The supply of critical and life-saving medicines will now be protected with the Federal Parliament passing landmark legislation.
Under the new law, which comes into force on 1 January 2019, 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, the Department of Health must be notified by the manufacturer at least 12 months in advance, or as soon as possible.
Mandatory reporting will apply to all prescription medicines as well as other medicines which are 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.
Federal Health Minister Greg Hunt said that earlier this year, Australia was one of several countries hit by a shortage of EpiPens.
“In this and a number of other cases, the shortages were not reported in advance to the TGA within the Department of Health. As a result, patients and doctors were not alerted in time for them to make alternative arrangements.
“Under the new law, a critical medicine is deemed to be in shortage if there is not enough, or likely will not be enough, for all patients in Australia who take it or may need to take it, at any time in the next six months. If a medicine company decides to discontinue a critical medicine, the Department of Health must be notified at least 12 months in advance, or as soon as possible,” Mr Hunt said.