ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians...................... — ADIA Strategic Plan

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TGA Red-Tape Reduction Claim Debunked By Deloitte Report

TGA Red-Tape Reduction Claim Debunked By Deloitte Report

9th Mar 16

Summary —

A Deloitte Access Economics analysis has found that attempts by the TGA to reduce red-tape has back-fired, resulting in regulatory compliance costs increasing by around 34% for businesses in the dental industry placing products on the ARTG, the list of medical devices that can be lawfully supplied in Australia.

Key Issues For The Dental Industry —

With the stated aim of reducing regulatory compliance costs on business, the Therapeutic Goods Administration (TGA) changed the way it levies annual charges on business for making entires on the Australian Register of Therapeutic Goods (ARTG), the list of medicines and medical devices that can be lawfully supplied in Australia.  The Australian Dental Industry Association (ADIA) is the peak business organisation representing manufacturers and suppliers of dental products and, from the outset, had concerns that the TGA’s new arrangements would increase regulatory compliance costs for businesses in the dental industry. 

The only independent analysis of the TGA’s new fee structure has confirmed ADIA’s concerns – that the TGA's changes increased the dental industry's compliance costs.  This analysis was undertaken by Deloitte Access Economics.

Deloitte Access Economics was engaged to undertake an in independent analysis of the cost impact on the Australian dental industry of the revisions to the TGA’s annual charges scheme.  The key findings of the analysis are set out below.

 

TGA Annual Charge Exemption Scheme Impacts On The Dental Industry —

The TGA’s new scheme resulted in an average 34% increase in regulatory compliance costs for the dental industry between FY2014-15 and FY2015-16;
Although there have been small administration cost savings, these have been significantly outweighed by increases in the annual fees; and
The TGA’s regulatory change was intended to reduce regulatory compliance costs to business; however, the regulatory change does not appear to have achieved its objective.

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The full Deloitte Access Economics report can be downloaded from the link below.  This includes a summary of how the TGA levies charges associated with ARTG entries, how the changes increased costs for businesses in the dental industry and the methodology behind this analysis.

Deloitte Access Economics Assessment Of TGA Charges —

Impact on the Australian dental industry of the TGA Annual Charge Exemption Scheme  [PDF]

As an exercise in red-tape reduction, the introduction by the TGA of the ACE scheme is an unmitigated disaster for the dental industry.  Rather than reducing regulatory compliance costs, businesses in the dental industry have seen these increase of 34% on average. 

Significantly, the Deloitte Access Economics report is consistent with an preliminary forecast by the TGA, undertaken in February 2015 and therefore before the scheme was introduced, that estimated that the dental industry would face regulatory compliance cost increases of 30%.

As a result of the independent analysis undertaken by Deloitte Access Economics that established that the introduction of the ACE scheme increased regulatory compliance costs for businesses in the dental industry, ADIA has requested that the TGA reform the ACE scheme so that the dental industry’s compliance costs are consistent with those under the LVT scheme.

Member Engagement —

ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. The policy advice tendered to the TGA and other stakeholders within government on matters associated with medical device regulation is developed by members serving on the ADIA-DRC Dental Regulation Committee.

Currency of Information —

This update was issued on 9 March 2016 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.

Disclaimer —

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 information is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated. 

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