Federal law designed to protect against medicine shortages

Paul Hayes

11/09/2018 11:39:40 AM

Medicine companies will have to report shortages of important medicines as soon as they occur under new legislation passed by the Federal Government.

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‘I make no apologies for taking a hard-line approach to ensuring patients aren’t kept in the dark about a potential medicine shortage,’ Greg Hunt said of the new law’s financial penalties. Image: AAP

The Federal Government last night passed what it has described as ‘landmark’ legislation designed to protect patients against medicine shortages.
‘Under the new law, medicine companies will now have to report shortages of important medicines as soon as they occur,’ Federal Health Minister Greg Hunt said. ‘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.’
The new law, which will come into effect on 1 January 2019, comes on the heels of a number of medicine shortages in Australia, including EpiPens and various inhalers.
In the case of the nationwide EpiPen shortage that occurred earlier this year, Australia’s only EpiPen supplier did not inform the Therapeutic Goods Administration (TGA) until January, despite having known of the issue since November 2017.
Medicine companies will face significant penalties for failure to comply, including fines of up to $210,000 for each infringement and the possibility of further court action.
‘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,’ Minister Hunt said.
‘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.
‘Responses to a shortage could include re-directing the available supplies to patients who need them most, nominating alternative treatments and providing Pharmaceutical Benefits Scheme coverage for the alternatives.’

EpiPen shortage EpiPens medicine shortages


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