Copywriting and compliance for therapeutic products - the essentials
Are you new to medical copywriting for therapeutic products in Australia and overwhelmed by Therapeutic Goods Administration (TGA) rules? That’s completely understandable! All the advertising codes, regulations and guidance can be so complex and confusing.
But TGA compliance is crucial for your clients. And not just for the sake of their reputation. It’s essential for protecting consumer health and safety.
As an experienced regulatory affairs professional now working as a medical and health copywriter, I want to help you through the quagmire.
Let’s start with the essentials for successful and compliant advertising campaigns.
What is a therapeutic product?
This is THE fundamental question. And the answer is: probably more complicated than you realise.
Many people think therapeutic products are just the medicines they get from the pharmacist. But there’s much more to it.
Therapeutic claim = therapeutic good
According to the Therapeutic Goods Act (TG Act), a therapeutic good is ANY product that has — or claims to have — a therapeutic use or benefit. This broadens the scope and captures a whole host of products: devices, cleaning products, some cosmetic goods, vitamins and more.
Sometimes, even product makers are shocked to learn their products qualify as therapeutic goods.
Let me give you a (rather silly) example.
Here is an ad for my new product, the Thera-Bangle: “A miraculous product guaranteed to eliminate all your osteoarthritis pain.”
A fake ad for a fake product. It illustrates how making a therapeutic claim in promotional material will cause a product to be deemed a therapeutic good by the TGA.
Truthfully? It’s just a bangle. But because of the claim I’ve made, it’s now a therapeutic good. Since it’s not on the Australian Register of Therapeutic Goods (ARTG), I might get fined for supplying and unregistered therapeutic good. I’d certainly be sanctioned for non-compliant marketing (see more below).
Development and commercialisation of therapeutic goods is a complex journey. A therapeutic good must be included, listed or registered on the ARTG, with some exceptions. To get onto the ARTG, the maker needs to jump all the necessary regulatory hurdles. And some of these hurdles require significant evidence of quality, safety and efficacy.
And advertising therapeutic products, whether on the ARTG or not, must comply with TGA rules.
Photos of a selection of therapeutic goods, for the purposes of demonstration A. A saline product with no AUST R or AUST L. But since it has a therapeutic purpose, it’s therapeutic good and TGA advertising rules apply. B. Dietary supplement included on the ARTG, as indicated by the AUST L number. C. A “pharmacist only medicine” that’s registered on the ARTG, as indicated by the AUST R number. B. A “prescription only medicine”, a registered medicine as indicated by the AUST R number. Products with an AUST R number are considered higher risk products.
For non-prescription products, any advertising that’s directed to the public must comply with the Therapeutic Goods Advertising Code (TGAC). And remember: you can’t promote prescription products directly to consumers.
So, is the product you’re writing about a therapeutic good or not?
Therapeutic goods at the local pharmacy
To illustrate what falls under the TGA’s definition of a therapeutic good, let’s take a tour of my local pharmacy. Welcome.
As you enter you see perfumes on the left. Perfumes are not therapeutic goods. (Although… if your advertising claims the fragrance will treat depression, then it WOULD be a therapeutic good).
Next to the perfumes, you have the makeup and nail products. There are probably no therapeutic goods here (unless a bottle of fungal nail treatment is in this section).
Over in the middle aisle are the cosmetic skin care products. There will be a mix of therapeutic goods and non-therapeutic goods here. For example, there may be a body wash that helps with mild eczema, or perhaps skincare that claims to help with acne. Your client will know if their product is strictly a cosmetic or if it’s a therapeutic good.
The sunscreen aisle is next. Sunscreens are therapeutic goods, and there are particular things you must include (and not include) in sunscreen advertising. Make sure you ask your client about mandatory information to include in your sunscreen ad campaign.
Over on the right there’s the hair care products. Again, mostly not therapeutic goods. Exceptions might include head lice treatment shampoos.
As we start heading towards the back of the pharmacy, finding therapeutic goods is like shooting fish in a barrel:
Vitamins. Yes.
Supplements. Could be a food or a medicine.
Cough syrups. Yes.
Pain relief. Of course.
Allergy treatments. Yep.
These are commonly known as over-the-counter (OTC) medicines and “complementary” medicines. Supplements can be tricky to classify, so be sure to ask your client if the product is a therapeutic one.
There are also lots of therapeutic devices scattered around the pharmacy. You might see:
Insoles that treat Achilles heel pain
Face masks
Braces and guards for sports injuries
Thermometers
Blood pressure monitoring devices
These devices are therapeutic goods, and consumer-directed advertising for them must comply with the TGAC.
Behind the back counter are all the medical products that require a pharmacist interaction before you buy them. They’re known as “pharmacist-only medicine” and “prescription-only medicines”. Mostly, these products are not advertised to the public.
You can, however, promote them to healthcare professionals (HCPs). To do so, you’ll need to follow the parameters set out in the Medicines Australian Code of Conduct.
As you can see, many products in the pharmacy are clearly therapeutic goods. But some are less obvious. If the product boasts a therapeutic use or benefit, it’s likely to be deemed a therapeutic good.
Words to be wary of
In therapeutic goods advertising, you’re not permitted to use certain words. Let’s return to my Thera-Bangle, which you’ll remember claims to be “A miraculous product guaranteed to eliminate all your osteoarthritis pain.”
Several words in the copy are non-compliant under the TGAC.
Miraculous: not permitted
Guaranteed: not permitted
Eliminate: there’s no evidence to back this claim so it is not compliant
Osteoarthritis: this is a restricted representation, which means it cannot be used without TGA permission.
Although this example is extreme, it helps you begin to understand the TGA rules and how easy it can be to break them if you’re not aware of compliance requirements.
Quick links for advertising compliance in Australia
Why is advertising compliance so important?
The TGAC designed to ensure that product advertising directed at consumers is accurate, balanced, and not misleading. The rules protect the public. And the TGA take enforcement seriously.
Non-compliance can result in:
• Products being pulled from market
• Penalties such as fines and other legal actions
• Damage to company or brand reputation
A famous example of advertising non-compliance occurred during the height of the COVID-19 pandemic. Lorna Jane, an activewear fashion brand, began marketing a product that claimed to provide protection against viruses. By claiming this property, the activewear became a therapeutic good (under the definition of the TG Act). Therefore, the TGAC applied. The advertising breach cost Lorna Jane almost $40,000.
But that wasn’t the end of it. The company was later fined $4 million by the Australian Competition and Consumer Commission (ACCC) for its misleading advertising.
Do copywriters need to memorise all the TGA rules?
Medical copywriters don’t need to have an encyclopaedic knowledge of the TGAC and guidelines. We aren’t tasked with guaranteeing compliance. Appropriately trained medical and regulatory members of the client’s product/brand team should review and approve all copy.
But familiarity with the TGA requirements will help you create better campaigns for your clients and should minimise the number of revisions required.
Need help from an experienced copywriter who knows the ins and outs of the TGA rules?
Written by Sally Bathgate. Sally is an experienced Regulatory Affairs professional now working as a freelance health and medical writer. With a BSc (Pharmacology) and experience in the pharmaceutical industry in Australia, she brings a wealth of insight and understanding to medical and health communications.