ASMI calls on Government to boost investment and innovation in consumer medicines and support self care reforms

22 January 2013

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ASMI Pre-Budget Submission for the Federal Budget 2013-14: The Australian Self-Medication Industry (ASMI), the industry body representing evidence-based, non-prescription consumer healthcare products, has urged measures to promote greater innovation in the consumer medicines sector and to broaden the take-up of consumer self care, in its Federal Budget submission issued today.

Welcoming the opportunity to make this submission to Treasury for consideration, ASMI Executive Director Dr Deon Schoombie said: "A key element in helping Australians manage their health lies in actively promoting patient self care - the notion of taking greater personal responsibility for their health through nutrition, exercise and appropriate use of self-medication to treat and prevent illness, in partnership with a healthcare professional."

Australians already manage or treat a large proportion of their ailments without consulting a doctor. However, previous research commissioned by ASMI shows that seven per cent of all GP consultations involve the treatment of common or minor ailments, many of which could be managed by a pharmacist, with significant savings to the health system. Nationally, this translates into some 25 million GP consultations annually that involve minor ailments - that's 96,000 consultations each day.

ASMI believes the adoption of the following recommendations, outlined in detail in the submission, will deliver significant savings to the health portfolio as well as significant consumer, commercial and industry development benefits:

1)    Establish an 'Australian Self-Care Alliance' to build the evidence base to support policy decisions in relation to greater self care, improve health literacy and identify opportunities for more cost-effective healthcare delivery.

2)    Adopt a Benefit Risk Regulation Model for non-prescription medicines to assist both regulators and manufacturers to better assess risks and benefits, to improve risk management, and to enhance communication to consumers.

3)    Establish best practice regulatory scheme through the joint Australia New Zealand Therapeutic Products Agency (ANZTPA) to achieve efficient, cost-effective harmonisation in relation to the scheduling of medicines and other aspects of the regulation of medicines.

4)    Implement IP protection provisions for non-prescription and complementary medicines to ensure ongoing investment in research and innovation.

Currently one of the biggest obstacles to greater self care lies in the regulatory area.

ASMI believes that in Australia there is a prescription medicines approach to the regulation of non-prescription medicines, despite a different benefit-risk profile, and without a positive impact on public health.

"The combination of a risk-averse approach to medicines scheduling and the restrictions on the advertising of Pharmacist Only medicines which prevent sponsors from creating consumer awareness about these products present obstacles to increased access to medicines. There is ample precedent from Australia's peer countries to show that a more liberal approach can be adopted without any detriment to public health and safety," the submission says.

The submission also urges steps to encourage investment in research to build the evidence-base supporting complementary medicines and into increasing access to over-the-counter (OTC) medicines through rescheduling.

"The Australian situation discourages manufacturers from investing in research to generate sound scientific evidence and the regulatory data to support product applications.

"Significant costs are involved in generating the evidence the community is expecting but sponsors will only make the investment if they are given an opportunity to recoup the costs before competitor products gain market approval," the submission says.

One solution would be to provide a period of data exclusivity commensurate with the initial investment.

ASMI members make up 85 per cent of the $4 billion consumer healthcare market, employ approximately 17,000 people and generate exports worth an estimated $600 million per year.

For a copy of the ASMI Budget Submission, click here.