Donazione degli organi in UK: tra consenso presunto e consenso esplicito

Summary: 1. Presumed consent: a solution for organ shortage in the United Kingdom? – 2. Roels, speaking about the Belgium experience, argues, “The data presented show that, at least in Europe, the problem of chronic organ shortage can adequately be solved in the setting of an opting-out legislation”.[13]

1. Presumed consent: a solution for organ shortage in the United Kingdom?

This topic is one of the most controversial of our days because organ donation will always remain an intimate choice connected with personal beliefs. An expressed consent (opt-in system) or a presumed consent (opt-out system) are the two main models that it is necessary to analyze. An opt-in system requires explicit consent for organ donation, while an opt-out system does not because all adults are considered donors, but it must be remembered that there is the possibility of objecting this system with a statement.

The introduction of presumed consent in itself is not sufficient, but if we combine it with campaigns against the myths about donation, false information and public initiatives to raise awareness on the issue, from schools to adults, surely we will get a significant increase in the rate of organ donation in the United Kingdom.

Initially, I will show the results of the current donation system in the UK, with reports and statistics. Subsequently, the negative impact of this situation on the patients that are waiting for an organ in the transplant lists. Then, I will discuss the reasons to introduce an opt-out system and further fundamental aspects to be implemented in parallel with other issues that we should face in the future.

Organ donation in the UK is an opt-in system – except for Wales which introduced an opting-out system in 2015 – where persons are able to volunteer to become an organ donor, and if they have not done so, under the Human Tissue Act 2004, their nominated representative or a close relative might give the consent. The most important alternative is the one which allows to become a donor with a statement at the organ donor register (also called ODR). About 24.9 million potential donors (38% of the population) were registered by the end of March 2018 in the ODR, but where no wishes were recorded 50% of families refused donation.[1]

The current objective is to improve the systems to identify potential cadaver donors and to use public education to encourage voluntary altruistic donations. Unfortunately, this is not enough, and it is noted that there is a low percentage of registration compared to the request for organs.

So, how to raise the number of available organs? An Organ Donation Task force (also called ODT) was appointed in 2006 to investigate how this might best be achieved.

In 2008 the ODT provided an important report stating that the opt-in system was the right one to follow and they claimed that an opt-out system was far too expensive and unpredictable to be introduced in the UK. The task force believed that the number of organ donors registered in the ODR could be increased at a relatively modest cost through a more extensive publicity and engagement programme and not through a presumed consent system. They concluded that there is no convincing evidence that an opt-out system would lead to a significant increase in terms of the number of donated organs. They also set a national target, namely to increase the organ donor numbers by 50% within 2013.[2]

This target was not achieved by 2013, although there has been an improvement.

The statistics show that there were 899 deceased donors in 2008-2009 and 1212 deceased donors in 2012-2013, but, unfortunately, there was only an increase by 34,8% and this was not sufficient to solve the problem of organs shortage.[3]

The National Health Service (NHS) report said that 411 patients died while on the active list waiting for their transplant and a further 755 were removed from the transplant list. The removals were mostly a result of deteriorating health and consequently the impossibility of a transplant with a good success rate.[4]

There is an emergency in the United Kingdom and the opt-in system is not sufficient in order to deal with the situation, neither from a political point of view nor from a social and economic perspective, although there has been an improvement in the last decade.

The reforms are necessary to overcome the terrible crisis of organ donors, and the most promising way to do this is moving to the presumed consent system.

A typical situation in the context of organ donation is the one in which families may have a lot of strong negative feelings and considerations regarding this matter, while on the other side, someone could need a transplant to save his or her own life. According to professor John Harris, “(…) this conflict of interests or of values will be resolved by considerations of which interests or values carry most moral weight, for example, whether the interests served by one set of values are more significant or vital that those of the other.

This might happen if one set of values protected an interest in life itself (actually involved saving a life), whereas the counterpoised interest protected some less significant or less urgent value, like a sense of what is appropriate”.[5]

The presumed consent is often criticized on the ground that this system undermines the right of self-determination that is protected by article 8 of the European Convention on Human Rights. However, an opt-out system would be compliant to the principle of autonomy because people would still have the right to choose to not donate with a declaration.

Govert den Hartogh argues that as long as people are aware of the significance of their silence and the low costs of registering their disagreement with organ donation, an opt-out system is justifiable.[6]

Nowadays, something is changing. The government wants to move to an opt-out system by 2020. If the Organ Donation (Deemed Consent) Bill 2018 enters into force there will be a historic change. The Bill (also called “Max’s Law”) intends to amend the Human Tissue Act 2004 so that where a person over 18 has not made a decision regarding organ donation during their life, or appointed a representative for this purpose, the default position will be that consent will be deemed to have been given.[7]

The government said that up to 700 lives would be saved each year if the reform were approved.[8]

At this point, there are important reasons that should be pointed out in favor of an opting-out system.

Firstly, in Spain, there is a “soft” opt-out system, which means, relatives have a right of veto, but only if they prove that the deceased was against organ donation. Spain leads the world in terms of organ donation rates.[9]

Secondly, Austria has a “hard” opt-out system, that is, the failure to register the desire not to donate would be decisive, and the organs would be taken even if the relatives object. With this system, donation rates rose from 4.6 donors per million to 27.2 per million within five years, and each year the number of kidney donations almost equals the one of the people on the waiting list.[10]

In both cases, the introduction of presumed consent led to great results. Someone claims that this is not only a consequence of this reform. Indeed, there is a strong correlation between infrastructure improvements, more funding for transplant programs and an opt-out model; however, the available data from Spain and Austria cannot be ignored.

A third case is Belgium’s one.  After the implementation of the transplant law in 1986, which introduced an opt-out system, the kidney retrieval rate rose in the following two years by 86% to 37.4 per million population per year, and also, it is worth underlining that less than 2% of the population have registered an objection to organ donation.[11]

Furthermore, it seems that families have doubts regarding the decision to take about organ donations but, if they are confirming the intention of the deceased, it may be easier to agree. If this is so, the presumed consent system has the advantage of relieving pressure on family members in a very critical period due to the death of a loved one.[12]

2. Roels, speaking about the Belgium experience, argues, “The data presented show that, at least in Europe, the problem of chronic organ shortage can adequately be solved in the setting of an opting-out legislation”.[13]

There is also another aspect to underline, namely the state budget. For example, kidney transplantation is much cheaper than providing dialysis to a patient with renal failure. Gary Becker, Nobel Prize winner in Economics (1992), wrote an article for the Wall Street Journal in which he argued that dialysis for a single patient cost 80k dollars per year, while a transplant only 15k dollars.[14] Through his analysis, it is possible to understand that the difference between supply and demand for organ donation involves excessively high costs for the state and for the families.

This analysis was confirmed by the National Institute for Health and Care Excellence, which estimated that a 25 percent increase in the number of kidney donors would save the NHS 9.2 million per year.[15]

At this stage, it is clear that there are great examples of countries with fruitful results from the introduction of an opt-out system. Of course, it is not all thanks to this reform, as other factors have contributed to an organ donation rate improvement: campaigns against the myths about donation, public initiatives to raise awareness on the issue, structural improvements and a closer relationship between doctors, patients, and families.

However, I think that presumed consent is the decisive factor to increase the percentage of organ donations.

In an opting-out system, those who want to donate organs are likely to have their wishes fulfilled because they do not have to do anything to signal their will and it is unlikely that such wishes will be overridden by relatives where the deceased did not formally object.

By way of conclusion, the organ shortage is one of the key problems of our healthcare system. The current model has failed because even one lost life is a tragedy.

The evidence from other countries and the opinions of important authors suggest the importance to move to a presumed consent legislation to solve this emergency.

Of course, this solution is not sufficient because other reforms are required: infrastructure improvements, more funding for transplant programs, campaigns against the myths about donation and public initiatives to raise awareness on the issue.

However, I think that the effect of these reforms combined with the introduction of an opt-out system will improve, if not even solve, the organ crisis in the UK.

BIBLIOGRAPHY

Barber S, Baker C, and Rathbone D, ‘The Organ Donation (Deemed Consent) Bill 2017-19’ (25 October 2018) <https://researchbriefings.parliament.uk/ResearchBriefing/Summary/CBP-8236#fullreport> accessed 04 November 2018.

Becker G, Cash for Kidneys: The Case for a Market of Organs, The Wall Street Journal (18 Januar 2014)<www.wsj.com/articles/cash-for-kidneys-the-case-for-a-market-for-organs-1389992925> accessed 10 October 2018.

Den Hartogh G, ‘Tacitly consenting to donate one’s organs’ (2011) 37 Journal of Medical Ethics 344.

Donnelly L, Presumed consent for organ donation will save up to 700 lives a year, The Telegraph (London, 5 August 2018) <www.telegraph.co.uk/news/2018/08/04/presumed-consent-organ-donation-will-save-700-lives-year/> accessed 11 October 2018.

Gundle K, ‘The case for presumed consent in organ donation’ (1998) 351 The Lancet 1650-52.

Harris J, ‘Law and Regulation of Retained Organs: The ethical Issues’ (2002) 22 LS 527, 540.

Kennedy I, ‘The case for presumed consent in organ donation’ (1998) 351 The Lancet 1650-52.

Lyne N, Spain retains its lead in organ transplants, reduces waiting times, El Paìs (Madrid, 12 Januar 2017) <https://elpais.com/elpais/2017/01/11/inenglish/1484140053_212152.html> accessed 18 October 2018.

Michielsen P, ‘Presumed consent to organ donation: 10 years’ experience in Belgium’ (1996) 89 Journal of the Royal Society of Medicine 663-666.

National Institute for Health and Care Excellence, ‘Organ Donation for Transplantation Costing Report: Implementing NICE Guidance’ (2011).

NHS Blood and Transplant, ‘Annual Activity Report 2014-2015: Overview of Organ Donation and Transplantation’ 2015 <https://nhsbtdbe.blob.core.windows.net/umbraco-assets-corp/4661/activity_report_2014_15.pdf> accessed 12 October 2018.

–, ‘Annual Activity Report 2017-2018: NHS Organ Donor Register’ 2018 <https://nhsbtdbe.blob.core.windows.net/umbraco-assets-corp/12061/section-12-nhs-organ-donor-register.pdf> accessed 12 October 2018.

–, ‘Annual Activity Report 2017-2018: Summary of Donor and Transplant Activity’ 2018 <https://nhsbtdbe.blob.core.windows.net/umbraco-assets-corp/12063/tar-section-1-summary-of-donor-and-transplant-activity.pdf> accessed 12 October 2018.

Organ Donation Taskforce, The Potential Impact of an Opt Out System for Organ Donation in the UK (COI 2008) ch 15, para 15.7.

Roels L, ‘Three years of experience with presumed consent legislation in Belgium: its impact on multi-organ donation in comparison with other European countries’ (1991) 23 Transplantation proceedings 903-904.

[1] NHS Blood and Transplant, ‘Annual Activity Report 2017-2018: NHS Organ Donor Register’ 2018<https://nhsbtdbe.blob.core.windows.net/umbraco-assets-corp/12061/section-12-nhs-organ-donor-register.pdf> accessed 12 October 2018

[2] Organ Donation Taskforce, The Potential Impact of an Opt Out System for Organ Donation in the UK (COI 2008) ch 15 para 15.7

[3] NHS Blood and Transplant, ‘Annual Activity Report 2014-2015: Overview of Organ Donation and Transplantation’ 2015 <https://nhsbtdbe.blob.core.windows.net/umbraco-assets-corp/4661/activity_report_2014_15.pdf> accessed 12 October 2018

[4] NHS Blood and Transplant, ‘Annual Activity Report 2017-2018: Summary of Donor and Transplant Activity’ 2018 <https://nhsbtdbe.blob.core.windows.net/umbraco-assets-corp/12063/tar-section-1-summary-of-donor-and-transplant-activity.pdf> accessed 12 October 2018

[5] John Harris, ‘Law and Regulation of Retained Organs: The ethical Issues’ (2002) 22 LS 527, 540

[6] Govert den Hartogh, ‘Tacitly consenting to donate one’s organs’ (2011) 37 Journal of Medical Ethics 344

[7] Sarah Barber, Carl Baker, Daniel Rathbone, ‘The Organ Donation (Deemed Consent) Bill 2017-19’ (25 October 2018) <https://researchbriefings.parliament.uk/ResearchBriefing/Summary/CBP-8236#fullreport> accessed 04 November 2018

[8] Laura Donnelly, ‘Presumed consent for organ donation will save up to 700 lives a year’ The Telegraph (London, 5 August 2018) <www.telegraph.co.uk/news/2018/08/04/presumed-consent-organ-donation-will-save-700-lives-year/> accessed 11 October 2018

[9] Nick Lyne, ‘Spain retains its lead in organ transplants, reduces waiting times’ El Paìs (Madrid, 12 Januar 2017) <https://elpais.com/elpais/2017/01/11/inenglish/1484140053_212152.html> accessed 18 October 2018

[10] Kenneth Gundle, ‘Presumed consent: an international comparison and possibilities for change in the United States’ (2005) 14 Cambridge Quarterly of Healthcare Ethics 113-18

[11] Paul Michielsen, ‘Presumed consent to organ donation: 10 years’ experience in Belgium’ (1996) 89 Journal of the Royal Society of Medicine 663-666

[12] Ian Kennedy, ‘The case for presumed consent in organ donation’ (1998) 351 The Lancet 1650-52

[13] L. Roels et al., ‘Three years of experience with presumed consent legislation in Belgium: its impact on multi-organ donation in comparison with other European countries’ (1991) 23 Transplantation proceedings 903-904

[14] Gary Becker, ‘Cash for Kidneys: The Case for a Market of Organs’ The Wall Street Journal (New York, 18 Januar 2014) <www.wsj.com/articles/cash-for-kidneys-the-case-for-a-market-for-organs-1389992925> accessed 10 October 2018

[15] National Institute for Health and Care Excellence, ‘Organ Donation for Transplantation Costing Report: Implementing NICE Guidance’ (2011)