Opting out of the evidence?

Today is the deadline for responses to the Department of Health’s consultation on proposals to change the law in England to move to an ‘opt-out’ system of organ donation. The increasing possibilities for saving lives through the transplantation of donated organs and other bodily materials is a major success story for modern medicine. With so much at stake, it is unsurprising that the question of how the donation and transplant system should operate is a source of strong emotion, and the increased public awareness of the great benefits of donation, generated by the consultation, is to be welcomed. But – and this is an important but – I have been taken aback by the way in which the evidence of ‘what works’ (and even the facts about the current law) have been manipulated and inflated: by the media, in parliamentary debate, and even in the consultation materials themselves. This is not the way to support and maintain trust in our transplant system, nor indeed to demonstrate commitment to evidence-based policy.

A bit of background. The consultation is not on whether England should follow Wales and Scotland in adopting a system in which those who have not opted out during their lifetime will be ‘deemed’ to have consented to organ donation – but how such a scheme should be implemented. In other words, the essence of the policy has already been agreed at political level. The Prime Minister’s announcement of this policy at Conservative Party Conference in October 2017 took many by surprise, since it represented an abrupt change of direction from recent statements by ministers at the Department of Health. Answers to parliamentary questions only four months earlier had emphasised that it would take three or four years before there would be sufficient evidence to demonstrate the true impact of the Welsh changes, and that England would be monitoring this evidence closely.

In our 2011 report, Human bodies: donation for medical and research, we strongly supported organ donation where this is in accordance with the wishes of the donor, but did not advocate a change in the current law to an opt-out system. We concluded that such a system could be ethical – as long as a number of potentially onerous criteria were met. People need to be fully informed in order to be able to make an active choice about whether or not to donate, which implies a long term (and expensive) commitment to public information and education. Families need to be appropriately involved – recognising not only that they are likely to have the best knowledge of their loved one’s attitudes to organ donation, but also that they themselves, in their bereavement, have a stake in what happens to the deceased person’s body. Critically, the system must operate in a way that ensures that public trust in the donation and transplant system is not undermined, for example through perceptions that the state is intervening to ‘take’ organs against family wishes. We only have to look back two decades to the outcry caused by tissue retention in the NHS to be alert to the way in which trust can be undermined, not least by failing to take into account the complex family and personal meanings associated with the body in death.

Alongside these ethical questions, we also, importantly, looked at the issue of whether such a change in the law would actually work – in terms of achieving its desired aim of higher donation rates while respecting the wishes of individual donors. And the quick answer is that no one knows. In contrast with the claims (confidently asserted over past months) that opt-out will save “thousands of lives”, the Department of Health’s own Impact Assessment, published alongside the consultation document, described the evidence on the impact of opt-out on donation rates as “inconclusive”. This is because it’s impossible to separate out the effect of changes to consent practice from multiple other factors affecting donation, in particular improvements in infrastructure and changes in public attitudes that often accompany legislative change. Despite all the emotional rhetoric, the jury is still out on whether changing the law in this way will make any difference at all to the numbers of organs available for transplant.

While this may seem counter-intuitive (“surely more people can become donors if you don’t actually need to opt-in?”), it’s important to note that under England’s current ‘opt-in’ system, families can, and do, provide consent after a person’s death, on the basis of their own knowledge of what that person would have wanted. Getting round to signing the NHS Organ Donor Register is not essential in order to be a donor, although it’s obviously helpful to all concerned to make a clear statement of your wishes. (Worryingly, the Department of Health consultation document states that “under current rules in England, a person who has died can only be an organ donor if they have agreed to it when they were alive”– a misrepresentation of the current position which has unfortunately been endlessly repeated in subsequent coverage).

Indeed, this crucial role of families in the process is highlighted in the evidence that is available. We know, from the detailed reports published each year by NHS Blood and Transplant, that the key factors associated with high consent rates are support for families by specialist nurses, and families knowing what the deceased person wanted. Consent rates are as low as 27.5% when families are not supported by a specialist nurse. They increase to 68.6% when a specialist nurse is involved; and are over 90% where families are confident of the deceased’s wishes. Rafael Matesanz, the leading light of the Spanish transplant system ascribes the well-known successes of the Spanish system to its focus on efficient systems and excellent family support, and is on record as calling opt-out systems a ‘distraction’. Despite being classed as an ‘opt-out country’, Spain operates neither an opt-in or nor an opt-out register, and relies entirely on family authorisation for the legal basis of donation.

So, what are the practical arguments in favour of an opt-out system in which families are genuinely still able to express any reservations they may have (as we argue would be essential in any ethically-designed opt-out system)? How would that increase donation in a way that is not possible under the current system? Our Human Bodies report recognised the possibility that changing the legal basis of donation in this way might, over time, shift public attitudes to the extent that organ donation just becomes the norm – making it easier for families faced with sudden and traumatic bereavement to say ‘yes’. But again, this is speculation – there is no clear evidence one way or the other.

And this is where the change of the law in Wales in December 2015 appeared to offer the perfect opportunity to identify with much more confidence than ever before, what impact changes to consent systems might make on rates of organ donation. England, Wales, Scotland and Northern Ireland all share a common transplantation system, operated on a UK-wide basis by NHS Blood and Transplant, with the same system of specialist nurses to support bereaved families. While it may still be difficult to demonstrate direct cause and effect of the change in the law (because variables such as public awareness might still fluctuate and there are existing significant regional variations), nevertheless the consistency of the transplant system across the UK provides an important baseline for comparison, and hence for informed and evidence-based policy-making.

An evaluation of the Welsh law was published in November 2017, comparing the first 21 months of the opt-out system with the same period preceding the legislative change. It found no consistent change in the number of donors, either up or down. This is hardly conclusive given the relatively small number of potential donors – it seems to be widely agreed that it will take five years to show any meaningful trend – but it makes it even harder to understand the timing of the current consultation.

However, this early evaluation report was interesting and valuable for a variety of other reasons. It found that consent rates from families had increased compared with earlier rates in Wales (although they are still higher in some other parts of England under the opt-in system). Importantly, there was nothing to suggest that public trust in the system had been affected by the way the system had been introduced in Wales – a point our report had highlighted as a factor to take into account. On the other hand, levels of public awareness had dipped again after the initial rise linked with the launch of the new system, emphasising the need for continued efforts to ensure people in Wales are able to make genuinely informed choices about whether or not to opt out. And the number of NHS staff who misunderstood the role of the family (believing they no longer had any role) had increased, which is a matter of some concern.

This evaluation, along with the detailed activity reports published every year by NHS Blood and Transplant, provides a really solid basis for identifying what does work in the UK context, and for highlighting areas (public awareness, staff training, ensuring all families are well supported) where more needs to be done to ensure organ donation systems operate ethically. The evaluation itself concludes that “a longer period of time is need to draw firmer conclusions around the impact of the change in the law”. Instead of risking public trust by jumping to conclusions that are not yet supported by evidence (not to mention misrepresenting the existing law in its own consultation), is there really any reason why the Government can’t wait two or three years, and make its decision based on sound evidence and responsible debate?