The TGA has issued 45 infringement notices and fined InstantScripts Pty Ltd for the alleged promotion of prescription-only medicines through its telehealth services.

Key takeouts

  • Amid a surge in online telehealth platforms, the TGA is directing its focus to these businesses where they promote therapeutic goods in contravention of the Therapeutic Goods Act and Advertising Code.
  • Where serious non-compliance with the TG Act is identified, the regulator has said it will issue fines and undertake criminal or civil court proceedings against non-compliant entities.
  • Providers must regularly review their advertising practices and content to ensure compliance with Australian law.

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:

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:

  1. nicotine vaping products;
  2. medicinal cannabis, psilocybin and MDMA;
  3. 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
  4. 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.