Seeing things clearly - Updates to therapeutic goods advertising
Therapeutic goods advertising updates
On 30th July, the TGA released details of the 22 amendments made to the TGAC 2018 (2). These amendments were made in consultation with a select group of community and industry representatives to correct minor errors, provide clarification on discrepancies and ultimately facilitate better advertising compliance.
Most of the amendments are minor and unlikely to impact advertisers so the TGA have not allowed for any transitional arrangements. [Any advertising complaint received by the TGA will be assessed under this amended Code, unless it had been pre-approved]. Given the amendments allow for more flexibility in many circumstances, this will come as good news to some!
Of note to my clients who use catalogues as a means of advertising, the TGA media release included clarification around advertising pre-approval application arrangements.
Catalogues that include a mixture of complementary medicines, over-the-counter medicines and medical devices and that require pre-approval prior to printing (e.g. bundled within a newspaper or magazine – NOT those collected in-store or letter-box dropped) will need to have approvals from both the CHC and CHP Australia (formerly ASMI) Advertising Services Managers. The approval, if granted will need to indicate to which specific medicines the approval applies. Advertisers should be aware that this may impact timeframes and prepare accordingly.
This is a simple, easy-to-read, basic summary of the amendments – saving you wading through pages of legislation. Please be sure to seek the advice of a qualified consultant should you fully wish to understand the direct impact these changes may have on your situation.
The amendments are itemised under Schedule 1 of the legislative document, available at www.legislation.gov.au/Details/F2019L01013
Item 1 - omit and substitute
– clarification that when the term “Act” is used in section 3 of the Code, it is the Therapeutic Goods Act 1989 (expanding the to avoid ambiguity
Item 2 - repeal and substitute definition
– Amend definition used in section 4 of the Code to introduce a revised definition of ‘health warning’. The revision allows for devices and other therapeutic goods with health warnings to use a statement ‘to the effect’ i.e. a precise, word-for-word statement is not mandated.
– Revision also allows for messages identifying health conditions where device should not be used e.g. by persons with a serious medical condition, by people with certain implanted medical devices, by certain groups of people or those who are or may be pregnant.
Item 3 - repeal and substitute, inserting new subsection
– Amend section 6 of the Code to insert a new subsection 6(2)(b), clarifying that an advertisement that is part of Government health campaign is exempt from the requirements of the Code.
Item 4 – insert
– Amends subsection 7(1) of the Code to clarify that unapproved medicines are not covered by the exemption. As we know, unapproved medicines cannot be advertised at all.
Items 5 – repeal and substitute heading
– Replace heading “Pharmacist-only medicines” of section 11 of the Code with Therapeutic goods containing a Schedule 3 substance. A more encompassing term
Item 6 - omit and substitute
– Amend section 11 of the Code to clarify that it applies to all therapeutic goods that contain a substance included in Schedule 3 of the Poisons Standard (and not only to medicines)
Item 7 - repeal and substitute
– Inserts a new paragraph 12(3)(d) of the Code allowing for flexibility when advertising medicine product’s indication
– Indication may be modified in a manner that does not change the meaning from what is included on the label. I.e. advertisement does not need to include the label indication word-for-word.
Item 8 – insert
– Amend paragraph 12(3)(h) of the Code to clarify that statements required under 13(7) (i.e. the symptom statements) should also be prominently displayed
Item 9 - repeal and substitute
– Inserts a new paragraph 12(4)(c) of the Code allowing for flexibility when advertising medical device product’s intended purpose(s) or indication
– Intended purpose(s) or indication may be modified in a manner that does not change the meaning from what is included on the label. I.e. advertisement does not need to include the label indication word-for-word. [consistent with Item 7]
Item 10 - repeal and substitute
– Inserts a new paragraph 12(5)(c) of the Code allowing for flexibility when advertising other therapeutic good product’s intended purpose(s) or indication
– Intended purpose(s) or indication may be modified in a manner that does not change the meaning from what is included on the label. I.e. advertisement does not need to include the label indication word-for-word. [consistent with Item 7]
Item 11 - repeal and substitute
– Amends paragraph 13(1)(c) of the Code; the Picture/ Price/ POS exemption. Representations other than therapeutic claims can still be used without affecting the exemption for PPP, provided these do not imply a claim relating to therapeutic use.
– ‘Other representations’ such as flavor, country of origin etc. can now be used without affecting the exemption.
Item 12 - repeal and substitute
– Inserts a new paragraph 13(2)(b) of the Code allowing for flexibility when advertising medicine product’s indication
– Indication may be modified in a manner that does not change the meaning from what is included on the label. I.e. advertisement does not need to include the label indication word-for-word.
Item 13 – omit and substitute
– fixing up technicalities in 13(2)(c) that come about following implementation of Item 15 – the addition of new subsection (2A)
Item 14 – repeal and substitute
– Amends the table in paragraph 13(2)(c) for consistency
– Clarifies that although medicines can have health warnings if they contain ingredients in Part 3, it is only medicines that do not include ingredients listed in Part 1 or Part 2 of Schedule 1 that this section applies to (i.e. Parts 3 and 4 of Schedule 1 are not relevant here)
Item 15 – insert
– new subsection section 13 (2A) allows for the use of a single statement in an advertisement promoting multiple medicines, rather than the statements specified in the table in paragraph 13(2)(c)
– Hooray, there is now the option to use a joint statement when advertising a group of medicines, where at least one has an ingredient in Part 1 or Part 2 of Schedule 1 for which there is a health warning: THESE MEDICINES MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE.
Item 16 - repeal and substitute
– Inserts a new paragraph 13(3)(c) of the Code allowing for flexibility when advertising medical device’s intended purposes or indications.
– Indication may be modified in a manner that does not change the meaning from what is included on the label. I.e. advertisement does not need to include the label intended purposes or indications word-for-word.
Item 17 - repeal and substitute
– Inserts a new paragraph 13(4)(c) of the Code allowing for flexibility when advertising other therapeutic goods’ intended purposes or indications.
– Indication may be modified in a manner that does not change the meaning from what is included on the label. I.e. advertisement does not need to include the label intended purposes or indications word-for-word.
Item 18 – repeal and substitute
– Inserts a new paragraph 16(1)(b) that allows for the use of the new ‘TGA assessed claim’ without breaching paragraph 16(2)(a) of the Code. (Prohibition of any actual or implied endorsement from, or endorsed of, among other things, a government authority
Item 19 – repeal and substitute
– Replace with a new section 28 to correct make it clear that healthy, normal pregnancies are not considered restricted representations.
– Historically was not captured by as ‘serious’ by previous Code, by is now due to changes in the way a ‘serious form of a disease, condition, ailment or defect’ is defined in the current Code.
Item 20 - omit
– remove ‘heart failure’ from Aspirin health warning statement in Schedule 1 of the Code.
Item 21 – insert
– Amend Schedule 4 to the Code to add text that relates back to item 4; the amendment made to subsection 7(1) of the Code that stipulated registered goods are covered.
Item 22 - Application of amendments
These changes are effective from 30 July 2019 and no transition arrangements have been made.
