In the face of growing numbers of complaints about misleading and deceptive therapeutic goods, the TGA has given up on systematic enforcement.
Just two years on from the implementation of new laws to control advertising for misleading and deceptive therapeutic goods, the scheme is in tatters.
Having failed to halt a wave of wrongful conduct and in the face of growing numbers of complaints the TGA has given up on systematic enforcement. Instead of investigating, and where necessary prosecuting unlawful conduct, the regulator is now closing files and sending the following dismissive note to complaints:
“Your complaint has been finalised. The information you provided will be used by the TGA to inform compliance and enforcement activities under the TGA’s updated advertising compliance framework. The TGA is transitioning towards responsive regulation by utilising an intelligence led, risk-based approach to compliance activities. Thank you for bringing this matter to the attention of the TGA.”
The new approach follows a review of the new regulatory scheme by consultants Rosemary Sinclair AM and ThinkPlace Australia Pty Ltd.
The review noted an unexpectedly high volume of complaints since the TGA took over the advertising complaints system (2,436 in 2018-19 and 3,047 in 2019-20, including 529 concerning COVID-19). This had produced a large and growing backlog. The review stated that providing more resources would not be in the public interest. Instead, it recommended a more cost-effective and efficient approach by amalgamating all complaints into a pool of information from which the TGA could consider compliance priorities.
Adjunct Professor John Skerritt, Deputy Secretary, Health Products Regulation Group, Department of Health, responded to issues raised at a recent panel discussion.
Given that the TGA is largely funded by industry, he was asked why industry charges were not increased to employ more staff? As the industry had caused the problem, why shouldn’t they pay to fix it?
He replied, “We don’t make up our own fees and charges; they are set by the Governor-General in Cabinet – the Executive Council; we put our resources into more important areas, such as the safety of vaccines and medical devices”. This answer was not satisfactory. The TGA does negotiate with industry on annual cost recovery increases. Furthermore, dealing with vaccines and medical devices should not negate obtaining additional resources to deal with the thousands of neglected complaints.
While it was acknowledged that the TGA had acted commendably on COVID-19 advertising breaches, Professor Skerritt was asked why the TGA had not taken similar action on numerous complaints about misleading and deceptive advertising of complementary medicines – many more than two years old. He blamed “the law of the land”. Presumably, he meant the Therapeutic Goods Amendment Bill (No. 4) 2000, which allowed ‘medicines’, following the applicant’s self-assessment, to be listed automatically in the Australian Register of Therapeutic Goods (ARTG).
Why can’t the TGA scan new entries for key words such as ‘fat’, ‘hangover’, ‘antiviral’, etc.? They could ask immediately for supporting evidence; if non-existent, the company could be fined via infringement notices and the product be delisted. But, apart from occasional token action, they don’t.
Professor Skerritt also said that the TGA could deal with only one specific product at a time. This can take several months; if the sponsor introduced a similar one, they had to start all over again. This statement was challenged. Many complaints not dealt with had provided detailed arguments and evidence as to why the claims breached the Code and/or Act. The TGA could simply ask the sponsor for a response (as did the previous Complaint Resolution Panel). If the reply were unsatisfactory, the TGA could act.
The Therapeutic Goods (Permissible Indications) Determination was introduced to limit advertising creativity. However, the TGA had allowed industry to create the list. The result was that 86% of 1,021 indications were justified by ‘traditional’ rather than ‘scientific’ evidence. This has largely removed the need for ‘complementary medicines’ to have a scientific evidence base. Not surprisingly, the industry increasingly uses ‘traditional’ indications, many of which do not fit the TGA’s definition of ‘traditional’ use.
The Royal Australian College of General Practitioners, the Friends of Science in Medicine, Choice and others want products making traditional claims to contain mandatory educational statements, such as, “These claims are based on traditional beliefs and practices, not on modern scientific evidence”. This educational statement was opposed by both the TGA and government. Regardless, it is needed.
One particularly egregious complaint discussed was the promotion in Sri Lanka of a skin-whitening product by an Australian company that was listed on the ARTG but omitted the skin whitening indication. This complaint had been dismissed.Professor Skerritt said that the TGA was powerless to act because the advertising offence was committed in another country. Had the TGA inspected the Sydney factory to see if the skin-whitening packaging and labelling breached other sections of the Act (such as s.42E(2)(a) – false representation of the goods)? He took this question on notice.
He was asked why the TGA had largely failed to deter unethical promotion, especially of ‘complementary medicines’. Did it lack expertise (insufficient medical, pharmaceutical, and public health staff)? Was it due to industry lobbying of government (and the TGA) to maintain a profitable and export-orientated industry despite breaking the law? Was it a regulatory culture favouring industry assistance over consumer protection?
He had no answer to these questions. Instead, the TGA’s solution to the increasing backlog of complaints (as advised by the Review) is to merely note them for ‘intelligence’ and then close them. Why would anyone bother to submit any more detailed complaints if this is the only response? Presumably, the TGA hopes for just this reaction. They will then be able to cite a falling-off of complaints as ‘evidence’ that unethical advertising has been brought under control.
As the Choice representative on the former Complaint Resolution Panel and Therapeutic Goods Advertising Code Council and, more recently the Therapeutic Goods Advertising Consultative Committee (TGACC), I had tried to encourage the TGA to focus more on consumer protection and less on industry assistance. However, like others, I have concluded that, given its current leadership, the TGA will not change.
I have now resigned as the Choice representative of the TGACC.
is a public health physician and consumer advocate with expertise in medicines policy. He is President of Friends of Science in Medicine and an Associate Professor in the School of Public Health and Preventive Medicine, Monash University.
This piece was originally published at John Menadue’s Pearls and Irritations.