Below is the text of the statement made by Helen Whately, the Minister for Care, in the House of Commons on 19 May 2020.
I beg to move,
That the draft Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020, which were laid before this House on 25 February, be approved.
Before I explain the draft regulations, I would like to say a few words about why we are changing the law on organ donation. Today more than 5,000 people in England are waiting for a transplant, but, sadly, by the time a suitable organ is found some people will have become too ill to receive one. Tragically, last year alone 777 patients were removed from the transplant list and 400 died waiting for a transplant. There is no option but to take decisive action to address the acute shortage of organs and save the lives of those waiting for a transplant. That is why we passed the Organ Donation (Deemed Consent) Act 2019, which amends the Human Tissue Act 2004 and sets up the new system of consent for organ and tissue donation in England, which is known as “deemed consent” or “opt-out”.
I wish to thank the hon. Member for Barnsley Central (Dan Jarvis), my hon. Friend the Member for South Basildon and East Thurrock (Stephen Metcalfe), my right hon. Friends the Members for Maidenhead (Mrs May) and for South West Surrey (Jeremy Hunt), a previous Member of this House, Geoffrey Robinson, and Lord Hunt of Kings Heath for their work and support, which has got us to where we are today. They all started this journey for us showing immense leadership, and they continue to show their strong commitment to this cause.
Subject to approval of these regulations, we aim for deemed consent to become legal on 20 May. While not many transplants are 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. Guidance on how best to restart or extend the transplant service was sent by NHSBT to all transplant units on 26 April. A letter was then sent on 1 May to all trusts with transplant units, asking them to actively review the situation where transplant units have reduced their services.
To illustrate the progress that is being made to get the transplant system up and running again, on a normal day NHS Blood and Transplant would have received about 55 referrals of a potential donor and would aim for five actual donors, and it would carry out about 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. Continuing the tremendous effort to restore all transplant services will enable us to reap the benefits of the deemed consent legislation as soon as possible; by “benefits” I mean save the lives of people waiting for transplants.
I understand that some have disagreed with the timing of going ahead with this law, but we assessed the impact of going ahead with deemed consent very carefully. This horrific pandemic taught us a lot about how precious human life is, and we know that the fight against it will continue for some time, while thousands of people will still be waiting for a transplant. I therefore believe very strongly that we have a duty now, more than ever, to push ahead with measures that will reduce human suffering and help people to improve their quality of life. 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 to the House in July 2017, and became law in March 2019, so it has 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 20 May implementation date has been used actively in communications since late February. Putting this legislation on hold would increase the anxiety of thousands of people, who see this law as their only hope to get a new lease of life, and would confuse the communications that have already been in the public domain for some time.
From the outset, we have been clear that deemed consent would apply only for routine transplants, to increase the number of organs and tissues available and help those that are on a waiting list. Examples of routine transplants are heart, kidneys or lungs. Novel transplants will still require express consent. The organs and tissues specified in the regulations are included because they could be used for non-routine transplants, such as a face transplant. Such transplants are outside the scope of what we want to achieve. 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 the regulations with no comments. Meanwhile, the Secondary Legislation Scrutiny Committee drew the regulations to the attention of the House, and this is testimony to how integral the regulations are for making the new system of consent work, and how important the law change will be when it is introduced.
Let me now discuss the detail of the regulations. The Organ Donation (Deemed Consent) Act 2019 sets out that deemed consent to transplant activities in England will apply only to permitted material. The Secretary of State has a delegated power to specify in regulations what relevant material—meaning, what organs, tissue and cells—will be excluded from the system of deemed consent. To clarify, the organs, tissues and specific cells that are listed in the draft statutory instrument are organs, tissues and cells that 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 that will require express consent in order to be transplanted under all circumstances—such as 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 put it beyond doubt that removing any parts of a reproductive organ will require express consent in all cases. This is to ensure that if and when such transplants are carried out in future in the UK, they will be outside the scope of deemed consent.
Regulation 2(3) sets out that some relevant material—for example, skin or 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, under which tissue from a leg, for example, is removed routinely, are not disrupted by deemed consent. So, although a leg transplant would require express consent, if only the skin from a leg is taken, deemed consent may apply; however, if tissue is required from reproductive organs, this will always require express consent. That addresses the 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 is to allow routine heart and lung transplants, which also require the trachea to be removed with the heart and lungs, to continue under deemed consent. 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 advanced therapy medicinal products—also known as ATMPs—which are therapies made from tissue cells or genes after manipulation in a laboratory. They are used for treatment of a disease or injury, and often use human tissues and cells as starting materials. For example, an ATMP can treat knee damage by taking cartilage cells from a living patient, growing and modifying them in a lab, and re-injecting 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 tissue and cells taken from living donors, but it is also possible to use material from deceased donors to develop novel ATMPs. As such ATMPs are novel, we want to make sure that the donation of such cells cannot happen without express consent being in place. Our consultation raised questions about the public’s understanding of such novel technologies, so we 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 regulations would be needed in future, the Government would need to consider evidence, public acceptability and clinical need, guided by recommendations from NHSBT’s advisory group research and innovation in transplants. Any changes would need to be approved by Parliament, following the same procedure as we are now, so Parliament would have full oversight. The regulations restrict deemed consent to routine transplants, so they continue current practice, under which express consent needs to be in place for non-routine transplants. There is no additional cost to the health system, so no impact assessment has been prepared.
In conclusion, I am glad that I am able to present these regulations to the House today. They are an important part of the implementation of the 2019 Act, as they prevent deemed consent from applying to novel transplants. The new system of consent will help to save and improve the lives of many people waiting for a transplant. Donating organs is one of the greatest gifts a person can give. I urge everybody to talk to their families and their loved ones about their wishes. I am proud that all of us present are playing a part in making something positive happen in these very challenging times. I commend the draft regulations to the House.