The Australian government has amended the country’s drug regulation to require pharmaceutical companies to report any shortages of their products.
The 10 September amendment to the 1989 Therapeutic Products Act introduces mandatory reporting requirements on drugmakers to ensure that the country’s health secretary is aware of any “critical impact” medicine shortages that could result in patient deaths within two working days, or within 10 working days in the event of standard medicine shortages.
Discontinuations of medicines, meanwhile, must be reported six to 12 months in advance, in standard and critical cases respectively.
Australia’s drug regulator the Therapeutic Goods Agency (TGA) set up a Medicine Shortages Information Initiative in 2014 to allow pharma companies to notify the authorities of shortages, but compliance was not compulsory. In support of the reforms, the TGA said the voluntary arrangements “do not provide a sufficient incentive for sponsors to report when their product will be in shortage,” meaning the country lacked a “complete or current source of information about medicine shortages.”
The amendment comes amid a shortfall in the supply of 0.3mg EpiPen adrenaline auto-injectors, used as an emergency treatment for severe allergic reactions, which has also hit supplies around the world.
The TGA announced in April that EpiPen’s local sponsor Mylan Australia has said the shortages were due to “manufacturing delays” and warned that supply would “not return to normal for some months”. The TGA’s latest update, published at the beginning of August, said the shortage “remains current”.
The US Food and Drug Administration extended the expiration dates on Mylan’s EpiPens by four months to mitigate shortages, while Health Canada in July advised patients to use expired EpiPens and “immediately contact 911”.
Greg Williams, partner at Australian law firm Clayton Utz, told PLN that local sponsors now need to be aware of the new obligations introduced by the amendment when discussing supply arrangements with their suppliers, who are often overseas.
“It is possible that their suppliers will provide information about future availability of medicines which triggers a notification obligation with potentially serious consequences if the strict time limits are missed,” he added.
The new Australian regulations are set to come into effect on 1 January 2019 and will impose penalties of up to A$210,000 on non-compliant companies.
“I make no apologies for taking a hard-line approach to ensuring patients aren’t kept in the dark about a potential medicine shortage,” said Australia’s minister for health, Greg Hunt. “Medicine shortages have become an increasing problem in recent years, as medicine companies have failed to comply with the current voluntary reporting scheme.”
“Shortages cannot always be avoided but, when they do occur, this mandatory reporting scheme will help Australian patients and health professionals to be more prepared.”
Australia’s Pharmacy Guild has welcomed the amendment, stating that medicine shortages “have become an increasing problem in recent years not just in Australia but around the world.”
“Too many times in the past, community pharmacists have been affected by shortages with no warning or readily available information,” it continues. “The legislation will significantly reduce the likelihood of sub-standard patient care arising from unforeseen and unnotified medicine shortages.”