Making Medicinal Cannabis A Reality

I am pleased to be speaking to the Narcotic Drugs Amendment Bill 2016, which will make a medicinal cannabis licensing scheme legal in Australia.

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The Labor opposition will be supporting the bill. We will asking that it be referred to a very short inquiry in the other place to ensure that the policy intent of the government and the Labor opposition has found its way into the bill and that there are no unintended consequences.

This bill is in line with Labor Party policy, which is to work with state and territory governments to ensure that there is a nationally consistent law which allows lawful access to medicinal cannabis for people who are needing it in this country; to ensure that the Commonwealth regulates the medicinal cannabis which is supplied to eligible patients and for scientific research purposes; and, finally, to ensure that we can work with state and federal regulators to improve controlled access to medicinal grade cannabis for legitimate scientific and medical research.

We have been pushing for changes to this law for quite some time. Over the last 12 months we have been consulting widely among stakeholders and ensuring that our policy settings are consistent with the direction that we want to go in. In our national conference last year I moved an amendment to our platform which would make it clear that, in government, Labor would introduce a scheme which would make available cannabis for medicinal purposes for patients who need it. Indeed, towards the end of last year, I announced that, if elected, a Shorten Labor government would make medicinal cannabis legally available. Over the course of this year, the government and I have been working with all parties, particularly my Labor colleagues from states and territories around the country, to ensure that the bill the government presented two weeks ago meets the objectives.

There has been a lot of discussion in state parliaments and territory parliaments for over 2½ years now on the issue of medicinal cannabis. Being a member from New South Wales, I am mindful of the parliamentary inquiry that was conducted by the New South Wales parliament, initiated in 2012 and conducted in 2013, which recommended the introduction of a uniform national scheme and also said that there would be mechanisms for a state to introduce such a scheme if there was not sufficient political will at the national level to do so. Of course, we are also aware—and you would be aware, Mr Deputy Speaker Broadbent, being a member from Victoria—that the recently elected Andrews Labor government went to the last election with a firm commitment to introduce laws which would make available medicinal cannabis by 2017 and, in particular, make available medicinal cannabis for children with severe epilepsy. It was also elected on a platform to introduce and to invigorate the process of medical and scientific trials into other indications.

Around the country, we also saw the Labor Premier of Queensland announce last year that she was keen to ensure that trials and law reform through a national or state based scheme was introduced together with Labor oppositions in Victoria, Tasmania and other states, and here in the Australian Capital Territory. I believe that that has occurred because of the vigorous campaigning of community advocates. Who could not have been moved by the passionate pleas of Lucy Haslam? Dealing with the grief of the loss of her son Dan, she has been walking the halls of this place lobbying all sides of parliament to ensure that we could reform our laws to ensure that families in the situation that she was in with her son Dan would not face the same hardship. I am pleased to see that, as a result of strong community advocacy, pressure from the states and pressure from the Labor opposition, we have a bill before the House in this session.

I have spoken about the push from state governments. We were faced at the beginning of this parliamentary year with a situation where we could have a patchwork of state and territory laws in relation to this issue. There is a significant problem with that approach. I believe the government had its head in a bucket of sand for too long over this issue and was leaving it to the states to take the lead. I always argued that there was a problem with that approach because we have a complex series of state, territory and Commonwealth laws that touch upon this issue. In addition to that, we are party to international treaties, which place obligations on the Commonwealth government, in relation to cannabis and other prohibited substances.

Making medicinal cannabis legal is a lot more difficult than changing one particular law in one jurisdiction. The Commonwealth currently has laws to regulate the import, export and manufacture of cannabinoids and cannabis raw materials used to make medicinal cannabis products. Cannabis is subject to the international treaty obligations of the Single Convention on Narcotic Drugs, 1961, which binds member parties so that the illicit use of narcotic drugs can be tightly regulated. The Poisons Act at state and federal levels also classifies or schedules drugs, providing different levels of access to the medicine and the poison. Rescheduling cannabis is another critical step in making medicinal cannabis available. Rescheduling this medicine is not dealt with in this bill but the Therapeutic Goods Administration is already considering the proposal.

It is clear that there needs to be a greater level of national leadership when it comes to medicinal cannabis. The patchwork of access arrangements cannot emerge across different states and territories. It would be intolerable if we had a situation where people could lawfully access and possess and use medicinal cannabis products whilst in Albury, but when they cross the border to Wodonga they could be finding themselves in breach of the law or vice versa. Pick any of the other border towns around a nation and you can come up with similar examples. We need a uniform system of laws, both medical as well as criminal, in relation to the access of this drug. We also need uniform clinical guidelines to be developed, guidance on what products are produced and national leadership to deal with problems as they arise.

Labor gives this commitment today. We will work with the government and all interested parties to ensure that the Commonwealth government can provide national leadership to get the job done and ensure that we can—as we aspire to do—make these products available in a safe and legal way. Labor's approach is driven by the science but it is also moved by compassion and I will have something to say about that in a moment. Australian Labor is committed to the approvals of the Therapeutic Goods Administration, which are based on the best available scientific evidence.

We also recognise the very human need of thousands of Australians for medicine. Right now, there are families accessing medicinal cannabis products on the black market—that is, illegally. They do this at the risk of being arrested or convicted as they are unable to determine the exact ingredients of the products they are purchasing or the quality of the medicines they are taking. There is no independent authority that has assessed or verified the claims made by the cultivators and the manufacturers of these products. Families find themselves caught between the risk of criminal action, on the one hand, and using an unreliable supply, on the other hand, and knowing that their loved ones will suffer if something does not change.

Good policy advances on the basis of sound evidence and reason, but it cannot divorce itself from emotion and compassion, and there is plenty of emotion and plenty of compassion on display on the subject of medicinal cannabis. Two weeks ago I had the pleasure of hosting, with my parliamentary colleague the member for Cunningham, an extraordinary young man from the Illawarra, Ben Oakley. He came to parliament with his mother, Caroline, and his father, Michael, to tell their story and to advocate for change. He is from the city of Wollongong. He is 20 years old. He suffers from a very rare disease known as stiff person's syndrome.

Three years ago he was competing in triathlons. Today he would find it very difficult to walk the distance from this chamber to the cafe across the hallway. He is struggling with this condition but shows enormous bravery. Just to give you an example of the condition and symptoms he suffers with, he has in excess of 90 or 100 spasms a day. Any one of these spasms could trigger a series of events that would bring his young life to an end. He has tried the whole range of available drugs recommended by medical practitioners. None of them bring the relief he needs to give him some semblance of living a normal life.

In an act of desperation his father, Michael, accessed medicinal cannabis resin, in the form of capsules, when everything else had failed. Ben describes the results of taking this as absolutely miraculous. He is able to complete his schooling. He is able to contemplate going to university and fulfilling his passion of getting a degree and having a career—something he thought would never be available to him because, quite realistically, he thought he might not live to see his 21st birthday. The medicinal cannabis has helped him get control of his spasms and has helped him get a handle on his life. But his father and mother are having to access an illegal supply chain to get their hands on the medicines that are making this lifesaving change on this young man's life. That is why this legislation is so important.

I would be surprised if there were not dozens of stories that had been brought to any of the 150 members so lucky to have a seat in this House by constituents in the same situation as young Ben Oakley

So while I say good policy advances on the basis of the best evidence and clear reason, we cannot avoid being moved by the examples of young Ben Oakley and literally thousands of other people in similar situations—people who are suffering from nausea as a result of undergoing courses of chemotherapy and other cancer treatments, and people who are seeking relief from pain because of some trauma or accident they have suffered, who have tried all of the opiate-based therapies and for one reason or another find that medicinal cannabis provides not only a better quality of relief but a better quality of life. It is for these people that we are moving these changes in the House today.

This bill is a first critical step that will enable medicinal cannabis to be produced in this country. Primarily it amends the Narcotic Drugs Act to permit the licensing of growers of medicinal cannabis in Australia. It also provides a fit and proper person test to be applied to licensees by the Department of Health. If adopted, the bill will ensure that Australia remains compliant with its obligations under the single convention. We know that there is broad public support for making cannabis products available for medicinal purposes. Survey after survey, poll after poll has proved this point. But there is also broad public support for having a regulatory system which ensures that Australian medicines are safe. In ensuring that we alter our laws to make medicinal cannabis available, we do not want to be throwing the regulatory baby out with the reformist bathwater. The AMA have previously called for a coordinated approach to medicinal cannabis and raised concerns about previous bills that have been brought before the parliament. The AMA said:

The AMA believes the current system adequately provides for the regulation of therapeutic narcotics. Medicinal cannabis should be held to the same standards of evidence, safety, quality, and efficacy as other therapeutic narcotic products. This will ensure that medicinal cannabis can be standardised and regulated in its pharmaceutical preparations and administration, thereby reducing the harm to potential users.

There is much force in this argument. If you are a parent who has a child with drug-resistant epilepsy and you want to ensure that they are receiving the medicine that is going to provide them with relief, you want to ensure that the medicine that you are providing your child is manufactured in accordance with the best manufacturing processes. You want to ensure that it does what it says it can do on the label. You want to ensure that there is a consistency of quality and quantity in the dosages that are provided to your child. Whether we are talking about a child with drug-resistant epilepsy, somebody who is suffering the ravages of pain undergoing a course of chemotherapy or somebody who is seeking to alleviate the pain that they are suffering in the final stages of their life, all of them deserve to have access to a product which is safe, reliable and affordable, and to be able to access that product without having to put themselves at risk through accessing it through the black market.

Currently all therapeutic goods such as medicines and devices must be approved by the Therapeutic Goods Administration—the TGA—and be listed on the Australian Register of Therapeutic Goods—the ARTG. Once listed on the ARTG, a product may then be considered for listing on the Pharmaceutical Benefits Scheme—the PBS. Once listed on the PBS it attracts, according to the conditions of its listing, a government-funded subsidy. In providing a licensing arrangement for medicinal cannabis products, the TGA regulatory system is left in place. Unlike the cross-party bill that was moved in the other place, this bill does not provide for a new regulator of medicinal cannabis products. Instead, the three existing pathways are utilised to get medicinal cannabis to patients who need it: firstly, through the authorised prescribers scheme; secondly, through the special access scheme; and, thirdly, through clinical trials.

An authorised prescriber can prescribe to their patients an otherwise unapproved medical product for a specific medical indication. The authorised prescriber must have special training and they must monitor the outcome of the therapy. They must also report back to the TGA about their prescriptions of the product twice annually. This is one of the schemes that will continue to be available.

The special access scheme is the other key way in which people will be able to access this treatment. The SAS enables patients to get access to a medical treatment not otherwise approved for use in Australia. Again, the patient's doctor needs to apply to the TGA. This is done on a case-by-case basis, so if a patient suffers from a condition that may well be treatable by medicinal cannabis products and they perhaps live in a remote community not close to an authorised prescriber, their GP may apply to provide the product to their patient through the SAS scheme.

The third mechanism by which a person may gain access to medicinal cannabis products for clinical purposes is through clinical trials. These are also regulated, apart from through the ethics committees of hospitals and universities, through the Therapeutic Goods Administration. Clinical trials can also provide access to as yet unapproved medicines. Of course, there is a risk with this. The persons engaging in those clinical trials do so in full knowledge of the associated risks. Of course the benefit of clinical trials is that the data gathered in clinical trials provides part of the dossier that is then used to assess whether a therapeutic product is safe and effective for use. These kinds of trials are an important step in the process of having a medicine listed or approved for use in Australia.

These are the three bases which will continue to be available as a result of this bill. So the bill does not disrupt or dislodge these mechanisms, but it does deal with an issue that many of the stakeholders who I have consulted with have said needs to be addressed if we are to make this product available more freely and more affordably in Australia, and that is the issue of having an affordable means of supply. The bill provides for licensing of growers and manufacturers. There will be two types of licences created by this bill: an authorisation to cultivate medicinal cannabis for manufacture into a medicinal cannabis product and an authorisation to cultivate medicinal cannabis for scientific research purposes.

To gain a licence, you must meet the strict conditions that are set down in the bill. It is proposed within the legislation that it is proper that anyone given a licence to produce medicinal cannabis fits a strict 'fit and proper person' test. The bill provides for the test to include tests in accordance with the regulations, looking at things such as criminal history; previous civil penalties; a revocation of any previous licences; connections, including business associates and family; a requirement that the person be of good repute in character, honesty, professional and personal integrity; and a capacity to comply with licensing arrangements. Other relevant considerations will be a person's previous business experience, their financial status and previous record of compliance with requirements of the Narcotic Drugs Act.

There are important security provisions within the bill as well. Australia has vast experience in managing controlled substances, such as the growing of poppies for the purpose of producing opiate based medicines. We also have the benefit and example of experience from our overseas partners. Growers licenses must be connected to the supply chain, meaning a grower will need to have an arrangement in place with a manufacturer in order to get a licence. Permits will be issued to control the amount of cannabis that is produced. This system will ensure that an oversupply of cannabis does not occur. The objective of this—or the malady this drives at—is to ensure that we do not have stockpiles of excess cannabis products being produced, thereby enhancing the risk of diversion for unlawful purposes. Similarly, a manufacturer must be able to demonstrate their connection to the supply chain and that, in turn, dispensing to the patient is consistent with the Therapeutic Goods Act. This will have the effect of restricting the number of licenses.

I understand that there will be many advocates within the community who will be disappointed by some of these provisions, and I ask them to consider the fact that we should not make the perfect the enemy of the good. We are, undoubtedly, advancing the cause of those who are advocating for change through the legislation which is before the House today. There are some mechanisms that a Labor government would do differently, but the measures within the bill, while not meeting all the needs of the advocates within the community, will definitely advance the cause.

The bill has strict security provisions which will apply to licensees, ensuring the product is not diverted into illicit uses. There will be substantial penalties for breaching the licence conditions and for unauthorised activities. It is also worth noting that the existing Criminal Code already captures offences such as the cultivating of cannabis without a license. These will continue to apply. The Secretary of the Department of Health will maintain the power to order the destruction of cannabis or cannabis products to prevent or rectify an accumulation of the product.

These are the main features of the bill. As I have said, they will enjoy the support of Labor members of this House. We will ask for a brief but focused Senate inquiry, to ensure that there are no unintended consequences of the legislation. But we should focus on what the objective is. The key point is this: no family—no family—should have to choose between getting their loved ones the medicine that they need and breaking the law. No parent should have to make this choice; a choice between seeing their son or daughter, their husband or wife, suffering uncontrollable pain or dealing with the dangerous side effects of a medical condition—having to witness that—or providing them with the medicine that they know is effective but which, on the other hand, is breaking the law. This is an intolerable choice.

This bill, and the processes that follow, will ensure that eventually Australian families will not have to make that choice. We know that there are thousands of Australians who are suffering from unbearable pain—muscle spasticity from conditions like multiple sclerosis or nausea resulting from chemotherapy—who will benefit from medicinal cannabis products. No-one can imagine how horrific it must feel for someone to see their child, their partner or their parent in immense pain, knowing that relief is available but that it is illegal to use. We must change this.

It behoves all members in this place to support this legislation and to monitor it closely to ensure that we have the right regime in place—one that drags our nation into the 21st century and deals with the needs of constituents like mine, in the case of Ben Oakley and in circumstances that have been advocated so powerfully by Lucy Haslam in memory of her son, Dan. It behoves all members of this place to ensure that we do what we are elected to do: to change the law in a considered, responsible way to ensure that we provide a better way for families such as these.

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