The Gene Technology Bill continues to make its way through Parliament following feedback from the Health Select Committee.
The long-awaited report, published last Friday, makes several recommendations. These include which organisms and technologies should fall out of the Bill’s scope, and that the definition of kaitiaki relationships be expanded to include both indigenous and non-indigenous species of significance to Māori.
The Science Media Centre asked experts to respond to the report.
Professor Robert Weinkove, Clinical Director, Malaghan Institute of Medical Research, comments:
“Certain medical gene therapies, including CAR T-cell therapies for relapsed blood cancers, have been standard medical care internationally for years – and Kiwis are travelling overseas to access them. As for all medicines, CAR T-cell therapies carry risks to the patients receiving them. However, they do not carry risks to other people or to the environment. The risks and benefits of CAR T-cell therapies are balanced against other treatment options by clinicians, and are discussed with patients as part of informed consent and shared decision-making.
“The Malaghan Institute supports measures to simplify and expedite the approval of medical gene therapies in New Zealand, and their availability for New Zealanders who need them.”
No conflicts of interest.
Dr Revel Drummond, Molecular Biologist, Bioeconomy Science Institute, comments:
“Biotechnology in its many forms is providing us with all sorts of benefits, from the enzymes used to make cheese to the insulin saving the lives of diabetics. The Gene Technology Act will let New Zealand better embrace these technologies, the alternative to which is to become ever more dependent on imports of these sorts of vital products and medicines.
“I am very pleased to see the Health Select Committee report on the Gene Technology Bill and applaud the effort they have put into improving the Bill. It is clear that significant and vigorous debate has gone into the production of the report and the revisions to the Bill. With such a complex topic it is heartening to see that issues raised during the hearings have been deeply considered and incorporated into the modified text of the Bill.
“One significant change has been the development of the out-of-scope class of technologies and organisms and their strict definition in the Bill. These tools and organisms were already not regulated by the HSNO Act and it is important they are not regulated in this new law either, as to do so would put New Zealand far out of line with all our trading partners and the scientific community. From a purely scientific point of view, it is disappointing that the simplest forms of gene editing are not included in this out-of-scope category as they produce the same types of changes to the modified organisms (frequently with more precision).
“In addition, the Bill has been tightened to prevent any gene technology from being exempted from regulation by the Regulator. It will only be organisms that have been developed using gene technology that can be exempted and only if those can be shown to be verifiably indistinguishable from natural or non-regulated organisms. Again this a greater limitation of the use of gene technologies than was proposed in the original version of the Bill and from a scientific point of view unnecessarily risk adverse.
“This Bill will set the up the Regulator and the framework for that Regulator to work within. It is very important that we now see the secondary regulations so that the details of how the Regulator will assign technologies and organisms to the different risk tiers (non-notifiable, notifiable, licenced) in the different use cases (contained, medical, environmental). This will need to be publicly consulted and discussed to ensure that the Regulator has a strong mandate to regulate these technologies for the benefit of New Zealand.”
Conflict of interest statement: I use gene technologies in the course of my work at the BSI. This is a personal statement and does not necessarily reflect the views of the BSI.
Associate Professor Phillip Wilcox, Kaiawhina Māori, Department of Mathematics and Statistics, and Affiliate Faculty, Bioethics Centre, and Kaikōkiri Māori, Genetics Teaching Programme, University of Otago, comments:
“The select committee report recommends an extension of Māori evaluation to a small number of non-indigenous taonga species, as well as aligning attributes of Māori Advisory Committee members with those of the 2022 Plant Varieties Act. Whilst these modifications slightly increase Māori input, particularly around taonga species, any subsequent draft that incorporates these recommendations nonetheless effectively removes the existing requirement for Māori community input into the release of genetically modified organisms of non-taonga species. As such this legislation – if passed – does not comply with articles of Te Tiriti, which guarantees governance over taiao – the environment – in which genetically modified organisms of non-taonga species could be released into.
“Moreover, it appears the many potential negative economic impacts claimed by multiple submitters from the NZ business community have been ignored. One example of how the proposed legislation – if enacted – places a substantive part of a major economic sector at risk is the recent statement by the Forest Stewardship Council (FSC) – who certifies many of NZ forest growers – that NZ forest products would not be certified if growers use gene technologies in trees.
“In my view the legislation needs to be more thoroughly thought through, and more deeply consider and identify specific paths for gene technology implementation that provide a high probability of positive outcomes for Aotearoa/New Zealand. Research has repeatedly shown that most New Zealanders prefer case-by-case evaluation. The use of tikanga Māori as an evaluation process has also been supported by Māori and non-Māori alike and repeatedly shown to be effective and needs to be part of that case-by-case evaluation process.”
Conflict of interest statement: “I work on gene technology applications with and for Māori communities, in health and primary sectors.”
Dr John Caradus, Chief Technology Officer, Grasslanz, comments:
“The activity this Act focuses on is – ‘a regulated genetically modified organism’ where ‘gene technology’ means any technology used to modify or construct genes or other genetic material with the exception of a range of activities now listed in a Schedule (3A). This is a new Schedule and does not seem to list any comments on gene editing. It does permit Null segregants, epigenetic changes, and spontaneous mutation, plus all other activities currently permitted under the HSNO Act. So essentially no real change from the current HSNO Act.
“This differs from Australia, which was used as a model for the New Zealand regulations. In Australia, gene editing knock outs (SDN1s) with no foreign DNA introduced are exempt from regulation. This does not appear to be the case for New Zealand.
“The Regulator is the one making the decision on ‘determinations as to whether or not an organism is a regulated genetically modified organism, or a technology is a gene technology, or whether an organism is exempt from the operation of this Act’ (6.1.b.i). The Technical Advisory Committee will be advising the Regulator on any decision made on an activity being declared ‘notifiable’ or ‘non-notifiable’ (49.1). Additionally, the Regulator must maintain a Register that now also includes – ‘introductions into the environment of an organism or a category of organisms registered under regulations referred to in new section 163A;’ (58.1.ia), entitled – ‘Regulations requiring details of certain organisms or categories of organisms to be recorded on register’.
“The feedback from opposing parties is not encouraging. They indicate they want to ‘continue to work with and discuss our concerns with our coalition partners’ but this could and should have been undertaken more effectively during the extend select committee process. Their main concern is about trading implications as New Zealand explores the possibilities of using genetic modification. This does not seem to have been a cause for concern in Australia, who now have three or four genetically modified plant species grown commercially.”
Conflict of interest statement: Grasslanz Technology Ltd invests in research involving genetic modification with the view to delivering improved cultivars and Epichloë endophytes.