Our previous submissions to TGA consultations have noted that many recommendations made by civil society had been ignored.
Most have still been ignored in this draft Guidance document. Accordingly, we see little point in responding in detail to this consultation.
Instead, we wish to highlight the key point repeatedly made in previous consultations.
‘No amount of “guidance” will improve the current dysfunctional regulatory system for complementary medicines and advertising unless the TGA accepts that consumer protection is an equal objective to industry assistance and gains the will to act against companies that consistently break the law.’
Over the 18-year life of the Complaint Resolution Panel (CRP), the TGA received 755 complaints referred for non-compliance or because repeated upheld complaints about the same matter required regulatory action. The TGA have published the outcome of only 80 (11%) of these referrals (Mal Vickers’ research).
The TGA have failed to remove medical devices such as BICOM despite expert opinion pointing out that it does not fit the criteria of a legitimate biofeedback device and the claims made are preposterous.
The TGA have failed to act on multiple complaints about the commonest scam complained about: detox food pads.
The TGA have failed to act on companies such as Pharmacare Laboratories Pty. Ltd. that consistently break the law, nor have they targeted for post-marketing review products of public health concern, such as weight loss products, that have had many upheld complaints.
The TGA’s new complaint system is much less transparent that the CRP system it replaced. No information is provided by the TGA on complaints it decides are “low-priority”, even if complainants provide detailed allegations that the company concerned had broken the law. The TGA closes these complaints by merely sending an “education letter” with no follow-up to see if these letters achieved compliance (which they usually do not).
Before it was abolished, CRP determinations revealed that around 80% of upheld complaints breached the Therapeutic Goods Advertising Code 2015 (and thus the Therapeutic Goods Act 1989) by containing misleading, incorrect or unbalanced statements which the sponsor was meant to have verified, but they could not!
The TGA has argued that its priorities are public health and safety, not protecting consumers from being deceived, misled, losing their money on products that don’t work, or having their health impaired because they have forgone more evidence-based solutions to their health problems. While this is convenient for industry and the TGA, it is appalling consumer protection. It also disregards the purpose of the Therapeutic Goods Advertising Code 2015 and the Therapeutic Goods Act 1989 which the TGA is meant to uphold.
The critique by Commissioner Hayes of the financial services industry and their regulators is equally applicable to the complementary medicine industry and the Therapeutic Goods Administration. A failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that. It also encourages others to break the law, leading to a race to the bottom.