The Therapeutic Goods Administration (TGA) has fined InstantScripts, a major Australian telehealth service provider, $742,500 for alleged unlawful advertising of therapeutic goods. The TGA claimed that the business, in the course of providing telehealth services, advertised prescription-only medicines directly to consumers.
In Australia, the Therapeutic Goods Act 1989 (Cth) prohibits the advertising of prescription medicines directly to consumers, as consumers are not able to critically evaluate whether a particular prescription medicine is appropriate for their treatment needs.
Most promotional activities directed to consumers in relation to prescription medicines are likely to fall under the definition of advertising. The TGA, in its press release on 14 November, stated that the direct to consumer advertising of prescription medicines could ‘create an inappropriate demand for these medicines by patients and lead to unnecessary or harmful prescribing’.
The TGA has a broad range of enforcement powers in respect to the advertising of therapeutic goods that does not meet legislative and regulatory requirements, which include:
- Suspension or cancellation of therapeutic goods from the Australian Register of Therapeutic Goods (the marketing authorisation);
- Public warning notices;
- Infringement notices (up to $18,780 for an incorporated body for each contravention);
- Enforceable undertakings;
- Criminal prosecution (courts can impose penalties of up to 5 years imprisonment and/or fines of up to $1,252,000); and
- Civil penalties (courts can impose penalties of up to $15,650,000 for companies, for each contravention)
We noted earlier this year that there is likely to be greater scrutiny of and regulatory enforcement against telehealth service providers in Australia (see our article: Regulatory enforcement on the horizon for online prescriptions in Australia).
Given the heightened scrutiny, companies should keep in mind the advertising requirements relating to therapeutic goods (see our articles on advertising requirements this year: Advertising therapeutic goods in Australia (don't let your ad make you sad), and You say “ed”, they say “ad”: The fine line between lawful educational campaigns and unlawful advertising of therapeutic goods in Australia), as well as those for healthcare services.
Additionally, telehealth service providers should also ensure compliance with the updated telehealth guidelines that took effect from 1 September 2023 (see our article on this update: Updated telehealth guidelines to increase protection for patients).