Drugs safety alarm raised for local patients

Author: Dan Harrison
Date: 08/01/2015
Words: 432
Source: Sydney Morning Herald

Consumer advocates say patients could be placed at risk if Australia adopts proposals to rely more heavily on foreign regulators to determine the safety of drugs and medical devices.

The proposals have been raised in a discussion paper issued as part of a federal government review of regulation for medicines and medical devices such as breast implants and artificial hip joints.

Consumers Health Forum chief executive Adam Stankevicius said he was concerned the government seemed "intent on meeting the demands of the drug and medical-device industries while giving scant regard to questions of consumer safety and the public interest".

Medicines with new active substances must be assessed by the Therapeutic Goods Administration for safety, quality and efficacy before they can be legally supplied in Australia, even if the drug has already been approved by an overseas regulator such as the European Medicines Agency. The TGA has accepted European approvals for most medical devices since 2002, but conducts its own assessments of higher-risk devices.

The discussion paper says this duplication was "of concern to the Australian government" which, as part of its competitiveness agenda, has adopted the principle that Australian regulators should not impose extra requirements on products that have been approved under a trusted international standard, "unless it can be demonstrated that there is a good reason to do so". Drug companies and makers of medical devices argue these checks impose an unnecessary regulatory and cost burden and create a barrier to consumers getting timely access to therapies.

The forum argues greater reliance on foreign approvals would complicate and perhaps delay Australia's response to safety issues.

"In recent years, thousands of Australians suffered as a result of malfunctioning hip prostheses and breast implants. Does the government expect consumers to believe that downgrading Australia's own assessment processes will reduce the risks to Australian patients of future product failures?" Mr Stankevicius said.

The forum's former chairwoman, Karen Carey, said the PIP breast implants scandal, in which the French-made implants of more than 500 Australian women ruptured, pointed to the dangers of relying on foreign assessments. While TGA approval relied in part on European assessments after the recall of the implants, the TGA was unable to get access to test results from the French regulator.

The Medical Technology Association of Australia, which represents medical-device makers, said the problems with PIP implants were not evidence of the failure of the European system because regulators could not have been expected to uncover the criminal fraud committed by the manufacturer.

A spokeswoman for Assistant Health Minister Fiona Nash said the minister would not comment while the review was under way.Consumer advocates say patients could be placed at risk if Australia adopts proposals to rely more heavily on foreign regulators to determine the safety of drugs and medical devices.

The proposals have been raised in a discussion paper issued as part of a federal government review of regulation for medicines and medical devices such as breast implants and artificial hip joints.

Consumers Health Forum chief executive Adam Stankevicius said he was concerned the government seemed "intent on meeting the demands of the drug and medical-device industries while giving scant regard to questions of consumer safety and the public interest".

Medicines with new active substances must be assessed by the Therapeutic Goods Administration for safety, quality and efficacy before they can be legally supplied in Australia, even if the drug has already been approved by an overseas regulator such as the European Medicines Agency. The TGA has accepted European approvals for most medical devices since 2002, but conducts its own assessments of higher-risk devices.

The discussion paper says this duplication was "of concern to the Australian government" which, as part of its competitiveness agenda, has adopted the principle that Australian regulators should not impose extra requirements on products that have been approved under a trusted international standard, "unless it can be demonstrated that there is a good reason to do so". Drug companies and makers of medical devices argue these checks impose an unnecessary regulatory and cost burden and create a barrier to consumers getting timely access to therapies.

The forum argues greater reliance on foreign approvals would complicate and perhaps delay Australia's response to safety issues.

"In recent years, thousands of Australians suffered as a result of malfunctioning hip prostheses and breast implants. Does the government expect consumers to believe that downgrading Australia's own assessment processes will reduce the risks to Australian patients of future product failures?" Mr Stankevicius said.

The forum's former chairwoman, Karen Carey, said the PIP breast implants scandal, in which the French-made implants of more than 500 Australian women ruptured, pointed to the dangers of relying on foreign assessments. While TGA approval relied in part on European assessments after the recall of the implants, the TGA was unable to get access to test results from the French regulator.

The Medical Technology Association of Australia, which represents medical-device makers, said the problems with PIP implants were not evidence of the failure of the European system because regulators could not have been expected to uncover the criminal fraud committed by the manufacturer.

A spokeswoman for Assistant Health Minister Fiona Nash said the minister would not comment while the review was under way.

Geoffrey Vaughan, National Manager, Therapeutic Goods Administration, CanberraGeoffrey Vaughan, National Manager, Therapeutic Goods Administration, Canberra writes in 'The Australian Prescriber'.