ASMI Senate Submission on Innovation argues for regulatory reform to support more research and development

31 July 2014

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31 July 2014 - In its submission to the Senate Standing Committee on Economics Inquiry into Australia's Innovation System, the Australian Self Medication Industry (ASMI) argues that key to maintaining a competitive position as an investment destination will be an increased focus on research and development.

ASMI Director Regulatory and Scientific Affairs Steve Scarff said: "The industry seeks to increase access to medicines by expanding the range and availability of healthcare products, to support the trend towards greater self-care and to contribute towards Government's efforts to make better use of scarce healthcare resources and improve health outcomes.

"This can only occur through investment in research and innovation and an appropriate regulatory framework, which balances the protection of consumers whilst also providing an environment conducive to industry investing in new products and services that meet the health needs of the Australian population both now and into the future.

"The non-prescription medicines industry contributes $2.1 billion per annum toward local manufacturing; exports products worth $1.2 billion per annum; employs 18,000 people in Australia, and includes 17,000 registered and listed product variants.

"ASMI estimates that turnover in Australia in the non-prescription medicines industry, which includes over-the-counter and complementary medicines, is around $4 billion, with 5 per cent annual growth. Innovation is critical to the continued success and growth of the sector.

"Many of ASMI's members have manufacturing operations in Australia producing a range of self care products for both the Australian and export market. As with much of the manufacturing industry in Australia, these operations are under pressure from the high value of the dollar, increased international competition (particularly from low cost sources) and rising domestic costs.

"ASMI is committed to finding ways of encouraging investment into non-prescription medicines as a means of maintaining and expanding this important and valuable sector as well as increasing consumer access to new effective medicines.

"Non-prescription medicines do not benefit from the same level of intellectual property protection as do prescription medicines and so, measures designed to encourage investment in innovation need to be tailored to suit these differences between the different types of therapeutic goods," said Mr Scarff.

ASMI makes the following recommendations for stimulating innovation in the non-prescription medicines sector:

Recommendation 1 Reforms designed to encourage innovation in the therapeutic goods area must accommodate the different protections available for prescription medicines, over-the-counter medicines and complementary medicines.

Recommendation 2 The many unfinished TGA reviews should be completed. Firstly to provide the certainty of requirements necessary for innovation. Secondly to provide an opportunity to develop solutions which are innovative in themselves or which facilitate innovation.

Recommendation 3: The medicines scheduling policy should be revised so as to encourage and reward innovative approaches to medicines scheduling.

Recommendation 4: The ASMI proposed model for direct to consumer communication of S3 medicines in a responsible, structured and balanced way should be implemented.

Recommendation 5: Remove impediments to industry growth and viability by providing appropriate incentives to develop new ingredients, new claims, new products and rescheduling applications.

Recommendation 6: Implement data protection arrangements for non-prescription medicines (e.g. by allowing a period of market exclusivity commensurate with the degree of innovation and investment).

Recommendation 7: Increase the research investment into complementary medicines to more appropriately reflect their market share.

Recommendation 8: Provide acknowledgement and support for the industry Working Group that has been established to examine research incentives in the non-prescription medicines industry.

About ASMI: The Australian Self Medication Industry (ASMI) is the peak body representing sponsors of non-prescription medicines - over-the-counter (OTC) and complementary medicines. Its members make up 85 per cent of the $4bn self care market. Membership totals 60 companies and ASMI members employ approximately 18,000 people with exports estimated at $1.2 billion annually. ASMI's mission is to promote better health through responsible self care. This means ensuring that safe and effective self care products are readily available to all Australians at a reasonable cost. ASMI works to encourage responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad national health strategy.

For more information or to arrange a media interview, please contact:
Marie Kelly-Davies
PR Manager, Australian Self Medication Industry (ASMI)
M:0408 256 381 E: