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Advertising reforms: Questions and answers

7 July 2017
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An external review after three years will allow the Government to consider the performance of the new system and refine the system to enable community expectations to be met and the complaint arrangements to reflect best practice.

The initial set up and transition costs will be funded from the TGA's cash reserves as announced in the 2016-17 Budget measure on the implementation of the Expert Panel Review of Medicines and Medical Devices.

The TGA currently contracts out the pre-approval of advertisements and the operations of the Complaints Resolution Panel. Savings from abolishing these functions (and from the management of these contracts) will directed to complaints management.

The TGA is currently implementing an enhanced system of sanctions and penalties and also looking to deliver additional education to industry, both of which we expect will improve compliance It is anticipated that when these have been fully implemented the number of complaints should reduce over time.

Other proposed reforms from the Expert Review, such as:

  • recommendation 12 - advertising of Schedule 3 (pharmacist-only) medicines;
  • recommendation 39 - a new assessment pathway for sponsors of complementary medicines to make claims substantiated by evidence; and
  • recommendations 14, 23 and 48 - the regulation of low risk products;

may also have an impact on the number of advertising complaints and, therefore, the ongoing cost of these new arrangements.

The new arrangements are intended to improve and simplify engagement by consumers, health professionals and advertisers and deliver more timely and more consistent decisions.

Advertisers will also benefit from the consistency in the complaints handling approach and interpretation of legislative requirements that can be achieved through the TGA being the single complaints handling body.

In addition, we expect that there may be some efficiencies for sponsors of therapeutic goods, as the complaints process and any other current regulatory matters can be coordinated through the TGA rather than handled separately.

In its response to the Expert Panel Review of Medicines and Medical Device Regulation, the Government indicated that both the Complaints Resolution Panel and the Therapeutic Goods Advertising Code Council would be disbanded.

Both these bodies have served us well for many years in upholding the standards for socially responsible therapeutic goods advertising.

However, it is necessary to move to a more contemporary model for dealing with advertising complaints, compliance and enforcement and a broader consultative model for establishing standards and ensuring that they remain relevant.

We will utilise the collective wisdom of these bodies in developing and transitioning to the new arrangements.

In 2018, the Government will be removing the legal requirement for pre-approval of medicine advertisements that will appear on television, radio, newspapers and magazines. This will bring therapeutic goods advertising in line with other products, and reduce unnecessary regulatory burden on advertisers. It also leaves the door open to industry associations to implement their own advertising clearance services.

Enhanced sanctions and penalties will be put in place as a deterrent to inappropriate advertising.

Complementing each of these initiatives will be a formal industry education program. This program should improve compliance and promote greater quality and consistency of advice provided to sponsors on advertising requirements and to help manage the public health risks associated with inappropriate advertising.

The Expert Panel Review of Medicines and Medical Devices Regulation recommended a further review of the Schedule 3 medicine Advertising Guidelines.

The TGA carried out a separate public consultation in relation to this recommendation earlier this year. The government is currently considering future options.

While consumer protection laws apply to the advertising of many therapeutic goods to the public, therapeutic goods are not ordinary items of commerce.

Therapeutic goods, by their very nature, exert an effect on the human body. Further, the promotion of therapeutic goods often targets specific sections of the population that are vulnerable due to age, illness or injury.

In addition, some therapeutic goods, like diagnostic machines and other therapeutic goods purchased by hospitals, are not considered 'consumer goods'.

Additional protections are needed around the advertising of therapeutic goods to the public. These protections are provided under the therapeutic goods legislation and apply in addition to Australian Consumer Law requirements managed by the ACCC.

The ACCC has an important role as a generalist regulator but in its submission to the public consultation process expressed its view that the TGA is the appropriate place to undertake complaint handling in relation to therapeutic goods given TGA's technical expertise and the efficiencies gained by locating complaint handling functions with that expertise.