The paper was published in November to promote discussion on ways health authorities could streamline their regulatory systems. Its first eight chapters look at issues concerning pharmaceutical medicines and medical devices. A new ninth chapter now covers laws involving complementary medicines.
‘A defining moment for industry’
Complementary health officials warmly welcomed the publication of the updated discussion document by the government panel, saying it meant the industry was now turning a corner.
“This is a defining moment for the complementary medicines industry. We have a once-in-a-lifetime opportunity to frame a regulatory system for Australia,” Carl Gibson, chief executive of Complementary Medicines Australia (CMA), told FoodNavigator-Asia.
CMA has been calling for what it calls a “light touch, right touch” regulatory regime that Gibson says is appropriate for the “low-risk nature of our industry that focuses on quality, safety and efficacy to protect consumers while reducing costs and boosting exports.”
Monitored by the Therapeutic Goods Administration (TGA), the Australian complementary medicines industry has one of the toughest regulatory frameworks in the world, pushing some quarters to believe that the system is more favourable for pharmaceutical companies.
Cutting through the red tape
Last year, Tony Abbott’s government pledged to cut swathes of red tape across the wider medical industry, alluding to complementary medicine but not referring to it by name. At the time, the industry hoped this would benefit complementary medicines by introducing a greater acceptance of international standards.
The current TGA system usually requires Australian manufacturers to gain home approval even if certification has already been secured in other trusted markets.
CMA argues that the complementary health industry would benefit in cost savings to the tune of A$70m (US$55m) if the system employed less restrictive practices while maintaining high consumer safety standards.
Currently, the industry brings in revenues of A$3.5bn [US$2.7bn], though this is expected to grow to A$4.6bn [US$3.6] in 2017-2018.
The role of the discussion document is to “promote discussion and to assist the [review] panel to form a view about whether there is a shared understanding amongst stakeholders of the issues and options for the future in respect of the regulation of complementary medicines in Australia.”
Personal, corporate and industry views can be submitted to the panel by April 8 before it makes its recommendations to the government.