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Wednesday, 10 February 2016
Page: 1164


Ms LEY (FarrerMinister for Health, Minister for Sport and Minister for Aged Care) (09:42): I move:

That this bill be now read a second time.

Introduction

The Narcotic Drugs Amendment Bill 2016provides a clear national licensing scheme allowing the controlled cultivation locally of cannabis for medicinal and scientific purposes.

Importantly this bill provides the critical 'missing piece' for the Commonwealth to enable a sustainable supply of safe medicinal cannabis products to Australian patients in the future.

This government understand that there are some Australians suffering from severe medical conditions for which cannabis may have some application, and we want to enable access to the most effective medical treatments available. At the same time, it is important we maintain the same high safety standards for products derived from cannabis that we apply to any other medicine.

There is also significant support for the use of medicinal cannabis in the broader community. From the 2013 National Drug Strategy Household Survey, 75 per cent of people would support a clinical trial of cannabis to treat medical conditions; and 69 per cent would also support a change to the legislation permitting the use of cannabis for medicinal purposes.

At the state and territory level, the New South Wales government is investing in clinical trials that will explore the use of cannabis and cannabis products in providing relief from a range of debilitating or terminal illnesses; and the Victorian government is taking steps to make medicinal cannabis products available to help Victorians in exceptional circumstances.

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 cannabis raw material.

This has meant Australian patients, researchers and manufacturers have had to try to access international supplies of legal medicinal cannabis crops and products—limited supplies and export barriers in other countries have made this difficult.

The government is concerned that some of these patients, or their parents, are seeking products from the black market, without appropriate medical supervision. This comes with risk of criminal prosecution, and also health risks because the safety of the supply cannot be guaranteed.

Under the United Nations Single Convention on Narcotic Drugs, 1961(the Single Convention), Australia, through the Commonwealth government, has an obligation to carefully control, supervise and report on various stages of cannabis cultivation, production and manufacture.

The purpose of the Single Convention is to establish a framework to both prevent abuse and diversion of controlled narcotics and to ensure the availability of such drugs for medical purposes. Within Australia, the enabling legislation for these obligations is the Narcotic Drugs Act 1967. This act also regulates the manufacture of licit narcotics such as morphine, of which Australia is the world's leading supplier. This is based on nearly 50 years of operating a strong and secure regulatory system that has the confidence of the international community.

The requirements for cannabis cultivation under the Single Convention are quite different to those for poppies grown for non-opium (alkaloids derived from concentrated poppy straw) producing purposes because of the significantly different risks to public health from the diversion of the crop.

Unlike poppies, cannabis can be used as soon as the plant reaches maturity. Because of this cannabis is treated differently under the convention, and the Commonwealth must take sole responsibility for regulating cannabis cultivation rather than leave it to the states and territories.

Presently, the Narcotic Drugs Act 1967 does not allow for the granting of licences for the production of locally cultivated cannabis for medical use.

Cultivation in Australia without these proposed amendments to the Narcotic Drugs Actcould put Australia in breach of its convention obligations, which could have consequences for our established multi-million dollar opioid narcotic industry.

National Approach

It is imperative we have a clear national licensing system to ensure we maintain the integrity of crops for medicinal or scientific purposes. This national approach will allow the Commonwealth , acting with the states and territories, to closely manage the supply of cannabis products from 'farm to pharmacy'.

Cultivation

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; and

the other to authorise cultivation for research purposes related to medicinal cannabis such as strain selection and assay identification.

For both forms of cultivation activity, an applicant for a license to cultivate would have to be found to be a 'fit and proper person' (according to criteria set out in the bill) and 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.

It does this by ensuring that the applicant or licence holder (and any relevant business associates) do not have ties to criminal activity; has the financial resources to participate in the industry; as well as satisfy security and other requirements of the conditions of the licence.

The quantities and strains of cannabis that can be cultivated will be controlled through the combination of a licence and permit system. 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 limits.

The government also wants to make sure that this approval and monitoring process for cultivation isn't fragmented across different jurisdictions and provides regulatory consistency.

Under the bill, the supply of unregistered medicinal cannabis products for clinical trials and specific patients would continue to be managed in accordance with current provisions under the Therapeutic Goods Act 1989 and the registration of new medicinal cannabis products would also continue to be regulated by the Therapeutic Goods Administration.

Additional amendments to the existing manufacturing provisions contained within the Narcotic Drugs Act, which has not been substantively updated since introduced in 1967, are also necessary to ensure consistency across manufacturing for all narcotic drugs and to reflect regulatory best practice.

Penalty Provisions

Other changes introduced include updated criminal and civil penalty provisions to create consistency with other Commonwealth legislation while continuing to reflect the serious nature of any breaches of licence conditions and regulatory requirements.

Management of the Scheme

Article 23 of the Single Convention requires a single agency to manage the cultivation of cannabis. This responsibility will sit within my department.

Creating one single, nationally-consistent cultivation scheme will ensure Australia could be confident of its compliance with international obligations under theSingle Convention.

This bill is not intended to override state and territory legislation dealing with criminal activities associated with the cultivation and trafficking of cannabis that occurs outside the regulatory scheme established by this bill.

Reporting

As with licit opiates, Australia must also report regularly to the International Narcotics Control Board, which oversees the implementation of the Single Convention, on quantities of narcotics produced, manufactured and used, with a view to preventing stock-piling of raw material beyond national and global needs. The legislation is designed to ensure the Commonwealth is able to fulfil this obligation.

Export/Imports

At this stage, the implementation of the new medicinal cannabis scheme will be domestically focussed with a provision for exports to be addressed at a later date when the scheme has demonstrated that it is sufficiently secure and robust to meet international and domestic expectations surrounding security and safety.

Cultivators will be authorised to import cannabis plants, including seed, and will access these through existing mechanisms to import seed stock and other relevant materials through existing provisions of the Customs (Prohibited Imports) Regulations 1956. Imports will also have to comply with relevant biosecurity requirements, which are in place.

Concluding remarks

In summary this bill, in conjunction with established mechanisms, provides a secure supply chain from 'farm to pharmacy', that will give patients access to medicinal cannabis products. The bill is not about the legalisation or decriminalisation of cannabis for recreational use. Nor is this a discussion about making cannabis products available 'over the counter' or outside of a discussion with a qualified doctor or through an approved clinical trial.

It is important we maintain the same high safety standards for cannabis derived products that we apply to any other medicine. I know many Australians would be concerned if medicinal cannabis products were to be subject to lower safety standards than common prescription painkillers or cholesterol medications. It is important to note that the manufacture of medicinal cannabis products will be also subject to quality manufacturing requirements under the Therapeutic Goods Act.

This bill, to allow the cultivation of legal medicinal cannabis crops in Australia under strict controls strikes the right balance between patient access, community protection and our international obligations.

Many people have worked incredibly hard for this day—for the day that the national parliament would provide the missing piece in the patient's journey when it comes to accessing safe, reliable, legal medicinal cannabis. It is a very proud day for many members and senators, as I have said, who have worked hard. For those in the community who have advocated strongly, who have pushed, who have prodded, who have expressed their passion loudly and determinedly, such as Lucy Haslam, and others who treat patients who are convinced of the efficacy and the relief that is provided by these products. They should be recognised here today. For my colleagues—and I will mention a few of them: the member for Leichardt, the member for Murray—who have worked long and hard. The member for Bass just came up to me outside the chamber and said how much this would be appreciated in Tasmania. For members of all parties who have believed strongly that this is a process and a product that we needed to bring to the Australian people.

Unless the Commonwealth provided, as I said, this missing piece, this actually could not happen. States and territories are waiting and ready, and in some cases underway with clinical trials. Universities, research bodies and those who are interested in the manufacture and supply are all working hard as we speak. We can lead the world in this important area of health science. Of course first and foremost it is about the patient. The relief that can be provided from these products for certain types of pediatric epilepsy and end-stage chemotherapy associated with cancer is quite well known. But when I speak to the researchers they also talk about relief from pain—the sorts of drugs that other drugs just cannot help or provide too many unpleasant side effects.

This is not a homogenous product that exists that will be processed through the processes that I have just described. This is an exciting area of research. Australia can lead the world—because we have the best scientists, because we have high-class clinical trials and because the regime that we are setting up today puts our TGA, our Therapeutic Goods Administrator, our drug regulator, at the centre. That is why it is so different from so many other jurisdictions around the world—because by putting this through that system we know that we have the integrity and the architecture of the scheme that we are setting up that will do the job, that will last for the long term and that will look after Australian patients now and into the future. I commend the bill to the House.