New laws ensuring the continued availability of life-saving medicines for Australian patients who need them have been passed by Parliament.
Minister for Health, Greg Hunt said that under the new law, medicine companies will have to report shortages of important medicines as soon as they occur.
“In addition, if a critical drug is being removed from the market, my Department must be notified by the manufacturer at least 12 months in advance, or as soon as possible,” Mr Hunt said.
He said the new law would protect patients who rely on vital medicines.
“They also give the community, medicine company and patients the opportunity to take action to mitigate against a medicine shortage.”
He said mandatory reporting would apply to all prescription medicines as well as other medicines which were vital for public health, such as EpiPens and inhalers.
“Tough penalties will apply to companies that do not comply with these new laws, including fines of up to $210,000 for each infringement and the possibility of further court action,” Mr Hunt said.
“I make no apologies for taking a hardline approach to ensuring patients aren’t kept in the dark about a potential medicine shortage.”
He said medicine shortages had become an increasing problem in recent years, as medicine companies (manufacturers or importers) failed to comply with the current voluntary reporting scheme.
Earlier this year, Australia was one of several countries hit by a shortage of EpiPens, which provide lifesaving adrenalin for people who have had an acute allergic response.
