AUSTRALIA'S consumer watchdog has excluded medical devices from a call for a new law to make it illegal for companies to sell unsafe goods.
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This is despite multiple implant device scandals and recent federal Department of Health acknowledgement only 0.5 per cent of device "adverse events" are likely to be reported.
The Australian Competition and Consumer Commission said chair Rod Sims' recent call for a general safety provision in law to protect consumers from goods that kill and injure thousands each year did not include medical devices, which come under medical device "specialist safety regulator", the Therapeutic Goods Administration.
"The application of a general safety provision to therapeutic goods and medical devices is ultimately a policy decision for government," said an ACCC spokesperson.
Health consumer groups have slammed the TGA and ACCC for leaving consumers in a "regulatory black hole" when it comes to medical devices, and will use a national forum in Melbourne on April 5 to raise major health system reforms as a federal election issue.
The forum follows TGA confirmation it has only initiated four medical device criminal cases in the past decade, and issued two infringement notices.
This is despite a series of implant device scandals including pelvic and hernia mesh, breast and hip implants, leading to civil action against device manufacturers brought by injured patients under Australian consumer law.
The forum also follows a federal Department of Health report in the European Medical Journal in January that estimated only 0.5 per cent of medical device "adverse events" were reported to the TGA, in part because of doctors' "fear of blame", and despite device manufacturers risking prosecution for failing to report device problems.
The report from the health products regulation group of the department's medical devices branch estimated fewer than 0.4 per cent of ventilator failures were reported to the TGA, despite being life-saving equipment, leaving the regulator "unable to determine the proportion of all failures that resulted, or may have resulted, in patient harm".
It estimated 1 in 66 patients could be affected by ventilator failures.
"The large disparity between the number of reports that regulatory bodies receive and the number of patients actually affected is undoubtedly a factor in the delay of action being taken to prevent further harm to patients," said the report.
It warned there would be "ever-increasing numbers" of adverse event reports even under the flawed existing system and "regulators and manufacturers need to reconsider current methods used to encourage the reporting of events".
Health Issues Centre spokesperson Danny Vadasz, representing peak state consumer health groups, said recent medical device scandals, including the pelvic mesh scandal, revealed a health system ill-equipped to respond to the rise of manufacturer and doctor-led devices, with sometimes catastrophic results for patients.
The large disparity between the number of reports that regulatory bodies receive and the number of patients actually affected is undoubtedly a factor in the delay of action being taken to prevent further harm to patients.
- Federal Department of Health report on medical device failure reports.
Governments had failed to act on expert panel recommendations on devices to improve public safety, including a 2015 review called by then Health Minister Peter Dutton which recommended establishing national registries to track high risk implanted devices.
It also recommended a move away from industry funding of the TGA to government budget allocations so the regulator can "more effectively fulfil its mandate to act in the public interest".
Both recommendations were rejected by the Turnbull Government in 2016. The Department of Health report in January noted registries were "expensive and take considerable resources to develop and run".
The TGA and ACCC failed consumers by not acting strongly against device companies in a regulatory system that prioritises company education, inspections and warnings over prosecutions, despite the ACCC and Productivity Commission acknowledging the risks of gaps, Mr Vadasz said.
He criticised the TGA's record of four criminal prosecutions against medical device manufacturers in the past decade. The TGA has not pursued criminal or civil proceedings against any pelvic mesh device manufacturers, despite serious questions about the very low level of mesh injury reports to the regulator in a system where manufacturers are the only mandatory reporters.
The ACCC prioritised consumer issues in the health sector in 2015-16 leading to a $1.7 million fine for misleading claims about pain medication Nurofen, and action over claims about e-cigarettes, genetic testing, hearing aids and IVF.
But there was no reported action on implantable devices, and the ACCC ruled out general "regulatory oversight of therapeutic goods and medical services" because it would "not duplicate the role of specialist safety regulators" such as the TGA.
The "new priority area" action in 2015-16 followed allegations of "unconscionable conduct and misleading and deceptive conduct by medical professionals" and aimed to "protect consumers from unlawful behaviours by medical and health providers", the ACCC said.
Mr Vadasz said the manufacturer and doctor-led rise of pelvic mesh devices in Australia from the late 1980s, which has left thousands of women with serious and permanent injuries, illustrates health system and government failures and the "black hole" of device regulation.
It was left to consumers to initiate class actions against companies alleging breaches of Australian consumer law relating to pelvic mesh devices, breast and hip implants, Mr Vadasz said.
"It took a royal commission for banking regulators to man-up and take responsibility for prosecuting banking industry malpractice. Will it take a royal commission to expose TGA and ACCC failures when it comes to medical devices?" he said.
Consumer groups have asked the Productivity Commission to review the regulation of devices and the cost to taxpayers when they fail, after a March, 2017 review of Australia's consumer law and enforcement.
The Productivity Commission did not examine the performance of specialist safety regulators or the adequacy of consumer protection under specialist regulatory regimes, but noted criticism of some regulators. Limited resources and "risk averse regulatory culture" were possible reasons for the lack of prosecutions, the Productivity Commission said.
It noted modern regulatory practice was to use "punitive enforcement... sparingly and strategically", but said there was a "strong case" for increasing maximum penalties because existing penalties are "small relative to the benefits that a business can accrue for breaching Australian consumer law".
A TGA spokesperson said devices needed to comply with six essential principles, including safety and benefits outweighing the risks, before they can be registered in Australia. High risk devices must undergo a TGA audit of evidence provided from a foreign regulator before they can be registered in Australia. Only a small number of pelvic mesh devices were subject to the audit before the TGA made all pelvic mesh devices high risk in response to legal action and publicity.
Federal Health Minister Greg Hunt declined an invitation to speak at the April 5 forum in Melbourne, which will focus on health system failures relating to implanted pelvic and hernia mesh devices. He is unavailable because of Budget meetings, his office said.
The Medical Technology Association of Australia, representing the medical device industry, did not respond to questions.
