Telehealth Providers Beware: TGA Cracks Down on Prescription Drug Advertising

With the recent Therapeutic Goods Administration (TGA) guidelines in March 2024 honing in on advertising cosmetic health services involving injectables, it’s clear the TGA is focusing on a number of different industries when it comes to advertising. A laser focus on compliance is more important than ever before.

So what laws apply to telehealth services and providers?

The Medical Board of Australia defines ‘telehealth consultations’ as “consultations that use technology as an alternative to in-person consultations between a patient and medical practitioner (doctor)”.  This is a broad definition and includes video, internet and telephone consultations, the electronic transmission of digital images and data, and the electronic prescribing of medicines.  

And the Therapeutic Goods Administration (TGA) is now flexing its muscles when it comes to telehealth and prescription-only medications. 

In a recent move in late 2023, they fined InstantScripts Pty Ltd a hefty $742,500 for allegedly promoting prescription-only medicines through their telehealth services.

This significant fine sends a clear message: telehealth providers need to be extra cautious about their advertising practices. 

Here’s a breakdown of what you need to know:

Why the Crackdown?

The core concern is protecting consumers. The TGA emphasizes that decisions about prescription drugs should be made by a qualified healthcare professional and discussed in a private patient consultation, and not influenced by misleading advertising. Direct-to-consumer advertising of these medications could lead to patients pressuring doctors for unnecessary prescriptions, potentially causing harm.

The Rules of the Game

Pursuant to s 42DLB(1) and (7) of the Therapeutic Goods Act 1989 (Therapeutic Goods Act), advertising substance or goods containing substances which are included in Schedules 3, 4 or 8 to the current Poisons Standard (but not in Appendix H of the current Poisons Standard) other than a reference authorised or required by a government or government authority, is prohibited. 

This means advertising prescription-only medicines like insulin, antibiotics, and blood pressure medication as well as substances such as botulinum toxin type A (often known as ‘Botox’) directly to consumers is strictly prohibited. 

This applies to telehealth providers as well. Section 42DLB of the Therapeutic Goods Act is a civil penalty provision – companies that breach this provision can receive large fines if they are found to be in breach, with the maximum penalty being 5,000 penalty units (currently $1.565 million) and 50,000 penalty units for companies (currently $15.65 million).

What Does This Mean for Telehealth Providers?

Here are some key takeaways and steps to take to ensure compliance:

  • Review your promotional, social and advertising content. Make sure it doesn’t advertise prescription-only medications in any way, even implicitly.
  • Focus on the service, not the drugs. Promote the benefits of your telehealth consultations without mentioning specific medications or treatments if it involves prescription medicines.
  • Brush up on regulations. Familiarize yourself with the Therapeutic Goods Act as well as the Therapeutic Goods Advertising Code, the legislative instrument was made under section 42BAA of the Therapeutic Goods Act.

Beyond the TGA:

TGA isn’t the only regulatory body keeping an eye on telehealth. The Australian Health Practitioner Regulation Agency (AHPRA) and the Medical Board of Australia are also focused on regulating this area of health services.

The new Telehealth Guidelines issued in September 2023, developed by the Medical Board of Australia under section 39 of the Health Practitioner Regulation National Law Act (the National Law), highlight the increased scrutiny on telehealth practices.

Not Just InstantScripts

The TGA has been busy enforcing regulations across the board in 2023. 

The TGA issued 20 infringement notices totalling $159,840 to Mode Medical Pty Ltd (trading as Drip IV Australia) and an executive officer of the company, for the alleged unlawful advertising of intravenous infusion products to Australian consumers on a company website and social media. There were multiple alleged breaches, including alleged prohibited and restricted representations, as well as advertising that referred to ingredients that are prescription only, such as glutathione. 

They’ve also issued fines and prosecuted various entities for offences like:

  • Unlawfully advertising nicotine vaping products.
  • Promoting unapproved treatments for serious diseases.
  • Selling unregistered sports supplements.
  • Manufacturing and advertising illegal performance-enhancing drugs.

The Takeaway

The recent enforcement actions show the TGA is prioritizing regulating the intersection of telehealth and prescription-only medications. Telehealth providers should take a proactive approach by regularly reviewing their practices and advertising materials to ensure compliance. Remember, avoiding hefty fines and protecting your patients’ well-being should be top priorities and engaging in best practice will help you stand out as an industry leader.

Need guidance in relation to compliance with TGA laws? Here at Law Quarter, our lawyers offer advice to clients in many areas and industries, including beauty and skincare, aesthetic medicine, cosmetic clinics and healthcare. We also run a sister business, Compliance Quarter so we can help you implement compliance programs in your business.You can also reach out to Jacqui Jubb, Partner at Law Quarter at jacqui@lawquarter.com.au or 0411 659 671 to discuss your concerns. We’d love to help.

Picture of Jacqui Jubb

Jacqui Jubb

Leave a Reply

Your email address will not be published. Required fields are marked *