Submission to the Health Select Committee on the Human Assisted Reproductive Technology ("HART") Bill SOP No. 80

July 2003

Introduction

Thank you for the opportunity to comment on the 29 April 2003 Supplementary Order Paper ("SOP") No. 80. The Bioethics Council ("the Council") supports the move to regulate, in consultation with the public, the issues surrounding human assisted reproductive technology, and supports the progression of the 1996 HART Bill. The Council suggests in this submission a range of modifications to the SOP that aim to incorporate the key developments in thinking around biotechnology that have occurred since the introduction of the original HART Bill.

General Points

Since the introduction of the HART Bill in 1996, the Royal Commission on Genetic Modification (RCGM) reported in July 2001, the New Zealand Biotechnology Strategy ("the Strategy") was released in May 2003, and the Bioethics Council has been established. Some of the key principles and themes running through the RCGM report and the Strategy are:

• The interface between science and society, and the need for an integrated whole-of-government approach to biotechnology.
• The need for futurewatch, as technologies develop.
• The importance of public involvement and consultation relating to biotechnology developments, research, uses and regulation.
• The need to manage risks, and to safeguard the people and the environment.
• The need to address cultural, ethical and spiritual issues and concerns.

It is the view of the Council that the HART Bill SOP has yet to adequately incorporate some of the developments in thinking relating to biotechnology that have occurred since the RCGM, as dotpointed above. These are explored in each Part of the Bill, below.

In addition, it is the view of the Council that the SOP and the proposed Ministerial Advisory Committee have a narrow focus revolving around reproductive technology. This is one component of human biotechnology that is, in turn, a part of the broader cross-sectoral biotechnology arena. The SOP in its current form will not future-proof for all health biotechnologies. Xenotransplantation and the use of drugs and other medical devices, for example, may become more controversial in the future because of developments in neurology and nanotechnology. The SOP raises a wider public policy question around the structures that might need to be established to regulate not only reproductive technologies but also other biotechnologies in the human area that may have cultural, ethical and spiritual dimensions.

The HART Bill SOP falls within the ambit of the Council's Terms of Reference which are to advise, provide guidelines, and promote dialogue on the cultural, ethical and spiritual issues associated with biotechnology.

Part 1AA: Preliminary Provisions

Clause 4: Principles

(a) The principle as drafted in the SOP states that the health and wellbeing of children born as a result of the performance of an assisted reproductive procedure should be paramount in all decisions about that procedure.

The Council suggests that this principle be modified to recognise that the adults involved in any relevant procedure also have rights as well as obligations. At the very least, the word paramount could be replaced with the word priority. More comprehensively, the principle could be redrafted to express that assisted reproductive procedures and decisions about those procedures should affirm the dignity of all human beings, with the health and wellbeing of children born as a result of these procedures regarded as having priority.

Neither suggested modification would be inconsistent with the Status of Children Amendment Act 1987 in relation to the status of persons conceived as a result of certain medical procedures.

(b) The principle as drafted is that human health, safety, and dignity should be preserved and promoted.

The Council suggests that the wording human health and safety should be safeguarded, and dignity preserved and promoted may better reflect the intention of this principle. Furthermore, the aim to safeguard human health and safety can help to "futureproof" the principle, as new technologies emerge over time.

The word dignity is not currently defined or interpreted in section 5 of the SOP. The Council recommends that this word be defined for the purposes of this Bill.

(c) This principle asserts that no assisted reproductive procedure should be performed on an individual and no human reproductive research should be conducted on an individual unless the individual has been given an opportunity to make an informed choice to submit or to refuse to submit to the procedure or the research.

The Council suggests rewording this principle to read no assisted reproductive procedure should be performed without informed consent. This approach would remove the language of "submitting".

(d) As drafted, the principle states that donor offspring should be made aware of their genetic origins and be able to access information about those origins.

The Council suggests replacing the prescriptive approach indicated by the words should be made aware of, with the words are entitled to be made aware of.

(e) The principle states that the needs, values, and beliefs of Maori should be considered and treated with respect.

The Council recommends that this principle be reworded to read the needs of Maori be accommodated, and their values and beliefs treated with respect. This approach would strengthen the principle, and would be consistent with the terms of reference of the Bioethics Council, approved by the Government late in 2002; in particular, its responsibility to consult and engage with Maori in a manner that specifically provides for their needs. In practical terms, this approach would ensure that service delivery and research better accommodate the needs of Maori participants and more appropriately involve Maori.

(f) This principle states that the different ethical, spiritual, and cultural perspectives in society should be considered and treated with respect.

This principle implicitly incorporates public dialogue and participation. As such, it relates to section 37 of the SOP - the requirement to consult. As it is currently drafted, however, the SOP does not explicitly link public dialogue and consultation with consideration of different perspectives. The Council recommends that this principle be reworded to explicitly make that link, in order to establish the significance of public consultation in the area of human assisted reproductive technology.

Part 1: Prohibited and Regulated Activities - Subpart 1 Prohibited Actions

Clause 7(1): Prohibited Actions

This section refers to Schedule 1 of the SOP that includes the list of prohibited actions relating to human assisted reproductive technology. The Council supports the list in Schedule 1.

While the SOP bans hybrid embryos for reproductive purposes, it does not explicitly ban their creation for research purposes. On the other hand, neither does it explicitly enable diagnostic tests that involve animal eggs and human sperm, as did the second schedule of the original HART Bill. However, the Council notes that the Ministerial Advisory Committee ("MAC" or the "Committee") could have jurisdiction over such tests. Section 36 indicates that the Committee will provide advice on the creation and use of hybrid embryos for non-reproductive purposes. The Council suggests that the MAC's deliberations include consideration of whether such tests should be accepted procedures.

Clause 7(3): Prohibited Actions

This section refers to ...that gamete, embryo, foetus, or thing. The Council recommends replacing the word thing with the word being, as it is used in section 7(2).

Clause 10(2): Duty to Stop Development of Embryos outside Human Body

While explicit about the importation or exportation or further development of embryos outside the human body once they are fourteen days old or more, the SOP is silent on such treatment within the first fourteen days. The Council suggests explicit rather than implicit guidance in the SOP relating to those first fourteen days.

The SOP is also silent on importation and exportation of genetically modified embryos. The New Organism and Other Matters ("NOOM") Bill that amends the Hazardous Substances and New Organisms ("HSNO") Act 1996 deals with imported GM gametes, but explicitly excludes human embryos. If this is the intention of the NOOM Bill, the Council perceives this as a gap in legislation that could be addressed through the HART Bill SOP.

Clause 11: Commercial Supply of Embryos or Human Gametes Prohibited

The Council notes the inclusion of commercialisation in the SOP, and the associated encouragement of public debate about the issue. This debate is part of a wider, and unresolved, tension between New Zealand's respect for individual rights and the New Zealand philanthropic approach to the donation of blood and body parts.

This section of the SOP raises questions for New Zealand society is unlikely to be addressed within the timeframe for consultation on the SOP. As such, the Council suggests that prohibition of commercial supply of embryos or human gametes versus its tolerance (where harm does not occur) be removed from section 11 and included in section 36(1): the list of matters on which MAC is required to consult and advise.

Clause 12: Status of Surrogacy Arrangements and Prohibition of Commercial Surrogacy Arrangements

The Council recommends that section 12 be treated in the same way as the Council's recommendation for section 11. There has not been sufficient time to elicit the views of the public on commercial surrogacy. The MAC could consult with the public and advise the Minister of Health on the range of views on this matter and where, on balance, the weight of views lie.

Part 1: Prohibited and Regulated Activities - Subpart 2 Activities Requiring Approval of Ethics Committee

The Council supports the formal recognition in legislation of the role of ethics committees in relation to human assisted reproductive technology, and supports the function as outlined in section 25(1)(c) of ethics committee/advisory committee liaison.

Part 1: Prohibited and Regulated Activities - Subpart 3 Advisory Committee

General Comments

The Council is concerned that the establishment of the MAC has the potential to further fragment the roles of existing ethics Committees, and diminish their efficiency and effectiveness. Some roles may inefficiently overlap. One example of this relates to public dialogue about biotechnology. The Bioethics Council is currently resourced to facilitate consultation. For the MAC to also successfully achieve its regulatory requirements, it may need to take a significant role in facilitating public dialogue and be resourced to do so. Funding two organisations to undertake similar roles might be more costly than funding one to do a wider range of roles.

The SOP also needs to be tied in with the Government's whole of government approach to biotechnology. As stated in the SOP, the MAC will exclusively focus on reproductive technology. The New Zealand Biotechnology Strategy, however, reinforces the need for a whole-of-government approach to biotechnology, including human biotechnology and the more narrowly defined reproductive technologies.

We note further that as technologies progress, boundaries between their types and impacts will blur, and not fit neatly into the health or non-health categories. Examples of this include xenotransplantation (involving animal ethics and human bioethics), and the implications of environmental biotechnology for humans. In addition, the public tends not to differentiate between human and other biotechnologies, and to expect consistency of approaches across technologies.

Thus the Council suggests that reproductive biotechnologies need to be considered and responded to as part of the Government's key health strategies, and within its whole of government approach to biotechnology. The approach to reproductive technologies also needs to enable "futurewatch" in relation to emerging technologies and their safety and risks for humans (Principle (b) refers). In relation to this, the Council notes that the areas of technology covered by the HART Bill SOP are within the scope of the Council's Terms of Reference, which require futurewatch and consideration of the cultural, ethical and spiritual issues associated with biotechnology.

Clause 33: Appointment of Members

The Council considers that the section on the composition of the MAC and the nomination of its members could be tightened to include:

• Public nominations for some or all of the members.
• A minimum size for the Committee.
• A clearer definition of the term layperson.
• A requirement for the chair of the Committee to be a layperson, in order to be consistent with similarly constituted committees.

Clause 34: Functions of Advisory Committee

The functions of the MAC will involve significant liaison with, and support from, the Bioethics Council and relevant ethics committees. The Bioethics Council will be a key provider of issue-based advice and a conduit to community consultation (refer also to section 37 below). This picks up the issue of the potential for inefficiencies and ineffectiveness to result from the establishment of a further committee.

Structural approaches that might help avoid fragmentation and inefficiency could include:

1. Adequate resourcing of the MAC so that it can parallel the work of, and work alongside, the Bioethics Council in relation to human technologies, including adequate public consultation.
2. Merging of the roles of the MAC and the National Ethics Advisory Committee, and resourcing it appropriately.
3. Combination of the roles and resources of the MAC into the Bioethics Council to:
   • Address the need for a whole-of-government approach (health, research, environmental, agricultural).
   • Ensure public involvement.

In this option, the Bioethics Council would need to be resourced with at least one additional member (and, realistically, probably more) who has human reproductive technology expertise, together with an additional person on the secretariat.

Clause 36: Advisory Committee Must Provide Specific Advice

The Council recommends that section 36(1)(b)(iii) explicitly include the words including sex selection after the words embryo selection, in recognition that sex selection versus sex neutrality may become an issue for public debate within New Zealand, as our population becomes more ethnically diverse.

Clause 37: Requirement to Consult

Public consultation as currently drafted in this section of the SOP is at the discretion of the MAC. It is the Council's view that issues relating to human assisted reproductive technology are issues for general New Zealand public involvement and debate. The Council strongly recommends that requirements for public dialogue, consultation and submission either be included as a mandatory part of the MAC's Terms of Reference, or that other structural approaches be progressed (as outlined under the Council's response to section 34 above) that will also ensure such public involvement.

Part 4: Information about Donors of Donated Cells and Donor Offspring

This section of the SOP requires only a subset of information to be provided to the Registrar General. The Council recommends that the remaining information kept by providers be audited and monitored, and that the responsibility for such auditing and monitoring be that of the Ministry of Health, as part of its role of administering the legislation.

Conclusion

In conclusion, the Council supports the move to progress the HART Bill, and is pleased to have the opportunity to comment on the Bill's SOP.

In general, the SOP does not appear to have incorporated the developments in biotechnology that have occurred since 1996, when the Bill was first introduced. Specifically, such developments relate to:

• The need for a whole-of-government approach.
• The blurring of boundaries between technologies.
• The need to futurewatch for emerging technologies.

The current SOP focus on reproductive technologies is narrow, considering its context within human biotechnologies generally and the broader cross-sectoral biotechnology arena. The SOP does not futureproof against all health biotechnologies, and raises questions about the structures that might need to be established to regulate not only reproductive technologies but also other biotechnologies in the human area that may have cultural, ethical and spiritual dimensions.

Human assisted reproductive technology issues will require ongoing public debate. As such, either the MAC's terms of reference needs to be broadened to explicitly require public dialogue, consultation and submission, or other structural Committee options should be considered.

The proposed establishment of the MAC will contribute to the proliferation of Committees and Councils. This proliferation has the potential to fragment the roles of existing ethics Committees, and diminish their efficiency and effectiveness, unless they co-operate and work together.