Our recent article TGA turns up the heat on advertising requirements focused on how The Therapeutic Goods Administration (TGA) regulates advertising of therapeutic goods including sunscreens. The second and third articles in this series will go “back to basics” on all things TGA.
What is the TGA?
The TGA is the government authority responsible for administering the Therapeutic Goods Act 1989 (Cth) (the Act). The Act establishes and maintains a national regime relating to the quality, safety, efficacy, and timely availability of therapeutic goods that are used in Australia (whether produced in Australia or elsewhere) or exported from Australia.1 In furtherance of this objective, the Act sets out the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (ARTG), including advertising, labelling, product appearance and appeal guidelines.
The TGA is responsible for evaluating, assessing, and monitoring therapeutic goods (discussed below) and other therapeutic goods (e.g. menstrual products, disinfectants and sterilants).
What are therapeutic goods?
Therapeutic goods are broadly defined and include goods that are represented in any way to be, or that are, for any other reason, likely to be taken for therapeutic use (or used as an ingredient or container for such goods). Therapeutic use means use in or in connection with:
- preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury; or
- influencing, inhibiting or modifying a physiological process; or
- testing the susceptibility of persons to a disease or ailment; or
- influencing, controlling or preventing conception; or
- testing for pregnancy; or
- the replacement or modification of parts of the anatomy.2
Common examples include medicines, vaccines, sunscreens, vitamins and minerals, medical devices, and blood products.3
What is the ARTG?
Generally speaking, if it can be established that a therapeutic good has the attributes of quality, safety and efficacy, then it can be included on the ARTG. The ARTG holds information such as:
- product name and formulation details; and
- sponsor (company) and manufacturer details.
Products listed on the ARTG may also be subject to around labelling, ingredient descriptions and batch manufacturing.
Penalties are imposed by the Act for the import, export, manufacture or supply of goods not approved for inclusion on the ARTG. If a therapeutic good is not listed on the ARTG, then it cannot be legally supplied in Australia.
What does the TGA do?
The TGA approves and regulates products following assessment of risks against benefits. Recognising that different types of therapeutic goods carry varying risk profiles, the TGA applies scientific and clinical expertise to aid decision-making. Factors such as side effects, potential harm through prolonged use, toxicity and seriousness of the medical condition for which the product is intended to be used, are taken into account when assessing an application for inclusion in the ARTG.
Another important function of the TGA is compliance and enforcement activities to ensure compliance with the Therapeutic Goods Advertising Code. For example, during the COVID-19 pandemic:
- the TGA authorised specific promotional materials to support the rollout of vaccines, which otherwise would have breached the general prohibition on advertising of prescription medicines (e.g. vaccines) to consumers; and
- any explicit or implied references to COVID-19 were deemed “restricted representations” and therefore not allowed without prior approval from the TGA.
The TGA has a range of compliance and enforcement tools available to address non-compliance, ranging from investigatory powers, educational letters, warning letters, public warning notices and enforceable undertakings to criminal prosecution and civil action, which may attract penalties of up to $1,375,000 for individuals or $13,750,000 for body corporates.
What does the TGA not do?
The TGA is not responsible for researching or developing therapeutic goods, funding development of therapeutic goods, or providing clinical advice.
It does not regulate the following industries:
- veterinary medicines (Australian Pesticides and Veterinary Medicines Authority);
- healthcare practitioners (Australian Health Practitioner Regulation Agency);
- health insurance (Australian Prudential Regulation Authority);
- food and beverages (Food Standards Australia New Zealand); or
- cosmetic and chemical standards (Australian Industrial Chemicals Introduction Scheme).
How can we help?
HopgoodGanim Lawyers’ Intellectual Property, Technology and Cyber Security team includes legal professionals with experience in the practical workings of the TGA.
We can assist individuals and companies involved in the manufacture, advertising and supply of therapeutic goods with matters including:
- assistance with determining whether your product is a “therapeutic good” and therefore subject to the TGA;
- liaising with regulatory consultants in Australia and overseas, to deliver comprehensive support in major international markets;
- preparation or review of contracts for research and development, manufacturing, clinical trials, resale and distribution arrangements;
- strategic licensing and commercialisation of your therapeutic good; and
- seeking patent and registered design protection for your therapeutic good, and trade mark protection for your brand;
- preparing agreements with brand ambassadors; and
- reviewing advertising collateral for compliance with Therapeutic Goods Act, Therapeutic Goods Advertising Code and Australian Consumer Law.
For more information or discussion, please contact HopgoodGanim Lawyers’ Intellectual Property, Technology and Cyber Security team.
A special thanks to Siobhan Beckett and Matthew Stark for their assistance in putting this article together.
1. Therapeutic Goods Act 1989 (Cth), s 4.
2. Ibid, s 3.
3. What are ‘therapeutic goods’?