‘The Project’ (09/02/2018) also had a hilarious segment on TGA traditional indication craziness.
For background see: Government machinations: Therapeutic Goods Amendment Bill 2017
The Bill was on the Senate notice paper for Monday, Feb 12, 2018, with the government aiming to get it passed. However, to-date, it keeps on being bumped down the agenda by other items.
In the Senate second reading of the Bill (Transcript 036V1400):
Senator POLLEY (Labor Tasmania) said: Many stakeholders made submissions to the inquiry suggesting that there should be a disclaimer in relation to indications based on traditional evidence, stating that there is no scientific evidence of efficiency.
Senator DI NATALE (Victoria—Leader of the Australian Greens) said: The Sansom review said there should be a disclaimer that says explicitly: this doesn’t mean that these claims have been assessed or verified by the TGA or that they’re supported by the TGA. That was the view of a number of stakeholders—for example, the Consumers Health Forum of Australia They said: ‘Our concern is that the limitations of this list of permitted indications may not be understood by many consumers and it may give them some misplaced confidence in the evidence behind the list’. We also heard a similar sentiment from the Royal Australian College of General Practitioners, which is obviously the group that represents GPs here in Australia. It said: ‘We strongly recommend that the TGA mandates that manufacturers must include a statement to accompany all non-scientific therapeutic claims, in close proximity and in the same font as the health claim. can indicate that the Greens will be moving an amendment in my name that would see the requirement for the disclaimer, as was recommended by Professor Lloyd Sansom in his review’.
Senator BROCKMAN (Liberal, Western Australia) said: There is evidence from the United States that a strong disclaimer has no real impact. In that context it is something, I think, that should be looked at further in the future, but the government, at this stage, does not support it. In that context it is something, I think, that should be looked at further in the future, but the government, at this stage, does not support it.
There is dispute about the educational value of such advisories which I addressed in my supplementary Senate submission 2.2. There is a need for appropriate independent research, in association with consumer organisations, into the best way of helping consumers make an informed choice about traditional and complementary medicines. NPS MedicineWise might be an appropriate partner in this endeavour. Until this has been conducted the illogical, inconsistent and ineffective measures suggested by the TGA should be put on hold (‘Seek advice from a registered Chinese medicine practitioner or Ayurvedic medicine practitioner to ensure this medicine is right for you’).
Australia is a multicultural and pluralistic society and it’s appropriate that we respect, understand and allow access to traditional, alternative and complementary medical traditions and products. However, it’s also important that we restrain purveyors of these medicines from taking advantage of consumer ignorance and that we protect consumers from misleading and deceptive claims (see attached). Hence the need for an advisory.
Finally, the permitted indications mentioned in Schedule 2, 26BF of the Bill must be activated by regulation. As with Regulations generally, the Legislative Instruments Act, requires registration of the permitted indications list before it comes into effect. It must be tabled in each house of Parliament within six days and members of parliament are able to move that the regulation be disallowed. This will allow another opportunity to get up the needed disclaimer.by