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In a Similar Vein? A Comparative Analysis of Organ Donation Systems

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About The Author

Ceylan Simsek (Regular Writer)

Ceylan Simsek is a law school graduate whose main area of interest is medical law and international law. Alongside her studies, she has obtained certifications from Stanford University School of Medicine on overprescription of antibiotics and unconscious bias in medicine. She works at Medical Protection Society, the world's leading medical defence organisation for medical, dental and healthcare professionals. Outside of law, she enjoys learning new languages and, in order to combat her fear of heights, rock climbing.

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Making a donation is the ultimate sign of solidarity. Actions speak louder than words.

Ibrahim Hooper

A change to the UK’s law on organ donation seems imminent. In July 2017, the Organ Donation (Deemed Consent) Bill 2017-19 (the Bill), proposed by Labour MP Geoffrey Robertson, was presented to Parliament. After the government declared its ‘whole-hearted support’ for the Bill, it passed the second reading in the House of Common in February. The Bill, if implemented, would lead to the introduction of a ‘soft opt-out’ system that involves the creation of a rebuttable presumption that, upon death, all adults in the UK have consented to being an organ donor.

The state of the UK’s current law on organ donation, the merits of the Bill, and other potential avenues the law may adopt of have already been discussed in more detail for Keep Calm Talk Law by Abbey Brimson. Expanding upon her analysis, this article will briefly consider the legal, ethical and practical challenges that will be faced by the UK before making comparisons to – and setting out the lessons the the UK can learn from – the variety of approaches towards organ donation taken in other jurisdictions.

A Spectrum of Different Forms of Consent

As well as the ‘soft opt-out’ system proposed by the Bill, a variety of other schemes can be implemented to determine whether a deceased person has given their consent in regards to organ donation. At one end of the scale is a ‘hard opt-out’ system, like that which operates in Austria, that sees consent presumed and organs are taken from the deceased unless they themselves have actively registered against it.

A less intense version of the ‘hard opt-out’ system involves consent being presumed but – as well as individuals being able to opt-out – certain demographic groups as a whole can register to opt-out together. This system is in operation in Singapore, where Muslims as a group have opted-out for religious reasons.  

By comparison, an ’opt-in’ approach currently operates in the UK. This requires the donor, or a designated family member on their behalf, to voluntarily place their name onto the organ donation register or otherwise indicate a positive wish to be an organ donor.

There are many different possible permutations of the ‘opt-in’ approach: it can be subdivided based on the extent to which families can be involved in establishing consent. This is illustrated by comparing the approach in Belgium – which allows the consultation of relatives in establishing consent – with Spain, which does not.

Legal and Ethical Implications of ‘Opt-Out’ Systems

An ‘opt-out system’ allows a country to increase the availability of organs for transplant by tapping into the potential source of organs comprising citizens who may not have had a chance to consider indicating their consent under an ‘opt-in’ system. However, the extent to which an ‘opt-out’ system functions in this way might be limited if the families of the deceased are given the opportunity to challenge and overturn the presumption that the deceased consented to donating their organs.

The attractiveness of an ‘opt-out’ system – which represents an extremely utilitarian approach to organ donation – has significant legal and ethical complexities. FA ‘hard opt-out’ approach does not consult the family of the deceased and if the deceased has not actively registered their lack of consent, the organs are taken regardless of other evidence of intention to the contrary. This could give rise to the possibility of successful challenges under the European Convention on Human Rights (ECHR).

Indeed, it might be argued that the taking of the organs or tissue constitutes ‘inhuman or degrading treatment or punishment’ that breaches Article 3 of the ECHR. Alternatively, carrying out the surgery in contradiction of the wishes of the relatives may interfere with the right to respect for ‘private and family life’ under Article 8 of the ECHR.

A method of circumventing this issue is introducing a softer form of the ‘opt-out’ system whereby families are notified, upon the deceased’s death, that they have failed to register an intention against donation and that organ donation is to proceed by way of presumed consent unless the family brings evidence on the contrary. This is the approach taken in Wales, which became the first country in the UK to introduce an ‘opt-out’ system on 1 December 2015. More specifically, when taken together, Section 4(2)(b) and Section 4(4)(a)(b) of Human Transplantation (Wales) Act 2013 hold that it is lawful for the deceased’s consent to organ donation to be presumed unless:

A relative or friend of long standing of the deceased objects on the basis of views held by the deceased, and a reasonable person would conclude that the relative or friend knows that the most recent view of the deceased before death on consent for transplantation activities was that the deceased was opposed to consent being given.

By opening the door to families being able to influence whether organs are actually taken, a ‘soft opt-out’ system arguably ensures that greater regard is given to the deceased’s intentions while maintaining the wider potential net for procuring organs. Abbey Brimson has questioned for Keep Calm Talk Law whether giving families the ability to overrule the presumption of consent undermines to some extent the purpose of introducing an opt-out system; however, her argument does not appreciate that this seems to be a justifiable trade-off that sharply reduces the risk of claims being brought under the ECHR and increases the ethical soundness of the system.

Another potential human rights issue that might arise on the application of a ‘hard opt-out’ system concerns Article 9 of the ECHR, which protects the freedom to manifest one's religion or beliefs. It is clear that the introduction of an ‘opt-out’ approach might impinge on the rights of certain religious groups: while in some religions, such as Christianity and Hinduism, organ donation is treated favourably or neutrally because no great weight is placed on the fate of the physical body following death, those who follow Islam and Judaism must adhere to clear restrictions on how their body is used after death. This involves the requirement of burial with 24 hours of death – where the heart still beats but the person has lost all brain function and cannot perform any of the involuntary activities necessary to sustain life- which is to be insufficient for the consideration of organ donation.

A Comparative Examination: Alternative Approaches

In addition to the approach taken in Wales – which looks likely to be introduced across the UK as the Bill continues to pass through Parliament – there have been a variety of other systems of organ donation implemented by countries across the world.

The USA and Iran: An ‘Opt-in’ System with Financial Incentives, and a Kidney Market

An ‘opt-in’ system currently operates all across America, under which individuals have to indicate whether they wish to consent to donation or not. This can be through adding their name to a register or by indicating their intention to consent on their driver’s license. Notably however, certain US states encourage organ donation by way of financial incentives. In 32 states, employees of federal executive agencies receive 30 days of paid leave for organ donation, and in 19 states (as well as the District of Colombia) tax incentives are provided.

To assess the effectiveness of these policies, Paula Chatterjee et al conducted a study between 1988 and 2010 to investigate the extent to which organ donation increased across America in that time period. The study found that there was:

[N]o observable effect on the rate of organ donation and transplantation in the United States. The one exception was the establishment of revenue policies to promote organ donation, which may have led to small increases in organ donations and transplantations from deceased donors.

Crucially, the extent to which money plays a part in the American organ donation system is strictly controlled: all states must comply with the National Organ Transplant Act 1984 (NOTA 1984), which prohibits:

[A]ny person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation.

This is intended to prevent the current system of financial incentives being stretched or manipulated in a way that develops a system of organ trafficking or sees advantage being taken of those with lower incomes due to their need for additional finance.

This stringent controlling of the monetisation of the organ donation system in America stands in stark contrast to the position in Iran, the only country in the world where it is legal for a person to sell their kidneys to the state in return for around £300 and a year’s medical insurance. This might be justified by the argument that a person should have autonomy to do whatever they wish with their body. However, concerns – which led to the enactment of the NOTA 1984 regarding the exploitation of the vulnerable and the poor – place great doubts on the ethical soundness of such an approach.

Germany and Austria: An ‘Opt-in’ System by Declaration, and a ‘Hard Opt-Out’ System

Germany and Austria are both part of the eight EU Member States (Austria, Belgium, Croatia, Germany, Hungary, Luxemburg, the Netherlands, Slovenia) within the European Organ Exchange Organisation (EOEO), one of a number of international organisations that see participating countries exchange organs for which there is no matching patient on the national waiting list. Despite both being part of the EOEO and having similar cultural, social and institutional characteristics, Germany and Austria operate two markedly different systems, and post notably diverging figures, for organ donation.

Germany operates an opt-in system by way of declaration: a potential donor indicates their consent to donating using a written declaration, an organ donor card or their driver’s license. They may also acquire a document through their health insurance company. In 2017, statistics showed that for every million people in Germany, only 9.7 were registered as willing organ donors.

However, the extent to which this can be solely attributed to the German’s choice of consent-acquiring system is limited. One reason often advanced for its low organ donation rates is the undermining of public trust following the fall-out of a highly-publicised scandal in 2012 that saw a doctor in Göttingen face charges – for which he was ultimately acquitted – for falsifying medical records in order to speed up the organ donation process.

In contrast, Austria operates the ‘hard opt-out’ system – documented earlier in this article – that has proved highly successful in securing high consent rates: Eric Johnson and Daniel Goldstein discovered that in 2002, 99.98 per cent of the population were potential organ donors. 

Spain: An ‘Opt-out’ System

Statistics in 2014 showed that Spain was the world leader in organ donation: its figures of 36 donors per million people outstripped the European Union average of 19 per million, and its model secured a recommendation from the World Health Organisation and many countries in Europe and Latin America. The Spanish operate an ‘opt-out’ system that allows individuals to withdraw their consent by registering their objections via an ‘opt-out’ form or – more simply – by informing the relatives of their desire to do so.

However, observers have noted that the reason for Spain's success stems more from its well-established infrastructure and societal attitudes (namely, the willingness to embrace organ donation as a positive change) than the system it operates in regards to the deceased’s consent. In 1989, Spain introduced the Organisation for National Transplants (ONT), a technical agency in charge of the coordination of donation and transplants. The ONT oversees an army of transplant coordinators who are posted in every hospital in Spain with the brief of ensuring that organ transplants are carried out as conveniently and swiftly as possible. The importance of the ONT was highlighted in a report by Rafael Matesanz et al, which formed the basis of an explanation given by one of the authors to EurekAlert!:

[T]he system [in Spain] has made organ donation be routinely considered when a patient dies, regardless of the circumstances of death. Professionals attending to these patients in our country consider that, in caring for patients at the end of their lives, it is their duty to systematically explore their wishes with regards to donating organs upon their death.

Conclusion

It is clear that the Bill's proposed adoption of an ‘opt-out’ system could have its benefits; it may increase the amount of organs available for transplantation and also encourage people to think about donation and discuss this with their families, ensuring that the intention of the deceased is clear and well-known.

However, in order to make sure these proposals fulfil their potential, the UK must learn lessons from abroad. As the experience in Wales suggests, introducing an opt-out system does not automatically suggest that organ donation rates will increase. Without the introduction of effective infrastructure within hospitals – like Spain’s transplant coordinators – and a successful awareness campaign, the UK might have great difficulty in increasing organ donation rates, let alone making it a societal norm.

In addition to the practical difficulties and financial straits in informing every individual within the UK about the change of law, the experience in Germany shows that care must be taken in this context; public trust and confidence in the system is brittle. The feelings of the general public must be carefully handled to prevent a backlash, whereby citizens feel manipulated or pressured into donating their organs. At a time when the NHS is struggling as much as it is, having this further strain on the system may risk too much.

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Tagged: Human Rights, International Law, Medical Law & Ethics

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