On 31 May 2013 the Therapeutic Goods Administration released a Consultation Regulation Impact Statement ("RIS") for "Regulating the advertising of therapeutic goods to the general public".
Despite referring to "therapeutic goods", the RIS does not propose any changes to the prohibition on advertising prescription and certain pharmacist-only medicines to the general public. Rather, it focuses on complementary, over-the-counter and herbal medicines and medical devices.
The RIS includes options for changes to the following areas.
- Pre-publication approvals of advertisements. Pre-approvals are currently granted by different industry groups depending on the media in which the advertisement appears. The TGA noted perceptions of subjectivity, inconsistency and bias in the current pre-approval process, and concerns about "new media" advertisements and medical devices falling outside the process. Options include appointing a single independent body to conduct pre-approvals and expanding their ambit to cover medical devices and a broader range of media.
- Complaints handling process. Advertisements can be challenged if a person makes a complaint to the appropriate body. There are multiple complaint-handing bodies, depending on the media in which the advertisement is made. The complaints process is generally regarded as cumbersome and suffering from uncertainty of outcome. An option for change is to appoint a single body to handle all complaints and establish an expert advisory committee with advice on advertising matters.
- Compliance and enforcement tools. There are limited compliance and enforcement tools available for offences relating to advertising. Significant expansion of these tools is suggested, including introducing new offences, imposing criminal penalties and increasing some civil penalties from 60 penalty units ($10,200) to 50,000 penalty units ($8.5 million).
- Advertising of high risk medical devices. Medical devices can be advertised to the general public. As advertising of prescription and certain other medicines is prohibited, an option outlined in the RIS is to prohibit the advertising of higher risk medical devices also.
- Advertising directed to health professionals. Advertising to certain healthcare professionals is excluded from the requirements for advertising to the general public, with the rationale that health professionals are more competent in assessing advertisements regarding therapeutic goods. The option is to restrict this class to groups accredited under the National Registration and Accreditation Scheme (NRAS), which would mean that advertising to groups with no single accredited peak body, such as homoepathic practitioners, naturopaths and some herbalists, would be regulated in the same way as advertising to the general public.
The TGA invited submissions on the RIS. Submissions closed on 19 July 2013. The submissions received by to the TGA generally supported the options to centralise and streamline the pre-approval and complaints processes. On the other hand, the proposed expansion of the compliance and enforcement tools was not supported (despite the TGA seeing "no disadvantage" in this expansion). The proposed prohibition against advertising of high risk medical devices was not supported by the Medical Technology Association of Australia, amid concerns that consumers would seek out information from less reliable sources.
The strongest response was received from groups representing naturopaths, herbalists and homeopathic practitioners. Their concern was that if advertising to those persons was regulated in the same way as to members of the general public, there would be restrictions on the information required to conduct their professions. Other commentators observed that this would be addressed if these groups agreed to consolidated representation and achieved accreditation under the NRAS.
After considering the submissions it has received, the TGA now intends to prepare a final RIS to assist Government consideration of the next steps.