Organ donation reform appears to be based on limited evidence

Under system proposed by the Human Tissue Bill, consent for donation will be deemed unless a person opts out

The Government’s plans to introduce a soft opt-out system of consent for organ donation are weakly supported by a limited evidence base.

They enjoy the support of some patient groups, while others are sceptical about their potential impact on organ donations and transplant figures.

Under the system proposed in the Human Tissue Bill, consent for organ donation will be deemed unless a person specifically opts out. This is a change from the current system where decisions on organ donation are the responsibility of the next of kin.

Crucially, however, the next of kin will continue to be consulted before any action is taken. As the Irish Kidney Association notes: “No hospital staff will go against the wishes of family when it comes to organ donation for transplantation, whatever legislation is in place.”


The Bill will for the first time put altruistic donation of organs on a legal footing, which should help increase the donor pool.

Overall, evidence on the effectiveness of opt-out systems internationally is scant.

A review of the literature carried out in Wales found international evidence suggesting that there is an association between presumed consent legislation and increased organ donation rates.

A similar Scottish study found little firm evidence that opt-out legislation causes increases in organ donation and transplantation but said there was “encouraging evidence” that this could happen with legislation as part of a package of measures.

Some countries with opt-out legislation, such as Spain, Austria and Belgium have high donation rates, while others with the same legislation, such as Luxembourg and Bulgaria, have low rates.

Bodily integrity

There is also the danger of unintended consequences, particularly in these strange times, where good intentions can be deliberately misconstrued. There was evidence of this within hours of the Government’s announcement, with anonymous posters on social media claiming it wanted to own people’s organs or infringe their bodily integrity.

The strongest evidence around improving transplantation rates involves other, non-legislative measures, such as improving infrastructure.

Spain, which has one of the highest rates of transplantation, is often cited as a model for Ireland and other countries to follow. At first sight, the implementation of opt-out legislation there had a beneficial impact on donations and transplants. However, closer analysis shows that the improvement in Spain’s figures followed a decade after the legislation was introduced, and was driven by big improvements in infrastructure.

The transplant programme was put on a national basis and skilled transplant co-ordinators were employed for the key engagement with families struggling with the loss of a loved one.

Like other activities in health, organ transplantation suffered during the Covid-19 pandemic. The number of transplants carried out each year fell from almost 300 to just above 200 due to interruptions in service.

Arguably the biggest contribution the legislation will make will be to put organ donation back on the agenda following the pandemic.