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The Therapeutic Goods Administration (TGA) issued a number of consultation papers in January 2019. Two of these will be of particular interest to medical device suppliers.
One of those papers seeks feedback on its proposal to introduce a globally harmonised Unique Device Identification (UDI) system in Australia in relation to medical devices. The proposal would require sponsors of most medical devices supplied in Australia to ensure that their devices carry UDIs and that relevant data is entered into the UDI. The TGA proposes that the UDI system be based on internationally harmonised principles as outlined in the International Medical Device Regulators Forum (IMDRF) UDI guidance and informed work done by regulatory authorities in the EU, USA and elsewhere. More details of the TGA’s proposal can be found here. Feedback is invited from industry and other interested parties during the consultation period that ends on 18 February 2019. Feel free to contact us if you would like to discuss your feedback.
Another consultation paper issued by the TGA in January 2019 seeks feedback on its proposed changes to scope and definitions concerning medical devices. Many of these changes are designed to harmonise Australian legislation and regulation with the EU Regulation on medical devices (2017/745). One of the key changes proposed is that certain products without medical intended purpose (including non-vision correcting contact lenses and devices used in cosmetic procedures) should be regulated as medical devices in Australia. More details of the TGA’s proposal can be found here. Feedback is invited from industry and other interested parties during the consultation period that ends on 18 February 2019. Feel free to contact us if you would like to discuss your feedback.
The TGA released a new version of its guide on “Advertising to the public” in January 2019. This document provides guidance on complying with the new Therapeutic Goods Advertising Code (No. 2) 2018 (2018 Code). Most of the provisions in the 2018 Code came into force on 1 January 2019. Some provisions in the 2018 Code dealing with health warnings in relation to certain identified ingredients will not come into force until 1 September 2020.
The 2018 Code contains significant changes and clarifications to the 2015 version of the Code. Some key changes and clarifications include:
Any presentation of a scientific or clinical claim must be substantiated before being advertised and must not be presented in a misleading manner. An advertisement which contains a scientific or clinical claim must identify the researcher and financial sponsor if the advertiser knows, or ought reasonably to have known, such information. The study which supports the advertisement must also be sufficiently identified. Advertisers should remember that these requirements in the 2018 Code sit alongside the requirements in the Australian Consumer Law, including the requirement that advertisers must not engage in conduct that is likely to mislead consumers. In this regard it is worthwhile remembering the $6 million penalty awarded against Reckitt Benckiser (Australia) Pty Limited as a result of its prosecution by the Australian Competition & Consumer Commission for the making of misleading representations about its NUROFEN branded specific pain products.
The Code has clarified the TGA’s position on testimonials in order to enhance their integrity. For example, advertisers must not use a testimonial provided by persons involved with the marketing of the relevant product and it is compulsory to disclose whether the person providing a testimonial will receive any valuable consideration.
While including an offer of sample of a medical device in an advertisement was previously permitted, it is now prohibited to include an offer of a sample in the advertising of therapeutic goods other than in the case of specific items listed in Schedule 3 being condoms, sunscreen, stoma devices for self-management and continence catheter devices for self-management.
Goods which consumers do not have an opportunity examine before purchase will attract new requirements set out in Section 12 of the 2018 Code. This is intended to capture internet marketing, direct marketing (eg telemarketing) and other digital sources of marketing. For example, advertisers will be required to provide the prescribed allergy-related health warning in Part 3 or 4 of Section 1 of the 2018 Code. Section 12 also contains labelling requirements for medicines which are not available for physical examination before purchase, including the requirements in the Therapeutic Goods Order No.92 – Standard for labels for non-prescription medicines.
Section 11 requires the prominent display of a new statement in relation to pharmacist-only medicines that can be advertised, namely, “ASK YOUR PHARMACIST – THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU”. This statement is intended to ensure that consumers understand that they need to talk to a pharmacist about their proposed use of the product.
Section 26 contains requirements for the advertisement of weight management products. Such advertisements must balance their claims in relation to the product with the need for a healthy energy-controlled diet and physical activity. Other requirements include that any “before and after” images used in advertisements represent results that would be expected to be achieved by the average user of the product.
While most of the requirements of the 2018 Code came into force on 1 January 2019, the TPA has stated that it will take a pragmatic approach to compliance with the 2018 Code during 2019. It has indicated that where an advertiser publishes an advertisement in the first half of 2019 that is not compliant with the 2018 Code, but would have been compliant with the 2015 Code, then this is unlikely to pose a significant risk to health and the action taken will involve a reminder about the advertising obligations under the 2018 Code, but is unlikely (in the absence of other non-compliance) to attract more serious action. It has noted that in the second half of 2019, where such a complaint is received, it would seek information including the process being applied to correct the advertising along with associated dates before determining whether to take enforcement action.
Advertisers should bear in mind that where specified advertising has been pre-approved on the basis of the 2015 Code, any complaints will be considered against the 2015 Code.
While the TGA stated it will take a pragmatic approach to compliance, particularly in the first half of 2019, serious infringements (such as those that endanger the health of individuals) will be dealt with in a serious manner. Maximum penalties for non-compliance are severe and can extend to imprisonment for criminal offences and civil penalties of up to $10,500,000 for corporations.
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