Support investment and innovation in OTCs: ASMI

In its 2016 pre-Budget Submission, ASMI has proposed three regulatory reforms to incentivise investment and innovation in the non-prescription medicines sector and increase consumer access to medicines.

“The non-prescription medicines sector (over-the-counter and complementary medicines) requires a regulatory framework balancing consumer protection with an operating environment that incentivises R&D, and investment in new products and services, local manufacturing, and employment and export growth,” says ASMI CEO Deon Schoombie.

“The level of regulation should be commensurate with the risk posed by the regulated products, with the aim of aligning with the COAG principle of ‘minimum effective regulation’.”

ASMI’s submission urges the Federal Government to remove regulatory obstacles to stimulate investment and innovation and increase consumer access to medicines.

This will contribute to reducing Medicare and PBS costs, improved health outcomes and increased sustainability of the Australian healthcare system, it says.

ASMI’s 2016 proposals for regulatory reform are:

  • Introduce new data protection and market exclusivity provisions for over-the counter and complementary medicines.
  • Implement a regulatory model permitting consumer communication of Pharmacist Only (Schedule 3) Medicines.
  • Overhaul the scheduling framework to support the National Medicines Policy.


“The reforms included in ASMI’s pre-Budget submission have the potential to reduce healthcare costs by providing the Australian population with greater options for self care,” says Dr Schoombie.

“They could contribute to a more efficient, effective and sustainable healthcare system at minimal cost to the Commonwealth.

“These regulatory reforms would stimulate investment and innovation by the non-prescription medicines sector,” he says.

To read ASMI’s pre-Budget submission click here.


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