Can legislation encourage organ donation?

Around three people in the UK die every day in need of an organ because there are not enough donors, according to NHS Blood and Transplant. Will changes to legislation be enough to save more lives?

To help more people, in Spring 2020 the law is being changed so that all adults in England will be considered as potential organ donors – unless they choose to opt-out or are in one of the excluded groups.

In 2006, the Organ Donation Taskforce was established to identify the obstacles to organ donation and suggest solutions that would deliver an increase in transplants. Their report included 14 recommendations, addressing three key areas: donor identification and referral, donor coordination, and organ retrieval – which, if looked at, could help save the lives of at least 1,000 people each year.

Claire Williment, Head of Legislation Implementation Programme at NHS Blood and Transplant (NHSBT), says the Taskforce and its recommendations led to improved clarity and reassurance about what is legal and ethical with regards to organ donation and transplantation.

Williment, who is responsible for making sure NHSBT is ready when the law changes, argues: “The work to implement the Taskforce recommendations made changes to the organ donation processes and infrastructure, which led to significant improvements in the identification and referral of potential donors. The number of deceased organ donors has nearly doubled since the Taskforce report was published. However, this increase is because we are now making sure that we approach the family of every potential deceased donor, rather than because of any significant improvements in consent. While the consent rate has improved slightly, around 40% of families still refuse to consent to donation. For ethnic minorities, the family refusal rates are nearly 60%. We know families support donation if their loved one had recorded a decision on the Organ Donor Register. However, whilst 80% of people support donation, a lot of people don’t find the time to put their name on the Organ Donor Register. This means that the families can’t be sure about what they wanted. We need more people to make their decision, record it on the Register and tell their family and friends.”

NHS Blood and Transplant has been taking action to ensure that they are ready for the change in law in England. This includes a campaign to raise general public awareness about the new legislation. Williment said “We have a wide programme of work underway, including raising awareness in both the public and the NHS that the change in law is coming. It also includes training for organ and tissue donation teams and making sure that the policies, documents and IT are all changed in advance of spring 2020. Part of my role is overseeing that work. It brings together all the changes that are required and making sure we are operationally ready and that the public is aware of the changes.”

Spain introduced presumed consent legislation for organ donation in 1979 and is currently the world leader in organ donation. However, Williment calls attention to the 10-year lag time witnessed in Spain between the law coming into force and seeing an improvement in the organ donation rate. In 1989, the National Transplant Organisation (ONT) was created under the Spanish Department of Health, and with it came the Spanish Model – a set of measures to improve organ donation.

The ONT has since been responsible for training medical professionals and transplant coordinators, conducting research into organ procurement and transplantation, ensuring a quality program is adhered to by transplant coordinators, and also working with the media to improve public awareness.

Williment said: “We learned from the experience in Spain that it is not enough to just change the law. You also need to have the infrastructure in place to support organ donation. In the UK we started with the infrastructure and that delivered huge improvements. We are hoping that the change in legislation will help improve the consent rate, so that it matches public levels of support for organ donation. We are already starting to see that in Wales, where consent rates increased by 15% since the introduction of opt out legislation in 2015. Wales now has the highest consent rates in the UK.”

A global issue

In Uruguay, under the country’s Organ, Tissue and Cells Donation and Transplantation Act (2013), any person of legal age has the right to express their consent or denial to the donation of their organs upon their death. Such consent may be revoked at any time. Guillermo Duarte, Partner, and Bruna Royol, Associate at Bergstein Law, Uruguay, explained that if an individual does not indicate their approval/denial, the Act establishes a presumption that the individual has given their consent for the donation, upon their death, of their organs, tissues and cells – for therapeutic or scientific purposes.

They explained: “The Act can be the subject of criticism, as presumed consent could be considered a violation of the general principles of freedom and autonomy. But saving people’s lives should be prioritised. Last year, the Ministry of Public Health confirmed that Uruguay registered the largest number of organ donors in the last decade. In 2018, the donation of organs increased 16 per cent from the previous year, with a ratio of 23.78 donations per million people – the highest in Latin America.”

Duarte and Royol argued that it is not common practice in Uruguay to launch massive campaigns to support families or encourage donations. “As far as we are aware,” they explained, “most of the work conducted has been focused on training medical staff and encouraging medical studies in this area. The Act also established that a donor’s family must be informed about the nature of the procedures implemented (or to be implemented), and during the surgery they are supported by a group of psychologists."

In Poland, since 2005, the Polish Transplantation Act has also provided an opt-out policy. However, Janusz Tomczak, Partner at Raczkowski Paruch, Poland, said: “It seems that there is still a huge amount of work to be done in the area of building awareness and social acceptance for organ transplants of deceased people. In 2007 for example, accusations made against transplant specialists led to a significant decrease in the number of transplants.” The accusations included manslaughter, harassment and homicide.

In 1988, Colombia enacted legislation for organ transplantation, making all citizens potential donors upon death. In 2016, a new comprehensive regulation (Law 1805/2016) established a set of conditions for postmortem donations to be made. It clarified requirements for potential donors to opt out and provided incentives for volunteer donation.

“This means you now have to register before a public notary to be exempt from donating,” Enrique Alvarez, Partner at Lloreda Camacho & Co, Colombia, said. “It also established clear conditions for hospitals and medical personnel on how to act when harvesting organs. It was a major step towards raising awareness about the need for organ transplants and donations for both the general population and the medical community in Colombia.

“Government figures for the first year after the new law was adopted showed that organ transplants rose 28 per cent, but then for 2018, the figure fell by 7 per cent. Although an optimistic perspective for organ donation remains within authorities and the medical community, waiting lists keep growing and demand still surpasses available organs. This is a situation that should have been eradicated with the new law.”

“Sources indicate that the practical aspects in the donation process are lacking. For example, there is a shortage of complete medical records for donors at the time of death, and many health care institutions have limited technical and financial capabilities - particularly those attending fatal trauma. Also, the cultural and educational aspects of donations and transplants need to be addressed to achieve a wider social impact.”

Raising awareness

In the UK, NHSBT is raising awareness among BAME (Black, Asian and minority ethnic) groups by understanding their concerns and learning how to address them. “There is a much higher need for organ transplantation among Black and Asian groups because of genetic predispositions to conditions that lead to organ failure,” Williment says.

According to findings from Kidney Health Inequalities in the UK: An Agenda for Change, people from BAME populations are less likely to receive kidney transplants, particularly living donor transplants, waiting between 168 and 262 days longer than Caucasian kidney patients. Donors from the BAME communities also only make up 7.2 per cent of the NHS Organ Donor Register. By reducing health inequalities, the UK could alleviate the burden of kidney care on the NHS, as hospital dialysis alone costs over £30,000 per year, per patient.

It’s clear from changes to legislation around the world that raising the organ donation rate in any country requires more than just passing a law. Public awareness is key to engaging with society and ensuring the right clinical and emotional support is available is paramount to saving lives.