Kevin Hogan (Page, National Party) Share this | Hansard source

I rise to talk for the Narcotic Drugs Amendment Bill 2016. I understand that some in our community may find this bill controversial, but this bill is about one thing. It is about giving our doctors and our medical professionals a range of options when prescribing pain relief for their patients who for various reasons cannot take pharmaceutical drugs. It should not matter that cannabis is naturally grown and is not made in a laboratory. This bill is not about legalising recreational drugs, nor is it the thin edge of the wedge on that issue.

Patients can currently access cannabis for medicinal purposes under the supervision of their doctor. However, it is difficult to find suitable products. I have two friends that I personally know have for palliative care reasons tried a number of pain relief methods. Both of them use an oil that they put on their necks. The medicinal cannabis has worked for them like that and has proven to be very valuable for their pain relief. There is growing community expectation that some patients such as those with MS or terminal cancer or children with forms of epilepsy have a ready source of medicinal cannabis products that their doctor can prescribe.

One of these friends has told me that they actually do access this illegally. It is recognised that in certain circumstances access to approved treatments may provide some benefits: pain relief, nausea control and increased appetite. There are many reports that patients and carers of patients are breaking the law by obtaining these products from illegal markets. They are not regulated; therefore, there can be no guarantees for their safety and their quality. When you are growing it or buying it from a source that is not regulated, obviously there can be great variance in the product. This obviously exposes patients, who are challenged with their health and doing this for palliative care, to health risks and, in many cases, their carers or themselves to criminal prosecution.

Because of the criminality associated with this, decisions to use medicinal cannabis are often made without the appropriate medical advice or a suitable medical practitioner. This particular friend of mine was not prescribed this or recommended this by a doctor; it was hearsay and word-of-mouth from someone else who was using it in a palliative care sense. If there is regulation as we are doing, it would always be by a doctor, it will be supervised as such and the product will be regulated.

There is significant support for this in the committee. In a 2013 survey 75 per cent of people supported a clinical trial of cannabis to treat medical conditions and 69 per cent would support a change to the legislation to permit the use of it. The different states and territories are also making different inroads to this. The New South Wales government is investing in clinical trials that will explore this as well. The Victorian government is doing similarly.

Currently in Australia, there are systems in place to license the manufacture and supply of cannabis based products in Australia; however, there is no mechanism to allow the cultivation of a safe, legal and sustainable local supply of the raw material. This has meant that Australian patients, researchers and manufacturers have had to access international suppliers of legal medicinal cannabis crops. Limited supplies and export barriers have also made this expensive and difficult. Permitting this for medicinal purposes will address the sourcing problem where supply has been provided for under the Therapeutic Goods Act.

Australia also has international obligations to carefully control, supervise and report on the various stages of narcotic drug cultivation, production and manufacture under the 1961 single convention. This enabling legislation for these obligations is in the Narcotic Drugs Act 1967, which is currently administered by the Minister for Health and the Attorney-General.

With regard to cannabis, the primary obligation is to prevent cannabis cultivated for medicinal purposes being diverted to illicit users. So this will be tightly administered, because obviously we do not want this product to start to be cultivated and produced in this country legally then diverted to illicit users.

Further, the Commonwealth is obligated under the single convention to take the sole legislative responsibility for licensing and determining where cultivation can take place. The Commonwealth cannot rely on state and territory legislation to fulfil its obligations. Australia is also expected to tightly control the amount produced so it only meets the demand for medicinal purposes. The Department of Health will be required to report regularly to the International Narcotic Control Board at the United Nations.

The circumstances under which medicines and chemicals are accessible to consumers in Australia are determined through a classification process known as scheduling. Scheduling decisions made under the Therapeutic Goods Act are independent of ministerial involvement. By this process, cannabis is included as a prohibited substance under schedule 9. This scheduling means the manufacture, possession sale or use of cannabis is prohibited unless approved by relevant authorities for medical or scientific research. On 21 January 2016 a proposal to reschedule specific forms of cannabis for specific uses was posted for public comment. The proposal will be considered by the advisory committee on medicines scheduling on 16 March following public comment.

A change to the schedule will still require prescribing to have very careful oversight, including by state and territory authorities, but would enable prescribing in many cases. At present, no form of cannabis can be registered for therapeutic use in Australia unless an application is made to the TGA with supporting data to assess its quality, safety and efficacy. Until a sponsor makes an application for registration of medicinal cannabis product, the TGA cannot register the product; however, the legislation recognises that there are some clinical situations where unregistered products should be prescribed after appropriate consideration by a medical practitioner in consultation with the patient.

Although the Commonwealth currently has laws to regulate the import, export and manufacture of some cannabis, existing legislation does not permit the cultivation of cannabis plants other than for industrial or horticultural purposes. In addition, existing manufacturing provisions are inadequate to appropriately manage the risks associated with the potential for diversion of medicinal cannabis products and other narcotic drugs.

This bill will provide a legislative framework that will enable cannabis cultivation in Australia for medicinal and research purposes. These amendments also ensure that, when cultivation, production and manufacture of cannabis for medicinal purpose begin, Australia will remain compliant with its international treaty obligations as defined in the single convention.

The Commonwealth will control all regulatory aspects of the cultivation for medicinal purposes through one national scheme, which is why it needs to be done at the Commonwealth level and not state. Manufacture will be a joint responsibility between the Commonwealth and the states and territories, which is consistent with the single convention obligations. Access to any cannabis products manufactured under the scheme is also a joint responsibility, with supply being controlled by provisions under the Therapeutic Goods Act working in tandem with state and territory drugs and poisons legislation.

The bill, importantly, does not override any state or territory legislation dealing with criminal activities associated with the cultivation and trafficking of cannabis that occurs outside the regulatory scheme it establishes.

The bill provides two types of cultivation licences: one that allows for the cultivation of cannabis plants for the production of cannabis for medicinal purposes; the other to authorise cultivation for research purposes related to medicinal cannabis. For both forms of cultivation, an applicant for a licence to cultivate must be a 'fit and proper person' according to the criteria set out in the bill and must demonstrate that they can adequately manage the physical security of the crop.

Cultivation of cannabis carries a particularly high risk of diversion because the product can be readily used in its raw state and is likely to be attractive to organised crime seeking to hide illegal activities under cover of a Commonwealth licence. The provisions in the bill are designed to manage these risks. They do this by ensuring that the applicant or licence holder does not have ties to criminal activity, has the financial resources to participate in the industry, and can satisfy security and other requirements of the conditions of the licence. The combination of a licence and permit system will control the quantities and strains of cannabis that can be cultivated. Where the cultivation is for production into medicinal cannabis products for supply to patients, these permits will be managed to ensure that the amounts of product manufactured are planned in advance, relative to proposed usage, and do not exceed permitted manufacturing limits. The permit system will also allow the Commonwealth to discharge its estimate and reporting obligations to the International Narcotics Control Board.

Additional amendments are proposed to the existing manufacturing provisions, which have not been substantively updated since they were introduced in 1967. This will deliver consistency in the requirements for a licence for manufacturing for all narcotic drugs, along with ensuring regulatory best practice. In particular, these changes introduce the same requirement for a cultivation licence of an applicant or licence holder and any relevant business associates; they must be 'fit and proper'.

The same high standard must be applied to all parts of the cultivation and production process. To only apply a higher standard to cultivation could focus criminal activity on the other part of the production chain, the manufacture, where entry is legally easier. This would seriously compromise Australia's ability to meet its public health and international obligations. Similarly, it would be inappropriate to limit the fit and proper person test to just the manufacturer of cannabis products. Other narcotic drugs represent significant public health risks, so a similar level of control for all narcotic drugs is necessary to protect public health.

Amendments to penalty units will ensure that the new legislation is consistent with other Commonwealth legislation. As the Narcotics Drugs Act has not been relevantly updated since 1967, this revised approach to penalties will also ensure that the penalties are a sufficient deterrent. The introduction of civil penalties and their enforcement ensures a consistent operation of the scheme.

The decision-making power to grant licences will no longer reside with the Minister for Health but with the secretary of the Department of Health. This will allow an internal review of decisions to be undertaken by the Minister for Health rather than through direct appeal to the Administrative Appeals Tribunal. This approach ensures that applicants and licence holders will have more timely recourse in case of a dispute over decisions made by the department. This also ensures that the process is consistent with the new licensing provisions for cultivation inserted into the act.

The bill provides for a secure supply chain, from cultivation to manufacture to product and then to patient, with a medical prescriber involved as appropriate. Product identification will occur in two ways. A product is defined for use in a clinical trial related to a particular condition and supplied to patients who qualify for inclusion in the trial. This product might subsequently be supplied to patients not fitting the clinical trial protocol through a pathway such as the Authorised Prescriber Scheme. A state or territory based access scheme identifies what product or products are to be supplied to a defined patient group. For example, the Victorian government has proposed a medical expert committee to help identify appropriate products.

Manufacturing can begin once a medicinal formulation of cannabis is identified. There are already provisions in the act through which manufacturing of a narcotic drug can be licensed. The bill updates and strengthens these provisions and introduces specific requirements for the supply of manufactured cannabis products for medicinal use in accordance with the act.

States and territories will continue to have a central role in enabling access to the products, particularly with regard to scheduling. Each jurisdiction will be responsible for enacting though the medicinal scheduling legislation. This will establish a robust and secure system. Importantly, it puts the medical professional back into the decision-making process to ensure better outcomes for patients while ensuring that patients have a safe supply of product.

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