Policy background
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
	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.
	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.
	Since the introduction of an opt-out system in Wales, consent rates in Wales have increased from 58% in 2015 to 72% in 20173. 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 (i.e. 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 transplant4.
	Under the pre-existing rules in England, a person was considered a possible organ donor following their death only if they actively took steps to consent in their lifetime. In practice, this was 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.
	The purpose of the Act 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 Act 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; 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 do 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.
	The policy underlying many of the provisions in this Act 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.
	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 passing of this Act and the changes coming into effect, to allow time for a public awareness campaign and new measures to accommodate concerns from faith groups.