Introduction

As part of the Australian Commonwealth Department of Health, the Therapeutic Goods Administration (TGA) contributes to the protection and promotion of public health through the regulation of therapeutic goods advertising.

Therapeutic goods are subject to special advertising requirements beyond those required for everyday consumer goods. These requirements are specified in the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code (the Code). The Act and the Code are administered by the TGA.

Therapeutic goods are, by definition, goods intended to have a therapeutic effect on the health and wellbeing of the people that use them. In addition, people who seek information about therapeutic goods can often be in a vulnerable position due to health concerns, including facing a serious disease or condition. This means it is vital they have accurate information about products and treatments they may access, as misleading information could seriously compromise their health outcomes.

Regulating the advertising of therapeutic goods also protects people who may not be able to critically evaluate advertising (including labels), especially those with a health condition who may be particularly susceptible to being misled.

About this report

On 1 July 2018, the TGA became the sole advertising complaints handling body as a result of recommendations from the Medicine and Medical Devices Regulation Review (MMDR). This report is the inaugural report on the TGA's work as the sole advertising complaints handling body.

It aims to give an overview of complaint handling activity in the 2018-19 financial year, highlighting compliance concerns in terms of industry sector (product category), the types of breaches, and actions taken by the TGA. This information will benefit advertisers by highlighting those areas where the TGA has needed to focus its efforts, and will assist our stakeholders to understand how we prioritise our work and manage our resources to most effectively contribute to the TGA's mandate to protect public health and safety.

This report builds on the update on the first six months of the new regulatory framework published on the TGA website in January 2019.

Size of Australian therapeutic goods advertising market

The size and scope of the therapeutic goods' market is vast, with a substantial proportion of the market consisting of products that can be advertised directly to consumers.

As of 30 June 2019, there were around 88,438 therapeutic goods included in the Australian Register of Therapeutic Goods (ARTG) by 4,126 sponsors. Of these goods, around 70,000 can be marketed directly to the public.

However, determining the precise size of the entire advertising market is difficult because:

• some therapeutic goods that can be advertised directly to the public are exempt from inclusion in the ARTG (e.g. certain homeopathic preparations), and
• a proportion of goods advertised to the public are illegal therapeutic goods (i.e. not in the ARTG when they are required to be).

Additionally, therapeutic goods that can be lawfully advertised to the public can be marketed by the sponsors of the goods, but are often also marketed by a broader range of retailers, including pharmacies, supermarkets, eBay and social media sellers, health practitioners and health food shops. There are over 5,700 pharmacies^[1] and 1,966 supermarkets and grocery stores^[2] which, together with a range of other retailers which sell (and advertise) therapeutic goods to the public in Australia, constitute a very large, and growing, market. Without estimating the numbers of other retailers, it is evident that the potential market for advertising therapeutic goods to the public in Australia is very large.

Background to the TGA's advertising framework

The MMDR examined the medicines and medical devices regulatory framework and processes, and made specific recommendations. The implementation of these recommendations has resulted in a broad advertising framework with four key pillars:

• clarifications and improvements to the advertising requirements in the Act, including enhanced sanctions and penalties, effective from March 2018
• the Therapeutic Goods Advertising Code (No.2) 2018 - external site (Code), which commenced on 1 January 2019
• a streamlined advertising complaints handling scheme, which commenced on 1 July 2018 and established the TGA as the single complaints management body with a new advertising complaints management system, and
• a continuing comprehensive educational campaign for advertisers.

Although the underlying principles have not changed, the Code provides greater objectivity than the Therapeutic Goods Advertising Code 2015 (2015 Code). This helps advertisers apply the requirements and supports the TGA's use of the sanctions and penalties where needed to achieve compliance. In addition, some long-standing key requirements have been clarified, such as the need to include certain mandatory information in advertising.

During 2018-19, two Advertising Codes were in effect:

• the Therapeutic Goods Advertising Code 2015 (the 2015 Code) was in effect until 31 December 2018,
• the Therapeutic Goods Advertising Code (No.2) 2018 (the Code) came into effect 1 January 2019.

The applicable Code will depend on the type of product, type of advertisement and when the advertisement was published or broadcast^[3].

To assist advertisers with the transition from the 2015 Code, the TGA implemented a compliance and enforcement discretion approach, where complaints received about advertising that fully complied with the 2015 Code, other than the mandatory information requirements, were treated with an element of discretion.

Following feedback from industry and the Therapeutic Goods Advertising Consultative Committee (the Committee), we identified and made minor corrections and further clarifications to the Code. These amendments took effect on 30 July 2019.

We have conducted or presented at twelve face-to-face training sessions on Code basics and presented three webinar education sessions. We have published improved advertising guidance, including guidance on the Code. Recent developments include guidance for advertisers in relation to making claims that a therapeutic good or ingredient is 'natural' without misleading consumers. See educational activities for information about our work on education and guidance.

More information about how the advertising of therapeutic goods is regulated in Australia can be found on our website.