Human Tissue (Authorisation) (Excepted Body Parts) (Scotland) Regulations 2020: consultation

Introduction

About this consultation

1. A deemed authorisation system of deceased organ and tissue donation for transplantation will come into effect in Scotland in autumn 2020^[1]. This is commonly referred to as an ‘opt out’ system.  

2. It is proposed that deemed authorisation will only apply to the commonly transplanted organs and tissue and will not apply to novel or rare transplants.  Applying deemed authorisation to only the more commonly donated types of organ and tissue reflects a measured approach in introducing deemed authorisation, and should avoid the unintended consequence of people deciding to opt out purely due to concern about donating a particular, rarely donated body part even though such donation would be extremely unlikely. 

3. This consultation is seeking views on proposed draft regulations which will make clear which parts of the body deemed authorisation will not apply to.  In practice donation and transplantation of these parts of the body is rare or doesn’t happen in the UK however it is important to set the exclusions out in regulations in order to provide certainty about what is included in deemed authorisation.  

4. The Scottish Government would welcome views on the proposed list of parts to be excluded from deemed authorisation and in particular on whether the proposed list would mean that deemed authorisation will include all and only those parts of the body which are currently commonly transplanted.

Practical context  

5. The circumstances in which a person can become an organ donor are limited; organ donation usually only happens where the person has died in an intensive care unit in hospital. Only around 1% of people die in these circumstances.  Tissue-only donation is slightly different as tissues can be donated up to 24 or 48 hours after death and currently tissue-only donation happens from a variety of hospital settings.

6. Currently, if someone has opted in to donation on the NHS Organ Donor Register (ODR), they can specify which of the commonly donated organs and tissue they want to donate. For example, it is possible for a person to say they want to donate certain organs and tissue but not their corneas. Under the opt-out system, people will still be able to use the ODR in the same way to specify which organs or tissue they wish to donate.  In cases where organ or tissue donation is a possibility, specialist staff will discuss donation with the family, including which organs/tissues it is possible to donate in the specific circumstances. 

7. Only certain organs and tissue are commonly donated for transplantation from deceased donors in Scotland or the rest of the UK.  For organs these include the kidneys, liver, pancreas, heart, lungs, small bowel and stomach and for tissue these include heart tissue, tendons, skin, bone, blood vessels and corneas.  Transplantation of these common types of organs and tissue is well established in the UK and is carried out frequently with a high degree of success.  

8. More novel or rare transplants, for example involving limbs, are carried out very infrequently in the UK because of the much lower level of need or demand.    

9. If a potential donor could be a suitable match for a novel or rare organ or tissue for a patient waiting for such a transplant, it would only take place when there is appropriate authorisation in place and with the support of the donor’s family.  

10. Including the parts of the body which may be the subject of more novel or rare transplants as part of the deemed authorisation system would be unlikely to increase their availability for transplantation.

Legislative context

11. On 11 June 2019 the Scottish Parliament passed the Human Tissue (Scotland) Act 2019 (‘Human Tissue (Authorisation) (Scotland) Act 2019’). This legislation amends the Human Tissue (Scotland) Act 2006 (‘the 2006 Act’) and provides for a deemed authorisation system of deceased organ and tissue donation for transplantation to take effect in Scotland. This is commonly referred to as an ‘opt out’ system of organ and tissue donation, replacing the ‘opt in’ framework currently in place. The Scottish Government has announced that the new deemed authorisation system will come into force in autumn 2020.

12. The legislation provides that when a person has not recorded an opt-in or opt-out decision, they may be deemed to have authorised donation of their organs and tissue after their death for transplantation.  This is subject to a number of safeguards set out in the legislation which seek to ensure that donation doesn’t proceed where it would be against the wishes of the potential donor.  Transplantation is the only purpose for which authorisation can be deemed – authorisation cannot be deemed for research or any other purpose.  

13. In order to provide certainty about the scope of deemed authorisation, regulations will set out which parts of the body deemed authorisation will not apply to, referred to in the 2019 Act as ‘excepted body parts’.  

14. If an adult is deemed to have authorised donation for transplantation, only parts of the body which are not listed as excepted body parts will be able to be donated under deemed authorisation.  In such cases, authorisation for donation of the excepted body parts for transplantation may be given by the donor’s family, provided they have no knowledge that the adult would have been unwilling to donate these parts.  However based on current practice, it would be rare that a family would be approached about the possibility of donation of excepted body parts. 

15. Section 6D(5) of the Human Tissue (Scotland) Act 2006 inserted by section 7 of the 2019 Act provides for Scottish Ministers to make regulations to specify parts of the body which are excluded from deemed authorisation - The Human Tissue (Excepted Body Parts)(Scotland) Regulations 2020.  The proposed content of these regulations, in the form of lists of parts of the body (see Intention of proposed regulations).  

16. Listing these parts in secondary legislation will mean that the list can be updated if required.  If a novel transplant became standard practice and there was clinical demand for transplants of that body part, then, following clinical advice and evidence the Scottish Government would consider removing it from the list of body parts which are excluded from deemed authorisation. However it is not expected that this will happen in the near future. Before proposing any such changes, the Scottish Government would consult with NHS Blood and Transplant (NHSBT), the Scottish National Blood Transfusion Service (SNBTS), clinicians, and any other relevant clinical stakeholders, before carrying out wider consultation.  The Scottish Government will discuss with the Scottish Donation and Transplant Group arrangements which might be put in place for it and other clinical stakeholders to consider the clinical rationale for any potential changes to the Regulations.