It was described by Theresa May as a ‘momentous step’ that would save thousands of lives.
In 2019, when Prime Minister, she announced a radical law change that meant everyone in the country would – overnight – become an organ donor, unless they chose to opt out.
The move was designed to boost the number of organs available for transplants in the UK, which at the time were in short supply. That year, more than 6,000 patients needed an organ transplant and 411 died while on the waiting list.
By changing the law, it was hoped that waiting lists would be slashed and deaths prevented. In fact, the Prime Minister went as far as to claim it would save ‘as many as 700 lives a year’.
It was to become known as Max and Keira’s law, named after Max Johnson, who became an avid campaigner for organ donation after receiving a heart in 2017 from Keira Ball, who had died in a car crash, when they were both aged nine.
However, seven years on from the law change, the Organ Donation (Deemed Consent) Act 2019 has failed to live up to its lofty hopes. And last week the NHS issued an urgent shortage warning – the first in its history – over the number of available organs.
Today, 8,700 patients are waiting for a transplant and, last year, more than 430 died on the list.
In the past 12 months alone the number of organ donors has fallen by nearly a tenth. While experts say there are several reasons why this has happened, they all seem to agree that one thing is clear: the opt-out donation system has failed.
Keira Ball before her death in a car crash… in 2019, a law named after her and one of her organ donor recipients Max made everyone in the country a donor, unless they chose to opt out
The law was named after Max Johnson, nine, who became an avid campaigner for organ donation after receiving a heart in 2017 from Keira, also nine
The Mail on Sunday has spoken to about a dozen NHS insiders who have revealed the chaos unleashed by the law change on hospital wards, which has left families in distress and has ultimately harmed efforts to raise the number of organ donors. We can also reveal that concerns over the safety of the scheme were raised at the time of the law change – but were ignored by the Government.
So, how did the opt-out system become an abject failure – and can anything be done to fix it?
First, it is important to explain how organ donation works.
Organ transplants are typically offered to patients who are in urgent need but are also believed to be healthy enough to go through the tough procedure and then survive long enough to make the most of the new organ.
The majority of organs donated in the UK are kidneys, making up about 3,200 of the approximately 4,600 organ transplants that happen every year. This is because more than seven million Britons have chronic kidney disease, where the blood-cleaning organs slowly shut down. This also means that the most waiting-list deaths are among those who need a kidney transplant.
Liver transplants are the next most common, followed by hearts and lungs.
However, whatever the organ required, there are not enough donors in the UK. This is because of the 600,000 people who die every year, very few are able to donate their organs – even if they want to.
Organs can be given in only two scenarios. The first is where the patient is alive but brain dead, for example, after a traumatic head injury. The second is when they are on life support and will not survive, such as someone with an irreversible brain bleed.
Harrison Sinclair with his mother Kirsty and sister Thea… he has Alagille syndrome and has been waiting 18 months for a new liver
Medics say the reason for this is that doctors need to ensure the organs are healthy enough for use.
Someone with a long-term illness, such as cancer, is unlikely to have strong enough organs for a transplant to be safe and effective. As a result, only around 7,000 eligible donors arise each year.
Previously, anyone who was willing to donate their organs had to register. They were then handed a donor card, which they could keep in their wallet or purse, and they would also be added to the organ donor register. Experts say this is crucial because, even after someone has signed up as a donor, their family still gets the final say over whether doctors can take their organs.
The organ donor register means that there is a record of the patient’s wishes in the event of a fatal emergency. Studies show that when someone has signed up for the register, the family respects their wishes in 90 per cent of cases.
At the time of the law change, about 40 per cent of the population were registered as organ donors.
The opt-out scheme was designed to boost these figures, as it was thought that organ donation was widely supported in the UK but many people did not get round to signing up.
By making it opt-out, the Government reasoned that only those who were strongly against it – say, for religious reasons – would object.
‘We knew there was widespread support for organ donation in the population,’ says John Richardson, a former transplant nurse who now works as assistant director of organ donation and transplantation at the NHS. ‘We hoped that the change would lead to an increase in the number of donations.’
Five-year-old Harrison has a rare genetic disorder that damages the liver and other organs. He has already undergone open heart surgery due to his condition
Similar opt-out schemes have been in place in other countries, such as Spain, France and Norway, for decades. The system was also initially tested for several years in Wales before it was expanded to the rest of the UK.
Crucially, experts say that there was one key caveat: the opt-out scheme was – like the opt-in scheme before it – non-binding.
In other words, if doctors wanted to take a patient’s organs they would still have to ask the family, who could simply say no.
‘No one wanted a situation where the NHS was taking organs from patients in the middle of the night without the consent of their family,’ says Dr Zubir Ahmed, a Labour MP, transplant surgeon and former health minister. ‘Doctors still needed to get explicit consent from the family.’
However, far from making it easier to get consent for donation, the opt-out scheme has made it more difficult.
‘Under the previous scheme, there was clarity on what the patient wanted because they had signed up to the register,’ says Fiona Loud, policy director for the charity Kidney Care UK.
‘But if families don’t know what their loved-one thought of organ donation, then they are more likely to say no, just in case.
‘This has made it harder to get consent for donation, rather than easier.’
The Mail has spoken to NHS insiders who have revealed the chaos unleashed by the legislation on hospital wards, which has ultimately harmed efforts to raise the number of organ donors
Experts say that a lack of awareness about the opt-out scheme has led to fraught, intense conversations with families.
‘These are people who are dealing with the loss of a family member,’ says Mr Richardson. ‘When a patient has opted in for donation, the nurse can go into the room and show them that their loved one wanted to donate. In this situation, the family are almost always likely to approve the request.
‘But if there’s nothing on the register, the nurse often has to explain the new legislation to the family there in the room and say that, since the patient didn’t opt out, we are assuming they are not against donation. That is a really difficult conversation to have.’
Medics say that another reason families are more likely to say no to donation under the new scheme is that they are often desperate to leave hospital.
‘These are families who might have been in hospital for four or five days,’ says Becky Gorf, a Watford-based specialist organ donation nurse.
‘For the family, it is the worst day of their lives. And then someone is asking them to make yet another big decision. If they don’t know what their loved one would have wanted, then the easiest answer is no, which is understandable.’
NHS figures reveal the serious flaw in the opt-out scheme. When no explicit decision has previously been made by the potential organ donor – as is the case in the opt-out scheme – family consent falls from 90 per cent to 50 per cent.
One of those affected by the fall in available organ donors is five-year-old Harrison Sinclair, who has been waiting 18 months for a new liver.
Harrison has Alagille syndrome, a rare genetic disorder that damages the liver and other organs. Harrison has already undergone open heart surgery due to his condition and now needs a new liver because his is failing.
His mother Kirsty, 40, a pharmacy worker from Staffordshire, says that Harrison’s health is getting worse by the day.
‘Everything is deteriorating,’ she says. ‘His skin has turned yellow and itches all the time. He scratches until he bleeds and cries.’
Kirsty believes that, if it wasn’t for the fall in available donors, Harrison would likely have got a new liver by now. She has now launched a petition calling on the Government to stop families from blocking organ donation.
‘I couldn’t believe it when I learned that there is a shortage because the next of kin can object,’ she says. ‘It’s crazy. You don’t need your organs after you die – they will just be burned or buried.
‘Why not give them to someone else, so they can live?’
Experts believe one of the reasons that the opt-out scheme has failed is because of the timing of when it was launched: March 2020, the same month that Britain entered its first lockdown of the Covid pandemic.
Insiders say the Government had planned a major marketing campaign to raise awareness of the change, but this was scrapped when the pandemic hit.
‘It should have been this big national conversation about the importance of donation and saving lives,’ says Dr Ahmed. ‘Instead, everyone was, rightfully, thinking about the once-in-a-generation pandemic. The change got lost in the noise and it never quite took off.’
Transplant nurse Becky Gorf agrees. ‘I remember at the time I was going around my hospital putting up posters explaining the law change,’ she says. ‘The aim was for as many people as possible to know this was the new law, so that it wouldn’t surprise people. Looking back, it could not have happened at a worse time.’
However, other experts point out that the opt-out scheme was always in doubt.
In 2018, a Queen Mary University of London study argued that, in many countries that had adopted the system, consent rates fell because there is less of a clear signal of a deceased person’s wishes.
‘In the event of uncertainty,’ the researchers wrote, ‘families are more likely to refuse consent.’
Despite this, the Government pushed ahead.
An NHS spokesman told The Mail on Sunday that the opt-out scheme was never meant to be a ‘silver bullet’ that would fix the donor shortage on its own.
Health service chiefs also argue that there are other reasons for the fall in donors, including a reduction in traumatic head injuries – meaning fewer brain-dead patients – as well as an ageing population resulting in fewer healthy donors.
However, the NHS is now making the extraordinary move – nearly seven years on from the law change – of asking members of the public to once again sign up as organ donors.
The organ donor register still exists and the NHS hopes that getting more people on it will reduce the number of families denying donation requests.
But experts argue there are other steps the NHS can take to boost the number of organ donations, which would potentially have an even bigger impact than fixing the opt-out scheme.
Dr Ahmed says that one of the biggest issues is that organ donations are handled by regions rather than the country as a whole.
‘This means a patient who needs a kidney in Newcastle cannot travel to Glasgow to get it,’ he says. ‘Organs are going to waste. It’s unacceptable. We need to have a joined up system.
‘The opt-out scheme hasn’t been a success but it was set up to fail by structural issues.
‘We need to fix those before we do anything else.’
