Comparative Analysis of TGA’s 2018 and 2021 Advertising Codes

3 min read

To educate patients and Health Care Professionals (HCPs) and promote treatment options, the pharmaceutical industry like many other industries dedicates billions of dollars to advertise and promote prescription drugs. The legislative framework of advertising in Australia comes under Section 42BAA of the Therapeutic Good Act 1989. The Therapeutic Goods Advertising Code outlines the minimum requirements to be followed by the drug manufacturers while advertising therapeutic goods to Australian consumers.

The Therapeutic Goods Advertising Code 2021 came into effect after eighteen (18) months of consultation with the stakeholders, on January 01, 2022. The amended Code provides clarity on therapeutic goods advertised to consumers and protects them from advertisements that lead to ‘fear and distress’.

The newly published Advertising Code 2021 permits a transition period of six (06) months to all the applicants allowing them to comply with the 2018 Code until June 30, 2022. The Code is divided into different parts to enhance readability. For instance, Part 4 is for mandatory statements, while Part 3 is for claims made in advertisements.

Commonalities between the 2018 and 2021 Codes

The overall structure of the advertising Codes remains the same. For example, advertising certain therapeutic goods are prohibited, and these include Schedule 3 (pharmacist only), Schedule 4 (prescription only), and Schedule 8 (controlled substances). Therapeutic goods for serious conditions still cannot be advertised without prior approval from the TGA.

The 2018 and 2021 Codes have been implemented to ensure ethical standards are followed by the drug manufacturers in a manner that they:

Promote therapeutic goods which are safe and effective
Do not mislead or project any misinformation related to the drug
Do not influence the HCPs to favor a preferred drug product
Are consistent with the current public health campaigns

Comparative Analysis: Major Changes Between the Codes

Requirements	2021 Code	2018 Code
Mandatory Statements:	The mandatory statements have been revised and are limited to direct-to-consumer advertising (DTC), where consumers cannot inspect the goods voluntarily before purchase. Additional mandatory statements have been included. For example: Advertisement of pharmacist-only products, ‘ask your pharmacist about this product’ statement is mandatory. Advertisement of therapeutic goods specific to HCP must include the statement, ‘this product is not available for purchase by the general public.’ Short form advertisements must include the ‘Always follow the directions for use' statement.	Medicines claiming to relate to a specific symptom of disease should include the mandatory statement, “If symptoms persist, worsen or change unexpectedly, talk to your healthcare professional.” Advertisement of pharmacist-only medicine, “Ask your pharmacist – they must decide if this product is right for you.” Direct/internet advertising of medicine must include,’ Always read the Label.’
The List of Product Samples:	Under Section 25 (Part 7), the 2021 Code expanded the list of samples that can be advertised. This list includes face masks and gloves, certain sanitary products, hand sanitizers, specific nicotine replacement therapies, and COVID-19 rapid antigen tests.	Included under Section 20 of the Code. Advertisers cannot advertise their products with a sample except for products listed in Schedule 3.
The Rules for ‘Safe and Proper Use’ of Therapeutic Goods:	Advertisement must ensure that the therapeutic good represented: Is consistent with the directions or instructions for use for the product Does not overstate efficacy or performance of the good Does not lead consumers to use the goods inappropriately or excessively Eliminates the advertising, which causes alarms of fear and distress	Advertisement must ensure: Proper use of medicine Medicine doesn’t show delayed effect Medicine doesn’t claim ‘cannot harm’ Medicine doesn’t mislead the consumers by stating it to be a miraculous, assured cure
Health Warnings:	Relevant warnings apply only on the direct purchase of drugs advertised, facilitating any purchase. These are applicable for physical and online purchases of therapeutic goods	Health warnings prescribed for medicines in Schedule 1 of the Code has been removed
The Testimonial and Endorsement Advertising Rules:	Section 24 (Part 6) consolidated testimonial requirements under section 24 The 2021 Code clarifies the prohibition of paid or incentivized endorsement and testimonials	Sections 16 - Endorsement: Section 16(1)(b) is not applicable for non-prescription medicines Section 16(1)(a) is not applicable for Testimonial under s(17) Section 17 - Testimonial Testimonial section is divided into three (03) sub-sections: s17(1) - Therapeutic good claim made by a person using the medicine s17(2)(a) - Characteristics of a person s17(2)(b)(c) - Obligation of the testimonial before being advertised s17(3) - Information disclosed in the ad about the testimonial
The Definition:	Includes modified information for the active ingredient, use, health warnings, price	Includes health warnings, prominently displayed, or communicated statements

Applicants must carefully assess the changes put forward by the TGA and comply with Code 2021 from July 01, 2022. The transitional period also allows the advertiser to check and evaluate if their current advertising is accurate and balanced. A seasoned Regulatory partner can assist in reviewing the promotional material as per the updated norms to comply with the Local Authority guidance and avoid any discrepancies with the new regulations and Codes alongside the transitional period. Explore Freyr’s expertise across ad promo services today.