Full Submission

June 2003

1. Toi te Taiao: the Bioethics Council ("the Council") was established by Government in 2002, as a ministerial advisory committee. The Council's Terms of Reference are closely based on recommendations made by the Royal Commission on Genetic Modification. The key responsibilities of the Council are to:

• Provide independent advice to Government on biotechnological issues involving significant ethical, spiritual and cultural dimensions.
• Promote and participate in public dialogue on ethical, spiritual and cultural aspects of biotechnology, and enable public participation in the Council's activities.
• Provide information on the ethical, spiritual and cultural aspects of biotechnology.

While the Council recognizes the importance of the Treaty relationship, we view the term 'cultural' in its widest sense as embracing all the people of New Zealand, rather than being used to mean cultural concerns of Maori only. Maori have for too long carried the burden alone of bringing cultural concerns to the fore.

2. The Council has no role in decision-making in regard to specific applications, and has no regulatory role. The Minister has however made it clear that a 'future watch' role is expected of the Council.

3. The Council regards the Royal Commission as the key body which, through an extensive democratic process, charted the overall course for genetic modification in New Zealand for the foreseeable future. We view ourselves as building upon the work of the Royal Commission rather than revisiting that work. In this respect the Council has a particular responsibility for considering how ethical, spiritual and cultural concerns are accommodated within the Commission's key recommendation of 'preserving opportunities'.

The Current Debate on Ethical, Spiritual, and Cultural Matters

4. The recent report from the Biotechnology Taskforce states:

"...While it is appreciated that ERMA has not wanted to further extend its hearings by providing for cross-examination, hearing procedures should be tightened to require submitters to adhere to normal rules of evidence and to support statements with relevant authority. This may circumscribe submissions which address religious, spiritual and cultural concerns, but these are matters which may now more appropriately be dealt with through the recently established Bioethics Council."

Part of the suggested Action 18 in the Taskforce report follows from this:

"Channel all generic submissions not specifically related to an application for HSNO approval through an appropriate ethics council, (e.g. bioethics) on the basis that a mechanism should be in place to ensure all year-round response..."

5. This statement and suggested action from the Biotechnology Taskforce demonstrates a misunderstanding of the role of the Bioethics Council. In relation to biotechnological issues which have significant ethical, spiritual and cultural dimensions, the Council's role is to provide advice to Government, to promote and participate in public dialogue, and to provide the public with sound information. As part of its advice the Council may propose frameworks or guidelines for use in relation to generic issues or particular forms of biotechnology. The Council has no role in dealing with submissions made to ERMA ("the Authority"), even if these concern ethical, spiritual, and cultural matters which the submitter believes to be relevant to a particular application.

6. If the Taskforce is suggesting that the decision-making on particular applications should be split between two different bodies (ERMA and the Bioethics Council), we are strongly of the view that this would be both inefficient and a means of side-lining issues relating to ethical, spiritual and cultural effects.

7. The Council is strongly of the view that ethical, spiritual, and cultural matters should be part of the mainstream decision-making process, as an integral component of ERMA's processes. The identifying, assessing and weighing up of the effects and risks of biophysical and cultural/spiritual/ethical factors together should be the role of the Authority.

8. The nuclear issue in New Zealand clearly demonstrates how technical and ethical issues are integral parts of any decision-making where risk and uncertainty in technical and scientific developments may potentially have significant societal effects. It is important not to lose sight of the fact that the technical and scientific spheres are not value-free zones. Choices about the use of scientific and technological developments have values embedded in them, even if these values are frequently unstated. The attempt to split scientific and technological developments from the associated ethical, spiritual and cultural matters only leads to inadequate policy because it overlooks societal values.

9. The National Party has been reported as saying that 'confusing phrases' relating to cultural and spiritual effects should be removed from the bill. The Royal Commission on Genetic Modification made it clear that these are matters that many New Zealanders believe should be taken into consideration when deciding on applications under the Hazardous Substances and New Organisms Act ("HSNO").

10. While there has been a concern expressed in some scientific and political circles about the effect that consideration of cultural, ethical and spiritual matters has on decision-making under HSNO, we reiterate that these are matters that greatly concern many New Zealanders in regard to new biotechnologies, including genetic modification.

11. The Authority has acknowledged difficulties in handling ethical, spiritual and cultural effects with the tools it currently has available. In its submission to the Royal Commission it pointed out:

"...The balancing up of spiritual beliefs and scientific endeavour has been problematic as this is not a matter solely for judicial weighing up. A broader approach is required to provide a context in which HSNO can operate in dealing with these kinds of issues."

"...no institution is entrusted with the big picture ethical issues."

12. The Bioethics Council certainly has a role in providing the big picture context and developing guidelines, principles and frameworks. But these need to be applied and interpreted in the context of particular situations. Each application has its own individual context, and consideration of ethical, spiritual and cultural effects needs to take account of that context. The provision of guidelines and broad over-arching principles is, on its own, not sufficient.

13. HSNO needs to clearly provide for the integration of those principles, guidelines and frameworks into the case-by-case decision-making of the Authority. Just as the Human Assisted Reproductive Technology bill provides for ethical input at both an overarching level and a case-by-case level, so too the Authority must have provision for case-by-case decision-making to include ethical, spiritual and cultural effects. Rather than side-lining these issues as suggested by some groups, we believe that they must be more clearly integrated into the regulatory processes at all levels, for exactly the reason stated in the Biotechnology Strategy:

"The regulatory framework is where innovation and opportunity meet society's safety and ethical concerns. The challenge is to ensure an appropriate balance."

Does the bill ensure that HSNO more fully reflects concerns about ethical, cultural and spiritual issues?

14. The explanatory note to the New Organisms and Other Matters bill ("NOOM") states in paragraph 3, page 15:

"Biotechnology, as with any new technology, raises ethical, cultural and social issues. HSNO does not fully reflect these concerns as it stands at the moment."

It is therefore important that the select committee gives consideration to the extent the suggested changes to HSNO do achieve a better reflection of the concerns about these issues and where they fall short. That the concerns are real has been highlighted by the Royal Commission and by submissions received by ERMA to publicly notified applications.

15. We are mindful in considering changes that unnecessary barriers should not be added to the application and decision-making processes. We are aware that ethical, spiritual and cultural issues are regarded by some sectors as being costly and time-consuming barriers to progress. In our view, the issues themselves are not the problem, rather the fact that ERMA, while making strenuous efforts, has not had the means to deal with them in the most effective way. The provision of more effective means of handling ethical, spiritual and cultural effects within the decision-making process may well reduce perceived barriers rather than creating them.

16. To provide ERMA with these means two matters need to be dealt with:

• the strengthening of the legislation so that cultural, ethical and spiritual matters are adequately recognised; and
• a requirement that structure and processes be established so that the overarching principles, guidelines or frameworks developed by the Bioethics Council can be integrated into the case-by-case decision-making of the Authority.

Strengthening through legislation the Authority's ability to deal with ethical, spiritual and cultural matters.

17. We note that HSNO and hence the current Methodology (which has the strength of a regulation) provide only limited assistance in dealing with ethical, cultural and spiritual effects. The relevant sections in the Methodology are:

Clause 25 (2): " Where evidence relating to an application refers to other values and matters relevant to Part II of the Act, including the relationship of Maori culture and traditions to their ancestral lands and taonga, the Authority must also consider the values and other matters in that evidence."

Clause 9: "When evaluating the information provided by the applicant ...so as to achieve the purpose of the Act, the Authority must: ...
(b) Recognise and provide for the principle of maintenance and enhancement of people and communities to provide for -
(i) Their own economic, social and cultural well-being; and
(ii) The reasonably foreseeable needs of future generations..."

The provision of more effective means of handling ethical, spiritual and cultural effects within the decision-making process requires a strengthening of the ethical, spiritual and cultural dimensions of HSNO, with flow-on effects for ERMA's Methodology and operation. To bring this about this legislative strengthening we propose the following changes to NOOM:

18. That NOOM be amended to ensure that Section 6 of HSNO includes a further matter relevant to the purpose of the Act, as follows:
(g) The ethical, spiritual and cultural effects of the introduction of a new organism.

19. That Clause 8 of NOOM be amended to ensure that Section 16 of HSNO includes a further matter to be considered in regard to eligibility for appointment as a member of the Authority, as follows:
When considering whether a person is suitable to be appointed as a member of the Authority, the Minister shall ensure that the membership includes a balanced mix of knowledge and experience in matters likely to come before the Authority, including knowledge and understanding of ethical, spiritual and cultural issues.

20. That NOOM be amended to ensure that Section 36 of HSNO includes an additional minimum standard relating to significant adverse effects which have ethical, cultural and spiritual dimensions. In regard to conditional and other release applications the Council believes that the current minimum standards do not fully reflect concerns about ethical, spiritual and cultural issues, and that an additional standard should be included to cover this aspect.

The need to integrate Bioethics Council overarching principles/guidelines with the case-by-case decision-making of the Authority.

21. The amendments we have proposed to NOOM which affect Sections 6 and 36 of HSNO would need to be incorporated into the Methodology through an Order in Council. The actual translation into the operations of ERMA is a matter for the Authority to determine, but we stress the need for processes and/or structures to ensure any overarching principles/guidelines from the Bioethics Council can be applied at the case-by-case level.

Ministerial call in powers.

22. The Council supports Clause 36 of the bill which extends ministerial call-in powers to include significant ethical, spiritual and cultural effects. This is a welcome but not adequate response to the need to make HSNO more fully reflect concerns of this nature. By itself, provision for call-in by the Minister does not ensure that there is continuing and consistent oversight at the case level. Call-in should be used as an additional provision, not the only provision, for dealing with ethical, spiritual and cultural issues.

Conditional release

23. When the current moratorium expires in October, under the existing HSNO Act ERMA can only approve release of a new organism without controls. In contrast there was a clear indication from the Royal Commission that a cautious approach to release is required, and that a conditional release option is needed.

24. The Council considers conditional release to be on a spectrum, from release of genetically modified organisms with no controls (after the moratorium is lifted in October) to allowing no release of genetically modified organisms under any circumstances. Legislated provision for conditional release allows for a more cautious approach than currently provided for in HSNO, and hence a better ability to protect the environment and human communities from any potential harm. When seen against the 'no release at all' end of the spectrum, the option of release with controls allows for a degree of scientific and economic opportunity. The Council therefore supports the conditional release provision in Clause 18, as better reflecting concerns of the New Zealand public and the recommendation of the Royal Commission to keep opportunity open, but to proceed with caution.

25. In relation to full release we recommend that NOOM be amended to ensure that HSNO requires any full release to be preceded by an appropriate period of conditional release.

26. We recommend that ERMA's Methodology require early advice of an application for conditional release to be provided to hapu and iwi, so that any appropriate measures needed for monitoring of ethical, spiritual or cultural effects can be part of the conditions for release. We also recommend that ERMA continue to work with Maori representatives on a local and national level.

27. The moratorium on consideration of applications for release of new organisms imposed in the 2002 HSNO Amendment Act has a limited life-span, and there have been calls for its extension. It has been proposed by some groups that the outcomes of research into particular aspects of genetic modification or its impacts should be the triggering factor for extending or removing the moratorium. We see this approach as being fraught with difficulty as the type of research and the validity of outcomes are unlikely to be agreed by all parties.

28. The Council sees the provision for conditional release as the key factor that provides the safeguards which would allow the moratorium to be removed in October this year.

29. For any release to occur, ERMA must determine that the minimum standards set out in Section 36 of HSNO are met. Currently the standards provide protection for human health and safety, native species, genetic diversity, and for the prevention of human or animal disease. Two protections are conspicuous by their absence - protection for the ethical, spiritual and cultural values of the community (see paragraph 21 of this submission), and protection from a negative effect on the economy of a region or the nation.

30. Protection from a negative effect on the economy of a region or the nation is best addressed through requirements for strict adherence to the conditions needed for the coexistence envisaged by both the Royal Commission and NOOM. Will the controls imposed be able to ensure ongoing segregation of GMOs and non-GMOs and their products beyond the growing stage? This relates to the very important matter of maintaining public choice by separation, identification and traceability throughout the lifetime of an organism and its products.

31. In regard to GMOs, New Zealand has chosen a path of separation and coexistence, as is being adopted in the European Union. This path depends upon requirements such as clear identification and separation of GMOs and their products at the growing, processing and marketing stages (for example, through food labelling). It is clear that New Zealanders want this consumer choice model upheld. We see it as a vital component in ensuring that non-GM products can continue to be marketed as such. It is also an example of both a precautionary approach and preserving opportunities. We therefore recommend that in the proposed new Section 38 of HSNO (Clause 18 of NOOM) this matter of the maintenance of consumer choice be addressed in the controls that ERMA may impose.

Streamlining

32. The Council supports the proposals for streamlining processes. The two proposals in Clause 9 relate to low risk GM work in containment, with one being for rapid assessment on a project rather than individual organism basis; the other relating to assessment of adverse effects of importing into containment. The Council is of the view that there is a need to ensure both fair access to research and economic opportunity, and protection from harm for the environment and for human health and safety. Because the organisms by definition must meet the low risk regulations requirements, the proposed changes in the approval processes will not increase the risk of harm. The changes will, however, provide fairer access to research by reducing the time and cost of applications for this type of work.

33. We also agree with the proposal in Clauses 12 and 26 to streamline the procedures relating to animal or human medicines that contain low risk GM organisms, including for situations of emergency.

Human cells and regenerative tissue

34. The Council is in strong agreement with the amendments proposed in Clause 5 which will ensure human cells and regeneration from tissue of animals not present in New Zealand are covered by the HSNO Act. This area is currently unregulated and hence poses an unacceptable level of risk with the rapid burgeoning of biotechnological opportunity.

Giving greater effect to the Treaty of Waitangi

35. The Council submits that a key aspect to giving greater effect to the Treaty of Waitangi through HSNO is ensuring that Maori have a legislated proper place in decision-making. We believe that this is best done in the following ways:

Section 8 - Treaty of Waitangi

36. Section 8 of the HSNO Act requires that "all persons exercising powers and functions under this Act shall take into account the principles of the Treaty of Waitangi (Te Tiriti o Waitangi)". The Royal Commission on Genetic Modification recommended that Section 8 be changed to "shall give effect to the principles of the Treaty of Waitangi". The Council supports this stronger wording, as it gives better protection to Maori interests which could potentially arise in the future and which cannot be foreseen at this time. "Giving effect to the principles of the Treaty" also has greater potential to encourage the formation of partnerships between hapu/iwi and research institutions.

Ngā Kaihautū Tikanga Taiao

37. We acknowledge and support the action of ERMA in setting up Nga Kaihautu Tikanga Taiao ("Nga Kaihautu") and believe it is now appropriate to change the HSNO Act as set out in Clause 10 to ensure Nga Kaihautu continues as an integral part of ERMA. We also support the provision in Clause 10 for a review of the Terms of Reference for Nga Kaihautu at intervals of not more than three years. However we submit that while the Authority is likely to carry out a consultation process with iwi and hapu as part of the review, it should be a legislated requirement included in Clause 10 (Part 4A 24D of the HSNO Act).

Membership of the Authority

38. We note that Clause 10 makes Nga Kaihautu an advisory committee to the Authority, which is the ultimate decision-making body. We note also that the Authority has the final control over the Terms of Reference, the membership and the appointment of the Chairperson of Nga Kaihautu.

39. It is therefore essential that Maori representation on the Authority is at a level where it can be ensured that Maori have that 'proper place' in decision-making. We therefore welcome and strongly support Clause 8 of the bill which includes "...matters relating to the Treaty of Waitangi and tikanga Maori" in the eligibility factors for appointment to the Authority. While there are currently Maori on the Authority, we consider that the inclusion of Maori should not be left to the discretion of the Minister but should be ensured by the amendment proposed in Clause 8.

40. However we submit that knowledge and expertise alone are not adequate, and that to represent Maori cultural values Maori community processes should be used to produce nominees for the Authority.

41. We note that it has been the practice within ERMA for the Chairperson of Nga Kaihautu to have a place with Authority members on the Board of ERMA. We applaud this and believe that provision should be made in either the legislation or the Methodology to ensure this is an ongoing practice.