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Simplified and improved arrangements for handling therapeutic goods advertising complaints
From 1 July 2018, the Therapeutic Goods Administration (TGA) will assume responsibility for receiving and considering all complaints about therapeutic goods advertisements directed to the public under a simplified complaints system.
Other aspects of the therapeutic goods advertising framework will also be overhauled to improve compliance with the therapeutic goods advertising legislation.
What are the benefits of the new complaints arrangement?
This new arrangement consolidates the handling of all complaints about therapeutic goods advertisements directed to the public within the TGA (irrespective of the advertiser, the type of therapeutic good or where the advertisement appeared). Expected benefits include:
- Simplification of the advertising complaints mechanism for consumers, health professionals and industry, including a single online portal for lodging complaints and improved transparency of complaint outcomes.
- Timely resolution of complaints - the new arrangements will streamline complaints handling and remove unnecessary duplication leading to more timely resolution and compliance.
- Direct lodgement of complaints with the TGA, a single body, through an online complaints portal.
- All advertisers will benefit from consistency in complaints decision-making and interpretation of legislative requirements.
- For sponsors, the consolidation of complaints will allow the TGA to improve the coordination of multiple regulatory processes where possible to minimise burden.
- Consumers will be protected from exposure to non-compliant advertising.
In addition, the new arrangements will be subject to an external review after three years of operation to confirm that the intended benefits are being realised and allow improvements to be implemented.
Compliant advertising is socially responsible, does not mislead consumers and assists in delivering good health outcomes. Compliant advertising also means a ‘level playing field', which removes inequities for businesses that are faced with non-compliant competitors.
What arrangements are being replaced? Why?
Responsibility for complaints about the advertising of therapeutic goods to the public is currently shared between the Complaints Resolution Panel (the Panel), multiple peak therapeutic goods industry associations, and the TGA. The Panel and the TGA consider the majority of complaints about advertising to the public.
Currently, the Panel and the industry associations cannot consider complaints about the advertising of all types of therapeutic goods, irrespective of the media in which the advertising appeared. Industry associations are generally limited to complaints about their members' advertising. The Panel also has limited compliance powers so matters of ongoing non-compliance have to be referred to the TGA for resolution.
Stakeholders of the therapeutic goods advertising framework have identified over many years that the advertising arrangements need to be improved and simplified. These sentiments were reflected in previous reviews of the advertising framework, and most recently through the public consultation on The regulatory framework for advertising therapeutic goods in November 2016. The decision to consolidate all complaints about the advertising of therapeutic goods to the public within the TGA is intended to address many of the criticisms of the current system.
Other proposed advertising reforms
A single complaints handling body is just one of the recommendations made by the Expert Panel Review of Medicines and Medical Devices Regulation to improve the therapeutic goods advertising framework. The TGA is also working to deliver the remaining reforms in 2018:
- Improving consistency in advertising requirements for medicines and medical devices will make it simpler for advertisers to understand the advertising requirements for their product.
- Removing pre-approvals for medicines - this will improve consistency between medicines and medical devices and across advertising media. It will also reduce regulatory burden.
- Formal advertising compliance education program - this will be designed to provide a range of information and tools across multiple channels to assist all advertisers in developing compliant advertising under the new regulatory framework.
- Broader and enhanced enforcement and compliance powers to deter the inappropriate and misleading advertising of therapeutic products.
The Expert Panel Review of Medicines and Medical Devices Regulation also recommended a further review of the Schedule 3 Advertising Guidelines. A separate consultation was carried out in relation to this recommendation. When the outcomes of this consultation are available, they will be published on the TGA website.
Will there be additional costs?
The TGA is working to negate the impact of the new arrangements on its fees and charges in the future.
The TGA will publish more information about the new arrangements, as it becomes available, on its website. Questions on the new arrangements can be sent to the TGA's Advertising Compliance Unit by email: Advertising.Consultation@health.gov.au.