The Therapeutics Goods Administration (TGA) has tried to bypass the Senate Committee system on the Therapeutic Goods Amendment (2017 Measures No.1) Bill by arguing that it was non-controversial! Which it certainly is not regarding its provisions for advertising and complementary medicine regulation! Fortunately, Senator Richard Di Natale (Greens) responded to requests to get the Bill reviewed by the Senate Community Affairs Legislation Committee.
In response, submissions were scheduled over the Christmas, New Year holiday period and the public hearing requested was rejected because Senators were on holiday. Regardless, several civil society organisations have joined together to hold a public hearing to debate contentious provisions of the Bill. The venue is the Australian National University, 24 Jan 2018, from 2:00-5:00 pm.
While leading experts in regulation, public health, and civil society are supportive of the positive aspects of the Bill proceeding, they ask that three contentious aspects be excised so that they can receive better consideration.
First, the Bill removes pre-approval of advertisements for therapeutic goods in favour of self-regulation.
Pre-approval is the only defence against seriously misleading advertisements appearing on prime-time television or in national newspapers. The current pre-approval process reviews over 2000 advertisements per year with an average turnaround time of 7 days. Most advertisements require changes, sometimes wholesale revisions.
The complaint system takes a long time to remove bad advertisements. Meanwhile, the damage has been done. Prevention is better than cure. It is also more economically efficient given that fraudulent therapeutic claims create unnecessary health expenditure and diverts scarce health resources from remedies that work, to ones that don’t.
We want pre-approval of advertisements to continue until the other measures being introduced (increased post-marketing reviews and more stringent penalties for regulatory violations) have shown pre-approval is no longer necessary.
Schedule 6, Part 2 ‘Removal of requirement for advertisements to be approved’ should be excised.
Second, the TGA is taking-over of the advertising complaint system without ensuring ongoing stakeholder input or transparency of complaint outcomes.
Stakeholder involvement is currently provided by the independent Complaint Resolution Panel and Code Council which are to be abolished from July 1, 2018. That’s happening even though the TGA has a track record of making bad decisions in isolation and an unenviable reputation as a ‘blackhole’ with respect to advertising complaints.
In addition, loop-holes in the complaint system such as those at the food-medicine interface need to be addressed by broadening the scope of the Therapeutic Goods Advertising Code and Complaint System to cover all therapeutic claims, regardless of whether they refer to a medicine, food or medical device.
Schedule 6, Part 1, Advertising system should be excised.
Third, the Bill will authorise an industry submitted list of ‘permissible indications’ for complementary medicines.
The TGA recently circulated a final list of 1019 such indications. It contains 140 indications which must be supported by scientific evidence and 879 indications that can be supported by a tradition of use, such as Traditional Chinese Medicine (TCM), Ayurveda, Homeopathy, etc. Examples of traditional indications include, ‘Balance Yin and Yang’, “Upraise/lift sunken middle Qi’, ‘Pacifies Kapha’, ‘Increases Pitta’ and ‘Replenish Essence’.
The TGA have ignored submissions that pointed out that including numerous traditional indications encourages industry to evade the requirement to have scientific proof of efficacy for their products, endorses pseudoscience and will confuse the average consumer as the terms used will not be understood.
The TGA have ignored requests that claims based on ‘traditional use’ should always have an advisory along the lines of what the US Federal Trade Commission uses for homeopathic products, ‘This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works’.
Schedule 2, Part 1, 26BF, ‘Permissible indications’ should be excised.
More information is now available at the ANU RegNet site.
Further information is available from: Assoc Prof Ken Harvey, Monash University (0419181910), Katinka Day, Choice (02 9577 3307), Allan Asher, Access2, (0408375642) and Prof John Braithwaite, Australian National University (0437788006)