Companies and individuals found to have sold or imported dodgy masks could face civil and criminal prosecution under consumer law, customs law and the Therapeutic Goods Act, with penalties ranging from the seizure and forfeiture of goods to heavy fines and imprisonment.
Under the Therapeutic Goods Act, medical devices including face masks used for therapeutic purposes must be listed on the Australian Register of Therapeutic Goods and have conformity assessment certificates to certify they comply with the standards before they can be sold in Australia.
Supplying counterfeit therapeutic goods, including masks, is a serious criminal offence under the Act, punishable by up to 7 years’ imprisonment and fines of up to $420,000 for an individual or $2.1 million for a company.
Civil penalties for supplying counterfeit goods include fines of up to $1.05 million for an individual or $10.5 million for a company.
A person who makes a false or misleading statement in connection with an application for a conformity assessment certificate for a medical device that is likely to result in harm or injury if used can be imprisoned for five years, fined $440,000, or both.
Health experts have told The Age and The Sydney Morning Herald that defective masks were sold in Australia after the TGA dropped regulations that required all masks to be tested before being registered.
Mr Hunt said while his department had issued an exemption to the national standard for masks being acquired by the federal government for the national medical stockpile, for masks being sold to hospitals or consumers “there’s been no change in the standards”.
The exemption was created to speed up approvals so the government could quickly secure masks on the international market when they were in short supply.
Acting health department secretary Caroline Edwards told the Senate inquiry into the government’s COVID-19 response on Tuesday that masks purchased for the stockpile were tested before being distributed to medical professionals, but not all of those bought had yet been tested.
Ms Edwards said masks intended to be used for “a therapeutic purpose … as opposed to if you buy at the chemist to wear for some other reason – around your house and so on”, must comply with the TGA standards.
Dana is health and industrial relations reporter for The Sydney Morning Herald and The Age.