ASMI calls on Federal Government to fine tune regulatory settings for non-prescription medicines industry

11 February 2015

Return to Media Release Index

11 February 2015 - The Australian Self Medication Industry (ASMI) today urged the Federal Government to establish a regulatory framework for the non-prescription medicines industry that balances the protection of consumers with regulatory settings that encourage industry to invest in new products and services, which meet the health needs of Australians now and into the future.

Dr Deon Schoombie, ASMI Executive Director, said: "ASMI's 2015 Pre-Budget Submission sets out four measures to increase consumer access to medicines and support a viable and responsible industry.

The submission calls on the Federal Government to support the Self Care Alliance in the development of a policy agenda to embed self care in national health policy.
"Self care requires informed consumers; the expertise of GPs; pharmacists and other healthcare practitioners; the supply by industry of evidence based-products; government to facilitate a regulatory environment conducive to self care, and private health insurers to create incentives that will encourage self care behaviour," explained Schoombie.

"Expanded self care along with improved health literacy should lighten the load on Australia's hard pressed health services and Federal Budget, whilst improving patient outcomes, consumer convenience and quality of life."
ASMI's Pre-Budget submission also advocates for an alternative regulatory model to create consumer awareness of therapeutic options in Schedule 3 in a structured, balanced and responsible way.

According to Dr Schoombie: "The proposed model is distinct from 'conventional' advertising where the main emphasis is on brand awareness in a genericised and crowded market environment. The proposed model shifts the emphasis to information about the symptoms and/or condition; product specific information and the requirement for counselling by a pharmacist."

The current Australian scheduling environment is not conducive to increasing access to non-prescription medicines. ASMI's submission calls on the Federal Government to support a multi-stakeholder review of the Australian scheduling environment; develop a scheduling policy and 'switch agenda', and reform the regulatory framework and procedures to support the 'switching' of medicines, consistent with the National Medicines Policy.

"In ASMI's opinion a review would be best dealt with through the establishment of a small working party of relevant technical specialists who can oversee the review process and report to the Australian Health Minister's Advisory Committee (AHMAC)," said Dr Schoombie.

Finally, ASMI's submission urges the Federal Government to apply the COAG principle of "minimum effective regulation" to the regulation of low risk medicines, including complementary medicines, while maintaining appropriate safety standards for consumers.

Dr Schoombie said: "Some key examples of beneficial reform include accepting overseas approved ingredients and adding them to the list of Australian approved ingredients as a fee-free administrative exercise in response to an application.
"The reforms included in ASMI's Pre-Budget Submission are consistent with the Government's deregulation agenda and also align with the stated policies to support consumers to take more responsibility for their health and well-being and to make better use of healthcare resources. The measures proposed have the potential to contribute to a more efficient, effective and sustainable healthcare system at minimal cost to the Commonwealth.

"These reforms would also support a responsible and viable non-prescription medicines industry," Dr Schoombie added.

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 (CM). ASMI members make up 85 per cent of the $4bn Non-Prescription Medicines market. Membership totals 50 companies and ASMI members employ approximately 18,000 people with exports estimated at $1.2 billion annually. ASMI's mission is to advance consumer health through responsible self-care. This means driving a viable and responsible industry and empowering the consumer with evidence-based products and information with the aim of improving health and wellbeing. To find out more about ASMI or how to become an ASMI member, please visit (

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: