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Reforms to the therapeutic goods advertising framework
A number of changes to the regulatory framework for advertising of therapeutic goods will be made between 2018 and 2020. These changes include:
- enhanced sanctions and penalties available for addressing non-compliant advertising from March 2018
- an amended Therapeutic Goods Advertising Code from 1 July 2018
- a streamlined complaints handling system from 1 July 2018
- the abolishment of the requirement for certain advertisements to be pre-approved from 1 July 2020, allowing for a transition period.
In addition a formal education program including guidance materials will be developed and implemented to support advertisers.
These changes reflect the recommendations of the Review of Medicines and Medical Devices Regulation (the Review) on reforms to the advertising framework for therapeutic goods.
Enhanced sanctions and penalties
The Review recommended that sanctions and penalties be broadened to more effectively deter inappropriate and misleading advertising of therapeutic goods.
The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, which received Royal Assent on 5 March 2018, contains changes to the Therapeutic Goods Act 1989 (the Act) which:
- amend existing sanctions and penalties (e.g. criminal offence provisions); and
- introduce new sanctions and penalties (e.g. civil penalties, infringement notices).
The broadened sanctions and penalties will complement the TGA's education and compliance tools to allow us to take a graduated approach to achieving advertising compliance.
The broadened sanctions and penalties will enable the TGA to operate more effectively when it becomes the single complaints handling body.
Revised Therapeutic Goods Advertising Code
The Therapeutic Goods Advertising Code (the Code) will be revised to:
- assist all advertisers in understanding the advertising requirements
- provide more objective tests to determine breaches of the Code, which is needed to support the broadened sanctions and penalties (including infringement notices)
- address the inconsistencies between medicines and medical devices (where appropriate) in accordance with Review Recommendation 54
- incorporate changes to the Code that have been discussed with stakeholders in recent years but have been on hold while the advertising framework was under review.
The proposed revised Code will be the subject of a public consultation in April 2018 before implementation on 1 July 2018. A consultation on proposed improvements to the Code was also held in August 2017.
We are working to develop the tools and processes necessary to support our role from 1 July 2018 as the single body responsible for handling complaints about the advertising of therapeutic goods to the public. This includes a new web form for lodging complaints which is under development.
The TGA will establish transition arrangements with the Complaints Resolution Panel to minimise the inconvenience to complainants.
Education and guidance
We are developing a range of educational materials and guidance to assist advertisers with the advertising requirements. This will include a formal education program as recommended by the Review.
As part of this work the advertising section of the TGA website will be updated.
Delivery of education and guidance will be staged, with materials relating to the Code and complaints handling our first priority.
Requirement for advertising pre-approval
Currently, advertisements to the public for medicines that are to appear in specified media require pre-approval under the Therapeutic Goods Regulations 1990. The Review recommended that this arrangement be stopped in favour of a more self-regulated regime (recommendation 55). The Review also recommended that requirements for advertising therapeutic goods to the public be made consistent for all medicines and medical devices (recommendation 54), which would be largely achieved through removing the need for pre-approval.
The Government has listened to consumer concerns raised during consideration of the Bill and has decided to extend the pre-approval process for a further two years (to cease on 1 July 2020). The next two years are a transition period in which the TGA will work to support advertisers by ensuring they have access to the required information to achieve compliant advertising.
The requirement for advertisers to obtain prior approval from the TGA before referring to serious diseases, conditions, ailments or defects (i.e. restricted representations) in advertisements for therapeutic goods will not change when the pre-approval requirements are removed in 2020.
For further information on the advertising reforms please subscribe to the TGA website updates.
You can also email any questions to Advertising.Consultation@tga.gov.au.