Proposed Legislative Competence Orders relating to Organ Donation and Cycle Paths - Welsh Affairs Committee Contents


Written evidence submitted by the Human Tissue Authority (HTA)

  • The Human Tissue Authority (HTA) welcomes the opportunity to make this submission to the Welsh Affairs Committee (WAC).
  • We have addressed those matters which are linked to the Human Tissue Act 2004 and within our remit. We have clearly indicated which of the questions posed by the WAC we have responded to.
  • Issues not addressed in the questions, but which we believe are significant and would aid the pre-legislative scrutiny process, are detailed in the Additional Considerations section at the end of this document.
    • The key points to note are:
    • No compelling evidence has been presented to demonstrate the move to an opt-out system in Wales will increase the number of organs available for transplantation.
    • There is a risk of public uncertainty as to whether or not an individual is affected by the opt-out system.
    • There is a risk that the "wrong" sort of consent is taken, which could lead to surgeons committing an offence under the Human Tissue Act.

Question 4—To what extent is there a demand for legislation on the matter(s) in question?

1.  There is little, if any, convincing data provided which suggests that there is demand for legislation on an opt-out organ donation scheme from the Welsh population. There is however, a growing demand for organs with people dying each day waiting for a transplant. Efforts to increase organ donation should be encouraged, but such a significant change to the consent process should only be considered in the light of compelling evidence.

2.  The memorandum quotes statistics from a number of research projects, indicating that the majority of people support organ donation. A commonly quoted statistic is that over 90% of people support organ donation, while only 28%[51] have signed the Organ Donor Register (ODR).

3.  It is of value to look a little further at the statistical evidence available. A recent HTA survey, conducted on our behalf by Ipsos MORI, found that 62% of people surveyed were either fairly likely, very likely, or certain to donate their tissue or organs for use in transplantation after their death. 25% of people were either fairly unlikely, very unlikely of certain not to.[52] With at least a quarter of those surveyed expressing an unwillingness to donate (a further 6% did not know how they felt on this issue) a move to presuming consent would appear premature.

4.  It should be noted that the responses to the Ipsos MORI survey were given with the current opt-in system in operation. Many of the concerns that people express when the issue of an opt-out system is discussed were unlikely to be at the front of their minds when responding.

5.  Spain is often cited as an example of a country which has both an opt-out system and high rates of deceased donation. The opt-out system was introduced in 1979, however the significant increase in donation rates took place during the 1990s. The director of the national transplant organisation in Spain was clear that the increase was not linked to the introduction of the opt-out scheme, but was likely to be linked to the implementation of a comprehensive national procurement system.[53] A number of the recommendations of the Organ Donation Taskforce were based on the successful system which operates in Spain.

6.  Not all countries which have an opt-out system in place have high rates of donation. Greece is an example of a European country where citizens are presumed to consent to organ donation, but the rates of deceased donation are low at 8.9 people per million, compared to 14.7 people per million in the UK.[54]

7.  The results of the Welsh Assembly Government's public debate on organ donation, held between October 2008 and January 2009, point towards the most popular organ donation system being that of mandated choice with support from 27% of respondents, with an opt-out scheme garnering 22% support. This is a clear indication that there is a desire of respondents to be able to make a positive choice, and for there to be compulsion to make a decision either way. Without substantive evidence that an opt-out scheme will increase the number of organs available in Wales, and having consulted on this issue, the case does not seem to be made to introduce anything except the most popular alternative to the status quo, which is mandated choice.

8.  Only 316 people expressed a preference for an alternative organ donation scheme, so the 22% who support the introduction of an opt-out scheme represents just 69 people. This small sample size means that there can be less certainty as to the proportion of the entire Welsh population who would support the proposal.

9.  The memorandum which accompanies the proposed LCO explains that the aim of the National Assembly for Wales is to increase the number of organs available for transplantation. No clear evidence is presented that the implementation of an opt-out scheme in Wales would do this.

10.  There is undoubtedly, however, a need for more organs to be made available. Across the UK three people a day die waiting for an organ;[55] this data only includes those who were on a waiting list at the time they died, and not those who under current listing criteria are not deemed suitable. The opt-out scheme proposed has not been found to conclusively increase the number of available organs, without such evidence a move away from the implementation and delivery of the recommendations of the Organ Donation Taskforce and the work of the Programme Delivery Board would seem premature. There are significant risks in moving from one system which is yielding results to another which is unproven and which will incur significant costs during implementation.

11.  The Ipsos MORI research also showed that those surveyed were more likely to donate when they knew regulation was in place. 52% of those surveyed stated they would be more confident to donate an organ or organs if they knew the system was regulated. This evidence suggests that ensuring the public are aware of the regulatory framework brings confidence in donation and is an important consideration when seeking to raise donation rates. It is likely to be more difficult to communicate the regulatory framework when consent is no longer a positive act, but rather indicated by silence.

Question 5—Are there any cross-border issues relating to the LCO? (eg financial or policy issues); and

Question 11—Does the LCO have the potential to cause confusion regarding legal jurisdiction and the individuals to whom any Measure would apply

12.  This LCO introduces both cross-border issues and potential confusion. We have addressed questions five and eleven together.

13.  The HTA is the statutory regulator responsible for ensuring that organs and tissue are only removed for transplantation with consent in England, Wales and Northern Ireland. While we do not have jurisdiction over this matter in Scotland, it should be noted that the organ donation system is consistent, with all four home nations operating an opt-in system.

14.  The ODR which is run and maintained by NHS Blood and Transplant (NHSBT) covers England, Scotland, Wales and Northern Ireland. Specialist Nurses for Organ Donation (SN-ODs) currently consult the ODR when they are informed there may be a suitable donor at their Trust. The information as to whether the person had signed the ODR or not, and any specific choices they have made, is shared with their family and friends to give them an indication of the person's wishes.

15.  Under the opt-out system proposed by the National Assembly for Wales it would be necessary for a separate, additional register to be kept of those people subject to the system (those over 18, who live and die in Wales, who are competent). The introduction and maintenance of such a register would be at a cost drawn from public funds. SN-ODs would need to consult this register to establish whether they would be applying the Welsh system or not. If the potential donor was not on this list then the SN-OD would be seeking consent under the Human Tissue Act.

16.  The Citizen Information Project, commissioned in 2004, established that the cost of a national population register would be in the region of £2.4 billion. Although the register of those affected by the proposal would be smaller, it should be noted that previous feasibility studies have found such registers to be costly and difficult to form and maintain.

17.  SN-ODs are employed and trained by NHSBT. It will be necessary to train all SN-ODs on all systems, so that they are all available to work in Wales and the rest of the UK, and can explain the differences between the two systems to a family if required.

18.  It is not clear from the information made available by the National Assembly for Wales how the capacity of the person before their death would be assessed. The proposal states that the opt-out system would not apply to those who lacked capacity prior to their death, rather this group of people would come under the jurisdiction of the Human Tissue Act. It would be possible to keep a register of those people ordinarily resident in Wales who permanently lack capacity, however it would be a much more difficult task for those whose lack of capacity is temporary. More information is required to fully assess this aspect of the scheme, however it is an area where confusion may arise as to which system of consent is to be applied.

19.  Under the Human Tissue Act it is an offence for a reward to be offered or sought for an organ.[56] It is unclear if the consent requirements of the Act were to no longer apply in Wales, whether the scrutiny of the activity of donation, and the offences associated with it, would still be the responsibility of the HTA. Any separation of these responsibilities is likely to cause confusion and increase bureaucracy.

20.  There will be the need for a communication campaign alerting people to the introduction of the new scheme. This will need to cover both Wales and England, with consideration given as to whether it should also be extended to Scotland and Northern Ireland. The primary purpose of this campaign in Wales will be to alert residents to the changes and provide them with information on how to opt-out, as well as the benefits of remaining opted-in. In England it will need to focus on explaining that those who are not ordinarily resident in Wales will not be affected by it, meaning that there is no need to opt-out in case you die in Wales, and do not wish your consent to be presumed.

21.  This communication campaign will have two very different aims and will be of significant cost. In 2008 the Organ Donation Taskforce identified the cost of a three year, UK-wide, communications campaign to be £25 million.[57] While the scale of the campaign under the proposed scheme would be smaller, it would clearly still cost millions rather than thousands of pounds.

22.  The potential for confusion is considerable, and special attention will need to be given to communicating with those living in the English towns and villages which border Wales. The HTA believes that there will be a relatively high number of incidences of people seeking to establish whether or not they are on the list and consideration will need to given to how people are informed of this, and how requests for information will be dealt with.

23.  There is a risk of the wrong system being applied. If the opt-out scheme is relied on for a person who in fact is subject to Human Tissue Act consent, then the surgeon who removes the organ or organs will have committed an offence.[58] Surgeons will need to ensure they have suitable professional and legal indemnity in place in case of mistake. If such an error was made the HTA would be required to refer the case to the Crown Prosecution Service (CPS) for consideration.

24.  If the primary aim is to increase organ donation by ensuring families are aware of the potential donor's wishes, and therefore increasing their likelihood to consent, then this could be done more economically with increased promotion of the ODR and full implementation of the recommendations of the Organ Donation Taskforce. This would also have the benefit of not creating any cross-border issues.

25.  In the absence of an impact assessment it is not clear how much the National Assembly for Wales expect this change will cost, however it would certainly require significant investment. If there was a guarantee that more organs would be made available, and less people would require dialysis, and those that do for a shorter period of time, then this may be seen as a proportionate step. However, in the absence of such evidence an increase in spend on the proposed scheme does not appear to be justified.

26.  It should also be noted that at present when consent is sought for organ donation, it is normally also sought for research. As research would remain a Human Tissue Act issue in Wales the family would be required to actively consent to this, potentially introducing confusion at an emotional time.

27.  There are also occasions when consent is sought to procure tissue for use in human application. This activity is governed by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and requires Human Tissue Act consent to be in place prior to the procurement.

Question 6—Are the purpose and scope of the LCO clearly defined, including the terms and definitions used?

28.  Broadly the purpose and scope of the LCO are clearly defined. The HTA has only one area of concern which is addressed below.

29.  The proposed LCO seeks to make consent or any other authorisation a matter for the Welsh Assembly Government. There is no definition of any other authorisation given in either the Order itself or the memorandum which accompanies it. We assume that this is to allow the introduction of the opt-out system detailed, however it is important that the precise intention of this form of words is shared as a matter of priority, to ensure that pre-legislative scrutiny is as robust as possible.

30.  We note that a Report of the National Assembly for Wales Legislation Committee No. 1 recommends that the term "or other authorisation" is "deleted or replaced by another form of words that more clearly describes the powers that the Welsh Government is seeking to acquire".[59] The HTA welcomes this recommendation and awaits the outcome with interest.

Question 7—Does the LCO have the potential to increase the regulatory burden on the private or public sector?

31.  The LCO has the potential to increase the regulatory burden to the public sector, and has limited potential to reduce it.

32.  There is no existing requirement that a register of potential donors is kept. While the ODR is both a record of people's wishes and a tool for the promotion of organ donation, it is not a statutory requirement.

33.  It will be necessary under the proposed system to maintain a register of people ordinarily resident in Wales, and record whether they have opted-out. This will need to be a dynamic and robust register which takes the recommendations of the Review of the Organ Donor Register conducted by Sir Gordon Duff[60] and implements them from the outset. This will impose an additional regulatory burden on the public sector.

34.  The National Assembly for Wales has the benefit of the recommendations and guidance contained in Sir Gordon's report and should seek to apply them where applicable.

35.  A standardised form is used in all hospitals in the UK to record the consent of the donor or their family and friends to donation, and in some cases research. It is unclear whether the National Assembly for Wales intends to continue the use of this form, or another one similar to it, or whether this requirement would be removed. In the case of removal this would reduce the regulatory burden. It would still be necessary however, to take details of the donor's medical and social history to ensure the quality and safety of the organ/s and/or tissue. This is currently standard practice and a requirement of the EU Organ Donation Directive which will be operational in the UK by August 2012. Therefore the removal of the need for a consent form to be filled in may not of itself significantly reduce the regulatory burden.

36.  As noted in paragraph 17, NHSBT will require their SN-ODs to be trained on both the Welsh system and that which applies in the rest of the UK, increasing the regulatory burden on a public sector organisation.

ADDITIONAL CONSIDERATIONS

37.  No mention is made in the memorandum of the effect of an individual's decision to opt-out during life. Would their family members still be approached to establish whether they will consent to organ donation (under the Human Tissue Act) or will the decision to be opt-out be taken as a definite and enduring "no"? It is important that this is made clear as a matter of priority to allow full consultation of the practical implications of this LCO.

38.  When an individual signs the ODR they are able to choose whether they wish to donate all of their organs, or to select a specific organ or organs. It is not clear whether the proposed system will allow for this level of flexibility, eg could you opt-out for certain organs, but remain opted-in for others?

39.  There is no information given on whether those affected by the proposed system will still be able to sign the ODR to express their wishes positively, and whether this will be checked as a matter of course as it is at the moment. There may be occasions where the two records are conflicting with the ODR showing a wish to donate, while the Welsh register shows a decision to opt-out. More information is needed in the relative status of the two registers.

40.  As noted above it would be the surgeon who would commit an offence if the absence of opting-out is relied on, when Human Tissue Act consent should have been. In light of this it will be necessary to communicate with this group specifically if the proposed system were to be introduced, and there would be value in engaging with this group to fully explore practical issues prior to implementation.

41.  The Human Tissue Act will need to be amended to introduce the proposed measure in Wales and a suitable legislative vehicle for this will have to be identified.

February 2011



51   http://www.organdonation.nhs.uk/ukt/default.jsp - 22 February 2011 Back

52   http://www.hta.gov.uk/_db/_documents/HTA_General_Public__report_FINAL_221010.doc  Back

53   http://www.organdonation.nhs.uk/ukt/newsroom/statements_and_stances/statements/opt_in_or_out.jsp  Back

54   2008 statistics-Committee of Experts on the Organisational Aspects if Co-operation in Organ Transplantation Back

55   http://www.organdonation.nhs.uk/ukt/default.jsp-22 February 2011 Back

56   s.32(1) Back

57   http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_090310.pdf Back

58   s.5(1) Back

59   http://www.assemblywales.org/cr-ld8395-e.pdf Back

60   http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_120579.pdf Back


 
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