In February 2021, we provided an update on the guidance issued by the Therapeutic Goods Administration (TGA) regarding the advertising of COVID-19 vaccines to the Australian public. That update is available here: COVID-19 | TGA issues guidance for advertising of COVID-19 vaccines to Australian public.
Under the previous guidance, advertisers were restricted to republishing materials that were produced by Federal, State or Territory Governments, or were otherwise factual in nature (such as how to book an appointment, opening hours of vaccine clinics, etc). Under the new guidance, organisations and individuals may produce their own materials to promote COVID-19 vaccination to the general public, provided certain conditions are met.
The formal legal instruments enabling this guidance are:
- the Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission 2021;
- the Therapeutic Goods Advertising Code (No.2) 2018 as amended by the Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument 2021; and
- the Therapeutic Goods (Restricted Representations – Government Health Campaigns) Permission 2019.
This guidance will cease to have any effect on 31 December 2022. Ordinarily, direct to consumer advertising of prescription medicines and vaccines to the public is prohibited under Australian law. Advertising of medicines and vaccines to healthcare professionals is also regulated at law and by industry codes of conduct. The regulatory environment for medicines and vaccines promotion in Australia ensures public confidence in how prescribing decisions are made by physicians, and ensures that vulnerable patients are not misled.
Communicating about COVID-19 Vaccines
The updated guidance allows any organisation (including the media, corporate entities or healthcare professionals) to create their own materials 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);
- 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; or
- any statement regarding COVID-19 vaccines that is false or misleading.
When preparing materials for use, organisations must remember that obligations under other laws, such as the Australian Consumer Law, continue to apply, such as the obligation not to mislead.
The TGA has also confirmed that organisations are permitted to offer valuable consideration (cash or other rewards) to people who have been fully vaccinated under the Government’s national COVID-19 vaccination program, provided the following conditions are met:
- 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 alcohol, 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’); and
- 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).
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.
If an offer is made via a competition or similar, it may constitute a trade promotion and additional State and Territory regulations may apply. Terms and conditions should be prepared, trade promotion permits may be required and specific wording may need to be included in advertising or promotional materials.
Factual and balanced information that does not constitute advertising
For clarity, the TGA has also provided guidance on what types of communications do not constitute ‘advertising’ for the purpose of the guidance. The TGA has confirmed that 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.
The TGA has provided the following examples of what types of communications do not constitute advertising:
- 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;
- retweeting or sharing valuable newsworthy 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.
The TGA has also confirmed that the obligations of advertisers do not apply to discussions between a healthcare practitioner and their patient, in the course of a patient consultation, about the merits of COVID-19 vaccination or a particular vaccine. Clearly, such discussions constitute ‘medical advice’ and not promotion or advertising for the purpose of the prohibition on direct to consumer advertising. However, this guidance provides clarity for healthcare practitioners on how the regulator interprets the legislation.
Endorsements by healthcare professionals
Ordinarily, under Australian law, health professionals are not allowed to endorse a medicine or other therapeutic good.
However, the TGA has also confirmed that, in the context of the pandemic, this prohibition will not apply to registered COVID-19 vaccines.
The complete guidance is available at the TGA website: Communicating about COVID-19 vaccines | Therapeutic Goods Administration (TGA)