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Thursday, 14 February 2008
Page: 320

Ms ROXON (Minister for Health and Ageing) (9:59 AM) —I move:

That this bill be now read a second time.

I must say it is nice to be presenting my first bill as a minister and to have so many familiar faces up in the gallery today. I suspect they might be here for a rather different first speech, but it is nevertheless nice to have people here who are so friendly to our cause.

This bill makes a number of amendments to the Therapeutic Goods Act 1989 to address the legal consequences arising from a recent decision of the Federal Court in Roche Products v National Drugs and Poisons Schedule Committee on 30 August 2007. In that case the Federal Court held that decisions made by the National Drugs and Poisons Schedule Committee under subsection 52D(2) of the Therapeutic Goods Act 1989, which include decisions to amend the Poisons Standard, are legislative in character.

On the basis of that decision, it is likely that the Poisons Standard and its amendments are legislative instruments for the purpose of the Legislative Instruments Act 2003. As such, they are required to be registered in the Federal Register of Legislative Instruments, known as FRLI, to be enforceable. However, as they were treated as non-legislative instruments prior to the Federal Court decision in Roche, the Poisons Standard and amendments made to it up to the time of the Roche decision have not been registered in FRLI. Furthermore, as certain amendments made to the Poisons Standard were not registered within the periods specified by the Legislative Instruments Act, that act operates to repeal the amendments. It is therefore necessary to reinstate those amendments, and provide for the integrity and enforceability of the Poisons Standard up until the Roche decision.

The Poisons Standard consists of decisions made by the National Drugs and Poisons Schedule Committee, established under the Therapeutic Goods Act 1989, regarding the classification of drugs and poisons into different schedules, from schedule 1 to 9, signifying the degree of risk. The Poisons Standard also contains a number of appendices which supplement the schedules by setting out additional controls, qualifications and exemptions affecting substances contained in the schedules. The higher the schedule, the higher the risk attributed to a relevant substance. Substances are then regulated under relevant state and territory legislation depending upon in which schedule the substances are included.

The Poisons Standard is also relied upon by the Commonwealth under the Therapeutic Goods Act for regulatory and enforcement purposes, such as for regulating advertising and labelling in connection with certain medicines.

Scheduling and rescheduling decisions by the committee are made based upon considerations of public health and safety, balanced with the need for public access to a substance. The committee may, for example, reschedule a ‘prescription only’ medicine to a ‘pharmacist only’ medicine on this basis, or vice-versa; or prohibit a substance from general access by the public to reduce the risk of abuse or dependence. It is therefore necessary in the interest of public health and safety to ensure that regulatory actions taken in reliance upon scheduling decisions made by the committee continue to operate.

To this end, the bill reinstates any scheduling decisions that may have been repealed, and puts beyond doubt that scheduling decisions made before the Roche decision are enforceable because they are deemed to have complied with the requirements of the Legislative Instruments Act.

The retrospective effect of the amendments will not add any new regulatory requirement. Rather, the retrospective effect of the amendments is necessary to preserve the status quo of the Poisons Standard, and amendments made to it, before the Roche decision. Decisions and actions taken by both the regulator and business relied upon the enforceability and integrity of the Poisons Standard and its amendments, and the retrospective effect of the bill is necessary to provide certainty for those decisions and actions.

The bill also makes it clear that the Poisons Standard and amendments made to it are exempt from the parliamentary disallowance process. This exemption recognises that it is inappropriate for Commonwealth instruments forming part of an intergovernmental scheme to be unilaterally disallowed, and the exemption is consistent with the operation of subsection 44(1) of the Legislative Instruments Act 2003. The exemption is also appropriate because of the need to ensure certainty in the continuing application of state and territory laws which refer to the Poisons Standard.

The bill also provides for a compensation regime in the event that the operation of the amendments to the act should result in an acquisition of property from a person other than on just terms.

Debate (on motion by Mrs May) adjourned.