Member-pharmacy only

Advertising of therapeutic goods and health services by pharmacies

Purpose of Document

The following information provides guidance for pharmacists considering  promoting and advertising therapeutic goods (devices and medicines) and professional pharmacy services. It should only be used as a guide to support compliance with the Therapeutic Goods Administration (TGA) Therapeutic Goods Advertising Code. It does not guarantee compliance. For specific advice, fact sheets and training, refer to the TGA Advertising Hub: http://www.tga.gov.au/advertising-advertising-code-and-guidance

Legislation relevant to advertising

Pharmacists should be aware that there are many laws that relate to advertising and pharmacy

These include:

Advertising of Therapeutic Goods (i.e. medicines and Devices

Therapeutic Goods Act 1989

Therapeutic Goods Advertising Code (No.2) 2018

Advertising of Regulated Health Services

Health Practitioner Regulation National Law

Fair Trading and Competition legislation

The Australian Consumer Law

Competition and Consumer Act 2010

Advertising related to the Pharmaceutical Benefits Scheme (PBS)

National Health Act 1953

Other

Local city council regulations related to signage etc.

This is not an exhaustive list as there may also be other state, territory and local government legislation that may be applicable.

It is possible that multiple regulations may apply to the same advertisement. Pharmacists should also be familiar with the PSA Code of Ethics, PSA Professional Practice Standards and other guidelines which may apply to their professional obligations in relation to advertising of medicines.  Failing to meet these obligations may be viewed as unprofessional conduct by the Pharmacy Board of Australia.

To assist Members, the Guild has drawn on the resources produced by the TGA to produce a basic checklist of information to consider in any advertising of products and services, including via social media. This document should only be used as a guide to support compliance with the Advertising Code and The Guild cannot provide legal advice on advertising and the information provided in this document is not a substitute for professional legal advice. The TGA has an ADVERTISING HUB which brings together news and information relating to advertising therapeutic goods.

Advertising Checklist

Print the checklist.

TGA Advertising code ensures that the marketing and advertising of therapeutic goods to consumers promotes the quality use of therapeutic goods, is socially responsible and does not mislead or deceive. Similarly, AHPRA oversees the advertising and promotion of regulated health services.

As a practical summary of the TGA Advertising code, and AHPRA guidelines, the below table is provided as a useful start. This table is not a substitute for compliance and the Guild takes no responsibility for any promotion of goods or services associated with any pharmacy. Members are advised to seek legal advice in order to ensure compliance.

An advertising compliance checklist to assist advertisers can be found on the TGA website (https://www.tga.gov.au/form/your-advertising-therapeutic-goods-compliant)

Any promotion of any therapeutic goods (available to non-pharmacists)

Basics

Be factual.

Don’t mislead through omission or unfair contrast.

Ensure claims are consistent with ARTG listing and in accordance with directions for use. Do not advertise indications not on the ARTG.

Support claims through references which reflect body of evidence, and communicated in readily understood language

Advertising for medicines in ‘specified media’ (TV, radio, newspapers, magazines, billboards etc) needs pre-approval under Regulation 5G

What cannot be advertised?

All Schedule 4 and Schedule 8 medicines, Schedule 3 medicines not in Appendix H of the Poisons Standard.

TGA guide on advertising of Schedule 3 (pharmacist-only) medicines can be found here

Also see the interactive tool ‘Can I advertise this therapeutic good to the public?’ on TGA website: https://www.tga.gov.au/can-i-advertise-therapeutic-good-public

Advertising Regulated Health Services (Health Practitioner Regulation National Law (National Law)

and Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)

Must not advertise a regulated health service, or a business that provides a regulated health service, in a way that:

a.1.is false, misleading or deceptive or is likely to be misleading or deceptive; or

b.2.offers a gift, discount or other inducement to attract a person to use the service or the business, unless the advertisement also states the terms and conditions of the offer; or

c.3.uses testimonials or purported testimonials about the service or business; or

d.4.creates an unreasonable expectation of beneficial treatment; or

e.5.directly or indirectly encourages the indiscriminate or unnecessary use of regulated health services.

Visit the AHPRA website for more information, including on overview of what pharmacists need to know, a Self-Assessment tool and a tool to assist with testimonials

Things an advertisement must NOT do:

An advertisement must NOT:

  • encourage   inappropriate or excessive use
  • claim   that the goods are safe, cannot cause harm or have no side-effects
  • claim   to be effective in all cases
  • guarantee   outcomes
  • claim   the goods are infallible, unfailing magical or miraculous
  • harmful   consequences may result from goods not being used

Warning Statements

Must be present.

Additional warnings required for analgesics, weight loss products and supplements.

Testimonials

Permitted, with restrictions and disclosures. You should consider the use of these very carefully and avoid if possible. See advice from AHPRA before considering using testimonials for health services.

Endorsements

Endorsements of therapeutic goods are prohibited by:

  • a   government authority, hospital or healthcare facility (does not include a   community pharmacy) (or an employee or contractor of one of these bodies)
  • a   health practitioner, health professional, medical researcher or a group of   any of these persons

Endorsements the permitted by the following organisations and individuals:

  • an   organisation representing the interests of healthcare consumers, or health   practitioners, health professionals, or medical researchers
  • an   organisation which conducts or funds research into any disease condition,   ailment or defect
  • an   employee or contractor of any of these bodies

The advertisement must name the organisation, disclose the nature of the endorsement, and also disclose whether the organisation, employee or contractor has received or will receive valuable consideration for the endorsement

Social Media

A social media post that promotes the use or supply of therapeutic goods is an advertisement. Whether an advertisement for therapeutic goods appears on social media or in any other media, the advertisement must comply with therapeutic goods legislation.

Business owners are responsible for the content of any social media page created or managed by them, including websites, social media channels, blog posts, hashtags or discussion forums. This responsibility extends to user-generated content, such as third party comments posted on those social media platforms that are controlled by the business.

More information can be found on the TGA’s social media advertising guide

Offer of free sample of therapeutic good or service.

Only for condoms, sunscreeens, stoma devices for self-management and continence catheter devices for self-management.

Any reference to serious health conditions.

Not permitted without TGA consent.

List & advice at: http://www.tga.gov.au/book-page/part-4-restricted-representations-and-prohibited-representations.

Reference to treatment, cure, prevention, diagnosis (incl screening), monitoring for: cancer, STDs, HIV/AIDS, HepC virus and mental illness.

Permitted only with Department of Health (Secretary) consent.

Antiseptics and disinfectants

Claims about bacteriostatic activity and other claims about activity and tests are prohibited.

Vitamins and minerals

Claims about expressing the quantity of a vitamin or mineral contained in a preparation as a percentage or a proportion of the recommended daily intake are prohibited.

Analgesics

Claims that consumption is safe; or will relax, relieve tension, sedate or stimulate are prohibited. Must include warning statement. 'INCORRECT USE COULD BE HARMFUL'

Biologicals

Not permitted.

Scientific information

Research must be identified, including financial sponsor and communicated in a readily understood manner.

Be wary of using statistical data including graphs and scientific jargon.

Only use supporting studies from reputable (e.g. peer reviewed) and verifiable sources and studies that can be easily accessed

Do not exaggerate or misrepresent the conclusions of a study

More information on using scientific or clinical claims in advertising can be found on the TGA's website

Marketing to minors

Cannot directly advertise to children under 12 years.

Only specific medicines can be advertised to children over 12 years.

Tips for preparing promotional materials

Marketing Platform

Standard approach: avoid being an advertisement

Branded sponsored content (non-prescription medicines excluding some Pharmacist Only Medicines only)

General

Avoid discussion of specific medicines, or groups of medicines

Avoid use of brand names or drug names.

Do not assume commercial content prepared by 3rd parties is compliant

The onus for compliance with the Code sits with the advertiser or promoter i.e. you!

Disclaimers and balancing content must be prominent and part of the ‘take-out’ message

Do not discuss ‘off-label’ use and stick to registered indications

Images

Do no use images of therapeutic goods (including cosmetic or weight loss) where the promotional benefits are visible

All therapeutic messaging on products should be blurred.

Blur or avoid brand names

Blur or avoid price information

Focus on customer and pharmacist images

Ensure therapeutic good images are not prominent – they must be only incidental

Care should be used with backgrounds and backdrops, so as not to ensure a perceived testimonial for a therapeutic good

Avoid pharmacist or other health professionals being depicted using, demonstrating or recommending the product

Must always be accompanied by mandatory statements, prominently displayed

Avoid capturing any prescriptions in image

Videos

Avoid close-up shots of therapeutic goods or displays promoting therapeutic goods

Focus on customer and pharmacist interactions, ensuring that therapeutic goods are only incidental to the image

Avoid pharmacist or other health professionals being depicted using, demonstrating or recommending the product

Avoid capturing therapeutic claims on product labels in videos

Must always be accompanied by mandatory statements, prominently displayed

If testimonials used, these must be documented at time it is captured and contact details retained for verification

Web Content

Avoid reference to brands or generic names of therapeutic goods

Do not reproduce or link to content from trade press where therapeutic goods are discussed

Do not link to commercial websites (eg pharmaceutical companies, online pharmacies, etc).

Must always be accompanied by mandatory statements, prominently displayed

Text should be no smaller than body text, not buried in footers and high contrast on background

Social media

A social media post that promotes the use or supply of therapeutic goods or regulated health services is an advertisement and therefore must comply with therapeutic goods legislation.

As the business owner, you are responsible for the content of any social media platform created or managed by you, including websites, social media channels, blog posts, hashtags or discussion forums.

Same obligations apply to shared/retweeted content

If a patient or a customer publishes content on your social media sites relating to a therapeutic good which is factually incorrect, the pharmacist may provide links to factually correct information, or delete the comment

Consider having an ‘acceptable use policy’ that tells third parties that there are requirements and you may remove non-compliant posts

Embed warning statements in images if unable to include in text due to character limits

Do not tag the TGA or a government entity in product-specific posts

Examples: Specific requirements for the advertising of particular therapeutic goods

Page last updated on: 20 November 2020