Biologicals regulatory framework changes from 1 July 2018
Including changes to regulation of autologous human cell and tissue products and classification of biologicals
Advertising to consumers is prohibited
Autologous HCT products cannot be advertised to consumers from 1 July 2018.
Before an autologous HCT product can be administered to a particular patient, a medical or dental professional needs to assess whether the therapeutic good is appropriate and suitable for that patient. Advertising that encourages consumers to seek out such treatments prior to such an assessment may undermine the 'medical or dental practitioner-patient' relationship, and is prohibited under the Therapeutic Goods Act 1989 (the Act).
Advertising of services is permitted
Services (that do not mention specific products) will still be permitted to be advertised.
However the advertisement must comply with:
- The Act and associated subordinate legislation,
- Health Practitioner Regulation National Law (and applicable advertising guidelines),
- Australian Consumer Law, and
- State and Territory Laws.
When non-compliant advertising comes to the TGA's attention, the advertiser is notified (see Penalties for non-compliance).
An advertisement for a health service that specifies the use of any autologous HCT product associated with that service is not permitted as it would promote the product also.
To advertise services and comply with the therapeutic goods legislation, the advertising should:
- Focus on the services that your business provides without referencing the autologous HCT product.
- Not make any specific reference to autologous cell and tissue products associated with the services.
- Not provide information and/or advice, on medical or dental professional's websites, for patients to consider particular types of treatments involving autologous cells and tissue products (however, such information can be provided to patients as part of a consultation with the professional).
- Not reference trade names of autologous HCT products (e.g. abbreviations, acronyms) or colloquial names such as 'stem cells'.
These requirements apply to health professionals, professional bodies, media outlets and commercial ventures. The requirements apply to all forms of media, including traditional media (such as television, radio, print media and posters/displays) and electronic media (such as websites, emails, blogs, discussion forums and social media). Testimonials that refer to autologous HCT products are also likely to be considered advertising and are subject to the same requirements.
Penalties for non-compliance
In the first instance, the TGA seeks to inform, educate and assist advertisers to comply with the rules relating to advertising. However, if this approach fails, we may take further action to achieve compliance.
The Act provides for financial penalties for advertising breaches. Fines for such offences can be up to $840,000 for individuals and up to $4,200,000 for corporations.
- These amounts are current as at the date of publication.