The row over consent to organ donation is as old as transplantation itself. With a government task force due to make a final decision soon it has had to navigate some murky ethical waters, writes Daloni Carlisle
There are ideas whose time has come and ideas that are past their sell-by date. Then there are ideas that simply will not go away - like presumed consent for organ donation.
It sounds so simple. The UK is short of organs for transplant. Most people support the idea of transplants but have not got round to signing a donor card and opting in to the current system.
So should they meet an untimely end, their family can rightly say they do not know what their loved one would have wished, so they had better say no to their organs being removed for donation. Four in 10 do so, restricting the supply of organs as waiting lists for transplants grow.
"It is apathy that stops people getting onto the register," says Tim Statham, chief executive of the National Kidney Federation, a charity that has been in favour of presumed consent since 2001. "So let's see a change in the law where they are automatically signed up."
In other words England should move to a system where we assume consent for organ donation unless a person has opted out. But like all apparently simple ideas, this is a bit more complicated than first appears. There are some serious questions to ask: is presumed consent any sort of consent at all? What about people who lack the language skills or mental capacity to consent? And would it really make more organs available?
The organ donation task force, appointed by the health secretary, is due to report by the end of the year. There are powerful arguments on each side and passionate people making them. But rumour has it that the "nos" have it - for now.
The debate of opt-in versus opt-out and then the sub-clauses of soft opt-out versus hard opt-out (namely, whether to consult with relatives before harvesting organs or simply go ahead with harvesting) has been around since transplantation surgery began in the 1960s.
Ins and outs
The current law in the UK is set out in the Human Tissue Act 2004, which covers England, Wales and Northern Ireland, and the Human Tissue (Scotland) Act 2006. Both are explicitly based on an opt-in model: informed consent is the cornerstone.
That is not surprising given its antecedence. The 2004 act stemmed directly from the organ retention scandal at Liverpool's Alder Hey Hospital and the subsequent inquiry, which uncovered the widespread practice of stripping - and retaining - organs from bodies during postmortems, all without consent.
While the parliamentary debate around the legislation did recognise that organ donation for transplant might be different and MPs thrashed out the issue of presumed consent, in the end it was voted down.
Then in 2007 chief medical officer Sir Liam Donaldson published his 2006 annual report on the state of public health, which among other things highlighted the shortage of donor organs and supported the idea of a soft opt-out system.
Health secretary Alan Johnson subsequently asked the donation task force to look at the complex moral and medical issues around presumed consent, including whether a dead person's family should have a say.
Essentially, it has two questions to answer. Would the British public accept such a change and what impact would it have?
Slap bang in the middle of its deliberations, Gordon Brown entered the fray. With 8,000 people in the UK waiting for a transplant, he too favours presumed consent and has called for a public debate. Writing in The Sunday Telegraph in January this year, the prime minister said it could make a huge difference.
"A system of this kind seems to have the potential to close the aching gap between the potential benefits of transplant surgery in the UK and the limits imposed by our current system of consent," he wrote.
Meanwhile, the House of Lords began its own examination of the issue as its European committee considered an EU directive on the quality and safety of organ donation and transplantation. It took a wealth of evidence and in July this year came out against moving to presumed consent.
So the debate has raged as various groups, from the medical and health professionals through to groups representing religions and patients, set out in detail the evidence for their case.
There are some odd facts about who is on which side. The Scottish chief medical officer is against; the English one is for. The Welsh Assembly's health committee is against while the Welsh health minister is for (see below).
Generally, bodies representing doctors - including the British Medical Association and the Royal College of Surgeons - are in favour of presumed consent.
But doctors closer to the subject - members of the British Transplantation Society and the Intensive Care Society for example - are ambivalent.
"We feel that the current situation, where there is a shortage of organs for transplantation, is unacceptable," says Tony Calland, who chairs the BMA's ethics committee. "Something needs to be done and our policy at the BMA is to support the concept of soft presumed consent."
Like the British Heart Foundation, National Kidney Federation and others, the BMA supports a system in which everyone is presumed to have given their consent unless they have explicitly stated otherwise. But an opportunity for relatives to have their say should also be built into the system.
The public also appears to be in favour, with polls showing 60-70 per cent support "soft opt-out". But many patient representative organisations are against, except, that is, those representing patients affected by organ shortages. For example, the British Heart Foundation, National Kidney Federation and the Transplant Support Network are all in favour.
"If relatives are aggrieved or upset or resistant it should not be pursued," says Dr Calland.
Any system would have to include safeguards for the vulnerable and for children, while an education campaign and systematic changes to improve both the management of organ donation and the capacity of transplant services would also be needed.
Dr Calland admits this is a pragmatic approach rather than an ethical one and is built on the idea that moving to presumed consent would increase organ supply.
"If you go into the pure ethics of consent you get into some murky waters," he says.
Quite so, say a significant number of patient groups who argue that presumed consent is no consent at all. The Royal College of Surgeons patient liaison group is against presumed consent, likewise campaign group Patient Concern, on these grounds.
"We feel that informed consent is paramount in human medicine," says Royal College of Surgeons patient liaison group chair Lesley Bentley. She points out that ordinarily doctors need informed consent for any procedure.
"Why should it be any different for this huge, momentous decision?"
There are other, practical problems, too. "The danger is that you can end up with people not knowing that they are automatically opted in," adds Ms Bentley. "How on earth are you going to ensure that someone with low levels of literacy or understanding or mental health issues or people whose first language is not English will understand this?"
Keith Rigg, British Transplantation Society vice president and a consultant surgeon at Nottingham University Hospitals trust, says: "It is very difficult for us, as a society, to say yes or no. The majority of members are in favour but there are a wide range of views."
A principal reason for supporting presumed consent is that it reflects the views of the general population. "Ninety per cent of the population support organ donation so there is an argument to make it the default position," says Mr Rigg.
Plundering The arguments against are more numerous. First, the legal situation was only recently arrived at with the Human Tissue Act 2004.
"Consent is the golden thread that runs through it," says Mr Rigg. "To change the law now would send out conflicting signals."
Here the Human Tissue Authority agrees. Provisions for consent have only just been established in the 2004 act, which has been in force for less than two years. The Human Tissue Authority believes that now is not the right time to make changes to the legislation.
Chief executive Adrian McNeil says: "As long as the act is in force, the authority will continue to support the requirement to obtain fully informed consent."
Another argument is whether presumed consent would shift donation from being the gift of an individual to something that the state is able to take willy-nilly.
"A number of people have said very vociferously that their perception about what happens to their organs is important," says Mr Rigg.
The Intensive Care Society has also argued that presumed consent could damage trust, as patients would view it as the state interfering. A number of churches have argued along similar lines.
David Jones is professor of bioethics at St Mary's University College in Twickenham and earlier this year gave evidence to the Lords inquiry on behalf of the Catholic bishops of England and Wales. He says the Catholic Church is in favour of organ transplantation and crucially frames its thinking around the altruistic act of giving, which places the church against presumed consent.
"Pope John Paul said in a speech that if you are taking without asking it is not giving. This is not donation, it is plundering of the body," says Professor Jones. He thinks a system of presumed consent could backfire.
"Saying to some relatives: 'Your loved one has died and there is a possibility that some good could come out of this but if you say no we are going to take the organs anyway,' is not going to help. Organ donation relies on goodwill. You do not want to waste that capital."
And while most people do support organ donation, there is a quiet and persistent grumble in the background from a minority voicing concerns about diagnosis of death. Quietly, some fear doctors may be too quick to pronounce a patient dead if there is a possibility the patient's organs could be suitable for harvesting.
"At the moment this has not been crystallised or catalysed and I am not overstating this, but if you move to an opt-out system, there is a real danger of people feeling pushed or coerced," says Professor Jones.
"That could provoke a backlash that could see some people become active and undermine public confidence. It is asking for trouble."
Professor Jones has a point. The presumed consent debate is already politicised - Gordon Brown is in favour; shadow health secretary Andrew Lansley is against and has argued that the state has no right to get involved here, saying in 2007: "The state does not own our bodies or have a right to take organs after death."
It would become even more so were the organ donation task force to recommend a change in law, creating a situation ripe for just such a backlash as described by Professor Jones.
The other big question is whether moving to presumed consent would actually increase rates of organ donation. The big hope is that it would prompt people to discuss their wishes with their family before anyone would be faced with such a decision. But there are doubts even among the move's advocates that it would have this effect.
"We don't believe [presumed consent] will increase the supply of donor organs," says Mr Statham of the National Kidney Federation. "We are campaigning for the change because it will keep the issue in the public eye and keep people talking about it."
The evidence base, largely from Europe, where some countries have presumed consent, is mixed.
"It is very difficult to look at presumed consent in isolation," says Mr Rigg. "Some studies show that it increases rates by 20-30 per cent. Others do not."
A review of that evidence should be coming as part of the organ donation task force's report.
For now, we sit and wait. The Department of Health is tight lipped about when exactly we can expect to see the report and committee members are discreet. Even so, rumours suggest the task force will come out against moving to presumed consent.
Will that put a stop to the debate? Not likely, says Mr Rigg. "Whatever the task force says, the lobbying will continue."
Detail in the donor debate
90 per cent of people polled by UK Transplant in 2003 support organ donation.
15 million people (25 per cent of the eligible population) have joined the UK organ donation register.
Four out of 10 relatives refuse permission for taking organs from their loved one.
8,000 people are currently waiting for an organ.
The waiting list for organ donation rises by 8 per cent a year
In 2006-07, organ donations reached an all-time high of 3,087.
Britain's organ donor rate is 13.2 per million of population. The EU average is 18.8 while Spain manages a whopping 34.3. Why?
Some have argued that it is to do with consent. Spain, Austria, Belgium, Sweden, Denmark, Finland, France, Italy and Norway all have a system of presumed consent.
Prime minister Gordon Brown cited the Spanish adoption of presumed consent as one reason for its high organ donor rate, although later examination has rather unpicked this.
Austria, meanwhile, uses a hard opt-out model in which relatives have no say - believed to be a cultural no-no in the UK.
The House of Lords European committee reporting in July 2008 said Spain's success was far more to do with effective organisation of donor services and the selection and training of staff than with legal differences.
Spanish National Transplant Organisation director Dr Rafael Matesanz agrees, telling a conference of medics this year: "Trying to modify the situation by changing the law, in my opinion, is dangerous because all the effort can concentrate in the law and you forget aspects that are more important."
Everyone agrees that organ donation and transplantation is a nationwide business. But there is widespread disagreement across the UK about whether to go for informed consent or not.
In England the chief medical officer is in favour while his Scottish counterpart Harry Burns is against, saying there is no evidence that the public would support it.
The Welsh situation is even more complex. In September this year, the Welsh Assembly's health committee produced a minority report that came out against moving to presumed consent. A legal change now would distract from current attempts to increase the number of potential donors, it said.
But health minister Edwina Hart did not agree and accused the health committee (chaired by shadow health minister Jonathan Morgan) of ignoring the public opinion in favour of presumed consent. She promptly launched a public debate on the issue and has refused to rule out a change in the law in Wales.