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Australasian Biotechnology, Vol. 12, No. 3, June-July, 2002, pp. 31-32 BIOTECH LEGISLATION LEGISLATIVE STEPS IN NEW ZEALAND TO IMPLEMENT THE RECOMMENDATIONS OF THE ROYAL COMMISSION ON GENETIC MODIFICATION Mark Christensen and Ingrid Jamieson Anderson Lloyd Caudwell, Lawyers, Christchurch, New Zealand. Email: mark.christensen@alclegal.com Code Number: au02019 In July 2001 the New Zealand Royal Commission on Genetic Modification released its report and recommendations to the government. The Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Bill and the Medicines (Restricted Biotechnical Procedures) Amendment Bill are some of the first legislative steps taken by Parliament to implement the Royal Commission's recommendations. This article reviews the changes that these bills make to the law. Introduction The Hazardous Substances (Genetically Modified Organisms) Amendment Bill was reported back to the New Zealand Parliament by the Finance and Expenditure Committee on 28 March 2002. On the recommendation of the Select Committee, the title of the Bill was changed to the Genetically Modified Organisms and Restricted Biotechnical Procedures Bill. However, at the third reading on 22 May 2002 it was split into two separate bills: the Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Bill, and the Medicines (Restricted Biotechnical Procedures) Amendment Bill. These two bills are some of the first legislative steps taken by the New Zealand Parliament towards implementing the Report and Recommendations of the Royal Commission on Genetic Modification ('the Royal Commission') released in July 2001. (For discussion of the Report and Recommendations see Australasian Biotechnology vol 11 No 4 July/August 2001 p 36.) The Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Bill This Bill implements a number of important changes to the Hazardous Substances and New Organisms Act ("HSNO Act"). In particular, Unlike the Report and Recommendations of the Royal Commission, which was generally accepted to be balanced and comprehensive, this Bill has provoked strong criticism from both sides of the parliamentary floor. In the Select Committee's report, the dissatisfaction of the minority parties was clearly expressed. And at the third reading in Parliament, members of the Green party walked out of the debating chamber to protest the temporary nature of the Bill's moratorium on field trials. The following two sections outline the main provisions and requirements set out in the Bill. The restriction on releasing GMOs ERMA is restricted from considering or approving applications to release GMOs from 29 October 2001 to 29 October 2003. Exemptions from this restriction may be granted for certain medicines under the Medicines Act 1991, certain animal medicines under the Agricultural Compounds and Veterinary Medicines Act 1997, and applications for release in emergency under the HSNO Act. Applications for an exempted organism must include information that demonstrates that the organism cannot persist viably in the environment beyond the human being or animal subject to treatment. This means that the organism is unable to regenerate or reproduce without human intervention. In addition, ERMA must have regard to any adverse effects of the new organism on human health and safety, the environment (particularly ecosystems), and the abilities of the new organism as a medicine compared to a non-genetically modified medicine. GMO applications to ERMA Currently, the HSNO Act provides that ERMA must consider certain matters when dealing with applications to import, develop, or field test new organisms in containment. This includes the ability of the organism to establish an undesirable self-sustaining population, the ease at which the organism could be eradicated if it did, and the ability of the organism to escape from containment. The Bill provides for a number of additional matters to be considered for applications to field test GMOs and applications for developing GMOs where the development would take place in outdoor containment. That is, the additional matters to be considered during an application for GMO field tests and the conditions for containment of GMO field tests also apply to the GMO development processes where the organism is kept in outdoor containment. To this end, the Bill introduces a new term containment structure; developments occurring outside these structures are subject to the GMO field test controls. This issue was identified in the context of an application to develop GM cattle that would have involved them grazing outside in a field at the development (rather than field test) stage. ERMA must take a number of factors into account when making a decision: any adverse effects of field testing the GMO on human health and safety; the environment, in particular ecosystems and their constituent parts; alternative methods of achieving the research objective that have fewer adverse effects; and any effects resulting from the transfer of genetic elements to other organisms in or around the field test site. A number of controls are imposed on approvals for outdoor containment developments and field tests of GMOs. At the end of the field tests, the organism and any heritable material from the organism must be removed or destroyed. The approval may include controls that some or all of the genetic elements remaining from the organism are removed or destroyed. The definitions of these two terms are crucial to the effect of the Bill. The Select Committee made a deliberate decision not to include DNA in the definition of heritable material. The decision involved an assessment of the risk posed by horizontal gene transfer (IIGT) where bacteria can assimilate DNA into their own DNA other than by descent. This raises the possibility that genetically modified DNA will transfer from the field<.test organism to the DNA of other organisms. The committee decided that the risks associated with HGT were not significant enough to warrant including DNA in the definition of heritable material. If it were, the clean up process from field rests would involve sterilising significant volumes of soil and result in a defacto moratorium on field tests altogether because of the prohibitive costs and practical difficulties involved. in order to make certain that this does not happen, the Bill even explicitly states that the definition of destroyed includes leaving genetic elements to break down or become inactive at the site. However, there is still provision for ERIVIA to impose a control on the field test requiring that the genetic elements (including DNA, RNA, and proteins) be destroyed if it considers that an application poses a significant enough risk of HGT to warrant a complete clean up. The Bill also amends the HSNO Act by requiring that approvals for field tests of GMOs specify inspection and monitoring of containment facilities during the field test, and inspection and monitoring of the site after the field test to ensure that all heritable material is removed or destroyed. ERMA may specify inspection of the site before field testing begins to check that containment controls are in place. Although the HSNO Act currently obliges ERMA to set controls governing a number of matters including inspection and monitoring of field tests, the majority felt it was necessary to clarify that this also includes inspecting and monitoring the site after the field test ends. Implementing the Royal Commission recommendations The Royal Commission recommended that the HSNO Act provide for another level of approval between development and release called conditional release that would have a similar role to clinical trials used in medical research. The Bill does not provide for this and it has been criticised by a minority of the committee for failing to do so. However the changes required to implement a new approval would be significant and the majority was not prepared to do so without further guidance. The government is considering incorporating conditional release into the HSNO Act but this will only occur after public discussion and consultation following the release of a discussion document proposed by the government. Additionally, the Bill does not implement the recommendation from the Royal Commission that provision be made for the importation of low-risk GMOs, through delegation of the approval process to the Institutional Biological Safety Committees (IBSACs), rather than HSNO. Currently, applications for the development of low-risk GMOs in New Zealand are made to 1SBACs but importation of the same organism involves applying to ERI\4A. While agreeing that the change should be made to provide for the importation of low-risk GMOs in this manner, the majority declined to do so as they considered that it was outside the scope of the Bill. The Medicines (Restricted Biotechnical Procedures) Amendment Bill This bill controls xenotransplantation, germ-cell genetic procedures and cloning procedures in humans (definitions discussed below) by requiring authorisation from the Minister of Health to proceed. This part of the bill expires on 30 June 2003 but there is provision for it to be extended to 30 June 2005 by an Order in Council. Authorisation can only be given by the Minister when he or she is satisfied that: the procedure does not pose an unacceptable risk to the health and safety of the public, risks will be appropriately managed, and all ethical, cultural, and spiritual issues have been adequately addressed. The definitions of xenotransplantation, germ-cell genetic procedure and cloning procedures are crucial to this part of the Bill. Xenotransplantation The definition of xenotransplantation covers medical procedures that involve inserting matter into humans that consists of, or includes, living biological material of an animal or blood or fluids that have been in contact with the living biological material of an animal as part of a biotechnical procedure. The provision on xenotransplantation was considered by the Select Committee in the context of an application for clinical trial to insert encapsulated pig cells into diabetic human patients. The concern with this type of procedure is that porcine retroviruses will spread to humans. The majority of the committee decided that although the potential risk of the spread of porcine retroviruses was unknown (and might be low), the potential health consequences could be significant. The definition is therefore worded in order to cover similar techniques. Germ-cell genetic procedures Germ-cell genetic procedures are defined to mean the artificial insertion or injection into a human being of a genetically modified gamete, embryo, zygote, or embryo derived from a genetically modified gamete. Because the definition is concerned with the artificial insertion or injection of GM germ cells into humans, research on stem cells is not encompassed by this provision. Cloning procedures Cloning procedures covered by the Bill include the insertion and injection into humans of cloned human organism8 which is defined broadly enough to include human cloning by nuclear transfer. Human cloning is the subject of more thorough consideration in two bills currently at the Select Committee stage. Conclusion The passing of the Hazardous Substances and New Organisms (Genetically Modified Organisms) and the Medicines (Restricted Biotechnical Procedures) Amendment Bills indicates that the government has taken the first steps towards implementing the recommendations of the Royal Commission. However, the HSNO Amendment Bill leaves out all the significant amendments to the HSNO Act that the Royal Commission recommended to reduce unnecessary compliance costs and to streamline the application process. In separate announcements, the government has established a Biotechnology Taskforce to advise the government on its Biotechnology Strategy, and is calling for nominations for the Bioethics Council. Establishing these bodies was recommended by the Royal Commission, and will help New Zealand prepare for the 'Biotechnology Century'. Copyright 2002 - AusBiotech Ltd. |
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