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Monday, 20 August 2018
Page: 7701


Mr HUNT (FlindersMinister for Health) (11:48): I'd like to thank all members for their contribution to the debate on the Therapeutic Goods Amendment (2018 Measures No. 1) Bill of 2018. I want to acknowledge the contributions, amongst others, of the opposition in general but particularly the member for Macarthur and the member for Dobell, who bring considerable personal experience and expertise in this space. I remain—and I would say this in the most constructive spirit to the member for Dobell—open to any meetings, discussions or suggestions she may have at a further time on further measures. I think as a former hospital pharmacist hers is unique knowledge in this building. She's probably still registered, I assume.

This bill will support Australian patients by introducing a scheme for the mandatory reporting of medicine shortages and decisions to permanently discontinue the supply of medicines in Australia for higher risk, mostly prescription medicines. Medicine shortages have become an increasing problem in recent years, and a shortage of critical medicines places patient safety at risk. The recent shortage of EpiPen autoinjectors, which are critical in the response to severe allergic reactions in many people, including children, whose lives can depend on having rapid access to this life-saving medicine is a case in point. The current voluntary scheme for reporting medicine shortages by sponsors has, unfortunately, proven to be ineffective and a significant number of shortages of critical patient impact not been reported to the TGA. This means the TGA is not always able to alert the Australian public or their health practitioners to such shortages or for steps to be taken to alleviate the effects of a shortage for patients.

The purpose of this bill is, therefore, to amend the act to require the reporting of all medicine shortages and decisions to permanently discontinue reportable medicines within specified time frames supported by appropriate civil penalties for noncompliance. In particular, a shortage that is of critical impact for patients must be notified to the Secretary of the Department of Health as soon as possible but no later than two working days after the sponsor knew, or ought reasonably to have known, of the shortage. This will enable complete and current information to be available to patients, healthcare professionals and those involved in stock management in healthcare facilities. Shortages cannot always be avoided. But, when they do occur, this mandatory reporting scheme will help Australian consumers to be more aware in advance and better enable measures to be put in place to minimise the risk to patients such as redirecting of supply to where it is most needed or considering alternative treatments for patients while the medicine is an shortage.

I would like to acknowledge in particular Professor John Skerritt, the head of the TGA, and other officials of the TGA for their work in developing this important new scheme. I also want to acknowledge both Alex Best and Sam Develin, my previous and current medicines and pharmaceuticals advisers, for their work and their contribution. This work, and this bill, adds to the broader improvements to medicines regulation resulting from the expert review of medicines and medical devices regulation which are being implemented by the government.

I would also like to recognise and thank state and territory health departments and the key industry and clinical representative groups for their support in developing this important scheme. In particular, the AMA has been extraordinarily constructive as have the Society of Hospital Pharmacists of Australia and members of the Medicines Partnership of Australia, including the Pharmacy Guild of Australia, Medicines Australia, the Australian Self Medication Industry, the National Pharmaceutical Services Association, the Pharmaceutical Society of Australia and the Generic and Biosimilar Medicines Association.

This has been an example of all sides of parliament, Commonwealth and state governments, the experts in the sector and community representatives working to achieve an outcome that will improve access to medicines with certainty and predictability and, therefore, improve patient outcomes. I thank all of those involved and commend the bill to the House.

Question agreed to.

Bill read a second time.