ASMI urges TGA to focus on real reform of complementary medicines
The Australian Self-Medication Industry (ASMI) welcomed the release by the Therapeutic Goods Administration (TGA) of the full list of evaluated, registered complementary medicines (CMs), but described it as a "first step" in much-needed reform to the sector.
The Executive Director of ASMI, Dr Deon Schoombie, said the public release of the list of AUST R (Registered) CMs, which have been fully evaluated by the TGA, was a good start and needed to be followed by other measures to provide greater consumer confidence in the use of evidence-based CMs.
"It is pleasing that we have greater transparency, and that consumers are now aware of products which have been fully evaluated for quality, safety and efficacy," Dr Schoombie said.
"However, reform is also needed to address the lack of data protection on the evidence required to support applications for registration," Dr Schoombie said.
"It is important that data protection measures are put in place
to encourage the research that will help to generate more evidence
necessary to build confidence and rigour in the CM sector, an issue
which ASMI has been pursuing for quite some time.
"ASMI is also calling for the implementation of the remaining industry reforms from the Expert Committee on Complementary Medicines in the Health System."
"Unfortunately, the publication of this list by the TGA does nothing to shift us to where we need to be with respect to strengthening the regulatory framework for 'Listed' CMs, given that the vast majority of CMs are listed products.
"This system requires genuine reform, where consumers have adequate information about evidence and health claims for medicines, and where the degree of regulation is commensurate with the risk posed by the medicines.
Dr Schoombie urged the TGA to get on with the task following
through on the key recommendations outlined in the 2011 report of
the Australian National Audit Office (ANAO) into CMs, including
increased post-market surveillance, together with penalties and
sanctions as deterrents against non-compliance.
Complementary medicines have a vital role to play in consumer health and wellbeing, with some 75% of consumers now using these medicines. It is vital that we have a regulatory framework which meets consumers' expectations in regard to evidence, safety and quality and which is consistent with the Quality Use of Medicines (QUM).
About ASMI: The Australian Self-Medication Industry (ASMI) is the peak industry body for the Australian self care industry representing consumer healthcare products including over-the-counter medicines and complementary medicines. 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. www.asmi.com.au
Media contact: Bob Bowden, Foresight Communications (02) 9241 2811, 0412 753 298