Proposed Amendments to the Gene Technology Act 2000
The National Gene Technology Scheme (the Scheme) is a collaboration between all Australian governments, supporting a nationally consistent regulatory system for gene technology in Australia (Australian Government, Consultation Paper. Draft Gene Technology Amendment Bill, accessed 15/10/2024).The Gene Technology Scheme is authorised through the Gene Technology Agreement 2001, and is comprised of Commonwealth, state and territory legislation, including the:
• Gene Technology Act 2000 (the Act);
• Gene Technology Regulations 2001; and
• corresponding state and territory legislation.
The Scheme arose from the need to provide regulatory oversight for GMOs not regulated under existing regulatory schemes. The regulatory model summarised in Figure 1 enables expertise on gene technology and GMOs to be centralised with the Gene Technology Regulator (the Regulator) and is designed to minimise overlap between other Commonwealth regulators and agencies whose work intersects with the Scheme (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill presentation, 2024).
The scheme was first created to address a regulatory gap (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill transcript. Information session on the proposed amendments to the Gene Technology Act, 2024).
The GT Act establishes an independent statutory office holder, the Gene Technology Regulator (the Regulator). The Regulator is responsible for making decisions and exercising powers under the GT Act and corresponding state legislation. The Regulator is supported by the Office of the Gene Technology Regulator (OGTR)
At its inception, the Scheme was designed to complement the remit of other agencies and regulators that already governed aspects of GMOs and GM product regulation (Australian Government, Consultation Paper. Draft Gene Technology Amendment Bill, accessed 15/10/2024).
The object of the Act is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill presentation, 2024).
The proposed amendments to Gene Technology Act 2000 (the GT Act) aim to ensure the Scheme maintains flexibility to deal with future developments and challenges. They are the first major changes made to the GT Act since it was implemented (Australian Government, Proposed Amendments to the Gene Technology Act 2000, accessed 15/10/2024).
Other measures requiring legislative amendment are outlined in the Decision Regulation Impact Statement (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill transcript. Information session on the proposed amendments to the Gene Technology Act, 2024).
This is the third review of the Scheme. There are 27 recommendations to future proof and modernise the Scheme (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill presentation. 2024), all of which gene technology ministers have agreed to implement (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill transcript. Information session on the proposed amendments to the Gene Technology Act, 2024). The review diminishes complexities. These are the main amendments:
In Chapter 1: Scope of Regulation, review recommendations 4 & 6,
- Updating existing definitions to clarify the scope of regulation in light of ongoing advances;
- Amending the definition of ‘genetically modified organism’ to clarify that humans are not considered to be GMOs (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill presentation. 2024), but the therapeutic may be a GMO and be under your remit, this depends on what is an organism, which depends on what you define as a biological entity in the act (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill transcript. Information session on the proposed amendments to the Gene Technology Act, 2024).
Proposed amendments to key definitions of ‘deal with, ‘gene technology’ and ‘genetically modified organism’ (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill presentation, 2024).
Some of the proposed changes relate to terminology and change of language to reinforce that dealings are within the scope of the scheme, but do not necessarily require notification to the regulator (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill transcript. Information session on the proposed amendments to the Gene Technology Act, 2024).
Meaning of ‘deal with’
The GT Act as amended also now proposes to incorporate ‘storage’ of a GMO as a primary dealing, regardless of the purpose for which the GMO is being stored. Persons storing GMOs would also need an appropriate authorisation to do so.
‘Possession’ of a GMO will remain as a dealing in so far as it is incidental to other activities captured in this definition.
To supplement the revised definition, the GT Act as amended proposes that additional dealings will also be able to be prescribed by the GT Regulations
The proposed amendments are intended to ensure that all future activities involving GMOs are regulated under the GT Act or another regulatory scheme, and there are no gaps in regulation of GMOs.
Meaning of ‘gene technology’ (section 12B)
While the Third Review noted that the definition of ‘gene technology’ has largely endured, it acknowledged that changes were required to reflect scientific advances. The proposed amendments are outlined below.
Synthesis of genes or other genetic material
Feedback received during the Third Review consultation identified that a limitation of the current definition of gene technology is that it primarily relates to the modification, but not the creation, of genes or genetic material. With advances in science, it is now possible to create genes or genetic material in addition to modifying them. The intent of the Scheme is that such techniques would be within the remit of what is ‘gene technology’. Proposed amendments to the definition of ‘gene technology’ contained in the GT Act as amended clarify that for the purposes of the Scheme, gene technology means a technique for the synthesis or modification of genes or other genetic material, subject to a number of listed exceptions.
Mitochondrial donation techniques excluded
Mitochondrial donation is an in vitro fertilisation based assisted reproductive technology. It has the potential to prevent mitochondrial disease in babies born to mothers who may otherwise pass on the disease.
The Research Involving Human Embryos Act 2002 (Cth) (RIHE Act) was amended via the Mitochondrial Donation Law Reform (Maeve’s Law) Act 2022 (Cth) (Maeve’s Law). Maeve’s Law inserted a new section 47 into the RIHE Act to deal with the interaction between the RIHE Act and the GT Act. This was necessary to ensure that there is a single regulator responsible for the approval of mitochondrial donation techniques in humans, and for associated research and training. Regulation by both the National Health and Medical Research Council (NHMRC) and the Regulator would be inefficient and duplicative, particularly considering the comprehensive and detailed regulatory scheme introduced into the RIHE Act through Maeve’s Law.
The GT Act as amended includes a number of proposed amendments to retain the existing regulatory settings put in place by Maeve’s Law and to make the Scheme easier to navigate. These include the addition of proposed paragraph 12B(c), the introduction of two new definitions for ‘mitochondrial donation licence’ and ‘mitochondrial donation technique’, and the proposed repeal of section 47 of the RIHE Act (see Chapter 7 below).
Including techniques via the GT Regulations
Previous consultation throughout the Third Review identified that, with rapid advances in gene technology, it is desirable for the legislation to have flexibility to respond effectively by enabling the GT Regulations to specify additional techniques to be ‘gene technology’. While the D‑RIS contemplated such an approach, it has since been reconsidered because the definition of gene technology is central to the Scheme and is sufficiently broad. Allowing the GT Regulations to prescribe additional techniques could lead to unintended consequences, including modifying the scope of the Scheme.
The GT Regulations will continue to specify techniques, and classes of techniques, which are not gene technology for the purposes of the GT Act.
Meaning of ‘genetically modified organism’ (section 12C)
The current definition of ‘genetically modified organism’ is cast broadly to capture under regulation any organism that has been modified by gene technology, has inherited traits due to the use of gene technology, or has been prescribed to be a GMO in the GT Regulations. Amendments to the definition are proposed to ensure it remains fit-for-purpose in the context of rapidly advancing technologies as described below.
Specifying GMOs via the GT Regulations
It is proposed that the Regulations will continue to be able to be used to specify what is or is not a GMO. While it is not anticipated that such regulations would be prescribed for the purposes of this definition at this time, it is important to note that if amendments were ever proposed in the future, they would be subject to a separate consultation process and endorsement by the GTMM.
Organisms that have been produced by gene technology
The current definition of ‘GMO’ in the GT Act does not capture organisms that have been created by gene technology. In the future, through advances in synthetic biology, it may be possible to create organisms without modifying a pre-existing organism. An amendment to the definition of GMO ‘s therefore proposed at section 12C to capture organisms that are produced by gene technology (Australian Government, Consultation Paper. Draft Gene Technology Amendment Bill, accessed 15/10/2024).
In Chapter 2: Risks Considered under the Scheme, review recommendation 21,
- Clarify the intersection between the Gene Technology Regulator, other Commonwealth regulators and their legislation, including identifying any emerging areas where legislative or administrative changes can be made to reduce any unnecessary duplication
Proposed amendments include:
- address duplication in the assessment of risks posed by GMO dealings under different regulatory schemes; and
- clarify that the Minister and Regulator are not required to consider intended negative effects of a GMO on a specific weed, pest or pathogen.
Review recommendations 9 & 11,
- Introducing additional risk tiering into the Scheme to facilitate flexibility and ensuring the level of regulation remains proportionate to risk;
- Making changes to better enable the GMO Register to be more effectively utilised within the Scheme.
Proposed amendments:
- Changes to authorisation pathways under the Scheme; and
- Proposed amendments to provisions governing the GMO Register.
Some dealings currently covered by a GMO licence may fall into lower authorisation pathways under the proposed new regulatory approach (E.g. GMO permit or notifiable dealing).
In Chapter 3: Authorisation Pathways (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill presentation. 2024), the draft Bill proposes to remove the current binary distinctions between whether dealings with GMOs involve the release of the GMO into the environment or not. Instead, through the GT Regulations, new risk-based factors will be introduced to tailor consultation requirements and assessment timeframes for licensed dealings.
Similar to the current GT Act, under the revised authorisation pathways, all dealings with GMOs must be licensed, unless the dealing is eligible to be regulated by the Scheme under another authorisation pathway.
Under the current GT Act, the Regulator may issue an inadvertent dealings licence for certain dealings for a period of 12 months if satisfied that the applicant came into possession of the GMO inadvertently.
Under the GT Act as amended, inadvertent dealings licences will continue to be available
Similar to how exempt dealings currently work under the Scheme, non-notifiable dealings are proposed to be a new category of dealings with GMOs that pose a very low risk: for example, contained research involving well understood organisms and processes for creating and studying GMOs (Australian Government, Consultation Paper. Draft Gene Technology Amendment Bill, accessed 15/10/2024).
In Chapter 6: Use and Disclosure of Information, review recommendation 10,
- Reducing regulatory burden through streamlining processes and current regulatory requirements where appropriate.
Proposed amendments include:
- Revising the CCI framework;
- Use and disclosure of Regulator information (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill presentation, 2024).
Consultation responses should be provided via the survey in the consultation hub. Where possible, reasoning and supporting information should be included. Providing consultation responses via the survey in the consultation hub will ensure that input can be clearly considered against the relevant proposed amendments (Australian Government, Proposed Amendments to the Gene Technology Act 2000, accessed 15/10/2024).
Submit your views via the Consultation hub by 8 November 2024, specifically considering:
- Are additional amendments required to give effect to the decisions of the GTMM (and the intent of the Third Review recommendations)? (Australian Government, Public Consultation on the Draft Gene Technology Amendment Bill presentation, 2024).
Questions during the consultation period may be directed to: gene.technology.implementation@health.gov.au
Please note that changes to the draft Bill may occur as a result of feedback received before the Bill is introduced into the Commonwealth Parliament
Commencement of the revised regulatory framework proposed to be 12 months after passage of the Bill through the Commonwealth Parliament (Australian Government, Consultation Paper. Draft Gene Technology Amendment Bill, accessed 15/10/2024).
References
(Australian Government, 25/09/2024) Public Consultation on the Draft Gene Technology Amendment Bill presentation. National Gene Technology Scheme. An Australian, State and Territory Government Collaboration.
(Australian Government, 25/09/2024) Public Consultation on the Draft Gene Technology Amendment Bill transcript. Information session on the proposed amendments to the Gene Technology Act. National Gene Technology Scheme. An Australian, State and Territory Government Collaboration. Information session on proposed amendments to the Gene Technology Act
(Australian Government, accessed 15/10/2024). Consultation Paper. Draft Gene Technology Amendment Bill. Department of Health and Aged Care. Proposed amendments to the Gene Technology Act 2000 – Australian Government Department of Health and Aged Care – Citizen Space
(Australian Government, accessed 15/10/2024) Proposed Amendments to the Gene Technology Act 2000. Department of Health and Aged Care. Proposed amendments to the Gene Technology Act 2000 – Australian Government Department of Health and Aged Care – Citizen Space