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 or the United States Food and Drug Administration.
The TGA has accepted European approvals for most medical devices since 2002, but conducts its own assessments of a range of higher-risk devices, including those containing materials of animal or microbial origin.
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 any additional 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 on the industry, and create a barrier to consumers getting timely access to new therapies.
The Consumers Health Forum argues greater reliance on foreign approvals would complicate and potentially 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 immediate past chairwoman of the Consumers Health Forum, 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.
“If you’re going to rely on other countries to do safety and quality assessments for Australians, that assessment is only as safe as the weakest link in the partnership, and if you’re looking for an example of the weakest link in the partnership, you only need to look at the PIP breast implant fiasco,” Ms Carey said.
Independent Senator Nick Xenophon said while the TGA’s partnership with overseas regulators had helped it approve the implants, it had hampered its response when concerns arose.
“We need to have the best system in place to deal with any problems as quickly as possible,” Senator Xenophon said.
In its submission, 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, which concealed its use of non-medical silicone, before the implants entered the market.
The association said instead the case highlighted the need for more-effective monitoring once devices were in use, and said the fact that there had not been more device failures in recent years suggested the European system was performing well.
“It needs to be acknowledged that no medical device is 100 per cent safe and all medical devices have some level of risk associated with their use. It is therefore impossible for any regulatory system to be completely foolproof,” the submission says.
A spokeswoman for the Assistant Minister for Health, Fiona Nash, said the Minister would not comment while the review was under way.
The review is being led by Lloyd Sansom, an academic and former chairman of the Pharmaceutical Benefits Advisory Committee, with assistance from retired pharmaceutical industry executive Will Delaat and former national chief medical officer John Horvath. The trio will provide their recommendations to government by March 31.