Pharmaceutical companies will be forced to report medication shortages within strict time frames or face financial penalties, under new laws that come into effect in January 2019.
The Therapeutics Goods Amendment Bill was passed in parliament on 10 September in response to concerns raised by medical groups about large numbers of essential medicines going out of stock at short notice and with little information being provided by manufacturers.
The new law gives companies two days to report to the TGA shortages that will have a “severe” impact on patients and 10 days for others. It replaces the current voluntary reporting scheme, which federal health Minister Greg Hunt said many companies had been ignoring.
In the last year Australia has been hit by shortages of products including EpiPens, vaccines for hepatitis and meningococcal disease and diabetes drugs such as metformin.
In a submission to the TGA, the Cancer Council of Australia gave examples of where a shortage of cancer agents could have or did lead to a significant disruption to patient care, including vinblastine, dacarbazine, etoposide phosphate, mitomycin and doxorubicin.
“Implications of shortages often go beyond a simple change in therapy that may be possible in other disciplines and may involve the use of regimes where data is less robust or older, or impact on other services such as radiotherapy, if combined modality treatment is involved,” it said.
While the new mandatory reporting rules won’t necessarily avert shortages, they may allow for arrangements to be made to source an alternative supply, the Senate was told when debating the legislation.