On December 1, 2015, the Welsh Government introduced new legislation to allow presumed consent in organ donation,1 whereas the status quo of operating an opting-in approach was maintained in Northern Ireland, Scotland, and England. The Human Transplantation (Wales) Act 2013 that amended the UK Human Tissue Act from 2004 had been passed after considerable debate within both Wales and the United Kingdom. Thus, Scotland, Northern Ireland, and England watched with interest and some degree of concern on the potential far-reaching consequences of this unilateral action by a confident devolved Welsh administration.
The catalyst for a change in legislation had been a campaign initiated and led by the charitable sector involving the Kidney Wales Foundation with support of the Welsh Kidney Patients Association, the Royal National Institute of Blind People, the British Heart Foundation, the British Lung Foundation, Diabetes Cymru, Cystic Fibrosis, and The British Medical Association.2 The campaign had been launched in 2008 in response to findings of the Organ Donation Taskforce (ODTF) established by the UK Government in 2006 that aimed to define barriers to organ donation and to make recommendations on how they could be overcome.
The first report in 2008 made 14 recommendations for improvements to the process and infrastructure of organ donation.3 No recommendations were made on the system of consent at that time. The UK Health Minister then asked the ODTF to extend their work to consider whether presumed consent should be introduced throughout the United Kingdom. The ODTF's second report in 2008 unanimously opposed a change of law enabling a system of presumed consent.4
The arguments for adopting presumed consent flowed from frustration among patient groups and the charitable sector in response to the growing waiting list for transplants and the knowledge of positive outcomes with such legislation in other countries. Media engagement culminated in successful petitioning of the Welsh Assembly and eventual change of the Law. It is some 2 years since Wales introduced a “soft” presumed consent for organ donation that remains to honor the objection of the next-of-kin (in which case organ donation will not proceed). At this time, it appears timely to review the outcome of this concept.
The percentage of the population opting-in to donation has steadily increased from 2014-2015 to 2017-2018 in Wales (34% to 40%, data of the Organ Donor Register.5 An increase of organ donation has also been observed in England but to a lesser extent (32% to 37% from 2014-2015 to 2017-2018, respectively).
The percentage of the Welsh population opting-out has remained steady; however, lower than the level of 19% predicted in a Welsh Assembly–commissioned study6 (from 5% in 2015-2016 to 6% in 2016-2018).
At the same time, consent rates increased from 58% in 2015 to 72% in 2017 in Wales. This rate compared favorably with 2017 rates in England (65%), Northern Ireland (71%), and Scotland (57%) in the absence of a presumed consent.
Specifically looking at consent rates for brain dead donors in Wales, rates had even been higher with 70% in 2015 and 83% in 2017.7 England had comparable consent rates in 2015 (69%), and 71% in 2017. Consent for donation was obtained in 53% donors after circulatory death (DCD) in Wales in 2015, increasing to 64% in 2017. There was a smaller increase in consent rates for DCD donors in England over the same period from 56% to 60%.
A further increase has been seen in Wales in the last quarter of 2017 with 89% consenting for eligible donors after brain death (DBD) and 68% for eligible DCD.7
Notably, Wales had the highest rate of organ donors in the United Kingdom in 2017 (24.3 per million population [pmp] compared with 18.1 pmp in 2015). Increasing, but less pronounced rates had also been observed in England (20.3 in 2015 to 23.2 in 2017), Northern Ireland (26.6 pmp to 21.7 pmp), and Scotland (16.1 pmp to 19.8 pmp) during the same time intervals.7
The DBD rates in Wales increased between 2015 and 2017 to a larger extent than in England (Figure 1). Similarly, increasing rates were also observed for DCD donors in both Wales and England, albeit not as pronounced. The NHS Blood and Transplant has undertaken an analysis of eligible donors (both DCD and DBD) for whom consent had been obtained using cumulative quarterly data and sequential analysis since the introduction of presumed consent in Wales.7 There has been a consistent trend to increased rates in Wales compared with England for DBD which has almost reached statistical significance in the last 2 successive quarters of 2017. A trend to an increase in DCD is also emerging in Wales. The mean quarterly consent rate for DBD in Wales increased from 77.9% in 2016 to 82.1% in 2017 compared with 66.6% (2016) and 72.3% (2017) in England.7 The mean quarterly consent rate for DCD increased from 51.6% in 2016 to 63.0% in 2017 in Wales, whereas rates remained stable in England (60.1% in 2016 and 59.5% in 2017).
Thus, the implementation of a presumed consent legislation in Wales saw an increasing proportion of the population registered for organ donation, a lower opting-out rate, and the highest overall consent, and organ donor rates of the 4 UK nations in 2017.
Although the observation period is short, the overall trend after the introduction of presumed consent process has been encouraging.
It would be difficult to argue that the Welsh results can be solely attributable to the change of legislation but rather that the implementation of the ODTF with recommendations for an improved organ donation infrastructure, and novel communication strategies have also contributed. The observation that that there has been a swing of the public opinion in the UK across political lines toward a presumed consent approach appears very relevant. Most recently, the UK government has undertaken a public consultation on an opt-out scheme, whereas Scotland has expressed intent to change legislation to allow presumed consent, and the British Medical Association has lobbied Northern Ireland to follow the same path.