Opinion: Amanda Ward
A bill has been introduced with the intention of increasing organ donation rates, but on experience elsewhere it needs to be part of a multi-faceted strategy to have an impact
Following a public consultation, where 82% of responses supported the move, the Scottish Government has introduced a bill changing organ and tissue donation from the current system where people have to opt in, to one where people would have to opt out. It will now be assumed that people agree to donate organs.
The Human Tissue (Authorisation) (Scotland) Bill amends the Human Tissue (Scotland) Act 2006 and will apply to adults (aged 16 and over). It contains new provisions to introduce more flexibility in the timing of the authorisation process, as well as clarity about authorisation for pre-death procedures. In an attempt to increase the likelihood of successful transplantation, it includes tests to ascertain if the person’s organs/tissue are suitable for donation. It also makes changes for authorising donation by, and on behalf of, children.
Based on the proposals, the “soft opt-out” system means people can opt in to donate, opt out from donating and if they do neither, deemed authorisation (commonly known as “presumed consent”) will take effect – unless the person’s family are aware that they have previously expressed wishes not to donate.
Authorisation is arguably the most important revision, as each year a significant proportion of families refuse to authorise donation of their relative’s organs. In 2017-18, in 44% of cases in Scotland where family members were approached, authorisation was not given or the family overrode the consent previously given. It is important, therefore, to ensure the individual’s wishes are paramount and respected above all. The Scottish Government has said the move to a soft opt-out system is a way to do this, but it will take effective communication and considerable joint working, due to the process being complex, multi-faceted and often operating to time pressures.
Family members still have a role, for example in providing medical history, but the bill does not provide for an override by them. However, where the potential donor has opted in or out, it will be possible for that person’s most recent views to be expressed by the relatives, thus determining whether donation ultimately proceeds or not. Similarly, in deemed authorisation cases the bill provides for family members or others to advise of any objection to donation which the potential donor held, but not to impose their own views.
Family involvement will also still be crucial for elements of authorisation for those in excepted categories, for purposes other than transplantation and for less common types of organ/tissue. In line with the approach in the 2006 Act, in these scenarios the nearest relative will be able to authorise donation as long as it was not against the person’s wishes.
The bill follows similar legislation passed in Wales in 2015, where an early assessment shows that the number of donors has not increased across its first two years. However, the effects of the law on family refusal rates has been positive, it has not affected living donation negatively and overall activity in the organ registry has been much improved.
Some countries who have an opt-out policy do have higher donation rates, but evidence shows that such a system works well when it is part of an integrated approach, where legislation is complemented by other measures including high profile public awareness campaigns. A good example is Spain, where proportionately more organs are donated than anywhere else in the world, in part due to the use of highly effective transplant co-ordinators and including donation as part of the school curriculum.
The Scottish Government has given assurances that a public awareness campaign will run the year prior to the system coming into force, and continuing after the date of introduction. Former Public Health Minister Aileen Campbell said the move was “part of driving a long term change in attitudes towards organ and tissue donation”, and that recent campaigns and work with patients’ families had already led to an increase of 146% in the number of donations since 2007.
The Scottish Parliament will be considering the legislation over the coming months. If properly implemented, with adequate resources and supported by a high profile public campaign, an opt-out system could be very effective. However, it should not be viewed as the sole answer to Scotland’s shortage problem. All systems and processes need integrated action to continue to drive improvement.
Amanda Ward is a PhD candidate in Medical Law at Strathclyde University, and a member of the Law Society of Scotland’s Health & Medical Law Subcommittee