ASMI urges innovation
February 10, 2016
Three regulatory reforms
to incentivise investment and
innovation in the non-prescription
medicines sector and increase
consumer access to medicines form
the foundation for the pre-budget
submission from the Australian Self
Medication Industry (ASMI).
ASMI ceo, Deon Schoombie,
said: “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.
“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 is urging for the removal of
regulatory obstacles to stimulate
investment and innovation and
increase consumer access to
medicines which leads to reduced
Medicare and PBS costs, improved
health outcomes and sustainability
of the healthcare system.
The three proposals in the
submission call for new data
protection and market exclusivity
provisions for over-the counter
and complementary medicines,
implementation of a regulatory
model permitting consumer
communication of Pharmacist Only
(Schedule 3) Medicines and thirdly,
an overhaul of the scheduling
framework to support the National
Medicines Policy.
Schoombie said, “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.”
For minimal government
investment, the proposals could
lead to a more efficient sustainable
healthcare system, he said.
“These regulatory reforms
would stimulate investment and
innovation by the non-prescription
medicines sector,” he added.
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