LEGISLATION RELATING TO ORGAN AND TISSUE DONATION AND TRANSPLANTATION: ANALYSIS OF CONSULTATION RESPONSES
CHAPTER 6: OTHER ISSUES RELATING TO ORGAN AND TISSUE RETRIEVAL FROM PEOPLE WHO HAVE DIED
The consultation raised a number of other issues relating to organ and tissue retrieval from people who have died. These are taken in turn below.
6.1 APPLICATION OF PENALTIES
The consultation stated:
The question arises of what types of enforcement, if any, should apply to cadaveric organ and tissue retrieval. Enforcement could take the form of criminal sanctions, a system of licensing or a system of inspection.
The Consultation Paper on Hospital Post-Mortem Examinations proposed criminal penalties for failing to obtain authorisation, or failing to abide by the terms of the authorisation given. In considering whether it would be appropriate to apply these penalties to cadaveric organ and tissue retrieval, a number of points should be borne in mind.
The consultation argued that there has never been a scandal associated with the process of cadaveric organ and tissue retrieval; that various bodies already monitor, set standards and oversee arrangements to provide protection against abuse; and that all of transplantation is subject to the general rules of clinical governance, as with any other hospital procedures.
The consultation stated:
In the light of these considerations, we do not propose to introduce a system of regulation or penalties in relation to the retrieval of organs and tissue from cadaveric donors for purposes of transplantation. In reaching this conclusion, we are aware that this embodies a difference in approach from the legislation proposed for the rest of the UK.
The consultation asked:
ARE THERE REASONS FOR WANTING TO APPLY THE PENALTIES PROPOSED IN THE HOSPITAL POST-MORTEM EXAMINATION CONTEXT TO CADAVERIC ORGAN AND TISSUE RETRIEVAL?
Fifty-one respondents provided a clear recommendation on the issue of application of penalties. The majority (71%) view was against the application of penalties in this context, with a minority (29%) favouring penalties.
Reasons Provided Against the Application of Penalties
The overriding rationale provided against the application of penalties in the context of cadaveric organ and tissue retrieval was that there are already adequate systems in place to ensure appropriate standards of practice are upheld. However, it was stressed that such frameworks should be seen to be operating rigorously with regular inspection and rules of clinical governance strictly applied (53 Pub Rep). One respondent remarked that maintaining good practice relied on persuasion rather than coercion (62 Indiv) and involved self-assessment, monitoring by peer groups, publishing results, and incorporating changes resulting from any problems into practice.
A few respondents were concerned that the application of penalties would result in an overly cautious culture regarding organ and tissue retrieval (9 Indiv, 51 Educ). Another view was that breaches of protocol in this context were usually the result of mistakes rather than any attempt to deliberately flout the law (9 Indiv). Pleas were made not to change a system that worked (6 Indiv) and not to create a new crime for no perceived obvious benefit (3 Indiv).
Reasons Provided in Favour of the Application of Penalties
The most common reasons provided in favour of the application of penalties in this context were consistency with the rest of the UK (8 Indiv, 27 Educ, 37 NHS/Med, 50 Legal) and to promote public confidence in the system (19 Educ, 33 Pub Rep, 44 Acad, 45 NHS/Med).
Two respondents favoured penalties but not if they included imprisonment or fines (39 NHS/Med) and only if they differentiated between deliberate flouting of rules and unintentional errors (27 Educ). One final view was that not introducing penalties would breach Council of Europe Protocol regarding Transplantation of Organs and Tissues of Human Origin ( 43 Prof Rep).
6.2 SHOULD HUMAN TISSUE AUTHORITY FUNCTIONS BE EXTENDED TO SCOTLAND?
The consultation stated:
Legislation in the rest of the UK proposes the establishment of a Human Tissue Authority, the functions of which would cover the full range of uses of human organs and tissues dealt with by the legislation. These would include post-mortem examinations as well as organ and tissue retrieval, and from the living as well as the dead. The Authority would have broad functions of maintaining a statement of general principles, providing general oversight and guidance, superintending compliance with the requirements of the legislation and codes of practice made under it, providing information to the public, monitoring developments and advising Ministers in the other countries of the UK.
The new legislation for the rest of the UK is not intended to affect the day-to-day operational activities of UK Transplant (UKT), as there is no intention of licensing the processes of retrieving organs for donation or the implementation of those organs in recipients.
As it seems unlikely that the Human Tissue Authority will have any day-to-day role in the business of cadaveric transplantation, it is not proposed to extend its functions to Scotland in the context of cadaveric organ and tissue transplantation.
The consultation asked:
SHOULD SOME OR ALL OF THE FUNCTIONS OF THE HUMAN TISSUE AUTHORITY IN RESPECT OF CADAVERIC TRANSPLANTATION BE EXTENDED TO SCOTLAND? IF SO, WHICH FUNCTIONS?
Forty eight responses referred to these issues. Of these, 63% were of the view that some or all of the functions of the Human Tissue Authority should be extended to Scotland in this respect; 25% of those who commented were against this proposition; 8% recommended that extending some or all of the Human Tissue Authority functions to Scotland should be considered; and the remaining 4% of respondents suggested waiting to see how the plans rolled out in England and Wales before committing to a firm view.
The overriding reasons for supporting an extension of the Human Tissue Authority functions to Scotland were to promote consistency with other jurisdictions and thus facilitate more effective sharing of organs and tissues across borders. One typical comment was that legislation should not be allowed to stand in the way of free movement of donations across national boundaries in the UK (28 NHS/Med). A further rationale in support of extending functions to Scotland was that it would prevent a duplication of function across different bodies (14 Pub Rep, 15 Pub Rep).
Relatively few (17) respondents commented on which functions of the Human Tissue Authority should be extended to Scotland. Most (76%) of these suggested that this should involve all the relevant functions. Others proposed that Codes of Practice be extended (33 Pub Rep); or common standards and practices (30 Prof Rep); or a system of regulation for non-heart beating donors (26 Acad); and that extended functions be restricted to avoid duplication with the functions of UK Transplant (47 Educ).
Very few reasons were provided by those opposing the proposition to extend functions of the Human Tissue Authority to Scotland. A few respondents commented that such an extension was simply unnecessary, particularly as UK Transplant performs its functions throughout the UK (32 Pub Rep, 39 NHS/Med). Another view was that it could be confusing to have one single authority overseeing practice across different legislative frameworks (29 Acad).
6.3 ENSURING LIFE IS EXTINCT
The consultation stated:
Section 1(4) of the Human Tissue Act 1961 provides that a doctor undertaking the removal or organs for transplantation is required to satisfy himself "by personal examination of the body that life is extinct". It is not clear that this provision serves any useful purpose in cases where death is diagnosed by brain stem criteria. Doctors independent of the transplant team will perform the necessary tests; if the criteria are met, the patient is pronounced dead. There seems to be no reason for the transplant surgeon to replicate the tests, though he or she should of course have to be satisfied that the brain stem death tests have been performed adequately. The provision of the 1961 Act has not been carried forward into the Human Tissue Bill. In relation to non-heartbeating donation, however, there are grounds for arguing that the provision of the 1961 Act should be continued. In these cases, death is confirmed by conventional means and by doctors independent of the transplant team who have been involved in caring for the patient during his or her life. As an additional safeguard, the retrieving transplant surgeon should be satisfied that death has been certified in the usual way.
The consultation asked:
SHOULD THE NEW LEGISLATION PROPOSED FOR SCOTLAND CONTINUE THE PROVISION OF THE 1961 ACT REQUIRING THE DOCTOR REMOVING ORGANS FOR TRANSPLANTATION TO SATISFY HIMSELF THAT LIFE IS EXTINCT, OR SHOULD THERE BE SPECIFIC PROVISION THAT HE SHOULD SATISFY HIMSELF THAT THE BRAIN STEM DEATH TESTS HAVE BEEN PERFORMED ADEQUATELY?
Of the 49 responses which contained commentary of relevance, 47 provided a clear recommendation on the issue. Amongst these responses, the majority view (64%) favoured changing the previous provision so that rather than repeating the tests, the doctor removing organs should have to satisfy themselves that the brain stem death tests have been performed adequately. However, a substantial minority of those who commented (36%) recommended maintaining the status quo.
Those in favour of amending the legislation provided a number of reasons for their decision:
There should be a separation of duties between the transplant team (representing the recipient's interests) and the doctor looking after the patient (representing the patient's interests) (25 Educ, 37 NHS/Med, 41 NHS/Med). Any doctor having to undertake brain stem death tests and retrieval functions is open to a conflict of interests - " No to requiring the organ harvester to repeat tests" (58 Indiv)
The retrieval doctor would not have the necessary expertise to undertake brain stem death tests (28 NHS/Med, 31 Prof Rep, 56 NHS/Med)
Determining whether life is extinct and removing organs are two completely separate tasks so it would be inappropriate to expect the same person to undertake both (44 Acad)
The retrieval doctor should be able to assume that the death has been certified correctly (9 Indiv)
Scotland should maintain consistency with the rest of the UK in this regard (50 Legal)
Undertaking the brain stem death tests again constitutes unnecessary replication of tasks (52 Educ)
Few reasons were specified in favour of retaining the 1961 legislation:
A brain stem death test by the retrieval doctor would provide a safeguard to ensure that the individual was indeed deceased (1 Indiv, 42 Indiv)
There is no good reason to change the status quo (22 Acad)
Contributes to public confidence (although needs to be balanced against the time available) (47 Educ)
The consultation asked:
SHOULD THE PROVISION BE RETAINED IF IT IS DECIDED THAT ORGANS AND/OR TISSUE COULD BE RETRIEVED BY SOMEONE ACTING UNDER THE DIRECTION OF A REGISTERED MEDICAL PRACTITIONER?
Unfortunately this question appeared to confuse many respondents who seemed to read it as referring to whether someone acting under the direction of registered medical practitioner should be allowed to retrieve organs and tissue. Because of this it is difficult to draw firm recommendations from the responses with any confidence.
6.4 RETRIEVAL OF ORGANS/TISSUES BY DIFFERENT PERSONNEL
The consultation stated:
Section 1(4A) of the 1961 Act allows eyes, or parts of eyes to be removed by a registered medical practitioner or a person in the employment of a Health Board or NHS Trust acting under the direction of a registered medical practitioner. The legislation proposed for the rest of the UK will not carry forward this restriction, on the grounds that there is no technical necessity for the removal of organs or tissue always to be carried out by a medical practitioner and that removal could be done by another suitably qualified person, such as a tissue bank technician.
In relation to the retrieval of organs for transplantation, such a change might appear to sit oddly with the backing which the Scottish Transplant Group and NHS Quality Improvement Scotland have given to the development of a single national organ retrieval team. The raison d'etre for such a team is that the quality of retrieved organs requires specialised surgical skills, since the better the quality of the organs retrieved, the better the outcomes are likely to be for the recipients. These considerations might suggest that organ retrieval should continue to be done by a registered medical practitioner. It could also undermine confidence in the transplantation process if the new legislation allowed this procedure to be undertaken by someone other than a registered medical practitioner.
On the other hand, it is possible that a member of theatre staff, trained to a very high level, could, under supervision, remove organs. This would help to address the implications for retrieval teams of the EU Working Times Directive. The change in the legislation for the rest of the UK could also lead to circumstances in which, for example, a retrieval team from England, including non-doctors, might be sent to retrieve organs in Scotland because no-one in Scotland was available to do so. It would seem sensible that the Scottish legislation should allow for this eventuality, rather than run the risk of organs not being retrieved because the law in Scotland had not been changed to allow non-doctors to retrieve organs.
The consultation asked:
SHOULD THE NEW LEGISLATION IN SCOTLAND ALLOW FOR THE RETRIEVAL OF ORGANS UNDER THE SUPERVISION OF A REGISTERED MEDICAL PRACTITIONER?
Fifty four responses contained commentary of relevance to this issue with 51 providing a clear recommendation. Of these a large majority (80%) of respondents favoured the new legislation allowing for the retrieval of organs under the supervision of a registered medical practitioner. Overall, 20% of those who provided a clear view were against the proposition. An additional two responses provided both support and opposition (28 NHS/Med, 31 NHS/Med). One further respondent requested further clarification on whether the question referred to supervision involving the actual physical presence of the registered medical practitioner (41 NHS/Med).
A few of the respondents who supported such retrieval of organs added qualifications to their recommendation:
Only if the person undertaking the retrieval was suitably qualified (24 Prof Rep, 45 NHS/Med, 55 NHS/Med)
Only in exceptional circumstances (23 Faith)
Only if there were nationally defined and assessed competencies for undertaking such procedures (56 NHS/Med)
Two main arguments were put forward in support of permitting the retrieval of organs under the supervision of a registered medical practitioner. These comprised the maintenance of consistency with the rest of the UK (25 Educ, 34 Pub Rep, 36 Indiv, 50 Legal); and to facilitate flexibility and to maximise every opportunity to use available organs (39 NHS/Med, 59 Indiv).
Some of the respondents opposing the proposition provided rationale to support their view. One key concern was to ensure that public confidence in the system was not damaged. It was the opinion of a small minority of respondents that retrieval of organs by personnel other than a registered medical practitioner may risk this (2 Prof Rep, 10 Educ, 29 Acad).
A further argument highlighted the skill required to undertake effective retrievals and stressed that the life and death of the recipient should not rest on the retrieval of organs by personnel other than a surgeon (11 Indiv, 19 Educ).
One respondent emphasised their support for the establishment of a national organ retrieval team and described apparently successful Spanish experience of such a system (47 Educ).
The consultation stated:
In relation to the retrieval of tissue, tendons and other tissues are currently retrieved by specialists such as orthopaedic surgeons, plastic surgeons and pathologists. As there are no technical factors equivalent to those in the organ retrieval context, such retrieval could be undertaken by non-medical teams, provided they were adequately trained and under the supervision of a registered medical practitioner. The new legislation should therefore not stand in the way of such a development.
The consultation asked:
SHOULD THE NEW LEGISLATION IN SCOTLAND ALLOW FOR RETRIEVAL OF TISSUE UNDER THE SUPERVISION OF A REGISTERED MEDICAL PRACTITIONER?
Fifty-four responses contained limited commentary of relevance to the issue with 53 of these providing a clear recommendation. The overwhelming view (94%) was in favour of the proposition with only a small minority of respondents (6%) in opposition.
Once again, a few of those in favour qualified their support by emphasising that, for example, any non-medical teams involved should be suitably qualified for the task (60 Indiv). One comment was that such legislation should be accompanied by an increase in the number of staff employed in Tissue Banking (41 NHS/Med). A few of those respondents who had opposed the involvement of non-doctors in the retrieval of organs, expressed their support of involving non-doctors in the retrieval of tissues on account of the latter's lesser technical component (19 Educ, 41 NHS/Med). One respondent fully supported the proposition and indeed suggested that it should go further with the establishment of specialist retrieval technicians and permission to operate without the need for supervision (62 Indiv).
Again, concern for preserving public confidence in the system underpinned the limited opposition to the proposal (2 Prof Rep).
6.5 PRESERVATION FOR TRANSPLANTATION
The consultation stated:
The new legislation for the rest of the UK will make clear that it is lawful for the person in charge of a hospital, nursing home or other institution to preserve a body or part of a body so that transplantation can take place. In doing so, the person concerned must take the minimum steps necessary and use the least invasive procedure. This provision is designed to deal with the need to consult those closest to the potential donor to make sure, as far as possible, that there is no reason why donation may be inadvisable. In some circumstances, such as after an accident, it may take some time to contact relatives. If steps are not taken to preserve the organ, the possibility of donation may be lost. The Scottish legislation should include a similar provision. It has the additional advantage of helping to raise public awareness about the possibility of such steps being taken after death, which means that relatives may be better prepared when they are approached.
The consultation asked:
IS THERE GENERAL SUPPORT FOR THE PROPOSAL THAT THE NEW LEGISLATION SHOULD INCLUDE A PROVISION TO PUT BEYOND DOUBT THE LEGALITY OF TAKING THE MINIMUM ACTION NECESSARY TO PRESERVE A BODY SO THAT CONSULTATION ON TRANSPLANTATION CAN TAKE PLACE?
Almost all respondents (57) addressed this question with 55 providing a clear recommendation. Of these, all but 2 (96%) supported the proposal.
One recurring theme was what some saw as the need for further public consultation on the issue (2 Prof Rep, 10 Educ, 26 Acad). Another was for further clarification on what comprised "minimum action" and "least invasive procedures" (41 NHS/Med, 56 NHS/Med).
A few respondents supported the provision's inclusion in new legislation but emphasised that there needed to be clarity on the difference between the proposal and the practice known as "elective ventilation" (8 Indiv, 19 Educ, 28 NHS/Med, 31 NHS/Med). Another request was for the provision to be time limited in order to protect the deceased and the " emotional sensitivity" of the surviving family and friends (1 Indiv, 3 Indiv).
Reasons provided in favour of the proposal comprised:
To clarify and legalise existing practice (11 Indiv - " as at present transplant teams are working in un-chartered territory"
To safeguard those involved in such practice (33 Pub Rep, 37 NHS/Med)
To increase the number of donated organs (30 Prof Rep)
To help to facilitate the wishes of the deceased (30 Prof Rep)
To bring in line with E&W legislation (18 Indiv)
One dissenting voice considered that legislation may not be appropriate on account of the changing technical definitions involved which, it was argued, would be better dealt with by Regulations rather than primary legislation (44 Acad).
6.6 "REQUIRED REQUEST"
The consultation stated:
At present it is at the discretion of the medical staff whether to approach the family to discuss organ and tissue donation. Families who are not approached may feel that they are denied the right to make a decision about organ donation. In the USA, it is the law that a request for organ donation must be made, in appropriate circumstances, after death. This is known as "required request", and means that staff in intensive care environments must always approach the family about organ donation when medical treatment has stopped and death has been confirmed by brain stem tests. It has been argued that such an approach encourages more positive attitudes within the NHS by taking away the feeling that complying with a request for organ donation should be done as a favour to the transplant unit. It emphasises that it is the right of the individual that the possibility of organ donation should be considered, and is consistent with an approach based on authorisation.
The consultation asked:
SHOULD NEW LEGISLATION IN SCOTLAND MAKE PROVISION FOR "REQUIRED REQUEST"?
Overall, 54 responses addressed this issue, with 80% favouring the proposal and 19% opposing. One respondent suggested that the proposal be "considered".
Of those supporting the proposition, several added qualifications to their recommendation. The most commonly raised concern was that staff would need to be suitably trained to make the request in a sensitive and sympathetic manner (20 Pub Rep, 21 Indiv, 47 Educ). It was suggested that a senior member of the transplant team be best placed to undertake this task (8 Indiv) or a transplant co-ordinator (10 Educ).
Others agreed to required requests in cases where the deceased had not given their authorisation (1 Indiv, 3 Indiv, 9 Indiv) and it was stressed that, even with the system in place, potential donors should still be encouraged to make their wishes known (2 Prof Rep).
Respondents emphasised that prior to the introduction of the provision, people would need to be made aware of the legislation (32 Prof Rep, 52 Acad) and associated resource issues addressed (29 Acad).
A few commentators highlighted that support from relevant healthcare professionals would be a pre-requisite (28 NHS/Med, 31 Prof Rep) with one suggestion that discussions with the Intensive Care Society are undertaken prior to introducing the provision (25 Educ).
One respondent urged that the provision be applied fairly and consistently (11 Indiv) with another stressing that they supported the proposal only if it produced a significant increase in donation rates (44 Acad).
Reasons for Supporting the Proposal
Respondents provided a number of reasons to support their recommendation in favour of the proposal:
Potential for an increase in donation rates (8 Indiv, 27 Educ, 41 NHS/Med, 55 NHS/Med)
Encourages NHS positive attitudes (20 Pub Rep, 43 Prof Rep, 52 Educ)
Reduces the perception amongst the public that they have been singled out (22 Acad, 41 NHS/Med)
Encourages a change in culture (27 Educ)
Encourages family discussion/raises awareness of donation (6 Indiv)
Makes the public better prepared when they are approached (6 Indiv)
Allows families to contribute in reactive fashion as they will be too distressed to be pro-active in suggesting donation (13 Indiv)
Reasons for Opposing the Proposal
A number of reasons were provided to explain respondents' opposition to the proposal:
Judgement is required in individual cases rather than a blanket approach, e.g. a donation may not be clinically worthwhile (26 Acad, 30 Prof Rep, 40 Educ)
Should rely on good medical practice and not legislation (16 Indiv, 49 Legal)
Appears to confuse the right of the deceased to authorise donation (30 Prof Rep)
May give families the impression that NHS trying to get "tick in the box" (30 Prof Rep)
Will require a system of penalties for non-compliance (37 NHS/Med)
No evidence that will increase the donation rate (37 NHS/Med)
Not in favour unless very strong evidence that has increased the donation rate (46 Indiv)
6.7 OTHER MISCELLANEOUS ISSUES
In the course of responding to the issues highlighted in the consultation, a few respondents submitted detailed comments on points of drafting of the paper. Others made more general comments about issues relating to those highlighted. A list of those responses containing more detailed drafting comments and comments extracted from the responses which addressed other issues are documented in Annex 3.
SUMMARY POINTS
Almost three-quarters (71%) of those who commented were opposed to the application of penalties in the context of cadaveric organ and tissue retrieval
A recurring theme was that there are already adequate systems in place to ensure appropriate standards of practice are upheld
Consistency with the rest of the UK was a common reason for favouring penalties
Around two-thirds (63%) of those who commented recommended that some or all of the functions of the Human Tissue Authority should be extended to Scotland
Again, consistency with the rest of the UK was a dominating reason for extension of functions of the Human Tissue Authority to Scotland
The majority view (64%) was for changing the previous legislative provision so that rather than repeating brain stem death tests, doctors removing organs should have to satisfy themselves that the tests had been performed satisfactorily
A common view was that requiring doctors to undertake brain stem death tests and retrieval functions would place them in a position of conflicting interests
A large majority (80%) of those who commented favoured the new legislation permitting the retrieval of organs under the supervision of a registered medical practitioner
Two main reasons for supporting this proposition were to maintain consistency with the rest of the UK and to maximise every opportunity to use available organs
The vast majority (94%) of those who commented favoured the new legislation permitting the retrieval of tissues under the supervision of a registered medical practitioner
Almost all (96%) of those who provided a view supported the proposal that the new legislation should include a provision to put beyond doubt the legality of taking the minimum action necessary to preserve a body so that consultation on transplantation can take place
80% of those who commented favoured the proposal for new legislation in Scotland to make provision for "required request"
The introduction of "required request" was seen by many as likely to increase the rate of donation and encourage NHS positive attitudes towards donation
However, some held the view that a "blanket approach" may not always be appropriate and good medical practice and judgement on a case by case basis should prevail instead