Claire Williment, Head of Legislation Implementation Programme at NHS Blood and Transplant (NHSBT), is responsible for ensuring NHSBT is ready when the law changes. She 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. ‘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’, she says.

Spain introduced presumed consent legislation for organ donation in 1979 and is currently the world leader in organ donation. However, Williment notes that in Spain there was a ten year period between the law coming into force and an improvement in the organ donation rate. NHSBT is working to raise general public awareness of the new legislation. The campaign includes training for organ and tissue donation teams and ensuring that policies, documents and information technology are changed in advance of spring 2020, when the new law takes effect.

Williment says deceased organ donors have nearly doubled in number since the Taskforce report was published, but says this is because the NHS now approaches 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 per cent of families still refuse to consent to donation,’ she says.

‘We learned from Spain that you also need to have the infrastructure in place to support organ donation,’ says Williment. ‘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.’

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, a partner at Bergstein Law, Uruguay, explains that if an individual does not indicate their approval or 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.

‘The Act can be the subject of criticism, as presumed consent could be considered a violation of the general principles of freedom and autonomy,’ says Duarte. ‘But saving people’s lives should be prioritised.’

Duarte adds that in 2018, the Ministry of Public Health confirmed that Uruguay had 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 amount in Latin America.

Since 2005, the Polish Transplantation Act has also provided an opt-out policy. However, Janusz Tomczak, Treasurer of the IBA Criminal Law Committee and a partner at Raczkowski Paruch, suggests there is still a huge amount of work to be done in building awareness and social acceptance for organ transplants of deceased people.

In 1988, Colombia enacted legislation for organ transplantation, making all citizens potential donors upon death. In 2016, a new comprehensive regulation 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.

People must now register before a public notary to be exempt from donating, explains Enrique Alvarez, Latin America Regional Officer of the IBA Healthcare and Life Sciences Committee and a partner at Lloreda Camacho & Co, Colombia. ‘The Law 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,’ says Alvarez. He says that while the Colombian authorities and medical community remain optimistic about organ donation, ‘waiting lists keep growing and demand still surpasses available organs. This is a situation that should have been eradicated with the new law.’