The legislative framework in Scotland

Legislation for deceased donation in Scotland is similar to the rest of the UK, but there are some key differences.

On this page:

Overview of the legislation in Scotland
Deemed authorisation
Duty to inquire
Pre-death procedures (Type A and Type B)

Overview of the legislation in Scotland

Deceased donation is governed by the Human Tissue (Scotland) Act 2006, which was amended by the Human Tissue (Authorisation) (Scotland) Act 2019 (the HTS Act).

The HTS Act 2019 introduced deemed authorisation, also known as the 'opt-out' system for organ donation in Scotland. This is similar to deemed consent in England, Wales and Northern Ireland.

Other key features of the Scottish legislation include:

the duty to inquire, which requires that certain checks are carried out to establish a potential donor's latest views on organ donation
a statutory framework for pre-death procedures, categorised into two types: Type A and Type B.

This page will cover these areas of the legislation in more detail, drawing on Scottish Government guidance on the HTS Act, which was published in 2021. The quoted sections on this page are from this guidance document rather than the legislation itself.

All NHS staff can access training on the Scottish legislation for organ and tissue donation. This includes eLearning modules, resources for trainers, a video and important links to further information.

For more information on deceased donation terminology used across the UK, visit our glossary of terms.

The HTS Act and organ donation in Scotland

Watch our video, in which Iain McLeod, Consultant in Critical Care in Aberdeen, explains the HTS Act and what it means for clinicians in Scotland.

Video transcript

Chapter 1: Why has the law changed around donation in Scotland? (00.00 - 2.36)

Hello, my name is Ian McLeod. I am a consultant in critical care in Aberdeen and I'm one of the Scottish regional clinical leads for organ donation.

Over the next 10 minutes, I want to speak to you about some recent changes to organ donation in Scotland – specifically around the introduction of the Human Tissue (Authorisation) (Scotland) Act earlier this year – to think about some of the lessons that we're beginning to learn and how those impact on you as clinicians and the patients that you look after.

The background to this is that despite all of the work that we've done over the past decade to improve both donation and transplantation, our numbers are remarkably stuck. There are still around 500 patients actively requiring a transplant today in Scotland, and our donor numbers remain around 100 to 110 per year.

Trying to move that forward, we're looking at other things that can be done in order to continue to make improvements to improve the life of patients who are waiting for an organ transplant. And part of that is to look at the legal framework which supports donation in Scotland.

You'll be aware that earlier this year the Human Tissue (Authorisation) (Scotland) Act came into force, and that brings some new concepts into play which we're now working with. The first of those is deemed authorisation. That really is bringing us in line with the rest of the UK. All of the devolved nations are now either actively under a deemed situation or working towards it, as are many other countries in Europe.

As well as the deemed authorisation, we also now have a system around duty to inquire what someone's last known wishes or decision was. And we also have a system of pre-death procedures in Scotland.

I'll cover some of these later in the talk, but I suppose this is all really part of a degree of societal change. We know that society is generally supportive of both organ donation and transplantation. But we also know that many people do not find themselves in a situation where they're ever able to become an organ donor, and so it's really important that in the cases where that does happen, that we do support the person's wishes.

It really is trying to put the person at the centre of this whole piece. It's about their decisions, about what they would want – not what their family would have wanted, not what healthcare workers around about them would have wanted – but the person's known wishes and a framework around those.

Chapter 2: Public awareness and legislation training requirements (02.36 - 03.51)

So the public has seen over the past year a publicity campaign which has asked them to think about donation and what they would want after they die if they find themselves in a situation where they can donate. They've been asked to record that decision on the organ donor register, and we know that this has worked.

Today, 51 percent of the adult population in Scotland has opted in or signed the organ donor register, whilst less than three percent – at 2.8 percent – has actively opted out. That leaves 46 percent in the deemed category, who have neither opted in nor opted out.

And it's our role, I believe, as healthcare practitioners to facilitate these decisions where at all possible.

From a staff point of view, we've seen a training package. I suppose we've all heard the publicity as citizens of the country, and we've heard the same messages on the radio and on the television as everybody else has. But we've also had specific training around these new legal frameworks to try and facilitate our knowledge and to allow us to support patients and families where possible.

Chapter 3: End of life care and the specialist nurse role (03.51 – 05.30)

So, I suppose there are four main things we need to talk about in terms of what we've learned so far.

The first is that the public are definitely more aware about organ donation. It's coming up increasingly frequently in conversations in ICUs, and it's coming up earlier and earlier – and often before, actually, as clinical teams we are ready to have those end-of-life conversations.

Secondly, the duty to inquire is really becoming an important safety check. Nobody wants to act against somebody's wishes. We want to facilitate someone's decision where at all possible. And so checking in what the last known decision was is really important, because we know that people change their minds.

My third point then, I suppose, is the importance of the specialist nurses in organ donation and specialist requesters. Because they're around this every day – they’re dealing with families, they're dealing with requests, they're dealing with sensitive discussions around the duty to inquire. And they have knowledge of how to proceed in a deemed situation, and they know about all the accepted categories and safety checks and caveats that are in there.

As clinicians, we may see this once, twice, three times a year, even if we're in a busy unit. But in quieter units or places where we don't see as much donation activity, this can happen really infrequently. So the importance of the specialist nurses has really come to light, and I would commend them to you as a service to use around this in the coming months and years.

Chapter 4: The clinician's responsibility (05.30 – 07.30)

My fourth point is that old habits sometimes do die hard, and we're still seeing clinicians going ahead on their own without speaking to specialist nurses. We are seeing clinicians approaching families without checking the organ donor register. And we certainly know that there are situations where the duty to inquire, for example, has not been carried out.

It is of paramount importance that this process is followed. The public have been asked to make a decision, we have a law in place, and therefore we as healthcare professionals need to follow that through. We need to ask these families, we need to ask about their last known decision, and we need to give them the appropriate information to allow them to facilitate their loved one's wishes.

So ultimately, we do end-of-life care as part of our role. We know that it should happen in a non-rushed environment. We know that we should have appropriate staff who are well trained and have knowledge of the situation. And that applies in donation situations as much as anything else.

As I've already covered, the importance of the specialist nurses and specialist requesters – they do this every day, so please use them.

In terms of accessing the specialist nursing team, the earlier that they get the heads-up that you're going to be having one of these discussions, the better, because they can get there to support you.

The other thing which we're seeing increasingly commonly is the idea of having to almost park a conversation, to say to a family, “Look, we're not quite ready to have this discussion yet. You're maybe further ahead than we are.”

It's the form of words that you use to allow that conversation to be put on pause until the clinical team is in the right place to then have that discussion.

It's not about being underhand. It's not about trying to do something against the patient or the family's wishes. It's about getting the right people with the right skill set to make the right decision and to help that family come to terms with what happens next.

Chapter 5: Summary including additional resources (07.30 - 08.52)

So in conclusion, I suppose I've tried to give you a bit of a flavour about what's happened over the last six months or so. The public is definitely more aware about organ donation, so you're going to hear it coming up in conversation more and more.

This is cultural change, and cultural change takes time. It was never going to be a situation that we went from where we were to where we're going to be in the future. There were always going to be steps in the meantime.

The biggest piece of advice and the biggest ask I have of you as a clinical community is to use the subject matter experts and to allow the family to not make the final decision. It is about the person – the patient's wishes. That's the bit that we're trying to facilitate. And it's about trying to support everybody to allow, no matter what that decision is, it’s to allow that person's decision to be fulfilled at the end of their life.

My final point would be around further training and where you get further information and help. I would always start with your local specialist nurses in organ donation or your local clinical leads in organ donation.

There's the online TURAS e-learning module, which if you haven't done, I would certainly recommend. And I'm sure we'll be back in touch in the future with further updates.

If there's anything else I can do, please feel free to get in touch. And I thank you very much for your time.

Deemed authorisation

The main aim of the HTS Act 2019 was to introduce a system of deemed authorisation for donation. This is intended to increase the number of life saving or enhancing transplants each year.

When someone has not recorded their donation decision on the NHS Organ Donor Register, or elsewhere in writing, then authorisation for donation for transplantation may be deemed, subject to certain exemptions. This is known as an ‘opt out’ system.

Deemed authorisation and children

In Scotland, a child is defined as anyone under the age of 16 years. Deemed authorisation (the opt-out system) does not apply to children.

Children aged over 12 may provide express authorisation (opt in) or ‘opt out’ declarations either on the NHS Organ Donor Register or in writing.

If a child aged 12 or over did not make a valid decision or was not competent to do so, authorisation is usually taken from the individual holding parental rights and responsibilities (PRR). This is usually, but not always, their parents.

The duty to inquire and pre-death procedures framework described below apply to children as well as adults.

Deemed legislation across the devolved nations

Deemed consent or 'opt out' legislation for organ donation has been introduced in all four nations of the United Kingdom (England, Scotland, Wales and Northern Ireland), and the Crown Dependencies of Jersey, Guernsey and the Isle of Man.

The concept of deemed consent/authorisation in each nation is broadly similar, but there are some subtle differences in the legislation. For example, there are differences in whose consent can or cannot be deemed.

In Scotland, deemed authorisation does not apply:

if an expressed decision has been recorded in writing or the NHS Organ Donor Register
to those under 16
to people not ordinarily resident in Scotland for the last 12 months
if the person is incapable of understanding the nature and consequences of deemed authorisation, over a significant period
to excepted body parts
if there is no nearest relative to consult

In England, Wales and Northern Ireland, deemed consent does not apply:

if a donation decision has already been made (verbally or in writing)
to those under 18
to people who have lived in [England/Wales/Northern Ireland] for less than 12 months or are not living here voluntarily
to those who lack the capacity to understand the new arrangements and take necessary action
to novel transplants
if there is no family or friend of long standing to consult

The Specialist Nurses in Organ Donation (SNODs) are experienced in navigating the deemed consent legislation and will be able to confirm if deemed consent applies to an individual patient.

It's important to note that whilst the law may permit donation, it never mandates it.

Duty to inquire

Checking whether a decision has been recorded by a potential donor, exploring the most recent views of that person, and demonstrating that there is no evidence they were unwilling to donate are the key principles of 'duty to inquire'.

Chapter 6 in the Scottish Government guidance on the HTS Act states the following:

"The HTS Act respects the principle that the decision to authorise donation rests first and foremost with the donor themselves (in relation to adults and children aged 12 and over). As such, the potential donor's valid express authorisation where this is recorded, or the potential donor's views about donation, including where authorisation may be deemed, should form an integral part of end-of-life care planning.

"In every case where donation is a possibility, the SNOD/SR/TDC should establish whether, at the relevant time, there is a decision in force by the potential donor, in line with the requirements of the duty to inquire."

The duty to inquire usually involves discussion with the potential donor's family about donation, including about the potential donor's views about donation, to ensure that donation doesn't proceed where it would be against a person's wishes.

"The HTS Act requires that certain checks are undertaken before the carrying out of any pre-death procedure or retrieval can take place to determine a potential donor's status, any decisions which they may have recorded, and their views about donation and pre-death procedures.

"The duty to inquire may only be carried out by a health worker, which in most cases will be a SNOD/SR/TDC. If the duty to inquire is being carried out by a health worker who isn't a SNOD/SR/TDC then they should do so following discussion with the SNOD/SR/TDC."

Watch video examples of the duty to inquire and exploring opt-out decisions.

Pre-death procedures

The HTS Act provides a new statutory framework for pre-death procedures, which is tailored to the practical and ethical issues relating to donation actions undertaken prior to a potential donor’s death.

A 'pre-death procedure' is defined as:

"A medical procedure which is carried out on a person for the purpose of increasing the likelihood of successful transplantation of a part of their body after their death and which is not for the primary purpose of safeguarding or promoting the physical or mental health of the person."

For detailed guidance on the legislation for pre-death procedures, visit chapter 8 in the guidance on authorisation requirements on the Scottish Government website.

The Donation Actions Framework may be useful in considering the appropriateness of actions where pre-death procedures do not apply.

Key points

Below are the key points from the guidance on the HTS Act about pre-death procedures.

Decisions about withdrawing treatment should be independent of any consideration of possible organ donation:

"Any decision about whether or not treatment should be withdrawn must be made purely in the interests of the patient and independently of any consideration of possible donation. It is important to give the patient's family time to come to terms with the probable death of a loved one, and to be able to consider fully all end of life options, including donation.

Guidance on pre-death procedures does not apply following death on neurological criteria:

"It is essential to be clear that up until the point at which the patient is confirmed to have died, the requirements of the HTS Act (as discussed below) must be followed in relation to any pre-death procedure. Once death has been confirmed, these requirements no longer apply and so this guidance does not need to be considered in relation to patients who have already been declared dead following brain-stem death testing."

Pre-death procedures can fall into two categories – Type A and Type B:

"The HTS Act makes provision for two different types of pre-death procedures - Type A and Type B procedures ... Type A procedures are those which are generally considered as routine procedures which would be needed to enable deceased donation to progress. Type B procedures are less routine and are generally more invasive."

Decisions about the timing and location of withdrawal of treatment are not considered 'pre-death procedures' under the HTS Act. These decisions will be guided by the specialist teams and will be specific to the individual circumstances.

Type A procedures

Collection of bodily fluids and microbiological samples

Type A procedures in this category include:

taking a blood sample
taking a urine sample including by way of a pre-established suprapubic catheter
taking a chest secretion sample (excluding bronchoscopy)
swabbing or scraping of the body including inside of the mouth, nostril or ear canal, but excluding the swabbing or scraping of any part of any other body orifice

Radiological imaging

Cardiovascular monitoring

Respiratory monitoring and support

Administration of medication or other product

Depending on the outcome of the duty to inquire, Type A procedures will be considered to be authorised by the donor when either of the following applies:

they have expressly authorised deceased donation for transplantation (such as where they had opted in on the ODR)
their authorisation for donation is deemed under the HTS Act

The HTS Act also enables a person to expressly authorise pre-death procedures.

However, when authorisation for donation is given by a relative, authorisation for Type A pre-death procedures must be sought from that same relative:

"Where authorisation for donation for transplantation is given by the patient's nearest relative (or a person entitled to authorise donation on behalf of a child), then that person must also authorise the carrying out of a Type A pre-death procedure before it can proceed.

"The person authorising would normally be expected to authorise these as a group during the authorisation process, rather than needing to consider and authorise each test or procedure separately."

Type B procedures

Collection of bodily fluids and microbiological samples

Radiological imaging

Type B procedures in this category include:

carrying out an MRI scan
carrying out a CT scan
carrying out an X-ray where the patient is transferred from their existing location
carrying out ultrasound imaging where the patient is transferred from their existing location
carrying out a transthoracic echocardiography where the patient is transferred from their existing location

Tissue sampling

Endoscopic procedure

Type B procedures are more invasive and/or rarely required procedures in a potential donor.

Before a Type B procedure may be carried out, two Registered Medical Practitioners (RMPs) must be of the view that carrying out the procedure is:

necessary
not likely to cause more than minimal discomfort to the person
not likely to harm the person

The two RMPs must also be of the view that it is not possible to obtain the required information by carrying out a Type A procedure.

The HTS Act guidance says:

"One of the RMPs must be the health worker primarily responsible for the person's medical treatment, which in most cases will be an ICU consultant. Neither of the RMPs can be part of the team involved in the retrieval or transplant process. A record of the agreement between the two RMPs must be made in writing."

Express authorisation of Type B procedures must be given either by the potential donor themselves or their nearest relative:

"Authorisation for the Type B procedure in question must be in place before it can be carried out. Authorisation may be given expressly by the donor themselves or by their nearest relative (or person entitled to give authorisation on behalf of a child)."

Best practice in authorisation

The principles on this page apply across the UK, but use the terminology of the Scottish legislation to highlight how this may be used in practice.

Read guidance

Procurator Fiscal referrals

There are specific procedures to follow when seeking consent from a procurator fiscal for deceased organ or tissue donation to proceed.

Learn more

Tissue donation in Scotland

The Scottish National Blood Transfusion Service (SNBTS) provides the dedicated 24/7 tissue donation service in Scotland.

Find out more

Donation and Transplantation Plan for Scotland

This plan for 2021-2026 sets out the Scottish Government's priorities for increasing organ and tissue donation and transplantation.

Read about the plan