Consultation outcome

Consultation on introducing ‘opt-out’ consent for organ and tissue donation in England

Updated 5 August 2018

This was published under the 2016 to 2019 May Conservative government

1. Introduction

The donation of organs and tissue after death helps to save thousands of lives in England each year. Just one donor could transform the lives of up to 9 other people. Earlier in 2017, national figures confirmed that over 50,000 people are known to be alive thanks to organ donation and transplantation.

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%. There are close to 24 million people on the NHS Organ Donor Register (figures from NHS Blood and Transplant).

Despite this, there is a shortage of donors in this country, with around 6,500 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.

Consent rates are also below the ambitious targets set out in the current UK strategy. Because of this shortage, 3 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 6 months longer on average if they need an organ transplant.

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. This can put pressure on family members to decide. The number of families in England that consent to donation of their loved one’s organs is significantly lower than many other countries with an organ donation programme.

In October 2017, the prime minister confirmed that we need to do more to help people who need transplants, which are currently limited by the number of donors that come forward, by shifting the balance in favour of organ donation.

2. Purpose and scope of the consultation

The government considers that it is the right time to revisit the issue of consent and to change the legal default on consent for organ and tissue donation in England. Although 8 out of 10 people say they would want to donate their organs and tissue after their death, most never register to be organ donors. This change would mean the system better reflects the position of the majority of people who would be happy to donate their organs and tissue when they die. It will also respect the decisions of those who do not wish to be organ and tissue donors.

The purpose of this consultation is to consider how changes to the organ donation system in England should be implemented and whether there are other steps that should be taken.

It seeks responses on the following:

• Proposals to make it easier for people to register their decision on organ and tissue donation. This is to ensure decisions people make about organ donation are honoured after their death.

• Proposals to change the law so that people would be considered willing to be an organ donor unless they decide to opt out. We invite views on the potential impact on certain groups, for example, people who have protected characteristics in law such as disability, race, religion or belief.

• How family members should be involved in confirming decisions in future.

• Proposals for changes, exemptions and safeguards for certain groups of people under the new system.

The consultation is considering consent for organ and tissue donation after death only. The government is not proposing any changes to the current rules and processes regarding living donors.

The consultation is open for comments for 12 weeks.

3. Making it easy for a decision to be known under ‘opt-out’ consent

3.1 Recording a decision about organ and tissue donation

Currently in England, there is an ‘opt-in’ basis for consent for organ donation. This means that donation will only ever proceed if a person had given their express consent for organ donation – either by registering on the NHS Organ Donor Register or making their decision known to their family.

If the person’s decision is not known, their family is approached for consent to proceed with a donation. People who are happy to be organ donors, but who do not make their decision known, risk this decision not being honoured after their death.

At present, people can decide through the NHS Organ Donor Register to opt in, to opt out, or to appoint a representative to make a decision after death. It will continue to be possible to record these decisions in future.

This would not change under the proposed new system. The aim is to make sure people are aware they can opt in or opt out, making both decisions easier to record.

3.2 What your decision means

Decision	Current system	Future system
Opt in	You can choose to donate all or some organs and tissues	You can choose to donate all or some organs and tissues
Opt out	You can choose not to be an organ donor after your death	You can choose not to be an organ donor after your death
Nominate	You can appoint a representative decide	You can appoint a representative to decide
Do nothing	Family approached for consent for donation to proceed	Would mean you support becoming a donor – this consultation asks what the family role should be

A new opt-out system of consent would have to make it much easier to record a decision, to change it if necessary and to keep it up to date. The government has plans for every patient in England to be able to access their own medical records and complete a number of different services online, which includes decisions on organ donation.

The core change proposed by the government is on the default legal position. Subject to certain exclusions, described later in this consultation, a person will be considered to have consented to organ and tissue donation after death unless they opt out. This makes it even more important that people are aware of the changes and can simply and easily make their decision clear.

Other government administrative procedures could be used to capture as many people’s decisions about organ donation as possible. This is already done, for example, when registering for a driving licence. Decisions could be recorded when using other health settings, such as dental surgeries or opticians.

Q1. Do you think people should have more ways to record a decision about organ and tissue donation?

• Yes – there should be as many ways as possible to record a decision, including when people are doing other things, such as registering with a GP
• No – you should only be able to record your decision directly onto the NHS Organ Donor Register online or on the phone

3.3 Potential recording of additional information on a decision

It could also be beneficial to record additional information on a person’s decision to donate. This could help build further confidence in the system and, for example, reduce concerns people can hold about treatment of a body after death, or help make information on a person’s faith clearer.

However, the government considers that any developments in this area would need to balance with the overarching priority of keeping processes for recording a decision as simple as possible. Simple processes are the best way of ensuring people engage in organ donation and are supported to register.

In addition, family members and clinical teams will always need to have confidence that a person’s decision is known and have easy access to it. Recording additional information around a person’s decision, or having increasingly bespoke requirements, could introduce complexity and uncertainty into the process.

Q2. What do you think are the advantages or disadvantages of including personal information on someone’s organ donation decision?

3.4 Public awareness

NHS Blood and Transplant, hospitals, stakeholder organisations and people with personal stories to share about donation or transplant already do a lot to promote the importance of organ donation across England.

This promotional effort focuses on encouraging people to sign up as organ donors on the NHS Organ Donor Register and to tell their families that they want to donate and save lives.

To implement the new system of consent successfully and support increased rates of organ donation, the government considers that an extensive communications campaign would be required both before and after legislation comes into effect.

Q3. How can we make people more aware of the new rules on organ donation?

Q4. If the law changes, would this affect your decision about organ donation?

• No – it would make no difference
• Yes – it would make me want to become an organ donor after my death
• Yes – it would make me want to opt out of being an organ donor after my death

4. Changing to an opt-out system of consent

4.1 Considerations of equalities

Moving to an opt-out system of consent would affect people from different backgrounds in different ways. The government considers there to be no impact for those with the protected characteristics of gender reassignment, pregnancy and maternity, and sexual orientation.

There could be some indirect impact on the protected characteristic of sex, if more women than men die in circumstances to donate (or vice versa).

Age and disability are important factors when considering how consent is obtained. The government does not consider either to be negatively impacted by proposed changes. Where a person is not able to make an informed decision on the basis of disability, the government is proposing that exceptions should be introduced on the basis of age and mental capacity to ensure that these individuals are not negatively impacted.

These are set out later in the consultation.

The proposed changes have a more significant impact in relation to race and faith.

4.2 Race

Patients from black and Asian backgrounds are more likely to suffer from certain diseases, which means they are much more likely to need an organ transplant. See ‘Organ donation and transplantation data for Black, Asian and minority ethnic (BAME) communities’, 2017 to 2018.

Transplants are more likely to be successful when the donated organ is a very close match to the recipient. The lack of organ donations from people from black and Asian backgrounds means that people from these backgrounds wait much longer for a transplant, and are therefore much more likely to die in need of a transplant.

The National Black, Asian and Minority Ethnic Transplant Alliance (NBTA) has described the main challenges facing organ donation among black and Asian communities in the UK, which include:

• lack of knowledge
• less willingness to discuss organ donation with family members
• concerns about bodily integrity after death

The government is committed to a national campaign, working with different member organisations and others, to increase the number of black and Asian organ donors. We also want to understand whether other actions could address any concerns on moving to an opt-out system of consent on the basis of race.

4.3 Faith

Faith and culture play an important part globally in people’s decisions to donate organs. (See ‘Death and organ donation: meeting the needs of multi-ethnic and multi-faith populations’, Randhawa G (2012), British Journal of Anasthaesia).

In recognition of this, active engagement of faith communities on the issue of organ donation has been a priority in this country (PDF, 649KB).

Engagement to date has included a Faith Action Plan, which has provided a basis for sustained engagement with a wide range of followers and worshippers from different faiths. There is a range of information on organ donation already available to increase awareness among the major faiths in the UK: Buddhism, Christianity, Hinduism, Islam, Judaism, and Sikhism. However, opinions will differ even within the same faith.

The Organ Donation Taskforce considered the attitudes of different faith and belief groups towards an opt-out system of consent. This work highlighted significant reservations from people of certain faiths about the impact of moving to an opt-out system of consent, particularly for people less comfortable with the prospect of the change. These concerns included:

• the definition of death as brain stem death being incompatible with the beliefs of some faith groups
• the need to allow for personal choice and the importance of donation under conditions of informed consent
• difficulty in establishing whether a person who has not opted out has made an informed decision to donate
• unease and negative perceptions about a shift in the balance of power between individuals and the state

With these concerns in mind, changing the default of consent could therefore increase the risk of more people deciding to opt out, where they would otherwise be happy to support donation under the current opt-in system.

Given the government’s aim to increase the number of organs available for donation, we want to understand how best to address these concerns where they occur on the basis of race or faith.

For example, this could include continued engagement with faith leaders, ensuring that the system of consent for organ donation is well-publicised over time, and considering whether additional information could be included in a person’s decision that reflects the requirements or traditions of their faith or other beliefs.

Q5. If the law changes, people would be considered willing to be an organ donor unless they have opted out.

Do you think this change could have a negative impact on people from some religious groups or ethnic backgrounds?

• Yes
• No
• Don’t know

4.4 Family involvement in decisions to donate

Changing the law on organ donation consent would have a direct impact on families. There are different options for settling the role of family members in decisions on organ and tissue donation consent. The government considers that there are 3 potential roles for the family in the future system.

The options for family involvement are:

• no role for families in consent
• an expectation that family members are consulted, to understand what their relative’s decision was
• a formal ability to overrule consent

Lack of family consent is an important factor that determines whether potential donations go ahead. Decisions on organ donation consent take place at a highly emotional time following the death of a relative.

Where a potential donor has not made their decision known, it can be difficult for relatives to decide on their behalf. This puts pressure on family members or close friends.

Families may not support organ donation because they are not sure what their loved one would have wanted, or because they knew their relative did not want to be a donor. They may also withhold consent if they believe their relative ‘had been through enough’ or out of concern that the time involved in the donation process increases distress.

Family members are approached, if organ or tissue donation becomes a possibility, to seek information about a number of issues, including:

• whether they knew the decision their relative had made regarding organ donation
• whether the family had reason to believe that their relative had changed their mind following recording a decision on the NHS Organ Donor Register
• medical and lifestyle history to ensure that organs would be safe to transplant

4.5 Family members making the final decision regarding organ donation

At present, there is no legal requirement to consult with the family of a deceased relative where appropriate consent is in place at the time of death. In practice, families or a nominated individual will be consulted to confirm a decision even where a donor has expressly recorded their wish to become an organ donor and ‘opted in’ under the current system of consent to organ donation.

Q6. If the law changes and someone has died, and they have not opted out of organ donation, should their family be able to make the final decision?

• Always – if someone has not opted out, their family should always be asked to make the final decision
• Sometimes – there are some circumstances where someone’s family should make the final decision
• No – if someone has not opted out, donation should always go ahead
• Other (please give details)

4.6 Family members overruling decisions regarding organ donation

Organ donation always occurs at a time of great distress for the family, after hearing that a loved one has died or is expected to die. Many people therefore find it very difficult to be confronted with a decision at this time.

In 2016 to 2017, 53% of families refused to allow donation to take place if, at the time of discussion with clinical staff, it was unknown if their relative had expressed a decision to donate or recorded their decision on the NHS Organ Donor Register.

In many cases, families find it much easier to support donation if they know the decision of their loved one. Over 90% of families agree to donation if they know it was what their loved one wanted to do after their death. However, around 100 families each year do not support a decision to consent as recorded on the NHS Organ Donor Register. As a result, the donation does not proceed.

This means that under current practice, clinicians are unable to honour a person’s active decision to become an organ donor. In Wales, deemed consent can be rebutted if the person’s family show that he or she was opposed to donation. In contrast, a different system of opt-out consent is in place in France. Under this system, everyone is considered to be an eligible donor unless they sign the ‘refusal register’, leave a signed letter or tell their next of kin, who must make a signed ‘declaration of refusal’.

Q7. Do you think someone’s family should be able to decide if their organs are donated, if it is different to the decision they made when they were alive?

• No – someone’s family should never be able to make a different decision about organ donation
• Sometimes – there are some circumstances where someone’s family should be able to make a different decision
• Yes – someone’s family should always make the final decision, even if it is different to what the person decided

4.7 Changes needed to introduce an opt-out system of consent

The Human Tissue Act 2004 provides the legal basis for the current opt-in system in relation to organ donation in England. People must actively consent to being an organ donor in England, meaning they have to choose to opt in. Organ donation (and other specified activities) are lawful if there is ‘appropriate consent’.

Changing to an opt-out system in relation to organ and tissue donation in England would require people to actively withhold their consent if they did not want it to be a possibility after death, and certain changes to legislation would be needed to achieve this.

The government accepts that there would have to be a solid and well-understood legal framework to any new system, in order to secure the confidence of the public and clinicians. A move to opt-out consent would also likely require changes to clinical practice and professional ethics, including the referrals process between clinical teams and specialist nurses for organ donation.

During this consultation period, the Department of Health will be engaging closely with clinical leaders to understand the implications of potential changes to practice and guidelines.

4.8 Exceptions and safeguards in a new system

In all forms of healthcare, it is an established legal and ethical principle that a person consents before starting a treatment or physical intervention. In most cases this means that consent must be voluntary and given by an informed person with capacity to consent to the intervention in question.

The government considers that, even following a move to an opt-out system of consent for organ donation in England, there are some groups of people where existing opt-in consent should continue to be obtained, from the individual either themselves or a parent, guardian or family member.

Living children, who are competent to make decisions, can give their own consent. Where a child is not competent (or has not decided), appropriate consent can be given by a person with parental responsibility for that child. If there is no such person, a person in a qualifying relationship can decide. Living adults must actively give their own consent on what happens to their body after death. Where an adult has not given consent, nor made a decision not to consent, a person who has been appointed as their nominated representative can decide. If there is no such person, a person in a qualifying relationship can decide.

A person in a qualifying relationship could include a spouse, civil partner, partner, parent, brother, sister, grandparent, grandchild, child of a brother or sister, stepfather, stepmother, half-brother, half-sister and friend of long standing.

There are exceptions that include people for whom there may be concerns about their ability to make a decision and fully understand the consequences of it. Exceptions include the following people.

Children

Generally in England, children are able to give consent to medical treatment themselves if they are competent to do so. The courts have stated that under-16s will be competent to give valid consent to a particular intervention if they have ‘sufficient understanding and intelligence to enable him or her to understand fully what is proposed’ (known as ‘Gillick competence’).

Although the circumstances will vary, consent to medical treatment is often obtained on behalf of a child from a parent or guardian where the patient is under 16. However, the government considers that it would be appropriate to exclude children aged under 18 from an opt-out system of consent for organ and tissue donation after death.

This would mean that, unless a child has capacity and has recorded their decision, the person with parental responsibility would continue to give consent for organ donation to occur. Under the system in Wales, for example, opt-out consent does not apply to people aged under 18.

People who lack capacity

This includes, for example, an adult with advanced dementia or severe learning difficulties who is unlikely to be able to understand the consequences of not opting out. The government agrees that it is important that a lack of capacity should not be assumed, and that support is provided to help someone to make an informed decision where possible and appropriate. However, the government considers that it would be appropriate to exclude people who lack capacity from an opt-out system of consent for organ and tissue donation after death.

The government intends to consider other groups for exclusion from the general position of an opt-out system because of their particular circumstances. These include:

• short-term visitors to England such as tourists
• people who are temporarily resident in England such as overseas workers, students and overseas armed forces personnel

Q8. Which of the following should not be included in the proposed new rules about organ donation?

• children under 18 years old
• people who lack capacity
• visitors to England
• people living in England for less than 12 months (for example, students from overseas, armed forces personnel)

Are there any other groups you think should not be included? Please say why you think this.

5. Impact assessment questions

An opt-out system of consent has been in place in Wales since 2015. The latest evidence on this shows that awareness of and support for the soft opt-out system of organ donation in Wales is high among the public and NHS staff.

Consent rates have also risen. However, analysis of routine data does not show any consistent change in deceased organ donations in Wales, and a longer period of monitoring is required to understand the impact of the change in the law.

Q9. Please tell us about any opinions or evidence you have about opting out of organ donation.

A consultation-stage impact assessment examines the evidence base for moving to an opt-out system of consent and provides additional information on:

• whether an opt-out system would change the organ donation consent rate
• whether higher consent rates increase the number of transplants
• whether implementing an opt-out policy is a good use of health system resources

The Department of Health would welcome any further quantitative evidence you have on the following areas:

• for people who have received a transplant:

  • any evidence on the financial costs of this to the health system and wider society
  • the quality of life of the individual and those around them

• for people who would benefit from a transplant but have not had a transplant:

  • any evidence on the financial costs to the health system and wider society
  • the quality of life of the individual and those around them

• any other factors that have not been considered in the consultation analysis, which could impact on the desired outcome to increase the number of organs for transplant in England, or which could have other considerable costs/benefits