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 of medicines in Australia. The TG Act and the associated legislative instruments are administered by the Therapeutic Goods Administration (TGA).  The TGA has published guidance on complying with the Code (including a guidance note on advertising medicines on social media platforms).

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

Additionally, while not the focus of this guide, the Health Practitioner Regulation National Law (as is in force in each State and Territory) (National Law) applies to the advertisement of regulated health services (in particular, advertising by pharmacists). The National Law is administered by the Australian Health Practitioner Regulation Agency (AHPRA) (in partnership with the National Health Practitioner Boards (National Boards)) who have developed guidelines for advertising a regulated health service. Further, the National Health Act 1953 (Cth) regulates advertisements related to the Pharmaceutical Benefits Scheme (being the medicine subsidy program funded by the Australian Government).

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 – sanctions may include requiring cessation of certain conduct/withdrawal of materials, corrective actions, monetary fines and suspension/expulsion from the relevant association. Compliance with the relevant Code of Practice may also be a condition of membership of the relevant association.  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.

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 package in which the goods are contained.¹

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 test² 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).  The total presentation and content of the advertisement (including the words, images, claim, advertising medium) will be considered.  If members of the public would reasonably consider the information to be intended to promote the use or supply of a product, then the TGA will be likely to consider it an advertisement.

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:

• An advertisement directed exclusively to certain health professionals (see (b)) below).
• An advertisement that is part of, or comprises, a public health campaign. Otherwise, the advertising of therapeutic goods cannot be inconsistent with any such public health campaigns (see below).
• An advertisement relating to COVID-19 vaccines (made in accordance with the Therapeutics Goods (Restricted Representations—COVID-19 Vaccines) Permission 2022 (Cth).
• Genuine news published or broadcast by a broadcaster, datacaster, the SBS, or the publisher of a print edition of a magazine or newspaper for purchase in Australia.

Pharmaceutical companies may undertake disease awareness campaigns to educate the public about 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 and the Code.

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

Subject to our comments below, the definition of ‘advertising’ under the TG Act applies equally to target audiences. Advertisements that are directed exclusively to the following persons are exempt from the application of the Code, provided that such advertisements are not accessible by the public and clearly target the following health professionals³:

• health practitioners (who are registered health professionals in their professions);
• certain other health professionals (including chiropractors and dentists);
• persons engaged in the wholesale of therapeutic goods or purchasing therapeutic goods on behalf of a hospital, charity, government or government authority; and
• herbalists, homoeopathic practitioners, naturopaths, nutritionists or practitioners of traditional Chinese medicine registered under a law of a State or Territory.

Physical advertisements for health professionals must not be able to be accessed by or seen by members of the public. Online content must also be secured (e.g. with secure log in information, confirmations and restrictions on IP addresses).

Generally, advertisements of medicines must not be directed to children under 12.  However, certain advertisements can be directed to children over the age of 12⁴ including for:

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

Footnote(s):

¹ TG Act s 3.

² Code pt 2, s 5(2).

³ Code pt 2, s 6(1)(a).

⁴ 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. More recently the TGA has published guidance for companies who are also listed on the Australian Stock Exchange (ASX) and who must comply with disclosure obligations under the ASX Listing Rules, reminding them of the prohibition against advertising in relation to regulated medicines⁵. ASX announcements must therefore be factual and not seen as promoting any particular medicines.

As noted above, the Code does not apply to genuine news that is broadcast or published by any medium by a broadcaster, datacaster, the SBS⁶ 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 Medicines Australia Code of Conduct 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.⁷ However, all material must comply with the requirements of the Medicines Australia Code of Conduct – in particular, such information must be current, accurate, balanced, consistent with the approved product information and not misleading, and otherwise contain the specific required inclusions.⁸

Footnote(s):

⁵ Complying with advertising rules for therapeutic goods when making an ASX announcement published 1 September 2022 and updated 1 April 2023; see also the Code of Best Practice for Reporting by Life Sciences Companies, Second Edition published by AusBiotech in collaboration with the ASX and the Victorian State Government.

⁶ Each as defined in the TG Act ss 42DLB(11) and 42DMA(2).

⁷ Medicines Australia Code of Conduct s 2.

⁸ Medicines Australia Code of Conduct s 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, the approval of the TGA, ACCC or any other regulatory code is not required for the release of any advertising material, however under the TG Act, there are certain representations which are either ‘prohibited’ or ‘restricted’ in the advertising of medicines and do require approval.

Advertisers are prohibited from making representations regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre-disposition to, sexually transmitted diseases, HIV or AIDs, Hepatitis C Virus, mental illness or neoplastic disease (i.e. conditions that cause tumour growth).  Prohibited representations can only be used if the TGA has permitted them⁹ 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.¹⁰  Notices of restricted representations that the TGA has approved or permitted the use of are available on the TGA website.

Footnote(s):

⁹ TG Act s 42DK.

¹⁰ TG Act s 42DL.

Comparative advertising (i.e. identifying a competing product and making or implying certain claims about it) is permitted under the Code, however advertising must not:

• suggest that the comparator goods are harmful or ineffectual;¹¹
• make broad comparisons like ‘higher strength’ or ‘better absorbed’; or
• use superlatives in describing the product such as ‘the best’, ‘the fastest acting’, or ‘most effective’.

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 substantiate the relevant claims. The advertising must not discredit other products, whether directly or by implication.

Footnote(s):

¹¹ Code s 9(3)(f).

Information about unauthorised medicines

Medicines that are not registered or listed on the Australian Register of Therapeutic Goods cannot be advertised, in Australia. The same prohibition applies to advertising unauthorised indications.  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.¹²

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 Medicines Australia Code of Conduct 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. Companies should be able to produce documentary evidence showing that the healthcare professional was briefed on this obligation. ¹³

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. Information provided must be consistent with the product information in the country where it is approved or registered.¹⁴

Providing material about unauthorised medicines / indications to healthcare professionals

Under the Medicines Australia Code of Conduct, 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.¹⁵ Such exchanges must be non-promotional in intent, content, and nature.¹⁶ Any information relating to unregistered products or off-label uses must be clearly identified as such.

Footnote(s):

¹² TG Act ss 21B(4), 22(2)–(5).

¹³ Medicines Australia Code of Conduct s 4.1.

¹⁴ Medicines Australia Code of Conduct s 4.3.

¹⁵ Medicines Australia Code of Conduct s 8.

¹⁶ Medicines Australia Code of Conduct s 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 complies with the TG Code and:

• are accurate and balanced;
• do not represent that the medicine is safe, without harm or side effects, effective or a guaranteed cure, or infallible, magical or miraculous;
• do not cause, or be likely to cause, undue alarm, fear or distress;
• 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;
• only contain easily understood scientific or clinical terminology;
• comply with TGA guidance as to restricted and prohibited representations (see Question 6 above);
• must not be directed to children under 12 years old (unless exempt);
• only contain compliant testimonials and endorsements;
• are not inconsistent with current public health campaigns; and
• contain relevant mandatory statements and other required information.

Restrictions on interactions between patients or patient organisations and industry are governed by the Codes of Practice rather than the TG Act, in particular the Medicines Australia Code of Conduct.

Guidelines concerning interactions with patients

Members of Medicines Australia can make available to patients (and their families) information about a product that is a credible and non-promotional source of information, such as ‘Consumer Medicine Information’, risk management materials, and ‘Product Information’ about their products. These materials must be provided in their entire form and not be amended, abridged or shown in a promotional manner.¹⁷

Product-specific programs, product information, and patient aids should only be provided to patients already prescribed the product.¹⁸ These items must not be promotional in any way. Where an item is likely to be used outside of the home and therefore be visible to the public, a company may include their company name and/or logo only on such materials.¹⁹

 Companies are also permitted to conduct patient support programs, with or without a patient organisation. Patient support programs aim to increase patient compliance with a prescribed medical treatment, in turn increasing health outcomes.²⁰ Patient support programs must be designed to address a legitimate need and must have a clearly documented clinical rationale.  Advertisements of patient support programs are bound by the TG Act and Medicines Australia Code of Conduct.

Guidelines concerning interactions with patient organisations

Generally, under the Medicines Australia Code of Conduct, 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.²¹ It is also appropriate for pharmaceutical companies to solicit information to assist in understanding relevant aspects of the healthcare environment relating to their products.²²  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.²³

More specifically, companies may enter into relationships with patient organisations with the objective of enhancing the quality use of medicines, and supporting health outcomes for the Australian community. Medicines Australia (together with the Consumers Health Forum of Australia) has developed a guide titled ‘Working Together: A guide to relationships between health consumer organisations and pharmaceutical companies’ to assist in doing so.

Footnote(s):

¹⁷ Medicines Australia Code of Conduct s 13.

¹⁸ Medicines Australia Code of Conduct s 13.

¹⁹ Medicines Australia Code of Conduct s 13.

²⁰ Medicines Australia Code of Conduct s 14.

²¹ Medicines Australia Code of Conduct s 11.

²² Medicines Australia Code of Conduct s 11.

²³ Medicines Australia Code of Conduct s 11.

While therapeutic goods advertisements directed exclusively to, among others,  healthcare professionals (see 3(b) above) do not need to comply with the TG Act and Code²⁴, the Codes of Practice provide guidance on the kind of information that is required or prohibited in such advertisements.

General requirements

For example, the Medicines Australia Code of Conduct requires that:²⁵

• 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 Medicines Australia Code of Conduct requires that all types of materials directed to healthcare professionals that include promotional claims must include certain information, including:²⁶

• 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;
• where to obtain the ‘product information’ (e.g. a url);
• 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;
• name of the supplier; and
• date that the material was prepared or last revised.

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.

Footnote(s):

²⁴ Code s 42AA

²⁵ Medicines Australia Code of Conduct s 1.

²⁶ Medicines Australia Code of Conduct s 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 Medicines Australia Code of Conduct 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.²⁷

However, under the Medicines Australia Code of Conduct 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.²⁸ Company-branded educational materials are also appropriate.²⁹

Companies may also provide hospitality, travel and/or accommodation to healthcare professionals who are participating in the event or providing a service subject to the principles outlined in the Medicines Australia Code of Conduct (any hospitality must be moderate and reasonable and subject to monetary limits set out in the Medicines Australia Code of Conduct ‘tool kit’).  Companies may not provide entertainment to healthcare professionals or provide the hospitality, travel and accommodation to the healthcare professional’s guests.³⁰ 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.

Footnote(s):

²⁷ Medicines Australia Code of Conduct s 3.

²⁸ Medicines Australia Code of Conduct s 3.

²⁹ Medicines Australia Code of Conduct s 3.

³⁰ Medicines Australia Code of Conduct s 4.5

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 Medicines Australia Code of Conduct provides that members can provide samples to healthcare professionals only when formally requested by a healthcare professional.³¹ 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.³² 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.³³

The Medicines Australia Code of Conduct permits companies to provide samples (i.e. starter packs) at no cost or reduced cost for the purpose of enhancing patient access or enabling prescribers to gain experience with the product to improve patient care.  Appropriate request forms must be completed, and records kept, in respect to the supply of starter packs.³⁴

Footnote(s):

³¹ Medicines Australia Code of Conduct s 7.

³² Medicines Australia Code of Conduct s 7.

³³ Medicines Australia Code of Conduct s 7.

³⁴ Medicines Australia Code of Conduct s 7.

The TG Act does not specify any requirements in relation to sponsorship or attendance at events, however the Medicines Australia Code of Conduct specifies the following:

• Sponsorship including hospitality (being costs for food or beverages), 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.³⁵ The sponsoring company must establish clear guidelines in relation to the awarding of the sponsorship.
• A sponsoring company must adhere to certain rules in relation to costs, flights and accommodation in connection with any event.³⁶
• Where the member initiates and manages the event, the member should:³⁷
  • 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.
• A member can sponsor educational events organised by a society, university, or other healthcare professional organisation.³⁸
• Members may host a trade display provided the audience is solely healthcare professionals. Where the primary audience is broader than healthcare professionals, the member 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.³⁹

Where an event takes place in countries other than Australia, the Medicines Australia Code of Conduct specifies that:

• A member can sponsor international travel in either economy or business class, though travel to and from New Zealand is by economy class only. The most direct route should be booked without the allowance of more time at the destination than is reasonably justified to enable the healthcare professional to effectively participate in the events.⁴⁰
• Any meal provided in another country should comply with the monetary limit set by the industry association in that country. Where there is no monetary limit in that country, the Medicines Australia Code of Conduct principles should apply;⁴¹ any spend on food and beverages must be moderate, reasonable and commensurate with the level of education being provided as judged by local standards. In Australia, the capped maximum spend per person is $140 per person per meal (excluding gratuities and GST).⁴²

Footnote(s):

³⁵ Medicines Australia Code of Conduct s 4.4.

³⁶ Medicines Australia Code of Conduct s 4.5.

³⁷ Medicines Australia Code of Conduct s 4.1.

³⁸ Medicines Australia Code of Conduct s 4.2.

³⁹ Medicines Australia Code of Conduct s 4.3.

⁴⁰ Medicines Australia Code of Conduct s 4.5.

⁴¹ Medicines Australia Code of Conduct s 4.5.

⁴² Medicines Australia Code of Conduct Code Resource Toolkit, Capped Maximum Hospitality Spend.

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 Medicines Australia Code of Conduct guidelines concerning company-initiated or sponsored events, and the Medicines Australia Code of Conduct’s  overarching principles such as ensuring all activities have the purpose of supporting the quality use of medicine.⁴³

The Medicines Australia Code of Conduct states that pharmaceutical companies cannot provide entertainment to healthcare professionals.⁴⁴ Previous versions of the Medicines Australia Code of Conduct specified that entertainment includes the provision of tickets to cultural, sporting or artistic events, including a band as a featured attraction at a dinner meeting or an invitation to a corporate box at a sporting event.⁴⁵ While the current version of the Medicines Australia Code of Conduct no longer expressly specifies this, it is highly likely that cultural, sporting, and other non-scientific events at scientific conferences would still be classified as entertainment.

The Medicines Australia Code of Conduct also states that a facility selected as part of the travel, accommodation and/or hospitality of the healthcare professional must be selected for its appropriateness to enable the activity to be conducted, and should not be chosen or utilised for the purpose of leisure, sporting or recreational activities.⁴⁶

Footnote(s):

⁴³ Medicines Australia Code of Conduct pt A, principle 1.

⁴⁴ Medicines Australia Code of Conduct s 4.5.

⁴⁵ Edition 18 of the Medicines Australia Code of Conduct version 2, October 2016, s 9.5.

⁴⁶ Medicines Australia Code of Conduct s 4.5.

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

However, in accordance with the Medicines Australia Code of Conduct, members can pay healthcare professionals for speaking at educational events and for their consultancy or advisory services.  These fees must be reported to Medicines Australia.⁴⁷ There should be a clearly identified legitimate need for the services prior to the pharmaceutical company approaching prospective healthcare professionals for services.⁴⁸ 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.⁴⁹ Any payment made to a healthcare professional must not be made as an incentive or in return for their attendance at an educational event or trade stand, and must not be conditional on the use of a specific product by the health professional.⁵⁰

Footnote(s):

⁴⁷ Medicines Australia Code of Conduct s 15.1.

⁴⁸ Medicines Australia Code of Conduct s 5.

⁴⁹ Medicines Australia Code of Conduct s 5.1.

⁵⁰ Medicines Australia Code of Conduct s 5.1.

The TG Act does not deal with grants or donations made by pharmaceutical companies.

Under the Medicines Australia Code of Conduct, Medicines Australia members can provide grants, financial support, or in-kind support to healthcare professionals or health-related organisations in specific circumstances, being:

• to implement a Quality Use of Medicine program;
• for educational, training or academic purposes;
• for medical research; and
• to improve patient outcomes.⁵¹

The Medicines Australia Code of Conduct recommends that financial support be paid to a healthcare institution rather than directly to an individual healthcare professional as payments to individuals may create an impression that the purpose is not related to the specific approved circumstances above.⁵²

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.⁵³

The member 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. Where an item is provided on permanent loan, this may be regarded as a gift.⁵⁴ Gifts for the personal benefit of healthcare professionals are prohibited, and companies are not to offer any items or services that could be considered to be a gift.⁵⁵

Footnote(s):

⁵¹ Medicines Australia Code of Conduct s 5.2.

⁵² Medicines Australia Code of Conduct s 5.2.

⁵³ Medicines Australia Code of Conduct s 5.2.

⁵⁴ Medicines Australia Code of Conduct s 5.2.

⁵⁵ Medicines Australia Code of Conduct Code Resource Toolkit, Gifts, Offers and Company Branded Items.

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 Medicines Australia Code of Conduct, members are required to report on transfers of value to healthcare professionals, third-party educational meetings and symposia, and health consumer organisations.⁵⁶ These reports must be publicly available for three years from publication.⁵⁷ This is irrespective of whether the member has products on the Australian market.

Transparency reporting is not a legal requirement, but breaching the Medicines Australia Code of Conduct may lead to sanctions being imposed and fines of up to $300,000 per complaint.⁵⁸ Companies must also comply with Australian privacy legislation (the Privacy Act 1988 (Cth) and associated Australian Privacy Principles) regarding reporting of individual healthcare professional data.

The Medicines Australia Code of Conduct 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.⁵⁹ Support provided to health consumer organisations including financial support or significant direct or indirect non-financial support should also be reported.

The Medicines Australia Code of Conduct is only concerned with payments made to Australian healthcare professionals by Australian companies. This means:

• if a global company with no Australian legal entity pays or provides support to an Australian healthcare professional, this is not a reportable transfer of value;
• if an Australian company pays or provides support for an Australian healthcare professional to undertake a global activity, this is a reportable transfer of value;
• if a global company pays or provides support for an Australian healthcare professional, but then the global company subsequently bills or invoices an Australian company, this is a reportable transfer of value.⁶⁰

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.

Footnote(s):

⁵⁶ Medicines Australia Code of Conduct s 15.

⁵⁷ Medicines Australia Code of Conduct s 15.

⁵⁸ Medicines Australia Code of Conduct s 16.5.

⁵⁹ Medicines Australia Code of Conduct s 15.1.

⁶⁰ Medicines Australia Code of Conduct Code Resource Toolkit, Transparency Reporting FAQ’s.

Advertising of medicinal products on social media is subject to the same regulation as traditional forms of advertisement under the TG Act. Accordingly, the requirements outlined in Question 9 remain applicable to advertisements on social media.

Social media advertisements for Schedule 2 and 3 medicines must include relevant mandatory statements and health warnings which are visible at all times and not ‘collapsed’ within a social media post.  Any non-compliant comments must be removed from the social media page.  The TGA recommends businesses to adopt an ‘acceptable use policy’.

The TGA has also noted that if a business becomes aware of misinformation in relation to its product (even on social media channels for which it is not responsible), they should provide corrective information.

The Medicines Australia Code of Conduct confirms that activities on social media are considered in the same way as traditional media, and recommends that companies have policies and procedures in place which describe the roles and responsibilities of employees and contractors when interacting on social media to ensure compliance with the Medicines Australia Code of Conduct.⁶¹

Footnote(s):

⁶¹ Medicines Australia Code of Conduct s 2.5.

The advertising of medicinal products on the internet is highly regulated where advertising is to members of the Australian public for products available for supply in Australia. When considering advertisements on the internet, it is critical for companies to ensure that any content with promotional claims about prescription medicines are not accessible to the general public.

Any advertising or information intended for health professionals should have access restrictions to ensure the information is only accessible 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 3 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’.⁶² This may 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; individuals can be liable for 7 years imprisonment for contraventions.⁶³

The Codes of Practice are also relevant. For example, the Medicines Australia Code of Conduct imposes fines on members of up to $200,000 for any activity that discredits or reduces confidence in the pharmaceutical industry.⁶⁴

Footnote(s):

⁶² Criminal Code Act 1995 (Cth) pt 7.6.

⁶³ Crimes Act 1900 (NSW) s 249B.

⁶⁴ Medicines Australia Code of Conduct s 16.5.

Statutory rules

Under the Health Practitioner Regulation National Law Act 2009 (Qld) (National Law), a recommendation by a practitioner that a person use a health product constitutes unprofessional conduct if the practitioner has a pecuniary interest in giving that recommendation, unless the practitioner discloses the nature of that interest to the person before or at the time of giving the referral or recommendation.⁶⁵ Queensland is the host jurisdiction for the National Law, with each other jurisdiction applying changes to the National Law through local legislation, with local variations. Accordingly, each Australian jurisdiction has legislation which governs the offering of benefits or inducements to healthcare professionals, though this varies slightly according to jurisdiction.

For example, in New South Wales, a registered health practitioner who accepts a benefit from a product supplier as inducement, consideration or reward in return for referring or recommending other people to use that product would be engaging in unsatisfactory professional conduct, regardless of whether the practitioner discloses the nature of any interest when giving the product recommendation.⁶⁶  Such conduct could attract complaints and disciplinary measures from AHPRA, and National Boards.⁶⁷

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.  Incentives to the pharmacists themselves are governed by the National Law as noted above.

Self-regulatory rules

The National Boards for each health profession such as the Medical Board of Australia and the Pharmacy Board of Australia have 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 Medicines Australia Code of Conduct 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 Medicines Australia Code of Conduct also imposes sanctions on any activity that discredits or reduces confidence in the pharmaceutical industry.⁶⁸  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.⁶⁹

Footnote(s):

⁶⁵ Health Practitioner Regulation National Law Act 2009 (Qld) s 5, definition of ‘unprofessional conduct’.

⁶⁶ Health Practitioner Regulation National Law 2009 (NSW) s 139B(1)(h) and (i).

⁶⁷ Health Practitioner Regulation National Law 2009 (NSW) s 144(b).

⁶⁸ Medicines Australia Code of Conduct s 16.5.

⁶⁹ Medicines Australia Code of Conduct s 4.5

The TGA is responsible for enforcing contraventions of the TG Act and its associated legislative instruments.  The TGA can issue infringement notices requiring the payment of a penalty or, for repeated or more egregious breaches, it 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 Question 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 (Code Committee), and Appeals Committee when necessary.

Companies submitting complaints against competitors to Medicines Australia 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 or representations. See for example AFT Pharmaceuticals (AU) Pty Limited (AFTP) v Reckitt Benckiser (Australia) Pty Limited (Reckitt) [2020] FCAFC 45. This case involved comparative advertising of over-the-counter pain relief products. Reckitt brought proceedings against AFTP alleging that its comparative advertising which claimed to have a more effective product than Reckitt amounted to misleading and deceptive conduct. ATFP subsequently cross-claimed on similar grounds against Reckitt, claiming that Reckitt breached ACL in claiming its product was superior.

At first instance, the Federal Court held that AFTP had breached ACL by making misleading representations about the product without evidence to substantiate the claims. The use of charts, percentages and footnotes in representations implied that the statements were ‘in the realm of science’, which the Court determined was not the case. Similarly, the Federal Court found that Reckitt had also made misleading representations. Accordingly, both parties were held to have breached ACL.

Following several appeals, the Federal Court of Australia found that there was an adequate scientific foundation for the comparative claims which AFTP’ made in its advertisements, highlighting the importance of having strong scientific support to support any claims of superior efficacy.⁷⁰ In April 2022, the High Court rejected Reckitt’s application to appeal the judgment.

Footnote(s):

⁷⁰ AFT Pharmaceuticals (AU) Pty Ltd v Reckitt Benckiser (Australia) Pty Ltd [2021] FCAFC 222.

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, issuing infringement notices (requiring the payment of a penalty), 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:

• $50,000,000;
• if Court can determine “reasonably attributable” benefit obtained, 3 times that value; or
• if Court cannot determine benefit, 30% of annual turnover in preceding 12 months from the month that the offence was committed.⁷¹

Where an offense is committed by a person other than a body corporate, the offence on conviction is punishable by a fine of not more than $2,500,000.

AHPRA / National Boards
A health practitioner who accepts inducements from a product supplier may be fined up to 250 penalty units (currently $78,250, but may increase to $82,500 if the Crimes and Other Legislation Amendment (Omnibus No. 1) Bill 2024 is passed).⁷² Disciplinary measures can also include cancelling registration or imposing conditions on registration.

Footnote(s):

⁷¹ ACL s 151(5).

⁷² Health Practitioner Regulation National Law 2009 (NSW) s 149B.

There is no specific relationship between the procedures taken by a self-regulatory authority (e.g. Medicines Australia Code of Conduct) and the procedures taken by the government or courts (e.g. by the 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.

When the TGA issues infringement notices for breach of the therapeutic goods advertising law, payment of the associated penalty will mean that the TGA will not initiate court proceedings for that specific alleged breach.

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 Medicines Australia Code of Conduct 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.⁷³

The Medicines Australia Code of Conduct also states that where a complaint is made to Medicines Australia against a non-member, Medicines Australia invites the non-member to have the complaint adjudicated by the Code Committee, subject to the non-member agreeing to abide by the Committee’s decision and any sanctions imposed. If the non-member declines the invitation, Medicines Australia has the right, but not the obligation, to forward the complaint to the TGA or ACCC.⁷⁴

Footnote(s):

⁷³ Medicines Australia Code of Conduct s 16.1.

⁷⁴ Medicines Australia Code of Conduct s 16.3.

The TGA is an active regulator. On 1 August 2024, the TGA published that it had issued over 70 infringement notices totally over $1million to 19 entities for alleged unlawful advertising of prescription medicines.  Of this amount, $300,000 related to weight loss medicines such as Ozempic and Saxenda.

Recent enforcement trends involving pharmaceutical advertising have focused on:

• the unlawful advertising of prescription-only medicines directly to consumers, including medicinal cannabis and weight loss injections;
• the use of restricted or prohibited representations in advertisements; and
• references to products being recommended or approved by the TGA.

In a significant Federal Court decision in October 2023, Vapor Kings Pty Ltd and its Director were fined a total of over $5 million for unlawful advertising of prescription-only nicotine vaping products. The company had been warned about alleged unlawful advertising but continued to advertise and sell the products following the warning, which led to the proceedings being initiated.

Advertising of medicinal cannabis continues to be an area of significant enforcement action for the TGA. Medicinal cannabis products are generally not registered or listed on the Australian Register of Therapeutic Goods, and so are unapproved. They may only be supplied through limited channels.

In the past two years, several civil proceedings have been commenced by the TGA and numerous infringement notices have been issued relating to unlawful advertising of medicinal cannabis.

• In December 2023, the TGA initiated Federal Court proceedings against CDA Clinics QLD Pty Ltd and its former director for alleged unlawful advertising of medicinal cannabis. Similarly, in April 2024, the TGA commenced proceedings against Montu Group Pty Ltd, its subsidiary Alternaleaf Pty Ltd and their common director. In May 2024, the TGA worked with the Dolphins National Rugby League club to remove Alternaleaf branding from rugby jerseys and signage at stadiums, highlighting that advertising can be any content that promotes the use or supply of a therapeutic good to the public.
• Also in May 2024, 11 infringement notices were issued to Better Leaf Pty Ltd and an individual for allegedly unlawfully advertising medicinal cannabis including by making prohibited and restricted representations that it would treat conditions such as epilepsy and PTSD. The TGA emphasised that medicinal cannabis products are prescription-only, so cannot be directly or indirectly advertised to Australian consumers including through abbreviations or acronyms (such as ‘THC’ or ‘CBD’) or through the use of colloquialisms (such as ‘plant medicine’).
• In June 2024, the TGA issued 35 infringement notices totally $627,252 to several companies and individuals for the alleged unlawful advertising of medicinal cannabis on their websites and social media platforms. In some cases, these advertisements implied that medicinal cannabis was approved or recommended by the TGA, and promoted products that were not entered on the ARTG.