The challenge facing the transplant community is how to engage the public in the benevolent act of tissue and organ donation. The arguments concerning the merits of the current opt-in system used in the UK are discussed elsewhere on this website. The principal drawback of this voluntary system is that is does not encourage enough popular support for the life saving process of transplantation. The opt-in system does not satisfy the growing demand for more transplants. [See the "Opt-out or Opt-in?" web link.]

Advocates of the opt-out system believe (presumed consent) argue that more organ retrieval would occur if the UK switched to a system where it is assumed that everyone wants to be a donor unless they declare their opposition publicly in writing. The default position would change from an opt-in to an opt-out approach.

The British Medical Association View

The following extracts from various BMA documents (British Medical Association) outline their justification for an opt-out system:

• It is reasonable and appropriate to assume that most people would wish to act in an altruistic manner and to help others by donating their organs after death.
• Studies show that the majority of people would be willing to donate but only a small number of these are on the NHS Organ Donor Register or carry a donor card. While this level of apathy exists, people will continue to die while waiting for donor organs.
• Given that the majority of people would be willing to donate, there are good reasons for presuming consent and requiring those who object to donation to register their views.
• Given that the majority of people would be willing to donate, there are good reasons for presuming consent and requiring those who object to donation to register their views.
• 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.

These extracts come from the BMA report “Organ donation in the 21st century: time for a consolidated approach” made available in December 2003. The following web link takes you to that report: [BMA web link]

In the debate aroused by Gordon Brown's publicly stated support for presumed consent in January 2008, the BMA published another report that states:

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 – who have been well informed of the options -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 discussed more openly and perceived as the norm 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. The BMA emphasises the need for a wide-ranging publicity campaign to inform the public prior to any legislative change and believes relatives should retain a role in the organ donation process.

The rest of the report published in November 2008 called "Organ Donation" can be read at the following web link: [BMA web link]

A Spanish View

The Spanish model for transplantation is often cited as the proof that presumed consent leads to more transplants. The architect of the Spanish transplant organisation, where they achieve three times the number of organ donation per head of population, is Dr Rafael Matesanz. In a Times article he and John Fabre, (Professor in the Department of Hepatology and Transplantation at King’s College London School of Medicine), made the following observations:

"Last year (2008), the Government embarked on a campaign to convince the nation that an “opt out” or “presumed consent” system for organ donation would improve the rate of donation. This decision, supported by the British Medical Association, is very curious given the weakness of the evidence supporting presumed consent as a factor in organ donation.

"Our view is that it contributes little or nothing to the improvement of organ donation rates and diverts resources to imaginary solutions. An effective transplant coordination network, as recommended by the Department of Health’s Organ Donation Taskforce, is the measure that would really make a difference. The idea that the absence of an objection represents informed consent is plainly nonsense, and consent that is not informed is valueless."

To view the entire article go to the following web link: [The Times article web link]

The Organ Donation Taskforce declined to support the move to presumed consent until such time as their 14 recommendations had been given a chance to succeed – see the recommendations for yourself.['ODT Recommendations' web page]. The recommendations develop further the principles outlined in the “Saving Lives, Valuing Donors -A Transplant Framework for England” from 2003.

We live in a pluralist democracy which simply means that we all share the freedom of expression and right to hold differing views and ideas without fear of recrimination. This leads to the competing and conflicting views highlighted by the differences expressed by the BMA and the two doctors in the Times article above.

‘You pay your money, you take your choice.’

We live in a country that accepts the rule of law. This is the belief that Parliament and government is elected to legislate on behalf of the people of the UK. Currently the legislation relating to donation is framed in the Human Tissue Act 2004. This law promotes an ethical and moral perspective about tissue and organ donation which is strongly based on the notions of informed consent given voluntary without any acceptance of reward. In this legal context donation is held to be an altruistic act of charitable generosity – the gift ideal. Donation is not compulsory or financially compensated.

Parliamentary legislation, particularly in relation to the field of medical activity, is informed by at least four ethical principles:

Autonomy – decision-making that allows the individual freedom of choice

Beneficence – the outcome of the decision benefits the individual

Non-maleficence – the decision does no harm to the individual

Justice – the outcome of a decision is fair & equitable for the people involved especially the patient

In some circumstances not all of these principles can carry equal weight. Sometimes the principles conflict with each other.

There are complex social issues such as assisted suicide and abortion that challenge legislators to create laws that benefit all groups in society. Conflicting priorities make it virtually impossible to satisfy all views in our pluralist society. For example, those seeking to protect the interests of the unborn child would never accept that current laws in the UK give justice to the unborn child. Pregnant women may feel differently. Their partners may hold different views again. Whose position should the law try to uphold and protect?

The dilemma facing families where a loved one wants to die because they are suffering from a terminal illness is impossible to address in a simple ‘black & white’ piece of legislation that can be compassionately applied to all circumstances. To support a relative by taking them ‘Dignatas’ in Switzerland to end their life in a peaceful and dignified manner would be abhorrent to many people. In strict terms it is illegal. But to watch a loved one experience a prolonged and painful death is unbearable too. Whose benefit is being protected? Presumably not the person suffering the intolerable pain. Their autonomy and human rights are being denied by current legislation.

In contrast other people would argue that vulnerable, terminally ill people need the protection of the law to safeguard them against mercenary individuals motivated to assist the death of the relative for financial gain.

These examples illustrate the difficulties in applying ethical principles to satisfy all perspectives. There are no moral absolutes when life and death issues are under discussion - other than the fact that life is sacred. But even then the abortion debate challenges the validity of the sanctity of life. We can follow certain cultural guidelines and maybe religious teachings can contribute to the discussion as well. Legal strictures will always appear fair and reasonable in the eyes of certain people.Whilst to others legislative interference is unwanted and authoritarian. Central directives are regarded as unnecessary constraints on individual liberty and human rights.

Let me put some rhetorical questions to you. If you were lying in a hospital bed waiting for a heart transplant watching the distress on the faces of your loved ones would you be too worried about the consent procedure? Would you care where the heart came from and how it was procured? Would your survival instinct not prevail over moral niceties such as individual liberty or whether the organ was procured in a less than legal manner? It is difficult to answer these questions with certainty unless you have been there.

Now consider this issue from the perspective of a dying patient who could be a donor. Or consider the feelings of the bereaved family members. Compassion and dignity for their deceased love one is paramount. If the wish of the deceased is to be a donor the circumstances of the request for donation become less complicated for all concerned. But what if their views were not known? What if the grief of the family is overwhelming? Whose autonomy should be respected? Donation may benefit the potential recipient but may cause great anxiety for the family. Whose benefit or entitlement to justice should prevail?

How does society balance these competing needs? How can an acceptable consensus be established?

The smoking ban in public places highlights what measures the state can take to achieve goals that are deemed as beneficial to society as a whole at the expense of individual liberty. What if similar authoritarian steps were taken to increase donor and transplant rates?

The smoking ban analogy

We can recall the outrage of smokers in July 2007 when the smokefree regulations were introduced in England banning the smoking of tobacco and other substances in public places.

Complaints about the ‘nanny state gone mad’ could be heard in pubs, bars and clubs throughout the country. The human right of the smoker was overruled for the greater good of society as a whole. State paternalism dictated to individual behaviour. People addicted to tobacco had to conform or be punished. Not only that, but punishments could be handed out to those who continued to damage their health in public places by smoking. The following regulations were imposed:

Local councils are responsible for enforcing the new law in England. If you don't comply with the smokefree law, you will be committing a criminal offence. The fixed penalty notices and maximum fine for each offence are:

• Failure to display no-smoking signs: a fixed penalty notice of £200 (reduced to £150 if paid in 15 days) imposed on whoever manages or occupies the smokefree premises or vehicle. Or a maximum fine of £1000 if prosecuted and convicted by a court.
• Failure to display no-smoking signs: a fixed penalty notice of £200 (reduced to £150 if paid in 15 days) imposed on whoever manages or occupies the smokefree premises or vehicle. Or a maximum fine of £1000 if prosecuted and convicted by a court.
• Failing to prevent smoking in a smokefree place: a maximum fine of £2500 imposed on whoever manages or controls the smokefree premises or vehicle if prosecuted and convicted by a court. There is no fixed penalty notice for this offence.

Local councils are responsible for enforcing the new law in England

The overriding justification for this smokefree legislation is that the health of the nation is improved by introducing this ban in public, which has to benefit the individual smokers too, even though their freedom to smoke has been reduced. Smokers would argue that their autonomy has been removed in order to serve the greater good.They have been denied justice and individual liberty in order for society as a whole to benefit. This demonstrates what can be achieved if there is the social and political will to make a real difference. Laws on wearing seat belts and crash helmets are further examples of decisions where the social good has prevailed over individual rights. So there is a clear precedent for this type of social change.

This is definitely a case of the ends justifying the means.

Supporters of presumed consent for tissue and organ donation would argue the same case. They claim that by assuming that everyone should be regarded as a donor the greater good of more life saving transplants would be achieved. Maybe we should apply the smoking ban principle to tissue and organ donation too?

But are there alternative systems that should be considered in a wider debate? Various options are discussed below. Some will seem extreme, others too moderate. I certainly agree with Doctors Rafael Matesanz and John Fabre that there is not one, single, simple solution to resolving the shortage of suitable organs for transplant purposes. That is why this section of the website must be viewed alongside the progress being made by the Organ Donation Taskforce (view the ODT web page). The shortfall of suitable organs is not just about too few registered donors or not enough consenting donors. There are other factors which have to be addressed. The most fundamental of these is to change the culture in the NHS to regard transplants as a ‘normal’ aspect of medical treatment, not an abnormal one. Every acute trust has a duty of care towards every patient on a transplant list even if they are not in their own hospital. Transplants are a collective and collaborative enterprise that has to confront many barriers. The Organ Donation Taskforce is endeavouring to remove those barriers, but that will take time. Acute trusts must also work hard with their duty of care towards dying patients. Much work has to be carried out to ensure that all patients and their families are offered end of life choices that meet their needs. One of these options should be the right to be a donor. Currently this duty of care does not carry high enough status in many hospitals – but this is slowly changing.

Alternative consent methods

In an ideal world our sense of civic responsibility would encourage all of us to be donors. It would be a cultural norm – something that we all expected to do. The dilemma would then be how to let people down gently because their tissue or organs were not needed! Currently we let people down by failing to procure enough life saving organs. The NHS gives all of us the life saving right to transplant. Only 27% are currently signed up to be donors. How do we correct this inbalance?

It is doubtful if we would ever achieve a full consensus on what type of consent process we should use in the UK. A voluntary approach is preferable, but not if this does not achieve the ultimate goal of saving all lives on transplant waiting lists. Values relating to individual choice and human rights support a voluntary approach in a pluralist liberal democracy. Yet the example of the smoking ban in public places graphically illustrates that a more authoritarian approach sometimes has to be imposed to achieve what is regarded as a social benefit.

Some of the following suggestions for change in relation to donation will offend certain people. They will be deemed too intrusive and authoritarian. Others may feel very comfortable with some of the suggestions, but not others. Gordon Brown called for a debate on the consent system. By considering numerous alternatives an informed debate can take place. Just considering one alternative, such as presumed consent, does not.

Some of the proposals are ‘tongue in cheek’ – playing devil’s advocate if you like. You have to decide for yourself which route you would like to follow. By offering different systems to assess you might be ‘nudged’ in a particular direction, if only because you do not like the alternatives.

I am grateful to Richard Thaler and Cass Sunstein who co-produced their very interesting book entitled “Nudge” (published by Penguin Books March 2009 ISBN: 9780141040011). The authors reason through a system of social change that involves ‘nudges’ – better governance not more government. They argue that the way change is designed and implemented has a real impact on the way we can modify people’s behaviour. They discuss ideas such as ‘choice architect’ and ‘libertarian paternalism’.

They define Libertarian paternalism as "a relatively weak, soft, and non-intrusive type of paternalism where choices are not blocked, fenced off, or significantly burdened. A philosophic approach to governance, public or private, to help homo sapiens who want to make choices that improve their lives, without infringing on the liberty of others. Addendum to sceptics: It is not pledge for bigger government, just for better governance.” In chapter 11 of their book the authors discuss the merits of a presumed consent system. I'm not sure they would support ideas such as 'routine salvaging' that are discussed below. Contempt for such ideas does however have the benefit of 'nudging' people in a directon they prefer more.

Whatever method you feel is the best way forward presumably the main objective of any change has to increase the likelihood of life saving transplants taking place. Otherwise we might as well stay with the current system. An alternative approach has to have legitimacy in the eyes of the public generally and the health professionals that have to carry out the system. The system has to be fair in the sense that it is viewed as equitable and transparent. Transparency is essential to maximise the integrity of the approach and trust from the public. The system should be inclusive and not discriminatory. Whatever method is employed it should allow for a consistent approach that is understood and respected by the public.

a. Routine Salvaging

This is not exactly a compassionate phrase, sometimes used in the USA. It reminds me of the times when I had to go to car disposal sites to salvage spare parts to keep my very old Austin Farina A40 on the road. It was a lovely old car, but in constant need of love and attention to keep it on the road. Recycling car parts was a common task for poor students at college wishing to keep their old bangers going. I’m not sure that using this term for ‘recycling body parts’ would be appreciated by the public. It is as distasteful as the term ‘organ harvesting’. To draw a parallel between the recycling of car parts and organ donation will definitely offend some people. It will challenge their perceptions of good taste and the sanctity of the human condition, whether the person is alive or dead. Routine salvaging will not sit comfortably with those that value informed consent and individual human rights. But watching people die waiting for life saving transplants does not sit comfortably with me and many families that have had to endure the death of a loved one waiting for a heart or new lungs. (Out of interest there is more Parliamentary legislation on the disposal and recycling of vehicles than there is on body parts – what does that tell us?)

Routine salvaging is a very blunt term for removing tissue and organs from deceased people without any reference to the individual’s wishes or their bereaved family. This approach removes the issue of informed consent. It gives the nation paternalistic control over the deceased body. It completely takes away the concept of the ‘gift’ ideal in terms of donation. It places greater significance on the benefits to society as opposed to the autonomy of the potential donor. End of life choices for the potential donor are removed. The balance of interest switches to the recipient. It will surprise readers that over the last two years in the UK only 30% of people that became deceased donors had actually signed the Organ Donor Register. Authority for organ retrieval had been granted by relatives. Seventy per cent of people had not given proactive active consent.

If we were to seriously entertain routine salvaging it would definitely bring about the desired effect of more organs for transplantation. Everyone that dies in a critical care location in a hospital would be a potential donor provided they had no medical conditions that would make them unsuitable. The only barrier to organ retrieval would be if the hospital had the facilities and resources to carry out the procedures.

How would the four ethical principles hold up in the context of routine salvaging?

This system would definitely be beneficial to society, especially patients on transplant waiting lists and their families. The benefit principle does not really apply to the donor because they are dead. If the next of kin had no power to overrule the retrieval of organs then the patient's desire to be a donor would be guaranteed. You could argue that this method achieves the best interests of the majority of people, because most of the public support organ donation even though they do not register their intention to do so. Individuals lose their autonomy with routine salvaging. But we would all be treated the same. Everyone has the right to a transplant – so everyone is rightfully counted as a donor. Difficult decision making is lifted from the shoulders of indecisive families and health professionals that are reluctant to ask families to donate. We are all treated equally.

The process is extremely easy to administer. There is no need to keep opt-in or opt-out databases on computers. There is very little public trust in terms of the accuracy and security of these computer records. Cost is minimised and transplant benefits are maximised. No harm (non-maleficence) comes to the deceased donor provided the diagnosis of death is certain. In this sense routine salvaging is just. It includes everyone and treats all people the same way.

But what about the feelings of the grieving family? In some European countries the family is not allowed to reject a request for donation. This is known as the ‘hard’ option. Routine salvaging would achieve its objective if the ‘hard’ rule was applied. Is this method appropriate when the emotions of recently bereaved relatives are involved? Is this compasionate at a time of acute distress?

What about the wishes of individuals who vehemently oppose the notion of transplants because they regard them as ‘unnatural’ or contrary to their religious beliefs? Is there scope for conscientious objectors? Liberal tolerance usually permits exceptions on the grounds of individual freedom. But should we tolerate ‘free riders’? Social justice is a complex issue. Routine salvaging brings survival for certain patients. It would stimulate more organ supply for transplants. This would remove the huge problems surrounding how to fairly allocate organs that are in short supply. It would give health professionals more scope to get on with saving lives.

So what do we do with moral objectors? Disregard their views? Give them special exemption? If we did this would they be denied the right to a transplant? There are cultural and religious reasons why people will not be donors. They hold a concept of the afterlife that requires them to protect their spirit or soul. Without this ‘wholeness’ they believe that their journey into the afterlife will be impaired. If their bodies are not kept intact then their spiritual identity will be destroyed. That is why certain religious groups are opposed to donation. Religious barriers to transplants and donation cost lives. Is this what God would want?

Out of curiosity am I banned from an afterlife? I am not intact. I no longer have my own heart. Does my donor get excluded from heaven because his body is not in tact? Surely such a generous, selfless individual ought to be guaranteed a place. Oddly enough I have yet to hear anyone refusing to be a donor on religious grounds and validate this position by referring to the ideas of their chosen prophet or God. Similarly I have never heard anyone state that they would not accept a life saving transplant even though they are not prepared to be a donor.

A final thought on routine salvaging. In common law who does the deceased body belong to? The coroner can exercise certain powers when a death is violent, unexpected or unexplained. But where does custody or stewardship lie?

It would be a brave Prime Minister of whatever political persuasion to get Parliament to legislate for routine salvaging. Can you imagine the public outcry and demonstrations that would take place the first time organs were removed from a conscientious objector? The media would have a field day. All trust in the transplant process would be lost over night. Surgeons would refuse to get involved for fear of litigation. NHS staff depend on informed consent to safeguard their actions and the interests of their patients. Routine salvaging does not sit comfortably in a culture of liberal democracy. It raises visions of the state ownership of deceased family members. I suspect that this would be a step too far and political suicide for any government contemplating its introduction. The protests against the possible introduction of presumed consent were very vociferous. I’m certain that a proposal for routine salvaging would lead to public up roar.

Sometimes society has to think the unthinkable to make changes that will benefit the so called greater good. We live in a society that is big on rights.

The Universal Declaration of Human Rights was agreed by the General Assembly of the United Nations in December 1948. Article 3 simply states that “Everyone has the right to life, liberty and security of person.” The full declaration can be accessed at the following web lnk: [Universal Declaration of Human Rights]

Perhaps the right of patients needing a transplant to survive requires us to think the unthinkable? Routine salvaging would certainly save more lives, money and misery. But are we prepared to forgo our autonomy when we die and give authority to the state to retrieve tissue and organs? Or is the preservation of life more precious than our right to determine what should happen to our bodies when we die? The altruistic approach to organ donation currently applied in the UK preserves individual, democratic choice – but it does not guarantee the right to life for people on transplant waiting lists.

I suspect that the human right to determine how your deceased body is respected will always prevail over the needs of people waiting for a transplant. Despite this conclusion the merits of routine salvaging are worth considering if only to inform our perceptions of other consent systems.

b. Priority consent

In the USA and New Zealand an organisation called 'LifeSharers' has been set up to encourage more people to opt-in to their organ donor register. For a detailed explanation of these schemes you can visit the American website at: [LifeSharers USA web link] and the New Zealand set up at:[LifeSharers New Zealand web link]

Right across the world transplant programmes are thwarted by the shortage of donated organs. This is particularly true in countries where we rely on a voluntary, altruistic, opt-in system.

The LifeSharers approach retains the opt-in approach but provides a significant twist. The idea behind LifeSharers is to motivate people to opt-in as organ donors in the same way that currently operates in the UK and USA. The big distinction lies in the fact that anyone who registers through Lifesharers gets priority to receive a transplant over people who are not registered through this ‘club’. The founder of the group, David Undis argues that altruism is not enough to increase the supply of desperately needed organs.

By encouraging people to sign up through LifeSharers the organisation claims it motivates more people to become donors because they can expect priority access to the organs of the other members of the organisation who have died and then DIRECT their organs to likeminded members. Directed donation is legal in the USA under federal law. It is not legal in the UK.

LifeSharers has around 13,000 members – mostly in the California area. There is no cost to join. Anyone is eligible to join regardless of age, physical health, ethnicity and so on. If you register to be a donor through LifeSharers you agree to donate your organs to the most suitably matched person on the LifeSharers register. This then gives priority to the club members. You have to be on their register for at least 180 days before you could become eligible to receive a transplant with organs from a fellow member. Membership of LifeSharers does not exclude a patient receiving organs from non-Lifesharer donors on the national donor list.

There are a number of factors that influence how scarce organs are allocated to patients on waiting lists. There are a variety of criteria that are applied. In the USA the organisation responsible for managing the national list of patients waiting for a transplant is called UNOS (the United Network for Organ Sharing: [UNOS web link] – this is the equivalent of the database managed by UK Transplant).

In very general terms urgency of medical need is the main criterion. Who desperately needs the available heart the most? Who is in the most need for the next available kidney or liver? The patient in greatest urgent need (i.e. nearest to dying) should be the first in the queue for the next available organ. Objective measures are applied in an attempt to remove subjectivity or preferential treatment in the allocation of scarce organs. In the UK for example a points system is used to allocate kidneys. A similar process is used in the USA for kidneys and livers. Compatibility in terms of blood type and tissue matching are the key issues. When a kidney becomes available the nearest biological match is highlighted on the database. With nearly 7,000 people waiting for a kidney in the UK there will usually be many people medically suitable for the same kidney. When matching a heart the physical size of the organ becomes a consideration too. Small hearts fail in large bodies; large hearts cannot be transplanted into small bodies.

Beyond biological considerations other criteria will then come into play. In the UK preference is given to younger patients waiting for a kidney transplant; or patients that have been waiting the longest period of time; the recipient’s proximity to the donor, the overall health of the potential recipient in terms of benefiting from the transplant, lifestyle considerations can be considered and so on. The medical criteria are the most important. The other criteria are applied to distinguish between medically similar candidates.

So how does priority consent improve on the current system?

It is argued that people are more likely to come forward as donors if they believe they have an increased chance of benefiting from a transplant themselves. LifeSharers claim that this will happen when their membership gets to a certain size. The idea of reciprocity encourages people to become donors. LifeSharers reason that people are more committed to become donors if they know that their organs will only go to people that are willing to reciprocate. They claim that people are deterred from becoming donors in a system where most organs go to people who have had no intention of being donors themselves. Social cooperation stimulates more donation. The elimination of 'free riders' encouarges people to donate - or so it is claimed by LifeSharers.

The following American news video highlights the pros and cons of the LifeSharers priority consent system.

The video footage refers to facts and figures that are relevant in the USA. No-one as yet has benefited from receiving a transplant that has been ‘gained’ by merely being a LifeSharer member. There is no objective, empirical data that demonstrates that this priority consent system will actually increase the number of registered donors overall or actual transplant procedures carried out.

On purely ethical grounds could we accept that organs can be allocated to people simply because they have joined a particular club? Is it right that a patient with a less urgent medical need could receive a kidney more quickly than someone on a national waiting list that is closer to death? Directing organs in this way would not be allowed under the terms of the Human Tissue Act in the UK. In the UK only living donors that have been through a rigorous assessment programme are allowed to direct their kidney, liver lobe or lung lobe to a specific, designated person in need who is invariably a blood relative.

Priority consent may increase the number of potential donors, but it introduces the possibility of ‘queue-jumping’ - allowing organs to go to other members in a ‘ring-fenced’ grouping. Organs should be allocated according to medical need, based on objective merit, not by virtue of club membership. This view is countered by the argument that the club is open for anyone to join. By attracting more donors to their register it takes pressure of the national waiting list too.

If the priority system were to be introduced in the UK various changes to the Human Tissue Act would have to be made:

• Giving priority to receive donated organs to club members is definitely an incentive or an inducement to register in this way. In the UK no inducements, incentives or rewards for tissue and organ donation is tolerated. The UK system is fixed on the idea of altruistic donation.
• For the priority system to work the UK would have to accept directed donation of organs from deceased donors to other club members.
• The Human Tissue Act regulates allocation of organs from deceased donors according to medical need. The priority consent system gives preferential allocation of organs on non-medical grounds. This is only tolerated in the UK within the living donation programme.
• Priority allocation of organs would lead to queue jumping. Please excuse the sarcasm, but this is very unBritish. We love to queue!

Without emphatic proof that priority consent would lead to more transplants I suspect the UK Parliament would not make any legislative changes to introduce such a system. This proof does not exist as yet and is unlikely to appear for the foreseeable future.

Further discussion of the LifeSharers model can be read at the following website: [LifeSharers discussion article web link]

c. Preferred consent

d. Conditional consent

e. A Social Contract

f. Mandated Consent

In the UK we accept that organ and tissue transplants are a vital part of medical care offered to the people of Britain. Kidney transplants started in the 1950’s and the UK performed its first heart transplant in 1968. Today there are 34,000 people alive as a result of an organ transplant. 42,000 people have had their sight restored because of cornea transplants. These are tremendous live enhancing and life saving procedures that bring huge benefits to transplant patients, their families and society generally.

Despite these great successes we know that many more people could benefit from transplant procedures if only more donated, viable organs were available. In the UK we have traditionally accepted that to donate an organ or tissue the donor must make a voluntary and informed decision to donate. In a liberal democracy we respect the right of the individual to decide what should happen to their bodies when they die. The autonomy of the individual is guaranteed with regard to organ donation because the individual has to opt-in to the process – a laissez faire or voluntarist approach. If the wishes of the individual are not known then their next of kin or carers can be approached. The surrogate decision makers can give their informed consent for donation. Nearly 70% of deceased organ donation occurs following surrogate authority being given by family members on behalf of the deceased person. In these circumstances the donor had not given an advance directive or explicit consent to donation. The family’s decision becomes a ‘best guess’ on behalf of the deceased donor which may not be a correct reflection of the person’s end of life choices.

The demand for transplants increases each year, yet the number of people who die in circumstances where they can be deceased donors falls well short of the number of organs required. In the last two years (2007/08 & 2008/09) there were 809 and 900 deceased donors respectively. In the same period there were 7,655 and 7,877 patients on the active transplant waiting list – 3,237 and 3,513 solid organ transplant procedures were carried but these figures included 813 and 927 living donors. In 2007/08 2,092 were suspended from the transplant waiting list because they were either medically unstable or too ill to endure surgery and 2,385 patients in 2008/09.

The tragic outcome of this data is that at least one thousand people each year die AVOIDABLE deaths waiting for a life saving organ transplant. It is morally unacceptable to acquiesce with this situation. This is a tragic human cost for the individual concerned, their relatives and friends. It is also an enormous waste of public resources. People with end stage organ failure cost the NHS a significant proportion of their budget simply to keep patients alive long enough to get to a transplant operation. A patient with kidney failure costs in the region of £35,000 per year on dialysis treatment – if there were more kidney transplants the NHS could save in excess of £150 million per annum. Transplants genuinely do save lives, money and misery. What a scandalous waste of resources if the patient ultimately dies for want of a transplanted organ.

In the England the donor rate per million population is 15; in Spain it is 33. Yet we are regularly informed by opinion poll surveys that over 90% of the population would donate their organs when they die. So why is it that four out of ten families refuse the request for organ donation when a member of their family dies? Why are only 16.7 million people signed up to the Organ Donor Register?

In the UK we value and respect individual freedom and human rights which is why we do not make organ donation a compulsory civic responsibility. But the current opt-in system does not provide enough consented organ donation to provide the human right to life for all people on transplant waiting lists. We have a moral obligation to investigate all possible solutions to avoid these unnecessary deaths.

Last year (2008) the Organ Donation Taskforce rejected the proposal of presumed consent because this does not guarantee an increase in public support for donation and is deeply resented by human rights campaigners because it removes the individual’s right to choose. There is a strong belief that donation should be based on altruism and compassion – not state compulsion. The Taskforce was not given the scope of authority to assess the merits of a Mandated Consent system. The Taskforce is implementing 14 proposals to increase the organ donor rates and transplant procedures in the UK. Some of these recommendations have already achieved positive results. This is an appropriate time to put together an evidence based assessment of whether a move to a Mandated Choice system would also increase the donor rate.

If Mandated Consent was introduced in the UK this should only be considered if we believe it would increase the rate of organ donation that would lead to more life saving transplants being carried out each year. This would reduce the grief of long waiting times for patients and the distress for families watching their loved ones die.

Mandated Consent would involve all people over the age of 16 years (or an agreed age of responsibility which might be 12, 14 or 18?) signing an advance directive to be tissue and organ donors when they die. The directive would be in the form of registration literature sent to every household in the UK maybe in conjunction with electoral roll information. After an initial nation wide launch sending registration documents to all hosueholds an alternative system could be used. For example, a regsitration form could be sent to every individual when they receive their National Insurance card.

The form would offer three choices:

a) Yes I want to donate my organs when I die for transplant purposes

b) No I do not want to donate my organs when I die for transplant purposes

c) I want to leave this decision to my family at the time of my death

There would be the opportunity to change the decision at a later date through an agreed formal procedure.

This system could only be implemented following a long period of public consultation and education that explains the benefits of transplantation. We all have the right to a transplant through the NHS if we meet the relevant medical criteria. Consequently we all share a collective responsibility in enabling this to happen – the saving of just one life from avoidable death benefits the whole of society.

What are the merits of introducing a Mandated Consent system?

Mandated Consent allows everyone to declare their explicit view on organ donation in a private and confidential manner. Unlike Presumed Consent the mandate allows people to give explicit consent in a manner which retains the ‘gift ideal’ so valued in British society. Altruism is protected as a virtue because people have to positively agree to donation. Presumed Consent (an oxymoron) takes away the act of altruism because it relies on a lack of objection.

By introducing this system it ‘nudges’ people towards making a decision that many of us agree with already but simply do not get around to fulfilling. Ninety per cent of people support organ donation yet only 27% have signed the Organ Donor Register. By sending registration literature to every household everyone is given an equal opportunity to declare their position. How many people die in hospitals that would have chosen to be donors if only they had opted-in to the current process? How many actual donors were volunteered by their relatives when in reality they did not want to have organs retrieved? Mandated Consent eliminates this doubt and confusion. It preserves personal autonomy. This system guarantees legitimacy and safeguards the interests of health professionals and the potential donor. The process delivers certainty rather than ambiguity.

All citizens of the UK would receive the registration literature conveniently at their households. This would negate the claims often made that donation registration is hard to understand, it is not convenient, people do not know how to access it and so on. Failure to register because of ignorance, hectic lifestyles or apathy would be significantly reduced.

No-one is compelled to be donor through this system, but everyone is asked to discuss their wishes with family members and proactively declare their view. Individual choice and human rights are preserved because people can choose from three options. No presumptions are made about people’s views and non-one is compelled to become a donor. Personal autonomy is maintained using a Mandated Consent approach.

As the registration literature is sent to all households this should stimulate family discussion of this sensitive issue. This would clarify the wishes of all family members and perhaps reduce the number of families that say ‘no’ to the request of organ donation when a relative dies – this figure currently stands at about 40%. Currently the opt-in system does not necessarily encourage family discussion. The process of filling out a registration document in the family home should stimulate discussions about end of life choices which people tend to avoid. Considering your own mortality is not an easy subject. Donation registration using Mandated Consent might help change British culture for the better by inviting people to think through their end of life choices without the stress of someone’s imminent or recent death. Avoidance of sensitive issues is understandable, but a Mandated Consent system would be beneficial in guiding people to give careful thought to this subject. The opt-in and opt-out systems do not present this opportunity to the whole of the population. The Presumed Consent system does not require informed consent at all – Mandated Consent does. When a doctor or a Donor Transplant Coordinator approaches a family with a request for tissue or organ donation they want to hear a strong, definite response. They want to hear an unqualified answer - whether it is a 'yes' or a 'no' response. The Mandated Consent method should increase the likelihood of family discussions and confidence in the answers they give. Family members will actually know what the dying wishes of their loved ones are. That is very far from the case with the current opt-in system or a Presumed Consent approach.

Deceased solid organ donors die in hospital settings – rarely in the wider community. Mandated Consent would inform health professionals about the wishes of all their patients in relation to organ and tissue donation. This knowledge allows clinicians and donor transplant coordinators to discuss this emotional issue with greater clarity when they approach bereaved family members which in turn should help families make a positive response with regard to donation requests.

Seven out of ten requests for organ donation are currently agreed by family members in a surrogate role because the wishes of the decedent are not known. This can be a very distressing discussion for family members at the point of a relative’s death. Mandated Consent would lift this burden of responsibility from the family at a time of loss and great sadness. This will assist the work of health professionals in providing compassionate bereavement support for family members when they are making their end of life choices.

Using Mandated Consent informed consent is assured. Everyone’s position is clearly documented in terms of organ/tissue donation. An estimated 50% of the population support organ donation but have not registered for a variety of reasons. These people will benefit from these proposals because they will be able to declare their informed consent. People who are opposed to donation will also be able to make their explicit position known. This safeguards the rights and wishes of all citizens. It also protects the surgeons. Explicit, informed consent for donation means that surgeons can remove organs secure in the knowledge that they are carrying out the ‘best interests’ of the deceased person because these have been unequivocally expressed. There is no risk of being sued for removing organs from people who did not want to be donors and it ensures that supporters of donation have freely given their informed authority to surgeons to proceed with organ retrieval. Currently there are patients who die that are supportive of donation who are overlooked because they have not given their formal permission for organ procurement to take place. They are not having their ‘best interests’ honoured.

If we can trust public opinion poll surveys many more people would commit to becoming donors if they were mandated to make a decision. This is the principal justification for introducing a Mandated Consent system of registration. More organ donation leads to more life saving transplants.

Are there drawbacks to a Mandated Consent system?

People are generally highly protective of their right to decide their own destiny. That is probably why no government in a liberal democracy would ever make organ donation compulsory. The Presumed Consent proposals were criticised for making assumptions on behalf of people who may not have ability to register their objection to organ donation and exercise their right to opt-out. Mandated Consent protects individual freedom of choice and treats everyone the same to either say ‘yes’ or ‘no’ to organ donation, or allow their family members to decide. There is, however, the criticism that the state should not force an individual to make such a declaration. What right has the state got to put this issue onto the agenda of all people who might prefer not to consider organ donation at all? On balance though the insistence on making someone decide is a very small loss of personal liberty when balanced against the possibility of saving over 1,000 lives a year. The moral equivalence of saving lives far outweighs the minuscule loss of liberty entailed from having to declare a choice by filling in a form occasionally. The human right to a transplant is definitely greater than the liberty lost by having to complete a donation registration form that gives you the option not to be a donor.

The administration of a Mandated Consent system could be costly and will raise certain complications which may be difficult to overcome. For instance;

• How frequently should the Mandated Consent registration forms be sent out? Annually with electoral registration documents or would this cause confusion and occur too often? We do not want people to feel that their right to vote was in any way connected to their views on organ donation. Similarly we need to guard against people’s fears that they will not receive equal treatment in the hands of the NHS if they vote ‘no’ against organ donation.

• More significantly we have to work harder to allay public concerns that clinicians will not fight hard enough to save your life if they know you want to be an organ donor when you die. This requires much more work being done on educating the public on how the donation and transplant process is actually carried out. This is an important issue regardless of what registration procedure is adopted.

• How can we guarantee the right to change our decision and be certain that the relevant medical databases are amended accordingly?

• What would happen with responses from people who refused to complete the registration form or spoilt the paper as a sign of protest? What would be their default position on the national database? Should conscientious objectors be recorded, but as what? How would their view be recorded?

• Who would be responsible for the educational programme that would have to accompany this social reform? Would funding be made available to organisations that want to campaign against this proposal?

• The issue of organ donation occurs in the lives of families at a time of emotional distress. End of life choices for the deceased relative require the input and support of close family members. It is after all an end of life choice that the family has to live with after the decedent has been buried or cremated. Should family members have the right to overrule the declared donation wishes of the dead family member? Currently that is the informal position. Clinicians and donor transplant coordinators will not pressure families into accepting donation even if that is the wish of the dead person. And rightly so. But by the same token though every family should be asked about organ donation as part of the bereavement support process. The legal position in the UK outlined in the Human Tissue Act (2004) states that health professionals should make every effort for the registered donor’s wishes to be honoured. All families should be consulted about their end of life choices and given the option of organ donation on behalf of their deceased relative. The family’s position on this issue should never be presumed however distressed they may be. The request for organ donation can restore some degree of comfort to the bereaved family. The opportunity for donation should never be denied to families by clinicians, even if their motives are well intentioned.

• A real strength of the Mandated Consent approach is that it protects the position of minority groups who are opposed to organ donation and transplants because they can simply vote ‘no’ on the registration form. But by asking all people to state their position all communities would have the opportunity to discuss their beliefs in relation to organ donation. There are some communities that for cultural or religious reasons are opposed to organ donation but will accept the life saving benefits that transplants bring to thousands of lives. The need for a transplant does not discriminate in terms of gender, age, ethnicity or religion. Yet some religious groups exert an influence that could well be at odds with the views of the individuals that make up that grouping. The introduction of Mandated Consent would give people the scope to exercise their free will without the fear of arousing prejudicial views from others in their own community. For example statistical data shows that non-white communities are least likely to volunteer as organ donors. Just 3-4% of people on the Organ Donor Register are from black or ethnic minority backgrounds. Nearly 25% of people waiting for kidney transplants are from these communities. The Mandated Consent system might go some way towards alleviating this health inequality by encouraging people from all ethnic groups to become registered donors free of undue influence from their communities.

No doubt other issues would arise as a full debate on this topic gets underway. When the Mandated Consent system was introduced in Texas it did not achieve the positive outcome that was anticipated. Perhaps this was a consequence of the fact that people were not given the option to leave the decision of organ donation to their families. As it is proposed in this context few people could object to the implementation of a Mandated Consent system. For thousands of people this is a debate that should have been resolved years ago. For 1,000 people each year the debate will come too late. Needlessly three people a day die waiting for the transplant that the NHS has told them will save their lives.

Postscript

David Borrow, the South Ribble MP, has successfully been given the opportunity to introduce a ‘Ten minute rule’ bill in the House of Commons on March 17th 2010. His bill is designed to introduce a Mandated Consent system for England. Given the limited amount of legislative time available before a General Election it is unlikely that David’s bill will pass into legislation on this occasion. But the debate will give MP’s and the media an opportunity to examine the issues surrounding informed consent for tissue and solid organ donation in this country. My sincere hope is that the next government will act on the merits of this system and make Mandated Consent the law in this country. Please contact your local MP to encourage them to support David Borrow on March 17th 2010. You can get David's contact details from his press release which you can read by clicking on the following button:  

g. Incentives

To be continued

TRANSPLANTS SAVE LIVES, MONEY and MISERY.