DRUGS, POISONS AND CONTROLLED SUBSTANCES AMENDMENT (CLINICAL TRIALS) BILL 2014

Written on the 14 October 2014

Second reading

Debate resumed from 17 September.

Motion of Hon. D. M. DAVIS (Minister for Health).

 

Mr JENNINGS (South Eastern Metropolitan) -- On behalf of the Labor Party, I am very happy to make a contribution to the debate on the Drugs, Poisons and Controlled Substances Amendment (Clinical Trials) Bill 2014, which will provide for simpler, but not necessarily streamlined, approaches to clinical trials for the use of medical cannabis in Victoria.

In my contribution to the debate, and in particular with regard to the questions that I intend to ask the minister during the committee stage of the bill, I want to make sure that people know that I want to discuss these matters with the minister and hear his explanation of how the clinical trial process will work. I ask him to put these arrangements on the record very clearly so that he will not be surprised if and when we move to the committee stage.I will seek to tease out with him the journey by which a medical practitioner in Victoria may make an application to embark upon a clinical trial of medical cannabis, the scope of the clinical trials that may be envisaged by the government now and in the future under this legislation and the means by which the minister can provide assurances to the community that the spirit of the second-reading speech will be complied with -- in that the second-reading speech promises hope to families of children who may be suffering, for instance, from severe forms of epilepsy that a clinical trial may be imminent in the state of Victoria.

I will be seeking some reassurances from the minister that that is indeed his intention. Whilst the second-reading speech implies it and gives that distinct impression, in no other setting has the minister given that degree of assurance. Indeed he has given quite the contrary message in relation to his intentions and the limitations of the clinical trial process.

That is the basket of issues that I will raise with the minister in the committee stage of the bill. I hope he will provide the chamber with some confidence about that, and very importantly that he will provide the community with confidence about these matters.The journey in terms of the public's consideration of the use of medical cannabis has taken a number of twists and turns over the years, but it has also taken a number of twists and turns during the course of this year. In fact earlier this year the minister was clearly on the public record as saying his government had no intention of changing the legislative framework that would enable the use of medical cannabis for medicinal purposes in Victoria. From the beginning of 2014 until somewhere close to the end of August the minister was giving no indication publicly that he or the government of which he is part was sympathetic to increasing the scope and potential for the use of medical cannabis in Victoria.

Indeed in the last week of August the minister had what some people might suggest was a conversion on the road to Damascus in his view of the policy settings and the appropriateness of the use of medical cannabis in Victoria. Certainly a number of people saw his change of heart, his change of intention and ultimately the urgent introduction of this piece of legislation during the last sitting week and noted that the speed and dramatic fashion with which he has moved have been very different from the glacier-like movement of the policy discussions prior to August.

One of the reasons why the Labor Party and a number of people in the community are somewhat sceptical about the minister's change of heart is the community's public perception of Labor's announcement on 24 August that, if elected in the upcoming November state election, as one of its first acts as an incoming government it would provide a reference to the Victorian Law Reform Commission to examine the interlocking legislative frameworks that deal with the therapeutic use of medical cannabis in Victoria. It was an announcement that I was party to along with the Leader of the Opposition, Daniel Andrews, the member for Mulgrave in the Assembly, and the shadow Attorney-General, Martin Pakula, the member for Lyndhurst in the Assembly at which we joined a number of families in our community who have been providing their children with cannabis oil to deal with their children's forms of epilepsy. The children and families are reportedly experiencing some quite remarkable impacts from the use of these oils, which have very low levels of THC (tetrahydrocannabinol).I do not want my contribution to be driven by a large chemical analysis, but THC is the chemical most associated with hallucinatory effects produced by marijuana, and the high content of THC leads to many adverse impacts on the quality of life of heavy recreational users of marijuana.

Labor's position on this issue is not intended to provide comfort to those who use marijuana recreationally. Labor will not indulge in public commentary about the relative merits of the recreational use of marijuana or its impact on the quality of life of Victorians, and Labor does not support any change to the scope of Victorian legislation relating to this issue. It can be argued that in many instances access to marijuana use has led to adverse impacts, medical and otherwise. However, Labor's contribution to this debate is not concerned with that topic.

We are talking about the use for medical purposes of a substance derived from cannabis but with low levels of THC. The chemical construction of these substances may in certain individuals lead to therapeutic benefits -- for instance, in the reduction of seizures that young people may experience. This substance may produce pain relief for sufferers of a number of significant illnesses, some of which are life threatening, including cancer, HIV/AIDS, multiple sclerosis, glaucoma and Parkinson's disease. Clinical trials and other research around the globe has demonstrated the efficacy of using medical cannabis. Pain reduction, an improvement in the quality of life and a reduction of many other adverse impacts has led to a number of jurisdictions across the globe being prepared to countenance legislation that permits the medical use of this substance. These jurisdictions include Canada, Austria, the Netherlands, Israel, Spain, Italy and a number of states in the United States.Victorian Labor believes this international experience justifies that further opportunities in a safe and regulated environment be provided in Victoria for the use of medical cannabis. Labor also wants to explore how clinical trial permits and medical treatment plans relating to the use of this substance in Victoria could be in unison with the commonwealth Therapeutic Goods Act 1989 and consistent with international learnings. The aim should be to ensure that law reform in Victoria harmonises with national frameworks and international best medical practice so that the Victorian community has a high degree of confidence in the medical use of cannabis. Quality assurance issues should be at the forefront, including ensuring the safe handling and use of this substance, because many people in our community may be not only sceptical about the therapeutic use of marijuana but also concerned about the potential for misuse and for adverse medical, psychological and social outcomes.

Labor wanted to make sure that in its framework it addressed all of those concerns simultaneously through a rigorous process of evaluating those interlocking issues and provided to government and therefore to the community legislative, regulatory and clinical advice on the preferred way of dealing with these matters. It was very interesting to note the Minister for Health's response to Labor's announcement of 24 August. The minister had quite a range of responses. He went from being quite sceptical, if not scathing, of Labor's recommendation to remind Victorians of the legal nature of the substance in question to saying that across the Victorian healthcare system relief may not be afforded within medical care settings.

Indeed whilst he did not expressly refer to matters of child protection during the course of these considerations, there had been a number of families in Victoria who had been subject to inquiries, if not interventions, by state child protection agencies due to concerns about the appropriateness of parents administering medical cannabis to their children.

In a formal sense Labor certainly does not dispute these legal concern or the concerns around the safety of Victorian children. While we recognise that in the strict black-letter law interpretation these agencies and the police have obligations to be seen to satisfy the statutory requirements and ensure that the laws of Victoria are complied with, in the past these concerns had been somewhat crudely interpreted and acted upon.

We continue to have concerns about the appropriateness of police and child protection resources being dedicated to these issues, which are very resource intensive, when there are certainly other priorities relating to state intervention and protection of children which seem more warranted in the first instance.

In the longer term if the spirit of the second-reading speech for this bill is to be enacted, indications are that the government seeks to follow the lead of Victorian Labor and other parts of the Victorian community in trying to change clinical practices and pathways and support the acceptance of the use of medical cannabis for these purposes into the future. Certainly in relation to the philosophical and legal aspects Labor seeks to bring to the interlocking legislative and enforcement framework a quality assurance that may put the community more at ease. It will allow parents to be more at ease in enabling their children to receive some relief from dire symptoms that they may be suffering from and enable cancer patients to have greater access to pain relief and so forth. In relation to the other conditions that I listed earlier, while the administration of medical cannabis may not offer an entire remedy it offers relief from pain and suffering for many Victorian patients.

That is the intention of Labor's intervention.

I believe that by the end of the week following 24 August the minister indicated for the first time that he was alive to changing the statute in Victoria to allow for simpler clinical trial approval processes, and that is what this bill purports to do. In some ways it can be argued that the bill clearly does that in that it specifies explicitly that an item that is currently defined as a schedule 9 poison by the Drugs, Poisons and Controlled Substances Act 1981 is available to be accepted by the Secretary to the Department of Health as a substance that could be used for a clinical trial in Victoria. It recognises that that a clinical trial might apply equally to one patient or to a number of patients, so it is not specific about the breadth of persons being covered by that clinical trial. The bill removes sanctions that may be applied to a practitioner or participant in that clinical trial in terms of penalties under the Drugs, Poisons and Controlled Substances Act 1981 for charges associated with the use and possession of those substances.Therefore it provides some relief and sends a message to medical practitioners and the community that, in theory, clinical trials may be developed for medical cannabis.

I turn to what the bill does not do. Interestingly, when I was briefed on the bill I discussed with the briefing officers -- and I thank them for their advice to me, their steerage of this piece of legislation and the advice they obviously provided to the government -- an aspect of Labor's approach that the minister had said he was concerned about: a review of the interlocking nature of approval processes. We intended this to cover not only the dispensing prescription and the regulation of the application of medical cannabis but also quality assurance issues about its manufacture, standards and compliance with the commonwealth Therapeutic Goods Administration Act 1989.

Whilst Labor had indicated that it wanted to cover the whole pathway of the production, distribution and clinical use of this substance, the minister, in a major attack on Labor's framework, accused Labor of being blind to the question of quality assurance in the manufacture of this product in the first instance. Indeed for two or three days I was asked a series of questions by the media based on the minister's criticism of Labor's approach, even though it had, by first principle, tried to address this in the interlocking nature of the reference it wanted to give to the Victorian Law Reform Commission.I draw attention to this issue in this debate, and I drew attention to it in the briefing session, because this bill is in effect silent on this question.

The second-reading speech indicates that a clinical trial would require the importation of medical cannabis that has been produced and regulated to comply with the quality standards of the Drugs, Poisons and Controlled Substances Act 1981 and the Therapeutic Goods Administration Act 1989 on the basis of being an imported product.

Whilst I understand that that is existing practice, in the future, if and when any practitioner in Victoria and indeed Australia seeks to embark upon a clinical trial, they will need to import a product that has been regulated and had its quality assessed in another jurisdiction. That in itself may be one of the biggest hurdles to a clinical trial proceeding -- indeed it may be an insurmountable hurdle.

The minister's criticism of Labor's position did not account for this issue.

The minister arrived in the chamber during the course of this discussion, and I indicate to him that the availability of this product, the certainty that it can be procured into the future and the question whether it can be procured in a way that will facilitate clinical trials are issues on which I will be seeking some responses from him. He may pleasantly surprise me with his determination to ensure that supplies are available for clinical trials, but if he makes that concession today and provides that reassurance, it will be the first time that he has addressed that question and provided some certainty that his legislative framework may be complied with.That concession is a very important thing for both medical practitioners and families in Victoria to hear. Unfortunately, at the moment many people who are administering medical cannabis either to themselves or to their children live in fear that the possession of plants from which to derive cannabis may give rise to charges of possession and use, which could prevent refined medical cannabis from being produced to a standard that would enable it to be used in a clinical trial. They fear that this is an insurmountable hurdle, a litigious conundrum and a condition that cannot be satisfied. That is the current legislative framework in Victoria and Australia, and it is the reason why medical trials have not occurred up to now. Without the spirit, the intent and the goodwill being offered by the government and the health department in terms of issuing permits and sanctioning trials, they may never occur.

These are not only very important legislative issues but also culture-setting issues within the medical world of Victoria and indeed Australia. Of recent times we have seen the minister make monumental shifts in his policy position, and it is interesting to note that the medical profession itself has also done some readjustment.

When Labor made its announcement on 24 August it was welcomed, virtually wholeheartedly, by the president of the Australian Medical Association (AMA) Victoria, Tony Bartone.In the days that followed that somewhat unguarded and open welcome had a series of qualifiers placed upon it. Obviously there is a divergence of views within the AMA about the appropriateness of clinical trials and the appropriate use of medical cannabis. That is understandable; Labor has accepted that professional differences may occur. In fact it underpins the reason clinical trials are useful. It also indicates a bit of a movable feast not only within the government but also within the medical profession and the way the profession deals with this matter.

I think there needs to be some certainty and consistency not only in the nature of the legal framework but also the practice associated with it.

There certainly needs to be some consistency in the way Victoria locks into national frameworks as well as the building of national medical practice in Victoria in accordance with the legislative framework. They are matters that we are very interested in providing for. Labor's preferred pathway is that if this bill passes, then it would provide a foundation and framework -- --

Ms Crozier -- Are you going to pass it?

Mr JENNINGS -- Am I going to pass it?

Ms Crozier -- Are you going to support it?

Mr JENNINGS -- The net effect of what we are going to do is to make a contribution. Acting President, you would appreciate that I have been invited by interjection to comment on the legislative program of the government.

The government has its own problems in relation to its legislative program. If it is in a position to pass any legislation, that would be good for the people of Victoria, but only if any changes are going to make a positive difference. This bill potentially will, but it is not the whole story. It warrants further provision of clarity and consistency of approach under the leadership of the minister and the department in terms of the government meeting its responsibilities and establishing conversations with the medical profession as to how those clinical trials are created and how they should proceed.

The minister and the department need to consider what will happen when those families who have been using medical cannabis for their children go to a Victorian hospital where their long-term paediatric physician, who has supported and been quite comfortable about the use of medical cannabis, is not in residence when the child is admitted. What if the prevailing medical opinion means that medical cannabis is not made available to that child?

These are the practical implications and why we need to take a consistent approach. We cannot jump all over the place in how we deal with the day-to-day realities of the pain and suffering of patients, the reliability and consistency of medical practice and how we bring them into line. They are the aspects of the work to which Labor is committed to putting in place, which is why we are referencing the Victorian Law Reform Commission. We are trying to get all of those things in place and harmonised so that there will be a greater degree of certainty. That continues to be the real challenge even if this piece of legislation is passed. This may be one of the few pieces of legislation passed in the last sitting week of this Parliament. I will be pretty happy if that is the case. However, we are nowhere near the end of its consideration.

I will conclude my contribution to the second-reading debate, but I look forward to teasing out some of these issues with the minister during the committee stage.

I will do so in the spirit of trying to provide greater certainty for practitioners, for the department, for families and for those individuals in our community who could benefit from the safe regulated use of medical cannabis now and into the future. I look forward to the minister providing clarity to the chamber about the way in which he will seek to obtain that certainty and consistency if and when this bill is passed.

 

Ms HARTLAND (Western Metropolitan) -- The Greens have long supported issues around trials for medical marijuana. This is not something we have come to recently; for a very long time we have believed that governments need to move on these issues. In the last few months many of us have heard the stories and been moved by the families struggling with chronically ill children, especially those with severe forms of epilepsy, where it would appear that the use of medical marijuana has a profound effect. I do not believe these families should live under the threat of criminalisation for treating their sick children. Let us be fair to them; they have suffered enough, and they deserve our compassion rather than police officers raiding their homes.

Medical cannabis, also known as medical marijuana, has been shown to be effective in treating pain, nausea, loss of appetite and other symptoms associated with terminal and very serious and debilitating diseases such as cancer, AIDS, HIV, multiple sclerosis, spinal cord injuries and epilepsy. A number of major international reviews have found that medical cannabis is effective and safe and that the side effects are few and acceptable.

In fact 20 countries across the world have already moved to legalise medical cannabis, including Canada, Austria, the Netherlands, Israel, Spain, Italy and more than 20 states in the US. Considering all of that, I would have thought it was time for Australia to move on this.Victoria can decriminalise medical cannabis through its drugs and poisons laws, but it is only the federal government that can legalise it. Legalisation is required to allow for proper prescription and importation. Without legalisation, decriminalisation will boost the underground industry. Lack of prescription could lead to mistreatment by self-medicating patients. Without legalisation, we will not have proper quality control standards and safety guidelines around dosage and side effects, which could put sick people at risk.

It was pleasing to see today a statement from the state government saying that there is general agreement around the country that we need to move to a state and federal agreement on these issues. I add to that by saying that the federal Greens health spokesperson, Senator Richard Di Natale, has been leading a cross-party parliamentary group and will introduce legislation to legalise medical cannabis. This would allow for its prescription by a doctor and proper standards and consumer protection. Today Senator Di Natale issued a press release stating that in the next sitting fortnight he intends to introduce a bill that would establish an independent body to regulate the supply and distribution of medical cannabis. This is the thing we need to be moving on.

While the Greens support this bill, we do not think there is enough here. The government could have moved much quicker on this issue. This is a small change, and we need federal and state legislation to make sure it happens -- and happens quickly.

Governments should stop being so afraid to look at how drugs such as medical cannabis can be used to help families with children with epilepsy and people suffering from a variety of diseases. With those few words, the Greens will support this bill. However, during the committee stage I will listen intently to the questions Mr Jennings asks, because I suspect he will ask a number of questions about issues that I also have concerns about.

 

 

Ms CROZIER (Southern Metropolitan) -- I am pleased to rise and speak on the Drugs, Poisons and Controlled Substances Amendment (Clinical Trials) Bill 2014.

I do so because this is an important bill that amends the Drugs, Poisons and Control Substances Act 1981. I am pleased the Greens are in support of the bill and take note of Ms Hartland's comments, but I am still at a loss in relation to Mr Jennings's support. I think he is going to support the bill. Nevertheless, we will hear what he has to say at the committee stage. I am sure he will be reassured by the minister's answers.

This bill simplifies the clinical trials process by enabling medical practitioners and researchers who are involved in treating patients with a schedule 8 or schedule 9 drug as part of a clinical trial to have a single permit rather than being required to apply for multiple permits -- that is, a permit for each individual participant who might be involved in such a trial. By way of example, cannabis is classified as a schedule 9 drug.

In recent times the use of cannabis and cannabis oil for medical purposes has received quite a lot of media attention.

I am sure all members are aware of the heartbreaking stories of parents using cannabis oil to treat children who suffer from multiple episodic seizures and of others who use cannabis on a regular basis to relieve severe and chronic pain or to treat the severe and debilitating side-effects of nausea and vomiting following chemotherapy.

As someone who has seen the persistent and wretched side-effects of chemo and the distressing ongoing pain experienced by chronic pain sufferers, I am certainly very sympathetic to their desire to explore all options that they feel may prevent some of these devastating symptoms and side-effects of treatments. Cannabis oil, however, is being obtained through various methods and is an unregulated so-called treatment for various complaints, such as seizures in children, spasticity and management of chronic and severe pain.

The government is concerned about instances where parents have been exploited by opportunistic suppliers of cannabis oil to treat their children. I saw a story a few weeks ago on ABC's 7.30 program that clearly demonstrated how unregulated the product is and how people are openly flouting the law. The 7.30 report importantly highlighted the issues and warned of the dangers and medical effects that cannabis can have. According to one interviewee on the program, all you need is a slow cooker, some cooking oil and marijuana. It is all put into the pot, cooked up, strained and then administered, with no idea of the strength of the cannabis that has been put into the pot, no monitoring of the effects of the cooking time on potency and no analysis of the final compound.

According to the transcript, this is what the report highlighted:

    ANDREW KATELARIS: ... The process is very, very simple.

    CONOR DUFFY: Back at home in his kitchen, he mixes a rare strain of cannabis imported from Spain that's rich in the medicinally useful cannabinoid CBD but low in THC, the part of the plant that gets you stoned.

    ANDREW KATELARIS: What we can do: we can make specific oils depending on their intended end use, right? For instance, I might combine this as a predominantly CBD cannabis with more THC cannabis depending on what we're treating ...

    CONOR DUFFY: He follows a special recipe, mixing pot with oil and heating it to about 50 degrees.

    In 12 hours we'll filter it and decant it into a bottle and it will be sealed and labelled and shipped for patient use.

This is the heart of the issue.

It is not an issue that needs to go off to the Victorian Law Reform Commission for further consideration, as the opposition believes it should. It is a medical issue, where properly conducted trials can demonstrate the future potential and efficacy of cannabinoid treatment for a range of conditions. Mr Jennings commented on the clinical trials, and he well knows that the Therapeutic Goods Administration is the appropriate organisation to conduct trials and approve medicines and medical products for use in this country.

The proper process needs to be followed, and it is being followed in the instance of Sativex. Sativex is cannabinoid mouth spray used to treat multiple sclerosis (MS) and alleviate symptoms such as neuropathy and spasticity. It is a mixture of compounds derived from cannabis plants -- procured, importantly, in a properly regulated environment -- and is a pharmaceutical product that is standardised in composition, formulation and dose.That is the difference between a properly regulated product and the brew in the slow cooker at home, which is derived from imported or homegrown products. Goodness knows what final composition of this snake oil is formed from that concoction. Sativex is currently being used in a trial at Royal Melbourne Hospital to treat the symptoms of MS and cancer patients to assess the reduction of pain symptoms.

This bill will enable proper cannabis products from recognised pharmaceutical companies and of known and standardised quality to be considered in trials. It will remove the barriers not only for medical practitioners and researchers to obtain a single permit for use in the trial, as I said, but also to recognise the legality of possession of the product when conducting trials. The government makes no apology for wanting a properly regulated process for the conduct of such trials.

Patients and families can then participate in such trials without having to be put into extremely difficult situations and know that they are undertaking trials in a legal, properly regulated environment. Trials such as these put the health and safety of patients first and hopefully enable them to see immediate benefits. We all know that a product which has undergone this rigorous and carefully considered process may be used in the future to benefit many other patients experiencing similar symptoms.

I congratulate the minister for taking this action. At a recent Council of Australian Governments health council meeting there was support from the Prime Minister, premiers and chief ministers for taking a nationwide approach to medicinal cannabis trials. This is an important step to take. I also note that the minister has foreshadowed the formation of a Victorian expert advisory committee on medicinal cannabis, which is also an important step to take.

I believe getting proper trials in place is the most appropriate way to progress this issue. Putting it to a bunch of lawyers for months and months of discussions will not do so. I commend the bill to the house.Debate adjourned on motion of Mr LEANE (Eastern Metropolitan).

Debate adjourned until later this day.


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