Health groups have raised alarm about a new bill that, if passed, would see the Therapeutic Goods Administration (TGA) abandon the pre-approval process of advertisements for complementary and alternative medicines.
While they support many elements of the therapeutic goods amendment bill, groups ranging from Choice to the Consumers Health Forum say the amendment to abolish the pre-approval process in favour of self-regulation and larger penalties is worrying and should be reconsidered.
Holistic health and wellness practices have helped Locke resident Angie Helms with struggles in her life, and she hopes others will discover their benefits, too.
Helms started a holistic health coaching and essential oil business in November called Hormonally Balanced. Her work focuses on women's health, helping find natural ways to address weight issues, adrenal fatigue and poor gut health.
"I wanted to open this up to start working with other clients, and specialize in working with women who struggle with hormonal imbalances," Helms said. "It's kind of the same path that I've taken. We focus on bioindividuality, and what that is, is really working with the individual to structure a program that is right for them. We look at all parts of their life, and how it affects them as a whole."
"People could die in the period between the shutdown of pre-approval of advertisements and the post-marketing prosecutions replacing them," said Professor John Braithwaite, a regulatory expert at the Australian National University (ANU).
Helms began taking classes at the Institute for Integrative Nutrition based out of New York City, and received her certificate for holistic health coaching in December. Helms has taken what she's learned in school and applied it to her own health and wellness.
The groups want the amendment to be reviewed, or at the very least, the pre-approval system to be maintained until it can be shown the new rules are successfully stopping companies from misleadingly advertising ineffective or even harmful products.
"We want to see that the TGA is fair dinkum about making prosecutions with tough sanctions happen when consumers are misled," said Professor Braithwaite.
Helms said she turned to essential oils after feeling like her acid reflux was wreaking havoc on her sleep. She'd take a bottle of Tums every week, and sleep propped up in bed every night. After being introduced to essential oils, she tried two drops on her tongue and in seconds, she said, the stomach pain was gone.
"Then if the prosecutions are working, OK let's consider abolishing pre-approval, but in the meantime, let's stick with prevention being better than cure."
Oils can be used topically, internally or aromatically, she added, and they are used for a myriad of things. For example, Helms recommends rubbing peppermint oil on one's temples for headaches. She'll mix lemon, lavender and peppermint for fighting allergies.
In defiance, opponents will hold a "civil society hearing" at ANU on Wednesday, which will hear from a range of concerned stakeholders, including former deputy chair of the Australian Competition and Consumer Commission Allan Asher and the Public Health Association of Australia.
Helms said she typically works with clients over the phone or through a video call. They'll fill out a health history form, and Helms will conduct a free 30-minute consultation. If they decide the health coaching is something they'd like to pursue, Helms said she will schedule two 50-minute sessions per month for at least six months, with the opportunity for email and phone support during that time. She helps develop a blueprint with small, sustainable changes to help them lose weight, Helms said.
Other proposed changes that will be discussed include the abolishment of the independent Complaints Resolution Panel and the Code Council and the establishment of a list of medicinal uses for complementary medicines that will not require safety and efficacy assessment by the TGA before they can be sold and advertised.
The current pre-approval system affects television and print advertisements for both complementary and over-the-counter products.
Professor Ken Harvey from Monash University said the system mostly captures complementary products, such as vitamins and herbs, because "that's where the cowboys are".
"A review of the pre-approval system found most of the new advertisements needed changes to avoid breaching the TGA code and the concern is that if we eliminate it and rely on penalties down the track there's nothing stopping bad ads for a cure for cancer appearing in the newspaper and getting a large number of customers," he said.
Professor Harvey, a long-time critic of the complementary medicines industry, said government bureaucrats had ordered TGA representatives to not attend the unofficial inquiry.
"Why won't the TGA come to hear our concerns? A lot of concerns were raised in TGA consultations but why weren't they passed onto the Health Minister or the ALP?" he asked.
Essential oils have helped Helms, too, not only with losing weight but with her acid reflux disease. Part of her new business is educating clients about oils and selling them. She sells oils from doTerra on her website, and also holds classes about their properties.
"I believe the TGA has misled Parliament. The TGA is captured by industry."
Carl Gibson, chief executive officer of Complementary Medicines Australia, said Professor Harvey's claims were "nonsense and disingenuous".
"Pre-approval is not required today for advertising on the internet, social media or subscription television and yet the sky hasn't fallen in," he told Fairfax Media.
"The pre-approvals is not the last line of defense, because even if it is axed, advertising will still be subject to the Therapeutic Goods Advertising Code and the ACCC rules on false and misleading claims."
In 2010, Helms said, she was overweight. Over a two-year period while working in the Caribbean, she continued, she focused on eating clean, whole foods and exercising. She lost 110 pounds.
A TGA spokeswoman said the proposed changes were crafted after extensive consultations with the public and stakeholders.
"The proposed amendments to the Act set out a package of reforms to improve consumer confidence when choosing self-selected medicines," she said.
"The changes will also bring increased transparency measures and accountabilities as well as tougher penalties for non-compliance."
A spokesperson for Federal Health Minister Greg Hunt said the bill would "help patients get earlier access to new medicines in cases where they address an unmet clinical need, while also providing more informed product choices and stronger consumer protections through tougher penalties."
Choice said ceasing pre-vetting would open a floodgate of issues: "Advertisers can say anything they want and, while the TGA has enforcement powers, once an advertisement has been aired or published, the damage has been done and consumers are unwittingly misled."
The Public Health Association of Australia said the pre-approval process was "largely efficient and effective" and "should remain until the associated reform package has been reviewed for effectiveness".
The Consumers Health Forum said the new enforcement provisions and larger penalties "should be in place and tested before removing the final safeguard of the pre-vetting process".