As of 1 July 2020, life sciences stakeholders and pharmaceutical companies are now independently responsible for ensuring their medicine advertisements in 'specified media' comply with Australian Therapeutic Goods Legislation. This is instead of relying on the Therapeutic Goods Administration (TGA) pre-approval process, which ended 30 June 2020. Under Therapeutic Goods Legislation, specified media includes magazines, newspapers, catalogues, billboards and displays on public transport about medicine.
While this may mean a faster publication process, the self-regulation comes with greater risk and a greater need to understand exactly what is required when advertising medicines. This is particularly important because with the greater self-regulation, the TGA has also introduced broader enforcement powers for non-compliance.
Former pre-approval process – what's changed?
Previously, the TGA required advertisements about medicine to be pre-approved by the TGA before being broadcast or published. This took the guesswork out of ensuring whether medicine advertisements were legislatively compliant. As of 1 July 2020, however, this prerequisite step has been removed as a result of the Expert Review of Medicines and Medical Devices Regulation. As such, advertisers themselves must ensure compliance with relevant legislative duties when advertising medicine. These duties are contained within a number of pieces of legislation and legislative guidance documents, including:
- Therapeutic Goods Act 1989 (Cth) (the Act);
- Therapeutic Goods Regulations 1990 (Cth);
- Therapeutic Goods Advertising Code (No.2) 2018 (Cth) (the Code);
- Australian Regulatory Guidelines for Advertising Therapeutic Goods 2019 (Guidelines); and
- Australian Competition and Consumer Act 2010 (Cth).
These legislative instruments outline broad as well as additional specific advertising requirements, depending on the product being advertised.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.