The Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017 passed through both Houses on 15 February 2018. The bills have yet to receive Royal Assent.
Notably, the Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 (Bill) reflects the second stage of legislative response to the Expert Panel Review of Medicines and Medical Devices Regulation (Review) and supports the implementation of further key Review recommendations.
The first stage of legislative change occurred with the Therapeutic Goods Amendment (2016 Measures No.1) Act 2017, which received Royal Assent on 19 June 2017 and supported the implementation of eight key recommendations of the Review.
The Bill brings significant changes to the Therapeutic Goods Act 1989 (the TG Act).
Broadly, the Bill impacts the regulatory framework for complementary medicines by introducing a new pathway for listed medicines and a new list of permitted indications. The regulations surrounding biologicals and medical devices will also be impacted. For example, there will be a number of changes to the conformity assessment procedures currently in place. There has also been an introduction of a two-staged process for the provisional registration of new medicines.
Impacting all therapeutic goods will be the changes to advertising, advertising offences, and enforcement actions.
What do you need to know?
We previously discussed the impact of the changes to the advertising of unapproved therapeutic goods here.
The new subsection 22(6) of the TG Act (as passed by both Houses) states:
“A person commits an offence if:
(a) the person claims, by any means, that the person or another person can arrange the supply of therapeutic goods; an
(b) none of the following subparagraphs applies in relation to the goods:
- the goods are registered goods or listed goods;
- the goods are exempt goods;
- the goods are exempt under section 18A;
- the goods are the subject of an approval or authority under section 19 that covers the supply of the goods by the person or other person;
- the goods are the subject of an approval under section 19A that covers the supply of the goods by the person or other person.”
Significantly, this captures unapproved therapeutic goods supplied under the Special Access Scheme (SAS) or by an Authorised Prescriber (AP) (under section 19).
Companies should consider the impact of subsection 22(6) and what they now may or may not be permitted to claim and/or ‘advertise’, noting that the definition of ‘advertise’ has also changed.
This means that, generally speaking, therapeutic goods companies can claim, by any means, that they or another person, can arrange the supply of therapeutic goods:
- the goods are registered or listed; or
- the goods are exempt goods (under the regulations); or
- the goods are the subject of an approval or authority under section 19 that covers the supply of the goods by the company or another person, such as:
- approval granted to a person for supply of unlisted/unregistered/ not exempt goods for use in the treatment of another person; or for use solely for experimental purposes in humans (unless conditions state otherwise);
- authority granted to a specified medical practitioner to supply specified therapeutic goods for use in treatment of humans; or a specified class of such goods to a specified class(es) of recipients (unless conditions state otherwise); or
- authority (by legislative instrument) to any health practitioner to supply specified therapeutic goods for use in the treatment of humans; or a specified class of such goods, to a specified class(es) of recipients under specific circumstances.
We anticipate that there will also be changes to the Therapeutic Goods Regulations and the Therapeutic Goods Advertising Code.
There have also been significant changes to advertising offences, in particular, section 42DL of the TG Act. The Bill introduces a new tiered offence regime in relation to the contraventions of specific requirements applying to advertisements about therapeutic goods. This provision applies to advertisements of all therapeutic goods and generic information about therapeutic goods.
We will consider the impact of these changes over the next few days.