Advertisements of Unapproved Goods

The TGA regulates the advertising of therapeutic goods through the administration of the Therapeutic Goods Act 1989 (the Act), and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code).

‘Advertise’ as the Act defines is “any statement, pictorial representation or design that is intended, directly or indirectly, to promote the use or supply of the goods”.

Subsection 42DL(10) of the Act prohibits references (whether expressed or implied) to prescription medicines in advertisements about therapeutic goods that are directed to the general public. Furthermore, subsection 42DL(12) of the Act prohibits the advertising of unapproved therapeutic goods to the public.

A reference to the brand name or generic name of a prescription medicine in an advertisement to the public is likely to be considered as a breach under the Act. The advertisement must not have the effect of promoting the trial good and must not allude to any claimed benefits of the product.

For further information please refer to the TGA Advertising Hub.

When submitting an advertisement for a clinical trial to the HREC, please ensure the following:

·                The Advertisement identifies the researcher name and contact number/email for inquiries

·                The Advertisement identifies the financial sponsor of the research

·                The Advertisement includes references to support any claims

·                The Advertisement does not mention the Investigational Medicinal Product

·                The Advertisement does not mention the class of drug of the Investigational Medicinal Product or its mode of action

·                The Advertisement contains a statement that the trial has been approved by the SLHD HREC (CRGH or RPAH Zone) (with the study protocol number)

·                The Advertisement contains a footer with a version number and date

FAQs

Question 1: I want to advertise a clinical trial comparing two antihypertensive drugs that are being used in accordance with their ARTG approval. Am I permitted to mention the drug names in publicity material, or should I just refer to them as two approved antihypertensive medications? 

Response: As set out in subsection 42DL(10) of the Act, advertisements directed to the public domain that refer to substances, or goods containing substances, included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard, other than a reference authorised or required by a government or government authority, are prohibited. Therefore, a reference to the brand name or generic name of a prescription medicine in an advertisement is likely to be considered as a breach under the Act. As the majority of ‘antihypertensive medications’ contain substances included in Schedule 4 of the current Poisons Standard, it is also likely that a reference to ‘antihypertensive medications’ in an advertisement will be viewed to be a reference to substances, or goods containing substances, included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard.

While the advertising for clinical trial participants can be conducted in the public domain, references should not be made to substances, or goods containing substances, included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard.

Question 2: Would advertising for a clinical trial of two unnamed treatments for cancer be a restricted representation?

Response: As set out in Part 1 of Schedule 2 in the Therapeutic Goods Regulations 1990 a representation that refers to a therapeutic good as a treatment of a neoplastic disease is considered to be a prohibited representation. Under subsection 42DL(5) of the Act, advertisements must not contain a prohibited representation if the representation has not been approved for use by the government or a government authority.

Question 3: I have produced a flyer for distribution at my clinic describing a clinical trial in some detail (drugs, dosage regimen, purpose of the study etc). It is intended that my staff will give it to patients who indicate that they may be interested in participating. Is this permitted?

Response: Under subsection 42AA(4) of the Act, information or advice that is given directly to a patient by a health practitioner, mentioned in subsection 42AA(1)(a) of the Act, in the course of treatment of that patient, is exempt from the advertising rules set out in Part 5-1 of the Act. However, if the staff you are referring to are not health practitioners, and they are disseminating the flyer outside the conditions set out in subsection 42AA(4) of the Act, it is likely that providing information about prescription medicines in this manner will be considered a breach of the Act.

Question 4: Is it allowable to refer to the investigational medicine product (IMP) as a ‘medicine’, ‘medication’ or ‘treatment’ on a clinical trial advertisement? 

Response: From the TGA’s perspective, you need to ensure any material you distribute would not be taken to ‘advertise’ the IMP. ‘Advertise’ as the Act defines is ‘any statement, pictorial representation or design that is intended, directly or indirectly, to promote the use or supply of the goods’. The intention above is gauged not by what the person responsible for the content intends, but rather what the reasonable viewer interprets as being intended by the content. Trial medicines cannot be advertised in the public domain as they are likely to be an unapproved therapeutic good and/or a prescription good which under the therapeutic goods regulations cannot be advertised to the public. (See subsection 42DL(12) for unapproved goods and 42DL(10) of the Act for prescription goods).

Please note, clinical trials can be promoted in the public domain solely for the purposes of recruiting participants, omitting any advertising of a trial medicine.

The TGA has not made indications about specific terms such as ‘intervention’ or ‘treatments’, it is up to you as an advertiser to determine which language would not have the effect of promoting the use or supply of the good.

Question 5: Is it allowable to mention the IMP’s mode of action on a public advertisement?

Response: If the IMP’s mode of action promotes the IMP it is likely to be considered advertising and is not permitted on recruitment advertising.

Please refer to page 49 of the Australian Clinical Trial Handbook for further information.

In addition, sponsors of clinical trials conducted under the CTN/CTA schemes must comply with the ICH Guideline for Good Clinical Practice and The National Statement on Ethical Conduct in Human Research issued by the NHMRC.

NOTE: These responses have been provided to the SLHD by the TGA. These responses are intended as guidance and is not legally binding on the TGA or SLHD.  If you require further advice, you can contact the TGA at Advertising.Enquiries@tga.gov.au