Thank you for the opportunity to make opening remarks.
I think that it is important—and I hope that it will be helpful to the committee—that I set out the context in which the draft regulations have been laid. The committee will be aware that the Human Tissue (Authorisation) (Scotland) Act 2019 introduced a statutory framework for the authorisation and carrying out of medical procedures that facilitate transplantation, which are termed “pre-death procedures” in the act. They are defined in the act as the medical procedures that might be carried out on a person for the purposes of ascertaining the suitability of an organ for donation or of
“increasing the likelihood of successful transplantation ... after ... death”,
and which are not for the purpose of
“safeguarding or promoting the physical or mental health of the person.”
The committee will recall that, in cases of donation following circulatory death, which account for around 40 per cent of deceased organ donation, such procedures must be carried out before, sadly, the donor dies.
The framework for carrying out pre-death procedures is an important part of the new legislative regime for donation and, essentially, provides transparency for the public about such procedures, which are already a necessary part of the donation process in order to ensure the health and safety of organs for the transplant recipient.
I turn to the regulations. Parliament passed equivalent regulations for type A procedures in March last year. Those procedures are more routine and less invasive, and are regularly carried out in order to facilitate transplantation.
In some circumstances, if the clinical situation requires it, further diagnostic procedures are available to clinicians to assess the health and safety of organs—for example, if there is a possibility of malignancy, which requires further investigation. The type B regulations, which are now before you, list those procedures that, unlike type A procedures, are not expected to be frequently carried out in order to facilitate transplantation but might sometimes be required as part of the donation process.
Such procedures are not unusual in the wider context of patient care in a hospital setting. However, because of their non-routine nature in the context of transplantation, and the fact that they are more invasive than type A procedures, the act permits the setting in secondary legislation of additional safeguards that must be met before a type B procedure can be carried out.
I will briefly set those out. The regulations include a requirement that, unlike type A procedures, which are authorised automatically by virtue of the donation itself being authorised, a type B procedure must be explicitly authorised before it can go ahead. Given the circumstances in which donation takes place, in which the patient will usually be unconscious in an intensive care unit, that authorisation will be sought from the patient’s family. Further, in line with the approach that is taken in the 2019 act, before that authorisation is given, the views of the potential donor must be taken into consideration so that such procedures are not carried out if they would be against the donor’s known wishes.
As well as requiring that explicit authorisation, the regulations require that, further to the safeguarding conditions in the 2019 act, two conditions have to be met before a type B procedure can be carried out. First, the regulations state that a type B procedure can proceed only if two doctors agree to the procedure being carried out, having both considered that all the conditions set out in the 2019 act have been met. In feedback from the consultation, stakeholders requested that the regulations specifically exclude doctors who are involved in the transplantation process from performing that role, and that is reflected in the regulations. The regulations also require that one of the doctors must be the doctor who is responsible for the patient’s care. Those requirements reflect current practice in decision making on a patient’s care in relation to donation, and they provide certainty and transparency around the process.
The second condition is that in order for the procedure to be carried out, the two doctors must also conclude that a lesser intervention—a type A procedure—cannot be used to provide the necessary information for transplantation purposes. That reflects the general approach to the carrying out of medical procedures and ensures that the minimum intervention is made to facilitate the transplantation.
Those additional conditions, taken together with the requirements in the 2019 act and the requirement for explicit authorisation, seek to ensure that, in cases in which it is necessary to carry out a type B procedure so that an organ can be safely transplanted, there are appropriate safeguards in place to ensure that the interests of the donor are protected. In practice, the requirements in the 2019 act and in the regulations mean that a type B procedure will not go ahead without family involvement or authorisation, and that it will not go ahead prematurely or if it is not absolutely necessary to facilitate transplantation.
In developing the regulations, we have worked closely with and taken the advice of clinicians who work in intensive care and across the donation and transplantation pathway. I am grateful for their input in helping to ensure that the specified procedures and additional requirements that we have in place are appropriate. We also consulted publicly, and the draft regulations before the committee take into account the responses to that consultation. I am happy to take questions from the committee.