Organ and tissue donation and transplantation: consultation

Introduction

Organ and tissue transplantation can save and significantly improve lives, but at present there are insufficient donors to meet the number of organs needed by people on the transplant waiting list, as well as the need for tissue transplants. This consultation seeks views on ways in which we can increase the number of organ and tissue donors and transplants in Scotland. We have already made good progress in increasing organ donation and transplantation in Scotland over recent years, with an 83% increase in the number of people who donated organs after their death in Scotland between 2007-08 and 2015-16. In 2015-16 there were 183 organ donors in Scotland (99 who had died and 84 living donors) and 415 people from Scotland received transplants. However, despite these successes, there were still 542 people on the active transplant waiting list in Scotland, waiting for an organ.

Background - What is organ and tissue donation?

Over the past few decades, surgical advances have allowed hospitals to remove organs from one person - a donor - and then transplant each of the organs into a person who needs a new organ. Donors who donate their organs after they die can potentially save the lives of up to nine people ^[1] .

Only a small proportion of people (less than 1% ^[2] ) die in circumstances where it is possible for them to be an organ donor. At the moment, it is only possible to donate if you die in a hospital - normally in a Critical Care area (for example an intensive care unit) - and, even then, there may be a number of reasons why organ donation is not possible, such as medical reasons (if some or all of the organs are not functioning well) or for legal reasons (where there is an investigation into the cause of death and the Procurator Fiscal may not be able to allow some or all organs to be donated).

Therefore, this makes it very important that, where a person has died or has an unsurvivable brain injury, and where they could be a potential donor, they are identified as such and the procedures necessary to enable possible donation are initiated.

In Scotland, donors who have just died (known as deceased donors), can donate:

• Kidneys
• Liver
• Heart
• Lungs
• Pancreas (including for islet cells)
• Small bowel (or multi visceral organs where a patient needs a transplant of several organs - this can include for example the stomach or spleen as well as the small bowel)

In addition to organs, donors can also donate tissue. This includes: eyes, tendons, heart valves, bone and skin. Such tissue can be used in anything from severe eye disease to reconstructive surgery and skin grafts. Donated tissue can significantly improve the lives of others - and in some cases, such as heart valves, saves lives. Unlike organs, which in most cases need to be transplanted within a few hours of the donor's death, it may be possible to donate tissue up to 48 hours after a person has died. Therefore, even if a person cannot be an organ donor, they may still be able to donate tissue. In this consultation, where we refer to measures to improve organ donation from people who have died, this would normally also include increasing tissue donation.

Over half of all donated organs in Scotland come from people who have died (deceased donors), but it is also possible for living people to donate some organs. Most living organ donors donate one of their two kidneys as it is possible to live healthily with just one kidney. It is also possible for a living donor to donate a part of their liver or occasionally their lung, but this happens less often. Some living people also donate some of their bone, for example if they have a hip replacement operation. The Scottish Government and NHS Scotland are working on a project to encourage an increase in the numbers of living kidney donors, but this consultation paper focuses on ways of increasing donation from deceased donors.

How does organ and tissue donation currently work in Scotland?

While Scotland has its own legislation governing organ and tissue donation and transplantation - currently the Human Tissue (Scotland) Act 2006 - organ donation and the allocation of organs to transplant recipients is managed across the UK by NHS Blood and Transplant ( NHSBT). Organs need to be carefully matched to a recipient, taking into account things like the blood group, age, weight and the tissue type of the donor and potential recipient. This is important to give the best possible chance for a transplant to be successful. If an organ is not a good match with the recipient, there is a significant risk that it won't function effectively.

NHSBT is responsible for managing the UK's national transplant waiting list and for matching and allocating organs on a UK-wide basis. While this means that some organs from donors in Scotland may go to people in other parts of the UK (and occasionally elsewhere in Europe), it also means that people in Scotland may receive an organ from elsewhere in the UK or the rest of Europe.

If someone is dying or dies in circumstances where they could be an organ donor, for example in an intensive care unit or occasionally an emergency medicine department, a Specialist Nurse for Organ Donation ( SNOD) will check to see if the patient has authorised donation themselves. People can formally authorise donation by joining the NHS Organ Donor Register, or can make someone close to them aware of their donation wishes. At this point, a sensitive discussion with the patient's family will start to take place with regard to donation.

If donation is to proceed, the clinical team caring for the patient will work with the SNOD, who will ensure all the necessary clinical checks are made. This will include checking that there are suitable recipients for each organ that can be donated. Throughout this process, the comfort and needs of the donor patient remain paramount and the main focus of the clinical staff in the critical care unit will be on caring for their patient. SNODs also work hard to support the donor's family during this difficult time and to answer any questions the family has.

The organs are then retrieved by a completely different team of specialist surgeons who are not otherwise involved in the care of the patient. Organs are always removed with the greatest care and respect. They are then stored in fluid and usually kept cool to help preserve them and transported to whichever hospital or hospitals will carry out the transplant(s). As soon as possible, a separate team of surgeons will then transplant each organ into the patient who is going to receive it.

While donated organs can normally be retrieved at most acute hospitals, there are three transplant units in Scotland, which each have specialist facilities dedicated to the transplantation of organs into recipient patients:

• The Royal Infirmary of Edinburgh (liver, kidney, pancreas and islet cell transplants)
• The Queen Elizabeth University Hospital, Glasgow (kidney transplants)
• The Golden Jubilee National Hospital, Clydebank (heart transplants)

Most Scottish patients have their transplant undertaken in one of the three Scottish transplant units. However, a small number of Scottish patients receive their transplant in other parts of the UK. These usually relate to rarer transplants where it is in the best interest of patients to receive transplants in specialist centres. These treatments are fully paid for by NHS Scotland.

Meanwhile, most tissue donation in Scotland is managed by the Scottish National Blood Transfusion Service ( SNBTS), although NHSBT manages donation of eyes across the UK. SNBTS has its own Tissue Donor Co-ordinators ( TDCs), specialist nurses who work closely with NHSBT SNODs to coordinate donations in cases where both organs and tissue may be donated.

Progress made so far

Considerable progress started being made after the publication of the UK Organ Donation Taskforce's report in 2008. In 2007-08 there were only 54 deceased donors in Scotland and 209 transplants from deceased donors. In particular, the development and training of dedicated SNODs to approach families, along with other improvements to the hospital infrastructure available to support donation, started to increase deceased donations. In 2013, the Scottish Government published A Donation and Transplantation Plan for Scotland 2013-2020 . This set out 21 recommendations to increase donation and transplantation, building on the earlier Taskforce report.

Significant progress has already been made through implementing these recommendations, such as:

• successful and ongoing awareness-raising campaigns, which have encouraged more people to sign up to the NHS Organ Donor Register ( ODR) - the proportion of the Scottish population who have joined the ODR increased from 29% in 2007/08 to 43% by October 2016;
• a project with Kidney Research UK which trains volunteers from black, Asian and minority ethnic ( BAME) backgrounds to become peer educators to increase awareness of kidney disease and promote organ donation within BAME communities. This is important because families from BAME communities are much less likely to authorise organ donation, but statistically are more likely to need an organ transplant because of increased incidence of diabetes, heart disease and kidney disease;
• a schools educational resource pack has been provided to all secondary schools in Scotland. It has been recognised internationally as an important resource in increasing awareness about organ and tissue donation among young people;
• a new dedicated regional manager for Scotland is in post. Her role focuses on managing the SNODs in Scotland and taking forward key initiatives to help increase donation (previously the postholder covered both Scotland and the Northern region of England).

However, while Figure 1 shows that numbers of organ donors has been gradually increasing overall over recent years, there is still more that can be done. Increasing the number of donors further remains a challenge, particularly given that fewer than 1% of people die in circumstances where they can donate.

Figure 1 - numbers of organ donors and non-proceeding donors in Scotland by financial year ^[3]

The Scottish Government, the Scottish Donation and Transplant Group and the dedicated Regional Manager for Scotland are taking forward a number of new initiatives, including:

• a project to raise awareness of and increase kidney donations from living donors in Scotland;
• considering piloting a model of designated requesters in two or more hospitals, which is based on an approach used in Australia where only clinicians and SNODs who have had specialist training approach families for authorisation of donation, to see if this helps increase authorisation rates further (currently any SNOD or clinician can approach a family about authorising organ donation);
• updating the existing agreement between the Scottish Donation and Transplant Group and the Crown Office and Procurator Fiscal Service ( COPFS) which seeks to minimise the number of occasions when Procurators Fiscal are unable to allow donation to proceed due to needing a full post mortem examination of the potential donor's body;
• the Scottish Government will be working with clinicians, SNODs and NHSBT to explore opportunities for children or very young babies to donate their organs. This is a very sensitive subject, but we know that parents can draw some comfort from the fact that some good has come out of the tragic death of their baby or child;
• in 2015-16, 19 families refused to authorise donation because they felt the process was going to take too long. NHSBT is therefore working to try to shorten donation processes generally and also to see if donation processes can potentially be undertaken in a different order to allow for quicker, limited donations (of only kidneys and possibly also the liver) in cases where families would otherwise refuse authorisation due to concerns about the length of time the process will take. This trial might help increase donations in at least some extra cases in future.

Summary of areas considered in the consultation paper

This consultation is split into two sections. They cover different parts of the organ donation process, but are closely linked: the hospital identifying and referring potential donors and then the donation being authorised by the family. Delivering real increases in the number of donors and transplants will require progress in both of these areas.

The first chapter seeks views on alternative ways of potentially increasing the proportion of cases where organ and/or tissue donation is authorised. This looks at the pros and cons of an opt out system allowing authorisation to be deemed in certain circumstances, with safeguards - that is where, for most people, unless they have opted out of organ or tissue donation or their family know they did not want to donate their organs or tissue, donation can be deemed to be authorised. Such a system could potentially help tackle the problem of people 'not getting around' to making their wishes known.

Other potential options, such as a reciprocity system (where in cases of equal medical need, a person who had joined the ODR would get priority over someone who had not), were considered carefully, but have not been included in this consultation because they were not considered practical and raised significant ethical concerns. The option of a 'mandated choice' system - where everyone would be legally required to make clear whether or not they wished to be a donor - was also considered, but not included as it raised significant issues about how people could be forced to make such a decision, as well as significant practical issues in establishing and enforcing a system to collect everyone's views.

The second chapter looks at whether we should encourage hospital clinicians to refer to a SNOD patients who are expected to die in an intensive care unit or emergency department in circumstances which would potentially enable them to be an organ donor. This would also include referring most patients dying elsewhere in a hospital to a TDC, to consider further whether they could be a donor. Such an approach could help tackle the problem of people who have expressed a wish that they want to be a donor not being referred to a SNOD or TDC at the point of death. While in some of these cases it may not be possible for the person to be a donor for medical reasons, this would help ensure that, where needed, a case was considered by a transplant surgeon - in many cases, the person may at least be able to donate some organs or tissue.