The Gene Technology (Queensland) Act 2016(Qld) commenced on 1 March 2017. It brings the State’s gene technology laws in step with Commonwealth legislation by automatically adopting Commonwealth laws, while allowing Queensland to opt out of future changes to Commonwealth laws where those changes aren’t in the State’s interests.
What is gene technology?
Gene technology is used to modify the genes and other genetic material of plants, animals, bacteria and viruses through the insertion or removal of specific genes. This results in the organism gaining, losing or changing a particular trait or characteristic. The modified organism is referred to as a ‘genetically modified organism’ (GMO).
Gene technology has developed drought-resistant chickpeas, herbicide-tolerant sugarcane, more nutritious bananas and insect-resistant cotton.
It has strengthened resistance to pests and diseases in agricultural products, and modified micro-organisms to produce therapeutic goods including insulin and vaccines.
Gene technology has a wide range of applications, both in Australia and around the world.
How is gene technology regulated?
Regulation aims to ensure that the commercial and humanitarian potential of gene technology is fully explored while also safeguarding the community and the environment against potential risks by requiring rigorous practices to be followed.
The law in Australia regulates all ‘dealings with’ a GMO. According to section 10 of the Gene Technology Act 2000 (Cth), this covers conduct such as experimenting, making, developing, producing, manufacturing, breeding, propagating, growing, raising, culturing, importing, transporting, disposing of or supplying GMOs.
Corporations and federal government bodies (such as CSIRO) are regulated by Commonwealth legislation (including the Gene Technology Act 2000 (Cth), the Gene Technology (Licence Charges) Act 2000 (Cth) and the Gene Technology Regulations 2001 (Cth)). Constitutional limitations on Commonwealth powers mean that the Commonwealth legislation cannot apply to all companies and government bodies, so Queensland legislation extends the regulatory scheme to cover Queensland state government agencies, higher education institutions and sole traders.
The Commonwealth legislation, along with corresponding State and Territory legislation, provides for a nationally consistent legislative system to regulate and encourage the development and use of gene technology throughout Australia.
The federal Act establishes the position of Gene Technology Regulator (Regulator), who is responsible for administering and enforcing the national gene technology regulatory system. The Legislative and Governance Forum on Gene Technology (GT Forum) and the Office of the Gene Technology Regulator (OGTR) provide support and guidance to the Regulator. In some instances, the Regulator is required to consult with prescribed regulatory agencies on licence applications for dealings involving the release of GMOs. Likewise certain agencies are required to consult with and/or notify the Regulator about applications for the registration of products that are genetically modified or contain GMOs. Examples of such agencies include the Therapeutic Goods Administration in relation to medicines, medical devices, blood and tissues, and Food Standards Australia New Zealand with respect to food products.
Why is legislative change happening in Queensland?
Under the 2001 intergovernmental Gene Technology Agreement (GTA), the States and Territories (including Queensland) agreed with the Commonwealth to maintain legislation that corresponds with the Commonwealth, to ensure a nationally consistent regulatory scheme for gene technology.
Under the previous Queensland regime, the State’s legislation operated as ‘mirror legislation’. Each time there was an amendment to Commonwealth legislation, Queensland would ‘mirror’ the amendment by altering its legislation. This was a manual process that required a bill to go before Queensland Parliament each time the Commonwealth legislation was amended. Given this process could take up to six months, there were periods of misalignment between the Commonwealth and Queensland legislative regimes. This resulted in uncertainty and inconsistency between entities subject to the Commonwealth law, and entities subject to Queensland law.
In 2013, an independent statutory review of this regime concluded (among other things) that efficiencies could be achieved by automatically applying Commonwealth laws as laws of Queensland (also called a “lock-step” approach). This recommendation was made on the proviso that there must be adequate safeguards for Queensland (ie an opt-out mechanism). The Queensland government’s response to the review in April 2014 agreed with the key conclusions made in the review, and in April 2016 the Gene Technology (Queensland) Bill 2016 (Bill), which adopted a lock-step, opt-out approach, was released for public consultation.
The Bill ultimately passed in October 2016 and its commencement date of 1 March 2017 was fixed by proclamation.
What are the legislative changes?
The Explanatory Notes to the Bill highlight that the objectives of the legislation are to meet Queensland’s commitment (as made under the GTA) to a nationally consistent gene technology regulation system and to provide certainty and consistency for Queensland government agencies, higher education institutions and sole traders.
In summary, the Act achieves these objectives by:
repealing the old Queensland regime and replacing it with this new legislation (section 23);
automatically applying the Commonwealth gene technology laws as the laws of Queensland (section 6);
ensuring Queensland Parliament autonomy by allowing it to modify automatically-adopted Commonwealth laws by regulation (section 7);
applying the Commonwealth Acts Interpretation Act 1901, criminal laws and administration laws to the Queensland Act (sections 8, 12 and 15 respectively); and
applying functions and powers of the Regulator under the Commonwealth laws in Queensland (section 9).
Lock-step – automatic adoption of Commonwealth laws
The Queensland Act achieves administrative efficiencies and national consistency by ensuring consistency with Commonwealth laws is automatically maintained. It effectively expedites the mirroring of Commonwealth legislation by ensuring they apply automatically in Queensland, which removes the need to bring forward a new bill for consideration by the Queensland Parliament every time there is a change to the Commonwealth laws. It also ensures certainty of regulatory oversight to all organisations based in Queensland, irrespective of whether they are covered by the Commonweal or State legislation, which may lead to greater planning and investment in gene technology research, development and innovation.
To keep Queensland Parliament informed of any changes, amendments to the Commonwealth laws must be tabled in the Legislative Assembly within 10 sitting days of commencement.
Opt-out – protection of Queensland autonomy
Queensland has preserved its ability to ‘opt-out’ of any amendments by way of regulation where it is not in the state’s best interests to adopt the Commonwealth amendments. The Act enables the state to make regulations specifying that an amendment to Commonwealth gene technology laws does not take effect in Queensland.
There is extensive consultation required between the Commonwealth and States and Territories prior to amending Commonwealth legislation. As well as this, the Gene Technology Standing Committee considers the proposed amendments, and the GT Forum must approve the amendments by special majority. As such, the Explanatory Notes outline that use of the opt-out provisions (which would result in misalignment between the regimes) is likely to be used infrequently. Any opt-out regulation that is tabled is also subject to disallowance by Queensland’s legislative assembly.
Where to from here?
The integrated national legislative regime regulates gene technology in order to protect the health and safety of the community and the environment while also enabling the development and release of productive, efficient and beneficial products.
Transitional provisions dealing with offences, licences, certification and accreditation (among other things) are included under Part 8 of the Queensland Act to ensure a smooth transition from the repealed legislation to the Queensland Act. The transitional provisions generally provide that, when a decision or action is pending at the point of commencement of the Queensland Act, that decision or action is made under the repealed legislation. Decisions or actions occurring from 1 March 2017 will be dealt with under the Queensland Act.
Gene technology isn’t just about increased efficiencies and commercial gains. It can be used to eradicate disease, improve nutrition, increase the availability of food, and develop vaccines. As was called out in the Second Reading Speech, not only is this the century of innovation in computers, electronics, robotics and digital disruption – it is also the time for Australia to embrace the use of gene technology.