Australia: Pharmaceutical Advertising

The primary legislation used to regulate advertising of medicines in Australia is the Therapeutic Goods Act 1989 (Cth) (TG Act), the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations) and the Therapeutic Goods Advertising Code (No. 2) 2018 (TG Advertising Code) which is created under s 42BAA(1) of the TG Act. It is a criminal offence to advertise medicines in a way which is not compliant with the TG Advertising Code.[1] In addition to the medicines specific requirements contained in the TG Act and TG Advertising Code, medicines advertising must also comply with the general provisions of the Australian Consumer Law (ACLCompetition and Consumer Act (2010) (Cth).

[1] – Therapeutic Goods Act 1989 (Cth), s 42DM.

Several self-regulatory codes of conduct cover aspects of medicines advertising in Australia. The Medicines Australia Code of Conduct (Medicines Australia Code) and the Australian Self-Medication Industry Code of Practice (ASMI Code) regulate the promotion of medicines by pharmaceutical companies and aspects of their interaction with the public more broadly. Additionally, the Australia Association of National Advertisers Code of Ethics (AANA Code) provides some general principles which apply to all types of advertising and promotion.

Medicines Australia is the Australian industry body representing producers of prescription medicines. Its membership includes the majority of research-driven pharmaceutical manufacturers in Australia. Although the Medicines Australia Code does not have legal force, all members are required to abide by its provisions. Medicines Australia may also refer conduct to the Therapeutic Goods Administration (TGA) or Australian Competition and Consumer Commission (ACCC) where appropriate.

The ASMI Code is administered by Consumer Healthcare Products Australia (CHPA), the industry body for manufacturers of all non-prescription healthcare products, including over the counter (OTC) medicines. Similar to the Medicines Australia Code, all members of CHPA must abide by the ASMI Code and various sanctions, including cessation of conduct, remedial action and fines may be imposed for breaches.

There is no statutory definition of “advertising” or “advertisement” in Australia; however, “advertise” is defined in relation to therapeutic goods in the TG Act[2] as:

in relation to therapeutic goods, includes make 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:

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

The TG Advertising Code extends this by defining “advertiser” as[3]:

a person who:

(b) causes the advertising, by any means, of therapeutic goods.

The Medicines Australia Code defines “advertisement” with reference to the statutory definition of “advertise” in the TG Act.

The ASMI Code adopts an even broader definition of “advertisement/promotion” as:

any form of communication, including by means of:

(vi) Any sound recording, radio, television, digital media or spoken word.

Outside of the pharmaceutical sector, the AANA Code defines advertising or marketing communication as:

any material which is published or broadcast using any Medium or any activity which is undertaken by, or on behalf of an advertiser or marketer:

(b) that draws the attention of the public in a manner calculated to promote or oppose directly, or indirectly a product, service, person, organisation or line of conduct.

The broad, purposive definition in the TG Act and TG Advertising Code covers all material intended to promote the use or supply of therapeutic goods and is not limited by the medium or type of communication used. The TG Act regulates the content of patient information leaflets. Whether materials are subject to the TG Advertising Code depends on the content and context of the materials. Depending on content then disease awareness campaigns can be captured and likewise catalogues.

The AANA Code excludes labels, packaging, corporate reports and media statements; however, the statutory and industry definitions specific to OTC and prescription medicines have been specifically broadened to ensure these types of materials are also regulated as advertisements.

The ACL applies to all forms of materials and has a broad prohibition on misleading and deceptive conduct together with more specific prohibitions.

The TG Advertising Code and the advertising provisions of the TG Act apply to all advertising of therapeutic goods, except those directed exclusively at health professionals or forming part of a public health campaign.[4] The TG Advertising Code also does not apply to genuine news broadcast or published by certain, defined news agencies or broadcasters.[5]

The Medicines Australia Code applies to advertising to both healthcare professionals.

The ASMI Code applies to advertising to healthcare professionals and consumers.

The ACL applies to all forms of materials to all target audiences. However the assumed knowledge level of the target audience (eg healthcare professional vs consumer) influences the determination of whether contravention has occurred.

[2] – Therapeutic Goods Act 1989 (Cth), s 3(1).
[3] – Therapeutic Goods Advertising Code (No. 2) 2018, s 4.
[4] – Therapeutic Goods Advertising Code (No. 2) 2018, s 6(2).
[5] – Therapeutic Goods Act 1989 (Cth), s 42AA(1); Therapeutic Goods Advertising Code (No. 2) 2018, ss 6(6)-(7).

Press releases regarding medicines are generally allowed in Australia, subject to the same restrictions as all other forms of advertising. If the press release promotes (including indirectly) the sale or supply of therapeutic goods, it will be considered advertising, unless it is exclusively directed to healthcare professionals or forms part of a public health campaign.

Of particular note is section 42C of the TG Act which prohibits certain types of advertising without prior approval from the Therapeutic Goods Administration (TGA). If a press release is to be published in mainstream or traditional media (i.e. not online) approval under Part 2 of the TG Regulations may be required – see section 6 below.

The Medicines Australia Code reiterates that press releases direct to the lay media must be educational in nature, not promotional and must contain certain information, including:
• The brand name of the product[6];

• The approved name of the active ingredient;
• It’s approved indications and therapeutic class;
• PBS listings or state the product is not PBS listed;
• A summary of side effects and warnings related to the product.

A product specific press release must be accompanied by a copy of the consumer medicine information, or a link to a website containing that information. No promotional statements, comparisons with other products or images of product packaging are permitted in press releases.[7]

Medicines Australia encourages members to submit press releases for approval prior to release.

[6] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 13.4.
[7] – Ibid.

There is no prescribed process for internal company review of advertising material prior to submission to the TGA for approval.

The Medicines Australia Code requires that any person involved in the approval of promotional material must have sufficient privacy, competition and consumer legislation knowledge and have completed training on the Medicines Australia Code.[8]

[8] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 6.5-6.6.

Advertising of medicines through all traditional channels must be approved by the TGA prior to release. It is an offence to publish or broadcast any advertisement which has not been approved, is not in the form which was approved, does not display the relevant approval number or does not comply with a condition of its approval.[9]

TGA approval is not required for advertising which is directed exclusively at healthcare professionals, wholesalers, hospital purchasing officers and certain registered complimentary medicine practitioners.[10]

Internet, email and SMS based advertising do not currently require TGA approval. Similarly approval is not needed for advertisements which only consist of the following information[11]:

(a) the brand name of the goods;

(b) the price of the goods;

(c) the type or style of the goods;

(d) a photographic or other reproduction of the goods that does not contain any claim for therapeutic use in relation to the goods;

(e) the locations or times at which the goods are offered for sale;

(f) any other information reasonably necessary to identify the person offering the goods for sale.

An application for approval of advertising material must be made in writing and will be granted if the material complies with the TG Advertising Code, does not contain certain prohibited or restricted representations about the product and does not present the product in an unacceptable way.[12]

From 1 July 2020 the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 will remove the general requirement for TGA pre-approval of therapeutic goods advertising.[13]

[9] – Therapeutic Goods Act 1989 (Cth), s 42C.
[10] – Therapeutic Goods Act 1989 (Cth), s 42AA(1).
[11] – Therapeutic Goods Regulations 1990 (Cth), reg 5C(2).
[12] – Therapeutic Goods Regulations 1990 (Cth), regs 5F, 5G.
[13] – Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, Schedule 4.

Comparative advertising of medicines is generally permitted, subject to the general restrictions imposed by the TG Act, TG Advertising Code and ACL. In particular, comparative advertising carries a substantial risk of being misleading or deceptive in breach of section 18 of the ACL if care is not taken to ensure a fair and representative comparison. The TGA considers that consumers are unlikely to be a position to effectively evaluate claims in comparative medicines advertising, so are particularly vulnerable to being misled.[14]

In addition, the TG Advertising Code requires that any comparisons are truthful, balanced and not likely to mislead consumers[15] and prohibits any comparison which directly or indirectly claims a comparator product or product class is harmful or ineffective.[16]

The Medicines Australia Code provides detailed requirements when making comparisons with competitor products or activities.[17] All aspects of comparative claims must be substantiated with comparable data and referenced by source. Hanging comparatives (e.g. “better”, “more widely prescribed” without reference to a comparator product) must not be used. Claims relating to safety or efficacy must be statistically significant (p<0.05), or the lack of significance must be clearly stated. Similarly the ASMI Code prohibits advertising which shows a competitor product as broken, inoperative or ineffective. Advertising where the comparator or the basis of comparison is unclear or which are not expressed in adequately substantiated terms is also likely to breach ASMI Code.[18] [14] -Therapeutic Goods Administration, Advertising to the Public: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018, version 1.3, January 2019, p 19.
[15] – Therapeutic Goods Advertising Code (No. 2) 2018, s 9(b).
[16] – Ibid, s 9(c).
[17] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 1.8.
[18] – Consumer Healthcare Products Industry, Australia Self-Medication Industry Code of Practice, November 2016, s 5.2.

Advertising a medicine by any means for an indication for which it is not registered on the Australian Register of Therapeutic Goods (ARTG) is prohibited and subject to both civil and criminal penalties, unless the product is exempt from inclusion on the ARTG.[19] This prohibition applies to all advertising regardless of target audience or medium, including when directed solely to healthcare professionals.[20] It is also an offence to claim that a supply of an unapproved medicine can be arranged, unless the medicine is exempted from registration.[21]

As a result of these prohibitions, information regarding unregistered medicines or unauthorised indications could only be provided if it did not amount to advertising or offering supply of the medicine. Providing information, for example in the context of a scientific conference, would be permissible if done in a way which the viewer would not understand as directly or indirectly promoting the use or supply of the medicine.

[19] – Therapeutic Goods Act 1989 (Cth), ss 21B(4), 22.
[20] – Therapeutic Goods Act 1989 (Cth), s 42DL(12); Therapeutic Goods Regulations 1990 (Cth) reg (7)(i).
[21] – Ibid, s 2(6).

All advertising of prescription-only medicines (those containing substances listed in Schedules 4 or 8 to the Poisons Standard 2019), Schedule 3 (pharmacist only medicines) and biologics directly to the public is prohibited, except those listed in Appendix H to the Poisons Standard 2019.[22] Advertising which consists solely of disseminating a price list which complies with certain requirements in Schedule 4 to the TG Advertising Code is permitted. The price information must only be provided by retail pharmacists (not manufacturers) and cannot be provided by radio, televisions, cinema, or displays in public areas.[23] The price list must contain at least 25 medicines and must not direct the consumer to a particular medicine, or give any prominence to the name, description or price of a medicine.

Advertising of OTC medicines to consumers must comply with the requirements of the TG Advertising Code. Non-compliance is subject to civil and criminal penalties.[24] Claims in advertising must be valid, accurate, truthful, substantiated prior to publication, not likely to mislead consumers[25] and consistent with the ARTG entry for the medicine. Comparisons with other products must not imply that the comparator product is harmful or ineffective.[26]

Certain restricted or prohibited representations must not be used in advertising of OTC medicines unless approved by the Secretary of the Department of Health in writing.[27] These representations include references to serious diseases or conditions, as defined in the TG Advertising Code[28] and additional representations regarding particular classes of medicine as specified in the TG Regulations.[29]

Advertising must support the safe and proper use of medicines, must not exaggerate their efficacy or be likely to lead people to delay seeking treatment from a medical practitioner. It must not encourage excessive use of a medicine, or imply that the medicine is completely safe, completely effective, infallible or able to deliver miraculous results. It also cannot be suggested that harmful consequences might result from not using a medicine.[30]

If the advertiser knows or ought to know about a relevant public health campaign, any advertising must be consistent with that campaign.[31]

Under the TG Advertising Code, advertisements, other than labels, patient information leaflets and those which do not contain a therapeutic claim, must generally contain[32]:

• A reference to the name of the medicine as listed on the ARTG entry for the medicine;
• At least one indication, as it appears on the medicine’s label;
• A prominently displayed warning “ALWAYS READ THE LABEL” and an additional health warning when the medicine contains certain ingredients specified by Schedule 1 to the TG Advertising Code;
• The prominent statement “FOLLOW THE DIRECTIONS FOR USE” or “FOLLOW THE INSTRUCTIONS FOR USE”;
• If the advertisement makes a claim regarding a symptom of a disease, it must prominently display “IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL” or “IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL”

In addition, advertising for medicines which are not available for inspection prior to purchase must also include[33]:

• The name of the medicine, as listed on the ARTG entry;
• The name of the dosage form, as listed on the ARTG entry;
• The quantity of the medicine; and
• A list of ingredients.

When advertising a Schedule 3 medicine which is permitted to be advertised to consumers by Appendix H to the Poisons Standard, an additional warning stating:

“ASK YOUR PHARMACIST—THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU” must be displayed prominently.[34]

Under the TG Advertising Code, advertisements must not:

• Offer any incentive to a salesperson who is not a health professional to recommend or supply the medicine;
• Be primarily directed to children; or
• Imply the medicine is endorsed by a government authority, hospital, healthcare facility, healthcare practitioner or medical researcher.

These requirements are reiterated in the ASMI Code.[35] Advertising in mainstream print and broadcast media must be submitted for approval to CHPA as a delegate under the TG Regulations.[36] Once approved by CHPA, any broadcast advertisement must be submitted to FreeTV Australia, the Federation of Australian Radio Broadcasters (FARB), Commercial Radio Australia (CRA) or the Australian Cinema Advertising Council (ACAC) as appropriate.

[22] – Therapeutic Goods Act 1989 (Cth), s 42DL(10).
[23] – Therapeutic Goods Advertising Code (No. 2) 2018, sch 4.
[24] – Therapeutic Goods Act 1989 (Cth), ss 42DM, 42DMA.
[25] – Therapeutic Goods Act 1989 (Cth), s 42DKB.
[26] – Therapeutic Goods Advertising Code (No. 2) 2018, s 9.
[27] – Therapeutic Goods Act 1989 (Cth), ss 42DJ, 42DK.
[28] – Therapeutic Goods Act 1989 (Cth), s 42DD; Therapeutic Goods Advertising Code (No. 2) 2018, ss 28-30.
[29] – Therapeutic Goods Regulations 1990 (Cth), sch 2.
[30] – Therapeutic Goods Advertising Code (No. 2) 2018, s 10.
[31] – Therapeutic Goods Advertising Code (No. 2) 2018, s 21
[32] – Therapeutic Goods Advertising Code (No. 2) 2018, s 13.
[33] – Therapeutic Goods Advertising Code (No. 2) 2018, s 12.
[34] – Therapeutic Goods Advertising Code (No. 2) 2018, s 11.
[35] – Consumer Healthcare Products Industry, Australia Self-Medication Industry Code of Practice, November 2016, s 5.3.
[36] – See[36] Consumer Healthcare Products Industry, Australia Self-Medication Industry Code of Practice, November 2016, s 5.3.1; Therapeutic Goods Regulations 1990 (Cth), reg 5Q.

The TG Advertising Code places restrictions on the use of endorsements by patients or patient organisations in advertising. Subject to limited exceptions, advertising cannot expressly or implicitly contain an endorsement from a patient organisation unless it specifies the organisation, the nature of the endorsement and any valuable consideration given for the endorsement.[37] Similarly patient testimonials can only be used under limited circumstances. A person providing a testimonial must be a verified patient, who has used the medicine for its intended purpose, prior to the advertising and must depict results which are typical for normal use of the product.[38] The advertisement must also disclose if the patient has received payment for the testimonial, if an actor is taking the place of the patient and if the patient is an immediate family member of someone involved in the supply of the product.[39]

The industry codes of conduct provide general guidelines for interaction with and sponsorship of patient groups. Interactions must be consistent with enhancing the quality use of medicines, transparent and able to withstand public scrutiny.[40] Support for patient groups must be appropriately declared and companies must not request to be the sole sponsor of a patient group.[41] A sponsor must not seek to influence the content of patient organisation material and must not make use of the organisation’s logo without obtaining express permission.[42] Further guidelines for relationships with consumer organisations are provided by Medicines Australia.[43]

Medicines Australia also requires members to report annually the names of any sponsored organisations and the nature and value of the support.[44]

[37] – Therapeutic Goods Advertising Code (No. 2) 2018, s 16(3).
[38] – Ibid, s 17.
[39] – Ibid.
[40] – Consumer Healthcare Products Industry, Australia Self-Medication Industry Code of Practice, November 2016, s 6.1; Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 14.
[41] – Consumer Healthcare Products Industry, Australia Self-Medication Industry Code of Practice, November 2016, s 6.5; Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 14.1.
[42] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 14.2-14.3.
[43] – Medicines Australia, Working Together – A Guide to relationships between Health Consumer Organisations and Pharmaceutical Companies, 2008, Medicines Australia Working Together Guide,https://medicinesaustralia.com.au/community/working-together-guide.
[44] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 41.1.

Advertising directed solely at healthcare professionals is self-regulated and not subject to the provisions of the TG Advertising Code;[45] however, it is still subject to certain restrictions in the TG Act. In particular, advertising to health professionals must not contain indications which are inconsistent with the ARTG listing for the product.[46]

The Medicines Australia Code provides detailed requirements in relation to all advertising directed to healthcare professionals.[47] The advertising must comply with the same general requirements of truth, accuracy, balance and good taste as consumer directed advertising. Claims must be substantiated, not false or misleading and must not make unjustified comparisons to competitor products.[48]

The Medicines Australia Code divides advertising into three categories, primary, secondary and short. Primary and secondary advertising may contain promotional claims, short advertising may not. Primary advertising must be used for 24 months from the first advertising of a new chemical entity, or 12 months from any change of clinical significance. Primary advertising and must contain:[49]

Gifts to healthcare professionals are not permitted under any circumstances, except for company branded stationary, educational materials, sponsorship to attend educational events and appropriate hospitality at those events.[55]

[55] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.12.

Companies may provide samples of non-prescription medicines to healthcare professions, with their permission.[56] Samples of prescription medicines may only be supplied if requested by the healthcare professional and in compliance with Medicines Australia guidelines.[57] In particular samples must generally not be more than 1/3 of the PBS quantity for the product and must only be supplied:

(a) for immediate use in the surgery for relief of symptoms;

(b) for the use of alternative treatments, prior to a prescription being written;

(c) for after-hours use; or

(d) for gaining familiarisation with products.

Note that samples of Schedule 8 medicines cannot be provided.

[56] – Consumer Healthcare Products Industry, Australia Self-Medication Industry Code of Practice, November 2016, s 6.6.
[57] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 7.

Companies can generally sponsor third party educational events or healthcare professionals’ attendance. There are no additional restrictions for international events compared to Australian events.

Providers of OTC medicines may sponsor educational events, provided their sponsorship is appropriately declared.[58] Sponsorship of healthcare professionals to attend events is permitted provided it is ethical, not likely to discredit the industry and any hospitality is reasonable and appropriate.[59]

Providers of prescription medicines may also sponsor educational events, subject to restrictions set out in the Medicines Australia Code. Company involvement in the events must have the objective of providing current and balanced educational content. The third party organiser should independently set the educational content for the event. The company should ensure the venue selection and hospitality are justified by the educational purpose of the event and are secondary to the educational content. Companies must not provide or subsidise entertainment.[60]

Companies may sponsor healthcare professionals to attend educational events both in Australia and internationally where the event is directly related to the professional’s area of expertise. Sponsorship must not confer any obligation to use or prescribe the company’s products or interfere with the healthcare professional’s independence[61] Clear guidelines must be available for awarding sponsorship and a formal agreement outlining the nature of the sponsorship must be provided. Reasonable travel, accommodation and food expenses may be provided, but they must remain secondary to the educational content of the conference. Travel must be by the most direct route, only for the duration of the event and must not subsidise travel costs for family members.[62] Healthcare professionals cannot be paid for their attendance or have subsidised entertainment.[63]

Details of sponsorships provided must be reported to Medicines Australia every six months.[64]

[58] – Consumer Healthcare Products Industry, Australia Self-Medication Industry Code of Practice, November 2016, s 6.4.
[59] – Ibid, ss 6.1, 6.2.
[60] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.5.8.
[61] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.7.1.
[62] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, ss 9.5.7, 9.7.5, 9.7.9.
[63] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, ss 9.5.8, 9.7.10.
[64] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 41.3.

Pharmaceutical companies’ involvement in conferences must have the primary objective of enhancing medical education.[65] Organising non-scientific events in relation to conferences is not likely to be consistent with this obligation. Additionally, organising any non-scientific event which could be considered entertainment is prohibited.[66]

[65] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.1.
[66] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, ss 9.4.6, 9.5.8.

Pharmaceutical companies may pay suitably qualified healthcare professionals for services such as consultancy and advisory board membership.[67] A legitimate need for the services must be clearly identified prior to engaging the health professional and details of the arrangement, including a clear objective, set out in a written contract. The number of healthcare professionals engaged and their remuneration must be reasonable in light of the defined purpose.[68]

When convening advisory boards, a document justifying the need, size and objective of the board must be available for public scrutiny. Advisory boards must generally meet in Australia and records of their activity must be maintained.[69]

[67] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, ss 9.8-9.9.
[68] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, ss 9.8.2-9.8.4.
[69] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.9.

Provision of financial grants for research or education is permitted under the ASMI Code and Medicines Australia Code, provided it is not conditional on the receiver recommending or supplying the company’s products. Any published research must identify the sponsorship.[70]

Companies may financially support appropriate and defined programs of medical practice activities provided they have a clinical rationale, are intended to support patient outcomes and comply with privacy obligations.[71] The support must be documented and must not underwrite a commercial business or interfere with the healthcare professional’s independence.[72] Any activity which encourages prescribing a particular product is prohibited.

Financial grants may be made to healthcare institutions for education, research, to improve the quality use of medicines or improve patient outcomes.[73] Equipment may also be loaned to facilitate the quality use of medicines, provided the loan is not permanent.[74] Grants must be awarded based on clear publically available guidelines and subject to written contractual agreement.[75]

[70] – Consumer Healthcare Products Industry, Australia Self-Medication Industry Code of Practice, November 2016, s 6.3; Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.11.
[71] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.10.
[72] – Ibid.
[73] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.11.1.
[74] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.11.4.
[75] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, ss 9.11.2-9.11.4.

Under the Medicines Australia Code transfers of value to healthcare professionals and sponsorship of third party conferences must be reported to Medicines Australia every six months. All members of Medicines Australia must comply with these requirements regardless of whether they have product on the market. These requirements are only applicable to activities related to prescription medicines.[76]

Detailed reporting requirements are contained in section 41.3 of the Medicines Australia Code. Generally companies must report any fees or reimbursements paid to healthcare professionals in relation to consulting, advisory board membership, or market research and any sponsorship to attend educational events. Fees relating to research and development, including clinical trials, need not be reported.[77]

Information which must be reported includes:

• The name, type of and address of the health professional;
• The date the service was provided;
• A description of the service or event;
• The amount of payment.

[76] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 41.
[77] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 41.3.1.

Until 1 July 2020 advertising through traditional media channels (e.g. broadcast and print media) must be submitted for approval to the TGA, CHPA, or the Complementary Healthcare Council prior to publication.

Advertising through non-traditional channels, including internet and social media does not require pre-approval from the TGA or delegate body.[78]

Other restrictions on advertising medicines apply equally to traditional media, internet and social media. For example, the prohibitions on advertising prescription medicines to consumers, advertising off-label use and the TG Advertising Code apply to internet advertising. Any online advertising intended to be directed exclusively to healthcare professionals should be subject to access restrictions, as accidental disclosure to consumers may breach the prohibitions on certain direct to consumer advertising.

[78] – Therapeutic Goods Act 1989 (Cth), ss 42B, 42BA, 42C; Therapeutic Goods Regulations 1990 (Cth), reg 5BA.

All States and Territories have domestic anti-corruption or anti-bribery provisions.[79] These are generally broadly defined to include any corrupt giving or receiving of an inducement by an agent to influence the affairs or business of their principal. The agent and principal may be private individuals, corporations or government agents. Bribery under these provisions is sufficiently broadly defined to make any attempt to dishonestly induce or influence a healthcare professional or healthcare organisation in order to gain a benefit (e.g. for a pharmaceutical company) an offence.

[79] – See Crimes Act 1900 (NSW), pt 4A; Crimes Act 1958 (Vic) ss 175-179; Criminal Code 2002 (ACT) pt 3.7; Criminal Law Consolidation Act 1935 (SA) pt 6; Criminal Code 1913 (WA) ch LV; Criminal Code 1924 (Tas) ss 266-266B; Criminal Code 1983 (NT) ss 236-237; Criminal Code 1899 (Qld) ch 42A.

Inducements of any kind made to healthcare professionals to prescribe, recommend, dispense or administer a company’s products are prohibited by the Medicines Australia Code.[80] Additionally, interactions between companies and healthcare professions must not discredit the industry. Inducements or benefits, other than legitimate consulting activities, conference attendance etc. as permitted under the Code are likely to discredit the industry.[81]

It is an offence under the Health Practitioner Regulation National Law section 136 to direct or incite any health practitioner to do anything which amounts to unprofessional conduct. Unprofessional conduct includes accepting a benefit for referring a patient, recommending a product or providing a service (including prescribing medicines) when not reasonably necessary.[82] As a result, offering inducements to recommend or prescribe a product is likely to be an offence.

[80] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.12.
[81] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.13.
[82] – Health Practitioner Regulation National Law (NSW), s139B.

Advertising regulations for therapeutic goods are primarily enforced by the Therapeutic Goods Administration. This includes non-compliance with the TG Advertising Code and, until 1 July 2020, non-compliance with pre-approval requirements.

Issues relating to advertising which breaches the ACL, e.g. misleading or deceptive advertising, are enforced by the Australian Competition and Consumer Commission. However they can also be the subject of court actions brought by competitors and consumers.

The Medicines Australia Code and ASMI Code are enforced by Medicines Australia and Consumer Healthcare Products Australia respectively. This includes enforcement of rules relating to advertising, sponsorship, inducements and company conduct generally. Medicines Australia and CHPA may refer matters to the TGA or ACCC as appropriate.

Breaches of the Healthcare Practitioner Regulation National Law are enforced by the Australian Health Practitioner Regulation Agency.

Companies can lodge complaints with the TGA in relation to breaches of pharmaceutical advertising regulations, including the TG Advertising Code. Member companies can lodge complaints Medicines Australia and CHPA for non-compliance with the advertising provisions of the Medicines Australia and ASMI Codes. General advertising complaints can be lodged with the Advertising Standards Board. Complaints relating to breaches of the ACL can either be lodged with the ACCC or action can be taken directly by the company in the Federal Court of Australia or a Supreme Court of any State or Territory of Australia.

The TGA can take a wide range of enforcement actions in relation to pharmaceutical advertising violations. This can include educational or warning letters, substantiation notices requiring evidence be provided in relation to claims. Failure to provide information under a substantiation notice can result in publication of a warning notice to the public or prosecution with fines of up to $105,000. The Secretary of the Department of Health may direct a company to take steps to correct non-compliant advertising or the TGA may accept enforceable undertakings from the company that corrective measures will be taken. Alternatively the TGA may issue an infringement notice and a fine of up to $12,600. Failure to comply with directions, warning letters, undertakings or substantiation notices may result in suspension or cancellation of ARTG registration and civil or criminal action in the Federal Court, with penalties of up to $10,000,000 or 5 years imprisonment.

Sanctions for breaches of the Medicines Australia Code include orders that the company cease or modify its conduct, undertake corrective action and monetary fines.[83] Fines may be up to $250,000 per breach and may be applied cumulatively.[84] Similarly CHPA may impose a range of penalties for breaches of the ASMI Code, including requiring written undertakings to discontinue advertising, retractions or corrective statements and fines of up to $50,000.[85]

Breaches of the ACL attract penalties of up to the higher of $10,000,000, three times the value of the benefit received, or 10% of annual company turnover. The ACCC also has the power to issue infringement notices with a fine of $12,500 per breach.

Breaches of the Health Practitioner Regulation National Law relating to inducements are punishable by fines of $60,000 per offence for a corporation.[86]

[83] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 28.
[84] – Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 28.3.
[85] – Consumer Healthcare Products Industry, Australia Self-Medication Industry Code of Practice, November 2016, s 10.2.
[86] – Health Practitioner Regulation National Law (NSW), s136.

Enforcement actions by self-regulatory bodies, such as Medicines Australia and CHPA are completely independent of any enforcement actions by regulatory agencies such as the TGA or ACCC, although complaints to self-regulatory bodies may be referred to regulators for further action where necessary.

The general trend in enforcement of pharmaceutical advertising regulations an increasingly proactive and aggressive stance taken by regulatory agencies, including the TGA and the ACCC.

In it’s recently released report the TGA noted that of 1468 complaints about non-compliant advertising received in the 2018-2019 financial year 68.5% were classed as low risk – representing isolated instances of non-compliance with minimal risk of harm to the public. A further 30.7% of cases were considered medium risk – involving repeat or ongoing non-compliance with low risk of harm. High and critical risk cases only amounted to 0.8% of the complaints received during the year.

By far the most common type of complaint related to advertising of products which were not listed on the ARTG. These predominantly involved products which were required to be registered on the ARTG, but also involved some products which are exempt from registration requirements under the Act. The majority of cases involved lower risk cosmetic, skin care and general wellbeing products. Of these the largest single category of complaints related to prescription medicines used for cosmetic purposes, such as wrinkle reduction. The prominence of complaints relating to cosmetic products highlights the challenges associated with “interface products” – products such as foods, cosmetics and consumer goods which are not necessarily regulated as therapeutic goods, but which cross over into this category if they are promoted for therapeutic purposes.

The TGA has adopted a risk based approach to complaint handling with a strong focus on educating stakeholders regarding their obligations. Despite this, the TGA has also shown a willingness to vigorously enforce the Act in high risk cases. For example, a $10 million penalty was ordered by the Federal Court against Peptide Clinics Pty Ltd for breaching the ban on advertising prescription medicines to the public.

The ACCC has also taken a very aggressive attitude to pharmaceutical advertising in recent years.

This is exemplified by two recent, high profile ACCC enforcement actions for breaches of the ACL against Reckitt Benckiser[87] in relation to the advertising of Nurofen (resulting in a AU$6 million fine) and GlaxoSmithKline in relation to the advertising of Voltaren Osteo Gel (which is ongoing).[88]

[87] – Australian Competition and Consumer Commission (ACCC) v Reckitt Benckiser (Australia) Pty Ltd [2016] FCAFC 181.
[88] – Australian Competition and Consumer Commission (ACCC) v GlaxoSmithKline Consumer Healthcare Australia Pty Ltd [2019] FCA 676.