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Permissions for therapeutic good ‘restricted representations’ concerning COVID-19

By Angela Wood & Sophie Vo

• 02 December 2021 • 8 min read
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We provide a summary of the Therapeutic Goods Administration’s permissions for the advertising of therapeutic goods for COVID-19

The therapeutic goods regulatory framework restricts the advertising of therapeutic goods using representations about a serious form of a disease, condition, ailment or defect (such as COVID-19), unless the Therapeutic Goods Administration (TGA) has issued an approval or permission for the advertising claims.

To facilitate the increased uptake of approved COVID-19 vaccines and testing in Australia, the TGA has issued a series of blanket permissions for the advertising of TGA-approved therapeutic goods related to COVID-19. This means that advertisers do not need to separately seek approval for the advertising, provided that all of the conditions of the permissions are met and more broadly, the advertising otherwise complies with the Therapeutic Goods Advertising Code (No. 2) 2018.

Note that all of the permissions below, except the first one for Government Health Campaigns, are presently due to expire on 31 December 2022.

COVID-19 vaccine permissions

The Therapeutic Goods (Restricted Representations – Government Health Campaigns) Permission 2019 allows the advertising of vaccines that form part of a Commonwealth or State/Territory health campaign (i.e. that are conducted, approved or funded by the Commonwealth or a State or Territory). Because COVID-19 vaccines included in the Australian Register of Therapeutic Goods (ARTG) clearly form part of the federal and State/Territory health campaigns, they are covered by this permission.

However, this permission is limited as follows:

  • The advertiser can only use material produced by the Australian Government or an Australian State or Territory government (Government Material) to promote COVID-19 vaccines as part of the health campaign.
  • The Government Material cannot be altered or added to in a promotional way, however it is allowed where there is dedicated space for advertisers to add specific information.

The Therapeutic Goods (Restriction Representations – COVID-19 Vaccines) Permission (No. 4) 2021 allows the advertising of COVID-19 vaccines included in the ARTG using an advertiser’s own material (not the Government Material). The advertising material may expressly or by implication, reference that the COVID-19 vaccine is approved by the TGA, the Australian Government Department of Health or the Commonwealth Government (which is normally not allowed).

However, the advertisement must:

  1. not be on the label of the COVID-19 vaccine, on the package in which the vaccine is contained or on any material included with the package in which the vaccine is contained
  2. be consistent with Commonwealth health messaging on the National COVID-19 Vaccination Program
  3. not contain any reference to the trade names or active ingredients, of the COVID-19 vaccine, unless the advertisement is made by an approved COVID-19 vaccination provider
  4. not contain any statement comparing the COVID-19 vaccines
  5. not contain any statement to the effect that the COVID-19 vaccines cannot cause harm or have no side effects, and
  6. not contain any statement regarding the COVID-19 vaccine that is false or misleading.

This permission also allows a representation that valuable consideration (cash or other rewards, but not tobacco or medicines (other than listed medicines)) may be given to people who have been partly or fully vaccinated under the Government’s National COVID-19 Vaccination Program.

Interestingly, the permitted rewards for being vaccinated against COVID-19 were previously restricted to those who were fully vaccinated and the rewards had to be made available retrospectively. Now, there is greater flexibility, as the incentives could be offered to people who are fully or partly vaccinated, and it could be available to those vaccinated from the date of the offer only or retrospectively as well.

The advertisement for cash or a reward must:

  1. contain a statement to the effect that the vaccination must be undertaken on the advice of a health practitioner
  2. not promote a specific COVID-19 vaccine, and
  3. not contain an offer of alcohol that encourages excessive or rapid consumption of alcohol or has a strong or evident appeal to minors (and must comply with Responsible Service of Alcohol requirements).

For more information, see the TGA’s guide on communicating about COVID-19 vaccines.

Advertising COVID-19 rapid antigen tests

The Therapeutic Goods (Restricted Representations - COVID-19 Rapid Antigen Tests) Permission (No. 3) 2021 permits representations that a therapeutic good may be used to detect possible infection with SARS-CoV-2 for COVID-19 rapid antigen test kits (both point-of-care and self-test home kits) that are included in the ARTG, classified as a Class 3 IVD medical device, and may (or may not) be supplied for use in conjunction with an instrument or analyser that is a Class I IVD medical device.

However, the advertisement must:

  1. be consistent with government health messaging for testing for infection with SARS-CoV-2 (COVID-19)
  2. not be inconsistent with the intended purpose of the therapeutic goods accepted for the inclusion of the goods in the ARTG, and any conditions of inclusion relating to the goods
  3. contain certain statements, which are prominently displayed or communicated, and
  4. not include certain claims, make certain inferences, or include endorsements or testimonials.

For more information, see the instrument itself and the TGA’s guide on advertising COVID-19 rapid antigen point-of-care tests and self-tests (home use tests).

Advertising COVID-19 tests

Put simply, the Therapeutic Goods (Restricted Representations - COVID-19 Testing Advice) Permission 2021 permits representations that expressly refer to COVID-19 in the context of advising individuals to follow health advice about COVID-19 testing where they have symptoms. These representations are to be used in advertisements for therapeutic goods that are included in the ARTG, or other goods containing a substance included in Schedule 3, 4 or 8 to the current Poisons Standard (but not a substance that is specified in Appendix H of the current Poisons Standard).

Some questions we are frequently asked are:

Can we advertise a specific brand of the COVID-19 vaccine?

As stated in the COVID-19 Vaccine Permission, an advertisement by a person or organisation must not contain any reference to the trade names or active ingredients of a COVID-19 vaccine, unless the advertisement is made by an ‘approved COVID-19 vaccination provider’.

An ‘approved COVID-19 vaccination provider’ is defined in the COVID-19 Vaccine Permission as a provider who is:

  • a ‘recognised vaccination provider’ within the meaning of the Australian Immunisation Register Act 2015 (Cth) (which includes a general practitioner)
  • approved or authorised under relevant State or Territory legislation to administer relevant COVID-19 vaccines, and
  • approved by the Department of Health to participate in the National COVID-19 Vaccination Program.

Can a qualified health professional advertise a specific brand of the COVID-19 vaccine?

Ordinarily, health professionals are prohibited from endorsing a therapeutic good.[1]

However, in accordance with the COVID-19 Vaccine Permission, a health professional who is an ‘approved COVID-19 vaccination provider’ may advertise COVID-19 vaccines as well as reference specific trade names or active ingredients in those advertisements. This reference to a COVID-19 vaccine by brand, while allowable, does not permit making comparisons between brands.

What is advertising?

‘Advertise’ is broadly defined in section 3 of the Therapeutic Goods Act 1989 (Cth) as follows:

advertise, in relation to therapeutic goods, includes 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.

The TGA’s guidance material states that factual and balanced information would not be considered promotional and therefore not constitute ‘advertising’ that is subject to the restrictions above. Examples of factual and balanced information would include technical information about the vaccine and whether the vaccine is in stock.

The assessment of whether a statement or material would be factual or promotional requires consideration on a case-by-case basis, with regard to the context of that statement or material. For example, where a business partners with an approved vaccine provider to provide vaccinations to staff in the workplace, the business can advise their staff internally of the brand of the COVID-19 vaccine being used, but cannot promote a particular vaccine brand or include this statement with other promotional material or an incentive.

[1] Section 16(2)(c) of the Therapeutic Goods Advertising Code (No. 2) 2018 (Cth).

By Angela Wood & Sophie Vo

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