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Thursday, 27 November 2014
Page: 9507

Senator DI NATALE (Victoria) (12:22): I present the explanatory memoranda and I move:

That the bill be now read a second time.

I seek leave to have the second reading speech incorporated in Hansard.

Leave granted.

The speech read as follows—


Cannabis is an ancient plant that has been used for thousands of years to alleviate pain and treat certain medical conditions. It has been used to relieve some distressing symptoms, especially when front-line treatments have failed to work.

The anecdotal evidence from those who have used medicinal cannabis has been corroborated by international studies and trials, and there is a growing body of evidence appearing in peer reviewed and reputable medical and scientific journals supporting the use of medicinal cannabis under strict regulations.

That is why I am introducing a Bill to establish a Regulator of Medicinal Cannabis.

The Regulator will be responsible for licensing the production, manufacture, supply, use, research and import and export of medicinal cannabis.

The Regulator's role will be to approve medicinal cannabis products for inclusion in a register. This system of regulating medicinal cannabis will operate separately from the Therapeutic Goods Administration.

The establishment of the Regulator would not prevent pharmaceutical companies applying to the TGA instead of using the scheme established by this Bill. They will effectively have a choice about which system to use. So too will the States and Territories, who under this Bill can elect to be part of a regulated system for the cultivation, supply, research and use of medicinal cannabis.

This Bill has been drafted so that it is consistent with the Single Convention on Narcotic Drugs and ensures that cannabis used in ways not authorised or licenced by the Regulator will be subject to state and territory criminal sanctions.

The Bill is divided into five parts, each setting out the functions and operations of the Regulator of Medicinal Cannabis. The Regulator will provide a national system for licencing the cultivation and manufacture of cannabis for medicinal purposes; it will authorise people to obtain and use medicinal cannabis and it will facilitate research into cannabis for medicinal purposes.

The Regulator will also maintain a number of confidential registers encompassing people granted licences to be authorised cultivators, producers, users, researchers and importers and exporters. Additionally, the Regulator will create and maintain a register of regulated medicinal cannabis products. To be included on the register, the Regulator must be satisfied that the cannabis is suitable for medicinal use, that it meets the appropriate standards, and that all designated requirements are met. The register is modelled on the Australian Register of Therapeutic Goods.

The registration process and the register will have a number of rules prescribed for those people applying to be included on the register and the Regulator will have the power to remove or vary registration.

In this way, the Bill will ensure that medicinal cannabis is manufactured, supplied and used in a safe, consistent and controlled way. The licensing scheme ensures that all standards and regulations are complied with and the product will have to meet certain standards. Those authorised to use medicinal cannabis will likewise be required to meet strict criteria.

It is important to note that State and Territory criminal sanctions relating to illegal substances and drug use will still apply to anyone who misuses medicinal cannabis or fails to comply with the intent of this Bill. For example, if an authorised cultivator or manufacturer was to sell medicinal cannabis in any way not prescribed by the Regulator, or an authorised user was to sell or supply medicinal cannabis, they would be subject to the criminal sanctions that apply in the relevant State or Territory the offence was committed in.

The principle purpose of this Bill is to create a scheme whereby authorised patients, their carer or their medical practitioner can access specific medicinal cannabis products for medical use.

The Bill is intended to operate in conjunction with medical practitioners, who can apply to the Regulator on behalf of a patient or carer.

Research and development of medicinal cannabis is a growing field of science. It is important that research into types and strains of cannabinoids and medicinal cannabis be encouraged and furthered by the Regulator. The experimental cannabis licensing scheme, which will be operated by the Regulator, will allow authorised persons to develop, evaluate, test and improve cannabis products for medicinal purposes. The Regulator will also be responsible for issuing licences and prescribing a scheme for research and experiments with medicinal cannabis.

The on-going research into medicinal cannabis is an exciting field and Australia can play a lead role in improving methods of cultivation, evaluating efficacy and safety, improving delivery methods - such as how medicinal cannabis can be consumed by an authorised patient - and performing other clinical trials. This will further our understanding of cannabis as a medicinal product.

The Regulator of Medicinal Cannabis will be a listed entity with codified functions and powers, such as a Board, Chief Executive Officer and staff. The Minister will appoint the Chair and qualified members. The authorisation to cultivate or use medicinal cannabis necessitates expertise in a number of areas, such as plant cultivation, pharmacy, medicine, legal implications and criminality, so membership of the Regulator will include people with expertise in one of the following fields: Medicine, Pharmacology, Palliative Care, Botany, Horticulture, Law and Law enforcement or patient advocacy.

The membership must include at least one medical practitioner, one member of the Australia Federal Police and one person representing patients and users. This provides a balance of interests.

Finally, this Bill recognises that cannabis is a drug that is not legal in Australian states and territories. As with the Australian poppy industry, cannabis can be used for medicinal purposes as well as being a drug that is not legally available and carries criminal sanctions for cultivation, possession and trafficking. It is necessary that sanctions and penalties apply to any authorised person who abuses or misuses their obligations to the Regulator to provide, supply or use cannabis for medicinal purposes.

Both the public and law enforcement agencies must be confident that there are strict provisions in place so that only those authorised have access to medicinal cannabis and that manufacture and use is conducted under strict guidelines.

The monitoring and investigative powers in the Bill apply only to people authorised by the Regulator to cultivate, supply, use or experiment with medicinal cannabis. A person or persons applying to the Regulator for a licence will be advised of the monitoring and investigative powers.

This Bill establishes a strict and controlled Regulator to licence every aspect of medicinal cannabis, from cultivation through to end users. It will allow authorised people to use a medicinal cannabis product where front-line treatments have failed or where it can alleviate pain or other symptoms.

Debate adjourned.