Australian Capital Territory
Public Health (Risk Activity) Declaration 2006 (No 1)
Disallowable Instrument DI2006–137
made under the 
Public Health Act 1997, s 18 (Public health risk activities and procedures – declaration)
EXPLANATORY STATEMENT

Subsection 18 (1) of the Public Health Act 1997 (the Act) provides that the Minister may, by instrument, declare an activity that may result in the transmission of disease, or that may otherwise adversely affect the health of individuals in the context of the wider health of the community, to be a public health risk activity.  Section 18 (3) of the Act provides that a declaration under Subsection 18 (1) shall indicate whether the declared activity is licensable, registrable or a non-licensable activity.

This instrument declares prescribing of clozapine to be a public health risk activity.  Clozapine is an anti-psychotic medication.  It is a prescription only medicine, and is also listed in Appendix D of the Standard for the Uniform Scheduling of Drugs and Poisons (the SUSDP). This means that the national standard for regulating prescription of this medicine is that it may only be prescribed by someone who has received an authorisation to do so. This reflects the need to ensure that doctors prescribing clozapine are properly qualified and aware of the monitoring that must be done in order to minimise the risk of an adverse incident for patients who are taking this medication.

This declaration of prescribing clozapine as a licensable public health risk activity makes it so that doctors who wish to prescribe it must seek a licence from the Minister to do so.  At the same time this declaration has been made, an amendment to the Poisons and Drugs Regulation 1993 is being made to remove clozapine from schedule 1 to that regulation.  While clozapine was listed in that schedule, only specialist psychiatrists could prescribe clozapine, and only then with the permission of the Chief Health Officer.

The net effect will be that doctors who wish to prescribe clozapine will still be required to be licensed, but will not necessarily have to be specialist psychiatrists.  This will still meet the requirements of the SUSDP, and will bring the ACT position more closely into line with the position in other Australian jurisdictions.

No regulatory impact statement has been prepared for this instrument. The instrument maintains a level of regulatory control over prescribing of clozapine very similar to that imposed by the Poisons and Drugs Regulation 1993, and in fact relaxes the restrictions to allow more doctors to be given permission to prescribe clozapine.

This instrument is a disallowable instrument.