Draft Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020

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.

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, the noble Lord, 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.

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.

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.

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.

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.