Complementary medicines regulation needs to be rigorous, timely and balanced to build consumer confidence

20 November 2012

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The Australian Self-Medication Industry (ASMI), the industry body representing evidence based non-prescription consumer healthcare products has urged a sensible approach to reform of regulation of complementary medicines.

ASMI was responding to comments from the Consumers Health Forum suggesting that only a small proportion of all complementary medicines available in Australia have been tested for efficacy by the Therapeutic Goods Administration (TGA).
Complementary medicines play a central part in Australia's healthcare system, and in particular, in areas such as minor ailments, chronic conditions, and preventative health.

It is important that we recognise the place of evidence-based complementary medicines, and support initiatives that build a robust and viable industry that all Australians can trust.

The Executive Director of ASMI, Dr Deon Schoombie, said there was room to improve the regulation of complementary medicines, and that this needed to be approached in a balanced way.

The vast majority of complementary medicines on the Australian Reregister of Therapeutic Goods are 'Listed' medicines, which means they have been tested for safety and quality, but not efficacy. A relatively small number of complementary medicines are 'Registered', which means that they have also been tested for efficacy.

Importantly, all complementary medicines, whether Listed or Registered, are rigorously controlled for safety and quality. They must only be produced by TGA-approved manufacturers, and only from ingredients approved as low-risk by the TGA.

"Unfortunately, the process for dealing with companies that make unsupported, or outrageous health claims is slow, cumbersome and often ineffective," Dr Schoombie said.

"The system requires genuine reform so that consumers have adequate information about evidence and health claims for medicines, and where the degree of regulation is commensurate with the risk posed".

"ASMI has long argued for appropriate regulation of the sector, with more accurate and timely advice to the public that helps to protect the credibility of those products that are proven and evidence-based."

The regulation of complementary medicines is currently undergoing a major review by the TGA.

A key focus area of the review is the type of evidence required to support indications made for Listed medicines. ASMI believes that the reforms also need to look at improved compliance through increased post-market surveillance, and the imposition of sanctions for those who persistently breach existing regulations.