Helen Polley (Tasmania, Australian Labor Party, Shadow Assistant Minister to the Leader (Tasmania)) Share this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018. This bill creates a compulsory reporting scheme for medicine shortages and the discontinuation of medicine supplies. Knowing with as much lead time as possible about medicine shortages is vital for public health authorities, health professionals and patients. Whilst this can't prevent a shortage from occurring, it might, for example, allow for arrangements to be made to source an alternative supply of medicine. The Therapeutic Goods Administration can also work with a sponsor to identify and authorise the supply of a suitable substitute medicine. Public health authorities can also prepare advice on alternatives for patients, and, in extreme circumstances, supplies can be rationed.

If we don't know about a shortage ahead of time, patients will simply turn up to a pharmacy to find out that their medicine is not available. They might then end up travelling from pharmacy to pharmacy in a futile search, only to find later that the shortage is widespread. This might be even worse for a patient with a mental health condition. Anthony Tassone from the Pharmacy Guild of Australia said:

When you have a medication that is used to treat a mental health condition become in short supply, some patients become anxious, which is the last thing they need.

Mr Tassone is absolutely right. The shortages will impact disproportionately on people who have a mental health condition. However, any person who suffers from a serious or life-threatening illness that requires medication is likely to be very concerned when they suddenly and unexpectedly find that they cannot obtain their medicine.

It is not just patients, though, who are left in the dark. Doctors often only find out about shortages through a call from a pharmacy or from their patients. This is clearly not good enough. It occurs despite the creation of the Medicine Shortages Information Initiative, launched in 2014, which aimed to improve the communication and management of medicine shortages. It is unclear if this scheme has resulted in any improvements. It is, however, a voluntary scheme which has been shown to have failed on several occasions where the supplier has not provided notifications in a timely enough manner. The shortage of the adrenaline auto-injector known as the EpiPen is a prime example. The TGA was only officially notified in January, despite there being reports about the issue since November. For people who are at risk of anaphylactic shock due to severe allergies, their adrenaline auto-injector is a life-saving device that many must have access to at all times.

Shortages are unfortunately becoming increasingly common, with 222 current shortages listed on the Medicine Shortages Information Initiative website. Of course, what we don't know is how many other shortages are known but have not been reported due to the voluntary nature of the reporting. In 2017, there was a shortage of the painkiller fentanyl, used during operations, resulting in rationing. There have also been recent shortages of antibiotics, antidepressant medications, oestrogen patches for women with menopausal symptoms, chemotherapy drugs and diabetic medication, to name just a few. Severe, prolonged or unresolved life-saving medicine shortages can put people's lives at risk.

The causes behind medicine shortages are numerous. They include manufacturing and transport issues and delays, closure, merging or relocating manufacturing facilities, changes in demand, shortages in raw materials, decisions to discontinue manufacturing a particular medicine, and natural disasters. In a more globalised world with rationalised supply chains, the increased reliance on overseas manufactured medicines adds to the uncertainty of supply. Medicine shortages have very real and negative impacts. The Australian Commission on Safety and Quality in Health Care had this to say about the impact of medicine shortages:

The association between medicine shortages and harmful medication errors is well documented. A survey undertaken by the Institute for Safe Medication Practices (ISMP) recorded approximately one in three (35%) respondents experienced a near miss during the past year due to a medicine shortage. One in five reported adverse patient outcomes over the year due to medicine shortages.

The commission continued:

A number of issues are associated with medicine shortages which have the potential to impact safe and effective use of medicines. These include:

Using alternative medications (or alternative concentrations, strengths or dosage forms of the same medicine) may introduce errors in prescribing, preparing, administering, and monitoring medicines

Standardising product formularies and concentrations may become difficult or impossible with an unreliable product supply

Clinicians may be more prone to make errors with unfamiliar products, concentrations, or dosage forms

Pressure to conserve medicines in short supply may lead to unsafe practices.

The commission's comments explain exactly why we need to be better prepared to deal with and mitigate the impact of medicine shortages.

The new mandatory reporting scheme will apply to both medicine shortages and decisions to permanently discontinue supply. Whilst the scheme applies predominantly to prescription medicines, the Minister for Health will have the power to include other medicines on the Australian Register of Therapeutic Goods. The sponsor will be required to notify the TGA of a shortage or decision to permanently discontinue supply. Medicines are considered to be in shortage if supplies won't or likely won't meet demand at any time in the next six months. Shortages are considered on a national basis. A disruption that is just limited to specific locations in Australia would not be taken to be a shortage.

The time frame for reporting shortages is to be as soon as possible, but not longer than either two or ten working days, depending on whether the shortage would have a critical impact or not. Shortage reporting time frames apply only after consideration of all relevant information has occurred. For discontinuation, reporting is to be either 12 or six months before the discontinuation will occur, depending on whether that impact is critical or not. These time frames, however, don't constrain a sponsor's decision-making ability, and if they are unable to meet their time frames the reporting must then occur as soon as possible after a decision to discontinue has been made.

My understanding is that criminal penalties were originally being considered; however, under the bill, noncompliance will result in civil penalties only. Whilst it is appreciated that there are a range of views on what the appropriate penalties should be, this scheme is a substantial improvement over a voluntary reporting approach. The effectiveness of the scheme will no doubt be put to the test, given how common medicine shortages have become.

Separate to the creation of the mandatory reporting scheme, the bill makes several minor amendments to the act to reduce inefficiencies in the regulation of therapeutic goods. These changes include allowing legislative instruments to refer to the most up-to-date version of a document rather than a specific version, enabling certain notifications to the TGA to be submitted by a health practitioner on behalf of another practitioner and permitting online submission of certain applications rather than requiring them to be signed. Finally, variations to a medicine's listing on the Australian Register of Therapeutic Goods, in certain circumstances where the changes are very minor, will now be able to be made without triggering the need for a new application for marketing approval.

These changes all appear to be reasonable, common sense improvements to the regulation of therapeutic goods. Mandatory reporting of medicine shortages appears to have widespread support amongst patients, health professionals and the industry. Labor supports the replacement of a voluntary reporting scheme for medicine shortages, which have proven to be insufficient, with a mandatory scheme and will be supporting this bill.