Organ donation opt out plans in England – not nearly as clear cut as it might seem

All adults in England will be presumed to be organ donors unless they have explicitly opted out, the government has announced.

The new plans follow a public consultation launched last December. Wales has had a similar opt-out system since 2015 and Scotland also plans to introduce one.

New legislation which will be introduced in parliament this autumn is intended to come into effect in spring 2020 giving people a 12-month transition period to make decisions about organ donation preferences.

According to the BBC, ‘Max's Law’ is named after Max Johnson, from Cheshire, who was saved by a heart transplant.

His search for a suitable heart was followed in a series of front-page stories in the Daily Mirror, as the newspaper campaigned for the change in the law.

Last year, Prime Minister Theresa May wrote to the ten-year-old, saying she chose the name after she heard his ‘inspirational story’.

Groups excluded from ‘presumed consent’ will include under 18s, people lacking the mental capacity to understand the changes, and people who have not lived in England for at least twelve months before their death.

People who do not wish to donate their organs will be able to record their decision on the NHS Organ Donor Register, by calling a helpline, visiting the NHS Blood and Transplant website or on a new NHS app.  

If people do not opt out they will be considered to be a potential organ donor but donation will not proceed if the family ‘objects strongly’.

A clear-cut case?

About 17,000 people responded to the government consultation. Of these, 72% said that the proposed change in the law would make no difference to their decision about organ donation. 13% said that the change would make them opt in, while 15% of respondents said that they would opt out.

Around 5,100 people in England were waiting for a transplant at the end of March 2018 but although 80% of people in England would consider donating only 37% have so far signed up.

The government claim that the new plans will result in an extra 700 organ transplants taking place every year in England.

The Royal College of Physicians, Kidney Care UK and the British Heart Foundation all back the proposals along with the British Medical Association.

It is therefore understandable that media coverage of the plans has been overwhelmingly favourable – so why do I have reservations?

Simply because, as the CMF advocacy team have argued many times before (see here, here, here, here and here)  the case for an opt-out system for organ donation is not nearly as clear cut as it might seem.

Marginalised voices

First, there is lots of opposition from authoritative voices who are now being marginalised in the rush to embrace it.

Professor John Fabre, former President of the British Transplantation Society, has led a chorus of critics warning that the evidence shows an opt-out approach is counter-productive.

Speaking to BBC Radio 4, Prof Fabre said it could be predicted ‘with a high level of certainty that it is not going to increase donor numbers in the way that we all want’.

Former National Clinical Director for Transplantation Professor Chris Rudge has said: ‘The only evidence I have seen is that it won’t make any difference and it is not the answer to the problem, but there is a risk that it may make things worse.’

Hugh Whittall, Director of the Nuffield Council on Bioethics, said he was concerned that the Government was asking how the law should be changed, rather than if it should be.

Keith Rigg, consultant transplant surgeon at Nottingham University Hospitals NHS Trust, felt that full results from Wales should be studied before such a move was considered in England.

These authorities have reservations because there is no clear evidence that opt-out actually works in increasing organ donation rates.

Lack of evidence

Before implementing an opt-out system, Fabre said, it is important to ask: ‘Does it actually make a difference?’ He concluded: ‘It actually doesn’t’.

Rigg again: ‘There is no clear evidence that this has resulted in an increase in organ donations and transplants where it has been introduced.’

Whittall: ‘The government should not be making this change until there is evidence that it works, and until we are confident that it won’t undermine people’s trust in the system in the long-term.’

In a September 2017 review, the BBC reported: ‘In Wales, where an opt-out system was introduced in December 2015, there has actually been a small dip in the number of deceased donors, from 64 in 2015-16 to 61 in 2016-17. This resulted in a drop in organ transplants from 214 to 187 respectively.

This is not to say the opt-out scheme is having a negative effect - some fluctuation is to be expected - but so far, despite the claims, we don't have any evidence that it is having a positive effect.’

Opt-out schemes don't consistently translate to increased organ donor rates. In Sweden, such a scheme has been in force since 1996 but it remains one of the lowest-ranked countries for organ donation in Europe. Luxembourg and Bulgaria also have opt-out systems and low rates of organ donation.

In France and Brazil, variations on a ‘presumed consent’ system actually led to a decline in the rate of organ donation.

A better way

Spain is often cited as an opt-out scheme success story.

‘Presumed consent’ legislation was passed in 1979 but donor rates only began to go up ten years later when a new national transplant organisation was founded which co-ordinates the whole donation and transplantation process.

In other words, it was not opt-out but rather other changes, like better infrastructure, more funding for transplant programmes and more staff working to identify and build relationships with potential donors before their death that really made the difference.

As Rafael Matesanz, an expert on the Spanish situation has recently argued: ‘Spaniards consider insignificant the impact of the type of consent on the donation activity. To the contrary, infrastructure, organization around the process of deceased donation, and continuous innovation are deemed the  keys for success… it was not until ten years after the (opt-out) Law approval that donation took off.’

In September the Nuffield Council on Bioethics confirmed that the evidence for introducing presumed consent is absent and highlighted instead the alternative option of investing more in Special Organ Donation Nurses. Where specialist nurses are available to speak to the family of the deceased they either donate or authorise donation in 68% of cases. Where they are absent the figure is just 27%.

Counterproductive

The positive spins on the impact of presumed consent also ignore the implications of people signing the opt-out register.  During 2016-17, 174,886 people in Wales, around 6% of the population, were signed up to the opt-out register. In the first two quarters of 2017-2018 this increased to 178,062.

This means that nearly 175,000 people have now effectively been removed from being possible donors when previously their families, as their living representatives, might have been happy to donate organs at their death, in the absence of express direction to do otherwise.  

The potential for presumed consent to alienate people, precipitating withdrawal from the donation system is real. In giving oral evidence to the National Assembly Health and Social Care Committee in Wales, organ transplant specialist Dr Peter Matthews, who was based in Morriston Hospital in Swansea, made the following statement:

‘My own experience is that the British psyche has a particular view that what it should do is donate organs as an altruistic gift, and if it is felt that the state is going to take over the organs, then there is the potential that people who may have been willing to become a donor will not do so. We have seen two cases in Morriston where patients who were on the organ donation register, on hearing about this, said to their families that if the state was going to take their organs, they were no longer willing to give them. We lost two donations because of that. So, there is a potential backlash.’

Organ donation should be a gift

This underlines the fact that organ donation should be an altruistic gift. Opt-out is not ‘presumed consent’ because no consent has been given.

Consent which is presumed is not actually consent at all. It amounts rather to the body after death becoming the property of the state and the state taking organs rather than the donors or their families giving them.

At a time when so much emphasis is placed on autonomy and free choice, this runs in the opposite direction. I’ve looked at this in more detail here.

Costly

In their 2008 report ‘The potential impact of an opt out system for organ donation in the UK’ the Organ Donation Taskforce looked at the costs for introducing a UK wide system of presumed consent.

They estimated that the cost of doing so would be ‘approximately £45 million in set up costs for IT and communications. There would be £2 million per year in IT running costs and an additional £5 million every few years to refresh public messages.’

Ths money would be far better spent employing trained specialist nurses in organ donation and developing an infrastructure like that of Spain.

Too many unanswered questions

There are simply too many unanswered questions about the opt-out system to be going precipitously down this road. 

There are strong voices against it because there is no evidence it will work, better ways forward exist, its coercive nature risks alienating potential donors, it undermines the idea of donation as a gift and it will be very costly to implement.

It seems that the government is ignoring the facts in its haste for a headline win based on ideology rather than facts. They should think again and refrain from whipping their uninformed MPs through the lobbies to force opt-out onto the statute books.