As part of its continuing raft of reforms to the Australian therapeutic goods regulatory framework, the Therapeutic Goods Administration (TGA) has released a further consultation paper, seeking stakeholders' views on proposed changes to the Therapeutic Goods Advertising Code 2015 by 13 October 2017.
The last major update to the Code occurred in 2007, and since then there has been a significant expansion of the types of therapeutic goods being promoted and sold to the public, as well as in the methods and media used. Aside from ensuring the Code responds to such a highly dynamic environment, changes are required to:
- improve the clarity of provisions in light of the proposed changes to the therapeutic goods advertising sanctions and penalties regime; and
- ensure that the Code is consistent with related reforms to the therapeutic goods regime that may have an impact on advertising, including the introduction of a permitted indications list and a new "assessed listed medicine pathway".
The TGA has recognised that the enhanced enforcement and sanctions regime being introduced will only be effective if the provisions in the Code (to which the legislative reforms are linked) are clear. To this end, the TGA proposes that changes to the Code be made to remove, or at the least, minimise subjectivity, in the interpretation and implementation of specific advertising provisions of the Code.
Aside from pursuing increased clarity, the TGA has also indicated that a new Code will require advertisements to satisfy four core objectives:
Advertisements comply with the Therapeutics Goods Act 1989, Therapeutic Goods Regulations 1990 and the Code.
Advertisements are truthful, balanced and not misleading. Claims about therapeutic goods must be consistent with the entry of the goods in the ARTG. At a high level, that is, an advertisement:
- must not mislead or deceive, or be likely to mislead or deceive;
- must not lead a person to believe that are suffering from a serious ailment or that harmful consequence may result from the failure to use a therapeutic good;
- must not contain any claim, statement or carry any implication that the good is safe or will not cause harm, has no side effects or risks, is effective in all cases or conditions, is guaranteed or a sure cure, or effective for specific demographics (without detailing the supporting evidence);
- must contain all mandatory and applicable information specified in the Code; and
- include any specific warning information specified in the Code.
All claims used in advertisements for therapeutic goods must be substantiated. This includes:
- ensuring that details of scientific information relied upon is publicly accessible;
- identifying the sponsor of the scientific study(ies) relied upon;
- detailing any direct or indirect commercial interest held by the sponsor in the therapeutic good or ingredient being promoted; and
- ensuring that testimonials are not from persons who are employees of or related to the sponsor or advertiser, are genuine and make clear whether any valuable consideration was received.
Advertisements of therapeutics goods must give adequate and appropriate information on any risks, cautions and side effects as well as providing a balance between promoting responsible self-treatment and encouraging consumers to seek timely professional help. This includes:
- not encouraging, or being likely to encourage inappropriate or excessive use of the goods;
- not discouraging consumers from taking medicines prescribed by a healthcare professional; and
- ensuring that sponsorship advertisements promoting a team, individual, competition, event or activity are the subject of the advertising requirements.
It is proposed that these requirements, among others, will be specified in a draft of the Code that will be made available for consultation in the coming months. The TGA is however currently seeking stakeholders' views on the requirements described above and any other details or requirements that they believe should be specified in the new Code.
New definitions of prohibited and restricted representation
The consultation paper also puts forward the proposal that the prohibited claims in the Code being "treatment, cure and prevention" be broadened to include all references to prohibited claims unless otherwise allowed in the Code.
It is also proposed that the list of restricted representations be expanded. For example, it is proposed that the provisions in the Code dealing with "scientific information" be amended to ensure that:
- references to a specific research study in an advertisement must sufficiently identify the study to allow consumers access to it;
- advertisements are phrased in educationally appropriate language; and
- advertisements identify the source or commissioning body for any study relied upon, as well as any relationship to the sponsor or advertiser.
An option for an advertising framework for pharmacist only medicines
The TGA has also proposed a framework for the advertising of pharmacist-only medicines containing Schedule 3 substances. The TGA proposes retaining Appendix H of the Poisons Standard to specify those substances that may be advertised to the public. It would then remain an offence to advertise any Schedule 3 medicine that is not included in Appendix H, directly to consumers.
This consultation closes on 13 October 2017. If you would like to know more, or want help with your submission, please contact us.