Dental Industry Backs Proposed Advertising Reform
7th Jan 17
ADIA has backed the general direction of proposed reforms to the therapeutic product regulatory framework so long as they complement other legislation, thus avoiding the creation of additional red tape for dental product manufacturers and suppliers.
Key Issues For The Dental Industry —
As the peak business organisation representing manufacturers and suppliers of dental products, the Australian Dental Industry Association (ADIA) was invited to provide comment to the reforms being proposed by the Therapeutic Goods Administration (TGA) to the regulatory framework for the advertising of therapeutic goods.
The review was made in the context of the Australian Government's response to the expert review of medicines and medical device regulation relating to advertising, specifically Recommendations 52, 54, 55, 56, 57 and 58. On behalf of the dental industry, ADIA provided the TGA with the following commentary that referenced issues raised in a consultation paper issued by the Australian Government.
Transnational information flows —
The proposed reforms set out by the TGA do not fully appreciate the impact that the internet is having on the advertising of medical devices and the limits that this places on the effectiveness of Australian therapeutic goods advertising regulation. Notwithstanding any domestic limitations on the type of information that is available in advertisements and / or to whom such advertising is directed, there needs to be an appreciation that most information is available in the public domain via websites hosted overseas.
Existing regulatory systems —
The TGA's reform pathway seeks, in some respects, to mirror the obligation that business has with respect to false and misleading claims under the Competition and Consumer Act (Cth) 2001. As this covers claims made in advertisements, packaging and online, ADIA recommends that any reform to the TGA's regulatory framework both reflects, and where appropriate, avoids duplication with the existing requirements set out in the Competition and Consumer Act (Cth) 2001.
Pre-approval of advertisements —
As arrangements for pre-approval of advertisements pertain to most over-the-counter and complementary medicines, such arrangements are of minimal concern to the dental sector. In this context, ADIA recommends that the TGA actively engage with the Australian Self Medication Industry Association (ASMI) and Complementary Medicines Australia (CMA) on this matter. ADIA does not believe it appropriate that a pre-approval regime be introduced for medical devices, something that has been in place for some medicines.
Sanctions and penalties —
ADIA believes that the enforcement provisions associated with advertising of therapeutic products should be enhanced so as to provide an effective deterrent as a means of elevating compliance levels. The use of infringement notices is welcomed and thus ADIA would support the introduction of civil penalty provisions to advertising offences.
The current limitation within the subordinate regulations that means orders cannot be enforced against advertisers that are not the sponsor of the product on the Australian Register of Therapeutic Goods (ARTG) is thought to be a serious deficiency in the legislation. ADIA therefore welcomes the proposal that failure to comply with an order by a non-sponsor advertiser should be an offence giving rise to an infringement notice.
ADIA is supportive of proposals that, in circumstances where a matter is referred to the Secretary to take action and this does not result in the appropriate response (because the respondent has not sufficiently complied), the TGA will publish the information on its website.
Complaints handling —
On balance, ADIA welcomes the proposed consolidation of complaints handling processes within a single agency. Subject to an appropriate process being developed and a qualification that the costs are not overly burdensome on business, ADIA believes that the TGA is well positioned to undertake this role.
In concluding its advice to the TGA, ADIA advised that is a strong advocate for reforms that deliver a regulatory framework for medical devices 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. ADIA believes that the broad direction set out in the TGA's consultation paper is consistent with this objective; however, reforms going forward need to align with the existing obligations of business set out in the Competition and Consumer Act (Cth) 2001.
Member Engagement —
Businesses that manufacture and supply dental products drive ADIA's policy advocacy priorities and, with respect to the regulation of therapeutic goods, do this through the ADIA-DRC Dental Regulation Committee with updates provided at the quarterly ADIA State Branch Briefings. If your business has an interest in this matter, get involved today.
Further Information —
For further information for ADIA's activities to support dental product manufacturers and suppliers in this area contact the ADIA Advocacy Team via email at firstname.lastname@example.org. To keep up to date follow ADIA on Facebook at www.facebook.com/dental.industry or subscribe to the Twitter feed @AusDental.
Currency Of Information & Disclaimer —
This update was issued on 7 January 2017 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.
5th Mar 18
The TGA is proposing to levy for the first time an application fee for placing Class 1 medical devices on the Australian Register of Therapeutic Goods (ARTG), a proposal that will significantly add business compliance costs.
7th Nov 17
SDI Limited has received a $10,000 fine for a determination that one of its promotions had influenced a healthcare professional to do other than select therapeutic products based upon genuine consumer health needs and clinical evidence