Since it entered power last year, the government claims to have already removed around 10,000 pieces of unnecessary legislation and regulations, as part of a A$700m (US$614m) project.
The complementary medicines regulator, the Therapeutic Good Administration (TGA), is well known on a world level for its extremely tight framework that usually requires Australian manufacturers to gain home approval even if certification has been secured in other trusted markets.
Booming market
Complementary Medicines Australia, which has consistently lobbied for the deregulation of of non-pharmaceutical medicines, announced in a report last month that the industry it represents would benefit in cost savings to the tune of A$70m (US$61m) if the system employed less restrictive practices while maintaining high consumer safety standards.
In a policy note posted on his website, Prime Minister Abbott announced that his government would consider accepting trusted standards from overseas as part of its innovation and competitiveness agenda.
“This is an important part of the government’s plan to cut red tape and foster a lower cost, business friendly environment with less regulation,” Abbott wrote.
“Businesses often have to undertake a regulatory approvals process to use or sell products in Australia that duplicates a process that has already occurred in other developed countries. This adds to costs and provides little or no additional protection.
“As an important first step, the government will enable Australian manufacturers of medical devices the option of using European Union certification in place of TGA certification. This will place Australian manufacturers on the same footing as overseas competitors.”
It is expected that the term “medical devices” will refer to various applications within the TGA remit, including complementary medicines.
Fiona Nash, the assistant health minister, later confirmed the TGA would accept European documentation from local manufacturers who wanted to enter the Australian market, as is the case for overseas manufacturers.
“This will cut red tape, provide more flexibility for local medical-device manufacturers and, in many cases, enable devices to get to market more quickly, which will benefit the public,” Nash said.
Key plank of agenda
Carl Gibson, chief executive of CMA, welcomed the PM’s announcement, telling us: “Accepting the standards by trusted overseas regulators was a key plank of Complementary Medicines Australia’s deregulation agenda and the announcement by the prime minster is warmly welcomed.
“Australia does not have a monopoly on regulation standards, and we welcome this common sense approach, which will cut costs and cut needless regulatory duplication.”
The move is bound to deliver further optimism to non-pharma companies, which have been witnessing rapid growth in recent years. Currently, the industry brings in revenues of A$3.5bn [US$3.26bn], though this is expected to grow to A$4.6bn [US$4.29] in 2017-2018.
According to Justin Howden, who is head of government regulations and public policy at natural products manufacturer Swisse, the key to this is “deregulation”, rather than “unregulation”.
“As an industry, we want the highest standards, and we want to maintain GMP, which is one of the unique things in Australia,” he told FoodNavigator-Asia.
GMP—or good manufacturing practices—is one of the key components of the TGA’s overall regulations, and is monitored through regular on-site audits or inspections to ensure the manufacturers are compliant with legislated manufacturing principles.
“This is about deregulation of a system that is already extremely safe and highly regulated. Consumer safety is a mandatory that is not on the table,” Howden added.
“There is an interest in achieving this from a consumer health outcomes points of view. The ability to get innovative products out faster will benefit both consumers and the industry.”
To ensure a thorough review of all regulations, ministers will write to regulators and work with stakeholder groups to develop criteria for assessing opportunities for the acceptance or adoption of trusted standards and assessments, the prime minister said.
Any changes will be subject the government’s regulation impact statement processes and progress will be reported at the twice yearly repeal days and in the annual deregulation report.