Advertising of Drugs and devices is controlled under the Australia’s Therapeutic Goods Advertising Code (TGAC), which is designed to ensure marketing and advertising of therapeutic goods are socially responsible and not misleading. The 2014 Expert Panel Review TGA regulation (the Sansom Review) recommended updates to advertising controls. Some are already underway, others in active consultation.
Key concerns were consistency, transparency and efficiency of controls – pretty standard worries for any regulation. So, most of the changes centre on these themes.
Soon to go will be the old arrangements of outsourcing advertising reviews to external bodies, with TGA now (re)assuming full responsibility for processing and adjudication of complaints regarding consumer advertisements of therapeutic goods. This change is intended to produce a more streamlined, transparent and simplified complaints system and process for consumers, healthcare professionals and industry alike. Planned to commence as of July 2018, it is promised to provide harmonious interpretation of the legislation and decision making allowing for timely resolutions. Watch this space…
Keep it Simple, but let’s not be Stupid
While completely aligning the processes for devices and medicines is improbable and unnecessary, adding consistency to advertising requirements for medical devices and medicines aims to reduce the complexity that surrounds advertising currently. A key approach to help achieve this is the removal of pre-approval for over-the-counter and complementary medicine advertisements which a paves way for a more self-regulatory regime. This will be welcome news for most, however, does also create concerns about future compliance levels under a self-assessment regime…
TGA proposes increased compliance training to mitigate these risks, providing the information and tools to help the industry accomplish compliance with advertising. But the agency also proposed greater use of the stick through the implementation of increased enforcement powers. This includes increasing the level of consequences, allowing for civil penalties, and suspending or cancelling ARTG registrations, all as a result of breaching the advertising requirements. Do take this seriously. Gone are the days of minor penalties or takedown notices. Ensure compliance with the Advertising Code. Don’t be misleading, stay within what’s permitted, only make claims within the ARTG approval terms and have evidence to substantiate advertising claims. These should keep you out of trouble! More than anything – if challenged by TGA, be upfront and transparent too (it works both ways) and provide timely and correct responses to the TGA.
Relaxed rules for Direct to Consumer Ads for low-risk medicines?
Among the TGA proposals is consideration of permitting direct to consumer advertising for certain Schedule 3 substances. However, additional requirements such as mandatory statements would be enforced.
Most changes have been welcomed by industry, health care professionals and consumers. A streamlined and transparent process for advertising and complaints decreases complexity and confusion for all concerned. Stricter and stronger TGA powers allow for tighter control on these changes and permit further accountability and responsibility on industry. Those that play by the rules should not be unduly concerned.
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