Addressing the annual conference of Complementary Medicines Australia in Sydney, Sussan Ley, the health minister, announced in a recorded statement that most of the demands the nutrition industry had made as part of a manifold regulatory review would be met.
The Expert Review of Medicines and Medical Devices Regulation, known as the Samson Review, has taxed Canberra bureaucrats for years and involved wide stakeholder consultation. Implemented by Tony Abbot's government, its goal was to cut unnecessary regulation across all of Australia’s health industry, and find ways to make it more competitive on the world stage.
“The [government’s response] contains several transformational recommendations that will be of immense benefit to the complementary medicines industry and to consumers,” said Carl Gibson, chief executive of Complementary Medicines Australia, the industry body.
“And we are especially encouraged by the inclusion of mechanisms to encourage firms to invest in bringing new products to the market and to invest in greater levels of research and development.”
The industry’s relief seems to be shared by the regulator, the TGA, after a process that began in 2014 reached its conclusion.
“You only get to make changes like this to a sector once in a lifetime. We can actually do a whole lot of work on the sector from here. There’s a whole lot of optimism [within the industry],” Lyndall Soper, assistant secretary for complementary and over-the-counter medicines at the Department of Health, told FoodNavigator-Asia.
“Bringing medicines onto the Australian market quicker will be achieved, in part, by greater use of assessment of medicines by comparable overseas regulators like the US FDA and the European Medicines Agency,” Ley said.
This means that Australian manufacturers will face less red tape as they seek approval for novel ingredients already accepted in other regulatory jurisdictions.
“Consumers will also benefit from more extensive post-market monitoring of products and better access to information about the effectiveness of complementary medicines,” Ley added.
“Under the reforms sponsors will be encouraged to publish on their website the evidence that they hold to support all indications included on the product as well as information that will assist consumers to compare complementary medicines.”
One of complementary health's eternal bugbears, Australia’s nutritional advertising framework, which is viewed as a hinderance by both the regulator and the industry, will now be addressed.
Changes include sweeping reforms to the way that nutrition companies can use advertising so that “strong compliance measures against misleading advertising will bring alterations that are long overdue,” Gibson added.
Ley said that the reforms would protect consumers and reduce paperwork for companies that import or manufacture new medicines, medical devices or complementary medicines.
“The reforms will also foster innovation for small- and medium-sized enterprises by helping Australian businesses navigate the regulatory processes for the supply of therapeutic products in Australia.”
The government allocated A$20.4m (US$15.8m) in the last budget to implement the reform measure, which are expected to roll out over the next two to three years.
“The recommendations outline a regulatory framework for complementary medicines that will be critical to the continued growth of the industry and its contribution to Australia’s preventive health agenda,” said Gibson.
“The review retains the existing core protections and exceptional standards while enhancing the sustainability and transparency of the system for consumers, industry and policy makers.”