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Medicine shortages reforms update

Mandatory reporting of shortages from 1 January 2019

25 September 2018

Mandatory reporting of medicines shortages will commence on 1 January 2019 with the recent passage of the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 through both houses of the Australian Parliament.

Mandatory reporting shortages (including those arising from discontinuation of products), will facilitate more proactive, timely and transparent management and communication about medicine shortages for the benefit of Australian consumers and health professionals.

Medicine shortages have become an increasing problem in Australia, as the current voluntary scheme for reporting shortages has proven ineffective. Many shortages of critical patient impact are not currently reported to the Therapeutic Goods Administration (TGA), which means valuable information cannot be shared with consumers and health professionals and causes delays to the effective management of medicine shortages.

From 1 January 2019, sponsors of medicines will be required to report all medicine shortages and the TGA will mandatorily and prominently publish information about all current and anticipated shortages of critical patient impact through its Medicines Shortages Information Initiative web page. Information about current shortages that are assessed as having low or medium patient impact may also be published, where sponsors agree to this.

Shortages of critical medicines will need to be initially reported within two working days, with all relevant related information provided within five working days. All non-critical shortages will need to be reported within 10 working days. The TGA will also have greater powers to penalise sponsors who deliberately fail to comply.

Improved communication will help consumers to be aware of medicine shortages that may affect them sooner, which will enable them to obtain timely advice and support from a health professional. In some situations, their health professional may be able to recommend alternative treatments or arrange supply of an alternative product.

It is important to note that sometimes disruptions to supply of a medicine cannot be avoided. The problem of medicine shortages is not unique to Australia. Mandatory reporting of medicine shortages will not prevent these disruptions, but early identification and notification will benefit consumers and health professionals.

The TGA has worked closely with industry to develop the reforms and will provide easy-to-use guidance and support to help medicine sponsors ensure they are compliant. In the time between now and implementation on 1 January 2019, the TGA will be working on enhancements to the current online reporting system and will engage with key stakeholders as part of that process.

Education and further communication activities will commence from November 2018.