New Organisms and Other Matters Bill 2003
Nathaniel Centre Staff
In May 2000, the government established the Royal Commission on Genetic Modification. In its report (July 2000) the Royal Commission made many recommendations, most of which were accepted by the government. The government has since introduced a Bill into Parliament called the "New Organisms and Other Matters (NOOM) Bill" covering a range of issues in response to the recommendations of the Royal Commission. It proposes amendments to the Hazardous Substances and New Organisms (HSNO) Act 1996 (47 clauses), the Medicines Act 1981 (8 clauses) and the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997(3 clauses).
Earlier this year The Education and Science Committee called for submissions on the above bill. The following submission was prepared by staff of The Nathaniel Centre in collaboration with its Panel of Advisers and Bishops from the New Zealand Bishops' Conference.
The introduction of the NOOM Bill includes recommendations that streamline the approval of the genetic modification of new organisms in laboratories and that will also allow for the approval of the conditional release of new organisms.
Readers seeking more background on the reasoning behind the particular stance taken by the New Zealand Bishops are advised to re-read the Bishops original Submission to the Royal Commission (see The Nathaniel Report Issue 2 or the Nathaniel website www.nathaniel.org.nz). This earlier submission canvasses many of the ethical dilemmas raised by the prospect of genetic modification while presenting a response grounded within the Catholic Moral Tradition.
Submission on behalf of The New Zealand Catholic Bishops Conference and The Nathaniel Centre – The New Zealand Catholic Bioethics Centre.
The Nathaniel Centre - The New Zealand Catholic Bioethics Centre - was established in 1999 as an Agency of the New Zealand Catholic Bishops Conference. Its role is to address bioethical and biotechnology issues on behalf of the Catholic Church in New Zealand.
The Church's Approach to the Environment
In the 1960's a growing environmental consciousness began to challenge concepts of development across the world. During the decade when this movement was emerging and gathering strength, the Catholic Church was immersed in its own form of renewal, the Second Vatican Council. Fundamental concepts concerning care for the environment and our use of the "goods of the earth" can be found in the documents of this Council [1962-1965]. These concepts have been built on and expanded over the last forty years in documents which have emphasized in many different ways that human dignity, care for the environment and sustainable development are inextricably linked.
The most recent of these documents is the Venice Declaration, signed by Pope John Paul II and Greek Orthodox Patriarch Bartholomew I in June 2002. In this Declaration there is a strong call for an environmental ethical code which would be acceptable to a broad range of people:
"...We therefore invite all women and men of good will to ponder the importance of the following ethical goals:
- To think of the world's children when we reflect on and evaluate our options for action.
- To be open to study the true values based on the natural law that sustain every human culture.
- To use science and technology in a full and constructive way, while recognising that the findings of science have always to be evaluated in the light of the centrality of the human person, of the common good and of the inner purpose of creation...
- To be humble with regard to the idea of ownership and to be open to the demands of solidarity. Our mortality and our weakness of judgment together warn us not to take irreversible actions with what we choose to regard as our property during our brief stay on this earth. We have not been entrusted with unlimited power over creation, we are only stewards of the common heritage."
We make our submission to the Select Committee out of this tradition of Catholic thought. The points we wish to make about the proposed legislation build on and develop the position taken by the New Zealand Catholic Bishops in their submission to the Royal Commission on Genetic Modification.
In their submission to the Royal Commission the Bishops said:
"We do not see the technology of genetic modification to be in conflict with ethical values... We believe that all human beings have a role as co-creators with God, and as participants in the evolutionary process. The responsible use of genetic modification is a further challenge for us as stewards of the gift of creation. To use genetic modification for both our benefit and that of other species, while at the same time preserving the rich biodiversity of life, is the essence of this challenge."
They also noted that:
"Beneath any considerations of technological possibility, safety, commercial gain, therapy or environmental impact lies the fundamental question of the moral acceptability of genetic modification. In itself, the technology of genetic modification is not unethical. Like many human inventions it has great potential for good, but also the potential for harm which could affect not just current but future generations. Ethical and moral principles need to be at the heart of our decision-making in relation to genetic modification."
This position in turn reflects the position on genetic modification taken by the Pontifical Academy for Life (Rome) in its 1999 document "Animal and Plant Biotechnologies".
The stated intention of the New Organisms and Other Matters Bill - "to provide a practical framework for proceeding with caution in the management of new organisms while preserving opportunities" - is consistent with the general principles underlying the approach of the Catholic Bishops of New Zealand to biotechnology.
We make the following specific points in relation to the proposed "New Organisms and Other Matters Bill":
Cultural Ethical and Spiritual Considerations
In the Report of the Royal Commission on Genetic Modification the Commission noted that an "effective process needs to be found to ensure that key cultural and ethical considerations are not excluded" [H 1:25]. The Explanatory Notes for the New Organisms and Other Matters Bill states that the Hazardous Substances and New Organisms Act (HSNO), as it stands at the moment, does not fully reflect the ethical, cultural and social concerns (page 15).
We welcome the establishment of Toi te Taiao, the Bioethics Council to act as an advisory body on ethical, spiritual and cultural dimensions in the use of biotechnology and to assess and provide guidelines on biotechnological issues involving significant ethical, cultural and spiritual dimensions.
Both HSNO and The New Organisms and Other Matters Bill (NOOM) lack provision for a means by which the broad guidelines and principles provided by Toi te Taiao, can be applied at a case by case level. Unless such provision is made in legislation, the incorporation of a means for ensuring that the ethical, cultural and spiritual dimensions of particular applications will be routinely and adequately taken into account is left to the discretion of ERMA. This is unacceptable.
We support the powers of the Minister to "call in" particular applications when "the decision on the application will have significant cultural, economic, environmental, ethical, health, international or spiritual effects." We support the addition of "cultural, ethical, and spiritual" effects as potential reasons for calling in particular applications.
We do not believe that making provision for the minister to "call in" particular applications will, however, result in a legislatively prescribed process that fully reflects the cultural, ethical, and spiritual effects as stated in the Bill's intention. Ethical, cultural, and spiritual features must be an integral part of all applications from their very inception and in all subsequent processes of review and approval. Therefore, the routine consideration of these elements needs to be a constitutive part of the consideration of all applications rather than, as is proposed, an add-on feature in exceptional circumstances, and only then at the discretion of the Minister. If ethical cultural and spiritual features were integrated more adequately into the application process, via the legislation and ERMA's Methodology, it would address the need to make HSNO more fully reflect these concerns.
We are concerned that the "risk management" framework – which is the basis on which ERMA operates – will not be appropriate for a comprehensive assessment of the ethical, cultural and spiritual dimensions pertaining to applications. A broader framework is required. A possible way forward may be through an ethical committee structure modeled on the existing regional Health and Disability Ethics Committees. These independent committees consider the ethical issues associated with health care research and the introduction of innovative treatment. They do so in an interdisciplinary manner that takes full account of the scientific, social, ethical, cultural and spiritual aspects of research protocols.
The Report of the Royal Commission on Genetic Modification states that "there will be times when we may chose to restrict choice because of a societal decision that there are some uses of a technology that are unacceptable for cultural, spiritual or ethical reasons...even were it to be 'safe'" [H1: 32]. Therefore, in line with our comments made above, we believe that Section 36 [Minimum Standards] of the HSNO Act, which sets out the reasons for which the Authority may decline an application, should include a standard covering significant adverse effects on the culture, spirituality, and ethical values of New Zealanders. Without this expansion of the minimum standards we believe that the HSNO Act does not adequately address ethical, cultural, spiritual issues, which according to the Explanatory Notes is one of the purposes of the NOOM bill.
Membership of Authority
Membership of the Authority should be interdisciplinary and representative of a variety of persons with the appropriate scientific, social, cultural, ethical and spiritual backgrounds and experience. We support Clause 8 which addresses Māori interests, and submit that it should be extended to include ethical, spiritual and cultural knowledge under "matters". In this respect we would see culture as including the culture of all New Zealanders.
Nga Kaihautu Tikanga Taiao
While we welcome a legislated place for Nga Kaihautu Tikanga Taiao, in practical terms this advisory status does not guarantee Māori any greater participation in the actual decision-making arena of the Authority. We do not believe this structure will give sufficient consideration to Māori community views as part of mainstream decision-making about genetic modification. We submit that Māori perspectives need to be an integral part of the decision-making process rather than being primarily part of an advisory role. We believe that Clause 8 is a vital component in giving Māori this place in decision-making, and that without acceptance of Clause 8 the new statutory status of Nga Kaihautu will change little for Māori.
We submit that the appointment of members to Nga Kaihautu Tikanga Taiao needs to be done in consultation with relevant Māori authorities.
Application for Approval to Import or Release Genetically Modified Human Cells and Tissues
With regard to the importing of genetically modified human cells or the genetic modification of human cells within New Zealand, we support the amendment to the definition of organism to include a human cell. This will ensure that the gap in current legislation is closed.
The HSNO Act currently provides for two scenarios concerning the release of genetically modified organisms into the environment, namely, no release or full release. Conditional release of genetically modified organisms represents a precautionary step, which is in keeping with the findings of the Royal Commission. It gives ERMA power to authorise release with certain conditions. We support this more cautious approach and suggest that Government consider conditional release as the only form of release for new organisms for a defined period of time.
Pecuniary Penalties and Civil Liability for Breaches
We support the strong pecuniary liability regime including the size of penalties because they help to underscore the need for safety and caution in the use of genetically modified organisms.
The Nathaniel Centre 2003