Don't send medicine safety checks offshore, govt urged

12 January, 2015

The proposal by the federal government to rely more heavily on offshore regulators to establish the safety of drugs and medical devices could place patients at serious risk, consumer advocate group Consumers Health Forum has said.

The proposals have been put forward in a recently released discussion paper which is part of the government's review of regulation for medicines and medical devices.

Australia will "seriously erode" the capacity to make its own assessment of new medicines and medical devices if the government follows through on proposals, CHF's Chief Executive Officer, Adam Stankevicius, said.

"The federal government's move … would dumb down Australia's capacity to determine which new drugs should come to this country."

CHF, in its submission to the review of the regulation of medicines and medical devices, said that Australia needed a robust regulator to ensure the supply of safe and effective therapies appropriate to Australian needs.

Consumer safety

"The government, in its review discussion paper, seems 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," Stankevicius said.

"The expert panel (should) ensure consumer safety is given a much higher prominence in its final report and recommendations.

"Consumers can play a central role in alerting doctors and authorities to product issues, yet there is no consumer representative or advisory group working with the review's Expert Panel.

"It is consumers however who bear the consequences of faulty medicines and devices.

"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?

"Making Australia's medical product regulation heavily dependent on overseas decision making also complicates and potentially delays Australia's response to adverse safety findings."

Medical Research Future Fund

Stankevicius said: "The Prime Minister recently said that new medicines should not need to be tested in Australia if they were already approved in similar jurisdictions.

"On such logic why should Australia seek to expand its medical research capacity as sought under the Medical Research Future Fund?

"The skills and capacity required in Australia to test and evaluate new medicines and devices are a vital and necessary part of the medical research future which this government espouses."