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30 Sep 2014

Prime Minister Tony Abbott has called for drugs approved in other countries to be automatically allowed onto the Australian market, bypassing the medicines watchdog.

In an extraordinary attack on the nation’s system of medicines regulation, Mr Abbott condemned it as “a thicket of complexity, bureaucracy and corporate and institutional self-interest”.

“If a drug is needed for a valid medicinal purpose and is being administered safely, there should be no question of its legality,” the Prime Minister said. “And if a drug that is proven to be safe abroad is needed here, it should be available.”

Mr Abbott was speaking in the context of the debate over the legalisation of cannabis use for medicinal purposes, but his comments have sparked fears the Government is looking more broadly at watering down the current system of medicines regulation, including the pivotal role played by the Therapeutic Goods Administration.

Criticism of the nation’s system of medicines regulation are nothing new – the TGA and the Pharmaceutical Benefits Advisory Committee are often accused of denying patients access to treatments available overseas.

But it is rare for the Prime Minister of the day to launch such a forthright attack, and his comments appear to call current levels of oversight of the drugs market into question.

Under current arrangements, it is illegal to supply or sell products with claimed therapeutic properties unless it is listed on the Register of Therapeutic Goods administered by the TGA.

Approving a drug for listing on the register can be a lengthy process because the TGA, like counterparts overseas such as the US’s Food and Drug Administration, requires detailed information about what it contains as well as evidence from clinical trials regarding its safety and efficacy.

AMA President Associate Professor Brian Owler said it was an important process that protected the public from useless or harmful concoctions.

“The way that we regulate medicines in this country for clinical indications is through the TGA, and I think we need to keep using those mechanisms, having experts look at the evidence that exists, whether there’s a gap, conduct a clinical trial,” A/Professor Owler said.

Adrian Rollins

Published: 30 Sep 2014