BMA Briefing Paper - Presumed Consent For Organ Donation, UK
November 13, 2017
Given the media coverage of the forthcoming report from the Organ Donation Taskforce on presumed consent, journalists covering this issue over the weekend may find the BMA's briefing paper on presumed consent useful.
A general quote on this issue follows:
Dr Tony Calland, Chairman of the BMA's Medical Ethics Committee (MEC) said:
"Every year people die because a donor cannot be found to allow their transplant to go ahead. Evidence from other countries has shown that a system of presumed consent can address the shortage of donor organs and can save lives. The BMA supports a "soft" system of presumed consent, where individuals who do not want to donate their organs have a formal mechanism for registering that objection and where families are consulted to identify any unregistered objection. We believe this is more likely than the current system to ensure that the individual's wishes are respected.
"Of course a system of presumed consent is not in itself a magical cure and the BMA has already stated that it strongly supports the raft of measures already proposed by the Task Force. We very much hope that these proposals will greatly enhance donation rates and the BMA will do whatever it can to help promote that goal. We still believe, however, that in the longer-term, the UK will need to consider legislative change. Public support for such a change is already growing but we need to continue to raise awareness and encourage public debate.
"We look forward to reading the full report and are committed to working with the Taskforce to achieve our common goal - to improve organ donation in the UK."
Useful background information: Click here.
The BMA supports a system of soft presumed consent, with safeguards, for organ donation by deceased people over the age of 16. In this system, relatives' views would always be taken into account.
The BMA believes that genuine choice over organ donation can be facilitated through a soft system of presumed consent whereby adults can choose to opt-out of organ donation during their lifetime, rather than having to opt into donation, as is the status quo. A culture in which donation is perceived as the norm rather than the exception would fit better with what most people claim to support. Rigorous safeguards are imperative to such a system, in order to ensure genuine choice is protected. In our view, relatives must still have a role in the organ donation process. This brief outlines the reasons the BMA supports such a change and addresses some common concerns around how such a system would work.
Each year hundreds of people die waiting for an organ transplant. At the same time, others die in circumstances where donation would be possible, but does not happen, not because the deceased objected to donation but because they never got around to signing up to the Organ Donor Register (ODR) or informing their relatives of their wishes. The gap between the supply of organs for donation and the numbers of people requiring a transplant is increasing at approximately 8 per cent per year. (Reference 1) The current system is unable to meet the increasing demands placed upon it and steps must be taken as a matter of urgency to both improve donation infrastructure and increase the availability of organs for transplantation. The BMA has long called for concerted action to improve all aspects of transplantation. (Reference 2) Improving organ donation infrastructure and increasing donor numbers are interdependent measures. Donation rates cannot be successfully improved without better infrastructure and resources. Creating an environment in which donation is the normal choice would allow for the improved resources to be fully used.
The BMA has welcomed initiatives to improve the situation and in particular the implementation of the Human Tissue Act 2004. Under this Act, transplantation in England, Wales and Northern Ireland is covered by a single piece of legislation. In addition, the Act clarifies the legal position on the use of non-heart beating donors and facilitates the donation by living volunteers. Legislation in Scotland - the Human Tissue (Scotland) Act 2006 - is based on the same principles as the rest of the UK.
The BMA has welcomed the Organ Donation Taskforce's recommendations to improve infrastructure and funding around donation. It is continuing to work to raise awareness, amongst the public and doctors, of the need for more organ donors, as this is essential to any system. If fully implemented, the infrastructural changes recommended by the Taskforce would address some of the shortfalls in the current system, such as missed opportunities for referral to a transplant co-ordination team and diagnosis of death by brain stem tests. One of the reasons for the relatively low donation rate in the UK, however, is the 40% of cases where relatives do not consent to donation. Often they have to decide without knowing what the deceased individual wanted and against a background in which saying no may appear to be the standard response to uncertainty. We believe that the introduction of an opt-out system for organ donation would reduce uncertainty and change the cultural context in which such decisions are made, by making donation the norm.
There is increased interest in presumed consent amongst the public, politicians and the profession. The Chief Medical Officers in all four nations have indicated their support for presumed consent, if the public endorse it and the Prime Minister has signalled his personal support for such a system. Professional support is also growing. The BMA adopted its policy eight years ago and was joined by the British Transplant Society and the Royal College of Nursing endorsing a move to presumed consent in Spring 2008.
The BMA strongly emphasises that public support for a shift to presumed consent is an essential pre-requisite for any change. A wide-ranging informed public debate is necessary and is gaining momentum following the work of the Taskforce. A broad public information campaign is also needed which gives careful consideration to targeting the most vulnerable sections of society.
Extent of the problem
The gap between the number of organs available and the number of people needing a transplant shows no sign of narrowing and the waiting list for organs stands at an all time high. (Reference 3)
- More than 9,000 people need an organ transplant in the UK.
- The median (average) waiting time for an adult kidney transplant is 841 days. Children wait on average 164 days.
- Adults wait an average of 103 days for a heart and 406 for a lung. Children wait an average of 143 days for a heart.
- Adults wait an average of 95 days for a liver transplant, while children wait an average of 76 days.
- More than 400 people die every year in the UK while waiting for a kidney, lung, heart or liver transplant and many more die before they even get on to the transplant list. (Reference 4).
We believe that a shift to a soft system of presumed consent, alongside increased funding and infrastructure, is necessary to address the increasing shortage of organs in the UK.
A 'soft' system of presumed consent
Repeated surveys show that the majority of the public say that they support organ donation. In the last survey conducted in 2003 for UK Transplant 90% of people claimed to support organ donation but, for various understandable reasons, only 24% of the UK's population is registered on the NHS Organ Donor Register.
Opponents of presumed consent often argue that such a system is an affront to patient autonomy because it removes choice from donors but we need to consider how patient choice works in the present system. Around 25 per cent of organ donors in 2006/07 had registered their positive choice for donation on the ODR. (Reference 5) In the remaining 75 per cent of cases, families decided on behalf of the deceased. Faced with the decision, around 40 per cent of relatives opt for the default position, which is not to donate. (Reference 6) We know that in some cases relatives refuse to donate because the deceased made it clear in their lifetime that they did not want to. (Reference 7) Everyone has the right to refuse to donate their organs after death and to have that wish respected. Under the current system, however, there is no formal mechanism for people who feel strongly against organ donation to register their objection. In the absence of such a mechanism it is impossible to be sure whether patient autonomy is being respected after death. A key reason relatives refuse donation is because the wishes of the deceased are unknown, on the other hand family members rarely go against the known wishes of the deceased. (Reference 8).Under a system of presumed consent, individuals are far more likely to have discussed their views with their families and to have made their views clear on the ODR before death.
Contrary to the view that under a presumed consent system individuals lose rights over their own bodies and power is devolved to the state, individuals are more likely to make decisions during their lifetime under such a system. They will also have their decision respected after death. Moreover, the burden of making a decision is removed from relatives in the most difficult of circumstances, when they often have no clear indication of what the deceased would have wanted.
The BMA supports the type of 'soft' system of presumed consent in which relatives' views are always taken into account. Retaining a role for relatives serves a dual purpose. First it acts as a safeguard - families may be aware of an unregistered objection to donation. Secondly, it recognises doctors' duty of care towards relatives to relieve, and not add to, their distress in bereavement.
The crucial difference would be in the approach to relatives. Instead of being asked to consent to donation, they would be informed that their relative had not opted out of donation. Unless they object - either because they are aware of an unregistered objection by the individual or because it would cause them major distress - the donation would proceed. Statutory guidance surrounding new legislation must provide clear guidance to professionals on how to deal with relatives' refusals. Assessment of what would cause 'distress' would have to be carried out on an individual basis by trained professionals who are experienced in dealing with bereaved relatives. The introduction of a 'soft' system of presumed consent would represent a shift of emphasis in favour of donation without major changes to practice. It would respect both the wishes of the potential donors and the sensitivities of their families.
In summary, a 'soft' system of presumed consent would allow organs to be removed for donation after the individual's death unless:
- the individual had registered an objection to donation during his or her lifetime; or
- it is clear from information provided by the individual's relatives that the individual had expressed an objection to donation that had not been officially registered; or
- it is apparent that to proceed with the donation would cause major distress to the individual's relatives.
Hard presumed consent
The BMA does not support a hard system of presumed consent, whereby no role for relatives is retained. Under such systems, relatives are not consulted after death and cannot object to donation if no formal statement of dissent has been made, even if they are aware of an unregistered objection.
In the BMA's view such a system would be unethical because it would not provide adequate safeguards for potential donors and would not respect the duty of bereavement care owed to relatives.
Registration for opting out
As mentioned above, prior to any presumed consent system being introduced, an extended high profile information campaign must take place. Any legislative change must be accompanied by continuing publicity, including about the mechanisms by which people can register their objections easily and quickly. A central computerised register of those who wish to opt-out would be required which must be properly designed and maintained to ensure that it is kept up to date.
Checking the register should be mandatory before any organs are removed and, as an additional safeguard, families should be asked whether they are aware of any objection that had not been registered.
Children and young people
The BMA believes that the system of presumed consent should apply only to those over the age of 16. Those under that age should certainly have information if they wish but the main responsibility for a decision after the child's death would continue to rest with their parents or guardians, who would normally take the child's known wishes into account.
Careful Parliamentary consideration needs to be given to safeguards to protect the most vulnerable adults in society, including those with impaired mental capacity, the socially isolated and those seeking asylum in the UK. Ultimately it is for legislators to decide on specific safeguards appropriate to the various different groups in society, in consultation with stakeholders. The BMA does not believe, however, that blanket exceptions or automatic exclusion of some groups from presumed consent are appropriate but rather that steps should be taken to facilitate individual decision making to the greatest extent possible. Where individuals cannot understand the choice, or have not had the time and information to choose for themselves, it clearly cannot be presumed that they consent to donation. Making it a priority for specially tailored information to be available in ways vulnerable people can comprehend it will help. Many people with impaired capacity, for example, will be able to make a choice and are entitled to have their wishes respected. In line with our general view, that relatives should also be consulted for all deceased potential donors, the views of families, advocates and legally appointed proxy decision makers would also be very important.
There has been a marked public shift in support of presumed consent over the past nine years. In May 1999 the Department of Health commissioned a survey of public opinion on preferences between the status quo and a change to a system of presumed consent. In that survey, 50% expressed a preference for the current system, 28% supported a shift to presumed consent and 22% expressed no preference. Since then, however, there has been more publicity about the shortage of donors and about presumed consent and a number of more recent surveys have shown increasing support for such a shift.
- In October 2007 a YouGov survey commissioned by the BMA showed that 64% of respondents would support a soft system of presumed consent.
- In July 2000, an Omnibus survey of 2,000 people carried out on behalf of the National Kidney Research Fund found that 57% of those questioned would support a system of presumed consent.
- In February 2001, a telephone poll conducted by Watchdog Healthcheck attracted nearly 52,000 people and found that 78% of those who responded supported a shift to presumed consent.
- A survey of MPs carried out in March 2001 by the National Kidney Research Fund found that 59% of the 163 MPs who completed the questionnaire supported a soft system of presumed consent.
- BBC 4's 'Today' programme before Christmas 2003 asked listeners to vote on suggested Private Members' Bills. The second most popular bill in the poll was to allow all organs to be used for transplant after death unless an individual had opted out.
- In May 2005, a representative sample of 2,067 people over 16 years of age were interviewed on behalf of the BBC and 6/10 respondents supported a shift to presumed consent.
The BMA believes that with further debate and information about the way such a system would operate, there will be widespread public and professional support for such a change.
It has been BMA policy to support a soft presumed consent model of organ donation since 2000. The BMA represents the majority of UK doctors. Its policy is determined at the organisation's Annual Representative Meeting by locally elected representatives.
The Royal College of Surgeons, the British Transplant Society and the Royal College of Pathologists have also declared their support for a system of presumed consent. The Royal College of Nursing removed its opposition to presumed consent in Spring 2008.
Assessing the success of presumed consent
Meaningful data on the success of presumed consent in other countries are difficult to achieve because such legislation is only one of a number of factors influencing donation rates. There is increasing evidence, however, that countries that adopt a system of presumed consent have higher donation rates than those that do not. The BMA believes that key factors centre on some things already identified by the Taskforce, such as better resources, higher staffing levels including numbers of transplant surgeons and coordinators, more training and availability of ITU beds and specialist units. It also believes that a culture in which donation is the normal thing to do could be hugely influential.
A study published in March 2003 (Reference 9) analysed whether a presumed consent policy and other variables can be used to predict the cadaveric organ donation rate per million population in Europe. It concluded that presumed consent (opting out) was a significant predictor of cadaveric organ donation rates. The authors suggested that the implementation of presumed consent legislation had a significant effect on the number of cadaveric donors per million population. They advised that "as the gap between the supply and demand for transplant organs continue to widen, professionals and policymakers should consider revisiting the implications of the legislation, or some hybrid of alternatives, as an effort to expand the 'gift of life' to those in need."
A detailed regression analysis (2006) comparing 22 countries over 10 years took account of determinants that might affect donation rates: per capita GDP, health expenditure, religious beliefs, legislative system, and number of deaths from traffic accidents and cerebrovascular diseases. It concluded that "When other determinants of donation rates are accounted for, presumed consent countries have roughly 25-30% higher donation rates than informed consent countries." One explanation is that, even if the family has the final say, countries with presumed consent legislation have fewer refusals. (Reference 10)
Although this is helpful background, clearly there is also a need for specific and contemporary UK research as well as attempts to extrapolate data from those existing countries with presumed consent.
The BMA's position
The BMA supports the introduction of a system of soft presumed consent for organ donation. The main factors underpinning this decision are:
Studies show that the majority of people say that they would be willing to donate their organs for transplantation purposes, but only around a quarter of the population are on the NHS Organ Donor Register.
Given that the majority of people say that they would be willing to donate, presuming consent rather than presuming objection is more likely to achieve the aim of respecting the wishes of the deceased person.
Unlike the current system, there would be a clear mechanism for protecting the wishes of those who do not want to become a donor.
While relatives would still be consulted, they would be relieved of the burden of making the decision in the absence of any indication of the deceased person's wishes.
A shift to presumed consent would prompt more discussion within families about organ donation.
With such a shift, organ donation becomes the default position. This represents a more positive view of organ donation, which is to be encouraged.
Despite the acknowledged difficulties of obtaining meaningful data about the success of presumed consent in other countries, the BMA believes that, as one part of a broader strategy, a shift to presumed consent is likely to have a positive effect on donation rates.
1. Department of Health. Organs for Transplants. A report from the Organ Donation Taskforce. January 2008
2. British Medical Association. Organ donation in the 21st century. Time for a consolidated approach. London: BMA, 2000.
3. UK Transplant. Record year for transplants - but need for donors greater than ever. Press release, 27 April, 2007.
4. UK Transplant. Record year for transplants - but need for donors greater than ever. Press release, 27 April, 2007.
5. UK Transplant. Transplant Activity in the UK, 2006-2007. UK Transplant: 2007.
6. UK Transplant. Potential donor audit, 36-month summary report, 1 April 2003 - 31 March 2006.
7. Barber et al. Potential for organ donation in the United Kingdom: audit of intensive care records. BMJ May 2006; 332: 1124-1127.
8. Siminoff et al. Factors influencing families' consent for donation of solid organs for transplantation. Journal of the American Medical Association. 286 (1), 71 -77.
9. Gimbel RW, Strosberg MA, Lehrman SE, Gefenas E, Taft F. Presumed consent and other predictors od cadaveric organ donation in Europe. Progress in Transplantation 2003; 13(1):17-23.
10. Abadie A, Gay S. The impact of presumed consent legislation on cadaveric organ donation: a cross-country study. J Health Econ 2006;25:599-620.
Note: the removal of organs from people after their death is covered by the Human Tissue Act 2004 (for England, Wales and Northern Ireland). Legislation on issues relating to human transplantation is a devolved matter for the Scottish Parliament and is covered by the Human Tissue (Scotland) Act 2006.