John Braithwaite is a Professor and Founder of RegNet (the Regulatory Institutions Network), now School of Regulation and Global Governance (RegNet) at the Australian National University.
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The public hearing and opposition to the Bill hit the headlines:
- ABC Radio and TV News (multiple reports)
- ABC Four Corners: Australians are spending billions on unproven vitamins and supplements
- ABC Radio National: The Roundtable: New regulatory framework for complementary medicines called into question
- The Project - at 22.29 mins
- Sydney Morning Herald: 'Public health groups slam removal of pre-approval of complementary medicine advertisements'
- Sydney Morning Herald: ‘‘Softens hardness’: TGA under fire for health claim list that critics say endorses pseudoscience’
- Sydney Morning Herald: ‘New list of permitted advertising lines for complementary medicine products does little to protect consumers’
- The Guardian: 'Science being 'thrown out the window' in Australia's health policy, experts tell MPs'
- The Guardian: 'Homeopathic 'scams' could be advertised on prime-time television'
- The Daily Telegraph: 'Health claims on medicines without scientific proof under radical push' (subscription required)
- The Conversation: 'Scrapping pre-approval of medicine ads will put consumers at risk'
- Croakey: 'Call for closer Senate scrutiny on regulation/advertising of complementary medicines'
- Croakey: ‘Forum calls for greater protection on claims from complementary medicines’
- Medical Journal of Australia InSight: ‘Tangled web around the TGA (2017 Measures No. 1) Bill 2017’
- AJP.com.au: 'Stakeholders hold own hearing on TGA Bill'
- AJP.com.au: 'An open invitation to health fraud'
- AJP.com.au‘Ad pre-approvals for therapeutics stay… for now’
- Pharmacy Daily: 'Concern over complementary medicine ad changes' (subscription required)
- Pharma in Focus: 'Call for ad approval backtrack' (subscription required)
- Australian Doctor: 'TGA under fire for 'endorsing pseudoscience''
- Australian Doctor: ''Regulate Chong channels': Read the TGA's new list of alternative medicine indications'
- Australasian Science: ‘TGA Endorses Pseudoscience for Complementary Meds’
The Bill, currently being considered by the Senate, is proving to be controversial because it plans to:
- abolish the pre-approval of advertisements for complementary and over-the-counter medicines, which currently prevents misleading advertisements appearing on prime-time television or in national newspapers;
- abolish the independent Complaints Resolution Panel and the Code Council, and give responsibility for complaints to the Therapeutic Goods Administration (TGA), which raises concerns about: (i) whether the TGA are equipped to take on this responsibility; and (ii) whether stakeholders will be able to have any input and whether decisions about complaints will be transparent;
- establish a list of medicinal uses (‘indications’) for complementary medicines that will not require safety and efficacy assessment by the TGA before they can be sold and advertised, which raises concerns about consumer safety, as well as concerns that the permitted list will encourage industry to evade the requirement to have scientific proof of efficacy for their products.
Whilst other aspects of the Bill are positive and have been welcomed, leading experts in regulation and public health, civil society and professional groups are opposing the aforementioned parts of the Bill because they raise significant concerns about consumer rights and consumer safety in Australia.
Allan Asher, Chair, Access 2 (The Foundation for Effective Markets and Governance) said:
“If the Government abolishes these important safeguards, Australian consumers will be left vulnerable to spurious and harmful medical claims. It is reckless to remove this consumer protection before the TGA can demonstrate that there is a cost-effective and timely substitute in place. This section of the Bill should be removed until major problems have been resolved.
“Termination of the pre-approval scheme and the Complaints Panel will guarantee a flood of misleading, unfair, confusing and even dangerous advertisements.”
Professor Sharon Friel, Director, School of Regulation and Global Governance (RegNet) said:
“Consumers and health practitioners have just as much interest in therapeutic goods as the industry that produces and sells those goods. If this Bill is passed in its current form it will be an affront to consumer rights in Australia.”
On 30 November 2017, the Senate referred the Bill to the Senate Community Affairs Legislation Committee for inquiry. A public hearing was requested, but rejected because of the short time-frame encompassing Christmas & New Year. Submissions to the Senate Community Affairs Legislation Committee inquiry are available on the inquiry webpage.