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17 Jun 2021
The Therapeutic Goods Administration and the Australian Health Practitioner Regulation Agency have published a joint statement today about the promotion of COVID-19 vaccinations.
Joint statement from the TGA and Ahpra
The Therapeutic Goods Administration (TGA), National Boards and the Australian Health Practitioner Regulation Agency (Ahpra) support vaccination as a crucial part of the public health response to the COVID-19 pandemic.
Recent TGA regulatory changes regarding the promotion of approved COVID-19 vaccines clarify the way healthcare professionals can communicate to the public about COVID-19 vaccines and gives greater flexibility to openly discuss vaccination. On 7 June 2021, the TGA issued updated guidance on the lawful communication and promotion of COVID-19 vaccines which explain these changes.
A number of healthcare professionals and their peak bodies have asked for clarification about the relationship between these changes, and the responsibilities that registered health practitioners and others who advertise regulated health services have under the National Law, as outlined in the National Boards’ Guidelines for advertising a regulated health service (the National Boards’ advertising guidelines).1,2
Not all statements about COVID-19 vaccines will involve advertising of regulated health services. Where promoting COVID-19 vaccines does involve advertising of regulated health services, it must comply with both the TGA’s guidance and advertising requirements of the National Law.
The updated TGA regulations and guidance permits health practitioners, and others, to develop their own materials to communicate publicly about COVID-19 vaccines, within particular bounds. The TGA’s guidance states that the materials must not make statements that are misleading or deceptive, claim that vaccination is totally safe, or compare the different types of COVID-19 vaccines. While more specific, this is consistent with the National Boards’ advertising guidelines and position statement on COVID-19 vaccination.
Under the National Law, offers of gifts, discounts or other inducements are permitted in advertising of regulated health services so long as the terms and conditions of the offer are stated. The TGA’s guidance explains that the offer of certain rewards to people who have been fully vaccinated against COVID-19 is now permitted under therapeutic goods regulations provided the offer complies with certain conditions (such as not offering alcohol, tobacco or registered medicines). While offers of a reward for being fully vaccinated are most likely to be provided by businesses who are not providing health services, it is possible that healthcare professionals such as GPs or pharmacists may also offer a reward. Advertising that seeks to attract a person to a specific regulated health service provider for the purpose of COVID-19 vaccination must comply with both the TGA’s guidance and advertising requirements of the National Law.3
Importantly, the TGA’s guidance on promotion of COVID-19 vaccines does NOT change responsibilities that health practitioners and other advertisers have under the National Law when advertising a regulated health service. Both sets of regulations and guidance operate in parallel, including the requirements under section 133(1) of the National Law about the advertising of regulated health services. In particular, the prohibition on advertising that is false, misleading or deceptive continues to apply.4
Additionally, where the offer of a reward for being fully vaccinated involves advertising a regulated health service, the advertisement must comply with both the TGA’s guidance and the advertising requirements of the National Law, including stating the terms and conditions of the offer.5
The TGA guidance notes that information shared between a doctor, pharmacist or nurse and their patient during consultation or treatment is not subject to the therapeutic goods advertising rules. 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 TGA’s advertising laws. This is consistent with the National Boards’ advertising guidelines which explain that a practitioner providing information about treatment in a consultation is not considered to be advertising a regulated health service.
National Boards expect all health practitioners to use their professional judgement and the best available evidence in practice, including when providing information to their patients and the public about public health issues such as COVID-19 and vaccination.6
Further information on the advertising requirements of the National Law is available on the Ahpra website at www.ahpra.gov.au/publications/advertising-hub.aspx
The 15 National Health Practitioner Boards work in partnership with Ahpra to regulate Australia’s 800,000+ registered health practitioners. The primary role is to protect the public. National Boards’ registration standards, codes and guidelines form part of the regulatory framework for each profession and guide the professional practice of registered health practitioners in Australia.
Download the joint statement: Promotion of COVID-19 vaccinations: further information for healthcare practitioners and other advertisers (83.3 KB,PDF), Word version (103 KB,DOCX)
1 A regulated health service is a service provided by, or usually provided by, a health practitioner (as defined in the National Law). 2 Health Practitioner Regulation National Law, as in force in each state and territory (the National Law). 3 The National Law, s 133 4 The National Law, s 133(1)(a) 5 The National Law, s 133(1)(b) 6 The National Board Codes of Conduct or equivalent provide more information about how practitioners should provide advice on treatment options and obtain informed consent.