New Restrictions on Therapeutic Goods Subject to an International Agreement

Federal Parliament has introduced new laws with significant penalties for the import, export, manufacture or supply of therapeutic goods prohibited under an international agreement.

Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 (Cth)

This article applies to organisations that deal with therapeutic goods.

Please be advised that the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 (Cth) (the Bill) received its third reading in the Federal Parliament on 18 February 2021 and received Royal Assent on 19 February 2021. The Bill will amend the Therapeutic Goods Act 1989 (Cth) (the Act) and commenced on 20 February 2021.

Background

The Bill allows for the making of regulations to prohibit the import, export, manufacture and supply of products containing substances that are prohibited or restricted under an international agreement that the Australian Government ratifies. It is expected that such regulations may relate to the prohibition of therapeutic goods that are mercury-added products prohibited under the Minamata Convention on Mercury that aims to protect both human health and the environment from anthropogenic emissions and releases of mercury and its compounds. Before ratification of an international agreement like the Minamata Convention, Australia must be able to comply with its obligations under the agreement. The amendments to the Act introduced by the Bill are designed to create a preparedness for the anticipated ratification of the Minamata Convention, and to put that level of preparedness in place for other possible future international agreements that also relate to therapeutic goods.

To that end, the Bill introduces new Chapter 2A to the Act, providing the above-mentioned regulation making power, however, further detail will be provided in the regulations themselves. For the time being, subscribers should note the significant penalties introduced by the Bill (as discussed below).

Prohibition on import, export, manufacture or supply of therapeutic goods – international agreements

The Bill provides that if therapeutic goods are the subject of an international agreement prescribed for the purposes of new section 9K of the Act, the regulations may prohibit the import, export, manufacture or supply of such therapeutic goods or of therapeutic goods containing an ingredient or component that is the subject of such a prescribed international agreement. The prohibition may be absolute, for example a complete prohibition on one or more of the import, export, manufacture or supply, or may be subject to such conditions as are prescribed.

The offence provision sets a penalty of 300 penalty units for an individual (currently $66,600) and 3,000 penalty units for a body corporate (currently $666,000).

These maximum penalty levels are designed to provide an effective deterrent to importing, exporting, supplying or manufacturing prohibited goods, and to reflect the seriousness of such conduct particularly in relation to the potential risk to human health if a person were to be exposed to harmful prohibited substances, such as mercury, as a consequence of such action. 

Please click here to access the full Bill.


Contact

For further information please contact the Law Compliance team:

Phone: 1300 862 667

Email: info@lawcompliance.com.au

Share this post

Ready to get in touch?