The Therapeutic Goods Administration (TGA) has recently issued the telehealth provider 'InstantScripts Pty Ltd' (InstantScripts) with 45 infringement notices and fines amounting to $742,500. This comes after InstantScripts allegedly promoted prescription-only medicines through its telehealth services. Under the Therapeutic Goods Act 1989 (TG Act), the advertisement of prescription only medicines including insulin, antibiotics, blood thinners and blood pressure and cholesterol medication directly to consumers is prohibited.
In its media release on 14 November 2023, the TGA reinforced that "appropriate treatment options involving prescription medicines should be determined by a health professional in consultation with their patient" and explained that "advertising directly to consumers could create an inappropriate demand for these medicines by patients and lead to unnecessary or harmful prescribing". The TGA also indicated that where serious non-compliance with the TG Act is identified, it will take enforcement action including issuing fines and undertaking criminal or civil court proceedings against non-compliant entities.
Rise of telehealth necessitates regulatory focus
Given the relatively recent surge in the provision of healthcare through telehealth (and particularly online telehealth platforms), providers need be cautious about the substance of their promotional content. Providers must ensure that content does not impinge on the prohibition against advertising of prescription only medicines to consumers. Where the provision of health services is being advertised, it is important that the advertisement is not also an express or implicit promotion of a prescription only medicine. This often requires careful consideration of the promotional claims being made.
Healthcare providers and those promoting healthcare services must also familiarise themselves with regulatory requirements under the Health Practitioner Regulation National Law Act, which establishes requirements for advertising a regulated health service.
This recent TGA action, coupled with AHPRA's new Telehealth Guidelines which came into effect in September 2023 signals a greater regulatory focus on telehealth providers. It also serves as a timely reminder to those providing telehealth services that regular review of their practices and advertising is necessary to ensure compliance.
TGA recent enforcement activity
The TGA has been busy on the enforcement front throughout 2023, issuing a number of significant infringement notices as well as prosecuting various non-compliant entities. For example:
- October 2023, in Federal Court proceedings, the TGA obtained a combined $5 million penalty against Vapor Kings Pty Ltd and a Director for unlawfully advertising nicotine vaping products in contravention of the TG Act by the Federal Court of Australia;
- October 2023, the TGA issued Ovira Pty Ltd 6 infringement notices totalling $82,632 for alleged unlawful advertising of a system for the treatment of serious diseases including endometriosis, without approval from the TGA;
- September 2023, the TGA issued 8 infringement notices totalling $132,000 to Naturally Elevated Pty Ltd and 2 infringement notices totalling $6,600 to an individual for allegedly promoting the use and supply of prescription only medicinal cannabis;
- August 2023, the TGA issued 7 infringement notices totalling $115,500 to EmpireLabz Australia Pty Ltd for the alleged unlawful advertising and supply of sport supplement products which had not been included in the Australian Register of Therapeutic Goods; and
- March 2023, the director of AusLabs, Smart Labs and iSARMs was sentenced to 2 years imprisonment and fined $300,000 for his alleged role in the manufacture, supply and advertising of illegal Selective Androgen Receptor Modulators and nootropic products. The director's three companies also received fines totalling $2,225,000.
Priority areas of compliance
The TGA's recent enforcement actions show the regulator is turning its focus to the combined provision of healthcare services and therapeutic goods, amongst other areas of focus. The TGA has identified the following priority areas of focus for the 2023 – 2024 financial year. These compliance priorities include taking steps to investigate and penalise individuals and companies involved in the unlawful advertising of:
- nicotine vaping products;
- medicinal cannabis, psilocybin and MDMA;
- unapproved and high-risk medicines and medical devices used in the wellness and beauty industries including those intended to alter the body’s performance and appearance; and
- medicines and medical devices advertised as traditional or alternative treatments, particularly those that contain substances that pose a risk to human health and/or safety.
How we can help
Our Life Science and Health Regulatory teams at MinterEllison can support you in the assessment and management of compliance risks, including reviewing advertising strategies and your online presence.
