During national transplant week we are reminded of the triumph of modern medicine that allows organs and tissue of the recently deceased to be transplanted into those in need. There are currently 229 people on the transplant waiting list in Wales. With the potential for so many lives to be saved (or dramatically improved) through transplantation operations, there is a strong incentive for governments to take action to increase donation rates. To this end, and further to its election pledge, the Welsh government has departed from the current ‘opt in’ system under the Human Tissue Act 2004 (HTA), (which was informed by the scandals at Bristol and Alder Hey and demands express consent), to an ‘opt out’ model.
The goal is laudable, but it is far from clear that this legislative intervention (rejected by the Organ Donation Taskforce in 2008) will yield the predicted 25-30% increase in donation rates: no causal link has been established between changing the system of consent and increasing donation rates; the UK already outperforms some countries with opt out systems (e.g. Sweden); the director of one of the most successful transplant authorities in the world has claimed it is ‘dangerous’ to focus on the system of consent as a strategy for increasing donation rates; and some countries that have switched to opt out systems have experienced a drop in donation rates (e.g. Brazil). Indeed, since this matter appeared on the legislative agenda, Wales has experienced a year-on-year decline in donation rates, in contrast to the increases achieved in every other country in the UK.
A further concern is that the new Welsh law will complicate the organ donation rules in the UK. This is because clinicians in Wales will have to determine, within a highly time-sensitive period, whether the patient has been a Welsh resident for more than six months (s.5(3)(a)) and satisfies the capacity requirements (which call for a retrospective assessment of capacity) (s.5(3)(b)). It may be challenging to answer these questions both accurately and quickly.
Patients and their relatives may also be confused as to when deemed consent will apply. For instance, if a Welsh resident dies in another part of the UK, they will be assessed for organ explantation under an opt in system, meaning that unless they have expressed their consent (or express consent is given on their behalf) they will not become a donor. Similarly, people from other parts of the UK who die in Wales will not be subject to deemed consent unless they satisfy the residency requirements; but these requirements may be satisfied by people who might not expect to be included e.g. students. Precisely which organs and types of tissue will be the subject of deemed consent will also remain unclear until regulations are agreed upon.
Moreover, concerns have been raised about the very concept of ‘deemed consent’. In a public consultation, 92% of respondents were unconvinced that deemed consent is a true species of consent. Thus it is questionable whether families (whose decision-making role has been marginalised under the new legislation) will be as content to see their relatives’ organs and tissue removed on a deemed consent basis, (where there is no way of knowing whether the patient’s silence was intentional or a mere oversight) as they would be with evidence of express consent. There is also the troubling possibility that those who refuse consent, possibly for reasons of faith or conscience, will be shamed by the construction of organ donation as an expectation, rather than a supererogatory act.
Given these concerns, it must be questioned whether the Welsh government has opted wisely.
Tom was invited to present a paper on this topic at the Centre for Ethics in Medicine, University of Bristol (2012) and at the Institut für Ethik, Geschichte und Theorie der Medizin, Ludwig-Maximilians Universität München (2013) as part of a workshop on organ donation. A more detailed paper will appear in a forthcoming edited collection on organ donation published by Springer.