As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates the advertising of therapeutic goods in Australia. The following guidance explains how parties can lawfully provide communications about COVID-19 vaccines to support the Government's COVID-19 vaccine roll-out. The guidance also clarifies how approved vaccine providers can inform patients about the availability of particular vaccine brands.

It is important to note that this guidance only applies to COVID-19 vaccines registered on the Australian Register of Therapeutic Goods. The promotion of unregistered vaccine products is not permitted.

The information set out in this guidance does not extinguish responsibilities that any party has under other relevant laws, including but not limited to, the Australian Consumer Law. Additionally, health professionals also have responsibility to comply with the requirements of the Health Practitioner Regulation National Law.

Patient consultations are exempt from the advertising requirements

The information contained in this guidance does not apply to information shared between a doctor, pharmacist or nurse (or other appropriately qualified and authorised health professional) and their patient during consultation or treatment. For example, if a patient asks their doctor during a consultation about the relative merits of each vaccine and which one is suitable for them, the doctor can advise the patient without risk of breaching the advertising laws.

Lawful communications about COVID-19 vaccines

Using government materials

In 2019, the TGA issued a permission that allows advertising of vaccines (including COVID-19 vaccines) that is, or forms part of a Commonwealth or state or territory health campaign (the 2019 permission). Under this permission, any party can use material produced by the Australian Government or an Australian state or territory government to promote COVID-19 vaccines. This material should not be altered or added to in a promotional way. However where the material has dedicated space for the advertiser to add specific information, this is allowed.

Some government material may specify vaccines by for example, referring to brand names.

Self-developed materials

In recognition of the importance of responsible communications regarding the COVID-19 vaccination program, the TGA has issued a subsequent legal permission (the 2021 permission) that allows advertisers such as health professionals, participating vaccination sites, corporate entities, media outlets and others to develop their own materials to communicate publicly about COVID-19 vaccines subject to the conditions below.

It is important to note that the 2021 permission does not apply to advertisements made in accordance with the 2019 permission.

Any party can create their own content to promote COVID-19 vaccines, provided:

• the content is consistent with current Commonwealth health messaging regarding the national COVID-19 vaccination program, including content found on the Australian Government Department of Health website; and
• the content does not contain:
  • any reference to the trade name, sponsor name or active ingredient or any other information that would identify the vaccine (e.g. Pfizer or AstraZeneca), unless the advertisement is made by an approved COVID-19 vaccination provider
  • any statement, or implication comparing different COVID-19 vaccines (or comparing vaccines with treatments such as medicines)
  • statements to the effect that COVID-19 vaccines cannot cause harm or have no side effects
  • any statement regarding COVID-19 vaccines that is false or misleading

The arrangements set out in the 2021 permission cease on 31 December 2022.

Offering rewards

Under the 2021 permission, any party can offer valuable consideration (cash or other rewards) to people who have been partly or fully vaccinated under the Government's national COVID-19 vaccination program, subject to the following conditions:

• the offer can only be made to people who have been partly or fully vaccinated. The TGA does not prescribe the means by which vaccination is to be verified. Whether the offer is to be made for first or full vaccination is a decision for the organisation offering the incentive
• the offer must contain a statement to the effect that the vaccination must be undertaken on the advice of a health practitioner
• rewards must not include tobacco or medicines (other than listed medicines)
• the offer must only refer to COVID-19 vaccines generically (i.e. not by trade name or another reference to a particular vaccine, such as 'the mRNA vaccine')
• an offer of alcohol must not encourage excessive or rapid consumption of alcohol, have a strong or evident appeal to minors and must be served consistent with the Responsible Service of Alcohol arrangements

The offer can be made to all eligible people who have been vaccinated. The incentive program can be designed so that all people who have been partly or full vaccinated are entitled to the incentive (i.e. the offer can be applied retrospectively), or the offer can be made only to those people getting vaccinated from the date of offer.

The offer can be made to a certain group, for example the employees of the business, or the members of the organisation, or to all members of the public.

'Partly vaccinated'' means a person has received at least one dose of a COVID-19 vaccine under the national COVID-19 vaccination program but will require further doses to be considered fully vaccinated in accordance with the recommendations made by the Australian Sponsor of the relevant vaccine.

'Fully vaccinated' means a person has received the required dose(s) of a COVID-19 vaccine under the national COVID-19 vaccination program to be considered fully vaccinated in accordance with the recommendations made by the Australian Sponsor of the relevant vaccine.

'Valuable consideration' includes any offer of value. Simply stated, valuable consideration occurs when a person receives goods, services or some other benefit (except for tobacco, or medicines other than listed medicines), in exchange for being partly or fully vaccinated under the national COVID-19 vaccination program.

Factual and balanced information that does not constitute advertising

Any party can publicly present factual and balanced information, that is not promotional and therefore not subject to the advertising rules, about the COVID-19 vaccines. Some examples of factual and balanced information include:

• technical information relating to how the vaccines were developed and manufactured
• a statement that a clinic or pharmacy does not have stock of a particular vaccine
• sharing scientific reports from reputable sources (like the World Health Organization) about vaccination, without including promotional material or language
• re-tweeting or sharing valuable news-worthy information from reputable sources about the COVID-19 vaccines; or
• presenting comprehensive information that doesn't emphasise the benefits over, for example, the risks and limitations.

For businesses facilitating vaccination in the workplace

Australian businesses who partner with approved vaccine providers^[1] to facilitate vaccination of their staff in the workplace, can advise employees of the trade (brand) name of the vaccine being used. In doing so, businesses must ensure the advice remains internal to the business and is for information purposes only - that is, it must be factual and not promote a particular vaccine brand.

Additionally, the advice must not be included in or with material that does promote COVID-19 vaccines and vaccination. In order for the information to fall outside of 'advertising' (as outlined in the section above) it must merely inform employees of the vaccine being used in conjunction with other relevant logistical details which enable staff to access the vaccination service.

• An internal email to employees includes a statement to the effect: "Staff are advised that the [vaccine trade name] vaccine is being offered in the staff gymnasium on [dates and times]."
• A statement to the effect: "[business name] has partnered with [approved vaccine provider name] who is an approved vaccination provider of the [vaccine trade name]".
• An internal email to employees includes a statement to the effect: "Staff are advised that the [vaccine trade name] vaccine is being offered in the staff gymnasium on [dates and times]. Vaccination is the best way to keep ourselves and our family protected. You will receive a discount voucher for [incentive] after your first dose!"

Health professional endorsements

Ordinarily, health professionals are not allowed to endorse a medicine or other therapeutic good. However in the context of the pandemic, and under the 2021 permission, this prohibition does not apply to registered COVID-19 vaccines.

Further information

• The Australian Government materials on COVID-19 vaccines are available from:
  • vaccination clinic resources
  • provider Kit for General Practices
• The arrangements described in this guidance are enabled by:
  • The Therapeutic Goods (Restricted Representations - COVID-19 Vaccines) Permission (No.4) 2021
  • The Therapeutic Goods (Restricted Representations - Government Health Campaigns) Permission 2019
  • The Therapeutic Goods Advertising Code (No.2) 2018 as amended by the Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument (No.5) 2021
  • The Therapeutic Goods Act 1989
• If you have questions about the legal requirements regarding advertising of therapeutic goods including vaccines, please lodge an advertising enquiry online with the TGA.
• You can also contact the TGA by phone on 1800 020 653 (free call within Australia) or 02 6289 4124 (for mobiles that do not allow 1800 calls).