Regulation of advertising therapeutic products to the public will be simplified by:

• ceasing pre-approval of advertisements in favour of a self-regulatory regime
• implementing a more transparent and efficient complaints management process
• establishing greater consistency across regulation of advertising of different types of therapeutic goods
• implementing a formal education program for industry to encourage compliance
• broadening and strengthening the TGA’s investigation and enforcement powers

The intention of reforms to the regulation of therapeutic goods advertising is to increase safety for consumers by reducing the incidence of misleading advertising. This will be facilitated by improved public confidence in the complaints management process.

Removal of the involvement of government in the pre-approval process for advertising will reduce regulatory and administrative burden for industry but will not preclude industry bodies offering a self-regulatory model should they wish to do so. Compliance with the therapeutic goods advertising requirements will be managed and enforced more effectively (through a strengthened compliance framework), improving consumer and health professional confidence and reducing risks to consumers from exposure to non-compliant advertising.

The reforms aim to reduce complexity and inconsistency in the current framework, where requirements vary depending on product type, advertising media and form of advertising.

No.

Potential risks from removing pre-approvals will be mitigated by increased sponsor education, improved complaints management and stronger penalties and sanctions for non-compliance, potentially including injunctive powers.

The formal education program has the potential to 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.

Broadening and strengthening enforcement and compliance powers will benefit consumers through deterring inappropriate and misleading advertising of therapeutic products.

The removal of pre-approval requirements to enable an industry self-regulatory regime will bring therapeutic goods advertising in line with other products, and reduce regulatory burden on sponsors.

A single agency will be empowered to receive and triage complaints on the advertising of therapeutic products to the public. This approach to complaints management will reduce complexity and encourage greater consistency in decision-making, benefiting consumers and industry alike. The new complaints management process will be designed carefully in consultation with consumer groups, health care professionals, industry and other affected stakeholders.

An education program will be developed for sponsors. Presentation of this program will be in collaboration with industry associations and provide information and tools to assist their members in achieving compliance with advertising requirements under a new regulatory framework.

The current framework will continue to apply until the changes are implemented (see below). Until the changes are implemented, you must ensure that your advertising continues to comply with the current therapeutic goods legislation, including the need for pre-approval of advertising (where relevant). You should also participate in the current complaints resolution framework in the event that a complaint arises in relation to your advertising.

Prior to the implementation of the changes, you will need to review and update your business processes to ensure that they will accommodate the new framework. To assist you in preparing for implementation, educational information will be provided through website content and seminars.

Sponsors of therapeutic goods may also be affected by other reforms. See Further information below.

The reforms will be progressively rolled out by the TGA over the next 18 to 24 months, with new regulatory pathways for some medicines in place within 12 months.

• Fact sheet: Simplifying regulatory arrangements for advertising of medicines and medical devices
• Fact sheets on other reforms are available