Australia: Final report of Review of Medicines and Medical Devices Regulation

The second, and final, report from the Australian Independent Review of Medicines and Medical Devices Regulation has been released. It highlights the importance of cutting red tape for the rapidly expanding complementary medicines sector, while improving access to information for consumers and health professionals to inform their health and health expenditure decisions.

This is important to the two out of three people in Australia who use complementary medicines. The report acknowledges the importance of maintaining the safety and quality of complementary medicines in Australia, as well as a regulatory environment that enables growth and competitiveness in the sector.

Both the first report (which was released earlier this year) and the second report make recommendations to improve regulatory frameworks and reduce red tape for prescription medicines, medical devices and complementary medicines, without compromising safety and quality.

Streamlining processes for complementary medicines

The second report makes further recommendations related to expanding approval pathways and streamlining processes for complementary medicines, while increasing the transparency of efficacy evidence that supports consumer confidence levels.

The second report also makes recommendations to streamline and improve the regulation of advertising of therapeutic products, to ensure consumers receive accurate information about products and their effectiveness to optimise their health outcomes.

The landmark review was led by Emeritus Professor Lloyd Sansom, assisted by Will Delaat and Professor John Horvath.

The second report makes 26 recommendations that address the regulatory frameworks for complementary medicines, and for the advertising of therapeutic goods. The report accompanies and builds on the first report that made 32 recommendations on the regulatory frameworks for medicines, medical devices and unapproved therapeutic products.

The Review reports put forward proposals that can support improved productivity by reducing the cost of red tape on businesses, organisations, and individuals, while retaining the appropriate protections for all Australians.

The first and second reports of the Independent Review of Medicines and Medical Devices Regulation are available at the Department of Health’s website. A Government response to the reports is expected in due course.