Australia: Pharmaceutical Advertising

In Australia, the advertising of medicinal products is governed by a combination of legislation and industry codes. The Therapeutic Goods Act 1989 (Cth) (TG Act) and its subordinate legislation (principally, the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations) and the Therapeutic Goods Advertising Code (TGAC)) provide the legislative framework in relation to therapeutic goods (extending to both medicines and medical devices) and direct-to-consumer advertising (where permitted). The TGAC applies to all advertisements for therapeutic goods other than those directed to health care professionals (HCPs) or wholesalers.

The TG Act and relevant delegated legislation is administered by the Therapeutic Goods Administration (TGA).

Industry codes govern advertising of medicines to healthcare professionals (see question 2).

The advertising of therapeutic goods is also subject to the same laws which regulate advertising generally, most notably, the Competition and Consumer Act 2010 (Cth) (CC Act), and the Australian Consumer Law (ACL), which is Schedule 2 to the CC Act. The CC Act is administered by the Australian Competition and Consumer Commission (ACCC).

There are a number of Codes of Practice which contain provisions relating to the advertising of therapeutic goods. The most relevant to the advertising of medicinal products are:

• the Medicines Australia Code of Conduct (MACC). Medicines Australia is the industry body, which primarily represents the interests of sponsors of innovative, prescription-only medicines. The current (19th) edition of the MACC is described as a principles-based framework for appropriate and ethical decision-making by companies when promoting prescription products and interacting with HCPs, health consumer organisations and the general public. In addition, the listing of prescription medicines by the TGA is generally subject to a condition that promotional material for the medicine must comply with the MACC (whether or not the sponsor is a member of Medicines Australia);
• the Generic and Biosimilar Medicines Association (GBMA) Code of Practice, also describes itself as “principles based”. The fifth edition of the Code of Practice came into effect in June 2021 and it applies to members of GBMA, the industry association for generic and biosimilar medicines; and
• the Australian Self-Medication Industry (ASMI) Code of Practice (2016 edition, currently under review), with which members of Consumer Healthcare Products (CHP) Australia must comply. Members of CHP include manufacturers and distributors of consumer healthcare products, including non-prescription medicines.

There are other industry codes forother types of therapeutic goods; e.g. the Medical Technology Industry Code of Practice in relation to medical devices and medical technology (applying to members of the Medical Technology Association of Australia (MTAA)) and Pathology Technology Australia’s Industry Code of Conduct (applying to member companies who are typically sponsors, manufacturers and distributors of in vitro diagnostic products and innovative pathology technology in Australia).

The TG Act defines ‘advertise’ in relation to therapeutic goods broadly. “Advertise” under the TG Act, means: ‘any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:

a) is on the label of the goods;

b) is on the package in which the goods are contained; or

c) is on any material included with the package in which the goods are contained.’

Whether or not something is an advertisement depends on whether it is ‘intended’ to promote the use or supply of goods. Any patient leaflet, catalogue, disease awareness campaign or correspondence carries a risk of being or containing “advertising”, if it appears to encourage the use or supply of a treatment involving therapeutic goods. The TGA has provided guidance about the kind of activities that represent advertising,¹ TGA guidance states that, depending on the content and context, the following examples may not be advertising:

• reference material, factual informative statements or announcements that they do not make therapeutic or promotional claims;
• information about human health or diseases where there is no reference to therapeutic goods;
• correspondence, possibly accompanied by material of a non-promotional nature, to answer a specific unsolicited question about a therapeutic good.

We are not aware of any case law that determines how the test of “intent”is to be applied, but in practice it is applied broadly. Guidance published by the TGA states that the intention is to be determined from the end viewer’s (audience) point of view.

The definition applies equally to target audiences, with relevant industry codes adopting the TG Act definition or substantially similar text to that definition. The impact of the designation will vary, depending on the audience. For instance, advertising prescription only medicines to patients directly is prohibited by the TG Act.

Footnotes
1. https://www.tga.gov.au/book-page/activities-represent-advertising.

There are no provisions in the TG Act or the current edition of the MACC which deal specifically with press releases.

Press releases are subject to the general prohibitions in the TG Act which relate to the promotion of unapproved medicines, including unapproved indications. Anything which is promotional is prohibited and care must be taken that any press releases are purely educational.

The MACC provides that companies may engage with HCP-only media for promotional purposes, including issuing media releases and developing advertorial content. It does not contain any provisions relating to media releases to lay media. However, the previous edition of the MACC (edition 18) did include specific guidance about communication with healthcare professional media and product-specific media statements to the consumer media, including press releases regarding new approvals (medicines or extensions of indication) on the basis that non-promotional statements to consumer media are allowed in limited circumstances. Sponsors may have regard to the previous edition of the MACC for an indication of how MA is likely to apply the “principles-based” Edition 19.

The MACC sets down requirements for advertisements for prescription medicines directed to HCPs. Sales representatives are required to complete a Medicines Australia endorsed education program within six months of commencing employment and on an ongoing basis. The Continuing Education Program contains six core programs covering the MACC, the pharmaceutical and healthcare industry, anatomy and physiology, pharmacology, product information (PI) and clinical evidence.

Persons:

• directly involved in the development, review and approval of promotional materials relating to prescription medicines or educational material directed to consumers or the general public; or
• who have direct interaction with HCPs for the purpose of promoting a prescription product or providing medical or clinical education,

must complete the MACC component of the program within 12 months of commencing employment.

Aside from the above (and as set out in question 6 below) , there are no formal procedures or requirements for the internal approval process a company may put in place to ensure promotional and educational materials are compliant with the MACC and relevant laws.

No. There was previously a requirement (removed from 1 July 2020) for advertisements in certain types of media to be approved before publication.

However, ‘restricted representations’ as defined in the TG Act and TGAC cannot be made in advertisements unless they are first approved by the TGA. A ‘restricted representation’ is an express or implied reference to a serious form of a disease, condition, ailment or defect, of a type specified in the TGAC. A person may apply to the TGA for approval of use a restricted representation in advertising material (including labelling) by completing an ‘application for approval to use a restricted representation’.

There is no prohibition on the making of statements or representations comparing medicines or medical treatments involving the use of therapeutic goods in advertising or promotional material. However, care must be taken to ensure that any such claims are accurate and capable of substantiation, and not false or misleading.

Further, the TGAC prohibits comparative advertising which claims that the comparator is harmful or ineffectual

Insofar as promotion to HCPs is concerned, the MACC provides a number of general principles in relation to the use of comparative claims in advertising, including in relation to comparing clinical study data. Any disclaimers or explanatory text about the nature of the comparison or supporting data must be clear and prominent. For example, section 1.1 of the MACC provides that comparative claims based on studies reporting clinically important differences must include sufficient detail to enable the reader to understand the significance of the data.

Promotional claims must be consistent with the indications for use and the PI of both the product the subject of the advertising material and any competitor product/s. Other guidance set down in the MACC include that:

• companies should consider the appropriateness of superlatives, ensuring that any use of superlatives is substantiated by the appropriate level of evidence; and
• ‘hanging’ comparative claims (that a product is better, stronger, or more widely prescribed) should not be used.

While there is no prohibition per se on referring to a competitor’s unapproved product in an advertisement, the usual rules prohibiting advertising of prescription medicines to consumers, prohibiting advertisement of unapproved indications, and the prohibitions against misleading or deceptive conduct will still apply.

Medicines must be registered or listed on the Australian Register of Therapeutic Goods (ARTG) before they can be advertised in Australia. Each indication of a medicine is treated by the regulator as a separate product, so the prohibition on advertising unregistered products also applies to promoting medicines for uses outside of their approved indications. The TG Act also prohibits making claims that a person can arrange the supply of unregistered therapeutic goods.

As noted above, not all references to a medicine will necessarily be ‘advertisements’. Generally, there are no prohibitions on persons other than manufacturers or suppliers making statements about unregistered products or indications, provided that those statements do not amount to ‘advertisements’ as defined.

However, it will rarely be appropriate for a company intending to become the named sponsor for a medicine in Australia to provide information proactively about unapproved medicines to the general public. In certain circumstances, it may be appropriate for a company to provide information about unapproved medicines to HCPs, including pharmacists or prescribers. The MACC provides further guidance in this regard.

For example, the MACC states that only company medical department personnel may provide information to HCPs on unapproved products or subjects not covered by the PI (e.g. unapproved indications/‘off-label’ uses) provided that:

• the exchange is non-promotional in intent, content and nature;
• any information relating to unapproved products or uses are clearly identified as such; and
• the requirements of the MACC have been complied with (e.g. provided information to HCPs on (password-protected) digital medical platforms only where the information is viewable when the HCP executes a search
• that includes specific search terms relating to the unapproved product or use).

The MACC also provides further guidance about the organisation or financial support of scientific congresses or conferences. In relation to unapproved medicines or indications, companies should ensure that HCPs speaking at company-sponsored educational events in Australia are aware of the obligation not to promote unapproved products or indications. Further, where an international or Australasian congress is held in Australia, the MACC states that it is acceptable to display or supply information about a product or indication not approved in Australia, 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.

The TG Act prohibits the advertising of prescription-only medicines to the general public.

Advertisements directed to consumers for medicinal products that are not prescription-only (e.g. over-the-counter, complementary or traditional medicines) must comply with the TG Act, the TG Regulations and the TGAC, as well as the ACL, which applies to advertising generally. The TGAC sets out general and specific requirements for advertising such therapeutic goods, text for specific health warnings where certain ingredients are present, and guidance as to restricted and prohibited representations.

Disease or condition awareness campaigns which do not specifically mention potential treatments may be directed or available to consumers, including in circumstances where the potential treatments include prescription medicines. However, care must be taken to ensure that the purpose for providing the material is informational/ educational only and encourages patients to seek further information from the appropriate HCP. Their emphasis should be on the condition and its recognition, as opposed to the treatment options. Encouraging use of a particular type of treatment option (even without naming a medicine or class of medicines) carries risk.

The MACC also provides guidance in relation to the content of disease awareness campaigns (section 13.2 of the MACC), which provides that:

• information may include descriptions of the therapeutic category but not any reference to a specific product;
• information should be presented in a comprehensive, balanced and fair manner without emphasising any particular option or the need for treatment; and
• the tone must not unnecessarily cause alarm nor stimulate demand for a particular product.

Yes. The same prohibitions relating to advertising to consumers will apply in relation to all interactions between companies and patients or other individuals who are not HCPs (because “advertising” extends to statements and representations).

The MACC provides guidance in relation to interactions between industry and ‘health consumer organisations’. At section 12, the MACC states that companies may enter into relationships with health consumer organisations with the objective of enhancing quality use of medicines and supporting better health outcomes for the Australian community. Companies should refer to “Working Together – A Guide to Relationships between Health Consumer Organisations and Pharmaceutical Companies”, developed through collaboration between Medicines Australia, the Consumers Health Forum of Australia and other health consumer organisations.

A company must consider whether a financial relationship is appropriate (e.g. offer or proposal to sponsor or fund a health consumer organisation). In addition, any selection criteria for sponsorship to enable patients or representatives from a health consumer organisation to attend third party scientific and medical conferences should be based on their specific interest in a therapeutic area (section 12, MACC).

Medicines Australia members must report any payment or transfer of value to health consumer organisations that relate to prescription medicines, as part of its transparency reporting obligations under section 15 of the MACC. This information is published on Medicines Australia’s website.

In addition, the MACC provides further guidance about communications with stakeholders more generally (section 11), including health consumer organisations and patient advocacy groups. The MACC confirms that such communications should be non-promotional in nature, not made with the intention to inform patient-level prescribing or clinical decision-making relevant to individual patients, limited to information that may assist the stakeholder in their role, and conducted by appropriately qualified and selected company personnel.

Advertising directed exclusively to HCPs is governed by industry codes (although compliance with the MA Code is a standard condition on registration for prescription-only medicines). Section 2 of the MACC provides general and specific guidance in relation to the requirements for material directed to HCPs. This includes:

• companies are responsible for ensuring that materials directed to HCPs are only able to be viewed or accessed by HCPs;
• promotional material must be clearly distinguishable as such;
• in all material containing promotional claims, an HCP must have access to sufficient prescribing information for them to appropriately prescribe the product for a person consistent with the product’s approved use;
• presentation of Product Information (PI) or Minimum Product Information (MPI), qualifying statements and references must be clearly legible.

All materials (in whatever media) that include promotional claims must (section 2.1, MACC) must include:

• the brand name of the product;
• the Australian approved name of the active ingredients placed next to the most prominent presentation of the brand name;
• information about the product by either including the MPI (described in the MACC), a hyperlink to the PI for electronically accessed materials, a direction to where the MPI or PI is in the same print publication, or a direction is available from a trade display;
• a statement indicating the Pharmaceutical Benefits Scheme (PBS), Medicare Benefits Scheme (MBS), National Blood Authority (NBA), National Immunisation Program (NIP) or the Life Saving Drugs Program (LSDP) status of the product, with or without details of listing, or a direction to where the relevant information is available;
• the name of the supplier and the city, town or locality of the registered office; and
• the date that the material was prepared or last revised.

In addition to the above, all information and claims made in promotional material must be current, accurate, balanced, consistent with the approved PI, and do not mislead directly, by implication, or by omission. These principles apply to the inclusion of or reference to studies in promotional material.

Companies may provide medical literature, reprints and proceedings of educational events to HCPs, and these will not necessarily be considered to be advertising. No part of a reprint or article should be specifically highlighted to draw the attention of the HCP (section 3, MACC).

Subject to very limited exceptions a pharmaceutical company cannot offer any gift to an HCP where it may (or may appear to) induce the prescribing habits or clinical decisions of an HCP. There are therefore no monetary limits on such gifts (although the MACC contains guidance about the maximum acceptable dollar value of hospitality that may be offered by a company).

The MACC provides that a company may not offer brand name reminders or other gifts which may inappropriately influence prescribing a product; however, company-branded items of low monetary value, relevant to conduct of an educational meeting, or company-branded educational material, may be provided (section 3). HCPs must also comply with relevant codes of practice, including the Medical Board’s Code of Practice (“Good medical practice: a code of conduct for doctors in Australia”, October 2020) does not permit an HCP to accept a gift or hospitality of more than trivial value from companies that sell or market drugs, appliances or devices, or provide services that may affect, or be seen to affect, the way the HCP prescribes for, treats or refers patients (clause 10.12.6);

Similarly, the MACC prohibits payments (including donations) to an HCP as an incentive or in return for their attendance at an educational event or trade stand or that are conditional on the use of a specific product. A payment to an individual HCP may create the impression that the purpose is not related to the quality use of medicines, education, research or improving patient outcomes. Any financial support should be paid to a medical practice or health-related organisation, rather than directly to an individual HCP.

Yes, provided certain requirements are met. The MACC sets out guidance relating to the provision of samples or ‘starter packs’ of prescription medicines in sections 6 and 7 of the MACC. The MACC provides that samples must only be provided in response to a signed request of an HCP (including the name and address of the person supplied and the name, strength and quantity of the starter packs). Starter packs must be:

• only for the purpose of enhancing patient access or enabling prescribers to gain experience with the product to improve patient care;
• stored and supplied consistently with related product labelling;
• only supplied by representatives employed by the holder of a manufacturer’s licence or wholesale dealer’s licence or by authorised company representatives;
• compliant with the labelling requirements under Therapeutic Goods Order 91 (Standard for labels of prescription and related medicines); and
• carried out in a reasonable manner including compliance with the conditions of registration of a product on the ARTG.

Companies should keep a record of the delivery (nature and quantity) of the starter packs for a minimum of two years.

Generally, any program for the supply of samples must be reasonable and withstand public scrutiny with regard to the amount of stock, the duration of the program and any other relevant aspects.

For completeness, samples of certain types of products will be permitted to be offered to consumers from the commencement of the new TGAC on 1 January 2022.

Companies can initiate or manage educational events attended by HCPs, provided that they are consistent with the MACC (refer to question 8 above).

The MACC prohibits member companies to make payments or other transfers of value to an HCP as an incentive or in return for their attendance at an educational event or trade stand or that are conditional on the use of a specific product. Any financial support should be paid to a medical practice or health-related organisation, rather than directly to an individual HCP. The driving consideration is the improper influence by pharmaceutical companies on clinical decision-making.

Section 15.2 of the MACC requires companies to report on all sponsorships of independent educational meetings and symposia directed to HCPs.

Section 4.4 of the MACC permits companies to sponsor an HCP to attend an educational event, which extends to their own continuing medical education, provided the support is publicly disclosed. Companies must develop their own sponsorship guidelines.

The MACC permits provision of hospitality to HCPs, provided that the hospitality does not compromise the independence of HCPs and upholds the integrity and reputation of the industry. Section 4.5 of the MACC sets out principles relating to the offering of hospitality to HCPs.

Where a company provides the contents of and hospitality arrangements for scientific meetings it sponsors or organises, it is responsible for ensuring that they comply with the MACC requirements. Companies must ensure facilities chosen for the events are chosen for their appropriateness for the activity and not for their leisure, sporting or recreational facilities. Companies are held accountable by way of the reporting mechanism in the MACC.

One of the overarching principles of the MACC (Principle 9) is that all events initiated or sponsored by member companies are reasonable and appropriate with respect to hospitality, travel and accommodation, thereby upholding the integrity and reputation of the industry.

The MACC also provides (section 4.5) that:

• while companies may provide hospitality to HCPs in connection with activities and events, a facility should be selected for its appropriateness to conduct the activity, not for the purpose of leisure, sporting or recreational activities; and
• companies may not provide entertainment to HCPs.

There is nothing in the MACC or general law which prohibits suppliers and manufacturers of medicinal products from retaining HCPs for the purposes of providing expert services (e.g. participating in advisory boards). General principles governing the remuneration of HCPs in section 5.1 of the MACC require (relevantly) that: companies ensure that all transfers of value are reasonable, appropriate and balanced when considered in context, and any remuneration should not exceed that which is commensurate with the services.

Reports on transfers of value to Australian HCPs engaged in patient care or as sponsorship of a third-party organisation to conduct educational activities for Australian HCPs engaged in patient care activities must be reported by Medicines Australia members to Medicines Australia and those reports must be published in accordance with the Reporting Schedule in the MACC.

The MACC provides that a member company may provide a grant, financial or in-kind support to an HCP, medical practice, hospital, institution or health related organisation:

• to implement a quality use of medicine program; or
• for education, training or academic purposes; or
• for medical research; or
• to improve patient outcomes (section 5.2).

The MACC recommends that financial support should be paid to a medical practice or health related organisation, not an individual HCP. Care must be taken in formulating guidelines for providing such support and, in particular, in considering whether certain conduct may be viewed as a gift or other inducement to prescribe.

Transparency reporting requirements require certain “transfers of value” to be disclosed. The definition of “transfers of value” under the MACC includes a direct or indirect transfer of value, whether in cash, in kind or otherwise.

Pharmaceutical companies that are members of Medicines Australia are required to disclose details of payments or other transfers of value to HCPs and healthcare institutions. Section 15 of the MACC sets out the details of transparency

reporting requirements. Transparency reporting requirements relate to transfers of value:

• to Australian HCPs engaged in patient care;
• as a sponsorship of a third party organisation to conduct educational activities for Australian HCPs engaged in patient care; and
• to health consumer organisations to deliver valuable services to Australian patients.

Companies are only required to report payments or other transfers of value that are related to prescription medicines.

Because transparency requirements apply to Medicines Australia members and are linked to potential influence on treatment decisions for Australian patients, it is perhaps less likely that they will apply to foreign companies or companies without products on the market (although the latter may be possible in the launch phase for a product in Australia).

Reports of certain transfers of value to HCPs related to prescription medicines must: be published in accordance with the Reporting Schedule (section 15.4) using reporting templates in the Resource Tool Kit; be available on the company’s website; comply with Australian privacy legislation regarding the reporting of individual HCP data; and remain publicly available for three years from publication. A company representative must also declare to Medicines Australia that the report includes all transfers of value required by the MACC to be reported.

Reportable transfers of value to HCPs include:

• fees paid to the HCP in return for speaking at an education meeting or event;
• fees paid to the HCP in return for consultancy or advisory services;
• any remuneration or sponsorship of an HCP described in the MACC (not including payment to consultants for research and development work e.g. clinical trials);
• airfares, accommodation or registration fees directly associated with a meeting, consultancy or advisory service (whether within or outside Austtralia); and
• fees paid to HCPs for market research, where their identity is known to the company.

The reports must include the date and a description of the event or provisions of service, the HCP’s name, profession and practice address, whether the payment was to an HCP or a third party, and the total amount of the transfer broken down into registration fees, service fees, and any travel and accommodation.

Requirements that advertisements in certain types of media be approved were removed from 1 July 2020. However, ‘restricted representations’ must be approved by the TGA before they can be used in advertisements to consumers (see question 6 above).

Internet advertisements and social media are subject to the same regulatory regime as other advertisements for medicinal products (see questions 1 and 2 above).

Internet advertising direct to consumers is possible for non-prescription medicines (except for certain pharmacist-only goods), and for medical devices; however, Internet advertising of prescription-only medicines to consumers is not prohibited. Importantly, in relation to social media or other interactive content like comment functions on blog posts, the company will be responsible for publication of that user-generated content (from a TG Act/ TGAC, ACL and general law (e.g. defamation) perspective) and should therefore ensure it conducts regular and diligent review of these sites.

The TGA has published a sample social media acceptable use policy as guidance for companies promoting goods via social media and recently published a specific social media advertising guide in relation to therapeutic goods available at https://www.tga.gov.au/tga-social-media-advertising-guide. For the purpose of the MACC, all promotional activities on social media are considered in the same way as more traditional media activities. Generally:

• content viewable by the general public should not promote a prescription product;
• companies are responsible for the content on their platforms;
• content that does not conform to community standards of ethics or good taste, or that relates to an unapproved product or indication, should be promptly removed; and
• companies should create policies and procedures for social media usage to ensure compliance with the MACC.

Significant care must be taken in relation to the use of the Internet or social media for disease or condition awareness, or where particular content may be accessible by persons other than HCPs. For prescription medicines, a company may use the Internet to provide members of the public with the following information:

• a brief non-promotional summary of the company’s products available in Australia, in accordance with the current approved PI;
• a list of all available treatment options (without making comparisons). Such a website should always include a statement to the effect that ‘for further information, speak to your doctor’; and
• a copy of each product’s Consumer Medicine Information (CMI), a leaflet containing basic information about the use of a product, its contraindications and risks which the TG Regulations require companies to provide to consumers with each supply of a medicine.

Where a website includes information directed to HCPs, a company must take reasonable steps to ensure this information should not be accessible to the general public. The MACC provides guidance at section 2.4, stating that a mechanism such as password protection for system entry is consistent with ensuring online promotional content is only available to HCPs.

There are no anti-bribery rules specifically dealing with conduct directed at healthcare professionals.

Australia’s federal anti-bribery and corruption laws are found in the Criminal Code Act 1995 (Cth). These prohibit the giving of benefits offered to federal public officials, which may also extend to govern some interactions with healthcare professionals because the provision of medical services and the supply of prescription pharmaceuticals is subsidized by the federal government.

There are also laws in each state and territory of Australia that prohibit commercial bribery, and some Australian states also have commissions established specifically to investigate public corruption (for example, the Independent Commission Against Corruption in New South Wales).

See also question 12. HCPs are themselves required to comply with the Codes of Conduct applying to their registration as a health practitioner in Australia. For example, the Medical Board’s Code of Practice states that good medical practice involves (relevantly):

• not asking for, or accepting any inducement, gift or hospitality of more than trivial value, from companies that sell or market drugs, appliances or devices, or provide services that may affect, or be seen to affect, the way the HCP prescribes for, treats or refers patients (clause 10.12.6);
• not asking for or accepting fees for meeting sales representatives (clause 10.12.7);
• not entering into arrangements that could be perceived to provide inducements (clause 10.12.8).

In addition, the MACC sets down a range of rules applying to its members in relation to offering benefits or inducements to HCPs. These include:

• a company may not offer brand name reminders or other gifts which may inappropriately influence prescribing a product; however, company-branded items of low monetary value, relevant to conduct of an educational meeting, or company-branded educational material, may be provided (section 3);
• a company may provide moderate and reasonable hospitality to an HCP in connection with an activity or event, but not entertainment (section 4.5);
• a company may not provide hospitality, travel or accommodation to spouses, relatives, guests or companions of HCPs, or non-HCP practice staff accompanying an HCP, in connection with company-sponsored or initiated events (section 4.5).

All payments or transfers of value by Medicines Australia member companies to HCPs who are engaged in patient care must be reported as part of transparency reporting obligations (section 15, MACC).

The TGA is responsible for enforcing contraventions of the TG Act, TG Regulations and TGAC. The TGA can issue infringement notices and can pursue enforcement action against any person or company allegedly in breach of the relevant legislation, by commencing action in the Federal Court of Australia.

The Australian Health Practitioner Regulatory Authority (AHPRA) and relevant Boards governing registered health practitioners is responsible for enforcing professional rules relating to HCPs.

Industry bodies administer their own codes of conduct and complaints relating to alleged contraventions. For example, the Medicines Australia Code Committee manages and determines complaints, including between member companies, and (if they agree to submit to the process) between members and non-members.

Inter-party disputes relating to industry codes of conduct must be pursued through the dispute resolution or complaint mechanisms of the relevant industry body. The Medicines Australia Code Committee (or the Appeals Committee) can impose a range of fines depending on the severity of the conduct, up to AU$200,000 for a severe breach of the MACC or AU$250,000 for a repeat of a previous breach. The Code Committee can also require cessation of conduct and withdrawal of a promotional activity or corrective action.

Allegations of advertising infringements by one company against another usually relate to allegations of misleading or deceptive conduct or false or misleading representations (often arising from comparative or allegedly incomplete/ misleading advertising). These claims are actionable under the ACL and may be brought by a competitor. One example of such a claim is Novartis Pharmaceuticals Australia v Bayer Australia (2015) 322 ALR 621, which concerned an unsuccessful claim by Novartis that Bayer’s marketing of Eylea was misleading.

A company could also make a complaint to the TGA or ACCC about another competitor (and see further below); however, it will have no influence over what action the regulator may take. Such claims may also arise from claims under the ACL, or alleged non-compliance with the therapeutic goods regime.

The TGA’s focus is on ensuring that advertisers are responsible for compliant advertising, and it utilises a range of tools to encourage compliance. These include:

• education and guidance
• administrative responses, including warnings or cautions
• negotiating an enforceable undertaking
• applying for an injunction
• issuing a directions notice
• issuing an infringement notice
• issuing a public warning notice
• cancellation or suspension of a product from the ARTG, and/or recall of the goods, and
• applying to the court for criminal prosecution or civil penalties.

The ACCC has a range of powers under the ACL where relevant conduct is in misleading or deceptive or contains false or misleading representations. For example, in 2016, the Federal Court imposed a civil penalty of AU$6,000,000 on Reckitt Benckiser in respect of misleading conduct in the promotion of Nurofen (ibuprofen) “specific pain” products (ACCC v Reckitt Benckiser (2016) 340 ALR 25).

HCPs may be subject to conditions on their registration or other sanctions relating to their practice, for contravening the Health Practitioner Regulation National Law or applicable Codes of Conduct (e.g. for inappropriately accepting inducements).

There is no direct relationship between actions by self-regulatory authorities such as Medicines Australia, and procedures taken by regulatory authorities or in the courts. It is possible, for example, for a company to pursue a complaint before the Medicines Australia Code Committee, either against another member or non-member (if they agree to the process), and either simultaneously or subsequently commence court action. If a non-member declines to take part in the Code Committee’s process, Medicines Australia may (but is not required to) forward the complaint to the TGA or ACCC. Further, the Medicines Australia Code Committee will generally not hear a complaint which is the subject of a court proceeding until that proceeding is resolved.

In July 2019, the TGA sought advice from the Medicines Australia Code Committee in relation to certain promotional materials directed to HCPs used by Mundipharma for its Targin range of prescription-only (opioid) medicines. Although Mundipharma was not a Medicines Australia member and the material in question was directed to HCPs, it was a standard condition of the medicines registration on the ARTG that the sponsor was required to comply with the MACC.

In recent years, the TGA has been very active in issuing infringement notices and pursuing contravening conduct. Since November 2020, the TGA has moved to a new compliance framework, where it will focus its attention on published priorities. The TGA’s top priority is currently advertising relating to therapeutic goods associated with COVID-19. Other significant priorities include medicinal cannabis, therapeutic goods used in the cosmetic and beauty industry and weight loss products.

The TGA publishes annual Advertising Compliance Reports where it makes publicly available information about the number, source and outcome of complaints it has received during the previous year. During 2020 – 2021, the TGA issued 127 infringement notices for alleged breaches of the therapeutic goods advertising legislation or conditions of registration related to advertising. The most common contraventions which are the subject of enforcement action relate to promotion of unapproved therapeutic goods, promotion of prescription-only substances or advertising containing unauthorised use of a restricted or prohibited representation.

In July 2021, the Federal Court of Australia imposed its largest ever penalties for contraventions of the TG Act, ordering Evolution Supplements Australia Pty Ltd to pay $11 million for unlawful conduct. The Federal Court found that Evolution Supplements advertised a range of supplement products to consumers, which included prescription only and prohibited substances, and medicines that had not been listed or registered by the TGA. The director was also personally ordered to pay AU$1 million in penalties for failing to comply with an advertising direction issued by the TGA.

Also in July 2021, the TGA issued Starpharma Holdings Limited seven infringement notices totalling AU$93,240 for allegedly advertising a nasal spray not approved for use in Australia and for including a restricted representation that had not been approved for use by the TGA.