Slade Brockman (WA, Liberal Party) Share this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018, which amends the Therapeutic Goods Act 1989. This bill enables the Therapeutic Goods Administration to implement a mandatory reporting scheme for shortages of medicine in order to better address the public health implications associated with shortages of medicines in Australia. Medicine shortages have become an increasing problem in recent years for a number of reasons, including disruptions to manufacturing processes; unavailability of raw materials; manufacturing difficulties; changes in product formulation or manufacturer; commercial decisions by sponsors; industry consolidation; unexpected increases in demand due to, for example, a disease outbreak or new clinical practices; and the increasingly globalised nature of supply chains for many medicines.

There are currently shortages of 223 medicines in Australia that the TGA is aware of. A range of these medicines are critical for patients, such as EpiPen for anaphylaxis, of which there has been a shortage for much of 2018. Other shortages that currently exist are of medicines for the relief of angina symptoms, for the management of cardiac arrest and for the treatment of opioid overdose, amongst many others. Under the current voluntary scheme, the TGA is only made aware of such shortages if a company chooses to notify the TGA. This may occur in practice; however, this voluntary scheme for the reporting of medicine shortages by medicine sponsors, which has been in place since 2014, has, unfortunately, proven to be ineffective. Under this voluntary scheme, a significant number of medicine shortages of critical patient impact have not been reported to the TGA or have not been not reported in a timely manner. A recent example is EpiPen adrenaline 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.

Often the first indication of a shortage is through correspondence from a member of the public impacted by it, and the situation then has to be confirmed with the sponsor. There have also been delays on some occasions in confirming the details of shortages under the voluntary arrangements. Where such shortages are identified, it is usual practice for the Therapeutic Goods Administration to work with the sponsor and other pharmaceutical suppliers to minimise any disruption to the availability of medicines in Australia and to notify doctors, pharmacists and consumers of alternative options. However, the current voluntary arrangements do not oblige medicine sponsors to report, meaning the TGA is not always able to alert the Australian public of shortages or give them timely advice about steps they may be able to take to alleviate the effects of a shortage, and it is not able to inform health practitioners so that they can work with patients to minimise the impact of a shortage.

What will this bill do in practice? This bill amends the act to introduce a mandatory requirement for sponsors of important medicines to report shortages of their products and any decision to permanently discontinue their products to the TGA. The measures outlined in this bill largely support recommendations made by key stakeholders such as pharmacists, doctors, consumers and the medicines industry. The bill will ensure that the new mandatory reporting scheme is properly targeted to higher-risk medicines by defining reportable medicines as those containing one or more substances mentioned in schedule 4 or schedule 8 to the current Poisons Standard. This principally identifies prescription medicines, but other medicines that are registered in the Australian Register of Therapeutic Goods may come within the scheme if they are specified in a legislative instrument to be made by the minister, where the minister is satisfied that a medicine is critical to the health of Australian patients and that its inclusion in the scheme would be of interest to the public health. Examples of products that may be included in this way are EpiPen autoinjectors, which I've already mentioned, and Ventolin inhalers.

In the instance where a medicine shortage is of critical patient impact, the sponsor of a reportable medicine will be required to notify 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. It is important to note that the requirement to notify the Department of Health would only apply after the sponsor has considered all the information that they need to take into account for the purposes of identifying if there is or will be a shortage of their medicine and have concluded that a shortage applies.

For the first time, the definition of 'shortage' will be made clear. A shortage will exist at a point in time for a reportable medicine if its supply in Australia will not, or will not be likely to, meet the demand for it at any time in the following six months for all the patients in Australia who take it or who may need to take it. As such, this term takes a balanced approach by focusing on the overall situation of a medicine's availability in Australia, meaning that instances of short supply that only occur at particular locations in Australia will not be shortages under the bill, avoiding the over-reporting of events that may turn out not to be widespread shortages.

The bill will also require medicine sponsors to notify any decision to permanently discontinue the supply of a medicine in Australia. For permanent discontinuations of critical impact, the medicine's sponsor will be required to notify the Health 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 requirement will be to notify the secretary at least six months before the proposed discontinuation, or, if this is not possible, as soon as practicable after the decision is made. A shortage or a permanent discontinuation of a medicine will be of critical impact when either the medicine is included in a legislative instrument to be made by the minister, to be known as the medicines watchlist, or if the medicine meets certain other criteria relating to its importance for patients. The medicines watchlist will identify medicines containing a list of known critical ingredients that are vital for public health, assisting sponsors to easily understand their reporting obligations.

A shortage or permanent discontinuation of a medicine that is not on the medicines watchlist may still be of critical patient impact if a shortage or discontinuation could have a life-threatening or serious impact on users' physical or mental health and if there are no registered medicines that could be used as a reasonable substitute for the medicine—or, if there are, if there would likely not be enough of such substitutes to meet the increased demand for them if the medicine in question went into shortage or was permanently discontinued by its sponsor. To ensure the new mandatory scheme is effective, it is accompanied by penalties for nonreporting. The bill introduces civil penalties for sponsors who do not comply with the requirement to notify the secretary of a shortage or a decision to permanently discontinue a reportable medicine within the applicable time frame. The maximum penalties would be 100 penalty units for an individual and 1,000 penalty units for a body corporate. The details of such action and the names of noncompliant sponsors and affected products would 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.

In summary, these reforms are aimed, in particular, at addressing current gaps in how medicine shortages are managed in Australia, including, in particular, by introducing powers for the secretary to allow a more timely and proactive approach in managing and communicating medicine shortages; addressing the public health implications that are associated with medicine shortages in Australia; and improving collaborative efforts and transparency between sponsors, healthcare professionals, the TGA and consumers to ensure that the detrimental effects of medicine shortages are better mitigated and managed. These reforms build on the government's broader commitment to Australian patients and the commitment to medicines accessed through the Pharmaceutical Benefits Scheme.

The Morrison government has a commitment to list all medicines available to patients where recommended by the medical experts. To that end, I was pleased the see the Prime Minister and Minister Hunt announce the listing of a new cystic fibrosis medicine on the PBS last weekend. The listing of Orkambi on the PBS from 1 October will provide access to a medicine that would otherwise cost patients up to $250,000 a year. This is part of the broader commitment from the Morrison government to guarantee the essential services that Australians rely upon.