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Frequently asked questions
What you need to know about the Organ Donation Bill.
- What happens now if you want to donate your organs and tissues after death?
- What happens now if you do not want to donate your organs after death?
- To what extent has Wales delivered on the Organ Donation Taskforce recommendations made in 2008?
- Why did organ donation numbers drop in Wales in 2012/13?
- What changes are being proposed?
- When will these changes come into effect?
- Why are you proposing a change to the current opt-in system?
- What are the effects of the current shortage of organs?
- What are the benefits from introducing a soft opt-out system?
- What evidence is there that people support organ donation and would be willing to accept a change in the system?
- What will the legislation do?
- What is deemed consent, to whom will it apply and how will it work in practice?
- What is express consent, to whom will it apply and how will it work in practice?
- Which organs and tissues will be covered by the soft opt-out system?
- Will novel transplantation be included such as face and limbs?
- What is the role of family members in deemed consent cases?
- When you say you are going to give family members a right to object based on the wishes of the deceased, what do you mean by that?
- What about people whose family cannot be contacted, but who have registered a wish to be a donor?
- Why are families allowed to stop donation, even under the current system, if someone is on the register as an organ donor?
- Would family members be able to overturn a recorded opt-out decision?
- How will you decide who lives in Wales?
- What happens if I live in Wales but die in England?
- How will the soft opt-out system work for those without mental capacity? How will they be protected?
- Which system will you use to record individual’s wishes under the soft opt-out system?
- How will people be able to opt out?
- How can I register my objection?
- Will a decision not to be a donor ever be overturned?
- Will the existing Organ Donor Register be kept in Wales?
- Will there be an opportunity to opt-out of donating some organs and tissues?
- What will happen when a person turns 18, moves to or from Wales, or changes their mind?
- What are the likely costs of introducing a soft opt-out scheme in Wales?
- What plans do you have for a public awareness campaign?
- Won’t an opt-out system mean a change in the way patients are cared for, including the treatment they receive up to and including their death?
- How will organs donated under deemed consent be used?
Currently an opt-in system applies whereby people give their consent to donating their organs and tissues by joining the NHS Organ Donor Register.
This system very much relies on people making their wishes known, and this immediately presents a challenge, because only around 30 per cent of the population are on the Organ Donor Register. The result of this is that many people who may have had no real objection to being an organ donor do not end up donating organs after their death, even though they could have done so, because families often do not know what their deceased relative would have wanted.
Currently about a third of deceased donations come from people who said they wanted to be donors and joined the Organ Donor Register.
Two-thirds are therefore from people who were not on the Organ Donor Register at all. In the vast majority of cases, therefore, we do not know people’s wishes. In such cases families make the decision, but in many instances, they do not feel able to agree to donation going ahead because they do not know what their relative would have wanted.
If you do not want to be an organ donor, there is currently no way of formally recording your wishes and you must make your views clear to your family or put them in writing. However, there is nothing to stop family members from giving their consent to donation after your death if they choose to do so.
We have made significant progress in Wales thanks to the dedication of the teams involved across the Health Boards and within NHSBT. Nine of the fourteen recommendations of the Organ Donation Task Force have been fully implemented in Wales and work is ongoing to fully implement the remaining recommendations.
A significant proportion of the ODTF recommendations were about changing clinical practice particularly in relation to referral and approach. Considerable progress has been made such as development of clinical pathways and guidance, the appointment of embedded specialist nurses and clinical leads for organ donation in the critical care units and an Organ Donation Committee within each LHB.
Despite these improvements, in Wales there are still around 250 people at any one time on the active waiting list for a transplant and in 2011/12, around three people a month died while waiting for a transplant. We believe, having put the infrastructure in place, we need to take the logical step of bringing forward the right legislation to bring about further increases in the consent rate. This is what our soft opt-out will do.
Over the last five years, the numbers of deceased organ donors in Wales has followed a generally positive trend. For example in 2011/12 there was a 49 per cent increase in deceased donation compared to 2007/08.
Fluctuations in these figures are to be expected and, because the numbers involved in these statistics are relatively small, slight changes in numbers can affect the overall picture greatly. The trend, rather than single year changes, tells the important story.
There is no specific evidence that the fall in donor numbers is related to the Welsh Government’s proposed legislation on organ donation. We believe a system of deemed consent is the most effective way to increase the numbers of organs available for transplant and save lives.
On Dec 3rd 2012, The Welsh Government introduced the Human Transplantation (Wales) Bill into the National Assembly for Wales. The Bill provides for a soft opt-out system of organ and tissue donation for adults who live and die in Wales.
This means unless a person either registered a wish to be a donor, or not to be a donor, their consent to donation will be deemed to have been given. After death relatives will still have an important role to play in the processes around donation. No donation would take place unless someone close to the deceased person was present.
The Bill is currently going through the legislative scrutiny process in the National Assembly for Wales. If the Bill is passed by the National Assembly for Wales then it could receive Royal Assent by summer / autumn 2012.
However the new system will not come into effect until 2015. This will allow time for an extensive two year public information campaign to ensure members of the public are informed on what the changes will mean and about the choices they can make.
The shortage of human organs and tissues continues to cause unnecessary deaths and suffering, both to patients waiting for a transplant and their relatives. We believe a soft opt-out system will increase the number of organs and tissues available for transplantation. This is supported by international evidence which suggests an association between countries with opt-out type systems and an increased donation rate.
Organ and tissue transplantation is one of the most successful forms of modern medical treatment and is also very cost effective. One donor can improve or save the lives of up to nine other people by donating their organs and many more through the donation of their tissues.
Campaigns to encourage people to join the Organ Donor Register have succeeded in increasing the number of people expressing a wish to be an organ donor. In Wales, over a third of the population is now on the Organ Donor Register and in 2011/12 there was a 49 per cent increase in donation rates compared to 2008. Unfortunately, despite all the efforts, there is still a shortage of organs for transplant.
The Welsh Government believes that now is the time to bring forward a change in the law and introduce a soft opt-out system.
The Welsh Government acknowledges that no individual action such as introducing a change in the organ and tissue donation consent system will deliver all the necessary increases in organ donation. Other activity which has improved how organ donation and transplantation is organised, with better systems and more staff in place, will continue.
In Wales, in 2011/12, 37 people died as a donor could not be found to enable transplantation to go ahead. Across the United Kingdom more than 500 people die each year while waiting for an organ transplant.
Organ and tissue transplantation is one of the most effective forms of modern medical treatment that saves lives and improves quality of life for patients with organ failure.
The key benefit is to increase the number of organ and tissue donors in Wales resulting in a greater number of lives saved and quality of lives improved.
Very few of us will ever die in the circumstances where organ donation will be a possibility – because of this, it is important to have a system in place to ensure maximum numbers of donors as possible are identified.
Opt-out systems for consent to donation are already in place in a number of other countries in Europe and elsewhere. Their success varies and is dependent on a number of other factors but research suggests that organ donation rates from deceased persons increase by approximately 25 to 30 percent in countries where an opt-out system applies. A similar increase in Wales could mean an additional 15 or 16 donors and around another 45 organs becoming available.
Financially, it will also make a difference to the NHS in Wales, because people who have a transplant no longer have to receive expensive and sometimes long-term treatment like kidney dialysis. The money saved can be reinvested in services for other patients.
People who have had transplants also have a better quality of life and rely much less on other services, such as social care. This is better for them and helps relieve pressure on services too.
What evidence is there that people support organ donation and would be willing to accept a change in the system?
Most people when asked are very supportive of donation in theory. The vast majority would also accept an organ or tissue if they or a member of their family needed one. Organ donation and transplantation is also supported by all major religions.
The Welsh Government initially sought views on this issue in 2008/09, resulting in a consultation ‘Options for changes to the organ donation system in Wales’. The majority of responses to the consultation (81 per cent) supported a change to the organ donation system in Wales to a soft opt-out system.
The publication of the White Paper was the first stage in the development of the Bill and sought the views of the public on our proposals. While the White Paper was not consulting on the principle of the legislation, 52% of the 1,234 respondents to the consultation took the opportunity to indicate that they supported the policy, and 39% opposed it.
In addition, Beaufort Research Limited undertook a series of Focus Groups to support the formal consultation exercise. Those participating in the focus groups represented a range of ages and a number of to Black and Minority Ethnic communities. The participants were in favour of organ donation.
The BBC St David’s Day Poll published on 1 March 2012 indicated that 63% of the Welsh public supported the introduction of an opt-out system of organ donation.
The Bill sets out the legal framework for how consent is to be given in Wales to the donation of organs and tissues for transplantation. It covers transplantation activities for living and deceased donors in Wales.
The Bill creates two new types of legal consent to the donation of organs and tissues in Wales – these are express consent and deemed consent. Deemed consent will only apply to deceased donation.
The main change introduced by the Bill will be to treat those people who have not opted out as though they have no objection to organ donation. An adult will have had to have lived in Wales for more than 6 months before they died for deemed consent to apply to them.
This change will only affect adults who live and die in Wales. People who might lack capacity to understand the deemed consent arrangements will not have their consent deemed.
Deemed consent will be the main change introduced by the Bill. It will affect people over the age of 18 who live and die in Wales. Deemed consent will not apply to living donation.
For deemed consent to apply an adult will need to have been ‘ordinarily resident’ in Wales for 6 months or more, this includes people studying or working in Wales for a settled period.
Ordinarily resident does not include prisoners or other people not living in Wales voluntarily, such as members of the armed forces.
The reason for the 6 month minimum period is because people will need to have been given enough time to understand the new law and to have the opportunity to opt out, if they wish to do so.
In this category, adults will be deemed to have given consent to organ and tissue donation unless:
- they had already given consent themselves by saying they did want to be a donor (opted in)
- they had already stated they did not wish to be a donor (opted out)
- they had appointed a representative to make a decision about consent for them or
- they lacked capacity to understand that consent could be deemed or
- a person in a relationship to them objected on the basis of the deceased’s known wishes.
Express consent is either:
- consent given by a person during their lifetime to be a donor (opted in); or not to be a donor (opted out) or
- consent given by a person in a “qualifying relationship” with the deceased person, if the person does not fall within the deemed consent system (for example, because they did not live in Wales and they had not made their wishes known).
Anyone can express their consent during their lifetime, including children and young people under the age of 18 and people who lack capacity (who may be facilitated to make a decision).
The organ and tissues covered by the soft opt-out system will be the same as the current system. Donation covers organs and tissues including kidneys, heart, liver, lungs, pancreas, the small bowel, corneas and sclera (from the eyes), valves and pericardium (from the heart), skin, bone, tendons and cartilage.
Deemed consent will not apply to so-called “novel” forms of transplantation. The types of transplant being discussed (i.e. hand, face) are known as composite tissue transplants and even under the current system, they are dealt with differently.
Current practice, which has been endorsed by the Human Tissue Authority, is to require the express consent of family members even if the deceased person is on the ODR.
At the moment only two teams in the whole of the UK have carried out a very small number of novel donation/transplant procedures (i.e. limb transplants). The teams are in Leeds and London. We do not have the facilities in Wales to carry out these sorts of procedures.
Teams involved in these procedures take specific and separate consent from a qualifying relative. Regulations will set out which organs will not be covered by the deemed consent arrangements.
People close to the deceased will always have a very important part to play in any discussion about organ donation.
In a deemed consent situation, family involvement is essential to give a medical history, residency and possibly also a check on mental capacity (in other words to rule out that the individual might be an “excepted adult” in terms of the deemed consent arrangements).
They must also be present to be allowed to provide information about and safeguard the deceased’s wishes. Families will be able to object to donation in a deemed consent system if they know the deceased person would not have wished to be a donor.
It therefore follows that if family members cannot be contacted, a person’s consent to donation would not be deemed as it could not be assumed it would be safe to do so. Therefore, consent would never be deemed in the absence of family members.
When you say you are going to give family members a right to object based on the wishes of the deceased, what do you mean by that?
A clear right of objection for family members will be provided for on the face of the Bill, based on the deceased’s wishes. Where a person does not take action to record a wish either to opt in or opt out, this is in the knowledge that they are consenting to donation.
Allowing people who know the wishes of the deceased to object is a very important safeguard under a deemed consent system, giving priority to the deceased’s wishes whilst at the same time allowing family members to rebut the presumption of consent. This is in accordance with the prevalent approach in Europe.
If a person is on the register as an organ donor (i.e. they have opted in) then they have already given express consent and it is not legally necessary to seek the further consent of family members. It could therefore be seen as reasonable to proceed based on the express wishes of the donor.
Whilst this has happened in perhaps a very small number of cases, it is not generally thought to be good practice to proceed without family members present. This is because they are asked a number of questions about the deceased’s lifestyle and medical history which are there to assure the quality of donated organs and the safety of the recipient.
To proceed without these questions places the onus on healthcare professionals to make an assessment of the risks to the recipient in taking organs from a donor whose medical and lifestyle history could not be checked with family members because they were not present.
Why are families allowed to stop donation, even under the current system, if someone is on the register as an organ donor?
In these cases, as happens now, families do not have the legal right to object to donation, but in practice doctors would be unlikely to proceed if the family is acutely distressed.
Healthcare professionals have a duty to be sensitive to the surviving family members and cannot be compelled to do something which is against their conscience.
It is clear that if someone has opted out of organ donation, then their wishes must be respected and no organs should be taken.
If the patient could have been a candidate for organ donation, but had opted out, then it is likely that families will be told of the position, in the interests of openness and transparency.
However, only in the very unlikely event that family members could produce clear evidence of a change of mind could a reversal of this position be considered.
To decide whether a person is a Welsh resident they must satisfy each step of a three stage test, which is whether the person:
- has a current address is in Wales;
- generally lives at that address ('is ordinarily resident') ; and
- has lived at that address (or another address in Wales) for six months or more.
An address will be treated as being in Wales if it falls into the local 'gazetteer' of a local authority in Wales. The local gazetteer is a list of all addresses known to the local authority which they would use for example to send out electoral registration forms. It is a widely used system for determining addresses and will be used so as to avoid any doubt about the person residing in Wales.
As is the case now, the opt-in system will apply to a Welsh resident who dies outside Wales. This will mean that if they have expressed a wish to opt in, the next of kin will be sensitively encouraged to accept their decision. But if no wish has been expressed, it would be for the next of kin to give or withhold consent for donation. If a person has registered a wish not to be a donor under the new arrangements in Wales, this decision will still be valid, and would need to be respected, if they died in England.
How will the soft opt-out system work for those without mental capacity? How will they be protected?
The Bill does not alter the ability of any person to express, during their lifetime, a wish to donate their organs or not to donate and they will also be able to use the new register for Wales to express a wish. In doing so, their mental capacity will not be questioned.
Every effort should be made to facilitate those lacking capacity to understand the new law and to make a decision in the light of it.
Where a person had not expressed a wish to donate or not to donate, and, following discussions with family it became apparent they lacked capacity to understand that consent could be deemed, their consent will not be deemed to be given. In these cases, the person in a qualifying relationship or a nominated representative will be asked to make the decision about organ donation.
There will be one single register which will record:
- a decision to donate organs; or
- a decision to not to be an organ donor.
It will also be able to record 'partia' decisions, i.e. if someone only wants to donate some but not all of their organs. People who decide not to express a wish one way or other will not be included on the register.
The soft opt-out system would ensure there will be a robust and secure system for individuals to make an objection to donation of some or all of their organs, therefore, protecting the wishes of those who do not want to become a donor.
Under the new system, there will be a single new register recording a person’s wish to donate or not to donate. People who decide not to express a wish and to have their consent deemed will not be included on the register.
An individual will be able to register a wish not to donate via a number of ways. Direct online registration of wishes will be available, and there will also be forms and telephone assistance for those who do not wish to use the internet. All of the registration mechanisms will be available bilingually and in a variety of other languages.
If the legislation is passed, there will a period of time before the law is changed, giving people the opportunity to opt out if they wish. There will also be a communications campaign to advise people on how they can opt out.
For now, the Welsh Government would encourage everyone to ensure that people close to them are aware of their wishes regarding donation.
No. If someone has recorded a wish not to be a donor, then their family will not be approached and asked to participate in discussions around organ donation. Only in rare circumstances where a member of the family produces other written evidence contradicting a registered objection and dated later could donation even be considered.
Work is underway in conjunction with the other UK countries to decide on whether to update the existing Organ Donor Register to allow for developments in different parts of the UK. There will be the ability to register a wish to be a donor, as currently exists with the Organ Donor Register.
Yes, as under the current arrangements, an individual will be able to register their intentions to donate all organs and tissues or to select specific organs or tissues.
The Welsh Government recognises that a person will only be covered by the soft opt-out system if they had a sufficient opportunity to object to donation.
The soft opt-out system will need to be sufficiently flexible to accommodate changes after the main introduction of the new arrangements. Such changes will include:
- an individual changing their mind, for example previously objecting but now wishing to donate;
- people who move to or from Wales;
- young people reaching the age of 18.
Implementing the opt-out legislation will cost around £8 million over 10 years. The detailed costs are included within the Regulatory Impact Assessment.
Under the proposed soft opt-out system for Wales, consent to the removal and use of organs and tissues is deemed as having been given unless the deceased objected during their lifetime.
In order to ensure an individual has the opportunity to make an objection, there must be access and availability of information about the soft opt-out system in Wales and ability on the part of the individual to understand the information available and reach a decision.
The Bill places Welsh Ministers under an obligation to educate and inform the public of Wales about organ donation in general and in particular the arrangements for the soft opt-out system.
In order to be fair to all citizens and to safeguard their human rights it is essential that information is made available. For a soft opt-out system to be brought into law an extensive publicity campaign will be needed.
The public awareness campaign will be extensive both in its use of different forms of media and in its duration- from now through to implementation of the new law.
We will take all reasonable and proportionate steps to ensure the public is informed about the new legislation in a manner that is accessible.
Won’t an opt-out system mean a change in the way patients are cared for, including the treatment they receive up to and including their death?
No. There are very clear and strict standards and procedures for confirming death. Clinicians responsible for patient care and for confirming death are independent of those responsible for the retrieval and transplantation of organs. This will not change.
There is no intention to change the way that organs and tissues are allocated by NHS Blood and Transplant. This means organs donated in Wales may, as they do now, go across the border into England to be used there.
The Bill allows for the legal use in England of organs donated in Wales, as well as organs coming into Wales from elsewhere.
It is not possible to use all organs donated in Wales for Welsh patients, because there will not always be a suitable match to a person on the waiting list.
However, having more organs available in total will be of benefit to Welsh patients who may not have to wait as long for a suitable organ to become available.