Minister for Health Greg Hunt has introduced Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 into parliament this week.
This bill enables the TGA to implement a mandatory reporting scheme for medicine shortages to better address the public health implications associated with such shortages.
“The current voluntary scheme for reporting medicine shortages by medicine sponsors, which has been in place since 2014, has, unfortunately, proven to be ineffective,” Mr Hunt said. “A significant number of medicine shortages of critical patient impact have not been reported to the TGA, or not reported in a timely manner.”
The bill stipulates time frames by which sponsors must report. For shortages of critical patient impact, a sponsor will be required to report the shortage to the Secretary of the Department of Health as soon as possible but no later than two working days after they first know, or ought to have reasonably known, about the shortage. For shortages that are not of critical impact, sponsors must notify the Secretary no later than 10 working days after knowing of the shortage.
Welcoming the bill’s introduction, Medicines Australia says the legislation will go a long way to ensuring there is timely and relevant information available on the supply of medicines, which will assist patients and their doctors (and other healthcare providers) to manage their treatment plans to receive uninterrupted care.
The organisation adds that Mr Hunt’s approach for sponsors to report information about those shortages of particular impact on patients so that prompt action can be taken to address the needs of affected patients, is sensible and factors in the diverse needs of the supply chain.