TGA imposes severe penalties on supplier of online prescription medicines to consumers

The Internet can offer consumers a convenient way to access therapeutic goods, but online purchases of prescription-only medicines can be extremely dangerous.

Due to the increased prevalence of direct-to-consumer advertising, online sales of prescription-only medicines have come under particular scrutiny by the Australian Therapeutic Goods Administration (TGA).

This was highlighted by the recent federal court decision in Secretary of the Department of Health v Peptide Clinics Australia Pty Ltd (Peptide Clinics) where the court ordered Peptide Clinics to pay a $10,000,000 fine for breaching a number of provisions of the Therapeutic Goods Act 1989 (Cth) (Act) and the Therapeutic Goods Advertising Code (No.2) 2018 (Cth) (Code).

Peptide Clinics advertised the supply of prescription-only medicine to consumers on its website and Facebook and Instagram pages and during telephone consultations with consumers. No prescriptions were required to purchase these medicines.

The court found that, in its advertising, Peptide Clinics had breached the Code:

• by making both ‘restricted representations’ (that identified serious forms of diseases such as heart damage, joint diseases, bone diseases and other ailments that were beyond the ability of the average consumer to evaluate accurate without a suitably qualified health professional) and ‘prohibited representations’ (that referred to conditions such as anxiety and depression), without TGA approval; and
• by making statements, claims and implications that the advertised medicines were safe or would not cause harm, and that encouraged the inappropriate use of what were dangerous medicines.

The court also found the promotion of these medicines to consumers contained scientific information that was inaccurate, imbalanced and misleading.

Relevantly, the TGA had given Peptide Clinics several opportunities to correct its conduct which it failed to do.

Peptide Clinics argued that its practice of getting consumers to initially fill in medical questionnaires, have those completed questionnaires reviewed by medical practitioners and then having telephone consultations with consumers before selling the prescription-only medicines was exempted from the prohibitions under the Act. Peptide Clinics claimed that this was exempted because the advice or information had been given directly to a patient by a medical practitioner in the course of treatment of that patient. The court disagreed.

In coming to its view, the court took into account the fact that the identity of the medical practitioner was not known to the consumer and that the advice the medical practitioner gave fell well short of the minimum standards expected of a doctor when treating a patient in respect of a medical condition. The court found that this business practice had misled consumers into thinking that the medical practitioners involved were acting in their best interests.

This case serves as a reminder to businesses that:

• the public advertising of prescription-only medicines to consumers is strictly prohibited and can lead to significant financial penalties;
• they should ensure their advertising doesn’t contain any ‘restricted representations’ or ‘prohibited representations’ unless TGA approval has first been obtained;
• they should cooperate fully and promptly with the TGA when issues are brought to their attention in order to avoid formal proceedings being brought against them or significant financial penalties.

If you have any questions or would like advice on the advertising of therapeutic goods, please contact us.