Gene Technology Regulation

The report of the Third Review of the National Gene Technology Scheme, centred on the Gene Technology Act 2000 (Cth), states that

Gene technology makes changes to genetic material, including genes or parts of genes. Using gene technology techniques, scientists can modify organisms by inserting, removing, or altering the activity of one or more genes, or parts of a gene, so that an organism gains, loses or changes specific characteristics. Living things which have been modified by gene technology are known as genetically modified organisms (GMOs).

Australia’s National Gene Technology Scheme (the Scheme) is highly regarded, both domestically and internationally. The Scheme is designed to protect the health and safety of people, and the environment, from the risks associated with gene technology. It has continued to demonstrate its ability to achieve this objective since inception.

The Scheme is a national cooperative of all state, territory and Commonwealth governments, set out in the intergovernmental Gene Technology Agreement 2001 (the Agreement). The Scheme comprises the Agreement, the Gene Technology Act 2000 (Cth) (the Act), the Gene Technology Regulations 2001 (Cth) (the Regulations), and corresponding state and territory legislation. These Commonwealth and state laws provide national coverage for the regulation of GMOs. The Scheme also works in conjunction with, and complements, other regulatory frameworks that deal with genetically modified (GM) products.

The object of the Act, the primary piece of legislation regulating GMOs, 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 GMOs. The Scheme regulates gene technology using a risk-based approach8, where higher risk activities involving GMOs are subject to greater regulatory oversight. Further information about the current operation of the Scheme can be found in Chapter Two: What is the Gene Technology Scheme and how does it work?

All stakeholders with an interest in the Australian Scheme expect a regulatory framework that achieves the object set out above. To be truly effective, this framework must be reviewed and delivered at a national level, with all interested stakeholders playing their part. To support this aim, the intergovernmental Agreement establishes a collaborative mechanism across all jurisdictions – states, territories and the Commonwealth – to oversight regulation of gene technology across Australia.

Multi-jurisdictional arrangements can be difficult and challenging. Australia’s gene technology scheme is purposefully designed to create a consistent, predictable and transparent approach to the regulation of GMOs across the country. However, within this framework, our constitution supports jurisdictions advocating for their own interests. The Agreement provides a formal national framework to achieve the shared objectives of the Scheme, as well as a mechanism to work through any differing views.

The Legislative and Governance Forum on Gene Technology (the Forum) is the ministerial body charged, through the Agreement, with responsibility for ensuring the national consistency of the Scheme. All jurisdictions have equal membership on the Forum. The Review has identified 27 recommendations, some of which call for further investigation, to be progressed via a work program overseen by the Forum. Recommendation 1 specifically recognises the role of the Forum, and the importance of continuing collaboration to implement the recommendations.

Regular reviews of the Scheme are required under the Agreement. Since the Scheme commenced in 2001, two reviews have been conducted (in 2006 and 2011). They focused on the operation of the Scheme and whether the policy objectives were being achieved. While there was some attention given to technical considerations, these reviews were predominately retrospective in nature, reviewing how well the Scheme had been meeting its purpose. The Third Review of the Scheme (the Review) has continued to focus on the ongoing achievement of the policy objectives of the Scheme. This is in a global environment where governments and citizens are discussing appropriate regulatory approaches to manage future advances in gene technology, and biotechnology more broadly. The Review’s Terms of Reference emphasise the need to assess and support the Scheme with a view to the future, taking into account the rapidly developing and innovative area of gene technology. Additionally, the Review considered how best to progress any outcomes of previous reviews that require further attention. Terms of Reference for the Review can be found in the Introduction.

Separate to the reviews of the Scheme, the Gene Technology Regulator (the Regulator) may also conduct technical reviews of the Regulations. While they have no scope to amend policy settings, technical reviews can consider enhancements to the operation of the Scheme, and may also lead to Regulation amendments. As the timing of the Regulator’s most recent technical review overlapped with the Third Review of the Scheme, consultation approaches aimed to minimise confusion and duplication of effort for stakeholders.

Governance of the Review reflects the Scheme’s national governance structure. Day to day operational oversight was provided through the Gene Technology Standing Committee (the Standing Committee) – senior officials from all jurisdictions, who report to the Forum. The Review was designed to harness the spectrum of views of government and non-government stakeholders across Australia. Consultation was supported by research and expert technical advice, which helped to address the complex scientific and regulatory nature of gene technology.

In discussing findings and recommendations the Review states

A diverse range of views were heard through the public consultation processes. These views were further informed by discussions with the Gene Technology Regulator, other experts and relevant bodies. This input, in combination with information from related reports, reviews and adjunct research, supported 33 initial findings arising from the Terms of Reference, and the subsequent development of 27 recommendations. The recommendations acknowledge and address: • the aspects of the Scheme that have operated successfully since its establishment and which should be maintained; and • areas within the Scheme where changes may assist to future-proof and modernise the Scheme and help ensure efficiency and timeliness in this context. The Review outcomes are presented in Chapter 1, which details the rationale supporting each recommendation. A high-level summary, grouped under the following themes, is provided below: • Overarching issues • Technical issues • Regulatory issues • Governance issues • Social and ethical issues Overarching issues

The legislative framework, and the Agreement that establishes the national Scheme, remain central to the successful operation of the regulatory framework. Equally important is the legislative and governance oversight provided by the Forum. The Review’s first recommendation acknowledges this sound foundation and the expectation that it should continue, while also recognising the need for updates and enhancements as the Scheme evolves.

It became apparent early on in consultations that the complexity and scope of the Scheme mean that it is not always well understood by all sectors. However, the majority of stakeholders agreed that the Scheme effectively provides for, and should continue to provide for, the health and safety of people and the protection of the environment, from the risks posed by or as a result of gene technology. The Scheme benefits both the public and industry at this broad level, and there was no call to alter the object of the Act. The Review also found that the Agreement is working well to support a national collaborative arrangement between jurisdictions and across relevant portfolios, and recognised the importance of maintaining this to ensure the Scheme continues to work into the future.

Review theme one: Technical issues

The foundations of the Scheme, now almost two decades old, are still providing a solid regulatory framework. This is a strong testament to a well-designed Scheme. Many of the issues that have arisen over recent years do not relate to the base construct of the Scheme, but to its ability to keep pace with the technology. The Review considered several issues relating to technical aspects of the Scheme. This included exploring the degree to which the legislative definitions are able to appropriately classify a range of advances in technology. There is debate occurring at both national and international levels that may impact these definitions, with other key reviews and activities still ongoing. The Review also noted significant differences in stakeholder opinion as to how, or even whether, definitions should be amended. These matters are central to the Review outcomes, particularly given the scope to ‘future-proof’ the Scheme. Any further work to resolve the definitions should consider this context.

The Review also investigated issues relating to extensions or advancements of modern technology, including synthetic biology, human gene therapy, GMOs released into the broader environment and gene drive organisms. The Review discussed the ongoing regulation of these applications, and options to manage possible risks associated with their application.

Review theme two: Regulatory issues

The Review considered contemporary approaches to regulation, including current best-practice and risk-based approaches. This is in an environment where understanding about the science and any inherent risks is evolving. Opportunities to improve the flexibility and agility of the Scheme, while maintaining the appropriate oversight measures, were key areas of focus.

Like many other systems for the regulation of gene technology around the world, Australia currently employs what is known as a ‘process-based trigger’. This means that any organism developed using a gene technology process is subject, at least initially, to regulatory requirements. The Review explored an option where risk assessments focus instead on the end-use or ‘product’.

Despite much discussion, stakeholders generally agreed that maintaining the current ‘regulatory trigger’ would be the most sensible outcome at this point. This position recognises that other regulatory schemes (i.e. food, medicines, etc.) would also need to be reviewed and amended for any change to be effective. The application of different levels, or ‘tiers’, of regulation within the Scheme was discussed, with a view to finding ways to ensure that regulatory requirements are proportionate to risk. This included exploring mechanisms to determine additional regulatory tiers for organisms with a history of safe use, as well as appropriate regulatory pathways and requirements for these organisms.

Thought has also been given to whether additional mechanisms should be available, or existing mechanisms can be leveraged, to help future-proof the Scheme’s ability to address technological advances. These include improving the utility of the GMO register, incorporating a principles-based approach to some aspects of regulation, and utilising the Gene Technology Standing Committee to progress updates to the Scheme, where possible.

The Review includes recommendations for streamlining the Scheme’s regulatory requirements, and for ensuring the Scheme is suitably equipped to regulate work with GMOs undertaken outside of universities, research institutions or large companies. The Review also considered how the Scheme impacts market access and international trade, and the role for the Australian Government in this area.

In summary, the Review determined that the ability to capture a broader scope of activities within the Scheme, via the process trigger, should be maintained. However, better alignment of regulation to the level of risk would enhance this fundamental strength, and support contemporary best practice. Review theme three: Governance issues The Review discussed the credibility, integrity and legitimacy of the Scheme, its legislative and governance provisions, as well as the independence of the Regulator. Supporting the overarching view that the core of the Scheme is sound and should be preserved, the Review concluded the current governance mechanisms should be upheld.

Matters relating to national consistency were also considered. This included the mechanism for applying corresponding legislation across the country, and the benefits of states and territories ensuring that their gene technology Acts continue to facilitate a nationally consistent Scheme.

The Review found that stakeholders continue to hold conflicting views regarding the advantages and disadvantages of moratoria legislation (whereby states and territories may ban the commercialisation of genetically modified crops for marketing purposes). This issue was explored in detail, with a recommendation calling for states and territories to give ongoing consideration to the economic effects, value and scope of their moratoria legislation. Other recommendations recognise the role of the Forum in pursuing national consistency of the Scheme, and addressing practical issues that may arise from moratoria legislation (such as transport). Australia’s regulatory scheme for gene technology is based upon scientific evaluation, and any potential benefits arising from a GMO are not currently considered in regulatory decision making. Whether this remains appropriate was examined by the Review. It was concluded that the objectives of the Scheme – protecting the health and safety of people, and the environment – are best achieved through a focus on gene technology risks and their management. Evaluation of potential benefits should not form part of regulatory decision making at this time. However, the Review also determined that the Scheme should ensure that no unnecessary regulatory burdens are imposed that might prevent potential economic, health or welfare benefits from being realised. The Review explored whether specific topic areas would benefit from additional policy direction (for example, the release of gene drives into the environment). Significantly, the Review recommended that the Forum should lead an Action Plan for the implementation of the Review recommendations. This may include mechanisms to clarify policy positions on key matters.

Further, the Review considered, and made recommendations on, the interface between the Office of the Gene Technology Regulator, other regulators and legislation, the level of funding required for the sustainable operation of the Scheme, and the most appropriate funding mechanism to achieve this.

Review theme four: Social and ethical issues

The Review’s discussion on social and ethical issues explored public attitudes and understanding of genetic modification, and the impacts for Australia. Consultation was supported by market research, which identified a number of misperceptions and knowledge gaps. These highlighted the need for better communication with the public (including the most appropriate body, or bodies, to undertake such communication activities). Increased understanding of the regulatory process and what is and isn’t covered by it, is particularly needed, as is better information on risk assessment and the existing transparency measures for communicating regulatory data. To further build public understanding and confidence in the Scheme, the Review recommends the development of additional targeted communication mechanisms. Recommendations also address ongoing concerns within some sectors of the community about the safety of GMOs, and the ability of the Regulator to monitor commercialised GMOs for long-term impacts.

International context

When reviewing Australia’s domestic regulation of gene technology, it is also important to be aware of how it is regulated in other countries. The international context is complex, and there is currently no agreed international regulatory framework for gene technology regulation, with countries taking a variety of different approaches. Unlike some countries, Australia currently has a ‘one size fits all’ approach, which means that regulatory changes that may be considered justifiable by some sectors, may have unintended consequences not only nationally, but internationally. Additional information about gene technology regulation in the international context can be found in Chapter Two: What is the Gene Technology Scheme and how does it work?.

Scope of the Review

The Review acknowledges that some applications of gene technology raise concerns for some stakeholder groups. While those that are within scope of the Review have been addressed, some of the concerns raised are beyond the scope of the Review to consider, and these topic areas are highlighted on page 16 and in Appendix 2: Matters out of scope of the Review.

Next steps and implementation considerations

The Review acknowledges that the scope of work arising from the Review recommendations is considerable, wide-reaching and will require cross-jurisdictional and cross-portfolio coordination to achieve. Some outcomes may be delivered in the short term, while others may require a medium or longer term for implementation. The Review recommends that an action plan be agreed by the Forum, to outline and demonstrate governments’ commitment to delivering the national priorities of the Forum. Part of this action plan will include consideration of the Review recommendations and how and when they may be implemented. As such, Ministers, via the Forum, will have further decision-making opportunities to determine priorities, responsibilities and funding impacts. Consideration will also need to be given to any administrative, legal and financial implications, prior to implementation of recommendations.

The Scheme is legislatively complex, comprising corresponding Commonwealth, state and territory legislation. It operates in conjunction with other jurisdictional regulatory schemes relevant to GMOs and genetically modified products. Any recommendations that are implemented through legislative amendments will need to be thoroughly tested and enacted through all applicable legislation, noting the Review cannot recommend changes to legislation outside the remit of the Scheme.

Where possible, it would be sensible to implement recommendations via administrative changes rather than legislative amendments. The Standing Committee could be tasked with managing the operational aspects of implementation through the Forum’s action plan, which would include development of a comprehensive Implementation Plan. Working in collaboration with stakeholders could also support implementation of recommendations in a timely, appropriate and cost-effective manner.The Review was undertaken by all governments through the Forum, using a comprehensive consultation process that included government (and non-government) stakeholders. As such, the recommendations represent the views of all governments. Through the Forum, all governments will collectively decide how best to progress the recommendations, through an agreed action plan.

Recommendations are as follows -

Overarching Recommendations 

Recommendation 1: To build upon and futureproof the Scheme, which is highly regarded, the Review recommends: a) the Forum progress options to update and enhance the operations of the Scheme; and b) these options be implemented in short, medium and long-term tranches, according to an action plan to be developed by the Forum. 

Recommendation 2: The Review recommends that the object of the Gene Technology Act 2000 be maintained. 

Recommendation 3: The Review recommends that the Gene Technology Agreement be maintained. 

Review Theme One: Technical Issues 

Recommendation 4: The Review recommends updating, where required, the existing definitions in the Gene Technology Act 2000 (Cth), to clarify the scope of regulation in light of ongoing technical advances. Any changes to definitions should take into account concurrent work, including relevant domestic reviews and ongoing work internationally. 

Recommendation 5: The Review recommends that: a) extensions and advancements of gene technology, such as synthetic biology, continue to remain within the scope of the Scheme; and b) a watching brief on synthetic biology should be maintained, to ensure the appropriate level of regulation is applied to future applications of synthetic biology. 

Recommendation 6: The Review recommends: a) the definition of a genetically modified organism under the Gene Technology Act 2000 (Cth) be amended to clarify that humans are not [considered to be] GMOs; and that b) subject to consideration, the COAG (Council of Australian Governments) Health Council might also consider whether additional regulatory oversight is needed for humans who may receive or inherit germline therapies (or other somatic therapies not within the remit of the Scheme). The COAG Health Council should also consider which regulatory (or other) body would be most appropriate to undertake such oversight. 

Recommendation 7: The Review recommends clarifying, and where necessary strengthening, the mechanisms for regulating the: a) broader environmental release of genetically modified organisms; and b) environmental release of GM gene drive organisms (as well as any additional requirements for contained work). 

Review Theme Two: Regulatory Issues 

Recommendation 8: The Review recommends that a process-based trigger be maintained as the entry point for the Scheme at the present, to allow for any potential risks associated with new technologies to be initially considered within the scope of the Scheme. 

Recommendation 9: The Review recommends the introduction of additional risk tiering into the Scheme, to facilitate flexibility of the regulatory Scheme and ensure: a) the level of regulation remains proportionate to risk, and protects against under regulation and over-regulation; and b) where appropriate, there is flexibility to move organisms between categories, based on identification of new risks, a history of safe use, or other relevant factors. 

Recommendation 10: The Review recommends reducing regulatory burden through streamlining processes and current regulatory requirements where appropriate. For example, this may include streamlining facility certifications and application processes. 

Recommendation 11: The Review recommends that changes be made to enable the GMO Register to be more effectively utilised within the Scheme. 

Recommendation 12: The Review recommends that, to ensure the Scheme’s current monitoring and enforcement activities remain adequate: a) regular reviews of these activities are undertaken; b) regulatory requirements for working with gene technologies are widely communicated and known; and c) the scope and associated risks of ‘DIY biology’ activity continue to be monitored. 

Recommendation 13: The Review recommends that to better respond to changes in scientific understanding and understandings of risk, consideration should be given to: a) enabling the Gene Technology Regulator to make decisions on the applicability of regulation to any technological developments, until such time as a policy approach has been agreed; and b) introducing elements of principles-based regulation to some parts of the Scheme, focusing on areas of the Scheme with a history of safe use 

Recommendation 14: The Review recommends reaffirming and clarifying governance arrangements to increase the agility of the Scheme, including more effective use of mechanisms for: a) the Gene Technology Standing Committee to consider and recommend changes to the legislation for the Legislative and Governance Forum on Gene Technology endorsement; and b) delegating certain activities and work programs of the Legislative and Governance Forum on Gene Technology to the Gene Technology Standing Committee. 

Recommendation 15: The Review recommends that the Australian Government, including the Gene Technology Regulator on regulatory matters, continues to: a) engage with appropriate international fora on matters relevant to market access and international trade; and b) ensure that any relevant international obligations continue to be met. 

Review Theme Three: Governance Issues 

Recommendation 16: The Review recommends maintaining current governance mechanisms to ensure that the Scheme’s current levels of credibility, integrity and legitimacy are upheld. This includes maintaining: a) high level governance oversight provided by all states and territories through a Legislative and Governance Forum on Gene Technology; b) the independence and credibility of the Gene Technology Regulator; and c) robust governance processes providing oversight of advisory structures and appointments. 

Recommendation 17: The Review recommends that states and territories continue to ensure that their gene technology Acts remain corresponding and that appropriate mechanisms are in place to update corresponding state and territory legislation following amendment of the Gene Technology Act 2000 (Cth). 

Recommendation 18: The Review recommends that states and territories give ongoing consideration to the economic effects, value and scope of moratoria. 

Recommendation 19: The Review recommends that consideration of benefits (e.g. potential economic, environmental and health benefits) should not be introduced as an element of regulatory decision making at this time. 

Recommendation 20: The Review recommends that the Scheme ensures regulation remains commensurate with the level of risk posed by a dealing (see Recommendations 9 and 10) so that no unnecessary regulatory burdens are imposed. 

Recommendation 21: The Review recommends clarifying the intersection between the Gene Technology Regulator, other regulators and legislation, which may include: a) identifying opportunities to enhance communication mechanisms and linkages; b) identifying any emerging areas where legislative or administrative changes can be made, to reduce any unnecessary duplication; and c) adopting relevant effective mechanisms from other schemes (for example, the Therapeutic Goods Act 1989 Special Access Scheme) where they may strengthen the Scheme. 

Recommendation 22: The Review recommends that further consideration be given to the most appropriate funding mechanisms to support the ongoing operation of the Scheme, and to appropriate funding levels for the Gene Technology Regulator’s activities, taking into account any changes to the Scheme. 

Review Theme Four: Social and Ethical Issues 

Recommendation 23: The Review recommends that targeted communications be developed to aid public understanding and confidence in the Gene Technology Scheme and identify the most appropriate body/bodies to deliver communications materials. 

Recommendation 24: The Review recommends that the Gene Technology Regulator continue to lead communication activities on topics related to the assessment of risk associated with gene technology. 

Recommendation 25: The Review recommends that the Gene Technology Regulator continue to identify and manage the risks posed by, or as a result of, gene technology, and to increase transparency and understanding. 

Recommendation 26: The Review recommends a science-based review of monitoring arrangements to ensure that any post release risks continue to be appropriately managed. 

Recommendation 27: The Review recommends that the Gene Technology Regulator continue to make relevant information publicly available, to maintain a high level of transparency within the Scheme.