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Summary of changes to the Therapeutic Goods Advertising Code 2018

Made by the Therapeutic Goods Advertising Code (No. 2)

31 October 2018

Background

The TGA consulted on the draft Therapeutic Goods Advertising Code 2018 (the 2018 Code), and associated guidelines, between March and April 2018, ahead of its making and registration on the Federal Register of Legislation in June 2018. The 2018 Code had a commencement date of 1 January 2019.

Further consultation on the proposed guidance material to accompany the 2018 Code (including the recent October 2018 meeting of the Therapeutic Goods Advertising Consultative Committee), and a general review of the 2018 Code, identified some important amendments that were needed, as well as opportunities to improve the overall clarity of the 2018 Code and a number of its key sections.

The below table summarises the main changes that have been made to the 2018 Code, and their benefits. Please note that, in implementing these changes, the 2018 Code will be replaced with a new instrument (the Therapeutic Goods Advertising Code (No.2) 2018) (the No.2 Code 2018) that will commence from 1 January 2019 (meaning that the 2018 Code will not ever take effect). The No.2 Code 2018 also incorporates a number of minor changes in order to reflect advice from the Office of Parliamentary Counsel in relation to current drafting best practice.

Table 1 - Main updates to the 2018 Code to be made by the No.2 Code
Change Benefit

Delaying commencement of certain health warnings:

  • for medicines containing an ingredient identified in Part 4 of Schedule 1 to the No.2 Code 2018, the requirement to include the warnings for such medicines set out in Schedule 1 would only commence on 1 September 2020. This reflects that those statements are based on requirements in Therapeutic Goods Order No.92 - Standard for labels of non-prescription medicines (TGO 92) that will be mandatory under TGO 92 from that date.
Provides consistency between the No.2 Code 2018 and TGO 92.

Streamlining definitions:

  • removing the definition of 'displayed or communicated' as this largely duplicated the definition of 'prominently displayed or communicated', and removing the requirement that for a statement to be prominently displayed or communicated it must have the same prominence as the most noticeable representation or statement - the requirement for prominence is sufficient to achieve the objective that health warnings in particular will be noticeable to consumers;
  • clarifying the definition of 'health warning' to specify 'summary "must not"' statements for OTC and complementary medicines for which particularly serious warning statements are required to be included on their label under the Therapeutic Goods Act 1989; the option for advertisers of such medicines to use the health warning and "Always read the label", as an alternative to "This medicine may not be right for you. Read the warnings before purchase" remains.

Removes duplication and clarifies what is required when a therapeutic good has a health warning.

Provides additional flexibility for advertisers of medicines for which specific health warnings are set out in Schedule 1 (e.g. Aspirin, Chlorhexidine).

Providing transitional arrangements for pre-approved advertisements:

  • clarifying that advertisements approved before the commencement of the No.2 Code 2018 are required to comply with Therapeutic Goods Advertising Code 2015, until their approval number expires or their approval is withdrawn.
Clarifies what is the position at law anyway, that advertisements are required to comply with the version of the Code that was in place when they were approved, rather than the No.2 Code 2018, until the period for which they were approved expires or the approval is withdrawn.

Streamlining general requirements for advertisements:

  • removing unnecessary duplication in sections 11 and 13 of the 2018 Code, and re-ordering so that specific requirements for pharmacist only medicines and advertisements where the goods are not available for physical examination before purchase are clearly stand-alone obligations; they apply to the exclusion of the general requirements now in section 13;
  • removing the requirement that a statement required to be included in an advertisement for goods that are not available for physical examination before purchase must be displayed in close proximity to the first use of the name of the goods or (for goods other than medicines) the first use of the image of the primary pack, as this was not unclear and unnecessary in light of the revised definition of 'prominently displayed or communicated';
  • removing the requirement for advertisements for medicines to include all of the medicine's indications, as they appear on the medicine's label - it will now only be necessary to include at least one such indication (without precluding advertisers from using more than one if they wish to do so);
  • for advertisements containing a claim relating to the symptoms of a disease, condition, ailment or defect, and which must contain both specified symptoms statements, allowing the shortening and combination of those statements so as to avoid duplication;
  • clarifying that the requirement under section 13 of the Code for specified statements (e.g. for a medicine for which there are no health warnings in Schedule 1, "Always read the label") will not apply to radio advertisements of 15 seconds or less or to text only advertisements of 300 characters or less for which there is no capacity to include pictures, logos or other imagery;
  • clarifying that advertisements for medicines for which there are health warnings set out in Schedule 1 will not (except where the goods are not available for physical examination before purchase) be required to include a health warning in Parts 3 or 4 of Schedule 1 (principally, these are allergy related statements).

Removes duplication, and clarifies what is required when a therapeutic good has a health warning.

Improved clarity for general requirements for advertisements, including in relation to text-only advertisements consisting of 300 characters or less where pictures or other imagery is not able to be included.

Greater flexibility in relation to use of indications.

Ensuring, for protection of public health, that advertisements for medicines where the goods are not available for physical examination before purchase include the allergy-related health warnings in Parts 3 or 4 of Schedule 1; consumers will, in all other circumstances, before purchase, have access to those statements through examination of the medicine label, (noting also that such advertisements will be required to include the statement "Always read the label").

Clarifying requirements for scientific or clinical claims:

  • making it clear that the requirement that an advertisement that contains a citation to scientific or clinical literature must identify the researcher and financial sponsor applies where the advertiser knows, or ought reasonably to have known, that information;
  • also making it clear that for such advertisements, the study must be sufficiently identified to enable consumers to access it.

Addresses the scenario where scientific or clinical studies do not reveal the identity of the researcher or financial sponsor.

Ensures that consumers will be able to access studies which are used to support therapeutic goods advertisements.

Clarifying certain requirements relating to endorsements and testimonials:

  • ensuring that medicines that are listed in the ARTG under the new listed efficacy pathway will be able to use the claimer relating to having been evaluated for efficacy by the TGA (when that claimer is determined), without breaching the endorsement provision in section 16 of the No.2 Code 2018;
  • making it clear that the requirement that advertisements must not contain an endorsement from a healthcare facility does not apply in relation to a community pharmacy;
  • ensuring that an advertisement for a therapeutic good must not use a testimonial provided by persons involved with the marketing of the goods;
  • clarifying that a testimonial must disclose whether the person providing the testimonial has received, or will receive, valuable consideration for providing the testimonial;
  • removing the requirement that testimonials must disclose where the person providing the testimonial is an "associate" of a person involved with the production, sale, supply or marketing of the goods;
  • replacing the requirement that a testimonial must disclose where the person providing the testimonial is a "relative" of a person involved in the production, sale, supply or marketing of the goods, with a reference to an "immediate family member", and defining this term by reference to the definition in the Regulations; that covers the parents, grandparents, spouse, de facto spouse, child or ward of such a person).

Ensures that when a claimer is decided on for listed efficacy medicines, it will be able to be used in advertisements without breaching the Code.

Protects consumers through enhancing the integrity of the testimonial requirements, including by requiring a testimonial to disclose if the person providing the testimonial will receive valuable consideration for having done so.

Improves the clarity of the persons in relation to whom the testimonials obligation applies.

Clarifying requirements relating to consistency with public health campaigns:

  • Adjusting the requirement to ensure that an advertisement must not be inconsistent with current public health campaigns, by making it clear that this only applies to such campaigns that an advertiser knows of, or ought reasonably to have known of.
Removes requirement for an advertiser to be aware of all possible public health campaigns when preparing an advertisement.