Presumed consent for organ donation: a clinically unnecessary and corrupting influence in medicine and politics

The hugely successful reorganisation of organ donation in the UK

It is important to step back for a moment and look at what has been happening to organ donation in recent years. Organ donation rates had been falling for almost 20 years, from a peak of approximately 920 donors per annum in 1989–90 – a matter of serious concern for both doctors and patients. However, from a baseline of 809 deceased donors in 2007, it has risen consistently year on year (899 donors in 2008, 959 in 2009, 1,010 in 2010, 1,088 in 2011, 1,212 in 2012) to 1,320 in 2013. This represents a rise of 50% to 2012, and 63% to 2013, and still rising.³ This ongoing and absolutely remarkable achievement has transformed organ donation in the UK, of course without presumed consent.

The credit for this transformation lies with the Department of Health's Organ Donation Taskforce, chaired by Dame Elisabeth Buggins and comprising 15 experts including transplant surgeons, intensive care physicians, nurses and administrators. In January 2008, the Taskforce issued an ambitious report entitled Organs for transplants.⁴ It contained 14 specific recommendations, mainly in the area of transplant coordination (eg the early identification and referral of potential donors) and the retrieval of donor organs. It also made the bold prediction that a 50% increase in donation was possible over 5 years. To the Department of Health's great credit, the recommendations were implemented throughout the UK, and the predicted increase has been not only achieved, but exceeded.

In 2013, the UK donation rate, ie the number of donors per million of population (pmp), was 20.7.

The country with the world's best donation rate does not use presumed consent

Spain has consistently had the world's best donation rate, about 32–35 pmp, for more than 10 years, and its family acceptance rate is an outstanding 85%.⁵ However, Spain does not operate a presumed consent system.

As a result of its pre-eminent international position, advocates of presumed consent very frequently misrepresent Spain, out of either ignorance or wishful thinking. Spain passed presumed consent legislation in 1979. However, the legislation did not have a positive influence on donation, and so, in 1989, crucial organisational changes were instituted at a national level. These changes created an organisational infrastructure for transplantation, now internationally known as ‘the Spanish system’, and it is this system that the UK has emulated so successfully in recent years. It is from 1989 that Spain's donation rate began to rise to the pre-eminent position that it currently occupies.

Many observers have wrongly attributed Spain's success to its 1979 presumed consent legislation. To correct this misconception, the Director of the Spanish Organ Donation Organisation, Dr Rafael Matesanz, was co-author of a paper published in the British Medical Journal (BMJ) in 2010, which clearly stated that the presumed consent law in Spain is dormant.⁶ This paper emphasised that Spain does not have an opt-out register for those who do not wish to become organ donors, and that Spain makes no effort to make its citizens aware of the 1979 legislation. How can there be an operational presumed consent system when citizens have no mechanism to opt out, and when the state does not inform citizens of the existence of the presumed consent law?

If there is any lingering doubt, it is worth noting that in Spain the consent of the donor (even the explicit consent of carrying a donor card) is not sufficient to permit donation to proceed. The written consent of the family is required.⁷

In these circumstances, it is difficult to imagine how anyone can sensibly or honestly persist in the contention that Spain operates a presumed consent system.

It is sometimes argued that the mere presence of the presumed consent legislation in Spain has had a positive cultural influence, even if the legislation has been dormant. It is impossible to argue definitively one way or the other on this point, other than perhaps to note that the positive influence was not seen for the first 10 years after Spain's legislation. In any case, a positive cultural influence of dormant legislation is certainly not what is being contemplated in the UK or what is coming into effect in Wales. Improving cultural attitudes is the key to improving consent rates, but there are less divisive, more effective and, almost certainly, less expensive ways of achieving cultural change than legislating for the consent of donors (see later).

The Department of Health's organ donation taskforce recommended against presumed consent

Once the Taskforce had completed its report ‘Organs for transplants’, the Department of Health asked Dame Elisabeth Buggins to examine presumed consent for organ donation. This time there were 21 experts on the Taskforce. There were also additional supporting committees to look at specialist aspects of presumed consent. This report, the most extensive examination ever undertaken of presumed consent, was published in November 2008 and entitled The potential impact of an opt out system for organ donation in the UK.⁸ Its conclusion was clear:

The Taskforce's members came to this review of presumed consent with an open mind, with many sympathetic to the view that presumed consent seems an obvious step forward. However, the more the Taskforce examined the evidence, the less obvious the benefit, and the more multi-faceted and multidimensional the issue of increasing donor numbers was revealed to be. Moreover, there are risks going down the opt-out route which could impact negatively on organ donation. The Taskforce reached a clear consensus in their recommendation that an opt-out system should not be introduced in the UK at the present time.

The popular appeal of presumed consent

The appeal of presumed consent is based on the notion that there are large numbers of organs out there, and if only we could presume consent these organs could be transplanted and save lives. Many well-meaning people favour presumed consent on the basis that there is an unnecessary wastage of organs caused by people oblivious to the needs of their fellow citizens. It is true that, however much effort is put into donor registers, only around 30 or 35% of the population join. The remaining 65–70% either do not like to contemplate their own deaths or are too preoccupied with daily life. The key question is this: will legislating for the consent of these 65–70% improve the donation rate?

That presumed consent will obviously improve the donation rate is based on two misconceptions: the first is the erroneous idea (espoused in high places, as we shall see) that one must be on the donor register to become an organ donor. If this were true, approximately 70% of the UK population could not become donors. The truth is that, if a person is not on the donor register, the decision about donation rests with the family. Currently, about 60% of organ donors in the UK are not on the donor register.³

The second misconception concerns the circumstances of donation. With rare exceptions, organ donation is possible only if someone is on a life support system in an intensive care unit (ICU). Otherwise, the organs deteriorate within a few minutes of death and are unusable. A typical circumstance for donation is that someone has cheerfully kissed their family member goodbye in the morning, and in the evening they are unexpectedly in an ICU with their loved one in a coma on a life support system (usually as a consequence of a stroke or a road accident), with doctors and nurses saying that their loved one is dead or dying. This is not a situation in which staff like to make assumptions about the family's wishes about something as sensitive as the removal of organs within a few minutes of death. It is also not a situation in which families are likely to place much weight on the failure of their loved one to have put their name on an opt-out register. Nor is it a situation in which, in practice, the wishes of the family can be ignored. It is a situation in which trust in doctors and the organ donation process is paramount.

Will presumed consent provide additional donors?

The potential for additional donors is likely to vary with the manner in which the legislation is implemented. If the consent of the family remains a requirement, the situation is little different from the current system, and the legislation is unlikely to make a discernible difference. This was recognised in the discussions leading to the presumed consent legislation in Wales, eg it is noted that ‘The closer you are to ordinary (ie current) practice, the less benefit there is in passing the legislation’.⁹ It is for this reason that families in Wales will not be asked for their consent (see later).

If any additional donors are to come from the presumed consent legislation, it will be from families who are not happy about organ donation, but who lack the social confidence to say so when it is left for them to oppose the system unasked. This is especially so in the daunting and unfamiliar environment of an ICU, and in the context of a sudden and unexpected bereavement. This is not a healthy foundation on which to build transplantation.

It is sometimes said that even one additional donor from presumed consent legislation would make it worthwhile. Things are not so simple. The Organ Donation Taskforce estimated in November 2008 that, for the UK, there would be set-up costs of approximately £45 million (secure database, public awareness campaign) and approximately £2 million per annum running costs.⁸ These costs represent NHS resources that might be spent more productively on other initiatives to improve organ donation, or otherwise improve healthcare in the NHS.

Presumed consent has compromised the integrity of the political process in Wales

Presumed consent will compromise the ethics of clinical practice

A hitherto uncompromised cornerstone of medical ethics is that consent that is not informed is valueless. Presumed consent is the absence of an objection, and the absence of an objection cannot be taken as informed consent. It has never previously been acceptable in clinical practice. Presumed consent will erode this fundamental principle, for no good reason.

The position of the British Medical Association

The British Medical Association (BMA) has been a vocal supporter of presumed consent since it was approved by its annual representatives meeting (ARM) in 1999.¹⁷ This was well before the Department of Health's Organ Donation Taskforce recommended against presumed consent in 2008. The BMA has constantly advocated presumed consent as part of a package, but has never been specific about the components of the package. In the interim (as noted above) the Department of Health's Organ Donation Taskforce recommended in 2008 against presumed consent and in the same year provided a detailed package of recommendations, the implementation of which has been spectacularly successful – a 63% increase in donation over 6 years, and still rising.³ The BMA continues to advocate presumed consent as part of a package.¹⁸

Motion 303 at the 2011 ARM was that the BMA should reconsider its position on presumed consent. None of the six speakers were involved in transplantation. The approximately 500 representatives, virtually none of whom would be familiar with organ donation, voted in favour of the BMA's retaining its support for presumed consent.¹⁹

The ARM is a democratic forum, well structured to consider issues of general relevance to doctors and healthcare policies. However, it is scarcely credible that the BMA could choose the ARM to make policy on a complex issue requiring informed scrutiny, particularly on the basis of the brief, uninformed and sometimes misleading discussion that took place in 2011.

Consent is now the key issue

The consent rate in the UK, ie the percentage of approached families who approve donation, was 57% in 2010, 55% in 2011 and 57% in 2012.³ By contrast, the consent rate in Spain in 2010, 2011 and 2012 was 81%, 84% and 84%, respectively,⁵ without presumed consent. This difference represents a massive and unacceptable waste of organs in the UK.

The huge increase in donation in the UK over the past 6 years, from 809 donors in 2007 to 1,320 donors in 2013, has been obtained by improving infrastructure, with better identification and referral of donors in ICUs, among other things. The consent rate has remained largely static over this period. If the consent rate in the UK could be increased from 57% to 84%, this by itself would bring the UK donation rate to about 31 donors pmp – one of the best in the world, and soon challenging Spain for the top slot.

The way forward

Rather than legislating for the consent of donors, we should be addressing the misgivings and misunderstandings of families so that they decline donation much less frequently, as has been done so successfully in Spain.

An acceptance rate of 85% is a realistic and achievable objective for the UK over a 5-year period. As previously, we have the Spanish as a model to guide us. It will not be easy. It will require planning, imagination, resources and a detailed plan at the national level, as was done in 2008 by the Organ Donation Taskforce for improving infrastructure. Perhaps Dame Elisabeth Buggins should be asked to chair another Taskforce. And perhaps influential medical organisations should reconsider the support that they gave to presumed consent in the early 2000s, in the light of the 2008 Taskforce reports^4,8 and the 2010 BMJ paper.⁶ The Royal College of Surgeons of England, noted by the BMA²⁰ and the press²¹ as a supporter of presumed consent in 2008, issued a position statement in 2013 that took a neutral stance.²²