Senate debates

Wednesday, 9 September 2009

Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009

In Committee

11:04 am

Photo of Stephen ConroyStephen Conroy (Victoria, Australian Labor Party, Deputy Leader of the Government in the Senate) Share this | Hansard source

Subsection 52A simply provides that the secretary can expand the definition of a substance by legislative instrument to ensure that it can be subject to scheduling control. It has no regulatory impact unless a substance is then scheduled. Accordingly, there is no real need for consultation. Proposed new subsection (4), establishing a requirement for consultation on regulations, is superfluous and redundant. The Legislative Instruments Act 2003 mandates appropriate consultation with affected parties.

Amendment (3) is also redundant as part of the rescheduling process requires interested parties to be given the opportunity to make a submission to the relevant expert advisory committee. It is also against the very basis of the act to require the secretary to be satisfied that scheduling decisions will not have a negative impact on the industry or access by consumers to therapeutic goods. The whole point of scheduling is to impose restrictions on access to goods in the interests of public health and safety. Under these amendments, the secretary would never be able to make a decision to schedule previously unscheduled substances or up-schedule existing scheduled substances. For example, if evidence emerged that a medicine currently available over the counter in pharmacies could be used as a precursor to an illicit drug, this provision would not allow the secretary to take action to restrict its availability by changing it to a prescription-only medicine as such a change would adversely affect the industry and access by consumers. It was recognised in the Galbally review that these scheduling controls can have negative impacts on industry but are needed for the protection of public health and safety.

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