Friday, July 12, 2013

Presumed Consent - Sorry cannot edit for some reason

Something strange is happening in the Welsh Assembly.

Professor John Fabre

Professor Emeritus, Kings College London, and past President (1992 – 1995) of the British Transplantation Society.

In January 2008, the Guardian commentator Polly Toynbee referred to the argument for presumed consent for organ donation as a “fight with the forces of superstition and reaction” In this spirit, the Welsh Assembly is proceeding apace with legislation to enable doctors to presume consent for donation unless the deceased person has registered their name on a national “opt-out” register or has unequivocally told their family that they do not wish to donate their organs. The mantra is that presuming consent in these circumstances will increase donation rates and save lives – a heroic banner by any reckoning, especially for politicians.

In 2007 the then Chief Medical Officer, Sir Liam Donaldson made presumed consent an important component of his plans for the NHS, and the then Prime Minister, Gordon Brown, considered it the foundation for his “transplant revolution”. However, against this strong tide, the Department of Health’s Organ Donation Taskforce, after the most comprehensive examination ever undertaken of presumed consent, reported in November 2008 against it. The Taskforce encompassed a large committee of experts, and the report ran to several hundred pages . Here is the their conclusion. “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 multifaceted and multidimensional the issue of increasing organ numbers was revealed to be. It became clear that what appeared to be a simple idea to increase numbers may not in fact generate additional donors in sufficient numbers to justify the significant investment needed to put a new system into place. Moreover, there are risks in 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”.

Nothing has happened since November 2008 to justify a change in this recommendation. Quite the contrary. Donation rates in the UK have risen spectacularly from 2008, after being static or falling, since 1989/1990. The number of donors per annum over the years 2007 to 2012 have been 809, 899, 959 1010, 1088 and 1212. This represents a rise of 49.8% over the 5 years from the 2007 baseline. The donation rate is still rising – the early figures for 2013 show a rise of 9.5% over 2012. This remarkable transformation, which presumably would fit Gordon Brown’s definition of a transplant revolution, has of course been achieved without presumed consent. It is a direct consequence of the carefully considered recommendations made in January 2008 by the Department of Health’s Taskforce, mainly in the area transplant coordination (for example the identification and referral of potential donors within intensive care units). Another crucial area is of course consent, to which we shall return.

In their zeal to save lives and to blaze what they see as a bold new trail for Wales, and to set an example for the UK as a whole, Welsh Ministers and the large majority of Assembly Members are behaving in a rather depressing fashion. Uncomfortable truths are being ignored. False statements are being accepted without challenge. Silly propositions are being accepted as facts. Disingenuous statements are being made without obvious qualms. There appears to be a collective loss of common sense and suspension of critical judgement.

As often happens in these situations, we have rebranding. What is “presumed” consent in the rest of the world has become “deemed” consent in Wales. Whether one is deemed to have consented or presumed to have consented is a fine point – but in practice it is the same thing, and for the sake of clarity I shall stay with “presumed” consent.

Point 1. Spain and presumed consent .The fact that Spain does not operate a presumed consent system is being studiously ignored and sometimes misrepresented. This is important because Spain has consistently had the highest donation rate in the world, and the best consent rate. If the Assembly were to accept this simple truth it would have several crucial but uncomfortable implications - hence the averted gaze.

Spain passed presumed consent legislation in 1979. However, it was not until 1989, when crucial organisational changes were instituted, that Spain’s donation rate began to rise to the pre-eminent position it currently occupies. Many observers have, wrongly, attributed Spain’s success since 1989 to its presumed consent legislation. To correct this misconception, the Director of the Spanish Organ Donation Organisation, Dr Rafael Matesanz, was the senior author on a paper published in the British Medical Journal in October 2010 Here is what the paper says. “Crucially, Spain does not have an opt-out register for those who do not wish to become organ donors. Not a penny is spent on recording objections to organ donation by Spanish citizens, nor on public awareness of the 1979 legislation. Clearly, the presumed consent law in Spain is dormant, and it pre-dates key policy changes made in 1989. In these circumstances, Spain’s outstanding deceased organ donor rate cannot reasonably be attributed to its presumed consent laws”. How can there be a legally binding form of presumed consent without giving citizens the opportunity to opt out, and without even making any effort to inform citizens of the existence of the law? When this was pointed out to Lesley Griffiths, the former Minister for Health in Wales, she replied that the Assembly’s Social Research officials had found “…….a wide consensus in research papers which consistently categorise Spain as a country with an opt-out system of legislation”. That is true, but hardly a substantive response, on two counts. Lesley Griffiths and her successor Mark Drakeford must surely be aware that having presumed consent legislation is one thing, and operating a presumed consent system is quite another. Moreover, although most research papers over the years have indeed classified Spain as a presumed consent country, others have not, and the latter might be the better informed. The Ministers have simply gone with the majority because it suits them. When the Director of the Spanish Organ Donation Organisation seeks to explain the basis for the misconception about Spain and presumed consent, and makes it clear that Spain does not operate a presumed consent system, nobody seems to listen.

The Ministers seem unaware that in Spain the explicit consent of the family is required. The consent (presumed or explicit) of the donor is insufficient. The family must sign a permissions form for organ donation to proceed. The central role of the family is demonstrated in Spain’s approach to donor cards. Here is what the National Organ Donation Organisation (Organizacion Nacional de Trasplantes) website says: “The donor card is a document that testifies to our desire to be an organ donor after death. However, the card has no legal value. We need to tell our families our desire to be donors, to authorise the removal of organs after death” In Spain, the explicit consent of the donor at the time of death by the carrying of a donor card is not sufficient to permit donation. The responsibility for permitting donation rests with the family. In these circumstances, it is difficult to imagine how anyone can sensibly persist in the contention that Spain operates a presumed consent system.

Once it is accepted that Spain does not operate a presumed consent system, several issues need to be addressed:

• Lesley Griffith’s claim that the introduction of presumed consent legislation in Wales is an essential component of any strategy to improve donation begins to wear thin.

• Clause 102 of the Explanatory Memorandum to the Human Transplantation (Wales) Bill must be recognised as containing a misleading factual error. Under the heading of “Evidence base to establish impact of Proposed Legislation” it states “For example, an opt-out system is operated in Spain and it has the highest donation rate in the world…”. Such a false statement at the core of the official papers underpinning the proposed legislation makes a mockery of the democratic process, and could mislead Assembly Members to vote in favour of this controversial Bill.

• Several of the papers quoted as supporting the introduction of presumed consent (especially that by A. Abadie and S. Gay) incorrectly classify Spain as a presumed consent country.

Point 2. “Soft” or “hard” presumed consent - the proposed role of the family in Wales. The system proposed in Wales has consistently been described as “soft” presumed consent, to distinguish it from hard presumed consent where donation may proceed without consultation with the family. The importance of the family has been constantly stressed. For example, in an interview with The Observer in May 2010, the First Minister for Wales, Carwyn Jones, said “We have decided on soft presumed consent, where relatives can veto organ donation, because we want to make it as easy as possible” Clause 16 of the Stage 1 report of the Health and Social Care Committee (HSCC) states that “A soft opt-out system is one ……where the next of kin will be involved in the decision-making process”. In a letter dated February 2013 to a concerned Welsh citizen, a government official wrote “Organ donation will remain a clinical decision in which families are always involved” and “families will be fully involved in the decision-making process”.

However, the truth is that the family will not be involved in any substantive fashion. Doctors will check the opt-out register, and if the deceased person is not on it (and therefore consent can be presumed) the family will be consulted purely to confirm that the deceased person did not oppose donation. Clause 44A of the Explanatory Memorandum states that “the next of kin will be able to say whether they have any information that would lead a reasonable person to conclude that the deceased person would not have consented”. If they have not, it is proposed to proceed with the donation. Clause 245 of the HSCC report states that “The family are merely being asked if they have any information that the deceased would have objected”. Clause 253 of the HSCC report states that family members “are not being asked to make a decision on donation, but rather to provide information. This is because the deceased has already made a decision to have their consent deemed”.

It is clear that the family will not be asked for their views regarding donation. The repeated reassurances that the family will be involved in the decision-making process are plainly disingenuous. Wales is in fact proceeding with what most people would regard as hard presumed consent.

It is worth looking at the legal position. If someone makes it clear in their lifetime that they do not wish to donate their organs, for example by going on to the proposed opt-out register or indeed any opt-out register even if not backed by legislation, that is their legally recognised view. Nobody can overturn it, and doctors cannot remove their organs under any circumstances. Equally, if someone makes it clear that they do want to donate their organs, that too is their legally recognised view, and nobody can overturn it. However, doctors are under no legal obligation to comply with the deceased person’s wishes. Doctors can therefore use their discretion as to whether or not to proceed with donation, for example in the face of family opposition or distress or any other factor which might adversely affect transplantation. A family opposed to donation for whatever reason, and with sufficient social confidence to express their opposition to the process engulfing them, can in practice halt donation if they show severe distress or express strong views opposing donation.

Point 3. The wishes of the donor. The wishes of the deceased person are said to be of fundamental importance in all the discussions and documents emanating from the Assembly. However, there is quite obviously no way of ascertaining the wishes of a dead person who has not put their name on an opt out register, who has not subscribed to the existing Donor Register, and who has not discussed donation with their family. The reality is that the absence of an objection cannot be taken as a reliable basis for consent. It defies common sense to say so, however legally expedient it might be, and it is humbug to adopt the posture that the presumption of consent defends the wishes of the donor.

Point 4. The current system in the UK involves expressed consent from donors or their families - it is NOT an opt in system. It is frequently stated that the UK has an opt in system for organ donation (simply because it does not have an opt out system!). This is not the case, and it is a very important point to note. This misconception implies that the 69% of the UK population who have not joined the Donor Register cannot become donors, and is sometimes seen as an argument for presumed consent legislation. For example the BBC Wales political reporter Carl Roberts states today that the proposed presumed consent legislation “….would mean a change from the current opt-in system, where would-be donors have to sign a register” . Another example is a statement from the First Minister for Wales. In the interview mentioned in point 2 above he stated “At the moment, if people are not carrying donor cards then it is presumed that they didn’t want to be a donor”. This is completely wrong. If people are not on the Donor Register and do not carry a donor card, no presumption is made about their wishes. In the current system, where the wishes of the deceased person are not known, the decision rests with the family. It is of course very valuable to join the Donor Register. However, the reality is that more than 60% of organ donors in the UK have not joined the Donor Register.

Point 5. There is a “majority” in Wales in favour of the proposed legislation. Various surveys have shown that between 49% and ~65% of Welsh citizens are in favour of the proposed legislation. This usually just fits the mathematical definition of “majority”. However, for a controversial Bill affecting all citizens, this is what the French once referred to as “un petit oui” – a little yes. More importantly, those voting in favour assume that they are voting for a soft opt out system where the family is involved in a substantive fashion in the decision to donate. They also assume that there is no alternative to legislation. Respondents are unlikely to know that the country with the best donation rate in the world and the best consent rate does not operate a presumed consent system.

Point 6. The aspect of donation directly addressed by presumed consent legislation is consent. It has been repeatedly stated that the presumed consent legislation will be one of a package of measures to increase donation. However, there can be only one direct beneficial effect of presumed consent legislation - an improvement in the consent rate. All of the associated measures (e.g. publicity) can be instituted without the legislation. Moreover, some measures will have no effect on consent but improve donation by other means, for example by increasing admission of potential donors into Intensive Care Units. It would help to focus the debate to acknowledge that the legislation itself can improve donation only by improving consent rates.

The consent rate in the UK, i.e. the percentage of approached families who approved donation, was 56.7% in 2010 and 55.4% in 2011. The corresponding figures for Wales were 63.5% and 58.7% respectively. By contrast, the consent rates in Spain in 2010, 2011 and 2012 were 81%, 84% and 84%, without presumed consent. This is a huge difference, and represents a massive and dreadful waste of organs. If the consent rate in the UK could be increased to 80%, this would represent an increase in the donation rate of more than 40%. In Wales, it would represent an increase of ~30%, higher than that envisaged for the proposed legislation. This high level of consent has been consistently achieved in Spain by promoting better public understanding of transplantation, better public appreciation of its outstanding benefits, and optimal approaches to the family at the time of donation – not by legislation. This is surely achievable in Wales, and is an area where Wales could indeed lead the way for the rest of the UK.

Point 7. The recent fall in donation rates in Wales. The number of donors per annum in Wales over the six years 2007, 2008, 2009, 2010, 2011 and 2012 has been 45, 35, 41, 66, 67 and 52 respectively. These numbers are small, and it is essentially impossible to ascribe the large fluctuations in particular years to particular causes (e.g. the rise of 61% in 2010 and the fall of 22% in 2012). It is therefore unwise of those opposing presumed consent to attribute the fall in 2012 to possible negative effects of the proposed legislation. It is equally unwise of those promoting presumed consent to see the fall as a threat and to respond with unfounded blandishments. Here is what Mark Drakeford said in the debate in the Assembly on the 16th April. “What happened in the last year is simple when you understand it. It is not so much that the rates of organ donation went down, it is that the number of people who were able to be donors went down in the first half of that year. That is a good news story, because we do not want people to be in the awful circumstances where they can be donors”. The number of potential donors is influenced by many factors, for example the occupancy of ICU beds and hence the probability of admission of patients who might become donors, as well as other factors when the patient is in the ICU. To describe the fall in donor numbers as good for Welsh citizens, if not for transplantation, is nonsense.

Point 8. The “robust” international research. The research under-pinning the proposed legislation is almost invariably described as robust, presumably in order to give it greater authority. However, it is not so. The Department of Health’s Taskforce had concerns about the selective inclusion of countries for analysis in these research studies. This, and the incorrect assignation of Spain as a presumed consent country,are some of the problems.

But why cling to old studies with uncertain conclusions? The simplest and most convincing “international” research one can do is to look around the world today. If one does that, it is clear that two of the top five countries for organ donation (Spain and the United States of America) do not operate presumed consent systems.

Point 9. The “robust” assessment of the effects of the proposed legislation. Given the substantial effort that has already put into the proposed legislation by various Committees and Assembly Members, and the very substantial future costs, it is frequently stated to be of the utmost importance that the effects of the legislation be not just assessed, but “robustly” assessed. Given the major fluctuations in donation rates in Wales in recent years (noted in point 7 above), the fact that the legislation in Wales will be introduced along with several other measures such as a publicity campaign, and the fact that the Department of Health is planning to introduce additional improvements nationally in the coming years, it is plainly obvious to all except the most credulous that to disentangle the effects of the legislation in any meaningful way is impossible.

Point 10. The future. If additional donors are to come from the proposed legislation, it will be from families who are not happy about organ donation by their loved ones, but who lack the confidence to say so if it is left for them to oppose the system unasked. This is not a healthy foundation on which to build transplantation in Wales.

In the debate in the Assembly on the 16th April, Byron Davies, the Shadow Minister for Transport, gave his view that “…..when someone dies without giving or withholding consent, the family, as the surviving representatives of the deceased, has the final say”. That must surely be the principle on which to move forward in Wales. It is the principle on which the outstandingly successful Spanish system is based.

The tragic irony of all this activity and lobbying for legislation is that the objective of substantially improving donation rates is achievable more cheaply, more effectively and in a socially inclusive manner without legislation. Wales should aim for a consent rate of 80%, which the Spanish have achieved consistently for many years, without presumed consent. The idea that you can legislate for consent is na├»ve. Addressing the issue of consent in a considered and comprehensive manner is the next logical step to build on the success of 2008 – 2013, both in Wales and nationally.


Glyn Davies said...

I was going to edit John's piece to blogpost length. Its quite technical and long. It is carefully argued though for those specially interested. Cannot understand at present why I cannot edit. Will try to fix it tomorrow. Glyn

Glyn Davies said...

For what its worth, my view is that the Welsh Gov't legislation is so flawed that no surgeon will be prepared to act on it. Preumed consent will be rather like in Spain - on the statute book but totally ignored. And than heavens for that.

Janet Thomas said...

This article should be read by every Welsh citizen who will be subject to the 'deemed' consent law in 2015. please don't edit it- every single word is crucial and it is up to date. I wish that you would give permission for it to be published in every publication which is willing to carry it. I shall be sending it to all whom I know to be concerned about this law so that they can bombard their Assembly members with the true facts.

Glyn Davies said...

Thanks Janet, I too think it a good article. I have worked with John Fabre for a long time now. He's probably britain's leading authority. I've also discussed the issue with Elizabeth Buggins, who chaired the Organ Donation Taskforce, who is also very knowledgable. And the Spanish Transplant system. All are dismissive of what the Welsh Gov't has done. The way this issue has been dealt with has shaken my confidence that the Welsh Govt is fit to make laws.

Alison Woodman said...

Hello. I found this post interesting and would like to cite Fabre's comments in a paper I am writing. I can't find the article elsewhere - if it's possible, could you kindly provide me with details of the original source so I would be able to reference it properly?