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Watchdog could be by-passed in drugs review

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Medicines accepted for use in other countries may get automatic approval in Australia under changes to be considered as part of review of drug and medical device regulations.

Just a month after Prime Minister Tony Abbott unexpectedly unloaded on the nation’s system of medicine regulation, Health Minister Peter Dutton has appointed an expert panel to put the operations of the Therapeutic Goods Administration and the medicines approval process under the microscope.

The review, to be led by Emeritus Professor Lloyd Sansom with the assistance of Professor John Horvath and Will Delaat, has been asked to “benchmark” TGA regulatory arrangements against those of “trusted international authorities”, to examine how assessments made by “trusted regulators” offshore could be used more extensively, to assess greater opportunities for cross-border collaboration between regulators, and to suggest ways to streamline approvals processes.

Mr Dutton said the TGA regulatory framework provided important protection in ensuring the safety and effectiveness of medicines and the way they were promoted, but it was time to assess its operations and identify opportunities for improvement.

“We need a modern regulatory framework to ensure Australians can access the latest treatments in a timely manner,” the Minister said, in a none-too-veiled hint that the Government was keen to move to a system that drew more heavily on the work done by regulators offshore.

The announcement has come after the Prime Minster argued that a drug approved for use in comparable overseas countries should be available in Australia.

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

The Prime Minister condemned the current system of medicines regulation as a “thicket of complexity, bureaucracy and corporate and institutional self-interest.”

But AMA President Associate Professor Brian Owler has urged that any changes to the system of medicine regulation should be approached with caution.

A/Professor Owler said it was an important arrangement that protected the public from useless or harmful drugs.

“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,” the AMA President said.

The review is being conducted as part of the Government’s productivity and competitiveness agenda.

In its terms of reference, the review panel has been told that the regulatory framework should “balance safety and market access priorities to the benefit of patients and industry, and align with the Government’s commitment to increase productivity and competitiveness”.

It has been directed to make recommendations that ensure “there is an appropriate balance between risk and benefit in the regulation of [medicines and medical devices]”.

It has also been asked to look at simplifying and streamlining the approvals process, including by “fast tracking approvals, [looking to] opportunities for working together with trusted regulators in other jurisdictions…exploring how risk assessments, standards and determinations of trusted regulators can be used more extensively by Australian regulators [and] streamline approvals that cross regulatory categories”.

But the Government declared that the Pharmaceutical Benefits Scheme would be off-limits for the review.

The review is due to report by 31 March, 2015.

Adrian Rollins

 

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