Australia Broadcasting Corporation (ABC) | Science Online | Tuesday, 28 November 2006
Free trade deal may fast track nanotech
Australia’s free trade deal with the US may mean nanotherapies may be rushed through tests for safety, efficacy and quality, one critic says. But not everyone agrees
Australia may be forced to rush through inadequately tested and unsafe medical nanotherapies because of its free trade agreement with the US, a health technology regulation expert says.
Dr Thomas Faunce, a senior lecturer at the Australian National University college of law and medical school, says Australia is obliged under the free trade agreement (FTA) to make innovative pharmaceutical products more readily available.
Drugs and medical devices using nanotechnology could fall under this banner, he says.
Faunce, who presented his concerns at the Australian Health and Medical Research Congress in Melbourne today, says as a result of the FTA, the Therapeutic Goods Administration (TGA) may come under pressure to rush trials of new nanotherapies, particulary during preliminary safety, efficacy and quality testing.
"The main concern is that the FTA puts obligations on the TGA to initiate a discussion [with US authorities] about fast tracking innovative medical products," he says.
"It’s not quite sure exactly what that means but the concern is that we’re still in a situation where it hasn’t been definitively established that nanotechnology is safe."
Nanotechnology involves using extremely small particles on the scale of one billionth of a metre.
In medicine, it could be used to create tiny ’machines’ that are introduced into our bodies to deliver medicine, diagnose disease or even fight cancer cell by cell.
But because the technology is so new there are concerns about its safety, Faunce says.
This is because the minute size of the particles means they could evade our normal respiratory and immune defences to enter the lungs or even penetrate our skin.
There are fears that once in our bodies, nanoparticles could enter our circulatory and nervous systems, potentially becoming lodged in organs including the lungs and brain.
"Major concern with this unprecedented research and development is that engineered nanoparticles may present unique health risks when used in medical applications," Faunce says.
"They are highly reactive and mobile within the human body and there are currently no effective methods to monitor exposure risks."
Is this a problem?
Monash University’s Professor Brian Priestly, director of the Australian Centre for Human Health Risk Assessment, says it’s probably true that developments in nanotechnology are happening too fast for the regulators to keep up with them.
"But that’s not to say that it’s being ignored," says Priestly, who has worked with the TGA in the past.
"I know that the TGA looks very carefully at all sorts of innovative technologies so they’ll certainly be looking at any developments in anotechnology."
A TGA spokesperson says rigorous testing is required for all new drug products and nanotherapies are no exception.
"Extensive, non-clinical, toxicological and clinical safety testing is required for all new drug products," the spokesperson says.
"No concessions or reductions in these requirements will apply to nanomaterials in therapeutic products."
The federal government is currently considering the need for a distinct nanotechnology regulatory body and is expected to release a national nanotechnology strategy in coming months.