Michael, Louise and Holly were law student interns, participating in the WS Society Summer Internship programme during August 2019. This article summarises their research and presentation.
By Autumn 2020, Scotland will have an opt out organ donation system. This means there will be deemed consent from all citizens to donate their organs upon death until they register otherwise. This change was introduced by the Scottish Government’s Human Tissue (Authorisation) Act in July 2019. This legislation reformed the Human Tissue (Scotland) Act 2006, under which Scotland operated an opt in organ donation system. The purpose of the 2019 Act is to increase the number of registered organ donors and to reduce the number of deaths, as a result of long organ transplant waiting lists. This change in the law brings to the forefront the turmoil inducing argument of, the right to self-determination against our duty of care as citizens.
In the last decade, Scotland has seen an 89% increase in organ donors. This steady, annual increase has correspondingly saw a decrease in the number of people on the organ transplant waiting list. This raises the question of the necessity of this change in the law. The need for change may have come from the staggering amount of people who currently find themselves on the organ donor waiting list. There are 6,267 people on the waiting list in the UK. On the other hand, studies show that 96% of Scottish citizens would be happy to receive an organ if needed, whilst only 40.5% are willing to donate their organs.
The International Approach
The World Health Organisation (WHO) which sets out a non-binding framework on organ donation in an attempt to establish international norms. This is evidenced by the varied approaches international countries have implemented -- some cases being more extreme than others.
In China, there is a controversial usage of executed prisoners’ organs to tackle the low donation rates. The number of prisoners executed in China annually is a state secret, however it is estimated to be around 3000 to 7000 people. In 2006, 95% of organ transplants were from the organs of these executed prisoners. This practice was banned in 2015, though reportedly still continues today.
Earlier this year, Iran passed a law allowing organs of death row prisoners to be pre-sold to buyers. For non-prisoners, the sale of organs after or upon death is illegal in Iran. However, it is the only country in the world where the sale of kidneys while living is legal. In response to Iran’s approach the WHO stated: - “transplant commercialism targets impoverished and otherwise vulnerable donors, and leads inexorably to inequity and injustice”.
Israel operates under a priority class system: ‘don’t give, don’t get’. The Organ Transplant Act 2008 introduced this priority-based system, where an individual requiring an organ or tissue transplant will only be eligible to receive this if they are a registered organ donor. This Act combined with the Cerebro-Respiratory Death Act 2008 -- which accommodates Orthodox beliefs by stipulating death to be cerebral-respiratory or cardiac respiratory death -- has resulted in a significant increase in registered donors.
“International norms on organ donation practices have not been established, though many legal, ethical, practical and religious issues are prevalent across all jurisdictions.”
In both Brazil and Chile, the implementation of an opt out system saw a decrease in the number of registered organ and tissue donors. This was deemed to be mainly down to general mistrust in government. In Brazil, the legislation introducing this system was abolished the year after due to public backlash.
In the United States of America, most states have an opt in system, with approximately 26 registered donors per million people. The lack of donors in some states is due to distrust, such as in California, where reports of registered donors who were in hospital for end of life care were injected with fentanyl in order to speed up their inevitable death. This practice, motivated by doctors under pressure to reach targets of organ transplants, was discovered by coroners who found the cause of death of these patients to be fentanyl. This highlights the significant ethical problems that can occur under an opt in system. Other states have moved away from opt in systems, such as New York, where a mandated choice system was introduced in 2012 under Lauren’s Law.
Evidently, international norms on organ donation practices have not been established, though many legal, ethical, practical and religious issues are raised. This brings to the forefront the question of how Scotland plans to tackle such issues.
The European Approach
Across Europe, the approach countries are taking to tackle the issue of low organ and tissue donation rates is becoming less varied and more uniformed. While there are no guidelines or directives established as binding European law, many European countries have implemented or are soon to implement an ‘opt out’ system. This system differs in each country depending on whether a hard opt out or a soft opt out approach is taken. One of the earliest introductions of the opt out system in Europe was in Spain in 1979. For the first ten years after implementation, there was no increase in the number of registered organ donors. Success came when the correct funding, infrastructure and required numbers of staff were put in place. Coordinators played a major part in ensuring the system addressed all the social, religious, ethical and personal questions organ donation raises. They also ensured that in the event of a death of an individual who has not opted out, family members are approached to discuss whether the donation of organs should go ahead. This framework effectively tackles the various issues that could stem from this concept of deemed consent.
Moreover, in both Austria and Belgium, the implementation of hard opt out systems demonstrate a more rigid approach to organ donation. The legislation in both countries allows organs to be procured from the deceased without consultation, and medical practitioners are not legally required to seek consent or approval from the family members of the deceased individual who did not opt out. The onus is placed on the family members to make it known to medical practitioners if they wish to refuse the removal of the organs.
Denmark and Sweden have both introduced a mandated choice system, requiring all citizens to state whether they do or do not consent to the donation of their organs upon death. This can be answered via an application for a passport, driving licence or national identity card. This system is effective in providing clarity, ensuring all citizens state explicitly what their wishes are. It also makes registering decisions easier and more accessible, while keeping the conversation of organ and tissue donation prominent among the public.
Though an opt out system can be fair and considerate, through the soft approach there is potential for error. In Petrova v Latvia ECHR 181 (2014) removal of organs without legal clarity of the states role in informing and consulting bereaved family members constituted a breach of Article 8 of the European Convention of Human Rights (ECHR). Likewise, the case of Elberte v Latvia ECHR 005 (2015) engaged Article 8 and Article 3 of the ECHR. The breach of Article 3 stemmed from the degrading treatment of a family following the removal of the deceased relative’s tissue. These cases highlight the importance of writing and adhering to legislation relating to opt out laws in an appropriate manner in order to prevent a breach of human rights.
The United Kingdom’s Approach
Three of the four UK countries have either implemented or are in the process of implementing the opt out system; Wales in 2015, with Scotland and England joining this movement in 2020. After deliberation, Northern Ireland decided to remain under an opt in system, though individuals can register to opt in or out.
What about Scotland?
Implementing an opt out system in Scotland under the 2019 Act raises the same issues other countries face. When considering presumed-consent, we draw reference to other areas of law where such a concept would be deemed unacceptable. For example, criminality will still be sought if an assault is carried out under the Sexual Offences (Scotland) Act 2009. In areas of family law, DNA or blood sampling in order to identify a parent cannot be taken without expressed consent from the individual under S70 of the Law Reform (Miscellaneous Provisions) Scotland Act 1990. In Horne v Whyte (2005) CSOH 115 (A1794/00) consent was only accepted when expressed by a person with full capacity. Arguably, in circumstances where an individual is near death, or experiencing loss of a loved one, they may be highly susceptible to undue influence from medical practitioners, with whom a relationship of “confidence and trust” generally exists.
Public Health Minister, Joe Fitzpatrick, addressed this issue: - “there is a duty on health workers to make inquiries of families and others who are entitled to provide information reflecting the most recent views of the donor".
Such a statement can raise confusion, as it did in Wales. Bangor University carried out a study 18 months after implementation, this study showed that despite the high-profile campaign that was promised alongside the legislation, confusion remained regarding the level of authority families have in the decision-making process when approached by medical professionals. The new Scottish Act includes the same provision regarding a campaign. Alarmingly, the campaign in Scotland is yet to be launched.
“Studies show that 96% of Scottish citizens would be happy to receive an organ if needed, whilst only 40.5% are willing to donate their organs. ”
There are three groups of individuals exempt from the presumption of consent. Firstly, those under the age of 16 are exempt, despite the fact they are able to register their decision from the age of 12. The decision ultimately lies with their parent or guardian until they reach 16. Adults without capacity are exempt and those resident in Scotland for less than 12 months will also be protected from the deemed authorisation system.
The 2019 Act allows for families or friends to provide information on the most recent views of the deceased. This takes into account the fact that individuals may have changed their views on organ donation, whether for religious or personal reasons, ensuring that organ donation does not go ahead against the wishes of the deceased. Furthermore, this new legislation could encourage individuals to write a will where this information could be stored to ensure their wishes are recorded.
Recommendations on the Law
Ministers have a duty to inform the public of changes in policy and their corresponding rights and responsibilities. As done successfully in Spain, and unsuccessfully in Wales - ensuring information is circulated and sufficient education is provided is key when changing legislation and opening up a conversation with the aim of promoting organ donation.
Aileen Campbell, ex Scottish Health Minister, said: -“recent campaigns and work with patients’ families had already led to an increase of 146% in the number of donations since 2007. Therefore, we are aware that publicity campaigns are effective. This reform would improve the rate further”.
As potential donors can legally make this decision from the age of 12, educating individuals on this topic at school level could make ensure the public remain informed. In addition, having a public vote on such issues, or introducing a mandated choice system are alternative ways to cater for a majority and ensure there is general public agreement, as well as an increase in donors.
Conclusion
Organ and tissue donation raise legal, practical, and ethical issues, regardless of the system it operates under. Legally, the application of ‘deemed consent’ is not analogous to other areas of Scots law. Practically, the provisions in the Act promise a high-profile campaign, however, there remains a lack of public awareness. Ethically, there are numerous questions surrounding how value should be apportioned in opt out system: altruism or lifesaving? There must be a majority of public support and there is a responsibility to ensure individuals make informed decisions. There is a need for the Scottish Government, the NHS, and cultural religious leaders to work together to acknowledge issues raised worldwide and establish a framework which identifies and accounts for these issues. Only once it is evident that all communities have been catered for will this legislation be fair and effective in raising the number of organ donors.