TGA Bill A Major Step In Red Tape Reduction
7th Mar 17
The Australian Dental Industry Association (ADIA) has backed legislative reforms that will significantly cut the red-tape associated with supplying dental products, particularly for businesses looking to introduce new and innovative patient diagnostic and treatment options.
Key Issues For The Dental Industry —
The Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 is before the parliament and currently being considered by the Senate's community affairs legislation committee. It is a significant piece of legislation that seeks to cut the red-tape faced by suppliers of dental products and other medical devices. The bill is one of a series of measures taken by the Australian Government to implement recommendations arising from the expert review of Medicines and Medical Device Regulation (the MMDR review) and represents a major advocacy achievement for ADIA.
Most dental products are, for regulatory purposes, designated as medical devices by the Therapeutic Goods Act (Cth) 1989 thus fall within the purview of the Therapeutic Goods Administration’s (TGA) regulatory remit. It was in this context that ADIA, on behalf of dental product manufacturers and suppliers, was an active participant in the MMDR review, a process that commenced in October 2014 and continues to this day as a result of the implementation arising from that review. The following are key documents associated with this review:
MMDR Review Key Documentation —
MMDR Stage one report addressing regulation of medical devices [PDF]
Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 [PDF]
ADIA Submission to the senate's community affairs committee [PDF]
The MMDR review panel’s recommendations are significant in scale and scope, something acknowledged by the TGA and reflected in its commitment to engaging with ADIA to review implementation options. ADIA was therefore well positioned to provide the Senate with comment on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016. The following sets out ADIA’s observations and recommendations with respect to the key issues presented by the Bill which were contained in ADIA's submission to the Senate inquiry:
Designation Of Australian Conformity Assessment Bodies —
The amendments facilitate the designation by the TGA of new third-party conformity assessment bodies which will, once active, provide a pathway for the timely regulatory approval of new and innovative medical devices to the Australian market. ADIA has has advised the Senate that these changes are therefore supported by the dental industry.
Special Access Scheme Notification Scheme —
The change streamlines administration of the Special Access Scheme for Category B patients, providing a simpler pathway to access medical devices not on the ARTG. ADIA has has advised the Senate that these changes are therefore supported by the dental industry.
Maintaining A Responsive Regulatory System —
ADIA believes that an appropriate balance has been struck with respect to limiting the number of persons who exercise delegated decision-making powers and the need for the Act to afford the TGA the ability to ensure that the regulatory system for the approval of medical devices is responsive to new and innovative diagnostic treatment options. ADIA has has advised the Senate that these changes are therefore supported by the dental industry.
Strengthening Post-Marketing Activity —
ADIA has long argued for the TGA to place increased emphasis on its post-market activities and the increased emphasis on data collection and interrogation, adverse event reporting and information exchange with overseas therapeutic product regulators is welcomed.
Further Matters Requiring Urgent Legislative Attention —
When it comes to alleged instances of illegal supply the TGA currently has no way to effectively enforce its legislation – there are no penalties that can be applied for those who illegally supply medical devices unless it can be proven the use of these products would harm a patient. ADIA therefore recommends urgent further amendments to the Act to provide for graduated penalties that allow the TGA to respond appropriately to the full range of non-compliance from repeated minor breaches through to serious non-compliance.
Like the MMDR review panel, ADIA believes that these reforms strikes an appropriate balance between supporting consumer choice, the safe and effective use of therapeutic products, creates flexibility for industry and ensures that regulatory settings are appropriately aligned to risk.
After consultation with dental product manufacturers and suppliers, ADIA has recommended in its submission that the Bill without amendment as, when the reforms its provides for are implemented, represents a significant reduction in the bureaucratic red tape faced by manufacturers and suppliers of dental products.
This is a major reform for the dental industry, and a significant policy win by ADIA that supports dental product manufacturers and suppliers. ADIA's work in this area reflects the commitments made in the ADIA Advocacy Agenda to ensure that the medical device regulatory framework 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. Resources to achieve this have been made available by the ADIA Board as a result of commitments made in the 2016-20 ADIA Strategic Plan.
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 3 March 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.
21st Sep 17
The Australian Parliament is considering major amendments to the way the Therapeutic Goods Administration (TGA) provides market approval and also enforces its regulatory framework. The changes are supported by the dental industry.
4th Sep 17
The annual 'Dental Industry Meets Parliament Roundtable' is being convened on 13 September 2017 in Canberra, providing an opportunity for member businesses to raise issues with senior Ministers and their opposition counterparts