“As the leading industry association for complementary medicines, we took up the Federal Government’s challenge to identify unnecessary regulation and red tape that creates inefficiencies and costs to industry and taxpayers,” said Richard Henfrey, president of Complementary Medicines Australia (CMA).
“We looked at regulatory duplication, unnecessary costs, time to market, impact on innovation or ability to effectively market products. And we found clear examples where the regulatory burden has outstripped the benefits, particularly in terms of reduced consumer risk.”
Calls for ingredient deregulation
The result of CMA’s review is a policy document containing a deregulation agenda, which Henfrey submitted to lawmakers, including to a representative of the prime minister, this week.
“[In it], we are proposing pragmatic deregulation solutions in three areas of complementary medicines regulation that will streamline these costs and burdens without compromising consumer safety,” Henfrey added.
CMA has identified three areas for deregulation that together account for a total value saving of A$70m (US$61.3m) each year. These include deregulation of ingredient approvals, which would net a saving of A$10m (US$8.75m) a year, of marketing approvals (A$25m, US$22m) and of manufacturing complexity (A$35m, US$30.6m).
“Well-informed Australian consumers are keen to access innovative new products, even if this means ordering these products on-line from international sources,” the document said.
It explained that many commonly used ingredients are only available overseas due to “a mandated costly and needless duplication of assessment”.
“This is the primary factor inhibiting the growth of the Australian complementary medicines industry. Where ingredients have been approved as safe by competent overseas regulators, these decisions should allow for a pathway to automatic or expedited adoption.”
Simplify marketing and manufacturing too
Moreover, by deregulating marketing approvals, an area regulated by the Therapeutic Goods Administration (TGA) through “a complex and inefficient process”, the industry could make substantial savings.
“The system is already limited as only a subset of advertising media are included; most notably the rapidly growing area of internet advertising is not covered,” the document cautioned.
“Advertisements for low-risk complementary medicines should not require pre-approval as they must comply with best practice under the Australian consumer law, similarly to foods and beverages that can also make health claims but don’t require advertising pre-approval.”
And in calling for deregulation of manufacturing complexity, CMA’s report touched on the industry’s perceived lack of a level playing field with respect to approval and audit of overseas manufacturing facilities.
“While the industry recommends that the current level of standards is maintained for global competitive advantage, the goods manufacturing process should be regulated by the TGA but using third party conformity assessment to allow for the most efficient and least costly accreditation framework.”
Henfrey added: “The savings in terms of direct costs to the industry is in the order of A$70m per annum. This is in addition to the potential cost savings to the regulator and spin-off benefits to innovation and growth.
“Instead of spending A$70m today on red tape, the savings could be used to invest in growth, benefiting consumers, families, businesses and government.”