Advertisement is defined1 as making 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:
- is on the label of the goods; or
- is on the package in which the goods are contained; or
- is on any material included with the package in which the goods are contained
Advertorial means2 content that looks like editorial content but is published under a commercial arrangement between an advertiser, promoter or sponsor of goods and/or services and the publisher.
Advisory Board means a group of healthcare professionals with specific expertise contracted by a Company to meet to provide advice on a Company’s product, group of products or general disease management.
Australian Approved Names means the active ingredients or chemical components of a product.
Australasian Congress means a congress held in Australia that is organised and controlled by an Australasian (or Australian and New Zealand) College or Society, or where a College or Society in New Zealand is actively organising and has joint control over the congress with an Australian Society or College.
Australian Privacy Legislation means the Privacy Act 1988 (Cth) and related legislation or any update to this legislation.
Balance refers to information that provides proportionate weight to the benefits and risks of a product.
Boxed Warning3 is a mechanism adopted by the TGA to highlight special warning statements in the Product Information (PI) to the prescriber and patient that could significantly alter the risk for patients when prescribed the product.
Brand name for the purpose of the Code of Conduct has the same meaning as ‘proprietary name’ which is the registered trademark of the therapeutic product or the unique name assigned to the product.
Chief Executive Officer means that person appointed to manage the affairs of Medicines Australia Ltd in accordance with the Constitution of Medicines Australia.
Clinical research means planned research involving humans which is designed to investigate and report upon the effectiveness (including, but not limited to pharmacokinetics, dosage regimens, routes of administration, efficacy) and/or safety (including tolerability, immunogenicity, side effect profile, drug interactions) of a medicine.
Code of Conduct Secretary means that person appointed by the Medicines Australia Board to act as Secretary to the Code of Conduct Committee.
Code Tool Kit means the current Code of Conduct Resource Code Tool Kit.
Company means companies supplying prescription products in Australia.
Company representatives are those persons, including medical representatives, authorised by a Company to disseminate information about a product to healthcare professionals.
Competition means any activity that includes an element of chance or random selection.
Congress means an event sponsored and organised by a Society, College, university or other non-company entity.
Consultant means an Australian healthcare professional or a group of Australian healthcare professionals providing consulting services to a Company in relation to specific projects. For the purpose of reporting consultant services, these are regarded as different from providing advice as a member of an Advisory Board.
Consumers are persons other than healthcare professionals.
Consumer Medicine Information (CMI)4 a leaflet that contains information on the safe and effective use of a prescription or specified over-the-counter medicine. A CMI document is written by the pharmaceutical Company (sponsor) responsible for the medicine.
Data on File is that body of unpublished clinical or scientific information held by a Company. It does not include evaluated data submitted to the TGA in accordance with the Australian Regulatory Guidelines for Prescription Medicines.
Educational material means any representation or literature which is intended to provide information about a medical condition or therapy which does not contain specific promotional claims.
Entertainment means the provision of any diversion or amusement.
General Public are persons other than healthcare professionals (see also Consumers).
Grants and Donations5 collectively, mean providing funds, assets or services freely given for the purpose of supporting healthcare, scientific research or education, with no consequent obligation on the recipient to provide goods or services to the benefit of the donor in return.
Graphics means the use of any pictorial or graphical representation in promotional material, including photographs, drawings, x‑rays, graphs and bar charts, but excludes any related promotional text.
Healthcare organisation means a healthcare, medical or scientific association or organisation such as a hospital, clinic, foundation, university or other teaching institution or learned society (except for patient organisations) through which one or more healthcare professionals provide services.
Healthcare professional6 has the same meaning as ‘health professional’ in the Therapeutic Goods Act 1989 (Cth). This Code relates to healthcare professionals who in the course of their professional activities may prescribe, dispense, recommend, supply or administer a prescription medicine in Australia.7
Health consumer organisations see Patient organisations.
Hospitality means the provision of food and/or beverages.
IFPMA means International Federation of Pharmaceutical Manufacturers and Associations. The IFPMA represents the research-based pharmaceutical companies and associations around the world.
Information means educational facts regarding the attributes of a product.
Industry means all companies supplying prescription products in Australia.
International congress means a congress held in Australia where a Society or College in an overseas country is actively organising and has joint control over the conference with an Australian Society or College.
Journal means a serial publication whose distribution is restricted to the members of the healthcare professions.
Literature means that body of published trials, findings and reviews which have appeared in medical and scientific publications.
Market research is the gathering of data on the scope or dimensions of a market and its components, including the needs of the customers in that market.
Medical information websites contain information and standard responses prepared by a Company’s medical information function in order to provide education or resources for Australian healthcare professionals. The website must not contain any advertising or promotional information.
Medicine delivery device is any device used for the administration of a prescribed product, including Schedule 3 products that are predominantly prescribed by a medical practitioner, that is distributed independently from the active ingredient. The device will be listed with the TGA as a device.
Medicines Australia endorsed education program means the professional training program developed by Medicines Australia. It is compulsory for all sales representatives employed by pharmaceutical companies to undertake this training. Also known as the Continuing Education Program (CEP).
Member means an entity registered as a Member of Medicines Australia Ltd.
Minor breach is a breach of this Code that has no safety implications for patients’ wellbeing and will have no or a minimal effect on how the medical profession will prescribe the product.
Moderate breach is a breach of this Code that has no safety implications for patients’ wellbeing but may have a moderate effect on how the medical profession will prescribe the product.
Non-Promotional Role is not commercial in intent, without likelihood to influence the intent to prescribe or use a product.
Patient Aids include written information, password-protected websites providing product-specific information and social media forums with access restricted to patients prescribed a specific product. It also includes items that may assist patients to take or administer their medicine, carry or dispose of their medicine, or monitor their treatment, including mobile media applications.
Patient Organisations (alsoreferred to as health consumer organisations) are not-for-profit organisations, mainly composed of patients and/or caregivers, that represent the needs and interests of patients, their families and/or caregivers. They may range from small volunteer groups or large organisations, and generally promote views that are independent of government, the pharmaceutical industry and professional health service providers.
Patient Support Program (PSP) is a Company-developed program that is intended to assist patients in gaining benefit from their prescribed medical treatment, to improve health outcomes and promote the quality use of medicines.
Payor means an organisation or entity that pays for the healthcare products and/or services provided by a healthcare professional or healthcare provider. A payor may be a government entity which subsidises the cost of healthcare services and medicines (such as the Commonwealth Department of Health or a State or Territory health department) or a health insurance company.
Personal information has the same meaning as the Privacy Act 1988 (Cth).
PBS means the Pharmaceutical Benefits Scheme of the Commonwealth Department of Health.
Prescribing software means a program on a healthcare professional’s computer which is used in the decision-making process with a patient prior to generating a script. They may also contain patient records, Product Information, access to information on drug interactions and other educational information.
Product means any pharmaceutical dose form and/or delivery method that is approved for registration by the TGA for human therapeutic use, provided that such compound has been scheduled for sale or distribution by prescription only in at least one of the States of Australia or that such compound is primarily promoted to medical practitioners for the purpose of encouraging them to prescribe or recommend usage of that compound.
Product Information (PI) means either the current Australian Approved Product Information or in the case of a product whose registration pre-dates the current regulatory review (‘Grandfathered Product’) the document registered is known as the ‘Full Product Information’. This Product Information must comply with the format specified in the TGA Australian Regulatory Guidelines for Prescription Medicines.
Promote means, in the context of the definition of ‘advertisement’, all informational and persuasive activities, the purpose, actual or likely effect of which is to encourage or discourage the purchase, sale, supply and/or use of therapeutic products8.
Promotion, Promotional or Promotional claim means any statement made by a Company or Company’s representative, whether verbal or written, which conveys the positive attributes of a product which extend beyond a simple non-qualitative or non-quantitative description of the therapeutic category or approved indication for the purpose of encouraging the usage of that product. It includes statements concerning efficacy, rate of adverse effects or other cautionary aspects of the product and comparative information.
Promotional material means any representation concerning the attributes of a product conveyed by any means whatever for the purpose of encouraging the usage of a product.
Quality Use of Medicines (QUM)9 means selecting management options wisely; choosing suitable medicines if a medicine is considered necessary; and using medicines safely and effectively.
Reasonable means generally accepted by most people to be appropriate in the circumstances.
Registration is the issue by the TGA of an AUST.R number for a product approved for marketing in Australia in accordance with the Therapeutic Goods Act and Regulations.
Repeat of previous breach means where the same or similar breach is repeated in the promotion of a particular product of a Company which had been found in breach.
Sales representative means a person expressly employed by a Company whose main purpose is the promotion of the Company’s products to healthcare professionals.
Scientific exchange means the legitimate exchange of medical and scientific information, in a non-promotional manner, concerning (but not limited to) an unregistered product or use. This information or activity must be without any reasonable likelihood to influence the intent to prescribe or use a product and must not constitute promotion.
Severe breach is a breach of this Code that will have safety implications for patients’ wellbeing and/or will have a major effect on how the medical profession will prescribe the product. A severe breach will also be found for activities that bring discredit upon or reduce confidence in the pharmaceutical industry.
Social media is an umbrella term that incorporates the various online platforms and activities that engage users to participate in, comment on and create digital content, and to allow them to interact, share information and network with others, including peer-to-peer conversations.
Starter pack means a small pack size of a product supplied at no cost to medical practitioners, dentists and hospital pharmacists. Starter packs are also referred to as ‘samples’ by healthcare professionals.
Substantiation means to give reasonable grounds in support of a promotional claim.
Supplier means the same as ‘Company’ – companies supplying prescription product in Australia.
Superlative means expressing the highest degree of quality or comparison.
Therapeutic class means the classification system used for defining and grouping products in an approved reference manual.
Therapeutic Goods Administration (TGA) is the Division of the Commonwealth Department of Health that is responsible for the regulation of therapeutic goods in Australia.
Trade Display means a display or exhibit of promotional or educational material about a product or products.
Trade pack means a package of a product which is sold by the Company.
Transfer of Value means a direct or indirect transfer of value, whether in cash, in kind or otherwise. A direct transfer of value is one made directly by a Company for the benefit of the recipient. An indirect transfer of value is one made by a third-party on behalf of a Company for the benefit of a recipient where the identity of the Company is known to, or can be identified by, the recipient.
- the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, or any subsequent version of this document ↩︎
- Adapted from Australian Press Council 2005 ↩︎
- https://www.tga.gov.au/publication/boxed-warning-guidance ↩︎
- https://www.tga.gov.au/consumer-medicines-information-cmi ↩︎
- EFPIA Code of Practice, 2019 ↩︎
- #46: What is a Healthcare Professional? ↩︎
- #69: How the Code applies to prescribing pharmacists ↩︎
- Adapted from: Ethical criteria for medicinal drug promotion. World Health Organization, Geneva, 1988 ↩︎
- The National Strategy for Quality Use of Medicines, Commonwealth of Australia, 2002 ↩︎