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Thursday, 28 June 2018
Page: 6739


Mr HUNT (FlindersMinister for Health) (09:52): I move:

That this bill be now read a second time.

I am pleased to introduce the Therapeutic Goods Amendment (2018 Measures No.1) Bill 2018, which amends the Therapeutic Goods Act 1989.

This bill enables the Therapeutic Goods Administration (TGA) to implement a mandatory reporting scheme for medicine shortages in order to better address the public health implications associated with medicine shortages in Australia. There are also a small number of minor, unrelated measures outlined in the bill, some of which support the implementation in 2017 of the government response to the Expert Panel Review of Medicines and Medical Devices Regulation.

Medicine shortages have become an increasing problem in recent years not just in Australia but around the world. A shortage of a critical medicine places patients' lives at risk. This bill responds to concerns raised by patients, their carers and health professionals as well as many representations from members of parliament on behalf of often-distressed patients seeking information about a shortage of a critical medicine. The recent shortage of EpiPen auto-injectors, 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 medicine sponsors, which has been in place since 2014, has, unfortunately, proven to be ineffective. A significant number of medicine shortages of critical patient impact have not been reported to the TGA or not reported in a timely manner.

As these voluntary arrangements do not oblige sponsors to report, the TGA is not always able to alert the Australian public to a shortage, give them timely advice about steps for alleviating its effects or, significantly, inform health practitioners so they can work with patients to minimise a shortage's impact.

In response to these concerns a medicine shortages working group comprised of the Medicines Partnership of Australia, the Australian Medical Association and the Society of Hospital Pharmacists of Australia, chaired by the Department of Health, developed a revised approach to deal with medicine shortages. In particular it will be mandatory for companies to report all shortages to the TGA. The TGA will principally publish information about those shortages that are of particular impact on patients, so that prompt action can be taken to address the needs of affected patients. I would like to thank these groups in particular—Medicines Australia, the wholesalers and the Pharmacy Guild, as well as the AMA and the Society of Hospital Pharmacists—for their input into this new regime and for their support and advocacy for this bill.

The bill would ensure that the new mandatory reporting scheme is properly targeted to higher risk medicines—principally prescription medicines, but other non-prescription medicines that are registered in the Australian Register of Therapeutic Goods may also come within the scheme. Examples of products that may be included in this way may be EpiPens and Ventolin inhalers.

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 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.

Under the bill, a 'shortage' will exist if its supply in Australia will not, or will not likely, meet the demand for it at any time in the next six months, for all the patients in Australia who take it or who may need to take it. This takes a balanced approach by focussing on the overall situation for a medicine's availability in Australia, meaning instances of short supply that only occur at particular locations would not be shortages under the bill—avoiding the over-reporting of events that may turn out not to be widespread shortages.

To allow for forward planning of patient care, the bill will also require sponsors to notify the secretary of a decision to permanently discontinue the supply of a medicine in Australia. For such discontinuations of critical impact the sponsor must notify the secretary at least 12 months before the proposed discontinuation or, if this is not possible, as soon as practicable after the decision is made. For all other discontinuations, the secretary must be told at least six months before the proposed discontinuation or as soon as practicable after the decision.

For the sake of clarity, a Medicines Watch List will be established as a legislative instrument. This list will set out those medicines that, if in shortage, would have a critical impact on patient care. A shortage or permanent discontinuation of a medicine not in the Medicines Watch List may still be of critical patient impact if certain criteria in the bill are met—for example, if the shortage could have a life-threatening or serious impact on affected patients. Meeting these criteria will trigger the mandatory reporting obligations for critical impact shortages or discontinuations.

The bill introduces civil penalties for sponsors who do not comply with the requirements to notify the secretary of a shortage or permanent discontinuation of a reportable medicine within the applicable time frame, with maximum penalties of 100 penalty units for an individual or 1,000 penalty units for a body corporate. The details of such action, and names of non-compliant sponsors and affected products, will also be published on the TGA's website.

It is important to note, however, that the TGA would, in practice, work with sponsors to ensure awareness of the scheme and an understanding of how to comply with it, and take a graduated approach to instances of noncompliance.

The bill also includes a small number of minor measures not connected to medicine shortages, mainly to remove inefficiencies or make minor improvements to the regulation of therapeutic goods under the legislation.

In particular, again, I wish to thank Medicines Australia, the Pharmacy Guild and the wholesalers, the AMA, for their very important work in the preparation of the bill, the Society of Hospital Pharmacists, the department and Mr Sam Develin. We have been very well served and I wish to thank both Sam and Jarryd Williamson for their work in advancing the legislative agenda. I commend the bill to the House.

Debate adjourned.