Zed Seselja (ACT, Liberal Party, Assistant Minister for Treasury and Finance) Share this | Hansard source

I want to thank all senators for their contribution to the debate on the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018. 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. I want to acknowledge the bipartisan support for this bill and thank all sides for recognising that the new regime to be enacted by this bill will benefit Australian patients and address recent community concern regarding the impact of medicine shortages.

Medicine shortages have become an increasing problem in recent years, and the shortage of a critical medicine 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 have not been reported to the Therapeutic Goods Administration. 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.

This bill will 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 a medicine is in shortage.

I want to acknowledge the health minister, Greg Hunt, for his focus in improving the process for reporting medicine shortages and his willingness to improve the system through legislative change. I would also like to acknowledge Professor John Skerritt and officials at the TGA for their work in developing the specifics of this new scheme in collaboration with key stakeholders. To that end, I acknowledge state and territory health departments, and the key industry and clinical representative groups, for their support in developing this important scheme—in particular, the Australian Medical Association, the Society of Hospital Pharmacists of Australia and members of the Medicines Partnership of Australia, which includes the Pharmacy Guild of Australia, Medicines Australia, Australian Self Medication Industry, the National Pharmaceutical Services Association, the Pharmaceutical Society of Australia and the Generic and Biosimilar Medicines Association. I commend the bill to the Senate.