Regulation of Advertising of Therapeutic Goods
The advertising of therapeutic goods to consumers or health professionals is administered via a co-regulatory system which is representative of all key stakeholder groups.
These stakeholders include consumers, public health advisors, health care professionals, regulated industry manufacturers, and distributors, as well as the media, advertisers, and Government agencies.
Advertisements for therapeutic goods are subject to the requirements of:
- the Therapeutic Goods Act 1989
- the Therapeutic Goods Regulations 1990
- the Competition and Consumer Act 2010
- and, primarily for advertisements other than advertisements directed to healthcare professionals or wholesalers, the Therapeutic Goods Advertising Code 2021 (the Code).
Additionally, advertisements for therapeutic goods directed to the public must comply with other relevant legislation. One example is the Medicines Australia Code of Conduct (MACC), which relates to the marketing of prescription-only medicines.
The objectives of the Code are to ensure that the marketing and advertising of therapeutic goods (including advertising of pharmaceutical products/medicines) to consumers:
- Is conducted in a socially responsible manner
- Promotes the safe and proper use of therapeutic goods
- Does not mislead or deceive the consumer
TGACC and TGA responsibilities relating to advertising
The Therapeutic Goods Advertising Consultative Committee (TGACC) is a forum comprised of representatives from all key stakeholder groups and is established under the Regulations.
Specifically, the role of the TGACC is to identify and propose improvements to the Code, based on consultations with industry stakeholders, the media, and publishing and broadcasting bodies involved in the advertising of therapeutic goods/medicines to the public.
The TGACC is responsible for the overview of the Code while the Therapeutic Goods Administration (TGA) administers the Code.
Advertising “includes any statement, imagery or design used to promote the product, along with its label, packaging and accompanying information.”
Source: Therapeutic Goods Administration
Advertising of therapeutic products
To be able to advertise a therapeutic good, that good must be entered into the Australian Register of Therapeutic Goods (ARTG) or specifically exempt.
Advertising is prohibited for certain therapeutic goods
Cancelled or suspended products from the ARTG cannot be advertised, even if that product is still available to the public via a different pathway (e.g., Special Access Scheme).
- Some therapeutic goods are prohibited from being advertised directly to the public
- Examples include prescription-only and certain pharmacist-only medicines or biologicals
- However, price information for these types of products can be advertised; and the Code is defining the conditions under which this may occur
Pre-advertising approvals for advertising of medicines and other therapeutic goods
Starting with 1 July 2020, except for the restricted representations, it is no longer mandatory to have therapeutic goods advertising to consumer approved before publication. However, compliance obligations remain in place for all advertisers.
Restricted representations must be approved before they can be used in advertisements. Example: refer to the Therapeutic Goods Restricted Representations – COVID-19 Vaccines. The mandatory advertising pre-approvals have been replaced with a self-regulatory system.
Where to get help to understand advertising rules for healthcare products
The Consumer Healthcare Products Australia (CHP Australia) provides a voluntary compliance service via the Advertising Advisory Service.
If you need assistance or want to review their information, visit their website at the link below. https://www.chpaustralia.com.au/Industry-and-Consumer-specific-Information/Industry
Advertisement of non-prescription medicines or medical devices
Advertising rules for over-the counter therapeutic goods (OTC products)
- Generally, advertisements for non-prescription medicines or devices may be directed both to consumers and to health professionals.
- Pharmacist-only medicines (including devices) that contain ingredients listed in both Schedule 3 and Appendix H of the Poisons Standard may be advertised to consumers only if specific statements are distinctly displayed or communicated.
- Non-prescription medicines or medical devices are otherwise known as “over the counter (OTC) products”.
- OTC products include non-narcotic pain medicines, certain types of complementary medicines, bandages, or hearing aids, and other generally low-risk product types.
Regulations of non-prescription products regarding advertising rules
- Advertisements for non-prescription therapeutic goods are regulated by both co-regulatory and self-regulatory arrangements operated by the TGA under the Act and Regulations, the Therapeutic Goods Advertising Consultative Committee (TGACC) and industry organisations, for example the Australian Self-Medication Industry (ASMI) and the Complementary Healthcare Council (CHC).
- Certain types of advertisements directed at consumers require prior approval by the Secretary of the Department of Health and Aged Care.
Approval processes for direct-to-consumer advertising of non-prescription therapeutic goods
The advertising legislation requiring the pre-approval for advertising about therapeutic goods that will be broadcast or published in specified media ended on 30 June 2020.
Specified media includes:
- Newspapers and Newsletters
- Cinema advertising
- Public display including posters, billboards or in or on public transport.
A new advertising regulatory framework, as defined by the Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG), was designed, and implemented concerning consumer interests’ protection.
The new compliance requirements are reinforced by a broader range of enforcement powers and support the new self-regulatory approach.
Additionally, a wide range of enforcement tools, combined with an increased range of sanctions and penalties to deter non-compliance, were put into place by the Therapeutic Goods Administration (TGA).
Complaints handling processes for advertising therapeutic goods
Based on the new complaints system put in place starting with 1 July 2020, complaints about the advertising of medicines and medical devices to the public are handled by the therapeutic goods regulator, TGA.
The TGA is now the single body for lodging, handling, and reporting on the outcome of the complaint.
Pre-approval requirements to post-approval advertising complaint processing
The change from a pre-approval process to a post-advertising complaints process indicates that an effective regulation of therapeutic goods advertising is dependent upon high levels of sponsor compliance or increased consumer.
Additional Blog related to Advertising of Therapeutic Goods:
TGA Infringement Notices on a Vertiginous Rise
Blog updated September 21, 2022