Draft Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020 — House of Lords, 2020-05-18
Topic: Health
James Bethell (Conservative, Centre-right): 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.