Monday, 10 September 2018
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018; Second Reading
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.
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.
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.