An update on TGA advertising regulations

We wish to thank everyone who completed the feedback forms that were circulated through our social media posts regarding what you would like us to negotiate on your behalf to the TGA regarding their new Advertising Guidelines for cosmetic injectable procedures.

We can confirm that we had an incredible response with many of you indicating how detrimental these regulations would be for your businesses through prohibitive costs, as well as difficulty in implementing them.

The challenge we have is that while cosmetic injectables are strictly a “cosmetic appearance” procedure, they are delivered using scheduled drugs that fall within the Drugs and Poisons Act. As such, the TGA has grouped us with similar restrictions to medical procedures for “health purposes”.

Even though technically we don’t come under the Health Act, the TGA has interpreted that the same limitations to advertising rules should also apply to us.

Through a closer examination of the new rules and ongoing discussions with several industry bodies, members of our National Advisory Council, and feedback from members and the industry, we are reviewing the issues we need to present to the TGA through our submission.

The key to such a proposal is to present the discrepancies in two specific areas

Regulatory justification

• An analysis as to whether these rules constitute a regulatory overreach that is not justifiable.

Financial implications

• How the new rules will financially impact and create incredible difficulty and consumer confusion in their compliance?

Previously existing regulations

Since 2013, TGA advised through their literature, website and brochures that those who performed injectable procedures were required to use the words “anti-wrinkle” and “dermal filler” in their advertising, with a full description of fillers and how they work.

These requirements were for the benefit of correctly informing the consumer, on what was involved.

• To comply with these advertising requirements, business owners heavily invested financially in designing their websites, brochures, SEO and social media material.

• Furthermore, AHPRA also placed similar requirements, stipulating that all “before and after” photos must disclose the nature of the treatment used.

For the TGA to now change their mind and request the total removal of these terms, is viewed as a regulatory overreach, and unnecessary, as there is no evidence of patient risk to necessitate these changes.

• Additionally, doing so would be highly disruptive and financially catastrophic for business owners as their website and marketing material would need to be recalled and completely changed. The feedback we are receiving from the industry is to pursue the TGA to rectify this problem that they have created.

If the changes to these regulations are intended for consumer safety, where is the evidence that this was previously compromised to justify such a decision?

Over the past 11 years, the rules in place have provided consumers with full transparency of what is involved with the treatments they choose to undertake. They were required to read and sign an Informed Consent form that clearly outlined risks, possibilities and limitations, and appropriate risk management strategies.

Technically speaking, advertising regulations come under the jurisdiction of the Australian Competition and Consumer Commission (ACCC) and not the TGA. However, the TGA has the right to restrict the way that scheduled drugs are promoted. As such we agree that specific drugs should not be named, however, an anti-ageing procedure or a filler is considered a ‘description of a procedure’ that delivers an outcome, it does not name any specific drug.

• Removing the right to use the term that describes the procedure would cause consumer confusion.

The recommendation to only use the term “we offer treatments to treat wrinkles” is not only confusing, but it could also be potentially inaccurate, as cosmetic injectables are not used only to treat wrinkles – they could be used to improve facial balance and harmony, improve the appears of the nose or jawline.

Where to next?

As this is a mammoth task, we are working collaboratively with several medical societies to establish a coalition that collectively represents 8,000 + injectors and approach the TGA with a well-drafted proposal that clearly outlines the reasons why we believe that the new guidelines will not work, as well as negotiate a potential alternative approach.

Today we received an invitation from a private organisation that is promoting a workshop in March on the Therapeutic Goods Advertising Code (TGAC). If you have received such a notification, we suggest that you wait for any further developments related to our industry before making any major changes within your business.

Industry uniting

We believe that the industry should unite and communicate their wishes to their respective industry body to represent their perspective to the TGA through this coalition of professional bodies, rather than attempt to communicate individually to the TGA.

This matter is quite detrimental to the industry, and we need a collective impact through a well-designed executive strategy if a workable change is to be achieved.

We can confirm that we are currently in discussions with the relevant bodies. We will keep you informed of developments. You can also put your feedback in our survey