National Guidelines

Welsh Consultation Document Presumed Consent


The Welsh public consultation on presumed consent ended on January 31st.

This was my submission.

29th January 2012

Dear Sir / Madam

RE: Proposals for Legislation on organ and tissue donation: A Welsh Government White Paper

I am an Adult Intensive Care Consultant, and a local and regional Clinical Lead for Organ Donation. I wish to make an observation regarding the proposal and its impact on the fastest growing form of deceased organ donation in the UK, controlled donation after circulatory death.

Donation after brain death (DBD) is currently and internationally, the most common form of deceased organ donation. DBD occurs after two senior doctors carry out a detailed clinical examination of the brain and establish that death has occurred. If death has occurred then the family of the patient is approached regarding the possibility of organ donation.

Controlled Donation after Circulatory Death (DCD) is a rapidly increasing form of deceased organ donation, accounting for 38% of all deceased donation in the UK. It is predicted, on current growth, that DCD will overtake DBD as the most common form of deceased organ donation within the decade. DCD occurs after two senior doctors decide that death of the patient is imminent and that the withdrawal of life-sustaining treatment is in the overall benefit of the patient. Once the decision is made to withdraw life-sustaining treatment then the family of the patient can be approached regarding the possibility of organ donation. Importantly, unlike in DBD, the family is approached while the patient is still alive. For donation to be successful in DCD, the family must give their permission for interventions to occur to the patient prior to death. Such interventions always include delaying the withdrawal of life-sustaining treatment for up to 12 hours and may include direct interventions to actively treat the organs for the benefit of the recipient. These direct interventions might require the clinician to insert large catheters into blood vessels into the persons neck and upper chest so that medications can be given to support the patient’s blood pressure, or require increasing support of the mechanical ventilator to assist the supply of oxygen to the patient, and might even include the necessity to withdraw life-sustaining treatment in environments usually considered less than ideal for end of life care. These interventions to support DCD are felt ethical and legal because they satisfy the Mental Capacity Act and respect the wider best interests of the dying patient.

The important difference between the two forms of deceased organ donation is that in DBD, the approach with the family and the facilitation for organ donation occur after death has occurred, and its legal framework is the Human Tissue Act. Whilst for DCD the approach with the family and the initial facilitation for organ donation occur before death has occurred, and its initial legal framework is the Mental Capacity Act.

This difference has a number of significant consequences to the Welsh proposal to introduce an opt out system for organ donation.

1. Whilst presuming consent for organ donation after death has occurred in DBD, has long been argued and debated in the medical and ethics literature, and has been adopted as a system for organ donation consent in many countries, this is not the case for DCD. 

2. Presuming consent for DCD is something new, with no support in practice or in the ethics literature.

3. Many ethicists and lawyers feel it is already a stretch to justify the presumption of consent after death has occurred in DBD; and presumption of consent does appear to directly contradict the ethos and the purpose of the Human Tissue Act which established the primacy of the patients explicit consent for the disposal and storage of human tissue. In DCD this difference is even more striking, because the Mental Capacity Act establishes a legal necessity for the clinician to seek out knowledge of the patient’s wishes, views and beliefs on any treatment, to remove any element of presumption by the clinician. It is explicit in the Mental Capacity Act that consent has primacy over best interests. Only when consent cannot be established is best interests used to decide the best action. Presuming this consent in living patients, for interventions that do not benefit the patient, is new territory for ethics and the law.

4. The presumption of consent in DCD might lead clinicians to commence interventions required for successful DCD donation, before family discussion has occurred. Some transplant surgeons in the UK believe that even more invasive interventions, while the patient is still alive, are required to improve recipient outcomes in DCD. One example is the cannulation of the large veins of the groin, in life, to allow organs, including the heart, to be restarted as soon as death has occurred. This invasive intervention, while the patient is still alive, is currently prohibited by the Department of Health and Welsh Assembly legal guidance on DCD (called at the time Non-Heart Beating Organ Donation), as it appears to violate the Mental Capacity Act. With a presumption of consent, this currently prohibited intervention appears legal.

5. No country in the world with an opt-out system for organ donation has any significant controlled DCD programme. Spain, the most successful organ donation country in the world has opt-out, but this is predominantly donation after brain death, as Spain has only a small DCD programme in certain large hospitals. Additionally their DCD programme is different to the UK’s as they practice uncontrolled DCD. Uncontrolled DCD is when death has occurred suddenly in the community or in the hospital, death is declared by a clinician, and then the heart and body is maintained for organ donation using mechanical chest compressors and artificial circulation devices via the large veins in the groin. Families will arrive in the hospital to find their relative being prepared for organ donation, before they even knew their relative was unwell. This is allowed in Spain because of presumed consent. Transplant surgeons want to introduce a similar system in the UK but there is considerable ethical concern about the practice. An opt-out system in Wales would allow this practice to commence, almost uncontested.

In summary whilst an opt-out system for donation after brain death has long international experience and has seen extensive debate in the ethics literature for decades, this is not the case for donation after circulatory death. The ethics and legal situation is very different, and the presumption of consent for organ donation will be applied to living patients before death. Interventions currently prohibited in donation after circulatory death, since they don’t satisfy best interests tests, will be satisfied if consent is presumed. The rest of the world will indeed be watching, as Wales will be very much, going this alone.

Yours sincerely

Dr Dale Gardiner (Nottingham, UK)