In Australia, the Therapeutic Goods Act 1989 (Cth) (TG Act) and its associated instruments including the Therapeutic Goods Regulations 1990 (Cth) (Regulations) and Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (Cth) (Code) are the main laws regulating advertising on medicines.  The TG Act and the associated legislative instruments are administered by the Therapeutic Goods Administration (TGA).

Australia’s competition and consumer laws also apply to the advertising of medicines, in particular the Australian Consumer Law (ACL) (set out in Schedule 2 to the Competition and Consumer Act 2010 (Cth)).  The ACL is administered by the Australian Competition and Consumer Commission (ACCC).

Yes.

a. If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?

These self-regulatory codes apply to the members (who are usually pharmaceutical or other healthcare companies) falling within the target area of focus for each organisation. These include:

(together the Codes of Practice).

b. What is the legal status of the self-regulatory codes?

The Codes of Practice are not legally binding,  but may include internal disciplinary mechanisms that members have agreed to.   However, breaches of codes or complaints made about members of an industry body may be forwarded to the TGA or ACCC for further investigation, and any failure to take corrective action may be publicised. [2]

[1] CHC Code

[2] Pg 25 MACC

Yes, the TG Act defines advertising for therapeutic goods.

(a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example?

Under the TG Act, ‘advertise’ has a broad meaning and includes making any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods.  This includes where the statement, pictorial representation or design is on the label, packaging or other material included with the goods.

Material that is purely factual and which is not, directly or indirectly, intended to promote the use or supply of the goods (e.g. scientific/medical information, provided there is no promotional claim, including price promotion claims) is unlikely to be considered advertising.  However, if factual material is presented in close proximity to advertising material (e.g. the factual material and the advertising material are on a website and appear close to each other), the TGA may consider both the actual advertising material and the factual material to together comprise advertising for the purposes of the TG Act.

The test is an objective test and involves considering whether the material or format on its face appears to be designed to draw public attention to and promote the supply, sale, or use of the particular therapeutic good (the actual intention of those concerned is irrelevant).

Catalogues from retail pharmacies (and certain others) are permitted to include limited price information regarding medicines included in Schedule 3 (i.e. pharmacist-only medicines), Schedule 4 (prescription-only medicines) or Schedule 8 (controlled drugs) to the current Poisons Standard (and which are not included in Appendix H of the current Poisons Standard). Otherwise, unless authorised, these medicines must not be included in advertising.

The Code does not apply to advertising that is part of a public health campaign conducted, approved or funded by the Commonwealth of Australia and / or any of its states or territories. Otherwise, the advertising of therapeutic goods cannot be inconsistent with any such public health campaigns.

Pharmaceutical companies may undertake disease awareness campaigns to educate the public around diseases or conditions that require diagnosis, monitoring, treatment or management by a health professional.  The campaigns may make reference to a range of treatment options, however if the information provided is likely to encourage consumers to seek to obtain a particular medicine, then the campaign will be considered advertising and must comply with the requirements under the TG Act.

(b) Does the definition apply equally to all target audiences? 

The definition of ‘advertising’ under the TG Act applies equally to target audiences.  However, advertisements that are directed exclusively to health professionals are exempt from the advertising requirements provided the advertisement is not accessible to consumers.

Further, advertisements of medicines must not be directed to children under 12.  Certain advertisements can be directed to children over the age of 12 [1] including for:

• sunscreens with SPF 15+;
• acne preparations;
• condoms;
• lip balm; and
• cold sore preparations.

[1] Products containing substances included in Schedule 2, Schedule 3, Schedule 4, or Schedule 8 of the Poisons Standard may not be advertised to children of any age unless specifically approved by the TGA for use in products such as those specified above (e.g. in acne preparations).

The TG Act does not specifically regulate press releases regarding medicines.  Press releases are subject to the same restrictions that apply to advertisements of medicines to the public as set out above. Please see our comments above regarding the proximity of promotional material with factual material.

The Code does not apply to genuine news that is broadcast or published by any medium by a broadcaster, datacaster, the SBS [1] or any person that is a publisher of a print edition newspaper or magazine that is or was available to the public by way of purchase in Australia.  Please see our comments above regarding any proximity of news items to advertising or promotional material.

The MACC permits members to engage with media where the primary intended audience are healthcare professionals (such as medical journals) for promotional purposes, including issuing media releases and developing advertorial content. [2]  However, all material must comply with the requirements of the MACC, in particular, certain required inclusions for materials directed to healthcare professionals. [3]

[1] Each as defined under subsections 42DLB(11) and 42DMA(2) of the TG Act.

[2] MACC section 2.

[3] MACC sections 2.1, 2.3

The TG Act does not specifically regulate the processes that companies must put in place internally concerning the approval of advertising of medicines. However, Codes of Practice may require members to comply with requirements for employees involved in the development, review and approval of promotional materials and educational materials for the general public, including minimum training requirements. Some of these requirements are outlined at Question 11 below.

Generally approval of advertising material is not required, however under the TG Act, there are certain representations which are either prohibited or restricted in the advertising of medicines.  Restricted representations can only be used in advertising with permission from the TGA.

Advertisers are prohibited from making representations regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre-disposition to, (amongst other things) neoplastic disease (i.e. conditions that cause tumour growth).  Prohibited representations can only be used if the TGA has permitted them [1] either because they are necessary for the appropriate use of the goods or necessary in the interests of public health. This is a high standard.

A representation in an advertisement about medicines that refers to a serious form of disease, condition, ailment or defect (i.e. one that usually requires diagnosis and / or management by a health practitioner and is not a prohibited representation) is a restricted representation.  A restricted representation can only be used with prior approval or permission from the TGA [2].  Notices of permitted restricted representations are available on the TGA website.

[1] section 42DK of the TG Act.

[2] section 42DL of the TG Act.

Comparative advertising is permitted under the Code, however it must not suggest that the comparator goods are harmful or ineffectual [1].

The TGA has stated on its website that generally ‘it is good practice not to compare one therapeutic good to other goods.’  Where comparisons are made they should be factual, fair, and not undermine the comparator goods.  This is consistent with the requirements under the ACL where advertisements must not be misleading or deceptive to consumers.  Any comparative claim should not be used unless there is clear evidence to support these claims.

When listing the price in an advertisement, the price information must not use a comparative adjective or term to qualify the purchase price of the medicine.

[1] section 9(3)(f) of the Code.

Under the TG Act, medicines that are not registered or listed on the Australian Register of Therapeutic Goods (ARTG) cannot be advertised. The same prohibition applies to advertising unauthorised indications.

Information about unauthorised medicines
A person or company that advertises an unregistered medicine, or includes an unauthorised indication in an advertisement for a medicine, could be subject to criminal and civil penalties. [1]

Providing material about unauthorised medicines / indications during scientific conferences

As stated above, providing information about unauthorised medicines or unauthorised indications is permitted where the information is purely factual and is not proximate to any form of advertising.  The MACC provides further information about this, stating that  members who have initiated or managed an educational event must ensure that healthcare professionals speaking at those events understand their obligation not to promote unapproved pharmaceutical products or indications. [2]

The MACC also sets out that it is acceptable to display or supply information regarding an unregistered product or indication in the case of international or Australasian congresses held in Australia that are purely for health care professionals, provided any material used clearly identifies that it refers to a product or indication not approved in Australia, and that the product or indication (as appropriate) is approved overseas. [3]

Providing material about unauthorised medicines / indications to healthcare professionals

Under the MACC only the ‘Medical Department’ personnel of pharmaceutical companies (rather than sales personnel) may engage in exchanges with healthcare professionals about unregistered products or off-label uses. [4]  Such exchanges must be non-promotional in intent, content, and nature. [5]  Any information relating to unregistered products or off-label uses must be clearly identified as such.

[1] sections 21B(4), 22(2)–(5) of the TG Act.

[2] MACC section 4.1.

[3] MACC section 4.3.

[4] MACC section 8.

[5] MACC section 8.

The TG Act prohibits the advertising of prescription-only medicines (i.e. Schedule 4 and Schedule 8 medicines) and Schedule 3 medicines (other than those listed in Appendix H to the Poisons Standard) to the general public. The sole exception is the provision of price information by retail pharmacies and certain others.

Non-prescription medicines (e.g. over-the counter medicines) and certain permitted Schedule 3 (pharmacist-only) medicines can be advertised to the public. Under the TG Act, companies should ensure that any advertisements for pharmacy-only (Schedule 2) or permitted Schedule 3 medicines:

• are ethical;
• minimise misuse of their products and promote safe usage;
• are not misleading to the consumer as to the nature or performance of the product;
• support informed choices about healthcare;
• only contain information that is substantiated by the advertiser;
• are consistent with listed indications / intended purposes for the goods in the ARTG, if applicable;
• do not exaggerate efficacy and encourage excessive use;
• include warnings where specific ingredients are present;
• comply with TGA guidance as to restricted and prohibited representations (see Question 6 above); and
• remain in line with current public health campaigns.

These rules are governed by the Codes of Practice rather than the TG Act.

For example, the MACC prescribes guidelines, including restrictions, about interactions between industry and patients / patient organisations, such as those set out below.

Guidelines concerning interactions with patients

Members of Medicines Australia can make available to patients (and their families) and the general public ‘Consumer Medicine Information’, risk management materials, and ‘Product Information’ about their products if these are provided in their entire form and are not shown in a promotional manner. [1]  The member must refuse any requests from the public for medical advice on diagnosing disease or therapy options, and recommend the inquirer to consult their doctor. [2]

Product-specific programs, product information, and patient aids should only be provided to patients already prescribed the product. [3] These items must not be promotional in any way.

There are also rules regarding educational information provided to the public, which (among other things) should be for the purpose of educating the public and encouraging patients to seek further information or explanation from an appropriate healthcare professional. [4]

Guidelines concerning interactions with patient organisations

Under the MACC, communications with patient organisations (who may be consulted regarding a therapeutic good) is allowed provided the disclosure of information is limited to information that may assist that organisation with their role and is not promotional in nature. [5] It is also appropriate for pharmaceutical companies to solicit information to assist in understanding relevant aspects of the healthcare environment relating to their products. [6]  Communications cannot be promotional in nature, should only be conducted by appropriately qualified and selected company personnel, and cannot be made with the intention to influence patient-level prescribing or any other clinical decision-making relevant to individual patients. [7]

[1] MACC section 13.

[2] MACC section 13.

[3] MACC section 13.

[4] MACC section 11.

[5] MACC section 11.

[6] MACC section 11.

While therapeutic goods advertisements directed exclusively to healthcare professionals do not need to comply with the TG Act and associated laws, the Codes of Practice provide guidance on the kind of information that is required or prohibited in such advertisements.

General requirements

For example, the MACC requires that: [1]

• information must be current, accurate, balanced, consistent with the approved product information, and must not mislead directly, by implication, or by omission.
• members must ensure that all promotional claims are referenced and that cited references provide the appropriate level of evidence for the claim (including any statistical data).
• substantiating data should consist of more than just posters, abstracts, personal communication, and unpublished data.
• comparative claims based on studies reporting clinically important differences must include sufficient detail to enable the reader to understand the significance of the data.
• if qualifying statements are used with a promotional claim, they should be linked to the relevant claim with a readily identifiable symbol and appear directly below or adjacent to the claim. Qualifying statements must be prominent.
• any claims for clinical benefit need to be of a magnitude that is generally accepted as clinically meaningful and supported by the body of evidence.

Specific requirements

Similarly, the MACC requires that all types of materials directed to healthcare professionals that include promotional claims must include certain information, including: [2]

• the product’s brand name;
• Australian Approved Name(s) of the active ingredient(s) placed next to the most prominent presentation of the brand name; and
• a statement indicating the Pharmaceutical Benefits Scheme (PBS) status of the product, with or without details of listing, or a direction to where the relevant information is available.

Separately, as noted above, information that is purely factual and that would not be considered ‘advertising’ for the purposes of the TG Act may be provided to healthcare professionals. It will depend on whether the clinical trial information or journals are considered to be advertising as to whether they need to comply with the Codes of Practice rules.

[1] MACC section 1.

[2] MACC section 2.1.

This is governed by the Codes of Practice rather than the TG Act. For example, the GBMA Code prohibits members from providing personal gifts to healthcare professionals, whereas the MACC prohibits members from providing ‘brand-name reminders’ (for example lanyards, clinic supplies, diaries) or other gifts (for e.g. tickets to sporting events, gift vouchers, cash equivalents) to healthcare professionals which may inappropriately influence prescribing, approving, or using a product. [1]

However, under the MACC company-branded items (not product branded) of low monetary value that are relevant to the conduct of an educational meeting may be given to healthcare professionals attending the educational meeting, for example pens and notepads. [2] Company-branded educational materials are also appropriate. [3] Companies providing items as permanent loans to a medical practice or health-related organisation could be regarded as  gifts.  See also the response to Question 14 below.

[1] MACC section 3.

[2] MACC section 3.

[3] MACC section 3.

The Code permits the limited distribution of samples to the general public for certain specified goods (which generally do not include pharmaceuticals, other than oral rehydration products).  Where samples are permitted they must comply with the labelling requirements under Therapeutic Goods Orders 91 and 92 (prescribing standards for labelling of prescription and related medicines and non-prescription medicines).

Providing samples of other types of medicines to healthcare professionals is governed by State and territory legislation.  For example in South Australia, samples of certain medicines can be provided to registered health practitioners and veterinary surgeons provided that they comply with requirements of the Controlled Substances Act 1984 (SA) including manufacturing and packaging.  However, nothing in the SA legislation empowers any person to give a sample of a Schedule 8 poison (i.e. a drug of dependence).

The Codes of Practice may also impose further requirements for samples. For example, the MACC provides that members can provide samples to healthcare professionals only when formally requested by a healthcare professional. [1]  Additionally, the supply must only be for the purpose of enhancing patient access or enabling prescribers to gain experience with the product to improve patient care. [2]  They can only be supplied by representatives employed by the holder of a manufacturer’s licence or wholesale dealer’s licence, or by authorised Company representatives. [3]

[1] MACC section 7.

[2] MACC section 7.

[3] MACC section 7.

The TG Act does not specify any requirements in relation to sponsorship or attendance at events, however the MACC sets out the standards required for its members.

In accordance with the MACC:

• sponsorship including hospitality, travel, and accommodation may be provided to enable a healthcare professional to attend an educational event, provided the meeting is directly related to the healthcare professional’s area of expertise. [1] The sponsoring company must adhere to certain rules in relation to costs, flights and accommodation.
• where the member initiates and manages the event, the member should: [2]
  • be able to produce objective evidence of the educational value of the event (for example an invitation or agenda) that clearly describes the purpose, content, and meeting start and finish times;
  • review and approve the educational program through an internal company process; and
  • brief healthcare professionals speaking at the event about their obligation to not promote unapproved company products or indications. An exception to this are events where an independent scientific faculty has chosen the topics and speakers.
• members can sponsor educational events organised by a society, university, or other healthcare professional organisation. [3]
• members may host a trade display provided the audience is solely healthcare professionals.  Where the primary audience is broader than healthcare professionals, the member company should carefully consider whether the promotional trade display or the information from a trade display involves the promotion of products to the general public which may contravene the TG Act.[4]

[1] MACC section 4.4.

[2] MACC section 4.1.

[3] MACC section 4.2.

[4] MACC section 4.3.

The TG Act does not specify any restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies

However, a member of Medicines Australia must comply with the MACC guidelines concerning company-initiated or sponsored events, and the MACC’s overarching principles such as ensuring all activities have the purpose of supporting the quality use of medicine. [1] The MACC states that pharmaceutical companies cannot provide entertainment to healthcare professionals: cultural, sporting, and other non-scientific events at scientific conferences would likely be classified as entertainment. [2]

[1] MACC Part A, Principle 1.

[2] MACC section 4.5.

The TG Act does not specifically deal with payments by pharmaceutical companies to healthcare professionals.

However, in accordance with the MACC Medicines Australia members can pay healthcare professionals for speaking at educational events and for their consultancy services.  These fees must be reported to Medicines Australia. [1]  There should be a clearly identified legitimate need for the services. [2]  Remuneration for the services rendered should not exceed an amount commensurate with the services supplied and must be reasonable, appropriate, and balanced when considered in context. [3]

[1] MACC section 15.1.

[2] MACC section 5.

[3] MACC section 5.1.

The TG Act does not deal with grants or donations made by pharmaceutical companies.  Under the MACC, Medicines Australia members can provide grants, financial support, or in-kind support to healthcare professionals or health-related organisations: [1]

• to implement a Quality Use of Medicine program;
• for educational or training purposes;
• for medical research; and
• to improve patient outcomes.

A grant of financial support must not be provided to underwrite a commercial business, generate income for the practice / institution, or to pay for an employee’s salary in part or full. [2]  The member company may temporarily loan a piece of equipment to a medical practice or health-related organisation, provided it facilitates the quality use of medicines and has a mechanism to retrieve the equipment. [3]

[1] MACC section 5.2.

[2] MACC section 5.2.

[3] MACC section 5.2.

The TG Act does not deal with disclosure and transparency requirements in relation to payments between pharmaceutical companies and healthcare professionals or institutions.

However, under the MACC member companies are required to report on transfers of value to healthcare professionals, third-party educational meetings and symposia, and health consumer organisations. [1] These reports must be publicly available for three years from publication. [2]  This is irrespective of whether the member company has products on the market or is a foreign company.   Transparency reporting is not a legal requirement but breaching the MACC may lead to sanctions being imposed and fines of up to $300,000 per complaint. [3]

Further practical guidance on reporting procedures, especially pre-reporting procedures, can be found in Medicine Australia’s Transparency Reporting Quick Guide and Transparency Reporting FAQ’s.

The MACC outlines the items that must be reported, including fees paid to healthcare professionals for speaking at educational meetings; remuneration or sponsorship of healthcare professionals and any airfares or accommodation provided. [4] Support provided to health consumer organisations including financial support or significant direct or indirect non-financial support should also be reported.

[1] MACC section 15.

[2] MACC section 15.

[3] MACC section 16.5.

[4] MACC section 15.1.

Advertising of medicinal products no longer requires the TGA’s pre-approval.  However as outlined in Question 6 above, companies must still obtain approval where they intend to use restricted representations in their advertisements that are not one of the representations that have been pre-approved by the TGA.

Advertising of medicinal products on the internet and through social media is subject to the same regulation as traditional forms of advertisement under the TG Act.

When considering advertisements on the internet and social media, it is critical for companies to ensure that any content with promotional claims about prescription medicines are not accessible by the general public and are restricted to a verified healthcare professional audience. For example, companies can ensure that such material is hosted on a secure server that is restricted though password protection (as set out in Question 8 above).

The Codes of Practice also provide further guidelines for promotional claims directed at healthcare professionals.

Commonwealth anti-bribery legislation prohibits the offering of inducements to ‘Commonwealth public officials’. This could be relevant to pharmaceutical companies who interact with Commonwealth health organisations (or employees of those organisations).

Anti-bribery legislation at the State / Territory level also applies to interactions between private parties.  For example, the Crimes Act 1900 (NSW) prohibits agents (including employees) from receiving or soliciting (from another person) any benefit as an inducement or reward for doing or not doing something; they can be liable for 7 years imprisonment for contraventions. [1]

The Codes of Practice are also relevant. For example, the MACC imposes fines on members up to $200,000 for any activity that discredits or reduces confidence in the pharmaceutical industry.

[1] section 249B of Crimes Act 1900 (NSW).

The Health Practitioner Regulation National Law (National Law) states that any registered health practitioner who accepts a benefit from a product supplier as inducement, consideration or reward in return for recommending other people to use that product would be engaging in unsatisfactory professional conduct.  Such conduct could attract complaints and disciplinary measures from AHPRA, and National Health Practitioner Boards or Councils (National Boards). [1] The National Boards have developed the Guidelines for advertising a regulated health service under the National Law.  These guidelines have been developed to help practitioners and other advertisers understand their obligations when advertising a regulated health service.  The National Boards for each health profession such as the Medical Board of Australia and the Pharmacy Board of Australia have also developed their own codes and guidelines under the National Law that cover the offering of benefits / inducements to their respective members.  The case is the same for any state-based health professional councils.

The Codes of Practice also contain rules regarding the offering of benefits or inducements to healthcare professionals. For example, the MACC governs sponsorships to events (along with hospitality, travel, and accommodation) (see Question 14) and grants (financial or in-kind support) to healthcare professionals (see Question 17).  The MACC also imposes sanctions on any activity that discredits or reduces confidence in the pharmaceutical industry.[2]  It would be considered a gift or inducement if a Medicines Australia member provided hospitality, travel or accommodation to spouses, relatives, guests or companions of healthcare professionals and non-healthcare professional practice staff when they are accompanying a healthcare professional. [3]

Under the Code, an advertisement about a therapeutic good must not offer any personal incentive or commission to a pharmacy assistant, or any retail salesperson who is not a health professional, in exchange for recommending or supplying the goods.

[1] section 139B(1)(g) of the National Law.

[2] MACC section 16.5.

[3] MACC section 4.5

The TGA is responsible for enforcing contraventions of the TG Act and its associated legislative instruments.  The TGA can commence actions in the Federal Court of Australia against any person or company who breaches the legislation.

The ACCC may hold advertisers liable for contraventions of the ACL such as misleading and deceptive conduct. It can similarly commence actions in the Federal Court of Australia against any person or company who breaches the legislation.

AHPRA is the body responsible for enforcing rules concerning the conduct of healthcare professionals, including in relation to advertising and inducements. Similarly, the Health Care Complaints Commission deals with complaints against health service providers and health care professionals in NSW.

Industry bodies such as Medicines Australia administer their own codes of conduct, including in respect to advertising and inducement.

The primary regulatory bodies for advertising compliance regarding pharmaceutical goods are the TGA and the ACCC.

Individuals can anonymously report any infringements or suspected infringements of the Code to the TGA, who may then initiate proceedings where necessary.  The TGA also undertakes surveillance of advertising, including on websites.  It has a range of enforcement powers including initiating proceedings before the Australian Federal Courts (see Item 23).

The self-regulatory bodies have processes for the reporting and investigating suspected breaches of their codes of conduct. For example, Medicines Australia receives complaints (either from member companies about other member companies, or from health professionals or other members of the public) and considers them through their Code of Conduct Committee, and Appeals Committee when necessary.  Companies submitting complaints against competitors must provide evidence of intercompany dialogue, and demonstrate that they have made a meaningful effort to resolve the issue prior to submitting the complaint.

Companies have also initiated proceedings against competitors in relation to advertising under the Australian Consumer Law – generally on the grounds of the advertising constituting misleading or deceptive conduct.

See for example GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser (Australia) Pty Ltd (No 2) [2018] FCA 1. This case involved comparative advertising of over-the-counter pain relief products, and allegations of misleading or deceptive representations in their advertising campaign.

TGA

The TGA undertakes intelligence led, risk-based compliance and enforcement activities to ensure compliance with the TG Act.  It uses a number of compliance and enforcement tools ranging from education and the issue of warning letters for low compliance risks to suspensions, enforceable undertakings, fines and seeking injunctions from the Federal Court of Australia or court proceedings for more severe risks or ongoing or repeated noncompliance.  The TGA focuses on those matters that concern public safety, allege serious breaches of the TG Act and involve repeated or wilful non-compliance.

ACCC

The ACCC may investigate misleading and deceptive conduct which can lead to an action for injunctions, damages, or compensation orders in court. False or misleading representations about goods or services can also attract civil penalties for a company, being the maximum of the greater of the following:

• $10,000,000;
• if Court can determine “reasonably attributable” benefit obtained, 3 times that value; or
• if Court cannot determine benefit, 10% of annual turnover in preceding 12 months from the month that the offence was committed. [1]

AHPRA / National Boards

A health practitioner who accepts inducements from a product supplier may be fined up to 250 penalty units ($55,500). [2] Disciplinary measures can also include cancelling registration or imposing conditions on registration.

[1] section 151 of the Australian Consumer Law.

[2] section 149B of the National Law.

There is no specific relationship between the procedures taken by a self-regulatory authority (e.g. MACC) and the procedures taken by the government or courts (e.g. TGA), however as noted above the self-regulatory authorities may refer conduct of which they become aware to the TGA or the ACCC, where relevant.

Generally, any procedures before or measures taken by the self-regulatory authority are in addition to the normal rights of the parties under applicable laws (e.g. ACL and TG Act) and are not intended to restrict a party from referring a complaint to a court / tribunal / government competent authorities. For example, the MACC notes that where substantially the same subject matter is, at the same time, subject to review by the TGA, or is the subject of legal proceedings between the same parties in an Australian court or Administrative Tribunal, Medicines Australia has the discretion to either not accept a complaint, or accept and delay referring a complaint to the Code Committee. [1]

[1] MACC section 16.1.

The TGA is an active regulator. In terms of pharmaceutical advertising, recent enforcement trends have focused on:

• the advertising of unapproved products to consumers;
• false and misleading advertising in healthcare;
• making prohibited statements in advertising.

In September 2022, the TGA issued nearly $1 million in fines to a range of companies for the alleged unlawful advertising of medicinal cannabis products on their websites and social media platforms. This included fines for the alleged advertising of prescription-only products, the use of restricted representations and suggestions that the products were recommended or approved by a government agency. Further fines were issues to other companies in October 2022 for similar alleged infringements.

During 2022, the TGA has also issued fines in respect of the alleged advertising of:

• sports supplement products that were not listed on the ARTG;
• certain herbal and complementary medicine products promoted as a ‘miracle covid treatment’, in contravention of the Code;
• a complementary medicine that allegedly contained a prohibited representation and also implied the product was recommended or approved by a government agency; and
• a supplement which was advertised for an indication that was not included in its ARTG listing.