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

Lord Bethell Excerpts

Monday 18th May 2020 Lords Chamber

Moved by

[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 Motion was considered in a Virtual Proceeding via video call.

[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.

--- Later in debate ---

[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.

Motion agreed.