The latest insights from our Health Law team.
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Medicine companies required to report medicine shortages under new law
Last month, the federal parliament passed the Therapeutic Goods Amendment (2018 Measures No. 1) Act 2018 (Act). The Act will commence on 1 January 2019 and requires medicine companies to report shortages of important medicines as soon as they occur.
Mandatory reporting will apply to all prescription medicines as well as other vital medicines, such as EpiPens and inhalers. Fines of $210,000 may be issued for companies who do not comply with the new laws. It is hoped that the reporting of shortages will allow the supplies to be re-directed to the patients who are most in need and allowing time for other patients to be nominated suitable substitute medicines.
Further, if a critical drug is being removed from the market, manufacturers will need to inform the Department of Health at least 12 months before hand, or as soon as possible, in an attempt to try and mitigate the risks of medicine shortage.
Read the Department’s media release here.
ACCC takes action against hearing aid retailers for misleading statements
Last month, the ACCC commenced action against Oticon Australia Pty Ltd and Sonic Innovations Pty Ltd, both hearing aid retailers, for allegedly making false and misleading representations in advertisements for hearing aids available under the Australian Government Hearing Services Program (Hearing Program). The Hearing Program is available for pensioner concession card holders, veterans and defence force personnel.
The retailers published 85 advertisements which misled customers as to their rights to access hearing aids under the Hearing Program and resulted in a number of older Australians paying extra for additions to their hearing aids.
Both Oticon and Sonic have agreed that they contravened the Australian Consumer Law and have offered to refund customers who purchased additional equipment to use with their hearing aids. Both retailers may also be subject to significant financial penalties imposed by the ACCC.
Read the ACCC’s media release here.
Victoria’s SafeScript system begins roll out in Western Victoria
Victoria’s comprehensive real-time prescription monitoring system, SafeScript, goes online this month. SafeScript commences its roll out in the Western Victoria Primary Health Network catchment in October, before being introduced to the rest of Victoria early next year.
SafeScript has been introduced in an attempt to reduce the number of deaths caused by prescription medicine overdoses by giving medical practitioners and pharmacists up to date information about a patient’s prescription history.
In addition, a new awareness campaign is commencing, targeted at the general public, which highlights the dangers of certain prescription medicines. A new pharmaceuticals hotline is also being set up to provide advice and support for those who are concerned about their prescription medicine use.
Read the Victorian government’s media release here.
Find out more about SafeScript, including accessing public resources, here.