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

Background

Novel and rare types of transplants 

17. Medical science can advance rapidly, making new procedures and types of transplants possible. However, it can take many years for a new transplantation procedure to become standard practice. This is because of the need for careful evaluation at each stage of its development to ensure that it is safe, effective, ethical for patients, and meets the needs of the population.

18. Limb donation is a rare form of donation. Limb transplants are already offered in Leeds General Infirmary for patients across the UK. There is a very small number of patients who need a limb transplant - there have only been 6 limb transplants in the UK since 2012.

19. There is a small number of novel transplants from deceased donors being developed in the UK such as face transplants.  In addition, there are several transplant procedures currently undertaken in other countries, which may be taken forward in the UK at some point in the future, for example penis transplantation. 

2016 Consultation on increasing the number of successful donations

20. The Scottish Government consulted on ways to increase donation, including through the introduction of an opt out system of deceased donation, from late 2016 into early 2017.  The consultation proposed that deemed authorisation should only apply to the commonly transplanted organs and tissue^[2] and sought views on this.

21. The majority of individual respondents (83%) expressed a preference that deemed authorisation should apply to all parts of the body for transplantation, without exception.  Conversely, organisational respondents (such as NHS boards, local authorities, professional bodies etc.) were more evenly split, with 46% of respondents in favour of deemed authorisation applying to all parts of the body, and 54% in favour of deemed authorisation applying only to the more commonly transplanted organs and tissue.^[3]

22. Including all parts of the body in deemed authorisation is unlikely to increase the number of successful novel or rare transplantations as donation and transplantation of such body parts is rare because of the low level of need, rather than because of an absence of authorisation.  Excluding certain parts of the body from deemed authorisation is also consistent with the approach in other parts of the UK and given the UK-wide collaboration on donation and transplantation it is beneficial to take a similar approach.

23. Applying deemed authorisation to only the more commonly transplanted types of organ and tissue reflects a measured approach and aims to avoid the unintended consequence of people deciding to opt out of donation due to concern about donating a particular, rarely donated, body part even though such donation would be extremely unlikely.

24. Our proposed approach reflects the position set out in the 2016 consultation that deemed authorisation will not apply to novel or rare transplants.

UK Context

25. Solid organ and eye donation and transplantation is coordinated across all UK nations by NHS Blood and Transplant (NHSBT), a special health authority for England and Wales. This means that an organ donated in Scotland could be transplanted into a recipient in another part of the UK.  Similarly an organ donated in another part of the UK could be transplanted into a recipient in Scotland.  

26. The Scottish National Blood Transfusion Service (SNBTS) coordinates deceased donation and also provision of other tissues for transplantation across NHS Scotland.  

27. Similar regulations to those proposed in Scotland are in effect in Wales^[4] and have been consulted upon in England^[5], and they reflect the respective legislation in those jurisdictions.  Similarly the Scottish regulations reflect the legislative framework in place in Scotland and so do not replicate the English and Welsh regulations.  As far as is possible the effect is intended to be broadly the same, and differences in the regulations, either in drafting or effect will not affect cross-border transfer.