TGA - Therapeutic Goods Administration

07/09/2021 | News release | Distributed by Public on 07/09/2021 02:37

Communicating about COVID-19 vaccines

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 any party can lawfully provide communications about COVID-19 vaccines to support the Government's COVID-19 vaccine roll-out.

These arrangements cease on 31 December 2022.

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 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

Any party (including health professionals, corporate entities and media outlets) can use the following mechanisms, individually or in any combination, to communicate information publicly about COVID-19 vaccines.

It is important to note that this guidance, and the corresponding legal instrument, only apply to COVID-19 vaccines registered on the Australian Register of Therapeutic Goods. The promotion of unregistered vaccine products or of any other registered or unregistered medicines for the prevention or treatment of COVID-19 is not permitted.

Communicating about COVID-19 vaccines

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(link is external); 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)
    • 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

Commonwealth health messaging means material that is published on Australian Government websites (including social media). This material is updated in accordance with changes to Government policy about the vaccine program. The onus is on the party preparing the communications to ensure the message is based on current Government messaging. The use of promotional materials produced by the Australian Government or an Australian state or territory government for use by others is the safest way to be compliant.

Commonwealth messaging about the COVID-19 vaccines is crafted to both facilitate optimal uptake and to ensure the public receives accurate information about safety and efficacy. References to the safety and efficacy of COVID-19 vaccines must be in alignment with Commonwealth health messaging.

Compliant examples

Doctor's practice

Dr Smith posts on the clinic's Facebook page a statement indicating that they support the Government's vaccine roll-out and encourages their eligible patients to be vaccinated. Their post includes a link to information from the Australian Government Department of Health website, along with logistical information, including the opening hours of their COVID-19 vaccination clinic.

Employers

Happy Workers Co sends an email to their staff, using their own branding, indicating they encourage all eligible staff to receive the COVID-19 vaccine as recommended by the Government, and on the advice of a health practitioner. In the email they offer additional paid leave and an Uber ride to attend a vaccination appointment.

Offering rewards

Any party can offer valuable consideration (cash or other rewards) to people who have been 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 fully vaccinated, which for the current approved COVID-19 vaccines, means two vaccinations. The TGA does not prescribe the means by which full vaccination is to be verified
  • 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')
  • the offer must be made to all eligible people who have been vaccinated i.e. the offer cannot be made to only those people vaccinated from the date of the offer, it must also apply retrospectively (i.e. to those who have commenced or completed their vaccination schedule prior to an offer being announced).
  • 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 a certain group, for example the employees of the business, or the members of the organisation, or to all members of the public.

The 'advice of a health practitioner' means that the health practitioner has consulted with the prospective recipient and advised them of their suitability to receive a vaccination having regard to the individual's health circumstances.

The Health Practitioner Regulation National Law

The arrangements set out in this guidance do not affect the responsibility health practitioners have to comply with the requirements set out in the National Law, in particular section 133(1), regarding the advertising of regulated health services.

For example the National Law prohibits:

  • advertising that is false, misleading or deceptive or is likely to be misleading or deceptive; and
  • offers a gift, discount or other inducement to attract a person to use the service or the business, unless the advertisement also states the terms and conditions of the offer.

It is the responsibility of the heath practitioner to determine and communicate the applicable terms and conditions of any offer. For further information, refer to AHPRA's 'Guidelines for advertising a regulated health service(link is external)'.

'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 fully vaccinated under the national COVID-19 vaccination program.

Compliant examples

Business

Fly Away offers a 10% discount on flights to all 'Fly Away Club' members who have been fully vaccinated under the Government's national COVID-19 vaccination program. The offer is open to any club member on the provision of validated vaccination status. The offer includes a statement that it is only valid for vaccinations undertaken on the advice of a health practitioner.

Business

Dramatic Days theatre company publicly offers a chance to win a years' worth of free theatre tickets to anyone who is fully vaccinated under the national COVID-19 vaccination program. The offer includes a statement that it is only valid for vaccinations undertaken on the advice of a health practitioner.

Clinic and pharmacy

Uptown Medical Centre and Pharmacy publishes a Facebook post offering a free health check to anyone who has been fully vaccinated under the national COVID-19 vaccination program. The offer includes a statement that it is only valid for vaccinations undertaken on the advice of a health practitioner.

While businesses can limit the offer of the reward to particular persons, (i.e. members of an organisation or program, their staff etc.) the offer of the reward must not be conditional on the vaccination occurring after the offer is made.

For example, Fly Away announces the 10% discount to its club members on 8 June 2021. Club member Sam, was fully vaccinated on 1 April 2021 and therefore must be eligible to receive the reward.

Using government materials

Any party can use materials produced by the Australian Government or an Australian state or territory government to promote COVID-19 vaccines (see Further informatio n below for links to these materials).

It would be helpful for advertising parties to make reference to the Vaccine Eligibility Checker(link is external) for their staff, patients, customers, or stakeholders, to find out whether they are eligible to receive a vaccine, which vaccine they are eligible for and where it can be obtained.

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
  • 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.

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 legal instrument referenced below, this prohibition does not apply to registered COVID-19 vaccines.

Further information

  • The Australian Government materials on COVID-19 vaccines are available from: