Advertising Complaints Process Gets Industry Support
11th Jun 18
Australia's dental industry has provided advice to the Australian Government on the proposed new centralised complaints management body for the advertising of medicines and medical devices to the public.
Key Issues For The Dental Industry —
Through the 2018 Therapeutic Goods Advertising Code the Australian Government has set out a framework for the advertising of medicines and medical devices that seeks to promotes the safe and effective use of therapeutic goods by minimising misuse, overuse or underuse of the goods.
The 2018 Therapeutic Goods Advertising Code also ensures that advertising to the public is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance and therefore supports informed health care choices. Naturally, there is a supporting complaints handling process that is being reviewed.
The advertising of medicines and medical devices to the public was an issue canvassed extensively in the 2015 Review of Medicines and Medical Devices Regulation. This resulted in an outcome, broadly endorsed by the Australian Dental Industry Association (ADIA), for the Therapeutic Goods Administration (TGA) being designated as the centralised complaints management body for the advertising of therapeutic products to the public. This represents a significant simplification and clarification relative to the existing system of multiple different bodies which will make it easier for manufacturers and suppliers of innovative dental products to comply with advertising requirements.
Earlier this year, ADIA was asked by the TGA to contribute to the draft of the 2018 Therapeutic Goods Advertising Code and associated guidance materials. While supporting the overall direction of the Code, representatives of the dental industry serving on the ADIA-PRPC Product Regulation Policy Committee made a number of comments which were included in ADIA's submission to the TGA. These recommendations sought to ensure that businesses in the dental industry are not subjected to unintended outcomes of unreasonable compliance obligations, particularly with respect to internet advertising.
Following on from this, the ADIA has been engaged in further consultations with the TGA on the complaints handling process for breaches of the above Code. ADIA outlined its strong support for a graduated complaints handling model where regulatory activities are undertaken in a manner proportionate to the risk posed to the public and a business’s compliance history. The key documents can be downloaded below:
The model proposed by the TGA is consistent with its own risk-based approach to regulation and will enable it to enforce the Code without subjecting businesses to onerous requirements. ADIA did advise, however, that the TGA should also take into account the challenges faced by small businesses and should consider their limited resources when determining regulatory actions in response to breaches of the Code.
To support compliance, the TGA will also develop a suite of education and guidance material to support businesses and assist them in achieving and maintaining compliance with the Code. The TGA's commitment to develop education and guidance materials is strongly supported by ADIA which as offered its support to the TGA in drafting guidance material that is relevant and useful for businesses more broadly, but small businesses in particular.
As a result of the reforms which will see the TGA become the centralised complaints management body for therapeutic goods advertising to the public, and the development of a risk-based complaints handling model, compliance will become simpler and therefore easier for businesses in the dental industry.
ADIA has commended the TGA for the level of consultation associated with the development of the 2018 Therapeutic Goods Advertising Code and the supporting complaints handling process.
Consistent with the framework set out in the ADIA Advocacy Agenda, in actively lobbying for reform, ADIA continues working towards a regulatory framework for dental products that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.
Member Engagement —
ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. With respect to policy advocacy efforts to reduce the red-tape associated with the manufacture and supply of innovative dental products, the team in the ADIA national office receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee.
Further Information —
To keep up to date with the latest market statistics subscribe to the Twitter feed @AusDental or follow us on Facebook at www.facebook.com/dental.industry. Alternatively, you can contact the Association via email at firstname.lastname@example.org or by telephone on 1300 943 094.
Currency Of Information & Disclaimer —
This update was issued on 11 June 2018 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, images and where stated.
11th Apr 18
As the TGA acts to introduce an application fee for placing Class 1 medical devices on the ARTG, ADIA has meet with senior ministerial advisors in order to seek an outcome to alleviate the impact on the dental industry.
9th Apr 18
The Australian Government has released new guidance as to how the Therapeutic Goods Administration (TGA) implements cost recovery activities associated with the regulation of medicines and medical devices.