Organ and tissue donation: COPFS and SDTG agreement

Introduction

Successful organ transplants can be lifesaving, and for many people organ and tissue transplants are the most effective form of treatment. However, many people are unable to benefit from a transplant because of a shortage of donated organs and tissues.

In the UK, around 1000 people a year die while waiting for an organ to become available. Recognising therefore that unnecessary deaths occur every year in the UK the UK Organ Donation Taskforce produced its first report in January 2008^[1] with 14 recommendations designed to remove existing barriers to donation, and to make organ donation a usual part of all end-of-life care in every appropriate case. Implementation of these recommendations in Scotland had high-level Government support, acknowledging that Scottish donation rates have generally been the lowest in the UK.

Two of those recommendations are particularly relevant to this Agreement.

Recommendation 14: 'The Department of Health and the Ministry of Justice should develop formal guidelines for coroners concerning organ donation.' In Scotland, it was considered that this recommendation had been achieved already, because of the existence since 2004 of the Agreement between the Scottish Transplant Group and the Crown Office & Procurator Fiscal Service. It underlines the need, however, to ensure that the Agreement is kept up-to-date.

The other recommendation is Recommendation 3, the main element in which is:

"Urgent attention is required to resolve outstanding legal, ethical and professional issues in order to ensure that all clinicians are supported and are able to work within a clear and unambiguous framework of good practice."

The issues to which recommendation 3 particularly refers are those associated with donation after circulatory death (DCD). As a result of the development of DCD programmes in Scotland there has been a year on year increase in this type of donation. The increasingly important contribution which DCD has been making to the number of organ donors in Scotland has served to underline the importance of resolving the legal, ethical and professional issues associated with the process.

In May 2010, the Chief Medical Officer for Scotland issued guidance^[2] to NHS Scotland to clarify the legal issues relevant to DCD in the form of CMO Letter SGHD/CMO (2010)11 on 3 May 2010 (as clarified in CMO Letter (2012)08 of 23 July 2012)^[3]. Its release paralleled similar guidance issued in November 2009 to the rest of the UK. In essence, the Scottish guidance clarified the application of the principles of the Adults with Incapacity (Scotland) Act 2000^[6] to organ donation. Further clarification on these issues was provided through a consensus event on DCD organised by the 4 UK Health Departments and NHS Blood and Transplant (NHSBT) held in June 2010. The report on the event, Donation after Circulatory Death, was published in December 2010^[8].

Diagnosis and Confirmation of Death

Prior to the advent of modern Intensive Care techniques, the diagnosis of death was relatively simple. Death was diagnosed at the cessation of circulation. The advent of long-term ventilation techniques in the 1950s meant inadequate ventilation no longer immediately led to circulatory death. With the advent of these techniques, case series of patients with profound irreversible apnoeic coma began to be described.

The current UK consensus is that "Death entails the irreversible loss of those essential characteristics which are necessary to the existence of a living human person and, thus, the definition of death should be regarded as the irreversible loss of the capacity for consciousness, combined with irreversible loss of the capacity to breathe." (A Code of Practice for the diagnosis and confirmation of death. Academy of the Royal Medical Colleges 2008)^[4].

In the UK, death can be diagnosed after brain stem death or after circulatory death.

In the recent past organ donation has largely depended on donors being pronounced dead following brain stem death testing while still on mechanical ventilation in an intensive care unit. This is termed Donation after Brain Stem Death (DBD), having previously been known as heart beating donation.

However, more recently, partly because of a shortage of organs from DBD donors, there has been a ten-fold increase in the number of Donation after Circulatory Death (DCD) donors in the UK. DCD donation was previously known as non-heart beating donation or donation following cardiac death.

Donation after Brain Stem Death

The irreversible cessation of brain-stem function, whether induced by intra-cranial events or the result of extra-cranial phenomena such as hypoxia, will produce this clinical state, and irreversible cessation of the integrative function of the brain-stem therefore equates with the death of the individual and allows the medical practitioner to diagnose death. For organ retrieval to be legal and acceptable, the certification of brain stem death must be sufficiently rigorous to give those close to the deceased total confidence that death has occurred before any procedures relating to organ or tissue donation are commenced. Certification of brain death must be completed by two senior doctors who are independent of the transplant teams and can only take place after rigorous preconditions are met. Further protection is given by the terms of section 11(4) of the Human Tissue (Scotland) Act 2006^[5], which provides that the surgeon proposing to remove body parts for the purpose of transplantation must be satisfied that life is extinct.

Donation after Circulatory Death

Donation following circulatory death takes place after death has been diagnosed from the irreversible cessation of the heart. Kidneys, liver, pancreas and lungs from DCD donors can be successfully transplanted with graft survival results similar to those organs retrieved from DBD donors.

DCD is grouped using the categorisation agreed at Maastricht in 1995 (amended 2003) as follows:

I	Brought into hospital dead
II	Unsuccessful resuscitation
III	Awaiting Cardiac Arrest (i.e. following withdrawal of life-sustaining treatment)
IV	Cardiac Arrest in a Brain Stem Dead donor
V	Cardiac Arrest in a Hospital Inpatient

In terms of this classification, all of the current Scottish DCD programmes come within Category III, with the exception of a pilot Category II programme in NHS Lothian.

The Law

Until the point at which life is pronounced extinct, the relevant legislation is the Adults with Incapacity (Scotland) Act 2000 (AWI). The AWI Act requires that any interventions in relation to an incapacitated adult observe certain general principles. These are that the intervention benefits the adult, and that such benefit could not reasonably be achieved without the intervention. The intervention should always be the least necessary to achieve the end.

The guidance issued as CMO letter (2010)11 indicates that the concept of 'benefit' is likely to be wider than the adult's immediate medical situation, and can reasonably be interpreted as permitting something that the adult could reasonably be expected to have chosen to do if capable, even though the action was of a gratuitous or unselfish nature. If, having weighed up all of the factors relevant to the person's situation, and consulted their family and friends, it is decided that a particular action or actions that will facilitate DCD is for the person's benefit, then it may be carried out. This means that a range of non-invasive actions can be taken that would pave the way for DCD.

The position regarding invasive procedures that might be undertaken prior to death with a view solely to better preserving the person's organs for transplantation would count as medical treatment and are therefore governed by section 47 of the AWI (Scotland) 2000 Act. It provides that medical treatment can only be undertaken if it is intended to safeguard or promote the physical or mental health of the adult. As part of the process of implementing Recommendation 3 of the UK Organ Donation Taskforce's report, the Government will undertake a consultation in the future on the possibility of permitting more invasive procedures to preserve the adult's organs for transplantation, once the clinicians and family had agreed that further treatment would be futile. The consultation will also explore the type of authorisation considered necessary to support this approach.

Once death has been confirmed, the relevant provisions of the Human Tissue (Scotland) Act 2006 apply and must guide the next steps when organ donation is to take place.

The 2006 Act is based on the concept of authorisation. As explained in paragraph 8 of the "Guide to the Implications of the Human Tissue (Scotland) Act 2006", issued as HDL (2006)46 on 20 July 2006^[7], 'authorisation' is the expression of the principle that people have the right to specify, during their lifetime, their wishes about what should happen to their bodies after their death, in the expectation that those wishes will be respected.

This emphasis on the autonomy of the individual is also one of the underlying principles of the AWI legislation. It therefore underlines the importance of making sure that, where people's wishes are known, practical arrangements made around death the time of death are designed to ensure those wishes can be fulfilled.

NHS Organ Donor Register

Any adult or child aged 12 and over, who is able to make their own decisions can give authorisation for their organs or tissue to be donated after death for the purpose of transplantation. Signing up to the NHS Organ Donor Register counts as a form of authorisation under the Human Tissue (Scotland) 2006 Act. Similarly, simply telling someone also counts as a form of authorisation under the Act. Many people who have not put their names on the Register still carry an organ donor card, and this, too, is a form of self-authorisation.

Agreement between COPFS and the STG

An agreement was developed by the Crown Office and Procurator Fiscal Service (COPFS) and the Scottish Transplant Group in 2004 (updated in 2008) to cover the potential involvement of the Procurator Fiscal (PF) in organ donation. The most important points are:

• Where there is reason to believe that a death may be reported to the PF, no parts of a body will be removed without the Fiscal's prior consent (section 5 of the Human Tissue (Scotland) Act 2006) of this document).
• The PF may object to removal of organs in a case which is likely to result in a charge of homicide or where, in the time available, insufficient enquiry is able to be carried out to allow an informed decision. There are however procedures available which will allow the PF not to object to transplantation of organs in cases of homicide, but early discussion with the PF is essential;
• The PF will normally permit removal of organs, subject to the need to ensure that sufficient evidence is available for any subsequent criminal proceedings or Fatal Accident Inquiry and the need to establish that the death has not been caused, or contributed to, by the retrieval operation.

This agreement provides that, where necessary, deaths will be reported to the Procurator Fiscal and, in the case of a potential Category III DCD, the Procurator Fiscal will be advised in advance of cardio‑respiratory arrest to enable the Procurator Fiscal to make a rapid and informed decision about donation.

With Government approval, a pilot Category II DCD programme has been developed and will run in Lothian from January 2013, with the initial intention of enabling organ donation from the Emergency Department (ED) at the Royal Infirmary of Edinburgh (RIE). The pilot has the support of the Scottish Fatalities Investigation Unit (SFIU) and forensic pathology in the Royal Infirmary of Edinburgh. A form has been devised that will be sent from the ED at the RIE to the Edinburgh office of the SFIU containing the information needed to allow the Fiscal to decide whether consent can be given to organ donation in each case.