Medicines and Medical Devices Bill

Lord McColl of Dulwich Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord McColl of Dulwich (Con) [V]]

My Lords, I congratulate my noble friend Lady Cumberlege and her committee on producing such a thorough and important report.

I draw attention to a practice that many of us clinicians used for years. It detected clinical problems in treatment, equipment and management early on. We had weekly meetings for an hour or so to discuss any complications that had occurred in the previous week. It was attended by consultants, junior staff, medical students, nurses and a manager or two. It was always an interesting and very instructive meeting, and it brought problems to light early on. People were very honest about their mistakes; it became rather like the general confession. Of course, it was essential to have as a chairman of these meetings somebody who was friendly and encouraged people to adopt the attitude of “There but for the grace of God go I”. It was a very inexpensive and successful kind of quality assurance.

I have a few questions to put to the Minister. First, do the Government plan to mandate the tracking of all medical devices used in the UK and not just those selected at random? Secondly, will the use of medical device registries be extended to patient outcomes? Thirdly, will the Government go ahead and establish the post of a patient safety commissioner, as strongly recommended by my noble friend Lady Cumberlege and many of your Lordships? Some years ago, I used to carry out transplant operations and became very familiar with the problems involved.

I emphasise that in Committee I shall fully support the amendments in the names of the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff, dealing with forced organ harvesting. As mentioned before, Sir Geoffrey Nice QC stated in his report that forced organ harvesting has been committed for years throughout China. [Inaudible.]

[Baroness Penn (Con)]

I am afraid that we can no longer hear my noble friend. If he would make his concluding point, that would be wonderful.

[Lord McColl of Dulwich (Con) [V]]

Perhaps those who spend so much time attacking the Government about this and that might like to turn their attacks on the Chinese Government, whose morally corrupt behaviour demonstrates to the world what is going on in China.

Finally, I again congratulate my noble friend on her outstanding report.

Covid-19: Response

Lord McColl of Dulwich Excerpts

Monday 27th July 2020 Lords Chamber

[Lord Bethell [V]]

My Lords, the obesity package that the Prime Minister announced today is one of the most ambitious, impactful and thoughtful of any Government in recent history. We will see how it plays out and consider new measures when the time is right.

[Lord McColl of Dulwich (Con) [V]]

Covid-19 and obesity are so often a fatal combination, and it explains the high mortality in the UK, with its dense population and the fact that two-thirds of people are either overweight or obese. Is it not therefore time for those strangers to the truth in the media and in politics to stop demoralising the public with their repeated false news, including blaming the Government for the high death rate? Should we not expect the media and politicians to use their power to support the country and the Prime Minister’s campaign to reduce obesity and its complications, in order to minimise the number of deaths from the next pandemic?

[Lord Bethell [V]]

My Lords, it is not the feeling in the Government that we should duck hard questions about performance, and we embrace those who ask difficult questions about how things have gone. None the less, the noble Lord is entirely right that the country has a difficult challenge that it needs to face up to: that of obesity. It has had a profound effect on the health of the nation for a generation and we have been caught out by Covid, as obesity has undoubtedly had an impact on our total death rate. It is a point that the Prime Minister made powerfully in his video earlier today. That is why we have put together the package that we have, and we look to all civic leaders and the media to support us.

Independent Medicines and Medical Devices Safety Review

Lord McColl of Dulwich Excerpts

Wednesday 15th July 2020 Lords Chamber

[Lord McColl of Dulwich (Con) [V]]

My Lords, I first thank the noble Baroness, Lady Cumberlege, for such a wonderful and constructive report, and all the members of the committee, especially Professor Sir Cyril Chantler, whom I have known for many years.

I have just two questions. Will the report encourage clinicians to consult the appropriate royal college before designing a new treatment? Secondly, after introducing a new treatment or a new operation, should the clinician be encouraged to wait for an appropriate interval to ensure that no complications occur?

[Lord Bethell]

I thank the noble Lord for his searching questions. The role of the MHRA on both medical devices and medicines has been massively upgraded, and the review process for new medical devices has been improved. However, medical devices have different criteria from medicines.

One of the most important things that we have sought to do is to include a registry of the medical devices themselves and a registry of the medical devices inserted into individuals. Compliance with both procedures are the most important steps for clinicians embarking on new products.

Medical Teaching and Learning: Ethnic Diversity

Lord McColl of Dulwich Excerpts

Tuesday 14th July 2020 Lords Chamber

[Lord Bethell]

The noble Baroness is right; the representation of BAME communities at the higher echelons of the medical establishment is not good enough. In too many areas, the representation is not fair and does not reflect the much higher proportion of BME workers at other levels of the health service. We are working hard on a variety of agendas: the People Plan, which I have already mentioned, and the NHS workforce race equality standard. These measures are taken seriously and we are working hard to change the balance of representation.

[Lord McColl of Dulwich (Con) [V]]

Does the Minister agree that, in considering this important subject, there is certainly no room for complacency? However, we do need to know accurately the extent of the problem. Certainly, in all my years in medicine, I have always had this subject very much in mind in selecting and teaching students, selecting doctors and management generally.

Incidentally, I have been very close to members of ethnic minorities who have done much better in life than I have: fellows of the Royal Society, members of the Order of Merit, knights of the Order of the Thistle, presidents of royal colleges and even one who became a king.

[Lord Bethell]

My Lords, I completely agree with the noble Lord, Lord McColl, that complacency is our enemy. I recommend to him the NHS workforce race equality standard publication, which is very detailed in its analysis of the problem and is a guide to the challenge we face and a measure of how far we have come. I completely commend the achievements of those in the BAME community who often far outperform those of us who were born in Britain.

Covid-19

Lord McColl of Dulwich Excerpts

Wednesday 8th July 2020 Lords Chamber

[Lord Bethell]

On PPE, I pay tribute to my noble friend Lord Deighton, who has performed an amazing task in providing an enormous supply of PPE. There is sufficient PPE in the NHS, social care and other parts of the healthcare system for all those who need it. There is a PPE hotline for those who would like to order it directly and, at this stage, stockpiles are being created to get us through the winter months. On tests, a testing portal is available to all of social care. It can be accessed either by social care employers or, if employees or residents want a test, they can order one themselves through the public testing portal. It is my understanding that posted tests are no longer counted in the same way: they are counted not on dispatch but when they are processed. The “test and trace” programme initiated this change in the recent change of data, which I think was 10 days ago.

[Lord McColl of Dulwich (Con) [V]]

My Lords, last week I understated the figures on the deadly combination of Covid-19 and obesity. House of Commons Library figures show that 72% of UK people are either obese or overweight. What is even more tragic, 33% of 10 year- old children are overweight or obese. These appalling figures may help explain the high mortality from the coronavirus in the United Kingdom, so will the Minister endorse the urgent need to persuade people to lose weight? To save lives, we should follow the advice of the Prime Minister himself, who said, “Don’t be a fatty in your fifties”.

[Lord Bethell]

I think my noble friend and I need to have a chat about statistics, because the statistics I have differ from his. Mine suggest that 28% of the public are either obese or overweight, and it does defy common sense that 72% the public are obese or overweight. Maybe he and I can have a chat about that offline: I would be glad to clear it up. However, my noble friend makes a really important point that I and the Government completely endorse: the Covid epidemic has been a wake-up call for the country—in that, he is right. There is an urgent need to address the obesity epidemic and the Government are looking at ways to do so. The Prime Minister is personally vested in it and my noble friend’s points are extremely well made and supported on these Benches.

Covid-19 Update

Lord McColl of Dulwich Excerpts

Wednesday 1st July 2020 Lords Chamber

[Lord Bethell]

My Lords, it is beyond my reach to instruct the House on its debates, but I would entirely agree with the noble Baroness that one of the saddest and most challenging aspects of Covid is that it hits society where it is weakest. It has undoubtedly hit those with health issues the hardest and has exacerbated health inequalities. It is my sincere hope that this Covid epidemic will be an inflection point, when this country embraces a strong public health agenda and addresses those health inequalities with energy.

[Lord McColl of Dulwich (Con) [V]]

Does the Minister agree that the reason why so many people in the United Kingdom and the United States have suffered from Covid-19 is that the majority of people in both countries are obese? Covid-19 and obesity is a lethal combination. We urgently need a nationwide campaign to reduce the obesity epidemic—to persuade people to put fewer calories into their mouth before the next pandemic arrives to affect even more people.

[Lord Bethell]

The noble Lord overstates his case a bit—it is 28% of Britons who are obese—but his point is very well made. We have undoubtedly been challenged as a nation because too many of us are overweight, and I say this with a degree of personal humility. As I said in my previous answer, there is a significant opportunity for this country to regard Covid as a massive warning shot and a potential inflection point where we address overeating and, as a nation, embrace the opportunity to get fit and lose some weight.

Coronavirus

Lord McColl of Dulwich Excerpts

Monday 22nd June 2020 Lords Chamber

[Lord Bethell]

The noble Baroness, Lady Brinton, is right that the creation of a seamless network between the centre and local authorities is challenging. A huge amount of work has gone into refining the accuracy and speed of the exchange of data, and the joint biosecurity centre is investing a huge amount of effort in getting this right. The responses to Kirklees, Leicester and Cardiff show the progress that has been made, but also some of the shortcomings. We are fully aware of the challenge and difficulty of getting this right; we are very much focused on it and it is our top priority.

[Lord McColl of Dulwich (Con) [V]]

As obesity makes one more likely to suffer with Covid-19, and as more than half of people in the UK are obese, will the Government launch an all-out campaign this summer to reduce obesity by persuading people to put fewer calories into their mouth before the next pandemic arrives to kill even more people? Exercise is good for general health but will reduce weight only in grams, whereas eating puts on weight in kilos.

[Lord Bethell]

My noble friend makes a tough but serious set of points. It is undoubtedly true that this country has been hit hard by Covid because of the prevalence of obesity, and it is a truth long explained by Public Health England that there is a direct correlation between calorie intake and weight—there is no getting away from that. The Government are looking at how to address this issue, public health remains a massive priority for us and, when the time is right, we will look at ways of using marketing to communicate the message on this.

Academic Health Science Centres

Lord McColl of Dulwich Excerpts

Tuesday 2nd July 2019 Grand Committee

[Lord McColl of Dulwich (Con)]

My Lords, I shall describe how I tried to enhance the co-operation and understanding between academia and hospitals by having all the trainees in a third of the south-east region spend a year or two on the academic side. In 1971, as professor of surgery at Guy’s Hospital, I started a comprehensive training programme that lasted until the trainees were appointed to a consultant post.

Several years were spent in district general hospitals and several years at Guy’s. The trainees experienced a wide range of surgical disciplines, including anaesthetics and intensive care. They also spent a year or two on the research side, including a year at Harvard. This gave them an involvement in research that they carried with them into their consultant work in the NHS. In addition, many of them became professors of surgery. The Guy’s Hospital training programme gave junior staff not only more comprehensive training but more security and a more stable family life. It also shared out the junior staff more fairly with the district general hospitals in a third of the south-east region. Most important of all, it encouraged young trainees to embrace academia early on in their career.

Mental Health: Eating Disorders

Lord McColl of Dulwich Excerpts

Monday 25th February 2019 Lords Chamber

[Lord McColl of Dulwich (Con)]

My Lords—

[Baroness Bull]

I thank the noble Lord for giving way. While access to treatment is vital, I hope the Minister will agree that it is equally important to address modifiable risk factors for eating disorders. There is good evidence that weight-related bullying, teasing and criticism increase the risk of eating disorders, and young people studying physical subjects such as dance or sport are particularly vulnerable to inappropriate comments from teachers and coaches. The Minister will be aware that size is not a protected characteristic under the Equality Act 2010. Given this, can she confirm that guidance is available to support teachers who are dealing with young people in using language that avoids triggering long-term issues around eating and body image?

[Baroness Blackwood of North Oxford]

The noble Baroness is absolutely right. It is very important we send the right messages to young people at exactly the right time. That is why we are implementing the children and young people’s Green Paper on the basis that early intervention and prevention are the priority in mental health. In December 2018, we announced 25 trailblazer sites that will provide school and college-based services to help children and young people with mild to moderate mental health issues, staffed by a new workforce. Twelve of these trailblazer areas will pilot a new waiting time standard for children and young people’s mental health services. This is to address exactly the issue that the noble Baroness raised.

[Lord McColl of Dulwich]

My Lords, does the Minister agree that, when we talk about eating disorders, the most serious eating disorder by far is the obesity epidemic, which is now impinging on the Armed Forces? Ejector seats in fighter planes are having to be modified because of obesity, and no doubt the noble Lord, Lord West, will be interested, because we may have to enlarge the escape hatches of submarines.

[Baroness Blackwood of North Oxford]

I thank my noble friend for that question. I do not feel able to comment on ejector seats or submarine hatches—I may have to look to the noble Lord, Lord West, for advice on that matter—but I believe that obesity is a serious issue, and that is exactly why we introduced the children’s obesity plan.

Organ Donation (Deemed Consent) Bill

Lord McColl of Dulwich Excerpts

2nd reading (Hansard): House of Lords
Friday 23rd November 2018 Lords Chamber

[Lord McColl of Dulwich (Con)]

I too congratulate the noble Lord, Lord Hunt, on bringing this Bill through. I should declare an interest as a former transplant surgeon. I found kidney transplantation the most exciting operation that I did in my 50 years of surgery. Kidneys would be flown in from all over the place in order to try to achieve a good match. One would connect up the vein and then the artery and to my surprise I found that some of the kidneys would start peeing on the table immediately, which was wonderful, but I noticed it was only the French kidneys that did this. I asked what it was about these French kidneys, and they said, “It’s the French wine, you know”. Well, in fact there were other factors involved.

At present, around 6,000 people are on the UK transplant waiting list, and last year over 400 people died waiting for a transplant. With so much at stake, it is not surprising that the question of how the donation system should operate is a source of strong emotion. The increased public awareness of the great benefits of donation is to be welcome, but—and there is a “but”—I have been rather taken aback by the way in which the evidence of what works, even the facts about the current law, has been manipulated and inflated by the media, in parliamentary debate and even in the consultation materials themselves. I do not think this is the way to support and maintain trust in our transplant system, nor to demonstrate commitment to evidence-based policy.

The 2011 Nuffield report, Human bodies: Donation for Medicine and Research, which has been mentioned quite frequently, strongly supported organ donation,

“where this is in accordance with the wishes of the donor”,

but it did not advocate a change in the current law to the opt-out system. Nuffield concluded that,

“such a system could be ethical, as long as a number of potentially onerous criteria were met. People need to be fully informed in order to be able to make an active choice about whether or not to donate, which implies a long term and expensive commitment to public information and education. Families need to be appropriately involved—recognising not only that they are likely to have the best knowledge of their loved one’s attitudes to organ donation, but also that they themselves, in their bereavement, have a stake in what happens to the deceased person’s body. Critically, the system must operate in a way that ensures that public trust in the donation and transplant system is not undermined, for example through perceptions that the state is intervening to ‘take’ organs against family wishes. We only have to look back two decades to the outcry caused by tissue retention in the NHS to be alert to the way in which trust can be undermined, not least by failing to take into account the complex family and personal meanings associated with the body in death”.

In considering these questions of trust, the report also assessed, in more general terms, whether such a change in the law would increase donation. As it said,

“the quick answer is that no one knows. In contrast with the claims (confidently asserted over past months) that opt-out will save ‘thousands of lives’, the Department of Health’s own Impact Assessment, published alongside the consultation document, described the evidence on the impact of opt-out on donation rates as ‘inconclusive’ … Despite all the emotional rhetoric, the jury is still out on whether changing the law in this way will make any difference at all to the numbers of organs available for transplant”.

In beginning to assess the efficacy of presuming consent, we have to confront a misunderstanding about how donation works in England today. All too often, the assumption is made that only those who have signed the organ donor register are potential donors. Given that just 37% of the population in England have signed the register, it is thought that a shift to presumed consent will increase the pool of potential donors dramatically. Even if 10% of the public opt out, one would still increase the total pool of donors from 37% of the population to 90%. The difficulty with this logic is that it fails to appreciate that, at present, it is not only those who have signed the organ donation register who can donate. As Answers to Parliamentary Questions I tabled in July demonstrate, most donations in England at the moment come from families of people who have not left instructions about what they want done with their organs. To put the same point another way, at the moment, most organs are donated by people who have not signed the register. Critically, this means that clinicians in England are not limited to a pool of the 37% of people who have signed the register—they can approach the families of 99.3% of people. The missing 0.7% relates to those who have signed the opt-out register in England, and cannot be approached.

Rather than increasing the pool of potential donors, moving to informed consent reduces it. Whenever consent is presumed, some people take offence and sign the opt-out register. In Wales, prior to the instruction of its deemed consent law in 2015, there was no opt-out register, so 100% of people were potential donors. As a consequence of introducing presumed consent, however, 180,000 people, or 6% of the population, have now opted out. It is no longer possible for clinicians to talk to families about donation, when previously they could all have been approached. The organs of those 180,000 people are simply lost to the system. Rather than increasing the pool of potential donors, the introduction of presumed consent in Wales has involved spending public money to reduce that pool from 100% to 94%.

The truth is that, regardless of what system is operated at the point of donation, the key player is the family. Not having signed the organ donor register does not prevent doctors talking to the family about donation. Presuming the consent of the donor does not enable doctors to avoid talking to the family about consent. It makes no difference whether the donor had signed the register or had his consent presumed. At the end of the day, they will be unconscious, and the key conversation must take place between the clinicians and the family. In this context, the focus of our attention should be, as many speakers have said, on the family.

We know from the detailed reports published each year by NHS Blood and Transplant that the key factors associated with high consent rates are support for families by specialist nurses, and families knowing what the deceased person wanted. Consent rates are as low as 27.5% when families are not supported by a specialist nurse. They increase to 68% when a specialist nurse is involved, and to more than 90% where families are confident of the deceased’s wishes, as the noble Lord, Lord Patel, the noble Baroness, Lady Finlay, and my noble friends Lord Lansley and Lord Ribeiro have already said.

This is consistent with the experience of Spain, which, as has been mentioned, has sustained the highest donation rate for more than 20 years. Rafael Matesanz, the leading light of the Spanish transplant system, ascribes the well-known successes of the Spanish system to its focus on efficient systems and excellent family support. He is on record as calling the opt-out system a “distraction”. Despite being classed wrongly by some as an opt-out country, Spain operates neither an opt-in nor an opt-out register, and relies entirely on family authorisation for the legal basis of donation.

The official evaluation of the Welsh law was published in November 2017, two years after it came into effect. It showed that if you compare the resident Welsh donor rate for the 21 months before the introduction of the new system with the 21 months since, far from increasing, the numbers fell slightly from 14.6 donation decisions per quarter to 13.4 donation decisions per quarter. This is less than encouraging. Admittedly things have since improved, but it will take at least five years to show any meaningful trend. In assessing that trend, it will be critical to allow for increased investment in specialist nurses in organ donation and critical care beds, which has nothing to do with presuming consent but will increase donation rates. The official evaluation concludes that longer period of time is needed to draw firmer conclusions about the impact of changing the law.

In the context of 400 people dying while waiting for a transplant, and when we do not have limitless public funds, I find the prospect of spending millions of pounds of public money on presumed consent rather concerning. Any money that we spend on presumed consent, for which we have no robust evidence of success, we cannot then spend on things that we know will increase donor donations. We should wait to see what happens in Wales and spend any additional monies on more specialist nurses in organ donation and more critical care beds. If the Government are determined to back this Bill, it will be imperative to limit the potential scale of withdrawal from donation by assuring people on the face of the Bill that their families will be properly consulted. This statutory guarantee of consultation must be genuine and not limited to simply giving the family a right to provide evidence that the family member did not want to donate, as in Wales.

Finally, I have another interest to declare. My daughter is a potential transplant recipient.