Australia: TGA Regulations and Medicinal Cannabis Advertisement
Regulatory update: TGA targets unlawful medicinal cannabis advertising
As Australia’s medicinal cannabis industry grows, so too does the scrutiny over how it’s marketed. The recent actions taken by the Therapeutic Goods Administration (
TGA) against several entities for alleged unlawful advertising practices, signal a firm stance on upholding the standards set out in the
Therapeutic Goods Act 1989 (Cth) (
the Act). As the industry grows, this article serves as a timely reminder of the legal responsibilities surrounding the promotion of therapeutic goods and the consequences of non-compliance.
The TGA has issued 35 infringement notices totalling $627,252 to 6 businesses and 2 individuals for the alleged unlawful advertising of medicinal cannabis on their websites and social media platforms.
1 These businesses and individuals, unrelated to one another, include licensed medicinal cannabis manufacturers and importers, health clinics and retailers.
It is alleged that each business had unlawfully promoted the use and supply of prescription-only medicinal cannabis in contravention of section 42DLB of the Act.
The advertisements allegedly:
- used indirect references to medicinal cannabis, such as ‘plant medicine’;
- implied that medicinal cannabis had been approved or recommended by the TGA; and
- promoted their own prescription-only medicinal cannabis products. These medicines were unapproved medicines and were not entered on the Australian Register of Therapeutic Goods.
Section 42DLB of the Act holds that a person contravenes the Act if they advertise by any means, therapeutic goods or, cause the advertising by any means of therapeutic goods. Therapeutic goods are broadly defined to comprise of medicines, biologicals and medical devices. They may include things such as bandages, pregnancy testing kits, herbal remedies, tissue grafts, and medications such as paracetamol. Consistent with the definition of ‘Therapeutic Goods’ in the Act,
2 medicinal cannabis is classified as a therapeutic good.
The businesses and individuals subject to the infringement notices had allegedly also endorsed the use of medicinal cannabis for treating serious diseases and conditions such as post-traumatic stress disorder, chronic pain and cancer. These references were considered by the TGA to be ‘restricted or prohibited representations’ in accordance with part 8 of the Advertising Code.
3 Advertisement of prescription-only medicines such as medicinal cannabis directly to consumers is prohibited by the Act, as it may create inappropriate demand and lead to harmful prescribing. The TGA considers that treatment should be determined and monitored by a health professional in consultation with their patient.
Businesses and individuals are restricted in making representations relating to diseases, conditions, ailments and defects in advertisements, and must only be used with the TGA’s prior approval in circumstances where use is necessary in the interests of public health.
4
Significant fines and penalties apply if a business or individual makes restricted or prohibited representations in an advertisement without prior approval or permission from the TGA.
5
The TGA reminds health professionals and businesses that they are committed to taking strong enforcement action to deter and disrupt the unlawful advertising of medicinal cannabis. So much so, in the last 2 years, 2 civil penalty proceedings have commenced, and 165 infringement notices have been issued (inclusive of the 35 notices mentioned in this article). These notices total more than $2.3 million in penalties to organisations for alleged unlawful advertising of medicinal cannabis.
6
For any legal assistance and concerns regarding restricted or prohibited advertising of therapeutic goods and health services, please do not hesitate to contact us.
This article was written by Scott Chapman, Partner, Angela Pale, Special Counsel and Lily Galoustian, Solicitor.
1 More than $600,000 in fines issued for alleged unlawful medicinal cannabis advertising | Therapeutic Goods Administration (TGA).
2 Therapeutic Goods Act 1989 s3.
3 Applying the Advertising Code rules: restricted representations | Therapeutic Goods Administration (TGA).
4 Restricted representations | Restricted and prohibited representations in advertising | Therapeutic Goods Administration (TGA);
Therapeutic Goods Regulations 1990 Part 1, Schedule 2.
5 s42LDB of the Act.
6 TGA (n 1).
Special Counsel | Sydney
Source:
https://hwlebsworth.com.au/tga-regulations-and-medicinal-cannabis-advertisement/
