Materials for HCPs

Information provided in sales information materials must stay within the approved indications, dosage and administration, must rest on scientific and objective evidence that a third party can objectively evaluate and verify, and must state the source of any material quoted.

Advertisements subject to section 502(n) of the Act include advertisements in published journals, magazines, other periodicals and newspapers and advertisements broadcast through media such as radio, television and telephone communication systems, so journal advertising directed at prescribers is subject to the brief summary and fair balance requirements of 21 CFR 202.1(e).

In materials directed to health professionals the product information or a link to it must be presented within the main message, the brand name, non-proprietary name and federal drug schedule must appear in juxtaposition at least once, and the proposed layout must be submitted to PAAB for preclearance.

Any advertising to persons qualified to prescribe or supply must include essential information compatible with the summary of product characteristics and the supply classification, documentation transmitted as part of promotion must state the date on which it was drawn up or last revised, and quotations, tables and other illustrative matter taken from medical journals or other scientific works must be faithfully reproduced with the precise sources indicated.

An advertisement wholly or mainly directed at persons qualified to prescribe or supply must contain the particulars in paragraphs 1 to 8 of Schedule 30, namely the marketing authorisation number, the holder's name and address, the legal classification, the product name, the active ingredients by common name, indications consistent with the authorisation, the relevant SmPC entries and the cost excluding VAT.

A prescription drug advertisement must prominently bear the statement 'this advertisement is for reading by medical and pharmaceutical professionals only' (Advertising Law article 16(3) and article 5(2) of the Interim Measures for the Administration of the Review of Advertisements for Drugs, Medical Devices, Health Foods and Formula Foods for Special Medical Purposes). Article 22 of the Interim Measures provides that, apart from the products for which advertising is prohibited outright by article 21, advertisements for prescription drugs may be published only in the medical and pharmaceutical professional publications jointly designated by the health administration department and the drug regulatory department of the State Council; it also forbids using the name of a prescription drug to title or sponsor activities, and forbids using a trade mark or company trade name identical to a prescription drug name in media other than those professional publications as a disguised form of advertising. Article 2(2) forbids publishing such advertisements without review; article 9 requires the advertisement approval number to be prominently shown; article 16 requires the review to be completed within ten working days of acceptance; and article 20 requires publication exactly as approved, without editing, splicing or modification. Article 11(2) prohibits using the name or image of research institutions, academic bodies, trade associations, or of experts, scholars, physicians, pharmacists, clinical dietitians or patients, as a recommendation or proof. Article 21 prohibits advertising altogether for narcotic drugs, psychotropic drugs, medicinal toxic drugs, radiopharmaceuticals, precursor chemicals, drugs and devices for treating drug dependence, drugs for special military needs and preparations compounded by military medical institutions, and preparations compounded by medical institutions. Under article 29, a breach of article 11(1), article 21 or article 22 is punished in accordance with article 57 of the Advertising Law.

Part 5-1 of the Therapeutic Goods Act 1989 does not apply to advertisements directed exclusively to health practitioners and the other listed categories such as wholesalers and hospital purchasing officers (section 42AA), and the statutory Advertising Code likewise does not apply. What actually governs promotion of prescription medicines to health professionals beyond that exclusion is the industry's own self-regulatory instrument, the Medicines Australia Code of Conduct (Edition 20, adopted 30 October 2024, effective 30 March 2025). Its Scope section states that the Constitution of Medicines Australia binds member companies to the Code, and that 'the Therapeutic Goods Administration states that, as a condition of registration, prescription medicines must be promoted in accordance with this Medicines Australia Code of Conduct, whether the Company is a member or non-member'. Part B section 1 permits promotion of prescription products to health professionals so long as all information, claims and graphical representations are current, accurate, balanced, consistent with the approved product information and do not mislead directly, by implication or by omission; companies are responsible for referencing all promotional claims and for ensuring the cited references provide the appropriate level of evidence, reflect the body of evidence and allow health professionals to evaluate the validity of the results independently. Qualifying statements must be linked to the claim by a readily identifiable symbol, placed directly below or adjacent to it and be prominent; claims based on animal or laboratory data must be appropriately qualified; claims for clinical benefit must be of a magnitude generally accepted as clinically meaningful; and the statistical significance of comparative claims must be clearly indicated. Overarching Principle 8 in Part A requires all promotional claims, including claims about competitor products, to be consistent with the Australian Product Information. Sanctions are set out in Part F section 15.6: cessation of conduct and withdrawal of the promotional activity, corrective action including corrective letters and advertising approved by the Code Committee before release, and monetary fines with a schedule of maximums (minor A$100,000; moderate A$150,000; severe A$200,000; a severe breach where the activity was completed and there is no opportunity for corrective action, and a repeat of a previous breach, A$250,000; failure to complete corrective action within 30 calendar days A$50,000; failure to pay a fine within 30 days A$50,000), fines being imposable individually or cumulatively up to a maximum of A$300,000 per complaint.

The prohibition on advertising prescription drugs does not apply to advertising in professional pharmaceutical media aimed at medical and pharmaceutical experts, or to advertising using media or means of an academic character aimed at such experts.

The addressees of professional advertising are limited, within the scope of their entitlement to prescribe, dispense or use medicinal products, to physicians, dentists, veterinarians and chiropractors, pharmacists, druggists, the further persons referred to in Art. 24 and 25 HMG and the persons referred to in Art. 52(2) of the Medicinal Products Ordinance, and such advertising must carry all the mandatory particulars listed in Art. 6 AWV (Art. 3, 4 and 6 AWV). As to gifts and hospitality, former Art. 11 AWV was transferred with effect from 1 January 2020 to the Ordinance on Integrity and Transparency in the Therapeutic Products Sector (VITH, SR 812.214.31, of 10 April 2019), and that ordinance has now been read. Art. 3(1) VITH permits, as benefits of modest value under Art. 55(2)(a) HMG, benefits to professionals of a total value of at most 300 francs per professional per year that are relevant to medical or pharmaceutical practice; Art. 3(2) defines relevance as a direct connection with the professional's practice of their profession or a direct benefit to the professional's clientele. Art. 3(3) allows prizes in competitions only where they consist of a benefit of modest value relevant to practice, where the competition is addressed exclusively to the addressees of professional advertising under Art. 3 AWV, and where participation is not tied to the purchase of prescription-only medicines. Art. 4 requires support contributions for research, teaching and infrastructure to be given to the employing organisation rather than to the professional, to rest on a written agreement stating the intended purpose, to be used exclusively for that purpose, not to be tied to conditions concerning the prescription, dispensing, use or purchase of particular prescription-only medicines, to be paid into a dedicated account of the organisation to which professionals have no sole access, and to be shown in the organisation's accounts. Art. 5 applies the same requirements to support for the further or continuing education of professionals and requires the organisation to decide independently on the type and selection of the education and on the participants. Art. 6 requires written agreement for support of attendance at educational events and an own contribution (Selbstkostenbeitrag) from the attending professional or the employing organisation of at least one third of the costs for a continuing-education event (Fortbildung) and at least one fifth for a specialist-training event (Weiterbildung), calculated on participation fees, outward and return travel, accommodation and meals, and any ancillary programme of clearly subordinate importance; it prohibits refunding the own contribution in whole or in part, covering indirect costs such as loss of working time or income, covering the costs of an ancillary programme that is not clearly subordinate to the professional part of the event, and covering travel, accommodation, meals or ancillary-programme costs of accompanying persons, even where those persons are themselves professionals. Art. 7 requires remuneration for equivalent consideration to rest on a written agreement stating the nature and extent of the consideration and the remuneration and to be proportionate, with meal costs of up to 100 francs in the context of a professional discussion exempted from the written-agreement requirement.