting that the knock-on effect of that has been to reduce the rate in adults as well.

Children: Obesity

Lord Walton of Detchant Excerpts

Monday 20th October 2014 Lords Chamber

[Lord Walton of Detchant (CB)]

Will the Minister say what success, if any, the Government have had in persuading manufacturers to reduce sharply the sugar content of fizzy drinks? Has consideration been given to the possibility of restricting the sale of high-calorie-content drinks through vending machines?

[Earl Howe]

My Lords, our current emphasis is on overall calorie reduction, of which sugar forms an important part. The scope for reformulation to reduce sugar levels varies widely depending on the food that one considers and a reduction of sugar levels does not always mean that the overall calorie content is reduced. The issue is not black and white. An example of that is when sugar is replaced by starch or other ingredients. Nevertheless, we are discussing with the food manufacturing industry ways in which it can reformulate its food and the Scientific Advisory Committee on Nutrition is finalising its review on carbohydrates, looking at sugar as a particular component of that.

Healthcare Professions: Regulation

Lord Walton of Detchant Excerpts

Tuesday 10th June 2014 Lords Chamber

[Baroness Pitkeathley (Lab)]

My Lords, I declare an interest—

[Lord Walton of Detchant (CB)]

My Lords, I declare an interest—

[Baroness Anelay of St Johns (Con)]

My Lords, there are many with an interest but it is the turn of the Opposition.

--- Later in debate ---

[Lord Walton of Detchant]

Yet again I shall declare an interest as a past president of the GMC from 1982 to 1989. To follow up a point made by my noble friend Lord Patel, I spoke recently to the current chair of the General Medical Council, Sir Peter Rubin. He and his colleagues are very concerned about the introduction of a number of important changes in the interests of improving medical treatment and medical education, and to protect patients, which will require amendment of the Medical Act. What are the prospects of seeing any such amendments introduced in this House and debated before the next election if the Bill introduced by the Law Commission is to be long delayed?

[Earl Howe]

My Lords, I have already said that we will introduce a Section 60 order amending the powers of the GMC, as it has requested and as we agree should happen. There is a range of changes that we hope to incorporate in that Section 60 order and I hope to have further news on that quite soon.

National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) (No. 2) Regulations 2014

Lord Walton of Detchant Excerpts

Tuesday 6th May 2014 Lords Chamber

[Baroness Brinton (LD)]

My Lords, the regulations, which address an important Cinderella service in the NHS that not many know about, are extremely important. I thank the Specialised Healthcare Alliance for its briefings, which have provided an extremely helpful background. I know that the noble Lord, Lord Hunt, has provided a couple of figures, but it might be worth pointing out that there is a clear distinction between “rare” and “very rare” diseases. It sounds silly to say, but those with very rare diseases would welcome having, for the one in 17 or fewer of the population who will be affected by a “rare” disease—that is the ratio—a reasonable coverage throughout the country, although it may be in specialised areas. However, “very rare” diseases may affect fewer than 500 patients in the UK and, in the case of one or two diseases, may affect perhaps only one or two patients.

With the implementation of the new clinical commissioning groups it has obviously been important to reassess how treatments for rare diseases are commissioned. I do not have to declare an interest because I do not have a rare disease but, as someone who has to access rare biological medicines, I know that my local CCG and many others are struggling with the whole issue of prescribing expensive drugs. However, they cost pocket money when compared with the cost of medicines and treatments that we are looking for as regards rare and very rare diseases. The key is that one-size commissioning will absolutely not fit all, even within the definition of one rare disease, because it would be very unusual to find one clear clinical route. These days, the personalisation of drugs based on genes identification—80% of rare diseases have a genetic component—and the range of co-morbidities with most of these diseases mean that we absolutely must have clear and individualised treatment routes, with a much higher level of understanding of the diseases.

That is why I welcome the prescribed specialised services advisory group, which, for brevity, I shall refer to from now on as the PSSAG—I do not know what the Department of Health is calling it but we may as well add something else into the alphabet soup. It is important that the Secretary of State consults the PSSAG. The regret Motion was laid prior to the publication last week of the recommendation from that special advisory group. Inevitably, the timing is unfortunate, but life is like that. However, I believe that the publication of this report significantly reduces the concerns in the regret Motion about fragmentation and transparency. For example, the sections on membership and process on pages 7 and 8 of the report, some of which the noble Lord, Lord Hunt, referred to, make it very clear that both lay members and representatives from the royal colleges, as well as members with financial and technical expertise who can offer assistance, will come together to look at things. The noble Lord referred to what has to be reviewed but the other elements are equally important. The PSSAG must also consider how activity can be identified to enable separate contracting, monitoring and payment, which I think addresses the noble Lord’s point about what happens when things are devolved to a regional level. It also has to address the running costs associated with separate and direct commissioning, as well as consider defining elements of service to be commissioned. Therefore, I think that I am more reassured than the noble Lord, Lord Hunt.

It will be very important to monitor implementation, partly because, certainly in the early days, it will be difficult to budget for it, in part because of what I said about the personalisation of treatment routes and medication but also because, as we and the commissioners become much more familiar with the changes taking place in the treatments, particularly the gene therapy treatments, we may find that the costs of associated treatments are significantly reduced quite early on if the biologics and other superdrugs, as well as stem cell drugs, begin to work. Therefore, I would be grateful if the Minister could reassure the House about monitoring the situation once the PSSAG gets fully into its stride and commissioning starts to take place.

I have one area of concern, which is perhaps where more than one of the specialist groups that are going to be looking at treatment routes are involved in commissioning a patient’s treatment. Often two, three or possibly even four specialist groups are likely to be involved. In cystic fibrosis there would obviously be a principal neurological one but blood and kidney specialist groups might be involved as well. My fear is that we may end up, as we have done in the NHS in the past, with the position where a patient in a hospital sees lots of different consultants but does not know who has overall responsibility for holding the ring. Is there an equivalent in this sector to make sure that one group has a specific responsibility, partly so that clinicians and therefore their patients are not passed from pillar to post among these different specialist advisory groups?

[Lord Walton of Detchant (CB)]

My Lords, I am grateful to the noble Lord, Lord Hunt, for raising this crucial matter. This issue of rare diseases is of increasing importance with the developments in knowledge and in new forms of treatment that are beginning to emerge. For many years in the NHS, doctors and scientists recognised that there were a good many rare diseases, but those received comparatively little attention save for supportive treatment because no effective drugs were available that were curative or that would at least alleviate significantly the effects of such diseases.

Of course, one has to recognise that many rare diseases still exist in medicine but every single disease, even if it is incurable, can have its effects modified to some extent by pharmacological, psychological and physical means. However, that was not particularly brought to public attention until the past few years, when developments in molecular biology—not least in genetics—highlighted by the rare diseases consortium and by the Genetic Alliance UK meant that in a very large number of rare diseases the causal gene was identified, isolated and localised in the genome. In addition, drugs have begun to emerge which will alleviate or overcome the effects of the genetic defect. For those patients who have a rare disease, affecting up to several thousand individuals, these are known as orphan drugs; for those affecting a few hundred or a few dozen patients, these are known as ultra-orphan drugs, which are very expensive. The number of patients likely to benefit is relatively small so the commercial viability of these remedies is at least a matter of grave concern.

While there are important things to take on board here—we were talking about R&D and AstraZeneca a little while ago—we must recognise the fact that Britain has an outstanding record in medical research and development. As I have often said, today’s discovery in basic medical science and in applied science brings tomorrow’s practical development in patient care. People with rare diseases can be helped by these remedies that are now coming on stream much more rapidly than has been the case in the past. The important thing is this: as the noble Lord, Lord Hunt, said, before the Health and Social Care Act was passed, we had the Advisory Group for National Specialised Services which commissioned services for some people with rare diseases. When the Act was passed, we—those who debated it extensively in this House—were reassured by the knowledge that there was an agreement that highly specialised services would be commissioned by NHS England. In recent debates with the noble Earl, he has been able to reassure us that that organisation has a rare disease advisory group, advising it on the management of these conditions. He was also able to reassure us about the early availability in this field, and in others, of unlicensed drugs in specific circumstances that may be effective in the management of many conditions in medicine—not just for cancer but for rare diseases, too. That is crucial.

However, as the noble Lord, Lord Hunt, said, we are concerned that the services are somewhat fractured in the sense that I have been unable to find out with any great clarity the terms of reference of the prescribed specialised services advisory group. It is not at all transparent at the moment. As the noble Lord said, nothing has been clearly published about its membership, its modus operandi and how it will function, or to what extent it has a relationship, if any, with NICE on the new procedures that NICE is introducing for the examination of orphan and ultra-orphan drugs. We need reassurance and more information on how this group works and, in the interests of public scrutiny, how it makes an effective contribution to health service decision-making. These are matters of great importance because rare diseases, though rare, are a major blight on people in the community. However, we cannot assess human suffering in purely numerical terms. The suffering resulting from many of these rare diseases is in many ways serious and exceptional and deserves very special attention.

For that reason I was very concerned, and I hope that I have misinterpreted the remarks of the director of NHS England, Mr Simon Stevens, in his report to the Commons Health Select Committee. He said that he thought there was a need for the scope of specialised services to be reviewed because he thought that they had been overextended. This is a phase in medicine in the UK when that would cause great concern to patients and their families and to many doctors who are concerned about the treatment of these diseases.

Health: Folic Acid Fortification

Lord Walton of Detchant Excerpts

Wednesday 2nd April 2014 Lords Chamber

[Earl Howe]

My Lords, there are risks associated with the fortification of flour with folic acid. That was pointed out by the scientific committee and was why its recommendation was conditional on certain things taking place. As it pointed out, there is a potential for significant numbers of the population to be pushed above the guideline upper limit for folic acid. We have to take those issues seriously in reaching a balanced decision.

[Lord Walton of Detchant (CB)]

My Lords, does the Minister agree that it is time for this important public health development and this important contribution to preventive medicine to be enacted, as it has been in many other countries? I am aware that there are likely to be those who object to this addition to flour. Surely it would be possible to meet those objections of a minority if a limited amount of bread free of folic acid were to be marketed to meet that concern.

[Earl Howe]

My Lords, I note the noble Lord’s helpful suggestion but it is important that the Government take a decision on folic acid that is right for our own population, rather than anyone else’s. It is worth remembering that no other country in the European Union has taken the decision to fortify flour with folic acid. We need to do this by evaluating the risks and the benefits, as I said, based on the most up-to-date data we can get.

Health: Innovative Medicine

Lord Walton of Detchant Excerpts

Tuesday 1st April 2014 Lords Chamber

[Lord Walton of Detchant (CB)]

My Lords, in thanking the noble Baroness, Lady Thomas, for initiating this debate, I declare an interest as the honorary life president of the Muscular Dystrophy Campaign. I hold similar appointments with many other medical charities.

This is a very important issue. I have given support over the past few years to the Rare Diseases Research Consortium and Genetic Alliance UK, chaired by Alastair Kent. Many of the 300-plus rare diseases that have been carefully characterised and identified by those organisations affect the neurological, neuromuscular and other, similar systems. Some are fatal but virtually all cause increasing disability of various kinds. Advances in molecular genetics over the past few years have been immensely exciting. In many of these diseases—in fact, the majority are genetically determined—the causal gene has been identified and, often, located.

The missing gene product has also been identified, as in, for example, dystrophin, normally a constituent of the muscle fibre membrane missing in Duchenne muscular dystrophy. Similarly, in Pompe disease, a condition causing severe muscle paralysis and affecting the heart, acid maltase has been identified as the missing substance. However, in many other neurological disorders, including the various cerebellar ataxias, the condition has been found to be due to multiple amino acid triplet repeats that actually, instead of being absent and therefore not causing absent metabolic activity, damage the human cells.

Treatments have begun to emerge in diseases such as cystic fibrosis, and acid maltase can be effectively treated by gene therapy in Pompe disease. As the noble Baroness, Lady Thomas, said, haemolytic uraemic syndrome, which affects only a few dozen people in the UK and is inherited, is effectively treated with a drug called eculizamab, which is highly effective. It is a life-saving treatment; without it, the disease moves to a fatal conclusion.

Many more such drugs are being developed, and in Duchenne muscular dystrophy drugs have been identified and used for the technique called exon skipping, which appears to work only in specific mutations and by no means in all. But Dame Kay Davies and her colleagues in Oxford are working on a mechanism of utrophin uptake regulation, persuading utrophin to move along the muscle fibre membrane to replace the missing dystrophin. These drugs are being trialled in excellent treatment trials in London, Oxford and Newcastle, funded by the Medical Research Council, the Muscular Dystrophy Campaign and other organisations.

So what is the problem? The problem is that more and more such drugs are coming on stream but, because the number of patients affected by these rare diseases is comparatively small, the drugs are not likely to be commercially successful. The industry has been extremely helpful in making them available for trials, but this cannot go on indefinitely. The drugs that are likely to treat rare diseases affecting 100-plus people are called ultra-orphan drugs, whereas those affecting 1,000-plus people are called orphan drugs, and it is clear that they are going to present an increasing problem over the coming years.

The problem is that the cost-benefit analysis that has usually been employed by NICE in assessing the value of these drugs is not likely to be helpful or even appropriate in assessing their value in the case of rare diseases. However, we await the outcome of NICE’s consultation on what it calls value-based medicines, and we hope that this will be positive in relation to these drugs. The government initiative of creating a rare diseases advisory group answerable to NHS England has been helpful but, most particularly, the early access scheme, to which other speakers referred, is most welcome as being a very exciting development for the future.

As time goes by, though, in my opinion those initiatives are not in themselves going to be enough. As my noble friend Lady Masham said, we miss the advisory group on national specialist services, AGNSS for short, which had ring-fenced funding. At the end of the day, it is more than likely that ring-fenced funding will be needed for the management and treatment of these conditions with orphan and ultra-orphan drugs. I hope that the Government will agree that in their new structure a neuromuscular clinical reference group should be established for this purpose.

Human suffering is not something that can be measured in numerical terms. The needs of these patients and their families are paramount. Somehow or other, this problem is one with which this and future Governments are going to have to come to terms.