The Expert Panel Review of Medicines and Medical Devices Regulation recommended that further reviews be undertaken to potentially streamline the regulatory framework for low-risk products and increase consumer access to these products.

The reviews to be undertaken fall into two main categories:

• Review of appropriate regulatory frameworks for low-risk products. This may involve removing certain products from the therapeutic goods framework and regulating them as consumer goods or food. In other cases, products may remain regulated under the Therapeutic Goods Act 1989 but regulated in a way that is more aligned with their consumer risk; and
• Review of the Scheduling Policy Framework for medicines, to provide for the development and adoption of a formal risk-benefit methodology to assess scheduling applications and for opportunities to enhance input from interested parties into the scheduling process. The review would also address options for the future regulation of the advertising of Schedule 3 (pharmacist-only) medicines. Because the scheduling of medicines and chemicals is managed under a single framework, the review would also need to address related aspects of chemicals scheduling.

These reviews will commence in 2016-17 and will involve consultation with consumers, health professionals and industry. State and Territory Governments will also be closely involved in the review of the Scheduling Policy Framework and, if there is any interaction of proposed changes to regulation of low-risk therapeutic goods with food regulation, states and territories may also need to be consulted on these proposals.

Depending on the outcomes of the reviews, policy authority for any proposed changes to the regulatory framework would be sought from the Minister. In the case of the Scheduling Policy Framework, any reform proposal will be presented to the Australian Health Ministers Advisory Council (AHMAC) for endorsement.