Jenny Bergin
BPharm. MBA, FACP, GAICD
General Manager
Australian College of Pharmacy
Learning objectives
- Describe key elements of the regulatory framework for therapeutic goods, in particular the Therapeutic Goods Advertising Code (No 2) 2018.
- List the key changes to the Therapeutic Goods Advertising Code (No 2) 2018which come into effect from 1 January 2019.
- Identify professional practice issues which may be affected by the changes to the Therapeutic Goods Advertising Code (No 2) 2018.
Competency Standards: 1.3, 2.1, 4.7
Accreditation number: A1902ITK2
Accreditation expiry: 1 February 2021
This activity has been accredited for 1.0 hour of Group One CPD (or 1.0 CPD credit) suitable for inclusion in an individual pharmacist’s CPD plan which can be converted to 1.0 hour of Group Two CPD (or 2.0 CPD credits) upon successful completion of relevant assessment activities.
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Introduction
In Australia, the advertising of therapeutic goods is controlled via a three-tier framework: regulation, shared regulation and self-regulation.
As pharmacists are aware, advertisements for therapeutic goods are subject to a number of laws and regulations, including those set out in the Therapeutic Goods Act 1989 (the Act).
The advertising of therapeutic goods must comply with consumer protection requirements of the Australian Consumer law and pharmacist advertising may also be subject to Health Practitioner National Law (e.g. Guidelines for Advertising Regulated Health Services).
When advertising therapeutic goods to the public, advertisers must comply with regulatory frameworks, including the Therapeutic Goods Advertising Code (No 2) 2018 (the Code). This Code, (an updated version of the 2015 Code) is effective from 1 January 2019.
The Code sets out the minimum requirements for advertisements about therapeutic goods to the public. The Code is designed to ensure that advertising of therapeutic goods is conducted in a manner that:
- promotes the safe and effective use of therapeutic goods by minimising misuse, overuse or underuse
- is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance
- supports informed healthcare choices
- is not inconsistent with relevant current public health campaigns.
The Code applies to any person who might advertise, or cause the advertising of, therapeutic goods including, but not limited to:
- the sponsor of the goods
- any person in the supply chain for the therapeutic goods (e.g. manufacturers, wholesalers, retailers, franchisees, multi-level marketers) who advertises the goods
- any person who receives valuable consideration for advertising or promoting the goods (including influencers, bloggers and product ambassadors)
- any person publicly endorsing the goods
- a health practitioner advertising therapeutic goods or promoting services that require the use of a specific therapeutic good.
It should be noted that advertisements directed exclusively to health professionals (within the meaning of s.42AA of the Act) are not subject to the requirements of the Code.
Australian pharmacies, as part of remaining accredited to the Australian Standard AS85000: 2011 Quality Care Pharmacy Standard — quality management system for pharmacies in Australia — must comply with the requirements of 4.4 of the Standard (Advertising and Promotions). In summary, the Quality Care Pharmacy Program (QCPP) requirements for this element of the standard include ensuring that:
- advertising or promotional materials used by the pharmacy comply with relevant regulations and legislation
- any clinical or advertising claims are supported by evidence and an evidence-based medicine approach
- all advertising and promotion materials are accurate, balanced, do not mislead and are not capable of leading the consumer to unrealistic expectations
- any advertising of therapeutic goods does not promote inappropriate or excessive use
- any price lists comply with the relevant industry codes of practice and policy.
It should be noted that the Australian Standard was updated in 2017; however, the substance of requirements of the Standard appears unchanged.
The Pharmaceutical Society of Australia’s (PSA) Professional Practice Standards were updated in 2017. The criteria for 4.4 of Standard 4: Provision of Non-prescription Medicines and Therapeutic Devices require that the pharmacist:
- displays and promotes non-prescription medicines and therapeutic devices in a professionally responsible manner, consistent with the principles of QUM and legislation
- ensures that advertising materials are evidence based, and do not promote excessive or unnecessary use of non-prescription medicines or therapeutic devices
- considers the influence of promotion (display or advertising materials) on patients’ perceptions of the efficacy of non-prescription medicines and therapeutic devices and responds appropriately.
The key elements of therapeutic goods advertising requirements
Section 3 of the Act defines ‘advertise’ in relation to therapeutic goods to include:
- 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, pictor
ial representation or design is on:
— the label of the goods
or
—the package in which the goods are contained
or
—any material included with the package in which the goods are contained.
Thus, advertisements can be presented in a number of formats, including an oral or written statement, images and pictures (including moving pictures) and shop displays. Advertisements can be presented by actors who may make promotional claims through their words, gestures and demeanour.
The Therapeutic Goods Administration (TGA) advises that marketing of therapeutic goods can comprise many elements, including the name and logo of the sponsor, and tag lines (catchphrases) which are often used in a similar fashion to logos to identify goods or advertising as belonging to the sponsor.
Similarly, a range of goods may have a common or ‘umbrella’ name or brand to tie them together and differentiate them from similar ranges of goods marketed by competitors. Depending on the nature and context of these elements when used within advertising of therapeutic goods, they may be interpreted as claims about the advertised therapeutic goods.
A key point in the definition is ‘intent’. The consumer’s perception of the intent of the advertisement or the advertisement’s ‘take-out message’ (received by the consumer) is important when deciding if there is compliance with the requirements of the Code.
The TGA has provided a guidance example regarding what a reasonable consumer would perceive as the intent of an advertisement.[i]
An advertisement that states a particular therapeutic good is (only) for the relief of pain associated with mild arthritis but uses images of a person that is debilitated with pain from arthritis is likely to leave the viewer with the ‘take-out message’ that the goods may assist with pain relief for more serious forms of arthritis.
All parties involved in advertising therapeutic goods to the public have responsibilities to ensure compliance with the Code. The party or parties responsible for the advertisement are considered on a case-by-case basis. The TGA has outlined a compliance guidance example[ii] relevant to a community pharmacy.
In the case of a shelf ‘wobbler’ in a pharmacy chain or buying group, the responsibility for compliance may lie with that pharmacy chain or group. However, where the pharmacy chain or group or a pharmacist sole trader demonstrated that they had received the shelf wobbler in good faith from the sponsor of the goods and had undertaken reasonable steps to ensure the content of the wobbler was compliant (such as receiving documented assurance that the wobbler is compliant with the Code), the sponsor is likely to be considered the responsible advertiser.
There are different regulatory requirements which apply, depending on the type of therapeutic good which is to be advertised. For example, not all therapeutic goods are allowed to be advertised to the public, including:
- products containing ingredients specified in Schedules 3, 4 or 8 of the current Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard) unless, in the case of Schedule 3 medicines, the ingredients appear in Appendix H of the current Poisons Standard (section 42DL(10) of the Act)
- biologicals (section 42DL(11) of the Act)
- autologous human cell and tissue (HCT) products excluded from being subject to therapeutic goods legislation, because one of the criteria for exclusion is not being advertised directly to consumers.
In addition, when advertising therapeutic goods to the public, you cannot advertise:
- indications for products that are not consistent with those indications that have been accepted in relation to the product’s inclusion in the Australian Register of Therapeutic Goods (ARTG)
- therapeutic goods that are required to be entered but are not in the ARTG (illegal therapeutic goods) (section 42DL(12) of the Act).
The Code does not apply to the advertising of products that are not therapeutic goods, including food and cosmetic goods. However, sometimes advertising such products with therapeutic claims can render them therapeutic goods (interface products).
Before advertising to the public, advertisers are required to seek:
- permission or approval from the TGA before using Restricted representations. (A Restricted representation is a representation which refers to serious diseases or conditions even if there is no therapeutic claim.)
- pre-approval before publishing advertisements for medicines appearing on television or radio, newspapers, consumer magazines, billboards and cinema films (section 42C of the Act and Part 2 Division 2 of the Regulations).
Please note that pharmacy assistants are considered consumers for the purposes of advertising legislation.
Key obligations with regard to the advertising of therapeutic goods which apply to community pharmacists include:
- Advertising materials provided by sponsors must be removed if a problem with the advertising materials is identified.
- Advertising materials provided by sponsors must not be displayed in such a way so as to change the sponsor’s message. For example, if an advertisement was placed in front of a product from the same range, it may convey to the consumer that the product behind the advertising material has similar therapeutic use(s) to the advertised product.
Price information for Prescription and Pharmacist Only Medicines
As noted earlier, Prescription Medicines (Schedule 4 and 8) and Pharmacist Only Medicines (Schedule 3) not listed in Appendix H of the Poisons Standard cannot be advertised to the public.
However, as pharmacists are aware, following the Review of drugs, poisons and controlled substances legislation (the Galbally Review), price lists for such medicines can be issued to the public, providing the price list complies with Schedule 4 of the Code.
Price information may not be provided by manufacturers, distributors or sponsors other than pharmacy marketing groups. In general, price information for Section 100 medicines may not be provided other than dispensing fees for buprenorphine and methadone.
Schedule 4 of the Code also describes the requirements for price information regarding:
- the presentation of price information e.g. alphabetical order, medicine grouping according to Poisons Standard Schedule and minimum number of sponsors to be included in price information
- medicine name, strength, dosage form and units/quantity
- brand price premium and marketing group brands
- Pharmaceutical Benefits Scheme listed medicines — total purchase price (general or concessional), acknowledgement that the price is subsidised by the Australian Government and, where appropriate, a statement that a specified medicine is subsidised under the PBS only for a limited range of diseases, conditions, ailments or defects
- search functions of electronic sales systems
- restrictions with respect to promotion of medicines. For example, a price list must not present or describe a medicine in a way that directs consumers to a particular medicine over and above any other medicine.
Price information MUST:
- include at least 25 medicines
and
- be accompanied by the names and contact details of the retail suppliers from whom the medicine referred to in that price information may be obtained at the listed price.
Price information must NOT include/use:
- any promotional statement, picture or design
- adjectives or phrases that qualify the name of the medicine, sponsor’s pack size or formula of the medicine
- terms indicating the predicted or recommended length of supply
- promotion of the purchase of quantities or multiple packs that are not approved sponsor pack sizes or multiples of those sizes, (exception PBS quantities)
- comparative adjectives or terms to qualify the price of the medicine
- prominence of the text of the name, description or price of a medicine compared to the remainder of the price information text
- rewards or bonus points, or include an association with any other advertising that promotes rewards or bonus points
- any limit or qualification of the availability of the price, other than by including a statement of validity or expiry of the price
- any embellishment
- information (including implications or references to other sources of information) regarding approved or unapproved indications, diseases, conditions, ailments or defects so that a reasonable person could infer that the medicine will cure or alleviate those diseases, conditions, ailments or defects.
Key changes made by Advertising Code (No 2) 2018
There are a number of key differences in the Code from the previous version (2015). The key changes made by the Advertising Code (No. 2) 2018 include:
1. The mandatory statements and the requirements for how they should be displayed have been clarified and streamlined.
The concept of ‘health warnings’ has been introduced. Schedule 1 of the Code outlines the medicines’ ingredients which require specific health warnings and lists the associated health warning statements. Health warnings are explained in more detail later in this article.
The Code requires a range of information to be prominently displayed or communicated in advertising to the public for therapeutic goods, including:
- warnings regarding persistence or worsening of symptoms and the need to consult a healthcare professional
- advertising of goods that will not be available for physical examination before purchase for which health warnings exist, warnings alerting the viewer that the good may not be suitable for them or the relevant health warning(s)
- statements required for the advertising of Schedule 3 medicines and analgesics
- the appropriate use of sunscreens.
The requirements with regard to health warnings or other statements being ‘prominently displayed or communicated’ includes:
- visual statements need to be easily read from a reasonable viewing distance
- a spoken statement needs to be clearly heard and understood
- for each advertising medium the statement must be repeated as often as is necessary to ensure that it is likely to be noticeable to a viewer or a listener.
It should be noted that font embellishments (including serifs, italicised, cursive, shadowed, calligraphic, poster) and other fancy or irregular fonts, may affect the extent to which the required statement stands out so as to be easily read for the purposes of requirements of the prominently displayed threshold.
Health warnings and goods not available for physical examination
The advertiser may either use the statement:
— THIS MEDICINE MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE, followed immediately by information about where the health warnings can be found
or
— ALWAYS READ THE LABEL.
and
— the health warning(s) (listed in Schedule 1).
Where medicines are not available for physical examination before purchase, the health warning(s) applicable to the medicine in Schedule 1 must be provided for the consumer to view in some form.
For medicines for which there are no health warnings in Schedule 1, the following statement, prominently displayed or communicated is required:
ALWAYS READ THE LABEL.
The mandatory statement requirements do not apply to a label, consumer medicine information or a patient information leaflet for implantable medical devices (PIL).
The Code also specifies the warning statement requirements for medical devices and other therapeutic goods.
In addition to the statements above, advertising also needs to prominently display or communicate statements to advise the viewer to follow the directions for use and, if there are claims about a symptom in the advertisement, an appropriate symptom statement (covered later). While similar statements are required under the 2015 Code, there have been some changes.
It should be noted that the mandatory statements for goods not available for physical examination are not required for Pharmacist Only Medicines listed in Appendix H as the Section 11 statement outlined below applies.
Advertising of Pharmacist Only Medicines (S3) listed in Appendix H
A new mandatory statement is required in advertising for Schedule 3 (Pharmacist Only) medicines that can be advertised to the public (i.e. those listed in Appendix H of the current Poisons Standard).
Section 11 Subsection (2) mandates that an advertisement for such medicines must contain the following statement, prominently displayed or communicated:
ASK YOUR PHARMACIST — THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU.
This mandatory statement requirement does not apply to:
- a label, to consumer medicine information, or a patient information leaflet for implantable medical devices
- an advertisement displaying only the name or picture of therapeutic goods or their price or point of sale, or any combination of these, provided the advertisement does not contain or imply a claim relating to therapeutic use, or any other representation.
2. Other streamlining changes and clarifications to the Code
Other changes introduced to streamline and clarify the Code include:
- the requirements around the inclusion of indications in advertisements have been clarified. At least one indication (as included on the medicines label) is the minimum requirement. The minimum requirement of at least one indication may be achieved in an advertisement containing a ‘pack shot’ of the medicine label, provided the indication listed on the ‘pack shot’ is clearly visible.
- the mandatory statements required for advertisements containing a claim relating to a symptom of a disease, condition or defect have been modified. Namely:
IF SYMPTOMS PERSIST, TALK TO YOUR HEALTH PROFESSIONAL.
or
IF SYMPTOMS WORSEN OR CHANGE UNEXPECTEDLY, TALK TO YOUR HEALTH PROFESSIONAL.
In addition, the Code permits advertisers to shorten and combine these statements into one, so as to avoid duplication, where both statements are relevant.
- Section 13 of the Code has been clarified with regard to short radio advertisements and text-only advertisements of 300 characters or less.
3. Clarifications to the requirements for the inclusion of warnings, advisory statements and contraindications
The 2015 Code requirements relating to the inclusion of warnings, advisory statements and contraindications in certain advertisements were unclear. To address this, new mandatory statements (as described in Section 1 above) and the concept of ‘health warnings’, was introduced in the Code. Schedule 1 of the Code reflects a set of the most serious warning statements for (principally) registered over-the-counter medicines and listed (mostly complementary) medicines that sponsors are, or will be, required to include on the labels of their product.
Note that not all health warnings take effect immediately. Some statements are required from 1 January 2019, for example, Derived from Seafood (required for products containing Glucosamine) and Contains Gluten (required for products containing Avena).
Others, for example, Contains Egg, and Contains Nut (required for products containing tree nuts and tree nut products, including almond oil) are not required until 1 September 2020.
4. The requirements for scientific or clinical claims have been clarified.
An advertisement that contains a citation to scientific or clinical literature must identify the researcher and financial sponsor (where the advertiser knows, or ought reasonably to have known, that information). The study must be sufficiently identified to enable consumers to access studies which support therapeutic goods advertisements.
5. The requirements relating to endorsements and testimonials have been clarified.
Medicines listed in the ARTG under the new assessed listed medicines pathway will be able to claim the medicine has been evaluated for efficacy by the TGA (using the claimer specified by the TGA) without breaching the endorsement provisions of Section 16 of the Code.
It should be noted that the restriction regarding endorsement from a healthcare facility does not apply to a community pharmacy — but endorsements from pharmacists in advertising are still prohibited.
Advertisements must not include testimonials provided by persons involved with the production, sale, supply or marketing of the goods.
Testimonials must disclose if the person providing the testimonial has/will receive valuable consideration and/or is an immediate family member of an individual involved in the production, sale, supply or marketing of the therapeutic goods.
6. The requirements relating to consistency with public health campaigns have been clarified.
At the time of advertising therapeutic goods, the promotion must not be inconsistent with or undermine public health campaigns. Consistent with this requirement, there are special requirements around the advertising of sunscreens that claim or imply that the sunscreen will prevent sunburn or skin cancer.[iii]
The TGA website provides advice:
‘Statements or visual representations to the effect that prolonged high-risk sun exposure should be avoided and frequent reapplication or use in accordance with directions is required for effective sun protection must be prominently displayed or communicated.’[iv]
However, the TGA does not expect an advertiser to be aware of all possible public health campaigns when preparing an advertisement. The Code requirement relating to public health campaigns only applies to those campaigns that the advertiser knows, or ought reasonably to have known, about at the time of advertising.
Conclusion
The National Competency Standards Framework for Pharmacists in Australia 2016 includes Competency standard 1.3 Practise within applicable legal framework – Comply with statute law guidelines codes and standards. This standard is universally applicable to all pharmacists.
To comply with the Pharmacy Board Registration Standard: Continuing Professional Development (CPD) the requirements of pharmacy accreditation, and the requirements of the Professional Practice Standards, pharmacists need to be familiar with the Code and review their QCPP policies and procedures, in particular, the provision of price information (QCPP Procedure; P4A).
Those pharmacists who play a role in the development of promotional materials, such as advertisements about therapeutic goods and/or price information, including advertising on websites and social media, need to make sure all staff are trained in the requirements of the Code and that advertisements and price information comply.
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Submit your answers to earn CPD credits
Answers can be submitted through GuildEd at guilded.guild.org.au.
Australian College of Pharmacy members can submit answers online at acp.edu.au in the CPD Library.
Assessment questions
Lewis, a pharmacist, is employed by a pharmacy marketing group. Part of the role is to develop catalogues and price information and instore promotional material for the marketing group. Lewis needs to produce a catalogue for publication in March 2019.
1. Which of the following statements is correct? Choose ONE correct answer.
a. Lewis may include a pictorial representation of a package of a Prescription Only Medicine provided it’s not a PBS-listed medicine.
b. The group’s prescription price information component of the catalogue may be short (less than ten medicines) and may promote bulk purchases and two-for-one deals for OTC medicines.
c. Advertisements for Pharmacist Only Medicines listed in Appendix H of the Poisons Standard must contain a prominently displayed statement: Ask your pharmacist – They must decide if this product is right for you.
d, Lewis may use his artist talents to improve the catalogue’s look and feel through the use of font embellishments.
2. Which of the following statements is correct? Choose ONE correct answer.
a. Medicines that have no health warnings do not require any warning statements to be included in promotional materials.
b. Advertisements for medicines that have health warnings are required to list health warnings in cases when physical examination before purchase (e.g. online) is not possible to alert the consumer that the medicine may not be suitable for them.
c. Advertisements containing a claim relating to a symptom of a disease condition or defect have not changed in the 2018 Code.
d. Lewis may include a testimonial about the products in the catalogue that he uses personally on a regular basis.
3. Which of the following statements is correct? Choose ONE correct answer. Mandatory statements include warnings related to:
a. the persistence or worsening of symptoms.
b. sun exposure and the need for frequent reapplication of sunscreen.
c. allergies to certain ingredients.
d. the use of Schedule 3 medicines and analgesics.
e. All of the above
4. Lewis is also developing some instore shelf wobblers and patient leaflets. Which of the following statements is correct? Choose ONE correct answer.
a. The shelf-wobbler advertisement requires pre-approval prior to publishing.
b. A patient leaflet promoting a range of sunscreen products doesn’t need a warning statement.
c. Patient leaflets promoting cosmetics which include therapeutic claims are never treated as therapeutic goods and therefore do not need to comply with the Code.
d. Responsibility for compliance with the Code with respect to the shelf wobblers used in pharmacies in the marketing group may lie with pharmacy owners.
5. Lewis needs to consider professional practice issues associated with the introduction of the Therapeutic Goods Advertising Code (No 2) 2018. (This may include liaising with other relevant marketing group managers.) Which of the following statements is correct? Choose ONE correct answer.
a. QCPP policies and procedures don’t need to be reviewed.
b. All staff involved in advertising of therapeutic goods within the group need to be trained in the new/changed requirements of the Code.
c. Only pharmacists whose scope of practice includes marketing need to be aware of the new requirements of the Code.
d. Non-pharmacist pharmacy staff members don’t need training because they are consumers.
References
[i] Advertising to the public Complying with the Therapeutic Goods Advertising Code (No. 2) 2018 Version 1.2, October 2018 https://www.tga.gov.au/sites/default/files/advertising-public.pdf Page 12 of 80 Accessed December 16, 2018
[ii] Advertising to the public Complying with the Therapeutic Goods Advertising Code (No. 2) 2018 Version 1.2, October 2018 https://www.tga.gov.au/sites/default/files/advertising-public.pdf Page 13 of 80 Accessed December 16, 2018
[iii] Therapeutic Goods Advertising Code (No 2) 2018 https://www.legislation.gov.au/Details/F2018L01524 Page 45 of 80 Accessed December 16, 2018
[iv] https://www.tga.gov.au/book-page/part-3-requirements-relating-particular-therapeutic-goods Accessed December 5 2018.