Policy background
4 The donation of organs and tissues after death helps to save thousands of lives in England each year. Just one donor could transform the lives of up to nine other people. In 2017, national figures confirmed that over 50,000 people are known to be alive thanks to organ donation and transplantation. 1
5 There is widespread public support for organ donation, with around 80% of people saying that they support organ donation ‘in principle’, and would be willing to donate their organs and tissue after they have died. Over the last 10 years, the number of organ donors has increased by 75% and deceased transplants have increased by 56%. 2 There are almost 25 million people on the NHS Organ Donor Register.
6 Despite this, there is a shortage of donors in England, with around 5,100 people waiting for a transplant. Over half a million people die each year in the UK, but only around 5,000 people die in circumstances or from conditions that mean that their organs could be considered for transplantation.
7 Since the introduction of an opt-out system in Wales, consent rates in Wales have increased from 58% in 2015 to 72% in 2017. 3 However, UK consent rates overall are below the ambitious targets set out in the current UK strategy. Because of this shortage, three people die each day due to a lack of suitable organs. The situation is worse for people from black and Asian backgrounds who, due to genetic differences, are more likely to suffer from an illness that may lead to them needing a transplant. Due to the shortage of matched donors (donors with the same blood and tissue type, usually from the same ethnic group), people from these communities will wait six months longer on average if they need an organ transplant. 4
8 Under the current rules in England, a person is considered a possible organ donor following their death only if they actively took steps to consent in their lifetime. In practice, this is usually a question of whether they have signed the NHS Organ Donor Register and/or discussed their views with their family. Families can also give consent.
9 The purpose of the Bill is to change the way in which consent is to be given for organ and tissue donation in England, for the purposes of transplantation. The Bill provides that, in the absence of a deceased adult having made express provision in relation to consent before their death or having appointed someone to make a decision on consent for them, the default position in most cases will be that consent will be deemed to have been given. This means that, after death, a person will be considered to have consented to organ donation in their lifetime unless they made specific provision to the contrary in their lifetime, they appointed someone to make the decision on their behalf, or there is evidence that would lead a reasonable person to conclude that they would not have consented or an exception applies. It should be noted that these changes on the rules of consent would not apply in respect of all people and deemed consent does not apply to under 18s, as well as certain excepted adults - people who lacked capacity for a significant period before their death such that they could not understand that consent could be deemed in the absence of express action being taken, and people who had not been ordinarily resident in England for at least 12 months immediately before their death.
10 The policy underlying many of the provisions in this Bill was consulted on in the Government consulation Introducing ‘opt-out’ consent for organ and tissue donation in England, which was launched in December 2017. The consultation sought views on a number of issues regarding the implementation of the new system of consent. The Government received more that 17,000 responses from individuals and organisations.
11 The Government’s response to the consultation, New approach to organ and tissue donation in England, was published on 5 August 2018. The Government set out its proposals for implementation. This includes changes to the Organ Donor Register to make it easier to record a decision, a 12-month transition period between the legislation and the changes coming into effect, to allow time for a public awareness campaign and new measures to accommodate concerns from faith groups.
Clause 1: "Appropriate consent" to adult transplantation activities: England
12 This provision amends the 2004 Act to set out when deemed consent amounts to appropriate consent for transplantation purposes. The policy background to this provision is to amend the law regarding when consent is considered to have been given to better reflect the views of the 80% of the population that support organ donation in principle by shifting the default position in relation to consent away from an option to opt-in to an option to opt-out. There are, of course, people who actively made a decision before they died as to whether they do or do not consent to organ donation, or who opted to appoint someone to make that decision on their behalf. In these cases, as in the case of children and living donors, there is no change to the rules. The provision also provides for cases where certain people close to the deceased believe that they would not have consented to being an organ donor, and allows for the presumption of consent to be overturned.
13 The Government has amended the Bill to exclude novel transplants from deemed consent. This is to ensure that the new system of consent is in line with the common understanding of organ and tissue donation.The list of novel transplants will be detailed in regulations made by the Secretary of State following consultation. The regulations will be laid under an affirmative procedure (see Clause 2(5) and (6)).
14 Finally, there are exceptions to ensure that certain vulnerable groups and those that are not permanently resident in England are protected by a move to an opt-out consent system. This applies in respect of people who lacked capacity to understand deemed consent for a significant period before their death, and to visitors and short-term residents in England.
Clause 2: Consequential amendments
15 The purpose of these provisions is to ensure that any organs and tissues removed in England for transplantation purposes can be stored and used wherever needed across the UK, even where there was deemed rather than express consent to the removal of the organ. While the current legislative frameworks in respect of Wales and Scotland already allow for this to happen, without these amendments, only organs and tissue removed in England with express consent from the deceased, their representative or a family member or friend could be stored or used in Northern Ireland for transplantation purposes.
16 This clause also places a duty on the Human Tissue Authority to issue Codes of Practice to provide practical guidance about how deemed consent will work in practice, including the information a person in a qualifying relationship (partners, certain family members or a friend of long standing) would need to provide as evidence that the deceased person would not have agreed to their organs being donated.
17 This clause amends the 2004 Act to set out that the delegated power under Clause 1(5) for the Secretary of State to make regulations to specify relevant material to which deemed consent will not apply, is subject to the affirmative resolution procedure. It also sets out with whom the Secretary of State must consult on such regulations.
Clause 3: Extent, commencement and short title
18 This Bill extends to England and Wales and Northern Ireland. However, as is clear from the text of the amendments to section 3 of the 2004 Act in Clause 1, the deemed consent provisions only have practical application in respect of activities carried out in England. Clause 2(2) and (3) will apply in Northern Ireland, so the consent of the Northern Ireland Assembly will be sought, once it has been restored.
19 Apart from Clause 3, which comes into force on the day that the Act is passed, the provisions in this Bill will come into force on the day or days that the Secretary of State appoints through regulations made by statutory instrument.