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

Member Consultation —
Accelerated Assessment Of Medical Devices

A
To provide businesses across the dental industry with the opportunity to contribute to changes that affect the commercial, technical and regulatory environment the Australian Dental Industry Association (ADIA) seeks member advice and guidance when making representations to government. The following details pertain to an invitation that ADIA has received from the Australian Government to tender comment on behalf of the dental industry.
a

Subject:

The regulatory framework for advertising therapeutic goods

Status:

OPEN

Comment Due Date:

Wednesday, 14 December 2016

Department / Agency:

Therapeutic Goods Administration

Background:

The TGA is seeking comments from interested parties on the appropriate body or bodies for the handling of complaints under a new complaints management system for therapeutic goods advertisements directed to the public and other recommended reforms to the advertising regulatory framework.

Purpose:

The Australian Government has agreed to simplify the processes by which the advertising of therapeutic goods to the public is regulated. This includes the process for managing complaints about therapeutic goods advertisements directed to the public. The TGA has sought advice from ADIA for guidance on the appropriate body or bodies for the handling of complaints under the design of a new centralised advertising complaints management-process and other recommended reforms to the advertising regulatory framework.

The reform proposals stem from the review of medicines and medical device regulation that made seven specific recommendations in relation to advertising of therapeutic goods to the public. These could be broadly categorised as ceasing pre-approval of advertisements in favour of a more self-regulatory regime and implementing a more transparent and efficient complaints management process.

The review also provided recommendations to establish greater consistency across regulation of advertising of different types of therapeutic goods and to implement a formal education program for industry to encourage compliance. There were corresponding recommendations to broaden and enhance the TGA's investigation and enforcement powers.

The Australian Government has accepted the need to disband the current mechanisms for managing complaints about therapeutic goods advertising and that a new mechanism established with a single agency responsible for receiving and managing complaints. To progress this recommendation the Government also agreed that the Department of Health will consult with stakeholders on the appropriate design of the new complaints management process noting that the function could be established within the TGA, another Commonwealth agency or an external organisation.

Documents:

2016 TGA Therapeutic Goods Advertising Consultation Paper [PDF]

Member Engagement:

ADIA-DRC Dental Regulation Committee

Comments To:

ADIA Policy team via email at canberra@adia.org.au

a
ADIA member businesses with an interest in this issue are invited to comment by forwarding your thoughts via email to canberra@adia.org.au by the due date. Although comments of a technical / legal nature are welcome, a simple plain-English statement as to the extent this reform proposal will / will not affect your business is all that's required as such advice greatly assists ADIA in advocating on behalf of the dental industry, particularly in the context of our support for small business.

In pursuing policy reforms the work of the Association is set out in the ADIA Advocacy Agenda that seeks to create an environment in which businesses in the dental industry can grow, create jobs and operate sustainably.

Be sure to keep up to date on this issue by following ADIA on Facebook at www.facebook.com.au/dental.industry and by subscribing to the Twitter feed @AusDental. Members requiring further information can send an email to policy@adia.org.au or telephone 1300 943 094.


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

a

Dental Industry News