1.1 Successful organ and tissue 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 tissue.
1.2 Recognising that unnecessary deaths occur every year in the UK, the UK Organ Donation Taskforce produced its first report in January 2008 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. Nonetheless, the number of patients waiting for transplants still significantly exceeds the number of potential donors and it is therefore important to seek to enable donation to proceed wherever this is feasible and appropriate.
1.3 One of the Taskforce's recommendations is 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."
1.4 In Scotland, it was considered that this recommendation had been achieved already because of the existence, since 2004, of this Agreement between the Scottish Donation and Transplant Group (SDTG) and the Crown Office and Procurator Fiscal Service. It underlines the need, however, to ensure that this Agreement is kept up-to-date.
Diagnosis and Confirmation of Death
1.5 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.
1.6 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).
1.7 In the past, organ donation 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), sometimes referred to as donation after death diagnosed using neurological criteria (DNC).
1.8 However, more recently, partly because of a shortage of organs from DBD donors, there has been a significant increase in the number of Donation after Circulatory Death (DCD) donors in the UK.
Donation after Brain-Stem Death (DBD)
1.9 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 and/or tissue 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 and/or tissue donation are commenced. Certification of brain-stem 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, which provides that the surgeon proposing to retrieve body parts for the purpose of transplantation or another registered medical practitioner must be satisfied that life is extinct.
Donation after Circulatory Death (DCD)
1.10 Donation following Circulatory Death takes place after a monitored period of cessation of heart function in the donor. DCD programmes in Scotland come within Maastricht Category III or IV, wherein the heart is expected to stop following withdrawal of life-sustaining treatment in patients who are not (Maastricht III) or who are (Maastricht IV) brainstem dead. The great majority of such DCD donors are Maastricht Category III. Kidneys, liver, pancreas, islets, lungs, tissues and now also hearts from DCDdonors can be successfully transplanted. With some exceptions, results from DCD organs are generally poorer than DBD organs. New techniques are now being developed in DCD organ retrieval, with results similar to those in organs retrieved from DCD donors.
1.11 Once death has been confirmed or is anticipated following withdrawal of treatment, the relevant provisions of the Human Tissue (Scotland) Act 2006 apply and must guide the next steps when organ and/or tissue donation is to take place.
1.12 The 2006 Act is based on the concept of authorisation. "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.
1.13 The Human Tissue (Authorisation) (Scotland) Act 2019 amends the Human Tissue (Scotland) Act 2006 and enables a potential donor's authorisation to be 'deemed' under certain circumstances where the potential donor has neither self-authorised donation, for example on the NHS Organ Donor Register, nor 'opted-out'. The change in legislation will not affect the matters covered in this Agreement - in other words it will not impact on the need for the Procurator Fiscal (PF) to consent to organ and/or tissue donation proceeding in cases where a patient's death needs to be reported to the PF.
Agreement between Crown Office and Procurator Fiscal Service (COPFS) and the Scottish Donation and Transplant Group (SDTG)
1.14 This Agreement was developed in 2004 between the Crown Office and Procurator Fiscal Service (COPFS) and the Scottish Donation and Transplant Group. It describes the role of the Procurator Fiscal (PF) in relation to potential organ and/or tissue donation. It is updated regularly. 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 PF's prior consent (section 5 of the Human Tissue (Scotland) Act 2006).
- The PF will normally permit removal of organs and/or tissue, subject to the need to ensure that sufficient evidence is available for any subsequent criminal proceedings or Fatal Accident Inquiry.
- The PF may object to removal of organs and/or tissue in a case where there is evidence that the death has happened due to a crime having occurred or where there is insufficient time available to complete the enquiries which would allow an informed decision. In certain circumstances, the PF may be in a position to agree to the donation for transplantation of some and/or all organs and/or tissue in cases where there is evidence that the death has happened due to homicide; early discussion with the PF is essential.
1.15 This agreement provides that, where necessary, deaths will be reported to the PF and, in the case of a potential DCD donor, the PF will be advised in advance of cardio‑respiratory arrest to enable the PF to make a rapid and informed decision about donation.