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.