The maximum amounts for the 3. Substantial Civil penalty for failing to penalties in this option are equivalent civil penalties report a medicine shortage: to those imposed under existing and criminal sections 29A and 29AA of the TG Act Maximum civil penalty: offence for failing to notify the Secretary of information relating to adverse effects for an individual 3,000 – of registered or listed therapeutic penalty units; and goods that a sponsor is aware of. for a body corporate – Section 29A creates a criminal offence 30,000 penalty units. and under section 29AA the person is liable to a civil penalty for such Criminal offence for failing to conduct; report a medicine shortage: Subsection 4K(2) of the Crimes Act Penalty: Imprisonment for 1914 would apply (this creates a daily 12 months or 1,000 penalty or continuing offence for each day the units, or both. person is in breach after the day on which the person must take the This option would also required action ie in this case – include publishing the reporting the medicine shortage); names of sponsors who do not comply with the New section 42YCA of the Act would mandatory reporting also apply under this option (this requirements on the TGA provides for daily civil penalties for website (and potentially in each day of contravention after the other media), and the issuing day on which the person must take of an infringement notice for the required action ie in this case – a contravention in most reporting the medicine shortage); circumstances (in the Where the offender is a body amount of up to 60 penalty units for a body corporate), corporate, its executive officers could and publication of the notice potentially be personally liable, in accordance with section 54B of the on the TGA website. Act; The maximum amount of the potential penalties under this option would be more substantial, and may not be consistent with a regime in which repeated non-compliance is expected to be rare; The non-reporting of medicine shortages may not be directly analogous to the non-reporting of the adverse effects of medicines, particularly in relation to whether harm to a person is, or may be, directly related to the non-reporting; Criminal offences may not necessarily be the most effective sanction the
3. Substantial civil penalties and criminal offence Civil penalty for failing to report a medicine shortage: Maximum civil penalty: for an individual – 3,000 penalty units; and for a body corporate – 30,000 penalty units. Criminal offence for failing to report a medicine shortage: Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. This option would also include publishing the names of sponsors who do not comply with the mandatory reporting requirements on the TGA website (and potentially in other media), and the issuing of an infringement notice for a contravention in most circumstances (in the amount of up to 60 penalty units for a body corporate), and publication of the notice on the TGA website. The maximum amounts for the penalties in this option are equivalent to those imposed under existing sections 29A and 29AA of the TG Act for failing to notify the Secretary of information relating to adverse effects of registered or listed therapeutic goods that a sponsor is aware of. Section 29A creates a criminal offence and under section 29AA the person is liable to a civil penalty for such conduct; Subsection 4K(2) of the Crimes Act 1914 would apply (this creates a daily or continuing offence for each day the person is in breach after the day on which the person must take the required action – ie in this case reporting the medicine shortage); New section 42YCA of the Act would also apply under this option (this provides for daily civil penalties for each day of contravention after the day on which the person must take the required action – ie in this case reporting the medicine shortage); Where the offender is a body corporate, its executive officers could potentially be personally liable, in accordance with section 54B of the Act; The maximum amount of the potential penalties under this option would be more substantial, and may not be consistent with a regime in which repeated non-compliance is expected to be rare; The non-reporting of medicine shortages may not be directly analogous to the non-reporting of the adverse effects of medicines, particularly in relation to whether harm to a person is, or may be, directly related to the non-reporting; Criminal offences may not necessarily be the most effective sanction the
consultation-management-and-communication-of-medicines-shortages.docx