In February 2018, the Hon Greg Hunt MP, Minister for Health, committed to an independent review of the impact of the new advertising measures within two years from the commencement of the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018.
On 23 December 2019, a contract commenced with ThinkPlace Australia to review the TGA’s advertising complaints handling. In addition, an independent review of advertising reforms (the Review) has now commenced and is being led by Ms Rosemary Sinclair AM in association with Protiviti.
The independent review will assess the impact of the:
- New advertising measures as included in the Act.
- The TGA as the single body who took over responsible for implementing a complaints management system, including key performance indicators (KPIs).
- Broadened sanctions and penalties to deter inappropriate and misleading advertising of therapeutic goods.
- A comprehensive industry and consumer education program of the new advertising measures.
- Stakeholder engagement activities on therapeutic goods advertising with a particular focus on the effectiveness of the Therapeutic Goods Advertising Consultative Committee (TGACC).
- Classification of complaints, especially the high proportion of complaints classified as ‘low priority’. The TGA declares that these complaints have not breached the Act and Code and closes them by sending a ‘regulatory obligation letter’ which states no further action will be taken. This is despite detailed representations in complaints of specific breaches of the Act and Code.
- Numerous unresolved complaints, some dating back to July 2018 with an ever increasing backlog. For example, weight loss, hangover, homeopathic and other ‘traditional’ products, exploitative medical devices, and products at the food-medicine interface, especially dangerous sports supplements.
- Common and ongoing Code breaches unaddressed, for example:
- Failure of industry to keep up to date with new studies that invalidate older ones such as, Omega-3 for ‘heart health’, Glucosamine for osteoarthritis, Ginkgo biloba for mental enhancement.
- Failure to recognize new restricted representations in permitted indications such as Benign Prostatic Hypertrophy (BPH) and Saw Palmetto.
- KPIs that relate to process (time to close by sending a ‘regulatory obligation letter’), not outcome (time to compliance achieved).
- Ineffective sanctions and penalties. For example:
- The TGA recently had a $10 million fine awarded by the Federal Court against Peptide Clinics Pty Ltd for breaches of advertising regulations, including advertising prescription-only medicines to the public. However, the company involved went into liquidation some months earlier and did not pay. Similar complaints have yet to be addressed.
- InSkin Cosmedics Group Pty Ltd paid penalties of $37,800 in regard to the alleged supply and advertising of the Dermapen 4, a medical device that was not included on the Australian Register of Therapeutic Goods (ARTG). To date, this device (which still lacks an ARTG number) continues to be advertised by numerous clinics.
- Additional loss of consumer protection that will result from the removal of therapeutic goods advertising pre-approvals from July 1, 2020 (out of scope of the Review).
- Problems with TGACC meetings:
- Voluminous agenda papers arrive late, leaving little time for detailed consideration.
- Mainly talked at by TGA staff, very limited discussion of problems.
- Not a forum that makes use of member’s experience and expertise.
- Civil Society Public Forum on Therapeutic Goods Bill
- Advertising reform: watering down consumer protection (removing pre-approval)
- Launch of TGA Advertising Hub – Initial experience of submitting complaints
- Consequences of TGA failure to act on complaints about illegal products
- Complementary medicines: Exporting ‘White Australia Policy’