Human Tissue (Authorisation) (Specified Type B Procedures) (Scotland) Regulations: consultation

3. The Type B regulations

33. Type B procedures are medical procedures which a person might not expect to be authorised by authorising donation, including deemed authorisation for donation. Therefore additional requirements may be put in place, both in terms of authorisation and also the circumstances or manner in which the procedures may be carried out.

34. There are three components to the proposed regulations, listed below. The Scottish Government is seeking your views on these three aspects:

• the medical procedures which should be specified as Type B;
• the circumstances in which the specified Type B procedures may be carried out;
• how the specified Type B procedures may be authorised.

35. The 2019 Act permits different procedures to be treated differently in the regulations, to allow a proportionate approach to each type of procedure. This may be in the conditions which have to be met before the procedure can be carried out, or in how they are authorised.

36. However, it is proposed that the same conditions and authorisation methods apply to all of the proposed procedures for these regulations and your views are sought on this approach.

Consideration of rights of the patient

37. In setting out the framework in the Act for pre-death procedures, due regard was taken of the rights of individuals under the European Convention on Human Rights (ECHR), in this case the patient who may undergo pre-death procedures. The regulations to which this consultation refers will support the framework by identifying which pre-death procedures can be specified as Type B, as well as any additional conditions and authorisation requirements which must be met.

38. As with the development of the provisions in the Act, consideration must be given to each distinct pre-death procedure in terms of its justification, the authorisations and safeguards to be put in place for its use, and its compliance with the wider ECHR standards. This includes consideration of the invasiveness of the procedure and its impact on a patient's bodily integrity and privacy, as protected by Article 8 ECHR. Any possible interference with an individual's rights under Article 8 must be necessary in pursuit of a legitimate aim and proportionate to that aim. This means that the statutory framework must build in appropriate safeguards in proportion to the invasiveness of each procedure.

3.1 Proposed list of Type B Procedures

39. The Scottish Government is proposing that the medical procedures listed below will be specified as Type B pre-death procedures, and is seeking views on this proposed list. An explanation of what each procedure involves and its purpose is included in Annex A.

Carrying out radiological imaging which requires moving a patient from their existing location, including:

• Magnetic Resonance Imaging (MRI)
• Computerised Tomography (CT) scan

And;

• X-ray
• Ultrasound
• Transthoracic echocardiography^[7]
• Bronchoscopy
• Skin biopsy
• Scraping or swabbing of a body orifice (other than mouth, nostril or ear canal).

40. As noted earlier, once the new framework is enacted, a Type B pre-death procedure may only be carried out if it is included in the list of procedures specified in Regulations by Scottish Ministers, and approved and brought into force by the Scottish Parliament.

41. We would like to know your views on the proposed procedures listed as Type B procedures, particularly in regards to the questions below:

• Question 1. If there is any proposed medical procedure in the Type B procedure list that you think should not be included?
• Question 2. If there is any medical procedure not listed in the Type B procedures list, which you think should be included in this category?
• Question 3. If you think that any amendments to the wording in the Type B procedures list are required?

3.2 Circumstances in which Type B Procedures may be carried out

42. Due to the non-routine nature of Type B procedures, conditions which are additional to those contained in the Act (set out at paragraph 16) may be applied before they can be carried out.

43. The conditions outlined below may be considered to broadly reflect current practice around the carrying out of medical procedures in general to facilitate transplantation. However, specifying these in the regulations would make them a legal requirement. The Scottish Government would welcome views on their inclusion.

Taking account of Type A procedures

44. The first proposed condition is:

• that a Type B procedure may only be carried out where no Type A procedure could be used to provide the necessary information.

45. The Act already contains requirements that a pre-death procedure (whether Type A or Type B) may only be carried out where it is necessary to do so. What is proposed as an additional safeguard for Type B procedures is to include a specific requirement that Type B procedures can only be utilised where the carrying out of the specified Type A pre-death procedures would not provide the necessary diagnostic information.

46. This would reflect current practice around medical procedures more broadly, whereby interventions are required to be proportionate and a lesser intervention should be utilised where possible.

Registered Medical Practitioner agreement

• The second proposed condition is that a Type B procedure may only be carried out with the agreement of two Registered Medical Practitioners (RMPs). This would involve both RMPs being satisfied that the conditions for carrying out the pre-death procedures are met (specifically those set out in section 16E (2) (c) to (e) of the Act, and replicated above at point (c) to (e) of paragraph 16 earlier in this paper. These are namely around the necessity of the procedure, that it is unlikely to cause more than minimal discomfort, and unlikely to cause harm to the patient) and;
• That a record of this agreement is made in writing.

47. Donation and transplantation is a multidisciplinary field and involves many different medical professionals working together. Requiring agreement from two RMPs that a procedure should be carried out would reflect current practice in many cases but would also provide an additional level of assurance comparative to the carrying out of less routine procedures to facilitate transplantation.

48. In practice, agreement would likely be between the intensive care consultant who is primarily responsible for the patient's care, and another RMP, which might include the transplant surgeon who would carry out the retrieval operation after the patient's death. The Scottish Government has considered the whether the Regulations should include reference to particular specialisations of RMP. For example this could be to require the agreement from RMPs of a particular specialism, or to preclude a specific type of RMP from agreeing to the procedure, for example not permitting the agreement to be given by an RMP involved in the donation process.

49. There is a balance to be struck between ensuring there is a robust process in place to manage the carrying out of a Type B procedure in a hospital setting, alongside ensuring that the Regulations are not overly prescriptive. On balance, and taking into consideration the requirements around authorisation, family involvement, broader safeguards in the Act and the wider ethical framework surrounding donation in Scotland, the Scottish Government is not proposing that there should be further specification of a particular RMP or RMPs who may agree to a Type B procedure.

Recording of agreement

50. In order to ensure there is clarity about such agreement that the procedure may be carried out, and that the necessary conditions have been met, the Scottish Government has considered the need to make it a legal requirement that the agreement of two RMPs to carry out the procedure is recorded in writing. It is established clinical practice that medical interventions carried out on a patient are formally recorded in their medical record, so in practice the fact that there is such agreement could be included there, or on other documentation related to the donation. The Scottish Government proposes that this is a reasonable condition, which formalises the recording requirement in line with broader clinical practice.

Applicability of proposed conditions

51. The Scottish Government proposes that both conditions described above would apply and have to be met for all of the proposed specified Type B procedures, before those procedures could be carried out.

52. As part of this proposal, the Government has considered the applicability of conditions applying only to certain procedures i.e. a form of 'sliding scale' of conditions that need to be met based upon, for example, the invasiveness of any specified Type B procedure.

53. On balance, it is considered that these conditions are proportionate and appropriate to be applied to all the proposed Type B procedures which are included in the consultation. In addition, it is important that the effect of the Regulation is well understood and so having the conditions apply equally to all specified procedures is likely to assist with implementation.

54. We would like to know your views on the proposed conditions that are required to be met before a specified Type B procedure can be carried out, particularly in regards to the questions below.

• Question 4. We would like to know your views on the proposed condition that a Type B procedure may only be carried out if there is no Type A procedure which can provide the necessary information.
• Question 5. We would like to know your views on the proposed condition that the agreement of two Registered Medical Practitioners, which will confirm the requirements for the Type B procedure to be carried out have been met, must be obtained and that the existence of such agreement must be recorded in writing.
• Question 6. It is proposed that these conditions should apply to all specified procedures. We would like to know your views on this approach.

3.3 Ways in which Type B Procedures may be authorised

55. Specified Type B pre-death procedures may only be carried out where authorisation for them to be carried out is in place. The Scottish Government is seeking views on what authorisation requirements should be in place.

56. The Scottish Government has considered what form of authorisation for Type B procedures could be set out in the regulation. Authorisation methods that have been considered are:

• Nearest relative authorisation;
• Express authorisation;
• Court approval.

57. The Scottish Government does not propose that express authorisation or court approval should be required for the carrying out of Type B procedures included in this consultation. These authorisation methods are discussed further below.

Express authorisation

58. The Scottish Government recognises that whether a person wishes to donate organs and tissue after death is first and foremost a matter for them – this is reflected in the provisions of the 2019 Act, including in the duty to inquire. Similarly, whether a person would wish to undergo certain medical procedures is ordinarily, where they have capacity, a matter for them. It is therefore proposed that, similar to the approach to Type A procedures, a person will be able to make an advance authorisation for a Type B procedures if they wish, in writing.

59. If a potential donor has authorised donation, either expressly or deemed, every effort should be made to support their decision being fulfilled. In progressing towards deceased donation however, potential donors' interests must be fully protected and the pre-death procedures framework seeks to ensure that they are. Requiring that express authorisation should be in place for Type B procedures would contribute towards this and provide assurances that less routine procedures are only carried out where there is authorisation for them from the potential donor.

60. However there are a number of significant practical issues with requiring express authorisation for Type B procedures. Given the circumstances in which deceased donation takes place, it would be extremely rare to be able to obtain express authorisation for a specific pre-death procedure from the potential donor at the time they will be considered. Those who are progressing as potential DCD donors are unconscious and will therefore not have capacity to expressly authorise a pre-death procedure.

61. Although a public mechanism could be established to record specific authorisations in advance for such procedures, for example similar to, or as part of the NHS Organ Donor Register, this would not address any potential donor who is progressing via deemed authorisation for donation i.e. adults who have decided not to record a donation decision in life.

62. Express authorisation is unlikely to be achieved in practice for the reasons outlined above. Requiring express authorisation therefore could act as a barrier to donation ever proceeding in cases where certain information identifying the viability of an organ for donation could only be obtained by carrying out a specific Type B procedure.

63. Taking all these factors into consideration, whilst it is important that a person should be able to authorise Type B procedures during life if they wish, it is not proposed that express authorisation from the donor for such procedures should be required.

Court approval

64. Court approval has also been considered as a potential authorisation method, however it is considered to be disproportionate to the Type B procedures proposed in this consultation.

65. The time critical setting in which deceased donation takes place would present practical problems in making any form of application to a court. Furthermore, the introduction of such an authorisation process for Type B procedures would lengthen a process that is already very difficult for families. The potential time it might take for any such application to be considered would present a real risk that a potential donor would be unable to be progressed to donation, and would likely cause their family distress by unduly lengthening and complicating the donation process.

66. Given such considerations, in practice it is unlikely that clinicians would seek to gain court approval and therefore, if it was required, it would act in almost all cases as a barrier to Type B procedures ever being carried out.

67. Additionally, it may be considered to be disproportionate to require court approval for a Type B procedure to be carried out where that approval may instead be given by a nearest relative who, in certain circumstances, would also be permitted to authorise donation for transplantation and Type A procedures for their loved one. Since court approval would never be sought as a substitute for the views of the nearest relative, there is a risk that introducing an extra level of decision-making for Type B procedures could undermine the role of the nearest relative for transplantation in general.

Nearest relative authorisation

68. Taking into account the above considerations, the Scottish Government is proposing that a Type B procedure may be carried out either if a patient has given express authorisation for this procedure in advance (which is unlikely to apply in most cases), or with authorisation from the potential donor's nearest relative^[8], or person with parental rights and responsibilities in the case of a child^[9].

69. Donation and transplantation is progressed with the involvement of the potential donor's family and this will remain the case under the deemed authorisation system. Under current practice families are involved in discussions about what procedures might be required in order to progress donation, and are carried out with support from the family.

70. Formalising this practice and requiring a specific authorisation from the nearest relative, or person with parental rights and responsibilities in the case of a child, would broadly be in line with current practice while providing assurance that more novel procedures will not proceed without specific authorisation and with support of the potential donor's family.

71. Furthermore, as previously noted, the law already permits a nearest relative to authorise donation and Type A procedures on behalf of an adult, or a person who has parental rights and responsibilities to authorise on behalf of a child, in certain circumstances, and so enabling this kind of authorisation would be in line with other aspects of the legislation.

Applicability of authorisation methods

72. On balance, it is considered that a requirement for either express or nearest relative authorisation is a proportionate and appropriate method to be applied to all the Type B procedures proposed in this consultation.

73. We would like to know your views on the proposed way in which Type B procedure can be authorised, particularly in regards to the question below.

• Question 7. It is proposed that all specified procedures are able to be carried out either with express authorisation by the individual or with nearest relative authorisation. We would like to know your views on this approach.