Bioethics Council submission on the Human Tissue Bill

March 2007

Introduction

1. This submission is from Toi te Taiao: the Bioethics Council, PO Box 10362, Wellington. The contact person is John Pennington, Executive Officer, the Bioethics Council Secretariat, (04) 916-7673, PO Box 10362, Wellington.
2. Dr Marie Bismark wishes to appear before the Committee. Dr Bismark is a member of the Bioethics Council, phone (04) 462 0401.
3. Dr Waiora Port, member of the Bioethics Council and Dr Martin Wilkinson, Chair of the Bioethics Council also wish to appear in support of this submission, subject to their availability.
4. Toi te Taiao: the Bioethics Council was established by the New Zealand Government in 2002 as a ministerial advisory committee. The Council consists of 10 members and is chaired by Dr Martin Wilkinson. The Council’s Terms of Reference are based on recommendations made by the Royal Commission on Genetic Modification in 2001. The key responsibilities of the Council are to:
   • Provide independent advice to Government on biotechnological issues involving significant cultural, ethical and spiritual dimensions;
   • Promote and participate in public dialogue on cultural, ethical and spiritual aspects of biotechnology, and enable public participation in the Council’s activities; and
   • Provide information on the cultural, ethical and spiritual aspects of biotechnology.
5. This submission has the support of the Council and its secretariat. During the preparation of this submission, individual Council members consulted with members of their communities. The Council’s views are also informed by dialogue events conducted with members of the public in relation to various issues in biotechnology.

General Points

6. The Council believes that the use of human tissue for transplantation and research raises cultural, ethical and spiritual questions, which are of significant interest to the public.
7. The Council recognises that the use of human tissue in treatment and research can do much good. The Council also recognises that New Zealand currently faces a shortage of organ donors, which is likely to become worse with rising rates of obesity and diabetes.
8. The Council supports further public dialogue on some of the fundamental issues underlying this legislation, such as the meaning of death, and cultural beliefs relating to organ donation. The Council considers that such dialogue would allow people to deepen their understanding of the issues in this area, and enhance their confidence that their views have been heard and respected.
9. The Council is concerned that the Ministry of Health consultation process largely involved stakeholders. The list of attendees and submitters on the Ministry of Health submission document suggests that little genuine public engagement has been undertaken.  The Council considers that organ donation and research using human tissue require the willing participation of the public, which is best achieved through a participatory process. The Council is pleased to note that the Ministry of Health is about to undertake focus groups to provide data to support initiatives aimed at maximising organ and tissue donation from deceased donors. It questions why this research was not undertaken prior to the development of the Human Tissue Bill.
10. This submission refers only to the contents of the Human Tissue Bill. The Bioethics Council notes that further work is required to develop regulations and standards. The Council notes that human embryonic stem cells are largely unregulated, other than in clause 6. In light of this and, in particular, clause 76(3) which states that the standards must include requirements for ethical approval of all research using human tissue, the Bioethics Council would like the opportunity to comment further on these standards and regulations as they are being developed.
11. The Council supports the purpose of the Bill in clause 3: “to ensure that collection and use of human tissue occurs only with proper recognition of and respect for the autonomy and dignity of the individual from whom, or from whose body, the tissue is collected.” The Council also considers the cultural and spiritual needs of the family or loved ones of the dead person are important.

Consent

12. The Council supports the development of a consent framework for the collection and use of tissue from bodies. It notes that Clause 45 provides that if consent is given by the deceased or the nominee, this consent may be acted upon even if there is objection from the family or the person lawfully in possession of the body. The Council notes that this consent does not make collection mandatory. The Council supports this provision as there may be clinical or other reasons not to collect the tissue.
13. The Council suggests that the concept of “appropriate consent” be replaced with “informed consent”. The Council considers that “informed consent” is a well understood concept with an established meaning in medical law and practice in New Zealand. For example, The Code of Health and Disability Services Consumers' Rights, Right 7, refers to the right to make an informed choice and give informed consent.
14. The three key elements of informed consent are that the patient must be competent, must be sufficiently informed, and the decision must be voluntary. The Council recommends that the definition of informed consent in clause 7 should be redrafted to incorporate all three of these elements.
15. It is the Council’s view that the consent framework as set out in the Bill is unsatisfactory. In particular, the Council notes the following concerns:
1. Clarity
   1. The consent framework is ambiguous and unclear. For example, the expression “declines to give consent” in clause 31 could be interpreted as including either persons who refused consent, or persons who took no action at all, or persons who did not want to make a decision. Alternatively, it could include all three of these circumstances. The Council considers that this ambiguity should be resolved by clearer drafting.
   2. The Council believes that the expression “if no consent can be given” in clause 28 is ambiguous and could be interpreted in two mutually contradictory ways. The first interpretation is that if the individual was able to give consent (competent) and had either refused consent or done nothing, then, as consent could have been given but was not, the subsequent sub clauses will not apply and the organs or tissue will not be able to be collected. As most people do not give consent or appoint a nominee prior to death, this interpretation would result in very few body parts being collected. An alternative interpretation is that this phrase means “if no consent was given.” If the second interpretation is intended, the Council has the following further concerns about the resultant framework:
2. Veto
   1. Unlike the existing Human Tissue Act 1964, there is no provision to ensure that a veto (refusal) by the donor prior to death will be respected. If a majority of the family or a senior family member consents, the Bill appears to allow such consent to override the donor’s refusal prior to death.  This outcome is contrary to the purpose of the Bill, in particular the focus on the autonomy of the individual in clause 3. The Council believes that this is undesirable and that an expressed refusal by the donor should be respected.
   2. It is unclear whether clause 41 means that a veto put on the organ register would prevent use of the body, as “other donor information” as defined does not include a refusal. The Council believes that the National Organ Register should provide for the registration of refusals. Additionally, the donor should be able to specify limits to donation, such as consent to the collection of some organs or tissues but not others. The donor should also be able to specify selected recipients, such as family members, as living donors are able to do. The Bill should provide that such limitations or restrictions must be respected.
   3. Clause 31 provides that consent from family members is required for secondary use after the donor’s death. The Bill makes no provision for the donor to consent to, or veto, secondary use of tissues prior to his or her death, The Council considers that if a person specified that he or she would not want tissue to be used for secondary purposes after death, that view should be respected.
   4. The Council notes that when the Ministry of Health consulted about the proposal to remove the donor’s ability to veto the collection of organs, the response was: “Families should not be able to override a person’s wish not to donate” (see page 26 of the submission summary, question 12).
   5. The Bioethics Council considers that a refusal to donate organs or tissue should be respected so long as the person made an informed choice. If circumstances have materially changed since the person expressed his or her preference it may be justifiable to allow the family to override the deceased’s decision, because the choice was not reasonably informed.
3. Complexity
   1. The consent framework proposed is complicated and confusing. In light of the criminal sanctions in the Bill, it is important that all parties are able to readily understand their obligations.
   2. The proposed complex consent regime could result in delays so that the organs would be unable to be used for transplantation, or else the donor’s dying would be unnecessarily extended, with the person maintained on life support, while consent was sought.
   3. Clause 33 requires the family member proposing to give informed consent to identify those people who fall within the definition of immediate family and consult with members representing all the different interests in the family. The family member must believe on reasonable grounds that if all members were individually consulted, a majority would agree with the collection and use. The Council is concerned that this requirement does not clarify which relatives must be consulted and places an onerous obligation on the family member concerned.

Family conflict

16. The Council recognises that there are advantages and disadvantages from defining the family. If “immediate family” is to be legislatively defined, the definition should be as clear and straightforward as possible. The Council is concerned by some aspects of the Bill’s definition of “immediate family”. In particular:
    1. The meaning of “close relationship” is unclear as this could refer either to genetic relatedness or emotional closeness.
    2. The definition could include distant relatives if they were in a “close relationship” with the person or had responsibility for the person’s welfare and best interests in accordance with the customs and traditions of the individual’s community.
    3. The inclusion of part (b) appears to result in certain relatives forming part of the immediate family even if they are estranged from the donor. If a definition of immediate family is retained in the Bill, it is Council’s view that part (b) of the definition should either be clarified or deleted.
17. The Council considers the reference in clause 33 to a majority of members of the immediate family is undesirable for the following reasons:
    1. Majority voting is contrary to the decision making process within most families,
    2. Majority voting is inconsistent with the Bill’s stated intention of seeking to achieve a consensus (page 3 of the Explanatory Note).
    3. This is likely to lead to family disputes at an emotionally distressing time, particularly as many New Zealand families have family members from different cultural backgrounds or encompassing a variety of world views.
    4. As a senior available next of kin may override any refusal, the family may have undertaken a distressing process, involving family conflict, to no purpose.
18. It is the Council’s view that the consent regime for donation, in cases where the individual has not made his or her wishes known or appointed a nominee, should be simplified. The Council recommends either a priority list of decision makers, as in the United Kingdom Human Tissue Act 2004, or that the Bill should retain the status quo in the Human Tissue Act 1964.

Nominee

19. The Council supports the view that people should be encouraged to discuss their wishes with those close to them and that the appointment of a nominee to act on their behalf could give them confidence that their wishes will be carried out.
20. However, the Bill is silent as to the role of the nominee. That person might be a proxy for the deceased and thus make the decisions wanted by the deceased or, alternatively, decision-making may be delegated to the nominee, so the nominee could decide in accord with his or her own preferences. The Council considers that the role of the nominee should be clarified in the Bill.
21. Clause 32 (3) says that a nomination may be disregarded if no one is able to give consent under it. If a competent nominee refuses consent then they were “able”. It is unclear whether this clause refers to a situation where the nominee is incompetent or unable to be found or whether it refers to a nominee refusing to give consent. The Council considers that a nominee should be able to effectively refuse consent as should the donor themselves, as discussed above.
22. Medical procedures may be necessary while a prospective organ donor is on life support, to enable the subsequent collection and use of organs or tissue. The donor is likely to be unable to give informed consent to these. Consequently, the Council considers that the nominee’s decision-making authority should come into effect at the point of irreversible incompetence, rather than death. Such a change would require clarification of the respective roles of the nominee and an enduring power of attorney (though in practice, it is likely that frequently the same person would be appointed to both roles).

Children

23. At common law, children have the right to consent to any medical treatment once they have attained sufficient maturity and understanding to weigh the risks and benefits of any proposed treatment and to make an informed decision: see Gillick v West Norfolk and Wisbech Area Health Authority [1986] AC 112; [1985] 3 All ER 402 (HL). The common law only applies when there is no statutory provision to the contrary.
24. The House of Lords in Gillick held that the ability of a particular child to give an effective consent to medical treatment was dependent on that child’s capacity, not on attaining some fixed chronological age. It held that the parental right to control a minor child’s upbringing derives from parental duty and is a dwindling right, which exists only in so far as parental control is required for the benefit and protection of the child.
25. This view is supported by the Code of Health and Disability Services Consumers’ Rights which provides that, regardless of age, every consumer must be presumed competent to make an informed choice and give informed consent (Right 7(2)). Where a consumer has diminished competence, that consumer retains the right to make informed choices and give informed consent, to the extent appropriate to his or her level of competence (Right 7(3)).
26. In the Human Tissue Bill, clause 43, the approach set out in Gillick and the Code of Rights is not followed and a child’s capacity is based solely on his or her age. A child under 16 can consent to the collection or use of tissue not for treatment to be used for purposes such as genetic testing- but they cannot consent to anything else under the Act (clause 37), apparently because it is difficult to decide after death whether a child had been competent.
27. The Council is of the view that similar issues might arise if an adult was incompetent prior to death, and is not persuaded that this is an adequate reason for depriving children with the necessary competence of the right to make an informed choice regarding organ donation. Council is of the view that many 14 and 15 year olds would have the maturity and understanding necessary to make an informed choice regarding organ donation, and can see no good reason to deprive them of this right.
28. If it was known prior to a child’s death that a child was Gillick competent, the Council considers that the child should be able to decide the disposition and use of his or her body after death. If the child was under the age of 16 and either incompetent or it is not possible to determine whether or not the child was competent then, in line with the Care of Children Act 2004, the child’s parents or guardians should be the proxy decision makers.

Research

29. The Bill provides that human tissue can be used for research without consent with ethics committee approval (clause 22 and 23) even if the ethics committee knows that informed consent has not been given and would not be given for the research.
30. The Council is of the view that if it is known that the donor would oppose such use of tissue, the ethics committee should not be able to approve the unconsented use of human tissue for research. At the very least, if unconsented research is taking place, the data should be anonymised.

Commercialisation

31. Clause 55 provides that persons cannot sell their own human tissue and that the person lawfully in possession of the body cannot sell or buy human tissue from it. However, it seems that if a person obtains possession of tissue that was lawfully collected from another person it can be sold. Thus, researchers and others may be able to buy and sell tissue. This is of concern if the individual did not give informed consent to the collection or use, as the Council believes people may dislike the idea of their tissue being bought and sold without their consent.
32. The Council is aware that there are strong arguments for and against the sale of human tissue by donors.
33. Regardless of the merits of arguments for and against the sale of human tissue, the Council believes the Bill has gone too far in this area.  For example, it seems that human hair (commonly used by wigmakers in making wigs, for example, for cancer patients) cannot be sold as it falls within the definition of tissue in clause 55. The Council notes from page 24 of the Explanatory note that the Bill was originally intended to exclude material shed by the body naturally, for example, hair and urine.
34. There has been much concern overseas about unconsented research use of body parts and, in particular, the commercialisation of research outcomes. For example, the patenting of diagnostic tests has resulted in patient groups who donated tissue having limited access to tests because of licensing requirements and excessive costs. During its dialogue events within New Zealand, the Council has heard concerns about who benefits from research. A common concern is that research may be motivated by profit rather than social benefit. The Council believes that these are issues that require continuing public dialogue.

Property

35. Clause 69 suggests that human tissue has the status of property, as it is covered under clause 65(d) (ii). It is unclear whether this applies only after it has been seized or whether this means that human tissue generally has the status of property.
36. If it is intended that the Bill will create a property interest in human tissue, this would have substantial legal ramifications. If this is the intent of the Bill, the Council would like to contribute to further discussions about which human tissue is property and, if it is property, who owns it.

Death

37. The Bill does not define death. Clause 50(2) requires confirmation “that life is extinct”. Other clauses refer to “death”. The Council considers that consistency of expression throughout the Bill is desirable.
38. The Council accepts that a definition of death is difficult and may be contentious. Nevertheless, the Council believes that public dialogue around these sensitive topics is needed to ensure that the public’s beliefs and values about death are heard and respected. In particular, the Council notes that:
    1. Many people do not accept that a “brain dead” person on life support                      is actually dead, even though they may intellectually accept the                                  information given to them.
    2. There are also concerns about non-heart-beating donors. Unlike     brain-dead patients, whose organs are retrieved while the heart is still beating, with non-heart-beating donors the heart stops briefly before the organs are removed.
39. Further consideration of the cultural, ethical and spiritual issues associated with death and dying, and the use of biotechnology at these times, might form part of the Council’s future work programme.

Genetic testing

40. Clause 30 requires the consent of the individual for genetic testing to take place. However, Clause 25 allows unconsented collection and genetic testing for research purposes (similar to clause 22 and Right 7(10) of the Health and Disability Commissioners Code of Rights).
41. The Council considers that at the time human tissue is collected from a living person, whether or not it is non-consumer human tissue, the individual from whose body it is collected should be able to specify whether they wish the material to be destroyed or returned to them at the conclusion of the purpose for which it was collected. They should also be able to opt-out of future research use of the material and place restrictions on the type of research. These instructions should also apply to secondary uses after death.
42. The Council considers such requirements should commence at a stated date to avoid the effect of existing holdings of tissue being unable to be used.

Maori

43. The Council is concerned that the Bill does not provide adequate consideration and recognition of Tikanga Maori. Issues concerning the body are of particular significance to Maori culture. The body is considered tapu (sacred) and therefore requires specific consideration and respect. 
44. The Council is also concerned that the collection and use of human tissue for research may inadequately respect cultural values of Māori, particularly if approval is given by an ethics committee, rather than the individual. The Council reiterates the concern already expressed that a framework for the collection and use of tissue should allow for individuals to refuse or place limits on the use of their tissue for donation or research.
45. The Council acknowledges that human tissue donation is important for the retention of whakapapa for Te Ao Māori, however, the Council is of the view, that more dialogue, korero and wananga will need to be had with tangata whenua to discuss the issues involved with organ donation and enable tangata whenua to develop matauranga around these issues so that they can build knowledge and informed views about organ donation.

Recommended amendments

46. Therefore the Council makes the following recommendations for amendment to the Bill:
    1. That the noted areas of ambiguity in the Bill are clarified;
    2. That a veto (refusal of consent) by a donor should be respected and not be able to be overridden by family members;
    3. That a veto or any conditions or restrictions put on the organ register or otherwise expressed by a donor must be applied to any use of the body;
    4. That the consent framework be simplified so that consent or refusal could be given by the donor or by a nominee of the donor. If the donor was silent and did not appoint a nominee, then the Bill should include either a priority list of decision makers as in the United Kingdom Human Tissue Act 2004 or retain the status quo in the Human Tissue Act 1964;
    5. That the terms “informed choice” and “informed consent” be used, in accordance with New Zealand’s existing medico-legal framework, rather than develop a new concept of “appropriate consent”.
    6. That the Bill specify the role of the nominee;
    7. That competent persons under the age of 16 have the same powers as competent adults;
    8. That donors be able to refuse secondary use of tissue and ethics committees not have the authority to permit research use to proceed in the face of such a refusal.
    9. That if research is to take place without the consent of the individual from whom the tissue was obtained the data be required to be anonymised

Further recommendations

1. The Council further recommends that public dialogue be undertaken to consider the concept of brain death and the processes involved in non- heart beating donation.
2. The Council further recommends that public dialogue be undertaken to consider the “ownership” of human tissue and the ability of donors to negotiate a share of profits resulting from the commercialisation of biotechnology.
3. The Council further recommends that dialogue, korero and wananga be undertaken with tangata whenua to discuss the issues involved with organ donation and research using human tissue and to enable tangata whenua to develop matauranga of these issues.