The proposed changes under the Therapeutic Goods Amendment Bill 2005
The new Therapeutic Goods Amendment Bill 2005 (Cth) (Bill)1 has far-reaching implications. The Bill will introduce:
- a new regime of criminal/civil penalty offences
- higher penalties for such offences, and
for the Therapeutic Goods Administration (TGA) to deal with manufacturers and sponsors not complying with the Therapeutic Goods Act 1989 (Act), as well as their 'executive officers'.
New criminal/ civil penalty regime
The Bill provides that certain criminal offences2 under the current Act will attract a new criminal/civil penalty regime of sanctions.
Criminal offences
Criminal offences will be re-structured into three main ‘tiers’3 of criminal culpability, depending on the level of fault and consequences of the conduct, as follows:
