Further Medical Device Reforms Before Parliament
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.
Key Issues For The Dental Industry —
As a result of a major review into medicines and medical device regulation and sustained advocacy by the Australian Dental Industry Association (ADIA), parliament is reforming the way the TGA operates. The intent of these reforms is to identify unnecessary or ineffective regulation and enact opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.
Implementing the reforms is expected to take three to four years and many of the improvements can be brought about by amendments to the TGA’s administrative processes. Others, such as those set out below, require legislative amendments. The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 is the latest instalment in the reform process and was tabled in the House of Representatives on 14 September 2017 by the Minister for Health, the Hon. Greg Hunt MP. The Bill progresses reform in a number of key areas as set out below:
Australian conformity assessment body recognition
Legislation passed in mid-2017 provided the framework whereby the Australian Government could authorise Australian companies to undertake conformity assessments, the process of ensuring that medical devices meet the TGA’s design, performance and safety standards. The most recent amendments refines that scheme that allows the Australian Government to publish information in relation to Australian conformity assessment bodies and to ensure that the government has the same powers in relation to conformity assessment certificates issued by Australian conformity assessment bodies as it does in relation to conformity assessment certificates issued by the TGA.
The Australian Government is progressing the recommendation that advertising therapeutic goods to the public be consistent for all medicines and medical devices, and that the whole process of vetting and pre-approval of the advertising of therapeutic products to the public cease in favour of a more self-regulatory regime. The Bill supports the implementation of these recommendations by removing the distinctions in the Act between advertisements for therapeutic goods for which an approval is, or is not, required, with effect from 1 July 2018.
Enabling greater use of assessments of comparable overseas regulators
The Bill provides the legal basis for the TGA to make greater use of the assessments of therapeutic goods from comparable overseas regulators. This is achieved by requiring that a business seeking market approval to supply a medical device to certify that appropriate conformity assessment procedures applied by an Australian conformity assessment body, or an overseas regulator that is specified in a notifiable instrument should they elect not to pursue this assessment in Australia. ADIA supports these provisions which will bring medical device certification in line with the existing scheme for medicines.
Broadening investigation and enforcement powers
When the TGA is faced will instances of illegal supply it has been unable to issue an infringement notice as the Therapeutic Goods Act (Cth) 1989 currently requires the TGA to prove harm, or the likelihood of harm, for strict liability offences. This had the practical outcome of not allowing the TGA to enforce penalties for infringement where the infringement was not harmful or likelihood to be so. The proposed legislative amendments will remove these requirements and reduce the maximum penalties for these offences to enable the TGA to better enforce the scheme in relation to low-risk liability offences.
Alignment of enforcement powers across government
The Bill proposes to incorporate into the Therapeutic Goods Act (Cth) 1989 a number of powers from the Regulatory Powers (Standard Provisions) Act 2014 which will bring the powers of the Secretary in relation to monitoring, investigation, infringement notices and injunctions, into line with those of comparable Commonwealth regulators.
ADIA, as the peak business organisation representing dental product manufacturers and suppliers, is supportive of the changes. ADIA has supported the TGA as it has worked with multiple stakeholders to negotiate the package of reforms. Prior to the Bill being presented to the parliament ADIA met with the Minster for Health and signalled the dental industry’s support for the reforms.
These outcomes represent a significant policy win for the dental industry and have been achieved as result of the active participation of members supporting the work of the ADIA-PRPC Product Regulation Policy Committee. ADIA is committed to maintaining its ongoing dialogue with the TGA so that the reforms achieve the dental industry’s objective of ensuring that the regulatory framework for dental products 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 to matters associated with the regulation of dental products and other medical devices, ADIA staff responsible for negotiating policy outcomes with government receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee. Member updates are provided at the quarterly series of ADIA State Branch Briefings.
Further Information —
If you have an interest in ADIA's efforts to reform the regulatory standards for dental products 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 21 September 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 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.
|A —.. A D I A . .S T R A T E G I C . .A L L I A N C E S