The Interchurch Bioethics Council represents the Anglican, Methodist and Presbyterian churches of Aotearoa:New Zealand. We have nine members with a wide range of knowledge and experience, including medical, scientific, ethical, theological, educational and cultural expertise (many members wearing more than one hat!).

You have our submission, and I will not discuss all the points raised. I will make specific comments on these matters, and allow time for questions at the end.
Specific comments:

• We believe the Guidelines should be Interim guidelines.
• More attention needs to be given to cultural and spiritual issues, in addition to ethical issues.
• There are inadequacies in the consent procedures.
• There is an over-emphasis on clinical benefits.
• I will comment on the review process and the use of a register.
• I will point out that more consultation that will be needed when it comes to the matter of creating stem cell lines in New Zealand.

Reasons why we believe these should be Interim Guidelines:

It is unethical and illogical to import embryonic stem cell lines for use in New Zealand if the production of such cell lines in New Zealand is not approved. These guidelines must therefore be seen as an interim measure to allow research to proceed while the matter of producing embryonic stem cell lines is fully and publicly debated. Otherwise there is a danger that the present guidelines will become de facto guidelines for the creation of cell limes in New Zealand and there are reasons, as follow, why the current guidelines are not adequate for this.

The consultation time allowed for these guidelines was far too short, particularly as it came during the summer holiday period, and wider consultation is needed. For example, Te toi Taiao:the Bioethics Council found that the people in their limited focus groups were not happy with the use of embryos which were not required for implantation being used to make stem cells and that the creation of embryos for research purposes was more acceptable. We found that in our ‘constituency’ of church members the creation of embryos for research purposes was not generally acceptable, but there was more approval for the use of embryos which would otherwise be destroyed. Such different opinions from two significant groups support the need for wider consultation in the community.

Under Section 36 in the HART Bill the Advisory Committee is required to provide information and advice on matters relating to research including that on human embryos. This advice would be expected to be very relevant to the guidelines we are currently discussing but cannot be taken into account if the present timeline is adhered to. They could be taken into account in the future if the current guidelines are interim.

Insufficient recognition was given to cultural and spiritual issues.

Cultural and Spiritual Values:

The findings of the Royal Commission on Genetic Modification stated that the choices made by New Zealanders are linked to their spiritual, ethical and cultural values.

In the NOOM Bill (New Organisms and Other Matters) the Minister for the Environment’s call-in powers for applications submitted to ERMA were amended to include ‘significant cultural, ethical and spiritual effects’.

Te toi Taiao:the Bioethics Council appointed by the government following the report of the Royal Commission is an advisory body on cultural, ethical and spiritual issues in biotechnology in New Zealand.

These examples, and there are others, demonstrate that we recognise the importance of cultural and spiritual values. However, in the Guidelines we are discussing, there is a Section on ethical issues but very little on cultural or spiritual issues.

Some definition might be helpful here. There is a well-recognised ethical framework developed with reference particularly to clinical procedures and research. Cultural issues in New Zealand are mostly seen in relation to Maori values. However, in addition to having high regard to the values of our Treaty Partners, we need to recognise that all people have cultural values and New Zealand is a multi-cultural society with diverse values. The more difficult question is what do we mean by spiritual? There is no simple definition of spirituality, and it would take a lot longer than we have this morning to cover this topic. Spirituality is an awareness of the non-material aspects of life. Spirituality is a framework of beliefs and values which inform our living experience and our world view; world view being how we see the world and our place in it, and therefore how we act within the world. Maori spiritual values have added a huge amount to our understanding of spirituality, but we must also recognise that for all of us spirituality is that which gives us meaning to life.

Consent:

Guideline 12 requires the researcher to state how left over embryonic cells will be dealt with. This is a matter that should be addressed in the consent form and opportunity given for appropriates procedures to be used, e.g. a suggestion made to us was that it might be appropriate for Maori to have a karakia said at the time of disposal of cells.

It has to be recognised that it is not possible to predict how cell lines will be used and therefore consent is not fully informed. We favour embryonic stem cell research being limited to serious diseases and their treatment or related to the processes of human development. This would give the person(s) who give consent some control and the domain of research possible would still be very broad.

We raise the question of who will give consent to the use of embryos which are not required for implantation if the embryos have been created for parents who are not the genetic parents, and in fact donor gametes have been used. Such donors do not have any say in the use of embryos for implantation, so what will be the situation here?

Clinical Benefits:

We recognise that the Guidelines do say that the benefits will not be available for a long time, but still feel that the clinical benefits are over-stated. People hear what they want to hear, and it is common when talking to groups to find people are greatly influenced by what the research will mean for their family member who has an illness which may be researched. The enthusiastic reporting of work which has not yet been validated such as the SCNT work in Korea is likely to lead to false hopes.

Information is not given about alternative possibilities e.g. that the current work on spinal repair, which is admittedly also in very early stages, is being done with adult stem cells from the patient.
Review Process;

We think it is important that the ethical review of the use of human embryonic stem cells is done on a case by case by an ethics committee which has appropriate expertise and recommend that ECART take up this role. We agree it would be appropriate to establish a register so that stem cell lines would not have to be continually approved and re-approved. However we suggest that while transparency and openness is important, it may be unwise to list on a website the institutions which are holding/researching these lines. Such information could be available on request from the Ministry of Health.

Conclusions:

• In summary, these guidelines should be of an interim nature.
• More attention should be given to cultural and spiritual values.
• There are matters to be addressed in the Consent Forms
• Clinical benefits should not be over-emphasised, and more information could be given about some of the options e.g. use of adult stem cells.
• ECART would be the appropriate committee for case-by-case review
• MOH would be the body to maintain a register of approved embryonic stem cell lines

The next step following the publication of these guidelines will presumably be preparation of guidelines for the creation of human embryonic stem cell lines in New Zealand. Indeed, as I said at the beginning, it is not ethical to put in place guidelines for the use of imported cell lines if creation of such cell lines are not going to be approved within New Zealand. In the consultation required for these guidelines, there should be more consultation and public debate and inclusion of the points listed above.

1. That an independent NZ Genetic Modification Ethics Council be set up specifically to address the ethical and spiritual concerns being raised by many New Zealanders, in relation to all GM research and applications. As new situations and ethical dilemmas will arise with new applications, this requires an ongoing process.
2. That moneys be allocated from the current public good science funding to carry out research into the ethical and spiritual implications of GM technology in New Zealand.
3. That the terms of reference of ERMA be reviewed to ensure that appropriate notice is taken of the recommendations of Maori.
4. That measures be taken to ensure that the New Zealand public is given accurate and sufficient information regarding GM, GMO’s and GM products to allow it to make informed decisions to accept or reject GM technologies, including GM food. Where products are acceptable to a significant section of New Zealanders, wherever possible products alternative to GM products be available to safeguard the right of all consumers to choose.
5. That the patenting of human genes be illegal in New Zealand.
6. That recognition be given to the widespread intuitive unease regarding the transfer of human genes to other species, especially to higher animals. We do not know the full implications of this sentiment for public policy. However, the transfer of human genes into higher animals should only be approved where highly focused benefit is expected and after consultation in depth with the NZ community.

Our Recommendation

We wish to express support for the ratification of the Cartagena Protocol by the New Zealand Government.

Reasons for Supporting Ratification:

Principles of ethical, spiritual and cultural values.

In supporting ratification, we are mindful that our role as the Interchurch Bioethics Council is to represent the Anglican , Methodist and Presbyterian churches, with emphasis on the spiritual, ethical and cultural aspects of the issues considered. The core of values described for New Zealanders by the Royal Commission on Genetic Modification (RCGM) (page 25, Report and Recommendations) include being part of a global family, the well-being of all and freedom of choice. We believe that we have a duty of care to other countries, particularly those which are disadvantaged and underdeveloped. It was also pointed out by the RCGM that many New Zealanders believe economic and scientific factors should not always be the over-riding factors in making decisions in biotechnology.

Ethically, we have a duty to respect the rights of other countries to autonomy and self-determination. We also have a duty to ensure that our actions contribute to the welfare of others where this is possible. The Cartagena Protocol’s objective is ‘to help ensure the safe transfer, handling and use of LMOs that could have potential harmful effects on conservation and biodiversity (including human health)’. As such it is worthy of our support.

In terms of self-determination, the Protocol gives member countries the right to reject shipments of LMOs if they believe the LMOs could be harmful to their biodiversity. In terms of health and safety, it ensures the provision of accurate information regarding risk assessment for LMOs which are to be imported into the member country. The protocol will give both poor and affluent countries the same rights to decide on what to import, and those decision will be made by the countries themselves and not imposed by more powerful nations.No other country or individual exporter has the right to put the biodiversity or human health of a prospective importing country at risk without the explicit agreement of the prospective importing country. These rights to know and decide are rights that should not be constrained by the economic situation of a country. The poor have the same right as the wealthy to know about and decide what they will import.

Spiritually, the provision for individual countries to have responsibility for their own unique biodiversity would be in line with our concept of the responsibility of stewardship. Ratification of the Protocol may mean in some cases that NZ places the interests of others ahead of its own, but this would be in line with the Christian principle of servanthood as we seek the greater good, rather than our own, especially for those less fortunate than ourselves. If NZ can have input into such a document to enhance the protection of those in need, we should use our voice to its fullest potential.

Culturally, as a country, NZ is in a unique position to help countries grapple with cultural issues relating to LMO’s because this is what NZ has been doing We should share our expertise, especially as developing countries learn to deal with the ethical and spiritual issues involved in LMO import, as we ourselves have learnt. In particular, New Zealand has highlighted the rights of indigenous peoples in such decision- making processes and concerns, and could usefully share this expertise.
New Zealand’s experience and expertise

New Zealand is a small country, but we have considerable expertise gained from the ground-breaking work of the Royal Commission on Genetic Modification. New Zealand has the respect of many other countries for its attitudes and actions in matters which affect the environment. New Zealand has comprehensive legislation for the import of LMOs and could use its experience and expertise for the benefit of other countries. Ratification of the Protocol would therefore give New Zealand the opportunity to offer a lead in support of Third World countries.

Precautionary Principle

As stated in the discussion document, the ‘Government’s agreed policy approach to genetic modification is to proceed cautiously within an overall strategy of preserving opportunities’. We believe ratification of the Cartagena Protocol can be in keeping with this policy, both from the point of New Zealand and of other countries. The Protocol puts the Precautionary Principle into international law. As stated in the Discussion Document, the Protocol allows the importing country to take a precautionary approach, i.e. where there is insufficient scientific evidence and knowledge for a full risk assessment.
Evolving Document

We recognise that the Cartagena Document is an evolving document, and that there are some risks to New Zealand in becoming party to a document to which we will be bound by its future decisions. Against these risks, we would have the opportunity to leave the Protocol by the specified exit route, if it became evident at a future time that being a party to the Protocol significantly disadvantaged New Zealand’s interests. The Government needs to recognise that this may entail some financial costs to New Zealand, which would in all probability be borne by the Government.

However, by being party to the Protocol, we will be able to influence future decisions, and if we believe that New Zealand’s interests are threatened, to use our power of veto in the consensus decision-making which will be used. If we are not party to the Protocol, we are likely to still be bound by future decisions but will have little or no input into these decisions.

Costs to New Zealand.

The cost of ratification to New Zealanders would be small, since rules around importing GE organisms are already covered by HSNO and Biosecurity legislation, which meet the requirements of the Protocol. Some additional cost might accrue in the future for New Zealand exporters of commercially-grown LMOs should these become available, in terms of the requirements for information. However, because producers must get approval from ERMA to use or produce GE organisms in New Zealand, exporters will already have the information that the Protocol requires them to make available to prospective importing countries. Thus, this cost to exporters of New Zealand ratifying the Protocol will be minor. Furthermore, exporters will have to meet the requirements of importing countries whether or not we are a Party to the Protocol.

CONCLUSIONS

The ratification by New Zealand of the Cartagena Protocol is a chance for NZ to be involved in some ground-breaking legislation. Such a move would be in keeping with Government policy and the beliefs of New Zealanders regarding the rights of others to self-determination and to respect for their own needs and beliefs. New Zealand can provide leadership with respect to these issues for those countries who have yet to grapple with such concerns, and help make the Cartagena Protocol a piece of legislation which seeks the well-being of all peoples and of the biosphere as a whole.

There may be some risk and cost for New Zealand, and the Government would need to keep in mind the exit process available if unexpected difficulties arose in the future.

The Interchurch Commission was formed to express balanced and considered Christian views on the issues surrounding Genetic Modification research, crops, foods and other products in Aotearoa-New Zealand. The seven commissioners represent the Anglican, Methodist and Presbyterian churches. As an Interchurch Commission we have identified eight ethical foundations on which a response on behalf of the churches can be based. These would be differently expressed by different groups within the churches, but carry the same implications. These insights have emerged from our consultations with groups of interested church people throughout the country, and from the personal enquiries we have made in our own worship settings. These eight foundational categories are as follows :

1. Humility before the Creator

Humility before the Creator is a fundamental attitude which allows Christians to realise that they are part of something far greater than themselves. This inspires reverence in us for that greater being of which we are no more than a tiny part, as is expressed in passages such as Genesis 1:1: “In the beginning God created the heavens and the earth”, and Jesus’ reaffirmation of the first great law – “You shall love the Lord your God with all your heart, with all your soul, with all your strength, and with all your mind” (Luke 10:27).

2. Responsibility for/to the whole of creation

Responsibility for/to the whole of creation is another fundamental attitude. This responsibility is not only for what we may think we have power over, but also to that which gives us that power. We come from the earth, we are rooted in (or arise from) it, so that we have a two-fold responsibility, to the Creator and to creation. We find this expressed in Genesis 1:26 as humankind is “made in the image of God” and “given dominion over the creation” and in the New Testament, that “the creation itself will be delivered from corruption into liberty when we responsibly take up our inheritance in Christ” (Romans 8:20).

3. Our being and all of creation is grounded in God

Our being and all of creation is grounded in God. Traditionally that grounding is seen to be in the fact that we are called into being by God (Psalm 149:14), and this is related to the creating and sustaining activity of God through Christ.

4. The truth of God is eternal

The truth of God is eternal, which contrasts with the fact that our knowledge in all areas is limited by time and history. We find this powerfully expressed in Job (e.g. Job 38:4) where God asks: “Where were you when I laid the foundations of the earth?” This thought is also found in later writing when we are warned that “we are in danger of becoming fools where we most profess to be wise” (Romans 1:21,22).

5. We are called into Community with the faithful in Christ, and with all creatures who share the creation with us

We are called into Community with the faithful in Christ, and with all creatures who share the creation with us. We are taught that the proper attitude here is love and that it is good and pleasant when families dwell together in unity (Psalm 133). This ideal model includes harmony throughout creation. Love is the underlying principle here. Love is said to be the highest of the fruits of holiness. In expressing this love, the Church has concerns for the humble and needy people of the earth and does not condone the exploitation of their potential productivity, or the takeover of their traditional farming methods and their specialised knowledge of their own environment.

6. We are not in complete control of our own fates in this world, there are forces at work greater than us

We are not in complete control of our own fates in this world, there are forces at work greater than us. Today this in interpreted in many ways, the world has its natural catastrophes and accidents but the power and the riches and resources accumulated by some countries, some consortia and some companies are seen as dangerous, or mistrusted by many, on the evidence of their actions. This frequently-expressed position relates to our concerns for the disadvantaged in the world, as in point 5 above.
7. The reality of sin is an undeniable strand in the faith of the Church

The reality of sin is an undeniable strand in the faith of the Church. From Psalm 53’s vision of our own sheep-like tendency to stray, we are reminded that evil comes from within and we lose ourselves in debased thoughts (Psalm 53). This is harsh judgement, but the history of greed, ambition and the misuse of power by many who set out to be guardians and leaders among human beings gives powerful testimony to the existence in all humans of a propensity for self-interest that allows us to be controlled by forces or motives we know are not good.

8. Faith and hope

Faith and hope are ever-renewable and powerful motivators for Christians. For the scientist, the company or the country working with GM hope can guide and motivate so that decisions are made for good rather than evil.

Conclusion

It is in the light of this framework that we intend to present our case in relation to genetic engineering. We will try, as far as possible, to make our submission from the position of faith but able to be shared by a number of concerned individuals whatever their personal religious or secular orientation. Our use of biblical references is an attempt to resonate with the traditions and narratives of the Church of which we are a part. We recognise that the faithful come in many colours and interpret these strands in different ways, while yet retaining the fundamental attitudes that are expressed. Our submission in its entirety will seek to give expression to the foundational categories identified above.