Second Reading: Gene Technology Amendment Bill

Ms HENNESSY (Minister for Health) — I move:

That this bill be now read a second time.

Speech as follows incorporated into Hansard under sessional orders:

Gene technology has many applications. In biomedical research, for example, it offers the prospect of very precisely identifying and mapping the genetic origins of disease. The better the genetic characterisation of a disease, the better the interventions used to cure or limit it.

The Gene Technology Act 2001 is the mechanism by which Victoria participates in a nationally consistent regulatory framework for gene technology established by an intergovernmental gene technology agreement in 2001. The object of the framework is to protect the health and safety of persons and the environment by identifying risks posed by gene technology and then managing those risks by regulating certain dealings with genetically modified organisms.

The agreement establishes a statutory commonwealth Office of the Gene Technology Regulator and a scientifically based licensing system to stipulate conditions for managing genetically modified organisms used in research. If a proposed dealing cannot be managed such as to protect the health and safety of persons or the environment, the gene technology regulator cannot grant a licence for that particular dealing.

The amendments introduced in this bill follow from an independent review of the commonwealth Gene Technology Act 2000 conducted in 2011. Following an ‘all of governments’ response’ to this review, gene technology ministers approved legislative amendments to the commonwealth act which were passed by the commonwealth Parliament on 10 September 2015.

The review found the regulatory system is working effectively overall, with the Office of the Gene Technology Regulator operating in an efficient and transparent manner. In particular, it was noted that the gene technology regulator is working closely and well with other statutory regulators, such as Food Standards Australia New Zealand and the Australian Pesticides and Veterinary Medicines Authority.

Consequential amendments to the Victorian Gene Technology Act 2001 now need to be made to keep Victoria in step with nationally agreed changes to the commonwealth act. These amendments are minor, technical or machinery in nature and aim to improve the efficiency and clarity of the act at the margins. The fundamental policy settings of the act, aimed at securing the health and safety of persons and the environment, remain unchanged.

The Gene Technology Amendment Bill 2015 introduces provisions to:

•       discontinue the gene technology regulator’s quarterly reporting requirements;

•       clarify what dealings may be authorised by ‘inadvertent dealings licences’;

•       update advertising requirements for certain public consultation purposes;

•       remove the requirement for information about genetically modified products authorised by other agencies to be included in the list of genetically modified organisms dealings kept by the gene technology regulator;

•       change licence variation requirements to provide greater flexibility for applicants wishing to vary their licences;

•       clarify what matters must be taken into consideration before a dealing may be scheduled as a ‘notifiable low risk dealing’ — that is, a dealing not requiring a licence; and

•       clarify some ambiguous wording concerning whether it is a ‘licence’ that is granted when the regulator makes an approval decision or it is an ‘application’ that is granted.

The major amendment relates to the granting of greater flexibility to licence-holders seeking to vary the conditions of their licences.

At present, the regulator can only vary the conditions of a licence if any risks identified in the licence as varied have also been identified and addressed in the original licence application. If this is not the case, a new licence is required. As amended, a variation to a licence can be granted or if the risks posed by the licence as varied have been identified and managed in any dealing with the same genetically modified organisms, but only where a licence was actually granted. This means that the regulator has scope to take account of more information than that simply contained in the one application and those applying for licence variations will not unnecessarily be required to submit completely new licence applications.

These amendments proposed by this bill are minor but they do sharpen the focus and operations of the act; they make efficiency gains without sacrificing safety and simplify the operation of the act.

In being so amended, the Victorian act will remain consistent with that of the commonwealth, ensuring that the national regulatory framework for gene technology continues to operate in a seamless and integrated manner in Victoria. In making these amendments, Victoria will also fulfil its obligations under the intergovernmental gene technology agreement.

I commend the bill to the house.