Draft Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020
(4 years, 7 months ago)
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Lord Bethell
That the Virtual Proceedings do consider the draft Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020.
Relevant document: Special attention drawn to the instrument by the Secondary Legislation Scrutiny Committee, 8th Report
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, before I explain the draft regulations I will say a few words about our motivation to change the law for organ donation. Currently over 5,200 people in England are waiting for a transplant. By the time a suitable organ is found, some people will be too ill to receive one. Last year alone, 777 patients were removed from the transplant list and a further 400 died while on the active list waiting for a transplant.
It was therefore clear to us that we had to take decisive action to address the acute shortage of organs and help those whose lives were on hold waiting for a transplant. That is why we passed the Organ Donation (Deemed Consent) Act 2019 last year. The Act amends the Human Tissue Act 2004 and sets up the new system of consent for organ and tissue donation in England known as “deemed consent” or “opt-out”.
Subject to approval of these regulations, we aim for deemed consent to become legal on 20 May. While not many transplants were taking place earlier during the peak of Covid-19, NHS Blood and Transplant has already started the recovery process to get transplant units up and running as much as possible. To illustrate the progress we are making I can say that, on a normal day, NHSBT would receive around 55 referrals of a potential donor, aim for five actual donors and carry out 70 transplants a week. During the peak of the pandemic, there were days when there were no referrals, many days when there were no donors and many days when there were no transplants. As of last week, there have been 167 referrals, 11 donors and 38 transplants. I salute those in the NHS blood transfusion service who have worked so hard to save some lives and improve others.
Continuing the tremendous effort to restore all transplant services will include training nurses on the new law as soon as possible after they return. This will allow us to reap the benefits of the deemed consent legislation when it is safe again. I understand that some have disagreed with the approach, but I reassure the House that we made a detailed assessment of the options in front of us before taking the decision to restart donations on this new basis. This horrific pandemic has taught us a lot about how precious human life is. We know that the fight against this disease will continue for some time, while thousands of people are waiting for a transplant. I therefore believe very strongly that we have a duty, now more than ever, to push ahead with measures which will reduce human suffering and help to improve people’s lives. That is exactly what this law does.
We are of course fully aware that public confidence is important. The deemed consent legislation was first introduced in July 2017 and became law in March 2019. It has therefore had a long process of parliamentary scrutiny, alongside three public consultations. The Government have been raising awareness of the law and the choices available for over a year, and the implementation date of 20 May has been used actively in communications since late February. Putting this legislation on hold would only increase the anxiety of the thousands of people who see this law as their only hope to get a new lease of life, and would confuse the communications which have already been in the public domain for some time.
From the outset, we have been clear that deemed consent would apply only to routine transplants, to increase the number of organs and tissues available and help those on waiting lists. Examples of routine transplants are hearts, kidneys and lungs. Novel transplants would still require express consent. The organs and tissues specified in the regulations are included because they could be used for non-routine transplants—for example, a face transplant. Such transplants are outside the scope of what we want to achieve. The demand for novel transplants is very low, and people would not normally identify organ donation with them.
During formal scrutiny of the regulations, the Joint Committee on Statutory Instruments cleared them with no comments. Meanwhile, the Secondary Legislation Scrutiny Committee drew the regulations to the attention of the House. This is testament to how integral the regulations are for making the new system of consent work, and to how important the law change will be when it is introduced.
Let me now deal with the detail of the regulations. The Organ Donation (Deemed Consent) Act 2019 sets out that deemed consent to transplantation activities in England will apply only to “permitted material”. The Secretary of State has a delegated power to specify in regulations what “relevant material”—human organs, tissue and cells—will be excluded from the system of deemed consent. To be clear, I say that the organs, tissues and specific cells listed in the draft statutory instrument are organs, tissues and cells which cannot be transplanted without express consent being in place, as that would be a novel transplant.
Regulation 2(2) sets out the detailed list of organs and tissues which will require express consent in order to be transplanted under all circumstances: for example, the brain, spinal cord and face. As a result of our consultation, we expanded the list of reproductive organs and tissues in this regulation to provide clarity and to put beyond doubt that removing any parts of the reproductive organ will require express consent in all cases. As I mentioned, this is to make sure that if and when such transplants are carried out in the UK, they will be outside the scope of deemed consent.
Regulation 2(3) sets out that some relevant material —for example, skin and bone—will require express consent if used for a novel transplant but not if used for a routine transplant. This is to ensure that current practices for tissue donation—where, for example, tissue from a leg is removed routinely—are not disrupted by deemed consent. So while a leg transplant would require express consent, if only the skin from the leg is taken, deemed consent may apply. However, if tissue is required from reproductive organs, this will always require express consent. This is to address feedback from our consultation.
Regulation 2(4) allows for the trachea to be removed under deemed consent when it is attached to the lungs. This will allow routine heart and lung transplants, which also require the trachea to be removed with the heart and lungs, to continue under deemed consent. To clarify, however, the trachea is also listed in Regulation 2(2), as trachea transplants by themselves are novel and therefore excluded from deemed consent.
Regulation 2(5) excludes the removal of certain cells if they are to be used for an advanced therapy medicinal product, known as an ATMP. ATMPs are therapies made from tissues, cells or genes after manipulation in a laboratory. They are used for treatment of a disease or injury and often use human cells and tissues as starting materials. For example, an ATMP can treat knee damage by taking cartilage cells from a living patient, growing and modifying them in the lab, and reinjecting them into the patient’s knee. ATMPs are an exciting technology and new therapies are being developed all the time. Current ATMPs are being developed using tissues and cells taken from living donors, but it is also possible to use material from deceased donors to develop novel ATMPs. As these ATMPs are novel, we want to make sure that donation of these cells cannot happen without express consent being in place. Our consultation raised questions around the public’s understanding of these novel technologies and we therefore want to ensure that express consent is required.
Now that I have set out the detail of the regulations, I must highlight that, before deciding whether a change to the regulation is needed in the future, the Government would need to consider issues around evidence, public acceptability and clinical need. Any changes would need to be approved by Parliament following the same procedure as now; therefore, Parliament will have full oversight.
Because the regulations restrict deemed consent to routine transplants and they therefore continue current practice, where express consent needs to be in place for non-routine transplants there will be no additional cost to the health system, and therefore no impact assessment has been prepared.
By way of a conclusion, I am pleased that I am able to present these regulations to the House. They are an important part of the implementation of the Organ Donation (Deemed Consent) Act 2019, as they prevent deemed consent from applying to novel transplants. The new system of consent is expected to save and improve the lives of many people waiting for a life-saving or life-enhancing transplant. I am proud that all of us here have played a role in making something so positive in these challenging times. Many of your Lordships will know of Jim Lynskey, a high-profile campaigner who, through his own charity, Save9Lives, campaigned for the law change but sadly died at the age of 23 before seeing this law become a reality. I know that his twin sister Grace has continued to campaign. We owe it to Jim, Grace and many others to embrace the opportunities of deemed consent and save more lives. I commend the draft regulations to the House.
Lord Hunt of Kings Heath (Lab)
My Lords, along with Geoffrey Robinson, former MP for Coventry North West, and supported by Dan Jarvis MP, I was very proud to sponsor what became the Organ Donation (Deemed Consent) Act 2019 through your Lordships’ House, on which these orders are based. I hope that the Minister, when he comes to wind up, will join me in thanking Geoffrey Robinson and Dan Jarvis for the tremendous work that they did.
Our aim was to increase the number of organ donations while maintaining strong family involvement in the decision to donate, which remains a remarkable act of giving. The Bill was known as Max and Keira’s Bill—now Max and Keira’s law—in honour of the recipient, Max Johnson, for his immense bravery while waiting for a heart transplant, and the donor, Keira Ball, who tragically died in a road accident. I pay tribute to both of them. I also pay tribute to the Mirror newspaper and its readers for the tremendous support they gave to the campaign. Thanks, too, to Kidney Care UK and many other charities, who have been such a help.
Our aim is quite simply to inspire more people to have that incredibly important conversation with their loved ones, knowing that this could save the life of a person waiting for a transplant. It is estimated that 700 more transplants a year could take place. I fully support the regulations and the associated codes of practice, which have a greater focus on faiths and beliefs and should support better conversations and greater reassurance for many families.
I know that the NHS is working to continue organ donation where possible, but the impact of Covid-19 on transplants has been major, with many centres having to close or at least limit the scale of transplants. We know, for instance, that some people waiting for a kidney transplant have had to commence dialysis rather than have pre-emptive treatment. Although there is no known transmission of Covid-19 through organ donation, any risks need to be minimised as much as possible because patients who need a transplant must be immunosuppressed.
The Covid-19 outbreak has also brought the need to address health inequalities faced by people from BAME communities into sharp relief. There is too much inequality in transplant cases, too. As Kidney Care UK put it to me, people from BAME communities wait six months longer for an organ, despite being more at risk of kidney failure, because fewer organs are available from donors from this community.
I know that it is unlikely that transplants will proceed under the deemed consent provisions during the coronavirus pandemic. Perhaps the Minister could expand on that a little more. I hope that he will commit to a major public awareness campaign when we are out of the crisis; it is essential in maintaining public support and trust for organ donation. The campaign launched by NHS Blood and Transplant in April 2019 was successful in raising awareness and was an excellent start. However, it had to be significantly reduced during the epidemic to enable messaging to focus on keeping the public safe and well. That is quite understandable, but I ask the Government to ensure that, when we come out of this, they fund campaigns on a regular basis to encourage people to consent and understand the new issues that this legislation brings in.
I ask the Minister to ensure also that the NHS is fully prepared for the expected increase in donations. The specialist nurses for organ and tissue donation are essential to the successful implementation of the Act. These amazing people provide advice, support and information to the family. They determine the last known decision of the deceased and ensure that no organs or tissues are retrieved without consent being in place. It is essential that the number of nurses is increased so that families continue to receive the highest possible care and support.
During the passage of the then Bill, the Minister’s predecessor, Lord O’Shaughnessy, stated that the Government would
“make sure that there are enough highly trained staff to make the most of the changes resulting from this Bill”
and that we should
“make sure that they are fully trained and fully financed for the future.”—[Official Report, 23/11/18; col. 447.]
I seek a commitment from the Minister that that additional funding will be provided to ensure that the increase in nurses continues in future, so that the families of every donor can be approached with the necessary care, sensitivity and empathy.
It is also very important that we make the most of every single precious gift of donation. We know that transplant units are already under pressure. NHS Blood and Transplant recently established a new system for flagging instances where organs were declined for a named patient purely because of a lack of available resources to enable the team to undertake the transplant. We need to ensure that transplant units can keep pace with the anticipated increase in organ donation. They too need to be funded and resourced to make sure that every organ that could be transplanted is transplanted. No organ should be declined by a transplant team due to a lack of resources.
Finally, I refer to novel technologies. The UK is currently leading the world in novel technologies to support organ transplantation. We have developed new techniques and machines that enable us successfully to transplant organs that would not have been transplantable before. I ask the Government to confirm that they will support transplant units and fund them to ensure that they can use these novel technologies and save more lives through the gift of donation. And I hope, again, that the Minister will acknowledge the work of Geoffrey Robinson and Dan Jarvis MP in supporting the Bill through the other place.
Lord Oates (LD)
My Lords, I declare my interest: until recently, I was a non-executive director of NHS Blood and Transplant.
I welcomed the Government’s decision to support the deemed consent Act in the name of the noble Lord, Lord Hunt, and remain fully supportive of the move to deemed consent. Every year, hundreds of people die while awaiting a transplant, as the Minister said, and hundreds more come off the waiting lists because their health has deteriorated to the extent that they cannot receive a transplant. Anything we can do to reduce those tragic numbers is welcome. Deemed consent is not a panacea, of course, but the evidence from Wales is that, combined with an effective communications plan and, most importantly, a public debate and family conversations, it can mark a profound shift.
The Minister is aware of my concerns about the timing of bringing deemed consent into effect and the impact that it may have on public awareness, so I will not dwell further on this point in the limited time available. However, I hope that he will be able to tell the House what advice and representations his department received on the wisdom, or otherwise, of this decision.
Specifically, I want to ask him about NHSBT’s excellent advertising campaign and the Government’s assessment of its effectiveness in the light of the Covid-19 crisis, as the noble Lord, Lord Hunt, mentioned. Have the Government considered the impact that the current health crisis may have had on the ability of advertising to cut through? I would also be grateful if the Minister could tell the House why the draft codes of practice were not published online at the same time as the laying of these regulations—a matter highlighted by the Secondary Legislation Scrutiny Committee.
The Minister will be aware of the immense sensitivities around these issues. It is not good enough for the Government to drop the ball in this way. I am not sure if this is a result of the timing of the regulations, as the DHSC was obviously struggling to address the impending Covid-19 crisis at the time, but we need an explanation from the Minister. Sadly, as he pointed out, the transplant system is unable to work effectively during the Covid-19 crisis, but it is hoped that these life-saving and life-changing operations can resume as soon as possible.
When they do, the Government need to be aware that legislation alone will not meet the demand for transplants. What is required alongside the legislation is adequate resourcing of the transplant apparatus throughout the NHS. This is not a matter that can be delivered by NHSBT alone; it requires a whole-system approach. I hope that the Government take that fully into account. I also hope that the Government recognise the importance of new machine perfusion techniques to make the best use of donated organs, that these techniques will be properly funded, and that British ingenuity and innovation in this regard will be backed.
We also need to ensure that transplant medicine remains an attractive field for new entrants into the medical profession. It can be a tough life, with specialist nurses and transplant and retrieval surgeons on call at all hours—ready to travel often significant distances to retrieve an organ and save a life—and specialist nurses in organ donation playing an unparalleled role in helping grieving families at times of great distress and ensuring that the process works at every level.
I cannot pay sufficient tribute to the dedication of specialist nurses and transplant surgeons and the difference that they make to so many lives. They need to be properly recognised for the amazing job that they do. Most importantly, however, we should recognise organ donors and their families, who give the most precious gift available: the gift of life.
Lord Mackay of Clashfern (Con)
My Lords, I am strongly in favour of this instrument, as I am of the Act on which it is based. I first realised the importance of transplantation early on in its development. A very close friend of ours developed kidney failure and required constant dialysis. It then became possible for him to have a transplant. He had a twin brother who was willing to give his kidney. He was operated on in one theatre and my friend was operated on in a next-door theatre, so they were able to take the kidney across very quickly. It cured him completely and he had a considerable life. Sadly, he has now died, but Professor Woodruff, who was a pioneer of this technology, was his surgeon. I have felt tremendous emotional support for this whole field ever since.
I just wonder whether the code of practice that the authority has put out fully reflects what the Act the regulations are based on says. The Act says that the person concerned—somebody who is qualified—
“is to be deemed, for the purposes of subsection (6)(ba), to have consented to the activity unless a person who stood in a qualifying relationship to the person concerned immediately before death provides information that would lead a reasonable person to conclude that the person concerned would not have consented.”
In that situation it seems that if no objection is taken by a qualified person, consent is implied. The code of practice says at paragraph 91:
“In a situation where consent could be deemed but there is no family to speak with to establish the individual’s last known decision, donation should not proceed.”
I am of course well aware that the original Act does not require a donation to proceed, but it makes it lawful that it should proceed. The practitioners have to take into account many considerations in deciding whether a particular transplant will take place—considerations of the available organ and of the state of health of the person to whom it is proposed to be transplanted. It is quite clear that the Act does not require a consented donation to actually be carried out for reasons of that kind, but it is wrong for the HTA to say that it will not proceed in that case. I do not know on what basis it has the authority to do that, because the Act certainly seems to imply consent. Therefore, it seems that the only considerations that could not have that would be of the medical, practical kind such as I mentioned.
The only other thing I want to mention is that it seems the publication of the draft instrument was a matter to go on to the authority’s website. Was the department responsible for that particular matter?
Baroness Randerson (LD)
My Lords, I declare an interest as chancellor of Cardiff University, which includes Cardiff medical school. I thank the noble Lord, Lord Hunt, and many others for all the work they have done on this important issue. I strongly welcome this debate and the fact that England is now following the lead from Wales. I was involved in the campaign for deemed consent in Wales, which started around 2008. England will be able to build on the Welsh experience as the changes are introduced. I am delighted to see that the noble Lord, Lord Bourne of Aberystwyth, will speak later as well.
In Wales, after lengthy and thorough public debate and consultation, the Act was passed in July 2013 and the actual changes in procedure were introduced in December 2015, almost two and a half years later. However, by the crucial measure of organ donation consent rates, it has undoubtedly been a success. In Wales, that statistic is now over 80%, compared with around 66% in England.
I must stress how carefully this must be introduced. Thorough training and additional capacity are key to success. A false start now could undermine the whole scheme for years to come, because public confidence is vital, and so the failure to publish the draft code of practice on the internet on the date it was laid is a more than usually worrying omission. As the Secondary Legislation Scrutiny Committee said, this is unacceptable given the sensitivity of the subject matter. Can the Minister explain how this happened, and can he provide us with reassurance that procedures have been changed so that we can have more confidence that this will be rolled out properly in the future?
I understand and accept that it is not wise to introduce such sensitive changes while the NHS is under huge pressure because of the pandemic. However, the time must be used not for stalling change but for more preparation, including adaptation to the new ways of working. The rate of transplants has fallen sharply, but people still need organ donations at the same rate. Indeed, there is a backlog of people urgently requiring donation, many of whom have become even more seriously ill while waiting for a donor. The number of organ transplants has fallen by three quarters since the start of the pandemic, as ICU units have been devoted to coronavirus patients.
I was pleased to see that the codes of practice have a strong focus on faith. This is particularly important because of the long-term shortage of BAME donors. In Wales we worked with faith leaders from the early days of the campaign and found their insight and contributions essential in developing guidance.
I understand the decision to exclude certain organs from deemed consent. However, I ask that each of these organs is treated as a separate category, rather than them being grouped together. This is so that, as surgical practice develops, there can be ongoing reconsideration of their status. What is novel in 2020 could be routine by 2025.
Baroness Deech (CB)
My Lords, I have another question about the section raised a moment ago by the noble and learned Lord, Lord Mackay. The Organ Donation (Deemed Consent) Act 2019 inserts the following into the Human Tissue Act:
“The person concerned is to be deemed”—
for the purposes of another subsection—
“to have consented to the activity unless a person who stood in a qualifying relationship to the person concerned immediately before death provides information that would lead a reasonable person to conclude that the person concerned would not have consented,”
“reasonable” being a word much loved by lawyers. I spoke about this at Second Reading of the organ donation Bill in 2018. I raised then the issue of donation by members of faiths that are, in general, opposed to organ donation. There has been much discussion of this issue. The codes of practice emphasise the sensitivity surrounding this and encourage discussion with the family. There remains an ambiguity, in relation to which I would like the Minister’s clarification. The then Minister in 2018, the noble Lord, Lord O’Shaughnessy, said at the conclusion of Second Reading that
“no family will be forced to agree with the donation if they are strongly opposed to it,”—[Official Report, 23/11/18; col. 426.]
even when the deceased had expressly wished to be a donor. Yet the code of practice says that where the family disagrees with the deceased’s wish to donate, the specialist nurse should explore any issues raised by the family and support them to address their concerns.
Where indicated, the nurse can facilitate consultation with religious and non-religious leaders to provide counsel or clarification on donation. This is in paragraph 37 of revised Code of Practice A. I am not sure what this means or how the nurse can come to an acceptable conclusion in what must inevitably be a distressing and hurried period.
Judaism puts the saving of life as a priority, but significant elements within it believe that the body should not be interfered with. Is it to be the case that, where the family disagrees with the deceased’s wish to donate, or where he or she has made no declaration and is deemed to consent, the family will have to show that the deceased was expressly against donation, even though he or she had made no declaration to that effect? In other words, will the onus be on the family to prove that the deceased would definitely not have wanted to donate, or is it the other way around—that the presumption is in favour of donation and the nurse is to help the family come to terms with it? Need the family only object, full stop, to prevent donation? The code refers to reasonable information that would lead a reasonable person to believe that the deceased would not have wanted to donate, but this does not answer the question. There seems to be a different level of proof of objection, depending on whether the deceased made no declaration or wanted to donate.
I add, on accepted materials and from my experience as chair of the Human Fertilisation and Embryology Authority, that few actions can be more unethical than the removal without express consent of a person’s reproductive tissues—eggs, sperm and embryos. For that to be contemplated is not, like the rest of this law, a life saver or for medical purposes, but to satisfy the wish for a child by another party. It is illegal and it is quite right that this is spelled out, and that the distinct provisions on donation of gametes are in separate legislation. I hope this is the culmination of a long process directed towards increasing the availability of organs for transplantation. It is very welcome.
Lord Blencathra (Con)
My Lords, I strongly support these regulations but worry that, with them, we could see history repeating itself. The Act from which these regulations flow was regarded by all of us as the right thing to do, but I recall the iniquitous Liverpool care pathway operated by the last Labour Government. It became not a care pathway, but a death highway. It started with the best of intentions and high morality. It was originally for cancer patients, but soon the NHS expanded it to every patient who could be approaching end of life. It was one of the most disgraceful episodes in the history of the NHS.
Doctors, some very junior, concluded that a patient was terminal and then sent them on the death pathway, pumping them full of painkillers, keeping them sedated so that they could not ask for, or get, fluids. With a lack of fluids, they died off pretty quickly. That then justified their decision that the patient was terminal. Patients were denied sustenance for several days before their deaths, while others were written off even though they could have recovered. But many patients, supplied with fluid by caring relatives, survived the death pathway. The trusts were even given a financial incentive for every person they put down this pathway.
The coalition Government ordered an inquiry in 2012 and banned it in 2014, but some in the NHS carried on doing it. NICE had to intervene. Professor Sam Ahmedzai, chairman of the committee at NICE, 18 months after the pathway was effectively banned, said that it was still being used by some “teams” of doctors who
“thought they knew how to give end of life care.”
However:
“It turns out they’re the ones that don’t know.”
NICE finally outlawed the pathway once and for all and said that junior doctors must not to be left alone to make snap decisions about patients’ care; that there had to be an end to the tick-box culture, with patients treated with respect and as individuals; that staff had to be aware that patients who appear to be dying could stabilise or even recover; and that doctors had to ensure that patients had enough to drink.
That is the background perspective with which I read these regulations and code. Like all, I have huge admiration for the individual doctors, nurses and specialist medical people in the NHS but I do not, for one second, trust its slow, unwieldy, bureaucratic machine. When a patient gives consent under these regulations, there are very few worries, but deemed consent is a different matter. The decision on whether to go ahead with organ removal rests with the specialist nurse, not even a doctor, nor yet a registrar. That nurse has a hierarchy of relatives to consult, and the first one to give consent permits the removal to go ahead. How much effort does the nurse have to make to find the first relative who may be resistant to removal? Would there not be a medical bias to find the next relative who medical staff know to be in favour of it? It is much easier to go to a child who is in favour of removal than an equally ranked child who is not.
Codes A and F are 89 pages long, with incredible details for thousands of medical staff to master, including legal concepts. As the noble Baroness, Lady Deech, has just said, there is even the concept of what “a reasonable person” might conclude. We have all seen the nightmare of lawyers playing at being doctors with their second-guessing of medical competence. I do not want our nurses having to guess at what “the man on the Clapham omnibus” might conclude. These regulations and codes are very important, but they have the potential to turn into a Liverpool care pathway where medical staff know best and just tick the boxes. This has to be rigorously monitored so that another scandal does not occur and that this system goes from strength to strength.
Lord Mann (Non-Afl)
My Lords, I shall be brief. The noble Baroness, Lady Deech, made my key point most eloquently, so I will not repeat her words. How much have the Government reached out in their consultation to groups which are out of the mainstream in their religious beliefs? Will the Government be reaching out further to build support for what they are attempting to achieve—I wholeheartedly endorse that and am pleased to see it moving forward without delay? There is a danger that, at some stage in the future, those who genuinely but strongly adhere to more inflexible religious beliefs may create a major argument with the Government, through the courts or the court of public opinion. This could be damaging, as those groups have been less likely to offer donations than the rest of the community. That has been well documented and analysed in a series of reports. How will the Government reach out to those who are less instinctively desirous of this change to ensure that they are either supportive or feel sufficiently consulted to be neither hostile nor oppose it?
Lord Naseby (Con)
Good afternoon, my Lords. I am sorry that I am only on audio today; I have had some technical problems.
I want to focus on communication; I have spent a lifetime in that world. The starting point seems to be the statement from the Department of Health and Social Care on 25 February that, although 80% of people would be happy to donate organs and tissues on death, only 37% are currently registered. As the Minister said, demand has increased since the original briefing: the figure then was 5,100; it is now 5,200. I understand that deemed consent is likely to produce an additional 700 a year. That means that, if demand remains constant, it will take at least another seven years to work off.
On 25 April 2019, NHS Blood and Transplant launched a campaign called “Pass it on”, which aimed to communicate the change in the law and the choices available. Was any audit made of people who had ever heard of this campaign or were able to communicate back what it was about?
In the commercial world, it is normal with something as important as this for a whole structure of market research to be set up following some initial trials. My first question is on that. However, instead of just asking questions, I want to put forward a few thoughts on how we could communicate better. I went to my local surgery this morning to renew a prescription. I walked round; I could not see anything obvious about donations. A large number of people as NHS patients go to clinics. I am not conscious of anything in the publicity at the few that I have been to about what we are talking about.
I am waiting for an appointment for glaucoma at Bedford Hospital. I did not see anything last time I went in; I will check again. Each of us has to renew our driving licence after a period of time. Why do we not have a campaign attached to that renewal about the need for donations? We all of us have dental appointments. Would it not be a good idea if a leaflet or something was available when we went to the dentist? Above all, there are all the specialist medical charities—my goodness, they do a really good job. They are brilliant communicators. I first took out my donor card in 1981 because I had a particular interest in kidneys at the time. I have it in front of me. I was hoping to show it, but it is looking a bit moth-eaten as I flick it over now. Perhaps we could get all those medical charities on board. They would need financial assistance to do it, but they are like terriers and we need people like that to communicate this very important category of future life.
Then there are people coming to our country—the naturalisation permissions, the immigration approvals and, for UK people, passport renewals. There again is an opportunity to communicate.
Finally, there have recently been some really good, in-depth TV programmes on the challenge of the virus. Let us ask each of the channels to do a separate programme on this issue, so that we can get the 37% up to way over 50%, thereby giving us at least a chance of meeting the demand that is out there. It needs to be addressed. I wish everybody well in that. I thank the noble Lord, Lord Hunt, who rightly calls for —[Inaudible.]
Lord Goddard of Stockport (LD)
I too am on sound only, and some may say that that is for the better.
In my view, deemed consent legislation is long overdue. Subject to safeguards and ethical checks and balances, which I am sure finer minds than mine are addressing, we must get on with this.
I shall address my comments mainly to kidney transplants, as this is a cause close to my heart. By far the most common transplants are kidney-related, and the numbers for that particular sector are staggering: 3 million people in the UK have chronic kidney disease, including 1,000 children, while 65,000 people are being kept and treated for kidney failure by dialysis or transplant. In the UK, there are over 6,000 people on the transplant waiting list, and at least one person every day will die hoping for a kidney transplant. NHS Blood and Transplant has estimated that the change in the law has the potential to allow 700 more transplants each year by 2023, as the noble Lord, Lord Hunt, commented earlier.
To be clear, when kidneys fail there are three things that can happen: dialysis, transplant or death. Dialysis is distressing and demeaning; with four to five-hour sessions every week and dietary and fluid restrictions, people are unable to continue with work, families and relationships are strained, and depression is common. It has been reported that levels of pain are equivalent to those suffering from terminal cancer. Patients are exhausted, with aching bones, reduced mobility and constant aching.
A transplant is transformational in restoring quality and quantity of life. I commend NHS Blood and Transplant for its achievements, with over 50,000 people now alive with transplants. Kidney transplants are economically beneficial; maintaining a person with a transplant costs around £5,000 per annum, compared with over £30,000 per annum for those on a dialysis machine.
This legislation is not all about kidneys; the heart, liver and lungs are included specifically. However, other organs, such as the pancreas, the intestine and the uterus, are vital organs that can save lives and should be considered with express consent. Worldwide, the kidneys are the most transplanted organ, followed by the liver and the heart.
However, it seems that the Government have advised that it is unlikely that transplants will proceed under deemed consent during the Covid-19 pandemic, because people are distanced, and communication between relevant parties is more difficult. If this is the case, when will deemed consent actually come into force? I note that the noble Lord, Lord Bethell, stated confirmation on 20 May 2020. I hope he will clarify that later.
NHS Blood and Transplant was set up on 1 October 2005, taking over the functions of UK Transplant, founded by Dr Geoffrey Tovey in 1972. We live in unprecedented times of stress and uncertainty, and the sooner this legislation is enacted, the sooner many thousands of people will have renewed hope that their lives could be improved. It would be excellent if, less than 50 years from Dr Tovey’s initial ground-breaking work, this finally became the law.
Lord Bourne of Aberystwyth (Con)
My Lords, I refer noble Lords to my entry in the register of interests.
Like other noble Lords, I strongly support these regulations. I pay tribute to those who have made this possible, particularly the noble Lord, Lord Hunt, and the noble Baroness, Lady Randerson, who are participating in this debate. I also thank the Minister very much; I know the pressure that he is under at the moment and how busy he is, and it is a great credit to him that the regulations are with us today.
I have some practical questions about the operation of the regulations. The first is about the publicity campaign, which I would like to hear more about from the Minister. Unlike others, I have seen it referred to; I was exercising to Spotify at the weekend and heard reference to this measure coming in very shortly, so that is positive.
Secondly, paragraph 6.4 of the Explanatory Memorandum to the regulations refers to this applying only to people who have been ordinarily resident in England for 12 months. On the face of it, that does not seem unreasonable, but I wonder how that is operating in relation to our devolved areas. If someone moves across the border from, say, Brecon to, say, London, is there a break in the period? It seems that there probably is, unless I have missed this point in the regulations, and that was probably not intended. I would be grateful if the Minister can say something about that. If he is unable to answer now, I would appreciate a later response.
Further to that point, is there a regular coming together of devolved authorities, given that there is now a similarity of approach in devolved areas? It would be good if there was collaboration, co-operation and discussion. Is that happening and, if so, on how frequent and regular a basis?
Next, the Minister quite rightly referred to the advanced therapy medicinal products, and I agree very much that this is an exciting technology. Paragraph 10.7 of the Explanatory Memorandum states that one reason why the Government have not extended this measure into that area is because they are worried about pharmaceutical companies profiteering—I think I am paraphrasing that correctly. There is nothing wrong with a profit, provided it is not excessive. I wonder if the Minister could say something about how he looks forward to it being extended to cover these advanced therapy medicinal products and how likely that is to happen relatively quickly.
Lastly, on practical points, the Minister again quite rightly said that it will be the Secretary of State or the Minister who decides on exclusions and therefore on inclusions in relation to the list that is in these regulations. I understand that, but on how regular a basis will there be a review, and how will that review be brought before Parliament? Will it be done on an annual basis, for example, or can the Minister perhaps ensure that we are given at least an annual update by Ministerial Statement? That would be very useful.
This is a difficult period in which to bring these regulations forward, but as others have said I am sure that it is the right thing to do because they are life saving and therefore very much to be welcomed. However, I would be grateful if the Minister could seek to bring clarity to the areas that I have highlighted.
Baroness Barker (LD)
My Lords, the United Kingdom has been a world leader in transplant research and reconstructive surgery since the 1940s, and we continue to be the home to world-leading developments in bioscience. Moreover, we have been the outstanding leader in the ethical regulation of cutting-edge medicine and medical technology, due in no small part to the work of your Lordships’ House and the work of Baroness Warnock.
What we have today is a public policy settlement under which research scientists and medical practitioners develop pioneering research. That takes place within a framework of legal principles which is subject to parliamentary scrutiny and is regularly updated as the science advances. I pay tribute to the then Prime Minister, Gordon Brown, for setting up the Organ Donation Taskforce, which in 2008 published the Organs for Transplants report. The report provided a series of recommendations to help us to increase our organ donor rate by 2013. That 2008 strategy did indeed manage to increase the rate of donations by 50% from deceased donors and by 30% from living donors. However, that is still not enough; we need more organs, because people are dying. In 2013, NHS Blood and Transplant published its report, Taking Organ Transplantation to 2020, which set out a more detailed plan.
I congratulate the noble Baroness, Lady Finlay, and others who worked very hard to secure the Organ Donation (Deemed Consent) Act 2019, which amended the practice of the 2004 Act but not its principles by moving to an opt-out principle for routine donations. That was necessary, because many of the most suitable organ donors are people who have been involved in accidents or who have sudden life-threatening illnesses and have not given prior consent. At the point of such an emergency, they and their families are unable to give the consent that they may have wanted to do.
These are decisions that ideally are taken in advance after long and detailed consideration, but which often arise in an emergency medicine setting. I suggest to noble Lords that they go back and look at the contribution made in another debate by the noble Baroness, Lady Tonge, who comes from a family of medics. All her family members had discussed the matter and decided that they were all in favour of organ donation. However, when her daughter died in a very tragic accident, not only did nobody raise the matter with them, but they did not think about it either. That has always been a matter of regret to her.
The policy intent has always been to exclude novel and rare transplants, including situations in which cells are retrieved from organs that could be used to create an advanced therapeutic medicinal product, as other noble Lords have said. Although some people who wish to do so can leave their bodies to medical research, that research is regulated separately by the Human Tissue Authority, so there really should be no confusion between medical research and transplantation. However, the Minister stated that if a transplant that is currently considered to be rare or novel were to become common, the process of amending the law would be the one that we are following now: discussion, consultation and proposals brought forward by law. My question is this: what would be the trigger for proposing such a change in the law? As other noble Lords have said, looking back over the past 17 years, should we not be looking at a periodic review of transplant law—say, every five to seven years?
I have spoken about black and minority-ethnic communities in your Lordships’ House before. In 2003 my friends Joe and Grace Desa lost their 13 year-old only child Daryl to a brain haemorrhage. Grace and Joe showed remarkable dignity during that unimaginable tragedy. One of the things that comforted them was that many people benefited from organs and tissues donated by Daryl. In 2018, when we looked at the figures again, we saw that people from black and minority communities were still waiting longer than others and that there was comparatively low organ donation from people from the same ethnic groups. It is really important that we make these groups the focus of particular awareness campaigns. I know that my friends Joe and Grace took part in them to try to increase donations from people from south Asian communities.
I welcome the emphasis in this new code of practice on taking into account family and religious beliefs, but I go back to the point made by the noble Baroness, Lady Deech. Is the intention of the code of practice to ensure that a family’s religious belief can take precedence, but not where an individual who has mental capacity has made a deliberate decision that they wish to be a donor? Can the Minister clarify that point? What good practice guides will be given to make sure that specialist nurses who work in organ donation work to clear guidance?
I too hope that the Government set up an independent inquiry into the effects of Covid on black and minority-ethnic populations. I hope that it will not just be about the emergency process that we have been under for the last two months but will look over the longer term at what Covid has done to affect health inequalities in Britain, including transplants.
My final point has not been mentioned by other speakers in this debate. The Human Tissue Authority operates under the EU organ donation directive and the EU tissues and cells directive. If there is no deal, the EU organ donation and tissues and cells directives would no longer apply in the UK. The Government have previously said that in the event of no deal, organisations and authorities in the United Kingdom will continue to work to the high practice standards they do now, but if we are no longer under those same directives as the rest of Europe, people in this country who need organ donations will no longer be treated on the same basis as those in other European countries. The UK would be treated as a third country. Will the Government confirm that if there is a no-deal Brexit, people requiring tissues and transplants of organs from other countries will be at a disadvantage? Will they issue updated guidance on this? The guidance they produced back in 2018 no longer stands.
We all want better and quicker availability of life-saving transplants for people who need them. We broadly support these regulations, and I hope the Government will make sure that in these difficult times there are the resources to make them happen in practice.
Baroness Thornton (Lab)
My Lords, I draw attention to the register of interests and my position as an NED of a hospital trust. I agree with the very important last point made by the noble Baroness, Lady Barker, about the European Union rules and regulations. It would be a great shame if we lost our ability to access or give organs across Europe because the Government had crashed out.
It is a great pleasure and honour to speak in this debate. Of course there are some Covid-related questions to be asked, as anticipated by the Minister, but I confess that it is a relief to undertake some positive legislative work, which is the everyday business of this House.
I do not wish to appear ungracious at a time of great agreement and celebration about this Act and these regulations. However, listening to the Minister’s opening remarks, one might be forgiven for thinking that this was a government Bill, when it was in fact a Private Member’s Bill, brought forward by two of my honourable friends in the Commons. As the noble Baroness, Lady Barker, said, it is a great example of parliamentarians doing their job over quite a long period of time and bringing forward progressive legislation that people really want. That the Government backed this is of course vital, and I congratulate them and the Minister on doing so.
I thank the Minister for his excellent introduction, my noble friend Lord Hunt for his inspiring and thorough speech, and all noble Lords who participated in this debate. I commend my noble friend for taking the legislation through your Lordships’ House and gaining support across the House, as illustrated by the contributions today, for this important and life-enhancing change.
The Organ Donation (Deemed Consent) Act 2019 amended the Human Tissue Act 2004 to allow consent for organ donation from deceased donors to be deemed in specified circumstances. These new arrangements have been referred to as “deemed consent”, but “opt-out” has generally been used in public communication, including in the press. During the passage of the Bill, noble Lords scrutinised effectively how the very sensitive issues dealt with in it and these regulations might be handled, so we are now finally able to agree the final regulations.
I do not intend to rehearse the many moving stories about organ transplants here today. We all understand how important this change is and, as many noble Lord have said, that its effect will save lives and change lives for the better. However, I take this opportunity to further press the Minister about the low level of transplants during the period of lockdown. Just 99 organ transplants were carried out in the UK in April, which is the lowest number for 36 years.
While we understand the need to delay operations given the demands on NHS capacity, as well as the risk to patients of proceeding with a transplant and being heavily immunosuppressed in a hospital environment, the fall in the number of operations is deeply concerning. It will inevitably lead to a backlog of patients needing organ donations and increased waiting times and mortality rates. The data has also shown that just 206 patients were added to the waiting list in April, down from 524 in March, suggesting a delay in assessment that could leave patients waiting even longer for a new organ. This is especially important given that the Covid-19 pandemic has resulted in further pressures on the supply of organs too. Patients who test positive for coronavirus cannot be donors, while the lockdown measures have resulted in a decline in the number of road and industrial accidents so there are fewer organs available for transplantation.
Can the Minister give the House a timetable for when this situation will improve? What steps are the Government taking to ensure that those who may require a transplant are assessed and, if necessary, added to the transplant waiting list during the pandemic? How quickly will transplant operations be back to the level of before the crisis? If we are unfortunate enough to experience another spike in Covid-19 and have to bring back the lockdown, and have more Covid-19 patients in our hospitals, will the NHS—with the experience gained from the last few months—seek to have hospitals which can continue to undertake transplant surgery in a Covid-free and protected environment?
I find myself completely in agreement with the noble Lord, Lord Naseby, and my noble friend Lord Hunt that communication and promotion of these regulations and the new law is now vital. I close by paying tribute to Geoffrey Robinson, the former MP for Coventry North West, Dan Jarvis MP and my noble friend Lord Hunt, who sponsored the Organ Donation (Deemed Consent) Bill on which these regulations are based. The ambition is a big one: to achieve an 80% consent rate in England, which will add at least 280 extra donors a year. This could lead to as many as 700 more transplants a year, which seems a very worthwhile aim.
Lord Bethell
My Lords, this has been an excellent and wide-ranging debate. I welcome the moving and constructive contributions. We are committed to restoring transplant services as soon as possible and reaping the benefits of this excellent legislation. The statistics that I presented earlier are a ray of sunshine at a difficult time.
The noble Lord, Lord Hunt of Kings Heath, put it all very well: there are thousands of people up and down the country who are in desperate need of a transplant. While Covid-19 has completely stopped services in some countries, in Britain we have been able to continue with very urgent transplants, which is a testament to the great work of NHS Blood and Transplant and NHS England.
We now want to go further and take something positive from this horrible pandemic, which has been a stark reminder of how fragile life really is. We must take the chance offered by this excellent law to save lives. I thank the noble Lord, Lord Hunt, for his excellent contribution last year, as the noble Baroness, Lady Thornton, rightly reminded us all, in taking the Bill forward in the first place. He has shown remarkable commitment in following up this important cause and I reassure him that we will make sure that resources are in place to make this policy a success.
On marketing, I reassure the noble Lord, Lord Oates, and the noble Baroness, Lady Thornton, that we will pick up the campaign that was delayed at the beginning of the Covid-19 epidemic. We have every hope that it will cut through. As the noble Baroness, Lady Barker, rightly said, this campaign will target BAME audiences, who are often underrepresented among donors and often cannot find the match that they seek. In 2018, my department launched a campaign to address the myths and barriers, and to create a culture of normality around organ donation. This included funding of £140,000 for the community investment scheme for grass-roots projects. We invested a further £280,000 in 2019 and this work will now pick up again. I reassure the noble Lord, Lord Naseby, that, according to a survey by NHS Blood and Transplant, 58% of people are already aware of this change in the law and, with our marketing, this percentage will keep rising.
Noble Lords also raised the important issue of equality for those waiting for a transplant. Our aim is to help with health inequalities and we are aware that people from black and Asian backgrounds wait for six to 11 months longer for an organ match, compared with the general population. This is clearly unjust and we will put in measures to address it.
I reassure the House that discussions with the family will remain our paramount consideration at all times. On that point, I want to assure the noble Baroness, Lady Deech, by repeating the assurances made by my noble friend Lord O’Shaughnessy that, if the family strongly disagrees, no donation will go ahead as no doctor and no nurse will want to upset the family further. My noble and learned friend Lord Mackay, my noble friend Lord Blencathra and the noble Baroness, Lady Randerson, also raised an important point on deemed consent. However, as linked to the above point, from the outset we have said that the family will be involved. If the family is not around, clinicians cannot establish the medical history and other crucial information about the deceased, and the transplant would be risky.
Of course we take deemed consent very seriously. We have based it on the successful implementation in Wales since 2015. To respond to my noble friend Lord Blencathra, the Human Tissue Authority specifically consulted healthcare professionals and that body will be monitoring implementation in its role as the regulator. In addition, we will keep raising awareness of the importance of organ donation.
I reassure the noble Lord, Lord Hunt, that we will ensure that the additional specialist nurses are well trained, carefully managed and thoughtfully recruited so that they are the right people to have these delicate conversations. I reassure my noble friend Lord Blencathra that they are in fact much better suited than senior clinicians who, if I may put the point delicately, might not have the emotional intelligence or delicacy for such a sensitive moment. I reassure the House that I have spoken to the team about how they will continue their training on deemed consent, taking into account, if necessary, videoconferencing technology to hold the necessary conversations in a Covid environment.
My noble friend Lord Bourne of Aberystwyth asked an important question about deemed consent across borders. To be clear: you can deem the consent to remove, store or use the organ only in England under our new law, but once removed that organ can be transplanted to a patient anywhere in the UK.
The noble Baronesses, Lady Barker and Lady Thornton, made important contributions about continuing to secure organ transplants in the context of EU exit. Each year the UK exchanges a small number of organs with EU member states. In 2018-19, the UK received 14 organs from EU countries and there were 3,951 UK transplants. The focus is on negotiating a future relationship with the EU, but my department is also preparing for a scenario where no further agreement is reached with the EU, which is the legal default position. The current regulatory framework for organs is well established and sets high-quality safety standards for organs imported into the UK.
I thank the noble Lord, Lord Goddard of Stockport, for his positive words around this legislation. I reassure him that we want the conditions of deemed consent to be met, which means that transplants can go ahead when it is safe and training for returning specialist nurses has been completed. The legislation will come into effect on 20 May, but we acknowledge that it may not come into practice straight away due to the limitations of Covid.
I was greatly touched by the testimony of my noble and learned friend Lord Mackay, who spoke movingly of his friend’s experience. I remember that on 15 September 2002 my wife called me with a pain in her eye. She had a corneal puncture which threatened the sight in her right eye. Her left eye is very weak from childhood infections. I cannot disguise from noble Lords that that diagnosis was very grim and she was looking at a life without sight. The surgeon, the wonderful Mr Bruce Allan at Moorfields, helped find a cornea for transplant, which is an organ for which many families are reluctant to give consent. As a result, I am glad to say that my wife retains her eyesight today. To that donor and their loved ones, the Bethell family are enormously grateful.
Through the noble Baroness, Lady Randerson, I thank our friends in Wales, as we are in the privileged position of having modelled deemed consent in England and its implementation on its successful implementation in Wales. As the noble Baroness rightly suggested, our specialist nurses here will benefit greatly from their colleagues’ experience in Wales.
I reassure the noble Lord, Lord Oates, that we will make sure that the NHS has the resources to carry out the additional transplants, including using affordable novel technologies as appropriate. Following funding from the department, NHS Blood and Transplant has recruited 27 new specialist nurses, which is an increase of more than 10% in that important role.
The noble Baroness, Lady Deech, the noble Lord, Lord Mann, and my noble and learned friend Lord Mackay of Clashfern raised the important issue of faith. We are aware that organ donation is in some cases against someone’s culture, faith or belief. That is why we have worked closely with a wide range of faith and belief representatives regarding the change in the law. For example, there are pages on the NHS Blood and Transplant website about organ donation in the context of each of the major UK faiths and beliefs. We are grateful to the all those faith and belief groups which have engaged with us. We and NHS Blood and Transplant will also continue our work with faith communities as the law is implemented.
It is right that this legislation is approved to provide legal certainty that deemed consent will apply only to routine transplants which so many people in this country need. I reassure the noble Baroness, Lady Deech, that, after consultation, we have expanded the list of parts of the reproductive system that are to be excluded from deemed consent. We have clarified that no part of the reproductive organs, for example, vessels, will be removed without express consent, even if they were to be used to support a routine transplant. We have also added renal and lung epithelial cells to the list of advanced therapy medicinal produces as they are possible future technologies.
I thank all noble Lords for sharing their views on these regulations. I thank my predecessors, my noble friends Lord O’Shaughnessy and Lady Blackwood, and many others in this House and in the other place, such as Dan Jarvis and Geoffrey Robinson, who have supported this important measure. I join the noble Lord, Lord Hunt, in thanking the many charities which have campaigned for this, such as Kidney Care, the British Heart Foundation, NBTA and Team Margot. The regulations are an integral part of making the new system of consent work and I urge all my fellow parliamentarians to approve them. We owe it to everyone waiting for a transplant to make sure that this law comes into force and makes a difference to those in need.