I (C U M P 2014€¦ · Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014...

INQUIRY INTO THE EXPOSURE DRAFT OF THE DRUGS OF DEPENDENCE (CANNABIS USE FOR MEDICAL PURPOSES) AMENDMENT BILL 2014 AND RELATED DISCUSSION PAPER

S T A N D I N G C O M M I T T E E O N H E A L T H , A G E I N G , C O M M U N I T Y A N D

S O C I A L S E R V I C E S

A U G U S T 2 0 1 5

REPORT 6

I N Q U I R Y I N T O T H E E X P O S U R E D R A F T O F T H E D R U G S O F D E P E N D E N C E ( C A N N A B I S U S E F O R M E D I C A L P U R P O S E S ) A M E N D M E N T B I L L 2 0 1 4 A N D

R E L A T E D D I S C U S S I O N P A P E R

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COMMITTEE MEMBERSHIP

Dr Chris Bourke MLA Chair

Mr Andrew Wall MLA Deputy Chair

Ms Nicole Lawder MLA

Ms Yvette Berry MLA [until 10 February 2015]

Ms Meegan Fitzharris MLA [from 10 February 2015]

SECRETARIAT

Mrs Nicola Kosseck Secretary

Ms Jenny Mundy Research Officer

Ms Sarah Redden Editorial Assistance

Ms Lydia Chung Administrative Assistant

CONTACT INFORMATION Telephone 02 6205 0435 Facsimile 02 6205 0432 Post GPO Box 1020, CANBERRA ACT 2601 Email [email protected] Website www.parliament.act.gov.au

mailto:[email protected]

http://www.parliament.act.gov.au/

S T A N D I N G C O M M I T T E E O N H E A L T H , A G E I N G , C O M M U N I T Y A N D S O C I A L S E R V I C E S

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RESOLUTION OF APPOINTMENT

On 27 November 2012 the Legislative Assembly for the ACT agreed by resolution to establish legislative and general purpose standing committees to inquire into and report on matters referred by the Assembly or matters that are considered by the committee to be of concern to the community, including:

c) a Standing Committee on Health, Ageing, Community and Social Services to examine matters related to hospitals, community, public and mental health, health promotion and disease prevention, disability matters, drug and substance misuse, targeted health programs and community services, including services for older persons and women, families, housing, poverty, and multicultural and indigenous affairs;

The Assembly agreed that each committee shall have power to consider and make use of the evidence and records of the relevant standing committee appointed during the previous Assembly.1

TERMS OF REFERENCE

At its meeting on Thursday, 7 August 2014, the Assembly passed the following resolution:

That the exposure draft of the Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014 and the related discussion paper be referred to the Standing Committee on Health, Ageing, Community and Social Services for inquiry and report by the last sitting day in June 2015.

On 4 June 2015, the Assembly agreed to extend the Committee’s reporting date to the last sitting day in August 2015.

1 Legislative Assembly for the ACT, Minutes of Proceedings No. 2, 27 November 2012, pp. 24-27, at

http://www.parliament.act.gov.au/__data/assets/pdf_file/0005/393899/MoP_2.pdf

http://www.parliament.act.gov.au/__data/assets/pdf_file/0005/393899/MoP_2.pdf



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ACRONYMS AND ABBREVIATIONS ACT Australian Capital Territory

AIDS Acquired Immune Deficiency Syndrome

AMA Australian Medical Association

ARTG Australian Register of Therapeutic Goods

AS Ankylosing Spondylitis

Assembly Legislative Assembly for the Australian Capital Territory

ATODA Alcohol, Tobacco and Other Drug Association (ACT)

CBD Cannabidiol

CFS Chronic Fatigue Syndrome

CHO Chief Health Officer

Committee Standing Committee on Health, Ageing, Community and Social Services

1961 Convention Single Convention on Narcotic Drugs 1961

CPO Chief Police Officer

CSCs Cannabis Social Clubs

Cwlth Commonwealth

Commonwealth Bill Regulator of Medicinal Cannabis Bill 2014 as presented by Senator Di Natale into the Australian Senate as a Private Members’ Bill on behalf of Senators Di Natale, MacDonald, Leyonhjelm and Urquhart.

DFA Drug Free Australia

Draft Bill Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014 (ACT) – Exposure Draft

FFDLR Family and Friends for Drug Law Reform

INCB International Narcotics Control Board

MMAR Marihuana for Medical Access Regulations (Canada)

MMPR Marihuana for Medical Purposes Regulations (Canada)


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MS Multiple Sclerosis

MSA Multiple Sclerosis Australia

NCPIC National Cannabis Prevention and Information Centre

NSW Bill Drug Legislation Amendment (Cannabis for Medical Purposes) Bill 2014 (NSW; lapsed)

NSW committee NSW Legislative Council’s General Purpose Standing Committee No.4

NSW committee report NSW Legislative Council’s General Purpose Standing Committee No.4 – Report on the Use of Cannabis for Medical Purposes

PBAC Pharmaceutical Benefits Advisory Committee

PBS Pharmaceutical Benefits Scheme

PHAA Public Health Association of Australia

Regulator Regulator of Medicinal Cannabis (under Commonwealth Bill)

RTA Road Transport Authority (ACT)

SAS Special Access Scheme

SCON Simple Cannabis Offence Notice

TGA Therapeutic Goods Administration

TGA 1989 Therapeutic Goods Act 1989 (Commonwealth)

THC Tetrahydrocannabinol

TICS Terminal Illness Cannabis Scheme (New South Wales)

Winnunga Winnunga Nimmityjah Aboriginal Health Service



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TABLE OF CONTENTS

Committee membership ............................................................................................. i

Secretariat ................................................................................................................... i

Contact information ..................................................................................................... i

Resolution of appointment .......................................................................................... ii

Terms of reference ...................................................................................................... ii

Acronyms and abbreviations ...................................................................................... iii

R E C O M M E N D A T I O N S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I X

1 I N T R O D U C T I O N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Background ................................................................................................................. 1

Focus of this inquiry .................................................................................................... 1

Conduct of inquiry ....................................................................................................... 2

Report structure .......................................................................................................... 4

2 C A N N A B I S - O V E R V I E W . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Cannabis and cannabinoids ......................................................................................... 5

Efficacy of cannabis and cannabinoids for medicinal use .............................................. 6

Modes of administration ............................................................................................. 8

3 A C T , N S W A N D C O M M O N W E A L T H R E G U L A T O R Y F R A M E W O R K S . . . . . 1 1

Current regulatory framework in the ACT .................................................................. 11

NSW approach .......................................................................................................... 13

Commonwealth Government regulatory framework and international Conventions ... 17

Regulator of Medicinal Cannabis Bill 2014 (Cwlth) ...................................................... 17

4 P H A R M A C E U T I C A L C A N N A B I S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3

Pharmaceutical cannabinoid products ....................................................................... 23

Benefits .................................................................................................................... 26

Limitations of current pharmaceutical cannabis products ........................................... 28

Opportunities ............................................................................................................ 30

5 M E D I C A L R E S E A R C H . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3

Barriers ..................................................................................................................... 33


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Support ..................................................................................................................... 34

Pharmaceutical focus ................................................................................................ 35

Opportunities ............................................................................................................ 37

6 S U P P O R T F O R A M E D I C I N A L C A N N A B I S S C H E M E . . . . . . . . . . . . . . . . . . . . . . 4 1

Compassionate approach .......................................................................................... 41

Community support .................................................................................................. 43

Limited support ......................................................................................................... 44

Crude cannabis .......................................................................................................... 44

Case studies .............................................................................................................. 47

Necessity and urgency ............................................................................................... 51

7 C O N C E R N S W I T H M E D I C I N A L C R U D E C A N N A B I S . . . . . . . . . . . . . . . . . . . . . . 5 3

Health risks ............................................................................................................... 53

Diversion .................................................................................................................. 60

Risk of normalising .................................................................................................... 61

Catalyst for recreational legalisation .......................................................................... 61

8 T H E D R A F T B I L L - O V E R V I E W . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5

Overview .................................................................................................................. 65

General response to the Draft Bill .............................................................................. 66

9 D R A F T B I L L - K E Y I S S U E S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 9

Definitions ................................................................................................................ 69

Cannabis supply ........................................................................................................ 69

Role of the Chief Health Officer ................................................................................. 76

Role of medical practitioners ..................................................................................... 79

Prescribed medical conditions and symptoms (categories) ......................................... 83

Children .................................................................................................................... 86

Public health and safety ............................................................................................ 87

Legal issues ............................................................................................................... 90

Affordability .............................................................................................................. 95

Review of the Bill ...................................................................................................... 96

Other 96

1 0 A M E N D E D , A L T E R N A T I V E A N D P R E F E R R E D M O D E L S . . . . . . . . . . . . . . . . 1 0 1

Amendments and alternatives .................................................................................. 101

Preferred approach .................................................................................................. 105



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1 1 C O N C L U S I O N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 9

A P P E N D I X A S U B M I S S I O N S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2 1

A P P E N D I X B S P E C I A L I S T A D V I S E R R E P O R T . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2 3


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I N Q U I R Y I N T O T H E E X P O S U R E D R A F T O F T H E D R U G S O F D E P E N D E N C E ( C A N N A B I S U S E F O R M E D I C A L P U R P O S E S ) A M E N D M E N T B I L L 2 0 1 4

A N D R E L A T E D D I S C U S S I O N P A P E R

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RECOMMENDATIONS

R E C O M M E N D A T I O N 1

4.47 The Committee recommends that the ACT Government write to the Commonwealth Minister for Health requesting the Commonwealth Government:

consider including Sativex and Marinol on the PBS to improve affordability;

consider providing easily accessible guidance material to medical practitioners on:

how to go about prescribing approved pharmaceutical cannabis products off-label;

the requirements of the Special Access Scheme and associated importation requirements;

simplify off-label prescribing and Special Access Schemes so that the processes can be navigated by medical practitioners with ease and are not excessively protracted; and

consider expanding access to approved pharmaceutical cannabis products for additional indications.


5.27 To facilitate the research and development of medicinal cannabis and cannabinoid preparations, the Committee recommends that the ACT Government

write to the Commonwealth Minister for Health requesting the Commonwealth Government investigate amending the Poisons Standard by:

amending Schedule 9 to facilitate medical or scientific research; and

moving other non-psychoactive, non-addictive cannabinoids into a lesser schedule as has been done for cannabidiol.


5.28 The Committee recommends that the ACT Government work together with other State, Territory and Commonwealth governments to conduct further clinical trials

of pharmaceutical products and crude cannabis.

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5.29 The Committee recommends that the ACT Government work together with other State, Territory and Commonwealth governments to help facilitate ACT patient

access to upcoming interstate trials.


9.164 The Committee recommends that the ACT Legislative Assembly reject the

proposed Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014.


10.41 The Committee supports a national approach to medicinal cannabis and

encourages the ACT Government to continue to work with the Commonwealth, States and Territory on a national medicinal cannabis scheme.


10.96 The Committee recommends that if the ACT acts independently of the Commonwealth or other State and Territory jurisdictions on a medicinal cannabis

scheme it needs to address the regulatory concerns raised in this report.



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1 INT RO DUCT ION

BACKGROUND

1.1 On 7 August 2014 Mr Shane Rattenbury MLA presented the Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014—Exposure draft (the Draft Bill) in the Assembly along with a discussion paper prepared by the ACT Greens, dated July 2014, entitled ‘Medicinal Cannabis’.

1.2 The Draft Bill and discussion paper were referred to the Standing Committee on Health, Ageing, Community and Social Services for inquiry and report.

FOCUS OF THIS INQUIRY

1.3 The Committee has not provided a lengthy discussion on the cannabis plant, its properties or chemical makeup as there is a large body of information already available in the public domain providing key factual information.

1.4 The Committee has similarly chosen not to provide a history or analysis of cannabis use within Australia or internationally as there is a vast body of publicly available literature on the matter. The Committee has discussed, where relevant, the Canadian medicinal cannabis model as the discussion paper describes the Draft Bill as being based on the Canadian model. The Committee has discussed the medicinal cannabis system in place in the Netherlands in additional detail as it was raised in evidence to the Committee.

1.5 The Committee notes that the NSW Legislative Council’s General Purpose Standing Committee No.4 (NSW committee) report on the Use of Cannabis for Medical Purposes provides a fairly comprehensive overview of some of the key debates around medicinal cannabis.2

1.6 Additionally, the NSW committee report provided some background information on Australia’s current regulatory environment. It is not the intention of this Committee to re-present the factual and background information researched by the NSW committee. This Committee has instead focused on the ACT-specific regulatory environment and attempted to provide an update on changes and proposed changes in the NSW and Commonwealth regulatory environments.

2 NSW Legislative Council’s General Purpose Standing Committee No.4, Report 27, The Use of Cannabis for Medical

Purposes (NSW Committee report), 15 May 2013.

2 S T A N D I N G C O M M I T T E E O N H E A L T H , A G E I N G , C O M M U N I T Y A N D S O C I A L S E R V I C E S

CONDUCT OF INQUIRY

SU BM ISS IO NS

1.7 On 4 November 2014 the Committee called for submissions to its inquiry into the Draft Bill and related discussion paper, including via direct invitation and advertisement on the Assembly website. On the 11 November 2014, the Committee also advertised the call for submissions in the Canberra Times.

1.8 Submissions closed on Friday 13 February 2015, although some additional submissions were accepted after this date.

1.9 The Committee received 35 submissions from a range of stakeholders. A list of submissions is available at Appendix A ‘Submissions’.

HEA RI NG S

1.10 On 13 and 31 March 2015 and 9 April 2015, the Committee held public hearings, with a range of individuals and organisations, as well as ACT Government officials, appearing before the Committee.

Table 1.1 – Public Hearings – Summary Details

Date Organisation Witness

13 March 2015 Private Capacity Mr Grant Beale

Private Capacity Mrs Kathy Beale

Private Capacity Mr Nicholas Christodoulou

Private Capacity Dr Karen Downing

Private Capacity Mr Marc Pengryffyn

31 March 2015 Chief Executive Officer, Australian Medical Association (ACT) Mrs Christine Brill

Member, Families and Friends for Drug Law Reform Mr William (Bill) Bush

Secretary/Research Coordinator, Drug Free Australia Mr Gary Christian

Vice Chair, Drug Free Australia Dr Ross Colquhoun

President, Australian Medical Association (ACT) Dr Elizabeth Gallagher

Families and Friends for Drug Law Reform Mrs Marion McConnell

Secretary, ACT Branch, Public Health Association of Australia Mr David McDonald



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Chief Executive Officer, Public Health Association of Australia Adjunct Professor Michael Moore

9 April 2015 Director-General, ACT Health 3 Dr Peggy Brown

Chief Police Officer, ACT Policing Mr Rudi Lammers

Executive Director, Policy and Government Relations, ACT Health Mr Ross O’Donoughue

Deputy Chief Health Officer, ACT Health Dr Andrew Pengilley

1.11 Transcripts of the hearings can be accessed on the Legislative Assembly Website.4

SPE CI AL IST AD VI SE R

1.12 On 11 December 2014, the Committee agreed to engage Jonathon Arnold, Associate Professor of Pharmacology at the University of Sydney and Director of the Cannabinoid Research Group, to prepare a background paper for the Committee presenting a systematic review of the medical aspects of cannabis. The review was designed to assist the Committee with its understanding of cannabis and cannabinoid pharmacology details when considering submissions and other evidence tendered to the inquiry and includes:

a literature review bringing together existing evidence on the effects of crude cannabis products and pharmaceutical cannabis products on users including toxicology, efficacy and safety issues, and results from existing medical research trials;

an assessment of neurological effects including links to mental disorders, effects on memory, effects on brain development in teenagers and children; and

assessment of psychological aspects including dependence.

1.13 The review, entitled ‘Report on the medical applications of cannabis and cannabinoids’ is at Appendix B.

ACT ALC OH OL, TO BA CC O AN D OT HE R DRUG SECT O R CO NFE RE NC E AN D F OR U M

1.14 The Committee attended a conference on 23 September 2014 entitled ‘Better Understanding Evidence-Based Options for Medicinal Cannabis in the ACT’, which was co-hosted by the ACT Alcohol, Tobacco and Other Drug Association ACT (ATODA), the Public Health Association of Australia and the AIDS Action Council.

1.15 Some members of the Committee also attended the ATODA Drug Policy Forum held on Tuesday 10 March 2015. Presented by Professor Beau Kilmer, the forum was entitled ‘What

3 Dr Peggy Brown did not seek reappointment. Ms Nicole Feely is the current Director-General ACT Health. 4 Legislative Assembly for the ACT, Committee transcripts Eighth Assembly, at

http://www.hansard.act.gov.au/hansard/2013/comms/default.htm#health.

http://www.hansard.act.gov.au/hansard/2013/comms/default.htm%23health


will we need to do to keep a legal therapeutic cannabis market separate from the illegal market? The implications of the USA experience for ACT policy, legislation and practice.’

MEETI NG WIT H T HE NSW LEGIS LAT IVE COU N CI L ’S GENE RA L PUR POSE ST AN DI NG

COM MITT EE NO.4 (55 T H PAR LIA ME NT)

1.16 On the 5 February 2015 the Committee visited the NSW Legislative Council to meet with members of the NSW committee and discuss the key findings and learnings from its 2013 inquiry into the use of cannabis for medical purposes.

1.17 The NSW committee provided frank advice and reflections on their own inquiry, noting how members’ views had evolved as new evidence was provided to the NSW committee.

REPORT STRUCTURE

1.18 Chapter 2 of this report provides an overview of cannabis and cannabinoids, their efficacy in medicinal use and modes of administration.

1.19 Chapter 3 provides a summary of the current ACT regulatory arrangements as well as an overview of recent proposals and changes to the NSW and Commonwealth regulatory frameworks with regard to medicinal cannabis.

1.20 Chapter 3 considers current pharmaceutical cannabis products, their benefits, limitations and opportunities in the context of the wider medicinal cannabis debate.

1.21 Chapter 5 examines barriers and opportunities for medical research and development in the medicinal cannabis field.

1.22 Chapter 6 explores the evidence provided to the Committee in support of a medicinal cannabis scheme, the potentials of crude cannabis and the imperative for a medicinal cannabis scheme.

1.23 Chapter 7 explores the concerns and arguments against medicinal cannabis use including health risks, diversion and legalisation of cannabis for recreational use.

1.24 Chapter 8 provides an overview of the provisions in the Draft Bill.

1.25 Chapter 9 analyses the provisions of the Draft Bill, taking into account evidence tendered to the Committee.

1.26 Chapter 10 briefly considers proposed amendments and alternatives to the Draft Bill as well as including discussion on the features of a preferred regulatory approach to medicinal cannabis.



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2 CA NNAB IS - O V E RV IE W

CANNABIS AND CANNABINOIDS

2.1 In his report for the Committee, Associate Professor Jonathon Arnold provided an overview of cannabis and cannabinoid pharmacology. He wrote:

Cannabis is a plant of the common varieties of Cannabis sativa, Cannabis indica and Cannabis ruderalis.

There are 100 cannabinoid (cannabis-like) molecules found in the plant material, being most abundant in the leaves and flowering tops of the female plant.

Δ9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, was one of the first active molecules isolated from the cannabis plant, and its molecular structure became the template for all similar molecules characterised thereafter (cannabinoids). Molecules were originally classed as cannabinoids if they had similar behavioural or physiological effects as THC including “tetrad” effects in rodents such as motor depression, catalepsy, analgesia, and hypothermia. The term now applies beyond this narrow definition as many cannabinoids, particularly cannabidiol are not psychoactive, while having a similar chemical structure to THC.

Further, endocannabinoids have a distinct chemical structure to THC, as do many synthetic cannabinoids that have been synthesized by chemists and have recently found their way into recreational use as herbal “spice” incense.

THC acts upon the endocannabinoid system which naturally regulates a diverse range of important physiological functions, including learning, mood, the extinction of aversive memories, appetite and pain regulation. The study of the natural physiological role of endocannabinoids then provides a useful indication of what disease states cannabinoid therapies might be useful in treating. The endocannabinoid system was relatively recent discovered in the 1990s and is a complex network of receptors (proteins found in different tissues of the body that mediate chemical communication) called cannabinoid CB1 and CB2 receptors. 5

...

Unlike THC, CBD [cannabidiol] doesn’t induce classic cannabinoid tetrad effects (locomotor suppression, catalepsy, analgesia and hypothermia) ...CBD behaves as an indirect cannabinoid receptor agonist, meaning that it stimulates these receptors

5 Assoc Prof Jonathon Arnold, Report on the medical applications of cannabis and cannabinoids (Specialist Adviser

Report), pp. 2-3.


indirectly by increasing levels of the natural occurring endocannabinoids

Most research on medicinal cannabinoids has administered pharmaceutical formulations of THC and/or CBD.6

EFFICACY OF CANNABIS AND CANNABINOIDS FOR MEDICINAL

USE

2.2 A summary of evidence on the more significant indications for cannabinoid medicines is provided below, extracted from the report prepared for the Committee by Associate Professor Jonathon Arnold. For further information on the strength of the evidence, including details of the size and nature of studies these findings are based on, refer to the full report at Appendix B.

PAIN

2.3 There is evidence that pharmaceutical cannabinoid drugs have an analgesic effect, and have been used to treat a variety of pain including neuropathic pain, post operative, chronic pain, fibromyalgia, rheumatoid arthritis and pain associated with multiple sclerosis and cancer. Crude cannabis has also shown efficacy in treating pain.7

2.4 There are also potential benefits to cannabis therapies as adjunctive treatments to conventional analgesics.8

NAUSEA AND VOMITING

2.5 Cannabinoids have been successfully used to treat nausea, however an array of effective anti-emetic (anti-nausea) medications are now available that appear to be equally as effective as cannabinoid treatments, perhaps more so for severe nausea and vomiting. Cannabinoid therapies may prove useful where patients are resistant to conventional anti-emetic therapies.9

APPETITE STIMULATION

2.6 Cannabis and cannabinoid drugs have been used to stimulate appetite in conditions where there is loss of appetite and associated wasting such as for cancer patients and patients with AIDS. The effectiveness of cannabinoids as an appetite stimulator appears to be contingent

6 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 2-3, 4. 7 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 6.-7 8 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 7. 9 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 7-8.



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on the application of higher dosages, and may be less effective than conventional pharmaceuticals.

2.7 Cannabinoid treatments have potential where conventional therapies are ineffective or come with more significant risks for patients, such as the risks of impotence in males associated with the product megestrol.10

2.8 There is also some early evidence that THC is effective in stimulating the appetite in Alzheimer’s patients.11

RELIEF FROM SYMPTOMS ASSOCIATED WITH MULTIPLE SCLEROSIS AND OTHER

NEUROLOGICAL DISORDERS

2.9 For patients that remain unresponsive to conventional treatments, the pharmaceutical product Sativex is available to treat spasticity associated with Multiple Sclerosis (MS). Studies indicate benefits from Sativex for spasticity, pain, muscle spasms, sleep and bladder dysfunction. 12

2.10 Other cannabinoid products have shown potential in assisting with patient spasticity, pain, muscle spasms, sleep and mobility after a longer period of treatment (one year).13

2.11 Early research indicates there may be potential for the use of cannabinoids for symptomatic relief in other neurological disorders such as Parkinson’s disease, Huntington’s disease, Tourette’s syndrome, amyotrophic lateral sclerosis and Alzheimer’s disease however there is not yet convincing clinical evidence and is an area worthy of further research.14

EPILEPSY

2.12 Studies have indicated cannabidiol (CBD) to be effective in reducing seizures in treatment-resistant epilepsy patients. In particular, the use of cannabinoid drugs for treatment of intractable forms of paediatric epilepsy such as Dravet syndrome has shown promise. There is conflicting evidence on whether THC is effective in treating epilepsy.15

10 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 9. 11 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 8-9. 12 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 9-10. 13 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 9-10. 14 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 10. 15 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 11.


SCHIZOPHRENIA

2.13 Whilst THC may provoke symptoms that resemble psychotic episodes in some individuals and has the potential to increase the risks of developing schizophrenia, CBD has been shown to be an effective antipsychotic drug, with potentially fewer negative side effects than existing conventional treatments.16

INFLAMMATORY BOWEL DISEASE

2.14 There is evidence that cannabinoids have anti-inflammatory properties and anecdotal evidence that cannabinoids may assist chronic conditions like Crohn’s disease and ulcerative colitis. However, the efficacy of cannabinoids for inflammatory bowel diseases requires more rigorous trials on a larger scale.17

OTHER POTENTIAL USES

2.15 Further studies have shown promising uses for cannabis and cannabinoids, given their additional anti-inflammatory and antioxidant actions. Evidence exists for potential applications such as treatment to reduce the proliferation and spread of cancer, assist with multidrug resistance and possibly help sufferers of post-traumatic stress disorder with anxiety and forgetting traumatic events. Support for further research and development is needed to translate these findings into clinical treatments.18

MODES OF ADMINISTRATION

2.16 Crude cannabis plant can be administered via smoking, consuming in food or drink and inhaled through a vaporiser. Cannabis preparations like tinctures are taken orally (drops under the tongue).19

2.17 Smoking is the most common delivery method for recreational cannabis, most likely because ‘smoking introduces cannabinoids to the vasculature of the lungs, which then quickly and efficiently provide passage of THC to the brain’ and allows users to easily titrate (control and measure) their dose.20 Smoking can include inhalation from hand-rolled cigarettes (joints), often mixed with tobacco, or via water pipes (bongs).21

16 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 12. 17 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 12-13. 18 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 13. 19 NSW Committee Report, 15 May 2013, p. 5. 20 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 19. 21 NSW Committee Report, 15 May 2013, p. 5.



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2.18 Smoking cannabis comes with a number of risks and is not considered an appropriate method of administration for medicinal cannabis, as discussed in Chapter 7.

2.19 Oral consumption of cannabis can take hours to have an effect on the brain making it unpredictable and impractical for some treatments such as rapid pain relief. Some synthetic cannabinoids that show less variability in absorption are in development.22

2.20 Vaporisers allow cannabinoids to be inhaled without the need to combust plant material which gives rise to toxic bi-products such as carbon monoxide, irritants and tar.’23

2.21 Pharmaceutical preparations are also available in pill/capsule (dronabinole and nabilone) or for buccal administration, such as the mouth spray Sativex.24

22 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 19-20. 23 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 20. 24 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 20; NSW Committee Report, 15 May 2013,

p. 5.

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1 1

3 ACT, NSW AND CO MM O NW EA LT H

RE G UL ATO RY F RAM EW O RKS

CURRENT REGULATORY FRAMEWORK IN THE ACT

3.1 In regards to cannabis in the ACT, it is illegal to:

administer it to someone else;

possess any quantity of it;

cultivate or be involved in cultivating any quantity of it; or

sell or supply any quantity of it. 25

3.2 Relevant ACT legislation includes:

the Drugs of Dependence Act 1989;

the Criminal Code 2002; and

the Medicines, Poisons and Therapeutic Goods Act 2008.

3.3 Under these instruments there are provisions for offences in relation to a range of drugs including modern synthetic types. 26

DEFI NIT IO N OF C A NN ABI S

3.4 ‘Cannabis’ is defined in the Dictionary to the ACT’s Drugs of Dependence Act 1989:

(a) means a cannabis plant, whether living or dead, and includes any flowering or fruiting top, leaf seed, stalk or any other part of a cannabis plant and any mixture of parts of a cannabis plant or cannabis plants; but

(b) does not include cannabis resin or cannabis fibre.

3.5 Section 5 of the Drugs of Dependence Act 1989 also provides that a reference to cannabis includes a reference to an active principal, preparation or a mixture of the substance, or a salt of the substance or active principal.

25 ACT Policing, Drugs and the Law, at: http://www.police.act.gov.au/crime-and-safety/drugs-and-alcohol/drugs-and-the-

law 26 ACT Policing, Drugs and the Law.

http://www.police.act.gov.au/crime-and-safety/drugs-and-alcohol/drugs-and-the-law

http://www.police.act.gov.au/crime-and-safety/drugs-and-alcohol/drugs-and-the-law


3.6 Cannabis is described as a drug of dependence not a prohibited substance under the Drugs of Dependence Act 1989.27

SIM PL E CA N NAB IS OFFE N CE NOT IC E SC HE ME

3.7 Whilst cannabis remains illegal, the ACT has decriminalised simple cannabis offences meaning criminal charges are not laid in some circumstances.28

3.8 A simple cannabis offence notice is provided for in section 171A of the Drugs of Dependence Act 1989. The Drugs of Dependence Act 1989 defines a simple cannabis offence as:

(a) cultivation of 1 or 2 cannabis plants (an offence against section 162); or

(b) possessing not more than 50g of cannabis (an offence against section 171 (1)); or

(c) administering, or causing or permitting to be administered, to oneself cannabis (an offence against the Medicines, Poisons and Therapeutic Goods Act 2008, section 37 (2) (administering certain declared substances)).

3.9 The exemption to section 162 of the Drugs of Dependence Act 1989 does not include artificial cultivation of cannabis plants which includes hydroponic cultivation or cultivation ‘with the application of an artificial source of light or heat’.29 The ACT Policing website advises that:

The decision was made to exclude hydroponically grown cannabis plants from the [Simple Cannabis Offence Notice] SCON scheme as the trend towards hydroponic methods of cannabis cultivation indicates that the quantities of cannabis now able to be produced, and potentially the potency of that cannabis, are no longer in line with the original intentions of the scheme. 30

3.10 The prescribed penalty for a simple cannabis offence is a $100 fine which must be paid within 60 days in order for there to be no criminal record.31 ACT Policing advise that ‘police have discretion to issue a SCON or charge an offender with a criminal offence.’ 32 They also advise that failure to pay the fine ‘may result in criminal proceedings before the court.’ 33

27 Drugs of Dependence Act 1989 (ACT) s164. 28 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 97; Adjunct Prof Michael Moore, Transcript of Evidence,

31 March 2015, p. 66. 29 Drugs of Dependence Act 1989 (ACT) s162. 30 ACT Policing, Drugs and the Law. 31 Drugs of Dependence Act 1989 (ACT) s171A(7). 32 ACT Policing, Drugs and the Law. 33 ACT Policing, Drugs and the Law.



1 3

OTHE R CA N NAB IS OFFE NC ES

3.11 Cultivation and possession of cannabis not covered by the SCON scheme, as well as sale of cannabis are criminal offences. Penalties for these offences ‘range up to $250,000 fines and life imprisonment for more serious cannabis offences’ like possession and sale of large or commercial quantities.34

3.12 A trafficable quantity of cannabis in the ACT is 300g of cannabis, 25g of cannabis oil or resin, or 10 cannabis plants.35 Commercial quantities and large commercial quantities are also specified in the Criminal Code Regulation 2005. 36

NSW APPROACH

NSW COMMITTEE INQUIRY

3.13 In November 2012, the NSW Legislative Council referred the issue of cannabis for medical purposes to the General Purpose Standing Committee No. 4 (NSW committee) for inquiry and report.

3.14 The NSW committee’s terms of reference included:

the efficacy and safety of cannabis for medical purposes;

if and how cannabis should be supplied for medical use;

legal implications and issues concerning the use of cannabis for medical purposes; and

any other related matters.

3.15 The NSW committee reported in May 2013, recommending:

1) That the Minister for Health write to the Commonwealth Minister for Health and Ageing, expressing in principle support for the timely, evidence based expansion of access to approved cannabis pharmacotherapies by additional patient groups, including those suffering from chronic pain for whom existing pain management is not effective; further clinical trials of pharmaceutical cannabis products; and approved pharmaceutical cannabis products to be affordable to patients.

2) That the Drug Misuse and Trafficking Act 1985 be amended to add a complete defence to the use and possession of cannabis, to cover the authorised medical use of cannabis by patients with terminal illness and those who have moved from HIV infection to AIDS.

34 ACT Policing, Drugs and the Law. 35 Criminal Code 2002 s 601; Criminal Code Regulation 2005 Schedule 1 Part 1.2, Schedule 2. 36 Criminal Code 2002 s 601; Criminal Code Regulation 2005 Schedule 1 Part 1.2, Schedule 2.


The features of this system would include:

• provision of a complete defence for the patient’s use of cannabis and possession of up to 15 grams of dry cannabis or equivalent amounts of other cannabis products, and equipment for the administration of cannabis

• provision of a complete defence for the possession and supply of up to 15 grams of dry cannabis or equivalent amounts of other cannabis products, and equipment for the administration of cannabis, by the patient’s carer

• that the defence be restricted to persons listed on a register of ‘authorised cannabis patients and carers’, with eligibility contingent on certification by the patient’s treating specialist medical practitioner that the patient is diagnosed with a specified condition

• the defence to apply only where use and supply does not occur in a public place, and a review of the amendments to commence within three years of commencement.

3) That the NSW Ministry of Health establish a register of ‘authorised cannabis patients and carers’ certified by the patient’s treating specialist medical practitioner, and issue people on this register with a photo identity card verifying that they qualify for exemption from arrest and prosecution.

4) That the NSW Ministry of Health and Department of Attorney General and Justice give further and detailed consideration to the issues surrounding lawful supply of crude cannabis products for medical purposes.

5) That the NSW Ministry of Health implement an education strategy to accompany the legislative amendment set out in Recommendation 2 to inform the medical profession, community and relevant patient groups about the intentions and provisions made under the amendment. This should include information for patients about the harms that accompany smoking cannabis, and alternative forms of administration.37

3.16 The NSW Government supported only the first recommendation, stating that it did not support the production and supply and use of crude cannabis for medical use outside existing regulatory and legal frameworks, and that unregulated supply of cannabis was a major concern.38 In concluding, the NSW Government noted that ‘there are safe and effective medications currently available for the symptoms and conditions that medical cannabis is purported to be effective in treating’.39

37 NSW Committee Report, 15 May 2013, pp. xvii – xviii. 38 NSW Government response to the NSW Legislative Council General Purpose Standing Committee No 4, The Use of

Cannabis for Medical Purposes, November 2013. 39 NSW Government response to the NSW Legislative Council General Purpose Standing Committee No 4, The Use of

Cannabis for Medical Purposes, November 2013.



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NSW DRUG LEGISLATION AMENDMENT (CANNABIS FOR MEDICAL PURPOSES)

BILL 2014

3.17 In 2014 Dr John Kaye, Member of the Legislative Council and Member of the NSW committee, introduced a Bill which sought to implement the legislative amendments outlined in the NSW committee’s recommendations. That Bill lapsed on prorogation (with the end of the 55th session of NSW parliament) on 2 March 2015.

ALTERNATIVE LEGISLATION AND POLICY CHANGES

3.18 NSW Nationals MP Kevin Anderson also committed to introduce his own private member's bill for the decriminalisation of medical cannabis.40 According to media reports, Mr Anderson distributed his draft legislation to NSW Premier Mike Baird and Deputy Premier Andrew Stoner seeking support:

Mr Baird agreed to consider the bill if it solved the issue of supply and Mr Anderson fashioned a bill that he privately presented to the Premier... 41

3.19 On 16 September 2014, the NSW Government announced that it would ‘formalise the current arrangement which allows Police to exercise their discretion not to charge terminally ill adults who use cannabis to alleviate their symptoms, or charge their carers.’42 This policy change reflects Mr Anderson’s proposal 43 and has been implemented through the Terminal Illness Cannabis Scheme (TICS).44

NSW TERMINAL ILLNESS CANNABIS SCHEME

3.20 The TICS includes a register for eligible NSW residents who are aged 18 years or over and who have a terminal illness. Eligible adults may also nominate up to three adult carers to be registered. A medical practitioner registered in Australia must certify that the individual has a terminal illness, defined for the purposes of the TICS as:

an illness which, in reasonable medical judgement will, in the normal course, without the application of extraordinary measures or of treatment unacceptable to the

40 Mr Brad Ryan, ‘Medicinal marijuana: Nationals MP Kevin Anderson reveals proposal to 'license' patients and carers’,

ABC News, 29 July 2014 at http://www.abc.net.au/news/2014-07-29/push-for-cannabis-licences-for-nsw-medicinal-drug-users/5626166 and Mr Kevin Anderson, News and Media, ‘Anderson Proposes Historic Private Members Bill’, 29 May 2014, at http://www.kevinanderson.com.au/News-and-Media/Media/Anderson-Proposes-Historic-Private-Members-Bill/, accessed 3 August 2015.

41 Ms Harriet Alexander, ‘Nats MP a reluctant drug crusader’, Sydney Morning Herald, 22 September 2014, at http://newsstore.fairfax.com.au/apps/viewDocument.ac;jsessionid=EE82285DB1621A480EB4FD24C1C2FD3D?sy=afr&pb=all_ffx&dt=selectRange&dr=1month&so=relevance&sf=text&sf=headline&rc=10&rm=200&sp=brs&cls=3426&clsPage=1&docID=SMH140922K45CQ7LQ3E8.

42 Mr Kevin Anderson, News and Media, ‘Anderson Congratulates the Haslam Family and People Power’, 16 September 2014, at http://www.kevinanderson.com.au/News-and-Media/Media/Anderson-Congratulates-The-Haslam-Family-and-People-Power/, accessed 4 June 2015.

43 Ms Harriet Alexander, ‘Nats MP a reluctant drug crusader’, Sydney Morning Herald, 22 September 2014. 44 NSW Terminal Illness Cannabis Scheme, at: http://www.nsw.gov.au/tics, accessed 28 April 2015.

http://www.abc.net.au/news/2014-07-29/push-for-cannabis-licences-for-nsw-medicinal-drug-users/5626166

http://www.abc.net.au/news/2014-07-29/push-for-cannabis-licences-for-nsw-medicinal-drug-users/5626166

http://www.kevinanderson.com.au/News-and-Media/Media/Anderson-Proposes-Historic-Private-Members-Bill/

http://www.kevinanderson.com.au/News-and-Media/Media/Anderson-Proposes-Historic-Private-Members-Bill/

http://newsstore.fairfax.com.au/apps/viewDocument.ac;jsessionid=EE82285DB1621A480EB4FD24C1C2FD3D?sy=afr&pb=all_ffx&dt=selectRange&dr=1month&so=relevance&sf=text&sf=headline&rc=10&rm=200&sp=brs&cls=3426&clsPage=1&docID=SMH140922K45CQ7LQ3E8



http://www.kevinanderson.com.au/News-and-Media/Media/Anderson-Congratulates-The-Haslam-Family-and-People-Power/

http://www.kevinanderson.com.au/News-and-Media/Media/Anderson-Congratulates-The-Haslam-Family-and-People-Power/

http://www.nsw.gov.au/tics


patient, result in the death of the patient.45

3.21 TICS is administered by the NSW Department of Justice and ‘provides guidance for NSW police officers to assist them in determining appropriate circumstances in which to use their discretion not to charge adults with terminal illness who use cannabis to alleviate their symptoms, and carers who assist them.’46

3.22 Police may exercise their discretion under certain conditions:

The adult and their carers are registered for TICS;

The patient or carer possesses no more than 15 grams of cannabis leaf, 1 gram of cannabis oil and 2.5 grams of cannabis resin; and

The use/administration/supply of cannabis is used by the terminally ill person at their usual place of residence or any domestic residence.

3.23 The TICS does not allow for cultivation, supply to persons who are not registered, use of cannabis in public places, possessing more than the specified maximum amount of cannabis or drug-driving.47

NSW CLINICAL TRIALS

3.24 In September 2014, the NSW Premier, Mike Baird, formed a working group to initiate clinical trials of medicinal cannabis, as well as considering supply and distribution issues.48 The ACT Government participated in the working group.49

3.25 The NSW Government will lead three clinical trials of cannabis and/or derived products; one for adults with terminal illness, one for adults with chemotherapy-induced nausea and vomiting and one for children with severe, drug-resistant epilepsy. The trials are anticipated to commence in 2016 with results available in two to five years.50 The trials will be funded by NSW for a maximum period of three years.51

3.26 The Committee was advised that ‘while NSW will be leading work on a clinical trial(s), a collaborative inter-jurisdictional approach will be taken.’52

45 NSW Terminal Illness Cannabis Scheme Fact Sheet, at:

http://www.nsw.gov.au/sites/default/files/initiatives/carer_factsheet.pdf, accessed 28 April 2015. 46 NSW Terminal Illness Cannabis Scheme Fact Sheet. 47 NSW Terminal Illness Cannabis Scheme Fact Sheet. 48 NSW Government, ‘NSW leads the way on medical cannabis’, 16 September 2014, at

https://www.nsw.gov.au/news/medical-cannabis-trial, accessed 28 April 2015. 49 Submission 23, ACT Government, p. 9. 50 NSW Government, ‘NSW leads the way on medical cannabis’, 16 September 2014. 51 Submission 24, ATODA, p. 5. 52 Submission 23, ACT Government, p. 9.

http://www.nsw.gov.au/sites/default/files/initiatives/carer_factsheet.pdf

https://www.nsw.gov.au/news/medical-cannabis-trial



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3.27 The ACT Government has indicated that it is interested in collaborating with NSW but no actual opportunities to participate exist at present.53 The Committee heard that the ACT could be involved in the first NSW trial involving epilepsy but the ACT would probably not have a trial site here.54 The Committee was also told that the NSW trials may help to inform what sort of cannabis supply is actually provided under a legalised medical scheme. 55

3.28 The Victorian and Queensland governments have announced intentions to join in the NSW clinical trials.56

COMMONWEALTH GOVERNMENT REGULATORY FRAMEWORK

AND INTERNATIONAL CONVENTIONS

3.29 Cannabis use in Australia is governed by the following Commonwealth legislation:57

Customs Act 1901

Customs (Prohibited Imports) Regulation 1956

Crimes (Traffic in Narcotic Drugs and Psychotropic Substances) Act 1990

Narcotics Drugs Act 1967

Therapeutic Goods Act 1989.

3.30 Australia is also signatory to two relevant international agreements:58

Single Convention on Narcotic Drugs 1961 (the 1961 Convention)

Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances 1988.

REGULATOR OF MEDICINAL CANNABIS BILL 2014 (CWLTH)

3.31 On 27 November 2014, the Regulator of Medicinal Cannabis Bill 2014 (the Commonwealth Bill) was presented by Senator Di Natale into the Australian Senate as a Private Members’ Bill on behalf of Senators Di Natale, MacDonald, Leyonhjelm and Urquhart.59

53 Dr Peggy Brown, Transcript of Evidence, 9 April 2015, p. 89. 54 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, pp. 89-90. 55 Dr Peggy Brown, Transcript of Evidence, 9 April 2015, p. 87. 56 Rachel Baxendale, ‘States join marijuana trials’, The Australian, 20 April 2015, p. 8. 57 The ACT Government submission provides a summary of some of the relevant provisions of the Commonwealth

legislation and international agreements; Submission 23, ACT Government, pp. 6-7. 58 The submission by Mr Christodoulou, legal intern at the ANU, also provides an overview of international obligations and

Commonwealth legislation, including requirements under the TGA 1989; Submission 18, Mr Christodoulou, pp. 3-7. 59 Parliament of Australia, Parliamentary Business, Regulator of Medicinal Cannabis Bill 2014, at

http://www.aph.gov.au/Parliamentary_Business/Bills_LEGislation/Bills_Search_Results/Result?bId=s987, accessed 21 April 2015.

http://www.aph.gov.au/Parliamentary_Business/Bills_LEGislation/Bills_Search_Results/Result?bId=s987


3.32 On 12 February 2015, the Senate referred the Regulator of Medicinal Cannabis Bill 2014 (Cwlth) to the Legal and Constitutional Affairs Legislation Committee for inquiry and report. The Senate granted extensions for the Committee (Senate Committee) to inquire and report on the Bill, requiring the Committee to report by 10 August 2015.60

OVERVIEW OF THE BILL

3.33 The Commonwealth Bill establishes a Regulator of Medicinal Cannabis (the Regulator), a statutory agency that will be responsible for formulating rules for licensing the production, manufacture, supply, use, experimental use and import and export of medicinal cannabis.61 The Commonwealth Bill includes a number of components.

3.34 Firstly the regulator will create and maintain a register of regulated medicinal cannabis products. The register will operate like the Australian Register of Therapeutic Goods. 62

The Regulator may approve medicinal cannabis products for inclusion in the register of regulated medicinal cannabis products. Products included in the register are regulated under this Bill, rather than under the Therapeutic Goods Act 1989 (the TGA 1989).63

3.35 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.

3.36 The Regulator will also create a confidential register of licenses for producing, transporting, manufacturing and distributing medicinal cannabis.64 The licences will be subject to strict conditions.

3.37 The Regulator will establish a scheme for authorised patients, carers and medical practitioners to respectively use, supply and prescribe regulated medicinal cannabis.65 Medical practitioners ‘can apply to the regulator on behalf of a patient or carer to whom they intend to prescribe medicinal cannabis’.66

3.38 The Commonwealth Bill provides for experimental cannabis licences to allow authorised persons to produce cannabis, manufacture cannabis products, transport, provide, administer

60 Parliament of Australia, Parliamentary Business, Regulator of Medicinal Cannabis Bill 2014. 61 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) pp. 1-2. 62 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 3. 63 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 1. 64 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 4. 65 Regulator of Medicinal Cannabis Bill 2014 (Cwlth), Division 4. 66 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 4.



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or perform tests on cannabis and cannabis products for an experimental purpose.67 The Regulator will maintain a confidential register of experimental licences.

3.39 Experimental purposes include:

developing and testing varieties of cannabis for medicinal use;

improving methods of cultivating cannabis for medicinal use;

developing and testing cannabis products for medicinal use;

evaluating the efficacy or safety of cannabis products for medicinal use;

improving methods of using or administering cannabis products for medicinal purposes;

performing tests, trials and other experiments for the purposes of making or supporting an application under this Act or the Therapeutic Goods Act 1989, or considering whether to make such an application.68

3.40 The Commonwealth Bill also provides for import and export licences, allowing authorised persons to import or export cannabis or cannabis products for medicinal or experimental purposes. The regulator must maintain a public register of import and export licences.69

3.41 Finally, the Regulator may determine standards for medicinal cannabis and cannabis products, including specifying quality and quantity for a ‘labelled and consistent product for use’.70

CANNABIS DEFINITION

3.42 Under the Commonwealth Bill Cannabis has been defined in the same way as in the 1961 Single Convention on Narcotic Drugs:

The Convention defines “cannabis” to mean “the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated”. The Convention defines “cannabis plant” to mean “any plant of the genus Cannabis”... 71

3.43 Notably the Commonwealth Bill also includes cannabis resin and cannabis plants in the definition (within the meaning of the Convention):

“cannabis resin” to mean “the separated resin, whether crude or purified, obtained

67 Regulator of Medicinal Cannabis Bill 2014 (Cwlth), Division 5. 68 Regulator of Medicinal Cannabis Bill 2014 (Cwlth), Division 5. 69 Regulator of Medicinal Cannabis Bill 2014 (Cwlth), Division 7. 70 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 5. 71 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 2.


from the cannabis plant”.72

3.44 It defines a cannabis product as:

(a) Cannabis, or a product derived from cannabis, that is intended for medicinal use; or

(b) A synthetic version, that is intended for medicinal use, of a product derived from cannabis. 73

STATES AND TERRITORIES

3.45 The Commonwealth Bill is designed to be implemented cooperatively between the Commonwealth and the States and Territories.74 Under the Commonwealth Bill the States and Territories can elect to be a part of the national regulated system:

The Minister may make a determination that a State or Territory that has entered into an arrangement with the Commonwealth to participate in the system is a participating State or Territory. The Ministerial determination is a legislative instrument, but is not subject to disallowance. This reflects the fact that it represents the existence of an agreement between a State or Territory and the Commonwealth.75

3.46 The Explanatory Statement to the Commonwealth Bill notes that ‘the States and Territories are likely to have to change their own laws relating to cannabis if they wish to participate.’76 Clause 8 of the Bill provides for the concurrent operation of State and Territory law, as this Bill is not intended to override State and Territory laws.77

3.47 Officers or employees of participating States and Territories may be required to assist the Regulator, for example ‘keeping the Regulator abreast of state legislative developments’. 78

3.48 The Regulator may also delegate functions and powers to senior officers or employees in State or Territory governments. 79

OFFENC ES A ND S AN CTI ON S

3.49 The Commonwealth Bill does not alter State and Territory Criminal sanctions:

72 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 2. 73 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 2. 74 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 3. 75 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 3. 76 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 3. 77 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 3. 78 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 6; Regulator of Medicinal Cannabis Bill

2014 (Cwlth), Clause 53. 79 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 7.



2 1

State and Territory criminal sanctions relating to illegal substances and drug use may apply to anyone who misuses medicinal cannabis or contravenes this Bill or conditions of a licence under this Bill.80

3.50 Offences for failing to comply with a condition of a medicinal cannabis licence (including an experimental licence or an import or export licence) are also provided for in the Bill.81

3.51 Under the Commonwealth Bill, the Regulator will have certain monitoring and investigative powers by applying the Regulatory Powers (Standard Provisions) Act 2014.82 These include provisions such as search, entry and seizure powers; however those powers only apply in relation to people who have applied to become license holders or authorised cannabis users under the Bill, not the general public.83

SENATE INQUIRY

3.52 As of 10 August 2015, the Senate Committee had not reported its findings.

3.53 This Committee notes that there is some indication in the media that the Commonwealth Bill will be supported.84

80 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 4. 81 Regulator of Medicinal Cannabis Bill 2014 (Cwlth), Division 3; Explanatory Memorandum, Regulator of Medicinal

Cannabis Bill 2014 (Cwlth) p. 5. 82 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 7. 83 Explanatory Memorandum, Regulator of Medicinal Cannabis Bill 2014 (Cwlth) p. 7. 84 Adam Gartrell, ‘Senators give medical marijuana the green light’, Canberra Times, 26 July 2015, at:

http://www.canberratimes.com.au/federal-politics/political-news/senators-give-medical-marijuana-the-green-light-20150725-gik5oq, accessed 30 July 2015.

http://www.canberratimes.com.au/federal-politics/political-news/senators-give-medical-marijuana-the-green-light-20150725-gik5oq

http://www.canberratimes.com.au/federal-politics/political-news/senators-give-medical-marijuana-the-green-light-20150725-gik5oq



2 3

4 PHA RMA CE UT ICAL CA NNAB IS 4.1 When assessing the merits of cannabis for medicinal purposes, evidence tendered to the

Committee called for a distinction between discussions on crude cannabis and pharmaceutical cannabis (or cannabinoid) products.85

PHARMACEUTICAL CANNABINOID PRODUCTS

4.2 Many submissions highlighted that cannabis-derived pharmaceutical formulations have already been developed containing THC and/or CBD including Sativex, Marinol, Cesamet and Cannador.86 Below is an overview of these products and their applications.

SATI VEX

4.3 The Committee was advised that Sativex (nabiximols) is a botanical cannabinoid based mouth spray which delivers a fixed dose of 2.7 mg THC and 2.5 mg CBD.87

4.4 The TGA has already licensed pharmaceutical cannabinoid nabiximols [Sativex] for the treatment of those with muscle spasticity and neuropathic pain in treatment resistant multiple sclerosis patients.88

4.5 MS Australia (MSA) and MS Research Australia note that, to date, clinical trials of Sativex have proven to reduce spasticity, pain and spasms and improve the quality of sleep.89

MARI NO L (GE NE R IC N AM E DR ON AB INO L)

4.6 The Committee was advised that Marinol ‘is an oral synthetic THC preparation that has been used since 1985.’90 It is used for ‘loss of appetite associated with weight loss in people with acquired immune deficiency syndrome (AIDS)’. 91

85 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 34 86 Submission 1, Prof Jan Copeland, Att A – National Cannabis Prevention and Information Centre Bulletin (NCPIC Bulletin)

September 2014, p. 3; Submission 3, Directions ACT; Submission 15, DFA, pp. 6-12; Submission 33, Cannabis Social Club; Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 5.

87 Submission 1, Prof Jan Copeland, Att A – NCPIC Bulletin, September 2014, p. 3. 88 Submission 16, AMA, p. 2. 89 Submission 25, MS Australia and MS Research Australia, p. 6. 90 Submission 1, Prof Jan Copeland, Att A – NCPIC Bulletin, September 2014, p. 3; Assoc Prof Jonathon Arnold, Specialist

Adviser Report, 16 March 2015, p. 5; Mr Gary Christian, Transcript of Evidence, 31 March 2015, p. 58. 91 Marinol, ‘About Marinol’, at http://www.marinol.com/about-marinol.cfm, accessed 18 July 2015.

http://www.marinol.com/about-marinol.cfm


CES AM ET (NA BI LO NE)

4.7 Cesamet is ‘a synthetic cannabinoid analogue of THC’,92 produced as 1mg capsules, which is ‘purported to be more potent than natural THC.’93 Cesamet is indicated for nausea and vomiting caused by cancer chemotherapy and is used when other drugs have not been able to control these symptoms.94

CA NN AD OR

4.8 Cannador is an oral capsule containing a cannabis extract, with reportedly a 2:1 ratio of THC to CBD,95 ‘however the exact THC to CBD ratio has not yet been standardised.’96 It has been clinically tested for reduction of muscle stiffness, spasms and associated pain in Multiple Sclerosis, for anorexia/cachexia in cancer patients and for post-operative pain management.97

EPI DI OL EX

4.9 Epidiolex is an investigational drug for Paediatric epilepsy - specifically Dravet Syndrome and Lennox-Gastaut Syndrome. It is a liquid formulation of highly purified plant-derived CBD which has been granted Orphan Drug Designation by the US Federal Drug Administration. 98

AVAILABILITY

4.10 As noted above, Sativex is the only cannabis derived pharmaceutical registered on the Australian Register of Therapeutic Goods (ARTG) with approval for specific indications.

4.11 Registered drugs can also be prescribed for indications other than the approved indication, which is known as ‘off-label’ prescribing. Off-label prescribing is at the discretion of the prescribing medical practitioner and they may prescribe any medication they think is suitable to treat a particular condition. Off-label use is considered experimental as the TGA cannot vouch for the quality, safety or efficacy of the product for unapproved uses.

4.12 Additional controls on possession and supply of Sativex apply under the legislation of the States and Territories due to its listing in Schedule 8 and Appendix D of the Poisons Standard. Sativex also requires an import permit as it is captured under the Customs (Prohibited

92 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 5. 93 Submission 1, Prof Jan Copeland, Att A – NCPIC Bulletin, September 2014, p. 3. 94 Cesamet, ‘cesamet indications’, at http://www.cesamet.com/patient-home.asp; accessed 18 July 2015. 95 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 5. 96 Submission 1, Prof Jan Copeland, Att A – NCPIC Bulletin, September 2014 p. 3. 97 International Association for Cannabinoid Medicines, ‘Cannador’, at http://cannabis-

med.org/index.php?tpl=def&id=241&lng=en&red=deflist, accessed 18 July 2015. 98 GW Pharmaceuticals, ‘Epidiolex’, at http://www.gwpharm.com/Epidiolex.aspx, accessed 15 July 2015.

http://www.cesamet.com/patient-home.asp

http://cannabis-med.org/index.php?tpl=def&id=241&lng=en&red=deflist

http://cannabis-med.org/index.php?tpl=def&id=241&lng=en&red=deflist

http://www.gwpharm.com/Epidiolex.aspx



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Imports) Regulations 1967. An import permit may specify conditions or requirements concerning possession, safe custody, transportation, use or disposal of the drug.99

4.13 Evidence to the Committee discussed the inadequacy of current arrangements noting that pharmaceutical products are not well publicised, and may raise liability issues.100 Drug Free Australia (DFA), for example, advised that, in regards to the limitations on the use of Sativex:

That means that used off-label the doctor has to take responsibility for any adverse outcomes and is, therefore, not protected by any TGA approval for off-label use.101

4.14 The Committee was advised that other products such as Marinol are available in Australia through the Special Access Scheme (SAS) or under the importation of drugs schemes.102

4.15 The TGA website states that ‘In recognition that there are circumstances where patients need access to therapeutic goods that are not on the ARTG, the TGA manages the SAS and other programs.’103

4.16 Marinol is not listed on the ARTG so is not available for supply in Australia. However, it can be legally imported through personal import exemptions under the Therapeutic Goods Act 1989 and associated regulations. This process requires an Australian registered medical practitioner to obtain authority to prescribe the medication from the relevant State or Territory health department. The medical practitioner then has to apply to the TGA for Special Access Scheme (SAS) approval to treat the patient with the medicine (providing strong clinical justification over existing products). SAS applications are assessed on a case-by-case basis based on the patient, product and prescriber and there is no guarantee of approval. If the SAS application is approved, an application needs to be made for a permit to import, through the Office of Chemical Safety in the Commonwealth Department of Health.104

4.17 DFA proposes that Epidiolex could be made available in Australia on a similar basis to the United States under the Orphan Drug scheme.105 The TGA describes Orphan drugs as follows:

'Orphan drugs' are often developed to treat small and very specific patient populations who suffer from rare diseases and conditions.

The application and evaluation fees for orphan drugs can be waived to:

99 Email from Alex Walsh, Senior Pharmacist, Experimental Products, TGA [in Submission 15, DFA, pp. 9-10]. 100 Submission 15, DFA, p. 8. 101 Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, p. 62.

102 Submission 15, DFA, pp. 6-12; Submission 16, AMA; Submission 1, Prof Jan Copeland, Att A - NCPIC Bulletin; Submission 20, Att A, PHAA.

103 TGA, ‘Special Access Scheme’ at http://www.tga.gov.au/form/special-access-scheme, accessed 3 August 2015 104 Email from Kate Lawrence, Pharmacist, Experimental Products, TGA [in Submission 15, DFA, pp. 7-8]. 105 Submission 15, DFA, p. 11.

http://www.tga.gov.au/form/special-access-scheme


help reduce their development costs; and

facilitate their access to the Australian marketplace;

However, a medicine needs to be:

designated by [the TGA] as an orphan drug before an application can be accepted to register it on the ARTG; and

evaluated for quality, safety and efficacy in the same way as other registered medicines.106

BENEFITS

4.18 Some parties also demonstrated a distinctive preference to investigate pharmaceutical not crude cannabis for medicinal purposes.

4.19 Aside from their medical indications, the Committee was advised about the potential benefits of pharmaceutical cannabis products from a regulatory perspective, including that they:

are able to be regulated as a therapeutic good, which has been tested for efficacy, safety, quality and the side effects are likely to be known;

are able to be prescribed as a consistent, dosed product;

could be dispensed through a pharmacy and therefore monitored through existing prescription scrutiny arrangements; and

are possibly more publicly acceptable than crude cannabis, like other prescription medication.107

4.20 The AMA, for example, would prefer to see pharmaceutical cannabis products available for medicinal use that have been subjected to the existing quality and efficacy standards as other medicinal products:

We would like to see a quality controlled therapeutic substance. Raw cannabis has a lot of different components and chemicals within it, some of which have a therapeutic advantage and some of which purely give the highs and the psychotropic effects of cannabis, and they may well be quite different. We would really like to be able to get a quality controlled, targeted product out if we are going to use it, rather than just the crude product, which is more like a sledgehammer in terms of its effects.108

106 TGA, ‘Applications for orphan drug designation’, at https://www.tga.gov.au/applications-orphan-drug-designation,

accessed 18 July 2015. 107 Submission 16, AMA, p. 2; Submission 3, Directions ACT; NSW Committee Report, 15 May 2013, pp. 27-31. 108 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 35.

https://www.tga.gov.au/applications-orphan-drug-designation



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4.21 The AMA further advised that:

it is imperative that the integrity of our current pharmaceutical regulatory scheme is maintained. We do not believe that pharmaceutical cannabis should be held to any higher or lower standards for evidence of quality, safety and efficacy than other therapeutic products.

The standards and approval processes we have in place around pharmaceuticals in Australia are there to ensure that therapeutic products are safe and effective. Bypassing this system for pharmaceutical cannabis risks undermining the integrity of the pharmaceutical regulatory scheme, creating a precedent that could potentially be used to introduce other drugs into medical practice without evaluations of their safety and efficacy.109

....

In contrast [to crude cannabis], pharmaceutical preparations of cannabis can be standardised and strictly regulated in both their preparation and administration, thereby reducing the harm potential to the user and to the wider society.110

4.22 The Committee heard that a large number of alternative herbal-type preparations also go through a TGA approval process before they can be sold publicly.111

4.23 The Committee was advised that medication ‘that does not satisfy the internationally recognised standards of quality, safety and efficacy’ should not be used.112 Looking at other herbs that have been subjected to pharmaceutical extraction and synthesis, the Committee was advised that a pharmaceutical approach is preferred to:

establish a safe and effective standardised dose for the active principle in the herb so that the doctor would know exactly what the patient was getting and could alter the dose up or down to get the desired therapeutic response.113

4.24 The Committee heard from DFA that the availability of legal, safe, trialled pharmaceutical cannabis-based products should eliminate the need for crude cannabis to be considered medicinally. They advised that,

some 100 doctors already in New South Wales can legally prescribe these medications for known conditions, such as nausea and wasting diseases associated with AIDS et cetera. So there seems to us no reason why you would go beyond the use of these medications and legislate to legalise a form of cannabis that is lacking in

109 Submission 16, AMA, p. 2; Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 34. 110 Submission 16, AMA, p. 2. 111 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 41. 112 Submission 6. 113 Submission 6.


known purity, constituency or safety when we already have drugs that are available that have been through the regulatory processes, have been extensively trialled and are currently available.114

4.25 The AMA ‘acknowledges that there may be sufficient robust scientific evidence to indicate that pharmaceutical cannabis can be effective for certain conditions in very specific circumstances.’115

LIMITATIONS OF CURRENT PHARMACEUTICAL CANNABIS

PRODUCTS

4.26 Despite the possible benefits, pharmaceutical products also have limitations.

SI DE EFFE CTS AN D EFF I C ACY

4.27 In many cases the efficacy and side effects of products are still being established, particularly in regard to long term usage, due in part to the limited clinical studies that have been possible.

4.28 The Committee was advised that Sativex is not always effective and can have side effects that vary with each case including dizziness, tiredness, depression, memory loss and nausea.116

4.29 One submission noted the limitations of trials conducted with pharmaceutical cannabis product:

These trials ... found that while beneficial effects were achieved most trials were only short-term in duration and longer trials are needed in order to comprehensively gauge the therapeutic benefits of cannabinoids.117

LIM ITE D A PP ROV AL

4.30 The pharmaceutical cannabis products listed above are only approved for limited indications. Public Health Association of Australia (PHAA) notes, for example that Sativex is registered in Australia for just one indication, ‘symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis’.118

114 Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, p. 54. 115 Submission 16, AMA, p. 1. 116 Submission 25, MS Australia and MS Research Australia, p. 6. 117 Submission 1, Prof Jan Copeland, Att A – NCPIC Bulletin, September 2014, p. 1. 118 Submission 20, PHAA, Att A.



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CH EM I CAL M AKE-UP

4.31 Evidence tendered to the Committee advised that pharmaceutical cannabis preparations may be limited because they are unable to produce the ‘entourage effect’ (the synergistic mix of constituents) of crude cannabis.119 The purported benefits of crude cannabis are discussed further in Chapter 6.

4.32 DFA, however, advised the Committee that Sativex is a whole-plant extract that can offer the same benefits as botanical cannabis because the cannabinoids are intact.120 They note that as an oral spray it gets to the brain quickly through the mucous membranes. 121

COST CO N CE R NS

4.33 The Committee heard that one of the greatest barriers to the use of pharmaceutical cannabis products was cost.122 It was advised that Marinol costs around $2,500 a month and Sativex around $500 to $800 a month. 123

4.34 FFDLR advised that it is prohibitively expensive to use cannabis in pharmaceutical form like Dronabinol as it is not subsidised by the government. It also requires permission from the Commonwealth government to prescribe.124

4.35 DFA, however, advised that the cost for illegal cannabis is the same as Sativex: ‘it costs $12 a gram for illegal cannabis. It costs the same for Sativex - $500 a month for both, whichever way you go.’125 The PHAA advised that $20 a gram is the median price for hydroponic cannabis in the ACT.126

APP LI CAT I ON

4.36 The Committee heard that the application of some forms of medicinal cannabis may also be problematic. FFDLR advised, for example, that people suffering nausea have difficulty keeping products in capsule or pill form down.127

119 Submission 22, Mr Justin Sinclair, p.14; Submission 24, ATODA, p.6; Mr William Bush, Transcript of Evidence, 31 March

2015, p. 51. 120 Mr Gary Christian, Transcript of Evidence, 31 March 2015, pp. 58-59. 121 Mr Gary Christian, Transcript of Evidence, 31 March 2015, p. 61. 122 Mr Nicholas Christodoulou, Transcript of Evidence, 13 March 2015, p. 22; Mrs Marion McConnell, Transcript of

Evidence, 31 March 2015, p. 51; Submission 20, Att A, PHAA; Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, p. 54.

123 Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, p. 54; Submission 28, p. 6. 124 Mr William Bush, Transcript of Evidence, 31 March 2015, p. 44. 125 Mr Gary Christian, Transcript of Evidence, 31 March 2015, p. 63. 126 Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 69. 127 Mrs Marion McConnell, Transcript of Evidence, 31 March 2015, p. 51.


DE MA ND

4.37 DFA noted that there appears to be small demand for pharmaceutical cannabis preparations, possibly due to reluctance from doctors to prescribe it given known side effects and the availability of other, well understood pharmaceuticals. In addition to cost, patients may also be averse to trying them in light of side effects.128

4.38 It is difficult to assess how much the demand has been limited by the difficulties accessing pharmaceutical cannabis products.

OPPORTUNITIES

IMPORTATION PROCESSES

4.39 The Committee heard that streamlining the importation process could be possible if there was sufficient demand, enabling drugs like Sativex to be stocked in Australia. 129

4.40 MSA and MS Research Australia noted that they would welcome Sativex being more easily available in Australia if regulations regarding access to cannabis-derived products were to change.130

PHARMACEUTICAL BENEFITS SCHEME LISTING

4.41 Evidence to the Committee suggested that including existing cannabis-derived pharmaceutical products on the Pharmaceutical Benefits Scheme (PBS) would potentially overcome some affordability concerns.

4.42 The Committee was advised to lobby the Commonwealth Government:

to have Marinol, Sativex and, in due course, Epidiolex placed on the PBS scheme to reduce the cost of it. If that is the major barrier to people using it, a PBS listing might facilitate much wider use of the drug in those life-threatening situations where people are suffering nausea and loss of appetite and so on, where there is some evidence to show that cannabis is of some value.131

4.43 The Committee notes that inclusion of Sativex on the PBS does not appear likely in the near future with MSA and MS Research Australia advising that:

In July 2013 both MSA and MS Research Australia each wrote to the PBAC [Pharmaceutical Benefits Advisory Committee] secretariat in support of the inclusion

128 Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, p. 54. 129 Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, pp. 54-55. 130 Submission 25, MS Australia and MS Research Australia, p. 5. 131 Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, p. 55.



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of Sativex on the Pharmaceutical Benefits Scheme (PBS), although this application was not approved by the PBAC.132

ADDITIONAL USES

4.44 There are additional potential uses for cannabis derived pharmaceutical products that have been subject to some level of testing and clinical trial and show some efficacy as outlined earlier, such as for symptomatic relief for Parkinson’s disease, Alzheimer’s disease, and anti-inflammatory uses.

4.45 DFA advised that:

Certainly extending the uses to which it might be put would probably mean that doctors would be far more ready to prescribe it. There might be a barrier there to prescribing it, but not one that doctors are normally too concerned about. If they believe a product is in the best interests of the patient and there is an adverse outcome then generally the doctor has grounds for defence of that decision and is normally supported in that.133

COM MITT EE CO MM ENT

4.46 The Committee notes that there are opportunities to improve access to pharmaceutical cannabis products.

Recommendation 1 4.47 The Committee recommends that the ACT Government write to the Commonwealth

Minister for Health requesting the Commonwealth Government:

consider including Sativex and Marinol on the PBS to improve affordability;

consider providing easily accessible guidance material to medical practitioners on:

how to go about prescribing approved pharmaceutical cannabis products off-label;

the requirements of the Special Access Scheme and associated importation requirements;

simplify off-label prescribing and Special Access Schemes so that the processes can be navigated by medical practitioners with ease and are not excessively protracted; and

consider expanding access to approved pharmaceutical cannabis products for additional indications.

132 Submission 25, MS Australia and MS Research Australia, p. 5. 133 Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, p. 62



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5 ME DICAL RES EA RCH

BARRIERS

5.1 A range of submissions to the Committee noted the limitation to medical research and development caused by the illegal status of cannabis products.134

5.2 As noted earlier, cannabis is illegal in all Australian states. It is listed under Schedule 9 of the Poisons Standard135, meaning it has ‘no currently established therapeutic value’ or the dangers to the community outweigh any benefits and warrant ‘limiting use to strictly controlled medical and scientific research’.136

5.3 FFDLR, for example, advised the Committee that the illegality of cannabis has impeded the objective assessment of cannabis for good and for bad.137 They note that:

It has usually been the case that research funding has been provided for those studies that add to the weight of demonisation. Rarely has funding in Australia been given to research that runs the risk of challenging the stated position that the use of cannabis is dangerous. Indeed, the prohibition laws and the consequential propaganda have prevented research into the beneficial aspects of cannabis and have limited its use for medical purposes.138

5.4 ATODA similarly highlighted the difficulties for medical research caused by governments locally and internationally creating legislative barriers to accessing cannabis for medical research purposes, resulting in gaps in knowledge about the palliative uses of cannabis including,

the most effective modes of administration, and the most appropriate strains and doses of cannabis for particular conditions and to suit individual circumstances. There has been little progress in developing medical treatments using synthetic or semi-synthetic cannabinoids...139

5.5 The Committee was advised by Associate Professor Jonathon Arnold that the illegal status

134 Submission 3, Directions ACT; Submission 20, PHAA; Submission 30, FFDLR; Submission 24, ATODA. 135 Submission 20, PHAA, Att A. 136 TGA, AHMAC - Scheduling policy framework for medicines and chemicals, at https://www.tga.gov.au/book/chapter-3-

classification-medicines-and-chemicals-schedules. 137 Submission 30, FFDLR, p. 1; Mr William Bush, Transcript of Evidence, 31 March 2015, p. 46. 138 Submission 30, FFDLR, p. 2. 139 Submission 24, ATODA, pp. 2-3.

https://www.tga.gov.au/book/chapter-3-classification-medicines-and-chemicals-schedules

https://www.tga.gov.au/book/chapter-3-classification-medicines-and-chemicals-schedules


and prohibited drug scheduling has hindered research and development of medicinal cannabis and medicinal cannabinoids. He notes in particular that it ‘has placed roadblocks in the way of obtaining the required plant strains and compounds for conducting research.’140

5.6 Additionally, Associate Professor Arnold highlighted that:

Much of the current evidence concerning the therapeutic efficacy of the cannabinoids has focused on THC which is psychoactive, and to a lesser extent cannabidiol (CBD) which is non-intoxicating and holds much therapeutic potential. However there are 100’s of other non-intoxicating cannabinoids from the plant with promising therapeutic potential yet to be examined for their medical properties, for example CBDA [cannabidiolic acid], CBDV [cannabidivarin], THCV [tetrahydrocannabivarin], THCA [tetrahydrocannabinolic acid], THCVA [tetrahydrocannabivarin-acid], CBG [cannabigerol] and CBC [cannabichromene].

Current legislation groups all of these cannabinoids under Schedules 8 or 9 [of the Poisons Standard] in Australia, even though these drugs do not have psychoactive properties, have no addictive potential, and yet have promising therapeutic benefits in preclinical and early stage human explorations.141

SUPPORT

5.7 The Committee notes wide-ranging support for cannabis and cannabis-derived pharmaceutical products to be more easily and legally available for medical research and development purposes.142

5.8 FFDLR, for example, supports further research for the development of cannabis or its derivatives as a medicine.143

5.9 The Committee was advised by ATODA that it supports clinical trials in order to contribute to evidence-informed policy. They note that there is now widespread Australian support ‘on the part of state governments, professional bodies and others, for the implementation of clinical trials of therapeutic products containing or derived from cannabis.’144

5.10 MSA and MS Research Australia support research to develop ‘robust and reliable evidence to determine the possible benefits and risks of cannabis for managing symptoms of chronic

140 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 23. 141 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 23. 142 Submission 7, Prof David Penington, Att A – ‘Medical Cannabis: Time for Clear Thinking’, Medical Journal of Australia

(MJA), 2 February 2015, p. 75; Submission 20, PHAA; Submission 30, FFDLR; Submission 16, AMA; Submission 24, ATODA;. Submission 25, MS Australia and MS Research Australia.

143 Submission 30, FFDLR, p. 9. 144 Submission 24, ATODA, p. 4.



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illnesses such as MS.’145 They note that:

we would encourage the promotion of randomised controlled clinical trials to be conducted to determine the components, dosage and frequency of either cannabis or cannabis-based products and their effectiveness in managing a range of symptoms for people living with chronic conditions like MS.

5.11 They also note that Sativex is not a cure for MS and ‘while this treatment has clinical trial data and approval for spasticity, there may as yet, be other MS symptoms that could be investigated in clinical trials.’146

5.12 The AMA advised the Committee that:

the AMA has welcomed recent efforts by governments to support clinical research into pharmaceutical cannabis. We believe urgent investment in such research is vital to underpin and evidence-based approach to the clinical use of pharmaceutical cannabis.147

5.13 However, the AMA notes that a nationally consistent and coordinated approach to research is imperative to support policy and targeted research:148

We note that several clinical trials into pharmaceutical cannabis are already under way in Australia, and there is a growing evidence base showing its therapeutic value in treating some conditions. Policy decisions and research investment should be informed by the existing evidence, consolidating on what we already know, identifying gaps in our understanding, and pinpointing areas where further research is required. We believe a collaborative and cooperative approach will better support effective policy and targeted research, avoiding a reactive and ad hoc approach or the inconsistent patchwork of state laws and regulations that have emerged in some overseas jurisdictions.149

PHARMACEUTICAL FOCUS

5.14 The AMA advocates that the primary focus of clinical research should be on pharmaceutical preparations not crude cannabis:

...Pharmaceutical preparation[s] offer the most promising type of cannabinoid preparation for clinical research and, if proven safe and effective for medical

145 Submission 25, MS Australia and MS Research Australia, p. 5. 146 Submission 25, MS Australia and MS Research Australia, p. 6. 147 Submission 16, AMA, p. 1. 148 Submission 16, AMA, p. 1. 149 Submission 16, AMA, p .1.


prescription under supervision.150

5.15 DFA advised the Committee that there was no need for additional clinical trials of crude cannabis for medicinal purposes:

There are already trials. Plenty of studies have looked at crude cannabis versus Marinol—all those kinds of things. I do not think there is any real point at this stage. You can do studies, as they want to do in New South Wales. We spoke to them. They want to make their own Sativex, if you like; they want to make their own product. That is fine; that is great. Pharmaceutical—not a problem.151

5.16 With regard to research, the Committee also heard that the advancement of medicinal cannabinoids through scientific and medical development of ‘cannabis-like compounds’ should not be confused with the medicinal [crude] cannabis debate. Associate Professor Arnold advised that:

Medicinal cannabinoid development first aims to provide preclinical evidence for biological plausibility, therapeutic efficacy and toxicology of cannabinoid pharmaceutical drugs before examination at various stages of the clinical trial process.152

5.17 He advised that medicinal cannabinoids could be:

1) pure phytocannabinoids, 2) synthetic analogues of phytocannabinoids, 3) synthetic drugs that modulate the activity of the endocannabinoid system, 4) pure phytocannabinoid drug combinations or, 5) cannabinoid extract formulations like Sativex that contain consistent doses of THC and CBD that have been manufactured according to Good Manufacturing Practice (GMP).

The ultimate aim is to test in a phase III therapeutic trial that could provide sufficient evidence to support the marketing and sale of the product. The cannabinoid would be administered via a safe non-smoking route of administration using a formulation abiding by GMP.153

5.18 The Committee was advised that there is ‘emerging preclinical evidence for the efficacy of a variety of other plant-based non-intoxicating cannabinoids in treating a wide variety of disease states’ including ‘analgesic, anticonvulsant, anti-inflammatory, and anti-cancer properties’.154 These cannabinoids require ‘further more extensive characterisation’, noting

150 Submission 16, AMA, p. 2. 151 Mr Gary Christian, Transcript of Evidence, 31 March 2015, p. 61. 152 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 23. 153 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 22-23. 154 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 4-5.



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that they ‘can be isolated as pure substances and therefore, if found effective in treating a medical condition, might be more easily progressed to clinical trials.’155

OPPORTUNITIES

POISONS STANDARD SCHEDULING

5.19 The Committee was advised that the future of medicinal cannabis, including the ability to conduct additional and larger medical cannabis trials could be improved by relaxing legal restrictions on research and development. In particular, Associate Professor Arnold proposed reclassification of the scheduling for cannabis and certain cannabinoids under the Poisons Schedule, suggesting the Commonwealth should:

move the non-psychoactive, non-addictive cannabinoids into a lesser schedule... leaving only THC in Schedule 8. Cannabis itself also should be moved from Schedule 9 to Schedule 8 along with Sativex, reflecting the plants’ immense therapeutic potential.156

5.20 Until recently, cannabidiol was not specifically scheduled in the Poisons Standard. As a constituent of cannabis, the substance was captured by the entry for cannabis in Schedule 9. The Committee notes that in late 2014 the Victorian and Western Australian Departments of Health applied to the Commonwealth to have cannabidiol classified as a Schedule 4 substance, which is the least restrictive schedule for prescription medicines. 157 The TGA agreed to amend the schedule, classifying cannabidiol as a Schedule 4 substance from 1 June 2015.158 The Schedule 4 listing is for:

CANNABIDIOL in preparations for therapeutic use containing 2 per cent or less of other cannabinoids found in cannabis159

5.21 The Victorian Department of Health and Human Services noted that:

While there are currently no cannabidiol products available in Australia, there will be fewer restrictions around importing cannabidiol products from overseas or using them in clinical trials160

155 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 5. 156Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 24. 157 Department of Health, State Government of Victoria, Drugs & Poisons Regulation in Victoria: ‘Medicinal Cannabis’, at

http://www.health.vic.gov.au/dpcs/medicinal-cannabis.htm, accessed 28 July 2015. 158 TGA, ‘Reasons for medicines scheduling delegates final decisions’, 19 March 2015, at

https://www.tga.gov.au/book/part-final-decisions-matters-referred-expert-advisory-committee-2, accessed 1 July 2015.

159 TGA, ‘Reasons for medicines scheduling delegates final decisions, March 2015’, 19 March 2015. 160 Department of Health, State Government of Victoria, Drugs & Poisons Regulation in Victoria: ‘Medicinal Cannabis’.

http://www.health.vic.gov.au/dpcs/medicinal-cannabis.htm

https://www.tga.gov.au/book/part-final-decisions-matters-referred-expert-advisory-committee-2



5.22 The Committee notes that pharmaceutical cannabinoid preparations, if and when they meet all TGA requirements for registration, can be accessed off-licence. Others can be accessed under special access arrangements. Pharmaceutical products are more likely than crude cannabis to be acceptable to patients, regulators, law enforcement and the general public and able to be endorsed by the medical profession and those seeking firm assurance of efficacy, safety and consistency.

5.23 The Committee supports the availability of cannabis and cannabinoid pharmaceutical products for medical research and clinical trials.

5.24 The Committee notes that barriers to research and development in the field of medicinal cannabis and cannabinoids need to be reduced, commensurate with associated risks.

5.25 The Committee notes that there may be additional non-psychoactive, non-addictive cannabinoids that could be moved to a lesser schedule to facilitate additional research and trial opportunities.

5.26 The Committee also notes the trials being led by NSW, the ACT Government’s interest in being involved in those trials and similar, concurrent and adjoined trials being planned in other Australian jurisdictions. The Committee notes that there are patients in the ACT who may be suitable candidates for the proposed interstate clinical trials and that the ACT Government could help facilitate patient participation and support an ACT-based trial site.

Recommendation 2 5.27 To facilitate the research and development of medicinal cannabis and cannabinoid

preparations, the Committee recommends that the ACT Government write to the Commonwealth Minister for Health requesting the Commonwealth Government investigate amending the Poisons Standard by:

amending Schedule 9 to facilitate medical or scientific research; and

moving other non-psychoactive, non-addictive cannabinoids into a lesser schedule as has been done for cannabidiol.

Recommendation 3 5.28 The Committee recommends that the ACT Government work together with other State,

Territory and Commonwealth governments to conduct further clinical trials of pharmaceutical products and crude cannabis.



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Recommendation 4 5.29 The Committee recommends that the ACT Government work together with other State,

Territory and Commonwealth governments to help facilitate ACT patient access to upcoming interstate trials.



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6 SUP P ORT FOR A M E DIC INAL CA NNAB IS

S CHEM E 6.1 The Committee received a range of evidence supporting establishment of a medicinal

cannabis scheme, including evidence that it is proven to assist certain conditions and symptoms, it is affordable and is already available in some jurisdictions overseas.

6.2 In some cases, evidence specifically supported crude cannabis, and others pharmaceutical preparations only. The majority acknowledged that cannabis and/or cannabinoid preparations have potential medicinal applications.161

COMPASSIONATE APPROACH

6.3 The majority of participants in favour of medicinal cannabis argued for a compassionate approach, particularly for those with a terminal illness or serious health condition.162

6.4 The PHAA, for example, advocates for a compassionate regime, enabling authorised patients to possess and use cannabis without penalty, operating in parallel with the way medicines that are produced through medical science are managed.163

6.5 FFDLR advised the Committee that it unequivocally supports medical use of cannabis for symptomatic if not curative relief for a number of conditions as well as the removal of criminal sanctions, 164 stating that, ‘FFDLR wholeheartedly endorses the underlying rationale of the exposure draft as expressed in the discussion paper namely “that people suffering from chronic pain or terminal illness should have the right to make decisions about their treatment”.’165

6.6 Winnunga Nimmityjah Aboriginal Health Service (Winnunga) advised the Committee that they support the availability of medicinal cannabis in principle and acknowledge advocacy for

161 Submission 4, Mr Justin Kander; Submission 8; Submission 9, AIDS Action Council ACT; Submission 12; Submission 13;

Submission 14, Dr Karen Downing; Submission 17; Submission 19, Nimbin HEMP Embassy; Submission 22, Mr Justin Sinclair, p. 3; Submission 31; Submission 27; Submission 28; Submission 29; Submission 35.

162 Submission 2, Ms Barbara Mummery; Submission 3, Directions ACT; Submission 4, Mr Justin Kander; Submission 5; Submission 7, Prof David Penington; Submission 8; Submission 9, AIDS Action Council ACT; Submission 12; Submission 14, Dr Karen Downing; Submission 17; Submission 20, PHAA; Submission 22, Mr Justin Sinclair; Submission 28; Submission 29; Submission 31; Submission 32, Mr Shane Rattenbury MLA; Submission 35; Mr Grant Beale, Transcript of Evidence, 13 March 2015, p. 24.

163 Submission 20, PHAA; Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 51. 164 Submission 30, FFDLR, p. 8. 165 Submission 31, FFDLR, p. 2.


the Draft Bill.166

6.7 The Committee was advised that there is a need to ‘remove the legal burden and stigma experienced by otherwise law abiding citizens’167 and a legal medicinal cannabis system would reduce the anxiety of individuals who treat their condition or symptoms with cannabis and would prefer not to defy the law.168

6.8 The Committee heard that the ‘AMA ACT are generally supportive of looking into medical cannabis as an option for management or treatment of people with specific diseases that are unresponsive to other measures.’169 They advised that any scheme needs to be in the best interest of the majority of the community and based on evidence rather than emotion.170

EVIDENCE OF EFFICACY

6.9 A range of submissions supported medicinal cannabis, highlighting conditions and symptoms for which cannabis treatment is effective including side effects of chemotherapy and radiation therapies, pain relief, alleviating symptoms of nausea and increasing appetite.171

6.10 The Committee was advised by FFDLR, for example, that the US Institute of Medicine has concluded that, for patients with severe pain, appetite loss and nausea as a result of AIDS or chemotherapy treatments, ‘cannabinoid drugs might offer broad spectrum relief not found in any other single mediation’.172 They further note that:

It has been shown in numerous studies here and overseas that cannabis has the capacity to relieve nausea, depression or pain in terminal cancer, improve appetite in people with AIDS and other debilitating diseases and bring relief of muscle spasm in persons seriously disabled by multiple sclerosis.173

6.11 The Committee was also advised that cannabis is a recognised treatment internationally for glaucoma, ‘a condition of the eyes of rising intra-ocular pressure'.174

166 Submission 21, Winnunga. 167 Submission 28, p. 5. 168 Submission 26, Mr Grant Beale; Submission 28; Submission 17; Submission 31; Mr Marc Pengryffyn, Transcript of

Evidence, 13 March 2015, p. 15. 169 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 34 170 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 40 171Submission 4, Mr Justin Kander; Submission 5; Submission 7, Prof David Penington; Submission 9, AIDS Action Council

ACT; Submission 11, Dr June Garfit, Submission 19, Nimbin HEMP Embassy, p. 1; Submission 22, Mr Justin Sinclair. 172 Mr William Bush, Transcript of Evidence, 31 March 2015, pp. 43-44. 173 Mr William Bush, Transcript of Evidence, 31 March 2015, pp. 43-44. 174 Submission 11, Dr June Garfit.



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USE UNDER MEDICAL SUPERVISION

6.12 The Committee was advised that legalising cannabis for medicinal use would reinforce doctor-patient relationships.175

6.13 Mr Grant Beale told the Committee that his mother had discussed the idea of using medicinal cannabis with a number of her doctors, who did not raise any issues other than one comment that it is illegal.176 He noted a lot of doctors did not know of, or knew little about, the endocannabinoid system.177

6.14 FFDLR noted that a lot of patients ‘would prefer to have the direction of their doctor to help’.178

COMMUNITY SUPPORT

6.15 The Committee was also advised about the widespread public support for legislative change permitting the use of crude cannabis for medicinal purposes.179

6.16 The Committee received evidence that there is support in the Australian community for medicinal cannabis. FFDLR, for example,

notes that 69 per cent of people in a recent Australian Institute of Health and Welfare survey indicated that they support legislation to allow medical use of cannabis, matched with 74 per cent of participants showing support for clinical trials investigating the benefits of cannabis for medical conditions.180

6.17 ATODA noted that there is support within the ACT and Australian communities for a legal therapeutic/medicinal cannabis regime.181 ATODA also notes that it is concerned about the quality of information and debate taking place and has therefore been active in contributing to the debate in the ACT and more broadly.182

6.18 However, the Committee heard from DFA that published statistics supporting medicinal cannabis should not be relied upon:

Sixty-nine per cent of Australians approve the legality of cannabis for medical use. But 175 Submission 28, p. 5; Submission 24, p. 9. 176 Mr Grant Beale, Transcript of Evidence, 13 March 2015, pp. 27, 32. 177 Mr Grant Beale, Transcript of Evidence, 13 March 2015, p. 32. 178 Mr William Bush, Transcript of Evidence, 31 March 2015, pp. 45-46. 179 Submission 20, PHAA, Att A; Submission 24, ATODA; Submission 28, p. 9; Submission 30, FFDLR, p. 6. 180 Submission 30, FFDLR, p. 6. 181 Submission 24, ATODA, pp. 1, 3. 182 Submission 24, ATODA, p. 1.


most Australians are not medical practitioners and do not even have a vague clue about what conditions it might alleviate. Unfortunately, with the non-existent public debate on medical cannabis which the Australian media seems to have serendipitously denied the public, the latter approval percentages are based on ignorance and can carry no weight until such a robust debate has been had.183

LIMITED SUPPORT

6.19 The Committee also received evidence from those who acknowledged the potential benefits of cannabis for medicinal purposes, but do not appear to support a scheme based on the use crude cannabis.

6.20 The AMA advised that if medicinal cannabis is to be legalised, it should be done in the context of a trial:

where the risks and benefits can be quantified, where the doses can be monitored, and the method of delivery can be directed and administered in its safest form. Ideally, we would develop synthetic cannabinoids directed at the therapeutic benefits while bypassing the psychotropic and psychological effects.184

6.21 Directions ACT ‘unequivocally supports a compassionate approach to the use of pharmacological cannabinoids’ and notes that the medical, pharmaceutical and scientific fraternities are best placed to decide when and how medicinal cannabis should be made available.185

6.22 MSA and MS Research Australia also support ‘any proven treatment that has been deemed safe by the Therapeutic Goods Administration and that helps to minimise the impact of the disease and allow people with MS to live more fulfilling lives.’186

CRUDE CANNABIS

6.23 The Committee received a wide range of evidence in support of legalising the medicinal use of crude cannabis and its derivatives like oils and resins.187

6.24 ATODA supports a scheme that:

removes the legal impediments to people using cannabis medicinally, including 183 Mr Gary Christian, Transcript of Evidence, 31 March 2015, p. 56. 184 Submission 16, AMA, p. 3. 185 Submission 3. Directions ACT. 186 Submission 25, MS Australia and MS Research Australia, p. 5. 187 Submission 20, PHAA; Submission 24, ATODA; Submission 35; Submission 17; Submission 26, Mr Grant Beale.



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providing for the legal cultivation, possession, consumption and supply of the drug to be used for medicinal purposes by people experiencing debilitating health conditions that have been shown to respond positively (in some patients at least) to cannabis.188

6.25 ATODA advised the Committee that it wants the perspectives of people with a multitude of viewpoints to be considered, particularly those with health conditions relevant to the discussion. ATODA noted that it:

is concerned that sections of the medical profession are taking too narrow an approach on this topic, failing to acknowledge what many see as the bottom line: the fact that many people in our community have poor quality of life owing to debilitating illnesses that are not relieved by standard medical practice, or who are experiencing severe adverse side-effects of medical treatment, and that for many of these people cannabis used medicinally assists in relieving these distressing health conditions.189

6.26 As outlined in Chapter 4, however, the current suite of pharmaceutical medicinal cannabis products have limitations including use and accessibility.

6.27 The Committee was advised that the limited approval of pharmaceutical products supported calls for access to crude medicinal cannabis. The PHAA notes that:

Considering that pharmaceutical cannabis is legally available in Australia in only one form and for only one narrow indication, the regime needs to also include provisions for the removal of penalties in very limited circumstances for the use of botanical cannabis and its extracts ingested through various routes of administration including smoking (for adults only), vaporisers and food products.190

ENTOURAGE EFFECT 6.28 The Committee was advised about the benefits of the ‘entourage effect’ of crude cannabis191

which is currently not found in available pharmaceutical preparations:

This plant is not a single active constituent pharmaceutical agent that can utilise altered dosing regimes to change therapeutic outcomes...it is the differing levels of various constituents, and the synergistic effect they have, that produces an overall pharmacological action (the entourage effect), so represents a significantly different paradigm to what modern medical practitioners are used to in the current orthodox model.192

188 Submission 24, ATODA, p. 6. 189 Submission 24, ATODA, p. 2. 190 Submission 20, PHAA. 191 Submission 22, Mr Justin Sinclair; Submission 24, ATODA; Submission 28, p.7; Mr William Bush, Transcript of Evidence,

31 March 2015, pp. 51. 192 Submission 22, Mr Justin Sinclair, p. 14.


6.29 FFDLR highlighted their understanding of the benefits of crude cannabis:

As Professor Mather referred to, there is a so-called entourage effect of these other drugs. This is where a lot of the uncertainty in relation to cannabis arises. You have the relative purity of Marinol and Sativex and things like that, but how much of the benefit of natural cannabis comes from the so-called entourage effect of the interplay between this large range of particular drugs and their effect? It is really a ground for serious research, but it is going to take years and years to reduce that level of uncertainty.

6.30 ATODA noted that:

The currently available pharmaceutical products derived from the cannabis plant and synthetic cannabinoids fail to meet the needs of many people who are very unwell from health conditions that have been demonstrated, through sound clinical and epidemiological research, to respond well, among some patients, to cannabis in its various forms.193

AFFORDABILITY

6.31 Affordability was also touted as a strong reason for crude cannabis to be made available or decriminalised for medicinal use.194

A SCHEME FOR TERMINALLY ILL VERSUS CHRONIC CONDITIONS

6.32 The Committee received mixed advice on which medical conditions or indications should be included in a medicinal cannabis scheme.

6.33 The PHAA advised the Committee that the medicinal cannabis debate should be looked at as two separate issues: medicinal cannabis use by people with a terminal illness and then those with a chronic disease or pain. They note that removing penalties in the first situation is quite straightforward as there is little concern about side effects for terminally ill patients and this should be a starting point for legislative change. 195

6.34 ACT Medicare Local similarly advised the Committee that the majority of GPs would likely support the possession and use of medicinal cannabis for the mitigation of a symptom of a terminal illness or its treatment, noting it could be a ‘unique opportunity to study the drug’.196

193 Submission 24, ATODA, p. 6.

194 Submission 22; Mr Justin Sinclair; Submission 18, Mr Nicholas Christodoulou, p. 2; Mr Nicholas Christodoulou, Transcript of Evidence, 13 March 2015, p. 19; Dr Karen Downing, Transcript of Evidence, 13 March 2015, p. 3.

195 Adjunct Prof Michael Moore, Transcript of Evidence, 31 March 2015, p. 65. 196 Submission 34, ACT Medicare Local.



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6.35 PHAA noted that the issues become more complex with chronic disease:

The side effects of using cannabis to provide relief from the symptoms of some chronic illnesses need to be taken into account in assessing these trade-offs. Current evidence suggests that adverse effects of short-term use are generally modest, but further research is needed to evaluate adverse effects of long-term use including risk of dependence, exacerbation of cardiovascular disease and precipitation of psychotic disorder.197

6.36 The Committee also heard that legalisation of medicinal cannabis should be ‘made available to a wide range of people with chronic illness, not just the terminally ill.’ 198

6.37 The PHAA provided similar comments:

The compassionate medicinal cannabis regime go further than serving only terminally ill people, with possession and use of botanical cannabis and synthetic cannabinoids also carrying no penalty when used by people with other serious health conditions that their doctors and the state/territory health departments consider may be palliated through consuming cannabis, in situations where conventional approaches have been unsuccessful or are contraindicated.199

CASE STUDIES

6.38 None of the individuals that provided their personal stories to the Committee suffered from a condition for which a pharmaceutical cannabis product (like Sativex or Dronabinol) is indicated and approved for use, nor did any suggest that they had pursued pharmaceutical cannabinoid products off-label.

INDIVIDUALS WHO HAVE TRIED CANNABIS FOR MEDICINAL PURPOSES

6.39 The Committee received evidence from a number of individuals who have used crude cannabis or its derivatives to treat symptoms associated with various chronic conditions and/or the side effects of treatments for serious illness. These discussions add to the body of anecdotal evidence suggesting that cannabis has potential for medicinal use.

6.40 The AIDS Action Council highlighted that it is aware of people living with HIV using cannabis to alleviate symptoms related to the condition and/or effects of medication including pain, loss of appetite, neuropathy and nausea.200 It advised that ‘16.5 per cent of people living with

197 Submission 20, PHAA, Att A. 198 Mr Grant Beale, Transcript of Evidence, 13 March 2015, p. 24; Submission 26, Mr Grant Beale; Submission 20, PHAA. 199 Submission 20, PHAA. 200 Submission 9, AIDS Action Council ACT.


HIV report using cannabis as a complementary therapy’ in the HIV Futures Seven cross-sectional survey of Australians with HIV.201

CAS E STU DY 1

6.41 Mr Marc Pengryffyn, for example, advised the Committee that he found cannabis, inhaled using a vaporiser, helpful in alleviating symptoms of his chronic fatigue syndrome (CFS) including pain associated with fibromyalgia, energy levels, focus, appetite, quality of sleep and irritable bowel syndrome.202 He noted that his mental health had also improved. Having utilised cannabis medicinally in the past, Mr Pengryffyn advised that after an eight year break due mostly to supply issues he had only recently begun using cannabis again to treat the CFS symptoms. He advised that cannabis seemed to be a more beneficial treatment for his symptoms than over-the-counter or prescription medications he had tried and when taking cannabis he can stop his other pain medications entirely.203

CAS E STU DY 2

6.42 Another submission outlined a twenty-year-old’s experience with Ankylosing Spondylitis (AS) which she describes as ‘an autoimmune disease that manifests as a form of inflammatory arthritis, usually of the spine.’

I don’t have any memory of my life without pain. Prior to my use of cannabis I was taking up to 35 tablets a day and in hospital, on average, every 40 days over the last 2 years. After being told by multiple medical professionals that I was already receiving the best treatment available, and having no relief provided, my family started to investigate the research behind medicinal cannabis. I have now been medicating myself for two months and the results have been lifesaving!204

6.43 She notes the debilitating physical and psychological effects of living with AS as well as the serious side effects she experienced from prescribed medications including weight loss, vomiting, gastrointestinal issues and ‘reduced cognitive capacity’ as well as significant bouts of depression.205 The author found the use of a CBD cannabis oil dramatically reduced her pain and stiffness, allowing her to return to normal levels of day-to-day activity. She also trialled a vaporiser and a tincture of pure THC oil for the most severe pain occurrences, finding the side effects tolerable to non-existent.206

201 Submission 9, AIDS Action Council ACT. 202 Submission 8; Mr Marc Pengryffyn, Transcript of Evidence, 13 March 2015, pp. 7, 9-11. 203 Mr Marc Pengryffyn, Transcript of Evidence, 13 March 2015, pp. 10-11. 204 Submission 17. 205 Submission 17. 206 Submission 17.



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CAS E STU DY 3

6.44 Mr Grant Beale told the Committee about the experiences of his mother and father, each with medical conditions they have begun treating with medicinal cannabis tincture. His mother suffers from post-herpetic neuralgia in her right arm and hand, a nerve pain condition that he described as ‘pain so debilitating at times she had seriously considered having her right arm amputated.’207 Having been advised by medical experts that there were no further pharmaceutical options, her family looked for alternatives. Mr Beale’s mother was already taking a number of heavy duty prescription drugs which he noted have damaging long term side effects, uses a tens machine for nerve stimulation and even placed her arm in plastic bags filled with crushed ice to get relief from pain. She also developed sleep apnoea as a side effect from one medication.208

6.45 Mr Beale advised that it was difficult to convince his mother to try medicinal cannabis at first and a significant level of personal research preceded his attempts, all of which reinforced his belief that medicinal cannabis does possess healing properties.209

6.46 The Committee heard that since trying medicinal cannabis tincture his mother’s sleep apnoea has ceased, the improvement recorded by her continuous positive airway pressure machine (CPAP).210 Her pain has also reduced significantly and she is now trying to wean herself off prescription pain medication.211

6.47 Mr Beale also told the Committee about the considerable improvements in his father’s Parkinson’s disease symptoms as a result of trialling cannabis tincture. Also suffering from sleep apnoea, he now sleeps through, is more clear headed and energetic.212

CAS E STU DY 4

6.48 Another submission highlighted the author’s use of cannabis to assist with nausea and vomiting resulting from radiation treatments for cancer, having suffered and allergic reaction to prescribed anti-nausea medications.213

6.49 The Committee also received evidence from other individuals who had utilised cannabis, or who knew of family members or friends who had utilised cannabis, to assist with symptoms arising from a range of other medical conditions — with positive effect.214

207 Mr Grant Beale, Transcript of Evidence, 13 March 2015, p. 26. 208 Mr Grant Beale, Transcript of Evidence, 13 March 2015, p. 26. 209 Mr Grant Beale, Transcript of Evidence, 13 March 2015, pp. 25; 31-32. 210 Mr Grant Beale, Transcript of Evidence, 13 March 2015, p. 27. 211 Mr Grant Beale, Transcript of Evidence, 13 March 2015, pp. 27; 32-33. 212 Mr Grant Beale, Transcript of Evidence, 13 March 2015, pp. 27-28. 213 Submission 13.


IN DIV I DU AL S W HO WO U LD L IK E TO TR Y CA N NAB IS FO R ME DI CI NA L P UR POS ES

6.50 A number of individuals also indicated to the Committee that, if legalised, they would be interested in trialling medicinal cannabis to treat symptoms associated with their chronic conditions and/or serious illnesses or that of a family member.215 Evidence was also received from individuals who had suffered, or who had a family member suffer, through a serious illness who would like to have accessed cannabis at the time had it been legal.216

6.51 In most cases, the chief concerns stopping the individuals from trialling cannabis as a form of treatment included the current illegal status and difficulties or lack of knowledge associated with sourcing or growing a cannabis supply.

CAS E STU DY 5

6.52 The Committee received evidence from the family of a young boy suffering from severe epilepsy who are very interested to try medicinal cannabis as an alternative to, or in conjunction with, his current medicines. Their son currently suffers around four to 10 seizures a day despite medications and the side effects of those medications include loss of coordination, feeling dopey as well as more significant developmental delays.217 They feel that they have exhausted all of the approved medicinal and surgical options, noting that their son is currently prescribed medications that have not been tested on children so the long term effects of those drugs are not known.218

CAS E STU DY 6

6.53 Similarly, another submission outlined the story of a six year old boy suffering from Dravet Syndrome (a severe form of epilepsy) who has ‘exhausted every medicine that is legally available’ to treat the disease. His parents report that he takes three different anti-epileptic drugs a day, which come with significant side effects including sleep problems, a speech stutter, loss of appetite and shaky movement, yet he still has very poor seizure control. His family is eager to try medicinal cannabis and supports its prompt legalisation.219

CAS E STU DY 7

6.54 The Committee also heard the story of Dr Karen Downing’s son. Diagnosed with cancer at the age of ten, Dr Downing described for the Committee the side effects of the aggressive cancer

214 Submission 19, Nimbin HEMP Embassy; Submission 28, Submission 31. 215 Submission 12; Submission 27; Submission 29; Submission 31. 216 Submission 14, Dr Karen Downing; Submission 5. 217 Submission 12. 218 Submission 12. 219 Submission 27.



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treatment, which did save her son’s life but not without a significant suffering and pain resulting from the equally aggressive treatment.220 She advised the Committee how chemotherapy treatments caused serious side effects for her son including ulcerations of the oesophagus, loss of appetite and high pain levels. On reflection, Dr Downing would have liked cannabis to have been available to the care team as part of their options,221 believing that cannabis may have offered a gentler sedative, addressed her son’s pain, improved his appetite and assisted with withdrawal from methadone being used to treat the pain.222 The Committee heard that Dr Downing was not concerned about the unknown risks of cannabis, highlighting that her son was already a part of a research program during his treatment which was experimental.223 Discussing the availability of medicinal cannabis, Dr Downing expressed the view that:

Drugs are drugs and the line that we draw between illegal ones and legal ones is one we make ourselves, and that has always shifted depending on where and when you are. I think it is a very reasonable discussion to have and not everybody is going to be in agreement with it whatever you do.224

NECESSITY AND URGENCY

6.55 A number of submissions noted that, given existing evidence on the efficacy of cannabis for medicinal purposes, further clinical trials are not necessary or should continue concurrently with legislative changes to facilitate immediate access to medicinal cannabis for those in need.225

6.56 ATODA, for example, stressed to the Committee that further medical research and clinical trials should not be treated as an alternative to establishing a legal scheme for medicinal use of cannabis. They advised that both initiatives should run in parallel.226 They also highlighted that a large body of research already exists overseas into medicinal cannabis which has influenced the introduction of medicinal cannabis regimes in some overseas jurisdictions.227

6.57 The Committee was advised by the FFDLR that ‘we are a compassionate society and if the use of cannabis can relieve suffering immediately then it should be allowed.’228

220 Submission 14, Dr Karen Downing; Dr Karen Downing, Transcript of Evidence, 13 March 2015, pp. 1-3. 221 Dr Karen Downing, Transcript of Evidence, 13 March 2015, p. 3. 222 Dr Karen Downing, Transcript of Evidence, 13 March 2015, pp. 2-3. 223 Dr Karen Downing, Transcript of Evidence, 13 March 2015, p. 5. 224 Dr Karen Downing, Transcript of Evidence, 13 March 2015, p. 5. 225 Submission 4, Mr Justin Kander; Submission 11, Dr June Garfit; Submission 12; Submission 24, ATODA p.5; Submission

29; Submission 30, FFDLR; Submission 31; Submission 32, Mr Shane Rattenbury MLA. 226 Submission 24, ATODA, p. 4. 227 Submission 24, ATODA, p. 5. 228 Submission 30, FFDLR, p. 8.


6.58 Mr Rattenbury championed the need for immediate action to allow access to cannabis to those most in need.229 He argued that his Draft Bill implements a relatively basic system that permits those most in need to access cannabis as a treatment and removes the associated criminal stigma.230 He focused on a local regulatory scheme as an interim solution in order to initiate more immediate action. Mr Rattenbury noted that it is not a perfect scheme but should be implemented regardless because the barriers to moving to ‘a fully functioning and idea model of regulation and government supply’ may not be overcome for many years. 231 Barriers such as lack of TGA approval, awaiting completion of more clinical trials and waiting for external supply solutions will all delay action on establishing a medicinal cannabis scheme for people in need. 232

229 Submission 32, Mr Shane Rattenbury MLA, p. 2. 230 Submission 32, Mr Shane Rattenbury MLA, p. 2. 231 Submission 32, Mr Shane Rattenbury MLA, p. 2. 232 Submission 32, Mr Shane Rattenbury MLA, p. 2.



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7 CO NCE RNS WIT H ME DIC INAL CRUDE CA NNA B IS 7.1 Some submissions to the Committee argued against the legalisation of crude cannabis for

medicinal use.233 Reasons include health risks, particularly given variants in types and strengths of crude cannabis, and lack of information on appropriate dosages and methods of application, the risks of diversion and risks of associated with public perception of cannabis use for recreational purposes. In this chapter, the Committee considers evidence on:

health risks (physiological):

• side effects/harms;

• modes of administration ;

• unknown factors (dosage, application, concentration); and

• clinical evidence;

diversion; and

catalyst for recreational use.

HEALTH RISKS

7.2 The Committee received evidence regarding a range of side effects and health risks associated with the use of cannabis. The effects of cannabis can be grouped into acute and chronic effects.234

ACUTE EFFECTS

7.3 The Committee was advised that ‘acute cannabis intoxication, which lasts for 3-6 hours, impairs psychomotor skills, short-term memory, attention, perception of time and diminishes driving performance.’235 These ‘cognitive and performance deficits’ are less apparent in regular cannabis users due to tolerance. 236

7.4 With regard to the seriousness of acute effects the Committee was informed that:

The US Institute of Medicine in 1999 concluded that the acute adverse effects of medicinal cannabinoids were “within the risks tolerated for many medications”. A more recent review of the deleterious effects observed in numerous RCTs

233 Submission 6; Submission 15, DFA. 234Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 14; Submission 6. 235 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 14. 236 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 14.


[randomised controlled trials] and laboratory studies on cannabinoids concluded that 97% of the adverse effects of cannabinoids were minor, with the most common being that 20% of patients experienced dizziness.237

DR IV ING

7.5 The Committee was advised, in relation to driving, ‘new formulations of cannabinoids may have less or no psychoactivity which would need to be examined for their effects upon driving or driving-related tasks.’238

CHRONIC EFFECTS

7.6 Chronic effects of Cannabis use are more significant, although they affect only a small proportion of users. The Committee was advised that ‘the evidence is strongest for cannabis causing drug dependence, psychosis, chronic bronchitis, increased risk of heart attack in middle to old age users, and testicular cancer.’239

COG NIT I VE FU N CTIO N

Whilst the Committee was advised that there is evidence of impairment to cognitive function including to verbal learning, memory and attention as a result of long-term use from an adolescent age, cannabis is less likely to have a long-term impact on the cognitive functions of adults, dependent on dosage.240 Other social, behavioural, educational and mental problems are noted with frequent use by young people (15-25 years).241

AD DI CT I ON, TO LE RA N CE A ND W ITH D RA WAL

7.7 Evidence tendered to the Committee suggests that cannabis has the potential to be addictive, with prolonged use causing dependency with tolerance and withdrawal symptoms common to other drugs.242

7.8 Withdrawal symptoms may be experienced by cannabis dependent people including insomnia, depression, anxiety and gastrointestinal disturbances.243

237 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 14. 238 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 15. 239 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 14 240 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 16. 241 Submission 7, Prof David Penington, Att A – MJA, 2 February 2015, p. 74. 242 Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, p. 55. 243Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 17.



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7.9 The Committee heard that other side effects can include ‘brain damage through long term heavy use’ as well as memory problems, links with depression and anxiety.244

7.10 The Committee was advised that cannabis has habit-forming qualities with an estimated 10 per cent of recreational users becoming dependent on it at some point in their life, which could be considered a mild to moderate additive risk.245 By comparison, ‘30 per cent become dependent on tobacco, 20 per cent on heroin and cocaine, and 15 per cent on alcohol’.246

PSY C HOS IS AN D S CH IZOP HR E NIA

7.11 Short-lasting psychosis has been recognised as an adverse effect of cannabis, including ‘disordered thinking, hallucinations and delusions’ which reverse when the drug wears off.247

7.12 The Committee was also advised there are still contentions on whether cannabis causes schizophrenia248 but there is evidence ‘that adolescent cannabis use may accelerate the age of onset of schizophrenia.’ 249 Genetic vulnerability appears to have an influence on the likelihood of cannabis-induced psychosis and schizophrenia. Further research is needed to better understand any genetic vulnerability and the Committee was advised that at this stage ‘medicinal cannabinoid preparations that contain THC should not be prescribed to individuals who have a family history of psychosis.’250

OVER DO SE

7.13 The Committee was advised that there is little to no risk of fatal overdose from cannabis use.251

HARMS ASSOCIATED WITH SOME METHODS OF ADMINISTRATION

SMOKING

7.14 Whilst there was some evidence suggesting that smoking is ‘effective way of getting the relevant constituents of cannabis in the brain quickly’,252 there are known, serious risks.

244 Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, p. 55. 245 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 16-17. 246 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 17. 247 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 17. 248 Submission 7, Prof David Penington, Att A– MJA, 2 February 2015, p. 74. 249 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 17-18. 250 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 18. 251 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 14; Mr William Bush, Transcript of Evidence,

31 March 2015, p. 46. 252 Mr William Bush, Transcript of Evidence, 31 March 2015, p. 51.


7.15 Smoking cannabis presents risks to the user including bronchitis (cough, increased sputum production, wheezy airways) resulting from the irritant effects of smoking, and there is evidence of increased rates of respiratory cancer and risk of testicular cancer amongst cannabis smokers, most likely due to the carcinogens produced via the process of smoking.253 There are alternative methods of administration for crude cannabis that are similarly absorbed.254

7.16 There appears to be a general consensus amongst stakeholders that smoking crude cannabis has negative effects and is a not suitable method of delivering medicinal cannabis, particularly for long-term use.255

7.17 The AMA position statement on medical uses of cannabis highlights that:

Smoking or ingesting a crude plant product is a risky way to deliver cannabinoids for medical purposes. Other appropriate ways of delivering cannabinoids for medical purposes should be developed.256

7.18 The AMA further noted that:

Smoking crude cannabis poses unacceptable health risks, delivers a dose that is variable and unregulated, and is unlikely to be approved by the pharmaceutical regulatory process in Australia. From a medical perspective, it is entirely inappropriate for any person with an illness to seek out crude therapies that are supplied from unregulated and illegal sources. Marijuana smoke contains a number of carcinogens and other toxins similar to those found in tobacco smoke.257

7.19 Professor Jan Copeland provided similar advice:

One of the challenges in the move to legalise cannabis for medicinal purposes is overcoming the problems associated with inhaling cannabis smoke alone, or mixed with tobacco. Legalising the smoking of cannabis for medicinal purposes means that all of the risk factors of smoking (cardiovascular and respiratory and addiction to tobacco when mixed with the cannabis) remain.258

7.20 Winnunga noted the difficulty for health practitioners if they are recommending a product that will be smoked ‘due to the obvious harms of this delivery method’.259

253 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 18. 254 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 17-18. 255 Submission 1, Prof Jan Copeland; Submission 6; Submission 15, Drug Free Australia; Submission 16, AMA; Submission

21, Winnunga, Submission 23, ACT Government, Submission 18, Mr Nicholas Christodoulou. 256 Submission 16, AMA, Att A, p. 9. 257 Submission 16, AMA, p. 2. 258 Submission 1, Prof Jan Copeland, Att A – NCPIC Bulletin, September 2014, p. 5. 259 Submission 21, Winnunga.



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7.21 The ACT Government noted that:

Long term smoking of cannabis carries risks of damage to a patient's lungs, infection and allergic reactions to ingredients in the smoke and is not recommended except where a patient's life expectancy is limited.260

7.22 The Committee was advised that:

To address health concerns with smoking, crude cannabis should be supplied to patients via a prescription and administered via a vaporiser, meaning that the patients sustain the ‘advantages of pulmonary administration’, and have access to an affordable a product.261

EDIBLES

7.23 In general there was little support for the application of medicinal cannabis via edible products.262

7.24 The Committee was advised that edible cannabis products, created a diversion risk as well as risk of accidental ingestion. As mentioned earlier, oral consumption of cannabis is also unpredictable and takes many hours to have an effect on the brain.263

7.25 FFDLR note that they would not support the use of cannabis confectionary like chocolates, given the evidence of the effects of cannabis on young developing minds, and the influence of commercialisation on what should be a medical product.264

7.26 The Committee was also advised that, regarding accidental ingestion, there are:

Two groups that have been identified as vulnerable include infants and animals. Edible cannabis products are frequently sweet and attractive to children such as brownies, ice cream and sodas. This is extremely concerning as it is much easier for infants and young children to overdose on THC leading to coma and the need for urgent medical care. This risk also extends to domestic pets with cases of severe illness and death associated with cannabis butter in particular.265

260 Submission 23, ACT Government, p. 9. 261 Submission 18, Mr Nicholas Christodoulou, p. 12. 262 Submission 1, Prof Jan Copeland; Submission 30, FFDLR; Submission 23, ACT Government. 263 See Chapter 2; Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 19-20. 264 Mr William Bush, Transcript of Evidence, 31 March 2015, p. 51. 265 Submission 1, Prof Jan Copeland, Att A – NCPIC Bulletin, September 2014, p. 5.


UNKNOWNS

7.27 Due to limits on the nature of research that has been possible, there are also many unknown risks. The AMA, for example, advised the Committee that the adverse effects of long term cannabis use are still unknown, which may not be an issues for those with a terminal condition but may be for those with chronic conditions seeking treatment with cannabis.266

7.28 The side effects and efficacy of crude cannabis are also highly variable. 267 Emeritus Professor Penington wrote:

Response to cannabis varies from person to person, partly due to genetic variation among users. The content of THC and CBA varies among different strains of marijuana. Some users vary the type of plant they use to benefit from these different effects.268

7.29 The nature of available cannabis supply, particularly crude ‘street’ cannabis, also raises a range of unknowns which are discussed further in Chapter 9 in relation to the Draft Bill.

7.30 The Committee received some commentary that a medicinal cannabis scheme should be limited to a patient population that is not as likely to be affected by recognised health risks. FFDLR, for example, argued that, from the research they have read:

there is a significant body of evidence that is enough to proceed in relation to a drug where the harms that have been established overwhelmingly affect young people and not the population that would largely stand to benefit from the use of medical cannabis...269

7.31 Similarly, Professor David Penington advised in an article written for the Medical Journal of Australia that people aged between 15 and 25 years should be excluded as recipients, except where it is provided specifically for a cause covered by legislation.270

SY NTH ETI C A N D HY D ROP O NI C CA N NA BIS

7.32 The Committee was advised that hydroponically grown cannabis is much stronger than alternatives and produces significantly different results and side effects. A submission noted that hydroponic cannabis needs to be distinguished from organic cannabis.271

266 Submission 22, AMA, p. 3. 267 Submission 7, Prof David Penington, Att A –MJA, 2 February 2015, p. 75; Dr Ross Colquhoun, Transcript of Evidence,

31 March 2015, p. 54. 268 Submission 7, Prof David Penington, Att A – MJA, 2 February 2015, p. 75. 269 Mr William Bush, Transcript of Evidence, 31 March 2015, p. 44. 270 Submission 7, Prof David Penington, Att A – MJA, 2 February 2015, p. 75. 271 Submission 13.



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7.33 Another submission stated that hydroponic cannabis is ‘grown by organised crime in a bath of chemicals and bred to be big and fat for it is sold by weight.’272

7.34 The Committee was also advised that synthetic cannabis has its own unique risks273:

The stuff they are selling as synthetic Cannabis is nothing like Cannabis at all and in fact quite the opposite from my twice only experience. It is a chemical mix that used to be a copy of THC but not anymore, sprayed on another herb, Damiana or Mugwort usually. It would not exist without prohibition although a lot of its use is at mine sites as it does not register in drug testing.274

CLINICAL EVIDENCE

7.35 The Committee was advised about the need for evidence based clinical guidelines to accompany the introduction of any medicinal cannabis product (including crude cannabis)275 which ‘cover clinical indications, efficacy, safety, drug interactions, adverse effects, dosage, administration and medication monitoring’.276

7.36 Winnunga noted that:

Clinical situations where medicinal cannabis use is indicated are currently limited and further information is required. Clinical guidelines are needed based on good quality research of effectiveness, including where medicinal cannabis would be preferable to other treatment options. Risks and adverse effects of treatment are also important.277 The Winnunga client population has high rates of mental health and substance misuse conditions. We would be particularly cautious about potential harms of medicinal cannabis in this population. Potential benefits such as reduced opioid overdoses also need to be considered. 278

7.37 Professor Jan Copeland wrote that:

Almost all of the modern research literature on cannabinoids as medicine have utilised pharmaceutical preparations of THC and/or CBD. There have been no published human trials employing the accepted gold standard design of a randomised controlled trial using smoked whole plant. 279

272 Submission 19, Nimbin HEMP Embassy, p. 2. 273 Submission 16, AMA, Att A – Position Statement, pp. 5, 9; Submission 19. 274 Submission 19, Nimbin HEMP Embassy, p. 2. 275 Submission 21, Winnunga; Submission 1, Prof Jan Copeland; Mr William Bush, Transcript of Evidence, 31 March 2015,

p. 47. 276 Submission 21, Winnunga. 277 Submission 21, Winnunga. 278 Submission 21, Winnunga. 279 Submission 1, Prof Jan Copeland, p. 1.


7.38 On the question of efficacy and whether medicinal cannabis should be subject to the same testing and review system as other pharmaceuticals, FFDLR advised that :

Evidence can be used to facilitate things; evidence can be used to block things. It is a question of risk assessment. I cited to you work by Professor Mather and Professor Penington and the US Institute of Medicine. There is substantial evidence that it works for particular populations, and that is what I heard the AMA say. But the AMA is seeking enormous certitude, and that enormous certitude will effectively mean a barrier for years, if not decades, before you manage to get the necessary evidence. I think the committee needs to be very careful about how it uses the evidence argument. Yes, we are all for evidence—this is what we stand for—but what is sufficient evidence? The search for absolute certainty becomes a barrier to sensible decision-making.280

DIVERSION

7.39 Evidence tendered to the Committee also advised about the risks of diversion to the recreational cannabis market from a medicinal cannabis scheme based on crude cannabis.

7.40 The Committee heard from DFA, for example, about the risks of diversion to the recreational market in a crude cannabis scheme, particularly diversion to minors as evidenced by some US states.281 They advise that diversion of pharmaceutical products like Sativex is not likely and pharmaceutical products have additional controls through the prescription process and responsibility and care of the prescribing medical practitioners.282

7.41 Further discussions on the risks of diversion in relation to the Draft Bill are included in Chapter 9.

7.42 Other evidence indicated that significant diversion was not likely if appropriate regulatory arrangements are established.

7.43 In response to questions about the risks of diversion, the PHAA noted that since 1992 cannabis has been decriminalised in the ACT ‘with a single penalty point for use of or growing of small amounts of cannabis.’283 This ‘has not caused a complete flooding of cannabis, as was predicted back in 1992’.284 They advised that the ACT has the opportunity to build a regulatory framework that is going to deal directly with the potential for diversion, learning

280 Mr William Bush, Transcript of Evidence, 31 March 2015, p. 47. 281 Mr Gary Christian, Transcript of Evidence, 31 March 2015, p. 56. 282 Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, p. 59. 283 Adjunct Prof Michael Moore, Transcript of Evidence, 31 March 2015, pp. 65-66. 284 Adjunct Prof Michael Moore, Transcript of Evidence, 31 March 2015, p. 67.



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from regulatory models that have not worked well overseas.285

7.44 Noting that cannabis is already widely available, the PHAA advised that the bulk of existing penalties including possession offences and usage offences should be maintained for the majority of people:

We have a regulatory regime currently in place that is undoubtedly having an effect of preventing some people from using cannabis who would otherwise use it. That is one of the observations of criminological research. That framework stays in place for the vast majority of the people in our community.286

7.45 The Deputy CHO advised that:

I have to believe that the prohibition has some impact on the availability. It may affect who can access marijuana, whether people choose to and how much they do, rather than the absolute fact of whether it is available at all.287

RISK OF NORMALISING

7.46 The Committee heard that there is also a risk of crude cannabis use being ‘normalised’ if made available for a medicinal cannabis scheme.288

7.47 The AMA noted that there ‘seems to be some complacency about the risks of cannabis use.’289

7.48 The Committee was also advised that if cannabis is treated as a health issue, with proper heath advice, quality control and regulation it ‘may even help to deglamorise cannabis for the young and impressionable’.290

CATALYST FOR RECREATIONAL LEGALISATION

7.49 The Committee heard that the push for medicinal cannabis is a ‘Trojan horse’ for advocates aiming to secure the legalisation of recreational cannabis.291 The DFA, for example, stated that:

285 Adjunct Prof Michael Moore, Transcript of Evidence, 31 March 2015, p. 67. 286 Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 69. 287 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 76. 288 Submission 15, DFA, p. 65; Submission 6. 289 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 41. 290 Submission 19, Nimbin HEMP Embassy, p. 2. 291 Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, p. 53; Submission 6.


we believe this is a Trojan horse as such, the thin end of the wedge and an admission by the proponents of medical cannabis to produce the result of recreational use of cannabis being legal in this country.292

7.50 However, the Committee heard that whilst there are cases where medicinal cannabis schemes have been introduced that are poorly regulated and thus appear to have relaxed limitation on recreational cannabis use, they have been subject to significant criticism, including from the International Narcotics Control Board. Many of the submissions in support of medicinal cannabis noted that their aim is only to gain access to medicinal cannabis for those with conditions that it may assist, not recreational use.

7.51 ATODA, for example, argues that:

Although there are clear examples from the USA of poorly designed and implemented medicinal cannabis programs that have almost certainly resulted in increasing the availability of the drug for recreational use, those policy failures abroad simply remind us that the ACT approach needs to focus on providing cannabis to very ill people under a compassionate, palliative framework.293

7.52 The PHAA similarly highlighted that medicinal cannabis programs are not necessarily good or bad, ‘the devil is in the detail’. They noted the need for strong and careful regulation and enforcement, citing that the US experience offers a lot of models of what not to do and some examples of tight regulation.294 They also argued that there are likely to be very few people interested in using medicinal cannabis in the long term although there are no solid figures to support that.295

7.53 The FFDLR noted that, under international obligations:

The concern of the International Narcotics Control Board, which is the control body, as you know, that administers the single convention and the other drug conventions, has not been that medical marijuana or cannabis not be permitted, but they want very firm, effective controls on the production and administration of that scheme. That is something that we think is desirable too...296

7.54 The Committee was further advised that ‘the International Narcotics Control Board has found fault with the regulatory system for medical marijuana or cannabis schemes in the United States’ and has commented that some schemes:

pose a challenge in some countries. If medical cannabis schemes are not adequately

292 Dr Ross Colquhoun, Transcript of Evidence, 31 March 2015, p. 53 293 Submission 24, ATODA, p. 5. 294 Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 66. 295 Adjunct Prof Michael Moore, Transcript of Evidence, 31 March 2015, p. 67; Mr David McDonald, Transcript of Evidence,




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regulated, they can contribute to increasing levels of cannabis abuse, such as in some states of the United States of America. Evidence suggests that, in some jurisdictions, registered ‘patients’ do not present medical histories that warrant such prescribing or dispensing. Such a situation could be considered as a step towards the legalization of cannabis for recreational use by proponents of initiatives to legalize the possession of drugs for non medical or not scientific use. To put it plainly, if such “medical” schemes are not well managed and supervised (as requested by the 1961 Convention) they could be seen as ‘back-door legalization’ for recreational use. Gravely, if medical cannabis schemes are not adequately regulated, they can contribute to increasing levels of cannabis abuse.297

7.55 FFDLR further advised that there may even be a reduction in recreational use if a medicinal scheme was established because some of the using cannabis ‘recreationally’ now may actually be self-medicating. They note that ‘there has been a substantial reduction in the United States in the use of opiates in states where medical cannabis is permitted.’298

7.56 Although there may be pressure from some groups to legalise recreational cannabis, any legislative change seen to enable this would come under intense international scrutiny and criticism, perhaps even sanctions from the International Narcotics Control Board.299


7.57 The Committee notes that, as signatories to the 1961 Convention, cannabis can only be made available for medical or scientific use in Australia.300 The ACT and/or Australia could not establish a system that legalises recreational cannabis without being in breach of the 1961 Convention.

7.58 The Committee notes that the intent of the Draft Bill is for the medicinal use of cannabis only, not recreational use, and regardless of the preferred legislative approach, supports this limitation.

297 Submission 30, FFDLR, p. 4 [quoting the International Narcotics Control Board]. 298 Mr William Bush, Transcript of Evidence, 31 March 2015, p. 46. 299 Submission 18, Mr Nicholas Christodoulou, p. 8; Mr Nicholas Christodoulou, Transcript of Evidence, 13 March 2015,

p. 21. 300 The Convention provides at Article 4 - General Obligations:

The parties shall take such legislative and administrative measures as may be necessary: ...(c) subject to the provisions of this Convention, to limit exclusively to medical and scientific purposes the production, manufacture, export, import, distribution of, trade in, use and possession of drugs.

at:https://www.unodc.org/documents/commissions/CND/Int_Drug_Control_Conventions/Ebook/The_International_Drug_Control_Conventions_E.pdf, accessed 31 July 2015.

https://www.unodc.org/documents/commissions/CND/Int_Drug_Control_Conventions/Ebook/The_International_Drug_Control_Conventions_E.pdf

https://www.unodc.org/documents/commissions/CND/Int_Drug_Control_Conventions/Ebook/The_International_Drug_Control_Conventions_E.pdf



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8 THE DRA F T B I LL - O VE RVI E W

OVERVIEW

8.1 The Exposure Draft of the Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014 (the Draft Bill) amends the Drugs of Dependence Act 1989 to provide that a person may apply in writing to the Chief Health Officer for approval to possess and use cannabis (cl 7(1)). The application may be in one of three categories:

Category 1 – to mitigate symptoms of a terminal illness or its treatment (where life expectancy is less than one year)

Category 2 – to mitigate symptoms of cancer, AIDS, HIV, multiple sclerosis, spinal cord injury or disease, or epilepsy, or other condition prescribed by regulation

Category 3 – to mitigate any other medical condition or its treatment.

8.2 Applications must be accompanied by a medical declaration by a doctor, and in the case of Category 3, an additional medical declaration by a second doctor who specialises in an area of medicine relevant to the applicant’s treatment (cl 7(7)). For category 2 and 3 applications, the medical declaration must state that all conventional treatments have been tried and are medically inappropriate for specified reasons (cl 8(3)).

8.3 The Chief Health Officer (CHO) must approve an application that is in accordance with the Act, but must refuse an application on various grounds, including if he or she has reasonable grounds for disagreeing with anything stated in a medical declaration. The Chief Health Officer must refuse a Category 3 application if the applicant is not an adult. Approvals are subject to any conditions stated or prescribed by regulation, and must include regular monitoring by the holder’s doctor and a limit on the maximum quantity of cannabis that may be held at any time (cl 11).

8.4 The Draft Bill also provides for the CHO to grant a licence to cultivate cannabis for the purpose of an approval for a maximum of one year. A person can only hold one licence and must, amongst other things, not have had a licence revoked in the past five years (cl 18). The licence must include conditions about the maximum number of plants that may be under cultivation at any time and the maximum amount of cannabis that may be kept (not more than a trafficable quantity) (cl 19). An application for a licence must include the street address of the ‘cultivation place’, the place where the cannabis is to be kept and the proposed security measures for each place (cl 16(4)).

8.5 The CHO must keep a register of approvals and licences (cl 24). The register must include the information prescribed by regulation and anything else the CHO considers ‘appropriate’ (cl


24(2)). Decisions made under the Draft Bill are reviewable (Part 3). The Minister must arrange for a committee to review the operation of the provisions after three years (cl 25).

DIS C US SIO N PAP ER

8.6 The Draft Bill is accompanied by a discussion paper, which was released by Mr Rattenbury MLA for public consultation between 21 July 2014 and 15 September 2014.

8.7 The discussion paper provides an overview of the Draft Bill, some indication of how it is intended to be implemented (where details have been left to regulation or the discretion of the CHO) and attempts to address some possible concerns.

SU BM ISS IO N TO CO M MITT EE

8.8 On 19 February 2015, following the end of the consultation period on the ACT Greens discussion paper on Medicinal Cannabis, Mr Rattenbury provided the Committee with a submission which included further comment on his Draft Bill.301

8.9 Noting that public discussion about the Draft Bill had focused on ‘its perceived imperfections’ and had shown preference for TGA approved pharmaceutical products with a coordinated model of government supply and completion of further clinical trials, Mr Rattenbury posed the following questions:

What level of imperfection is tolerable in exchange for allowing sick and dying people access to a treatment that can assist and help relieve suffering?302

What action do we take while waiting for the completion of clinical trials, or for TGA approved drugs, or for a coordinated model of government supply? 303

8.10 Mr Rattenbury’s comments are addressed under the relevant key issues and in the chapter on amendments and alternatives (Chapter 10).

GENERAL RESPONSE TO THE DRAFT BILL

8.11 The Committee received evidence in support of the Draft Bill generally.304

8.12 One submission noted that the legislation is ‘a move in the right direction and a long time in coming’.305

301 Submission 32, Mr Shane Rattenbury MLA. 302 Submission 32, Mr Shane Rattenbury MLA, p. 2. 303 Submission 32, Mr Shane Rattenbury MLA, p. 2. 304 Submission 7, Prof David Penington; Submission 8; Submission 26, Mr Grant Beale; Submission 31. 305 Submission 31.



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8.13 The PHAA supports the underlying principles of the Draft Bill. They advised that one of the strengths of the Draft Bill is:

that it enables regulators to put in place a regime that is appropriate to our local circumstances and, indeed, appropriate to the circumstances of particular sick people and their families or their other carers who may be cultivating the product.306

8.14 The Committee also received significant evidence highlighting concerns with the Draft Bill.

8.15 The AMA, for example, does not support the proposed legislation but is ‘supportive of the conversation which might allow for medically prescribed cannabis to particular patients’.307 They advised the Committee that the proposed Draft Bill is too unregulated and ad hoc to be supported.308

8.16 In the following chapter, the Committee outlines specific issues and concerns raised about the Draft Bill in its current form.

306 Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 67. 307 Submission 16, AMA, p. 1. 308 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 34



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9 DRA F T B ILL - K EY IS S UE S 9.1 Wide ranging concerns about the Draft Bill were raised with the Committee including

medical, legal and practical issues. These are discussed in detail throughout this Chapter.

DEFINITIONS

9.2 The Committee notes that ‘cannabis’ is not defined in the Draft Bill.309 Since the Draft Bill proposes to amend the Drugs of Dependence Act1989, the definitions in that Act would apply. (See Chapter 3) By taking this approach, the use, possession and supply of cannabis resin, fibre and other cannabis derivatives are not addressed. Hydroponically grown cannabis is excluded from the ACT’s Simple Cannabis Offence scheme, however the Draft Bill does not distinguish between hydroponically grown and soil-grown cannabis.310

9.3 The use of the title ‘doctor’ in the Draft bill also raised some concerns as ‘the title doctor is not a protected title and can include professional and research doctorates in fields unrelated to medicine.’311 The Committee was advised that ‘medical practitioner’ would be more appropriate as it is a protected title in Australia. 312 The Committee notes that the NSW TICS scheme and the draft NSW legislation for a medicinal cannabis scheme used the terminology ‘medical practitioner’ and ‘medical specialist’.313

CANNABIS SUPPLY

9.4 As outlined above, the Draft Bill includes provisions for the CHO to grant a cannabis cultivation licence to patients with a medicinal cannabis approval or their carers. The conditions on the licence, such as the number of plants under cultivation, are to be decided by the CHO and can be prescribed by regulation. Patients who are not adults cannot obtain a cultivation licence (cl 18(3)(b)(i)). Under the provisions, cultivation appears most likely to occur at residential premises.

309 Submission 24, ATODA, p. 10. 310 Submission 24, ATODA, p. 10. 311 Submission 22, Mr Justin Sinclair, p. 6. 312 Submission 22, Mr Justin Sinclair, p. 6. 313 Terminal Illness Cannabis Scheme: Fact Sheet for NSW Medical Practitioners, at:

https://www.nsw.gov.au/sites/default/files/initiatives/mp_factsheet.pdf, accessed 31 July 2015 and the Drug Legislation Amendment (Cannabis for Medical Purposes) Bill 2014 (NSW), at: http://www.parliament.nsw.gov.au/prod/parlment/nswbills.nsf/0/B9AFD6BD2425708ECA257D71001B9BAB, accessed 31 July 2015.

https://www.nsw.gov.au/sites/default/files/initiatives/mp_factsheet.pdf

http://www.parliament.nsw.gov.au/prod/parlment/nswbills.nsf/0/B9AFD6BD2425708ECA257D71001B9BAB


9.5 It can be assumed that individuals that do not seek a cultivation licence for themselves or for their carers under the Draft Bill would be required to obtain their cannabis supply from the illicit market.

9.6 Evidence to the Committee suggests that the issue of cannabis supply for medicinal purposes is not adequately dealt with in the Draft Bill.314 The ACT Government submission, for example, notes that the Draft Bill does not address the need for a reliable, quality controlled supply framework. It highlights that this issue ‘is central to clinical, public health and public safety /law enforcement concerns.’315

9.7 In this section the Committee considers the following supply issues in relation to the Draft Bill:

health concerns related to illicit ‘street’ cannabis and home-grown cannabis supplies;

arguments for and against a grow-your-own approach including issues of practicality, law enforcement, safety and security concerns, and other factors that are inadequately or not addressed in the Draft Bill; and

other concerns with illicit supply.

HEALTH CONCERNS

QUALITY CONTROL AND POTENCY

9.8 Cannabis supply is a pivotal issue in the medicinal cannabis debate because the products available on the illicit market or grown privately have, from a medical perspective, many health and safety concerns including unknown factors, particularly quality, potency and effect, in addition to the known physiological effects of cannabis discussed earlier. 316

9.9 The Committee was advised that concentrations of THC and CBD vary significantly across cannabis plant species and strains. In particular, selective breeding for the recreational market has resulted in cannabis available on the illicit market that is very high in THC which is associated with psychoactive effects.317 A potency analysis of street cannabis in NSW indicated ‘THC concentrations averaging 15%’ with ‘CBD virtually absent from most samples’.318 The Committee was also informed that ‘the trend toward greater THC:CBD ratios

314 Submission 7, Prof David Penington, Submission 21, Winnunga; Submission 23, ACT Government; Mr Marc Pengryffyn,

Transcript of Evidence, 13 March 2015, p. 7. 315 Submission 23, ACT Government, p. 11. 316 Submission 6; Submission 3, Directions ACT; Submission 22, Mr Justin Sinclair; Submission 23, ACT Government, p. 3. 317 Submission 23, ACT Government, p. 3; Dr. Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 77. 318 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 3 citing Swift, W., et al., Analysis of Cannabis

Seizures in NSW, Australia: Cannabis Potency and Cannabinoid Profile. PLOS One, 2013 [Public Library of Science].



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is of significant public health concern given evidence that CBD may protect against the deleterious effects of THC such as cognitive impairment and psychosis’.319

9.10 The ACT Chief Police Officer, Mr Rudi Lammers (the CPO) highlighted the need for a regulated supply system for medicinal cannabis:

If cannabis is going to be prescribed and it is going to be in a form that is useful to patients then we want to make sure that there is good regulation around that. There is a great range of potency of cannabis grown in people’s backyards, for which we regularly arrest and prosecute.

There could be simply a difference between the potency of the leaves and the potency of the heads, for instance, with cannabis. There is no way of regulating that if it is grown in a backyard. The only way you could really do that is if it is grown under strict supervision and controls and then produced in a way where the potency could be controlled. Those people who home grow cannabis do not often have any idea about how potent their drug is.320

9.11 The CPO strongly emphasised that cannabis grown outside of a regulated environment poses an unacceptable risk to the user and was not suitable for a medicinal cannabis scheme. He highlighted the risks of an unknown product with unknown potency:

Cannabis can quite often be refined to a much more potent level. What type of plant is cultivated and what part of the plant is harvested and produced will affect the potency of the plant. How long it is dried for and how it is produced and under what conditions it is propagated, produced, and harvested all make a big difference. All of this leads to our argument that there is no control over cannabis that is grown outside a regulated environment.321

9.12 The CPO also noted that there is no way for buyers to be sure cannabis is unadulterated. The cannabis could be mixed with other substances which could be a bit more innocuous such as grass, something toxic or even deadly.322

9.13 The Committee was advised that cannabis grown outside of a regulated environment can be prone to ‘a host of bacteria, fungi and pests’323 as well as heavy metals and pesticides.324

319 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 3-4. 320 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 96. 321 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 97. 322 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, pp. 98-99. 323 Submission 22, Mr Justin Sinclair, p. 11. 324 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 21.


9.14 From a medicinal perspective, the ACT Government submission advised that in addition to variable concentrations of THC and CBD the ‘refinement’ of the product can alter its potency and makeup:

the uncontrolled production of cannabis in various preparations (dried to be smoked, ingested in food, in oils to be applied or eaten etc), can result in vastly different concentrations of the cannabinoid compounds in each product. As such, it is difficult to predict what pharmacological response any cannabis product is likely to elicit.325

9.15 Medical practitioners are also unlikely to prescribe or endorse the use of medicinal cannabis in the absence of a regulated supply, given the many unknown factors associated with grow-your-own or illicitly supplied cannabis. The Deputy CHO highlighted that ‘if you are going to go and obtain something and I do not know what it is, and it is probably not going to be the same from week to week, then the GP has nothing to work with.’326

9.16 The ACT Government recommended that cannabis cultivation not be permitted at residential addresses.327

GROW-YOUR-OWN

9.17 The Committee received a mixed response to the provisions in the Draft Bill enabling approved patients to grow their own cannabis or to nominate someone to cultivate crude cannabis for medicinal purposes on their behalf.

9.18 The AMA, for example does not support an approach whereby people have permission to grow their own cannabis, sighting issues such as efficacy, quality and dosage control, access and the legal responsibilities on the doctors agreeing to the treatment.328

9.19 The CPO advised that ACT Policing ‘opposes cultivation by individuals or groups of residential properties or private corporations.’329

9.20 The Committee notes, however, that there is some support for patients to cultivate their own cannabis, particularly in the absence of, or even in parallel with, a legal production and supply chain.330

325 Submission 23, ACT Government, p. 3. 326 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, pp. 85-86. 327 Submission 23, ACT Government, p. 11; Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 93. 328 Submission 16, AMA, p. 2; Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 34. 329 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 93. 330 Submission 5; Submission 7, Prof David Penington, Att A MJA, 2 February 2015, p.75; Submission 9, AIDS Action

Council ACT; Submission 19, Nimbin HEMP Embassy, p. 2; Submission 20, PHAA; Submission 22, Mr Justin Sinclair; Submission 24, ATODA; Submission 28, p. 12-13; Submission 30, FFDLR, pp. 8-9; Submission 35; Dr Karen Downing, Transcript of Evidence, 13 March 2015, p. 3; Mr Grant Beale, Transcript of Evidence, 13 March 2015, p. 29.



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9.21 The AIDS Action Council, for example, supports personal cultivation of medicinal cannabis, noting that:

some form of allowance for personal medical use would allow users more control over issues such as purity, strength and method of production of the cannabis consumed. This would be best achieved through allowing the personal growth of a limited number of plants or for support through certified growers and producers.331

9.22 The Committee also heard that enabling patients to grow their own is likely to be more cost effective for longer term palliative care.332

LAW ENFORCEMENT AND SAFETY CONCERNS

9.23 In addition to health concerns around potency and quality of cannabis, the cannabis cultivation provisions in the Draft Bill gave rise to significant concerns around public safety and security as well as the impracticalities of a grow-your-own approach and pressures on policing resources.333 These are discussed in more detail below.

PU BL IC C ON CE R NS

9.24 ACT Policing advised the Committee that it would most likely experience a large increase in contact from concerned members of the public through Crime Stoppers and Neighbourhood Watch in relation to cannabis cultivation at residential properties.334 This in turn would create an increasing need for police resources to investigate reported cultivation and establish if it is legal or not. 335 The CPO did not envisage that these problems would exist if cannabis production was appropriately regulated, which did not include private cultivation.336

SE CU RIT Y

9.25 The Committee was also told that cultivating medicinal cannabis at residential properties ‘has the potential to enable criminal influences on the production, supply, transportation and administration of cannabis.’337

9.26 The application requirements specified in section 16(4) of the Draft Bill include the need for

331 Submission 9, AIDS Action Council ACT, p. 1. 332 Dr Karen Downing, Transcript of Evidence, 13 March 2015, p. 3. 333 Mr Gary Christian, Transcript of Evidence, 31 March 2015, p. 55; Submission 23, ACT Government; Mr Rudi Lammers,

Transcript of Evidence, 9 April 2015, pp. 96, 103. 334 Submission 23, ACT Government, p. 4; Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, pp. 96, 103. 335 Submission 23, ACT Government, p. 4. 336 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 103. 337 Submission 23, ACT Government, p. 4.


applicants to detail security measures that will be taken at the growing premises, however the Draft Bill and discussion paper do not identify what these should be or how they will be enforced.338

PRACTICALIT IES OF GROW-YOUR-OWN

9.27 The proposed grow-your-own approach also raised a number of practicality issues including the effort for those with health problems, the time required to grow a suitable crop, horticulture skills, space, sourcing of the appropriate variety/strain of seed, Canberra weather, growing the necessary quantity and transporting crops.339

9.28 Whilst supporting a grow-your-own approach, one submission noted the time required to grow a suitable crop may be too long for some approved patients:

My Aunt passed away within 4 months of her initial diagnosis. Under the current proposal she would not have had the time or the ability to produce cannabis for her own use. This is the case with many patients diagnosed with cancer. They can begin treatment very soon after diagnosis. Having to procure the necessary equipment to grow cannabis and having to wait months for the plants to mature is in my opinion an unnecessary delay and would be detrimental to the patient.340

9.29 The Committee was advised that in many cases an alternative supply is required even if just for the interim period whilst crops mature341 and would be preferably purchased with a valid prescription through licensed and accredited dispensaries. 342

9.30 Winnunga noted that there can be a significant time lag in growing marijuana at home:

there would be a time discrepancy between the identification of need and availability of the product. This is not consistent with current medical treatments which are available immediately. Medical conditions change over time and health care providers cannot necessarily predict whether the need will still exist some months ahead.343

9.31 Cultivating cannabis could also be labour intensive, particularly if the individual has to establish a new garden bed.344

338 Submission 23, ACT Government, p. 4. 339 Submission 1, Prof Jan Copeland; Submission 5; Submission 21, Winnunga; Submission 22, Mr Justin Sinclair, pp. 10-11;

Mr William Bush, Transcript of Evidence, 31 March 2015, pp. 46, 50; Submission 30 FFDLR, pp. 4-5, 8; Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 70.

340 Submission 5. 341 Submission 1, Prof Jan Copeland. 342 Submission 5. 343 Submission 21, Winnunga. 344 Mr Marc Pengryffyn, Transcript of Evidence, 13 March 2015, p. 13.



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9.32 The Committee heard that a grow-your-own approach had limitations in the Canberra climate with only one cannabis crop a year able to be grown outdoors.345 Indoor growing would be possible but comes with a high cost, including lights and equipment.346 Either method would require the approved patient or carer to have the space to possibly grow up to ten plants.347

9.33 The Draft Bill does not address how patients will access ‘good seed stock’ to grow their crop, although it is presumed seeds would be sourced from the illicit market.348

9.34 FFDLR sums up these concerns noting that with a grow-your-own approach ‘you are adding a layer of stress unless you provide a means to ready access of material, in the most accurate grade of assessment that you can, with the least amount of hassle for the people who obtain it.’349

REL ATE D MATTE RS

9.35 The Draft Bill does not address whether cultivation is permitted indoors, including hydroponically grown. It also does not address possession of growing equipment.350

9.36 Additionally, the Committee was advised that the Draft Bill does not provide for redress if a nominee refuses to cultivate or supply cannabis for the approved patient; or even loses their cultivation licence.351

9.37 The required cultivating practices for growing medicinal cannabis and how to manage pests, bacteria and fungi are not specified in the Draft Bill. It does not, for example, establish any requirements around pesticide use nor require licensees to avoid using hormones, stimulants, fungicides and other contaminants.352

9.38 Transporting crops legally from a licensee to an approved user (if grown away from the patient’s residential address and) does not appear to have been addressed in the Draft Bill.353 Nor does the Draft Bill address absence or incapacitation of the licensee. An alternative nominee would presumably have to be licensed to maintain the crop in the absence of the primary licensee.354

345 Mr Marc Pengryffyn, Transcript of Evidence, 13 March 2015, p. 12. 346 Mr Marc Pengryffyn, Transcript of Evidence, 13 March 2015, pp. 7-8. 347 Mr Marc Pengryffyn, Transcript of Evidence, 13 March 2015, pp. 7, 9, 11-12. 348 Submission 22, Mr Justin Sinclair, p. 11. 349 Mr William Bush, Transcript of Evidence, 31 March 2015, pp. 46, 50. 350 Submission 22, Mr Justin Sinclair, p. 10. 351 Submission 1, Prof Jan Copeland, p. 1. 352 Submission 1, Prof Jan Copeland, p. 1. 353 Submission 1, Prof Jan Copeland, p. 1. 354 Submission 1, Prof Jan Copeland, pp. 1-2.


ILLICIT SUPPLY

9.39 As noted above, if a patient is not cultivating their own cannabis as allowed for under the Draft Bill, then it is assumed they are sourcing it through the illegal ‘street’ market which would give rise to the same health and safety concerns.

9.40 One submission to the Committee advised that approved patients should be able to legally access cannabis on their own.355

9.41 The Committee notes that the Draft Bill does not provide immunity for sales of cannabis to approved users.

9.42 The Committee heard additional safety and accessibility concerns exist associated with accessing medicinal cannabis from the illicit market. For instance, the ACT Government noted in its submission that:

Where illegally or self-grown cannabis has been legalised for medicinal use there have been problems with vulnerable patients interacting with drug dealers including violence and financial exploitation. Additionally, patients have reported frustration with not being able to obtain cannabis once it is prescribed where they lack the skills, time or material to grow the crop themselves. This has led to demand for growers collectives, or an organised sponsorship of supply for patients.356

9.43 The Committee was also advised that black market pricing and antisocial criminal elements were problematic for buyers, as well as knowing who or where to get a supply from through the illicit market.357

ROLE OF THE CHIEF HEALTH OFFICER

9.44 The Draft Bill specifies a number of roles for the ACT’s CHO including approving applications submitted by patients (with the appropriate medical declaration from a doctor) to permit use, possession and cultivation of cannabis for medical purposes. The CHO must keep a register of approvals and cultivation licences (cl 24) and must approve the applications (unless the CHO has concerns about the veracity of the information provided or has grounds for disagreeing with anything stated in an accompanying medical declaration (cl 10, cl 18)).358

355 Submission 26, p. 4. 356 Submission 23, ACT Government, p. 8. 357 Mr Marc Pengryffyn, Transcript of Evidence, 13 March 2015, p. 8; Mr David McDonald, Transcript of Evidence, 31

March 2015, p. 70. 358 Submission 23, ACT Government, p. 8.



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9.45 As part of this role, the CHO would set conditions on the approvals including that the cannabis only be used for the purpose of the approval, that the person’s doctor regularly reviews the medical condition and the impact of the cannabis use, as well as specifying the maximum quantity of cannabis a person may possess at any one time.359

9.46 The Committee was advised by the ACT Government that this proposed role for the CHO is problematic both from an administrative perspective and wider risks to public health and safety entailed by the scheme.360

9.47 The Committee heard that, in its current form, with the requirements to create and maintain the register and processing applications, the Draft Bill would create significant additional demand on health resources that are already under pressure.361

9.48 The ACT’s Deputy CHO, Dr Andrew Pengilley, highlighted that under the Draft Bill, the CHO is being asked to provide an approval with no real knowledge of the cases and no way to interrogate the information being provided in applications.362 The Committee was advised that there is no need for the CHO to be involved in the decision to prescribe to an individual.363

9.49 On this issue, the Deputy CHO raised concerns that the Draft Bill appears to establish a prescription monitoring role for the CHO, identifying how many scripts are coming from individual doctors. He believed this would create another sizeable regulatory burden because it could not be processed through existing prescription tracking mechanisms with pharmacies. As with patient applications, the Committee heard that there is no way for the CHO to interrogate or investigate the appropriateness of scripts or prescribing patterns under the proposed scheme.364 It creates a ‘cumbersome approval process’, with applications being recorded but seemingly not controlled in a way that would ensure compliance.365

9.50 The ACT Government referred to the introduction of an approval and license register proposed in the Draft Bill as a ‘regressive approach’ as ‘use (and abuse) is better tracked through electronic monitoring of prescriptions.’366

359 ACT Greens Discussion Paper, p. 5. 360 Submission 23, ACT Government, p. 8. 361 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 82. 362 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 82. 363 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 88. 364 Dr Andrew Pengilley and Dr Peggy Brown, Transcript of Evidence, 9 April 2015, p. 84. 365 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 84. 366 Submission 23, ACT Government, p. 9.


9.51 Other submissions to the Committee concurred that the proposed registration and monitoring approach would be difficult and expensive to administer.367

9.52 The Committee was also advised that unknown factors around quality, content and origin of cannabis that may be acquired by patients, as well as limited public health knowledge around cannabis were of great concern. The Committee heard that the CHO and doctors would need to be training themselves in an entirely unknown branch of medicine.368 The Deputy CHO advised:

We are signing off for them taking something they will have to obtain by means unknown. We are also apparently approving the number of plants you can have now. I have difficulty growing spinach. I really have no idea how many plants is a lot of plants and how many you are meant to have. So there is a real problem with just the public health knowledge.369

...What you are really creating is, to use an ugly phrase, red tape with no real, tangible outcome in terms of information added to the clinical interaction at any stage.370

9.53 The Committee was advised that there is no benefit in a scheme that involves the medical profession unless that involvement adds real knowledge or skill. Additionally, the nature of the CHO’s involvement in the current Draft Bill does not mitigate the potential for abuse of the scheme.371

9.54 The Committee was also advised that it is not appropriate to have a single-point of decision making resting with the CHO, shifting a medical decision into more of a bureaucratic decision that could also see lengthy approval processes.372

REF USI NG A N APP LI CAT IO N

9.55 The Committee notes that the CHO must refuse an application to possess and use cannabis if, amongst other things, he or she ‘has reasonable grounds for disagreeing with anything stated in a medical declaration accompanying the application’ (cl 10(3)(c)).

9.56 The Draft Bill includes a separate provision for patients providing false and misleading information in an application. It is therefore unclear what this provision is trying to address, noting that it appears to be a very broad discretion.

367 Submission 1, Prof Jan Copeland, p. 1. 368 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 82. 369 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 82. 370 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 82. 371 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 83. 372 Submission 24, ATODA, p.9; Submission 29, pp. 2, 5; Submission 31.



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9.57 The Committee also received concerns that, beyond the appeal process included in the Draft Bill, an appeals process through a review board or officials is required, as well as availability of a patient advocate.373

ROLE OF MEDICAL PRACTITIONERS

9.58 The Committee was also advised about a range of concerns in regard to the proposed role for medical practitioners in the Draft Bill, including the likelihood of increased presentations, the impact on health services by patients who abuse cannabis, as well as risks of diversion and lack of cannabis public health knowledge.

9.59 Clinicians are concerned about patients who abuse cannabis presenting more frequently, if doctors are viewed as an easy avenue for access to cannabis.374 The Committee was advised that this would be similar to the experience of some doctors with opiates:

If you are known to be a person who prescribes opiates freely, if you like, or is inclined to prescribe them, you can have a problem not only with legitimate patients turning up but with people who are not legitimate turning up.375

9.60 The ACT Government submission also noted possible impacts on clinical practice of increased presentations in Emergency Departments, rehabilitation and mental health services from patients who abuse cannabis.376

9.61 Additionally, there are increased risks of ‘doctor shopping’.377 The Committee heard that the issues that have arisen with opioid drugs are indicative of what may occur with medicinal cannabis:

There is an emerging phenomenon, a problem in prescribing in Australia generally, of analgesia. Many doctors are confronted with very diffuse symptoms of, say, chronic pain, and people can become dependent on prescription opioid drugs. That is an emerging problem where a licit drug is being used, arguably for a medical purpose: people are reporting chronic pain to their medical practitioner and medical practitioners respond to that by prescribing what they consider to be an appropriate drug. But you then see a massive increase in the use of those drugs and you see the potential for doctor shopping and for people to become inappropriate users of those drugs.378

373 Submission 31. 374 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 76. 375 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 76. 376 Submission 23, ACT Government, p. 9. 377 Mr Ross O’Donoughue, Transcript of Evidence, 9 April 2015, p. 81. 378 Mr Ross O’Donoughue, Transcript of Evidence, 9 April 2015, p. 81.


9.62 The Committee was told that there are also risks of a small number of ‘entrepreneurial’ doctors taking the opportunity to set up a practice founded on cannabis medicine, as seen in some other jurisdictions that have implemented medicinal cannabis schemes.379 Once the nature of the practice is known, ‘people obviously know that they can go to that practice and that becomes very difficult to control’.380

9.63 The Committee heard that doctor shopping would not be identified easily under the Draft Bill because the medicinal cannabis won’t be a prescribed product dispensed at a pharmacy and therefore there will be not be captured by existing prescription oversight by Medicare.381

9.64 The Committee heard that, given the way the Bill has been drafted, there are risks of increased illicit use, additional availability and diversion, whether from increased supply and availability of cannabis generally or failure of the gatekeeper role:382

what we have seen is that, if you create a legitimate avenue for supply, you have to create a supply to feed that. So if it became a situation of endorsing growers, for example, or a movement towards having to endorse growers to supply a prescription scheme, that could increase the supply and it could increase the ease of supply.383

...

It is not difficult for most doctors but it is difficult for absolutely everybody in the medical profession to fulfil the gatekeeper role of preventing either an increased supply of people who do not necessarily have watertight evidence of clinical need or diversion into the illicit supply. That is a question of how much is produced, the purity of what is produced and the ease of supply, all of which would be motivators, perhaps, to use a medical supply if it was available, as opposed to what is available criminally at the moment.384

9.65 As an example of the failure of the gatekeeper role, the Committee was told about Schedule 8 (controlled drug)385 approvals, which until recently had a similar system of approval to the Draft Bill. Schedule 8 substances are ‘pharmaceutical products with well-known indications’ and the Committee heard that ‘it is hard enough to get doctors to comply and to actually interrogate the use’ noting that there is a lot of misuse of Schedule 8 drugs.386

9.66 The AMA also advised that the role of doctors in the Draft Bill could ‘potentially undermine the doctor-patient relationship’ particularly if the doctor does not think it is appropriate for

379 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 84. 380 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 84. 381 Dr Peggy Brown and Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, pp. 84-85. 382 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, pp. 75-76; Submission 21, Winnunga. 383 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 76. 384 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 77. 385 Poisons Standard, June 2015 (Cwlth). 386 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 82.



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the patient to use medicinal cannabis. They note that the proposed approach is too open to potential abuse compared to prescription drugs which can be controlled to a large degree at the pharmacy level:

Once the doctor has given permission, they do not actually know how many plants the patient is going to grow and who is going to have access to it. It is too unscientific and too open to abuse.387

PR ES CR IB ING, EN DO RS IN G O R RE CO MME N DI NG

9.67 The Committee was advised that the Draft Bill is designed so that doctors are not prescribing medicinal cannabis in the traditional sense. They are making a medical declaration about the applicant’s medical condition, that they are suffering from symptoms associated with the condition or treatment and have tried (or considered and ruled out) all conventional treatments.388

9.68 The PHAA noted that the role doctors are being asked or invited to do and the authority they are being given is one of the real threshold issues, as there are interpretation issues with the word ‘prescription’ as compared to a recommendation or a certification that advice has been provided to the patient.389 They advised that if a traditional medical prescription route is proposed, ‘doctors will not touch it’.390 They believed that an approach seeking to strengthen the patient-doctor relationship with the authorisation being the responsibility of the CHO, as the Draft Bill provides, would be more attractive to medical practitioners and patients.391

9.69 However, the Committee was advised that any definitional distinction still does not overcome the concerns around the unknown, unregulated cannabis product doctors are being asked to endorse, as discussed at the start of this chapter.392 The Deputy CHO noted that it may be useful to have doctor involvement in the process to encourage more honesty from patients deciding to use cannabis, however it was only of use if doctors could actually ‘value add’ with knowledge of the product, potency, dosages and the best method/s for it to be used.393

9.70 The Committee was also advised that the requirements under Category 2 and Category 3 for the doctor to be a specialist in the area of medicine and the requirement under Category 3 for a second medical declaration were onerous given the difficulties and long waiting times

387 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 36. 388 Draft Bill, s8; Submission 32, Mr Shane Rattenbury MLA, p. 5; Submission 24, ATODA, p. 9. 389 Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 68. 390 Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 68. 391 Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 68 392 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 81; Submission 21, Winnunga. 393 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, pp. 82, 85-86.


to access specialists in the ACT.394 These requirements need to take into account ‘the realities of the medical workforce in Canberra.’395

ADMINISTRATION/APPLICATION OF MEDICINAL CANNABIS

9.71 The Draft Bill requires the doctor making a medical declaration to discuss with the patient how they would administer the cannabis and manage its use (cl 8(e)). This provision implies that doctors would be providing advice to applicants on the preferred method of administration of the cannabis.

9.72 The Committee was advised that the method of using/applying cannabis is a significant consideration because it can change the concentration and rate of absorption, and consequently the effectiveness and side effects of the product.396 The ACT Government advised:

Tinctures and other secondary processing...further complicate any assessment of the potential clinical effect of the product. Processing of botanical cannabis can significantly change the composition of the final medicinal product.397

9.73 The risks of smoking crude cannabis were highlighted earlier in this report along with the risks of edibles.

9.74 ATODA advised that the legislation ‘should make allowance for diverse routes of administration of the drug.’ They note that herbal cannabis may not always be suitable and in some cases extracts such as infusions or tinctures are more appropriate. 398

9.75 The Committee heard that vaporisers are one of the preferred methods of using crude cannabis as they heat the cannabis to a point where the cannabinoids vaporise without having to burn it.399

ME DI CA L K NO WL ED GE

9.76 In light of their roles outlined in the Draft Bill, doctors and the CHO would also require extensive training on cannabis products, properties and applications before they would be able to knowledgeably make a medical declaration, advise patients, endorse or prescribe the drug.400 The former Director-General of ACT Health noted that representatives at the recent

394 Submission 28, p. 12; Submission 34, ACT Medicare Local. 395 Submission 34, ACT Medicare Local. 396 Dr Peggy Brown, Transcript of Evidence, 9 April 2015, p. 86. 397 Submission 23, ACT Government, p. 9. 398 Submission 24, ATODA, p.10. 399 Mr Marc Pengryffyn, Transcript of Evidence, 13 March 2015, p. 14. 400 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 82.



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Clinical Senate expressed particular concern in relation to the need to up skill doctors in relation to medicinal cannabis, including clinical indications and dosing.401

9.77 Other evidence provided to the Committee supported this notion, noting a general lack of knowledge and training on the endocannabinoid system.402 The Committee heard that courses specifically designed to train medical practitioners in medicinal cannabis, including identification and management of dependency, side effects and monitoring efficacy are essential to support medicinal cannabis legislation.403

PRESCRIBED MEDICAL CONDITIONS AND SYMPTOMS

(CATEGORIES)

9.78 In the Draft Bill a Category 1 approval relates to the mitigation of ‘a symptom’ of a terminal illness or its treatment. Category 2 is aimed at the mitigation of specified symptoms (severe nausea, severe pain, weight loss, anorexia, cachexia (wasting), persistent muscle spasms and seizures) of specified medical conditions. There is capacity to add to the list of Category 2 symptoms or conditions by amending the regulations.

9.79 Category 3 is ‘for the mitigation of a symptom of any other medical condition or its treatment’. This is a broad definition, tempered by the requirement in cl 7(7)(b) for a second medical declaration by another doctor who specialises in a relevant area of medicine (cl 9). Category 3 would provide an avenue for people with conditions such as glaucoma, Crohn’s disease and Parkinson’s disease to access medicinal cannabis.404

9.80 For both Category 2 and 3 a medical declaration must state that all conventional treatments for the symptom or the condition are medically inappropriate for specified reasons (including that the treatment is ineffective; the applicant has experienced an allergic or adverse reaction; the drug is contraindicated etc).

CLINICAL INDICATIONS

9.81 The Deputy CHO advised the Committee that it is important to specify indications for which medical conditions and symptoms cannabis would be most appropriately administered. He noted that ‘all registered pharmaceuticals have indications’,405 generally written by the TGA.

401 Dr Peggy Brown, Transcript of Evidence, 9 April 2015, p. 77. 402 Submission 22, Mr Justin Sinclair, pp. 7; 13-14; Mr Grant Beale Transcript of Evidence, 13 March 2015, p. 32. 403 Submission 22, Mr Justin Sinclair, p. 7; Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 68;

Submission 34, ACT Medicare Local. 404 ACT Greens Discussion Paper, p. 4. 405 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 88.


The Committee was advised that whatever regulatory agency was running a medicinal cannabis scheme would need to specify those indications.406 The Deputy CHO noted that any decisions to specify indications would need to be undertaken following additional consultation with clinicians, as they ‘would be holding doctors to that as the standard of care’.407

9.82 The Committee heard ‘the problem with having no indications and just leaving it to general use is that you have that potential for somebody to essentially set up a very permissive system’.408 The Deputy CHO noted that a risk with this model is the potential for individuals to deceptively obtain medicinal cannabis by ‘presenting with symptoms that are not legitimate’ and increasing the potential for diversion.409

9.83 The AMA advised that any medicinal cannabis scheme needs to apply only to medical indications based on what has actually been trialled, and where there is some evidence to support its use, such as appetite stimulation in people with terminal cancer.410

9.84 The CPO also noted that there must be strict controls around what purpose medicinal cannabis is prescribed or dispensed for.411

APP ROP RI ATE NE SS OF CA TEGOR IE S A N D C RITE R IA

9.85 The Committee received a mixed response to the approved conditions listed in Category 2 and the flexibility of Category 3 in the Draft Bill.

9.86 The Committee notes that the Draft Bill includes indications for Category 2 applications, however the Committee was advised that these may not be adequately specified. In its submission, the ACT Government advised that:

there is a need to further consider the clinical indications for the categories for approval currently listed in Table 7 of the Draft Bill. This should be developed with the direct input of the clinical community and based upon the best available evidence. The definition of each prescribed medical condition should be drafted with close attention to the potential for a broad interpretation to support misuse or diversion.412

9.87 ATODA advised the Committee that the requirement under Category 2 that all conventional treatments are medically inappropriate overlooks the strong possibility of circumstances

406 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, pp. 88-89. 407 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 89. 408 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 89. 409 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 88. 410 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 37. 411 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 102. 412 Submission 23, ACT Government, p. 11.



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where a patient could benefit from both conventional and cannabis treatments in parallel. ATODA note, for example that cannabis could be used to relieve unpleasant side effects of conventional treatments.413 Other submissions supported this notion, as well as suggesting in some cases medicinal cannabis should be a first line treatment.414

9.88 The Committee was also advised that the criteria for approval by the CHO under Category 3, ‘any other medical condition and its treatment’, are too wide.415

9.89 The Committee notes there is support for the provision in the Draft Bill to include additional medical conditions or symptoms to Category 2 via regulation.416 The Committee also received examples of other conditions that would be worthy of consideration under Category 2 or 3, such as back injury and autism.417

9.90 The Committee heard arguments that the decision to use medicinal cannabis would ideally be a matter of discussion between a patient, their family and their doctor rather than strict categorisation in legislation.418

9.91 The PHAA acknowledges however, that ‘there are political and community concerns that require something far, far tighter’ so the proposed categorisation is acceptable. In this regard, the Committee heard evidence suggesting that the flexibility of Category 3 is appropriate and provides some leeway for patients and doctors.419 FFDLR also proposed a regular review process to enable the legislated conditions to be amended.420

OTHE R A PP ROA C HES TO IND I CAT I ON S

9.92 Other jurisdictions have approached the matter of clinical indications in a variety of manners.

9.93 The NSW TICS, for example, only applies to individuals with a terminal illness (outlined in Chapter 3). Medical practitioners are required to certify that the individual has a terminal illness, as specifically defined, in order to gain registration under the scheme.421

9.94 The proposed NSW Drug Legislation Amendment (Cannabis for Medical Purposes) Bill 2014, was intended to apply to a ‘serious medical condition’ with a definition focusing on symptoms that may be relieved through the use of cannabis. The definition is fairly broad-

413 Submission 24, ATODA, p. 9. 414 Submission 29, p. 3; Submission 4, Mr Justin Kander. 415 Submission 1, Prof Jan Copeland, p. 1. 416 Submission 22, Mr Justin Sinclair, p. 6; Submission 29. 417 Submission 29. 418 Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 73; Mr William Bush & Mrs Marion McConnell,

Transcript of Evidence, 31 March 2015, p. 48; Submission 28, p. 11. 419 Mr William Bush and Mrs Marion McConnell, Transcript of Evidence, 31 March 2015, p. 48. 420 Mr William Bush and Mrs Marion McConnell, Transcript of Evidence, 31 March 2015, p. 48. 421 NSW Terminal Illness Cannabis Scheme Fact Sheet.


reaching and includes ‘a symptom associated with, or with treatment for, a medical condition certified by the patient’s medical practitioner as a symptom suffered by the patient that may be relieved by the use of cannabis’ or a condition declared in the regulations.422 Medical practitioners certify that patients have, in the opinion of the practitioner, a serious medical condition.

9.95 Medical documents provided in support of the application under Canada’s Marihuana for Medical Purposes scheme do not need to state the type of medical condition or symptoms for which the marijuana is to be authorised; that is, there is no limit. Instead, the document needs to state only the daily quantity of dried marihuana to be used by the person (in grams) and the period of use, not exceeding one year.423

CHILDREN

9.96 The discussion paper notes that children can be eligible to apply for a permit under Category 1 or Category 2 but not under Category 3 of the Draft Bill (conditions not otherwise recognised in the legislation).424 Cl 10(3)(a) states that the CHO must refuse a Category 3 application if the applicant is not an adult. An application must be signed by the applicant. There is a requirement for the doctor to discuss the likely risks and benefits with the applicant as well as how the applicant would administer the cannabis and manage its use (cl 8(1)(e), 9(d)(iii)).

9.97 These provisions have raised a series of concerns. The ACT Government, for example, noted serious concerns about the use of cannabis by children due to possible impacts on brain development (including in-utero) and learning.425

9.98 The Committee notes that it is unclear how the requirements of the Draft Bill would apply to young children or people with certain disabilities. In particular, the Draft Bill does not address the need for a responsible parent or guardian to make the application or to be a registered carer.

9.99 Additionally, the Committee received concerns about passive exposure to cannabis prescribed to a child’s parent or carer. The Draft Bill does not address whether children can reside in the same premises as a licensee or approved patient. 426

422 NSW Bill, s30(c)(3)(a)(vi). 423 Health Canada, ‘Sample Medical Document for the Marihuana for Medical Purposes Regulations’, http://www.hc-

sc.gc.ca/dhp-mps/marihuana/info/med-eng.php, accessed 6 August 2015. 424 ACT Greens Discussion Paper, p. 4. 425 Submission 23, ACT Government, p. 8. 426 Submission 1, Prof Jan Copeland, p. 1.

http://www.hc-sc.gc.ca/dhp-mps/marihuana/info/med-eng.php

http://www.hc-sc.gc.ca/dhp-mps/marihuana/info/med-eng.php



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9.100 The ACT Government raised concerns about parents or guardians accessing and using a child’s cannabis supply, which is not addressed by the Draft Bill.427

9.101 The Committee also heard evidence suggesting that the provisions for children to access medicinal cannabis are too limited.428

PUBLIC HEALTH AND SAFETY

MENTAL HEALTH

9.102 The Committee heard from ACT Policing that the Draft Bill does not adequately address concerns about the causal link between cannabis use and mental health. The CPO highlighted that drugs, coupled with mental health issues, can evoke behaviour in people that is much more extreme than a mental health condition alone, including more violent, irrational and unpredictable behaviours. 429 Behaviour is even more unpredictable given likely variability in the type and potency of an illegally sourced or home-grown cannabis supply. 430

9.103 ACT Policing notes that they have ‘significant experience in dealing with mental health consumers affected by cannabis who, as a result of their consumption, become a risk to public safety.’431

9.104 Ideally, ACT Policing would like to see better regulation around the production and supply of cannabis as well as ‘sufficient testing and research done that shows the effect of medicinal cannabis on people of all types of mental health’.432

9.105 They would like assurances that this causal link has been given full consideration in the Draft Bill and recommended that the supporting commentary incorporate advice from health professionals on how that link will be addressed and be monitored for patients participating in a medicinal cannabis scheme.433

DRUG-DRIVING

9.106 The ACT’s Road Transport (Alcohol and Drugs) Act 1977 includes offences for persons driving

427 Submission 23, ACT Government, p. 8. 428 Submission 24, ATODA, p.10; Submission 28, p. 12; Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 73. 429 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, pp. 96; 99-100. 430 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 96. 431 Submission 23, ACT Government, p. 5. 432 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 96. 433 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 94.


a motor vehicle on a public road or road related area with a prescribed drug in their oral fluid or blood.434 THC is a prescribed drug under the Road Transport (Alcohol and Drugs) Act 1977. Additionally, the Road Transport (Driver Licensing) Regulation 2000 requires that a person must not drive a motor vehicle if the person’s ability to drive safely is impaired by the effects on the person of treatment for any illness, injury or incapacity suffered by the person.435

9.107 The ACT Government advised the Committee about the effect of cannabis on skills required for driving including:

decreased car handling ability;

impaired motor skills;

impaired sustained vigilance;

reduced perception skills;

slowed reaction time;·

dulled reflexes;

impaired time and distance perception; and

reduced capacity to respond quickly in stressful situations.436

9.108 The Committee was also advised that use of cannabis raised additional concerns for patients operating plant and machinery or driving, beyond the risks of other medications, due to the uncertainties about the nature of the cannabis being used given the unknown supply chain.437

9.109 The discussion paper acknowledges that ‘the effects of cannabis can impair a person’s ability to safely operate a vehicle’ and ‘under the ACT’s existing drug-driving laws it is an offence to drive while under the influence of drugs’.438 It notes that the Draft Bill does not propose a change to the current drug-driving legislation and patients using medicinal cannabis would not be permitted to drive whilst the drug is detectable in their system. 439

9.110 The discussion paper sought further feedback on the issue of drug-driving laws for patients using medicinal cannabis, noting that cannabis can remain detectable for a long period after it is ingested ‘even when it no longer impairs a person’s ability to drive’.440

9.111 A number of submissions noted that patients using medicinal cannabis in any form would

434 Road Transport (Alcohol and Drugs) Act 1977, s20. 435 Road Transport (Driver Licensing) Regulation 2000, s77. 436 Submission 23, ACT Government, p. 4. 437 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 91. 438 ACT Greens Discussion Paper, p. 11. 439 ACT Greens Discussion Paper, pp. 11-12. 440 ACT Greens Discussion Paper, p. 12.



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need to refrain from driving.441

9.112 The Committee was advised that the smallest presence of THC in the blood when driving gives rise to an offence. Current roadside drug testing uses a single buccal swab to test saliva for a range of prescribed drugs including ice, cannabis, heroin and cocaine. However, it does not have the ability to differentiate which drug is present or detect the level of THC or the potency of a drug. 442 Cannabis derivatives including the legally prescribed Sativex would also be detected. The CPO advised that:

If a test existed that allowed us to test uniquely for cannabis then that is something that we would consider, but that of course would need to be coupled with an authority to have taken the drug in the first place.443

9.113 However, the Committee heard that there was not yet a market for such a test so the technology may not be available in the near future.444

9.114 The Committee was advised that ‘the logic of inferring impairment based on a blood alcohol level cannot be straightforwardly extended to the cannabinoids’ due to the fat-soluble nature of the compounds and the possibility of THC being released back into the blood stream through exercise and stress.445

9.115 The Committee was advised that ‘cannabinoids are fat-soluble drugs that remain in the body for long periods of time. People may test positive to THC a week or more after they last used cannabis’.446

9.116 The CPO advised that the Draft Bill does not and should not change existing drug-driving laws.447 He noted that the ACT Policing would not support any proposal that would permit impaired driving that adds to road death or trauma.

9.117 The ACT Government acknowledged this situation in its submission to the Committee, noting that:

It is a defence to the prosecution of a person for an offence under this section if the person establishes that they were unaware that their ability to drive safely was impaired or they had a reasonable excuse for contravening the section. As cannabis can remain detectable for a long period after it is ingested or inhaled, it is plausible

441 Submission 1, Prof Jan Copeland, Att A – NCPIC Bulletin, September 2014, p. 5; Submission 22, Mr Justin Sinclair, p. 12;

Submission 24, ATODA, p. 11; Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 41. 442 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, pp. 94-95. 443 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 95. 444 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 95. 445 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 15. 446 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, pp. 15-16. 447 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 94.


that someone who has consumed cannabis for a medical purpose could unwittingly commit a drug-driving offence due to detectable amounts of cannabis in their body, and this issue will need to be addressed in further detail.448

9.118 The Committee was advised that patients using medicinal cannabis would need to be educated about road safety, including advice that they would not be permitted to drive whilst the drug is detectable.449

9.119 The former Director-General of ACT Health highlighted that only one category in the Draft Bill applies to the terminally ill, who may voluntarily abstain from driving or surrender their licence. However, the other two categories apply to people with chronic or undefined other conditions who may be young and use medicinal cannabis for long periods of time and are less likely to want to give up driving.450

9.120 The ACT Government advised that its preferred approach would be to establish a process whereby the RTA is notified when a medicinal cannabis authorisation is issued.451 That advice would need to include an assurance that appropriate measures have been or will be put in place to safeguard against that person driving a motor vehicle when impaired by medicinal cannabis.452 The RTA could then undertake a medical review of the person’s licence status during the course of treatment.453

9.121 The CPO noted that a medicinal cannabis scheme would be very resource intensive for police unless there was a very regimented prescription system for cannabis, particularly when conducting random drug testing and trying to establish whether individuals have the right authority to possess and use cannabis.454 A quick and accurate way to determine if cannabis has been legally prescribed for that individual is required, such as a photo ID.

LEGAL ISSUES

LEGISLATIVE AND INTERNATIONAL OBLIGATIONS

9.122 The Committee was advised that the Draft Bill does not address the Commonwealth Therapeutic Goods Act 1989 framework nor importation legislation or obligations under the

448 Submission 23, ACT Government, p. 5. 449 Submission 23, ACT Government, p. 5. 450 Dr Peggy Brown, Transcript of Evidence, 9 April 2015, p. 92. 451 Submission 23, ACT Government, p. 11. 452 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 94. 453 Submission 23, ACT Government, p. 11. 454 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, pp. 103-104.



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1961 Convention.455

9.123 The Committee was advised that the Draft Bill, and in particular the grow-your-own approach, does not meet the controls set out by the 1961 Convention because the Draft Bill does not establish a government agency or agencies to regulate the production and supply of cannabis for medicinal purposes. A system of controls is required, in accordance with Article 23 of the 1961 Convention, including requirements for a government agency to be established to carry out the functions of designating areas of land for cultivation to occur, licensing cultivators, as well as purchasing and taking physical possession of crops from cultivators within specified timeframes.456

9.124 The current approach in the Draft Bill could result in adverse consequences for Australia, with one submission noting that ‘In 1989, when the ACT introduced ‘infringement notices’ for inconsequential cannabis offences, the U.S. and International Narcotics Control Board “threatened to cut off international markets for Australia’s lucrative morphine industry”’.457 The Committee heard that Colorado, Washington State and Washington DC have taken a flexible interpretation of the Convention, and as a result received much criticism.458

LIABILITY – MEDICAL PRACTITIONERS

9.125 Both the absence of quality-controlled supply and lack of public health knowledge on cannabis products and administration increase liability concerns for medical practitioners, the CHO and ACT Health staff.459

9.126 The ACT Government advised the Committee that ‘clinicians who provide a medical declaration in support of an application may be liable for any adverse events that take place as a result of the use of cannabis.’460 The level of personal risk involved is therefore likely to prevent clinicians from providing medical declarations under the Draft Bill.

9.127 The Committee heard that, in the absence of a quality controlled supply of cannabis, medical practitioners are leaving themselves open to claims of negligence:

they are endorsing the use of a product whose quality they do not know and whose effects are uncertain. And if there was an adverse event, directly through toxicity or somebody running off the road or somebody getting something which is much more psychoactive than they had anticipated because it is a different batch, this would

455 Mr Nicholas Christodoulou, Transcript of Evidence, 13 March 2015, p. 17; Mr Gary Christian, Transcript of Evidence,

31 March 2015, p. 57; Submission 23, pp. 6-7. 456 Submission 23, ACT Government, p. 6; Submission 18, Mr Nicholas Christodoulou, pp. 3-4. 457 Submission 18, Mr Nicholas Christodoulou, p. 8. 458 Mr Nicholas Christodoulou, Transcript of Evidence, 13 March 2015, p. 21. 459 Submission 23, ACT Government, p. 4; Submission 21, Winnunga. 460 Submission 23, ACT Government, p. 4.


potentially be seen as negligence.461

9.128 Additionally, medical practitioners may be open to indemnity issues arising from adverse outcomes from drug interactions, where cannabis may enhance, mitigate or negate the impact of other prescribed medication.462 The Committee heard that the results are unpredictable and the risk is exacerbated because of the unknown potency and quality of product a patient may be acquiring.463

LIABILITY - CULTIVATORS

9.129 There are also liability issues for those licensed to cultivate cannabis. The Draft Bill allows for an approved person to nominate someone to cultivate cannabis on their behalf.464 However, as the ACT Government submission highlighted, the Draft Bill ‘does not give a person nominated under a cultivation licence immunity from prosecution for supplying cannabis to the person with a medical cannabis approval.’465 Nor does it ‘...propose amendments to exclude medicinal cannabis cultivation licence holders from offence in the Criminal Code.’466

POSSESSION AND CULTIVATION QUANTITIES

9.130 The Draft Bill requires a cultivation licence to include conditions about the maximum number of plants that may be under cultivation at any time, and the maximum amount of cannabis that may be kept at any time, being not more than a trafficable quantity467 (cl 19(2)(c)). Approval conditions must also include ‘a condition about the maximum quantity of cannabis the holder may possess at any time’ (cl 11(2)(c)).

9.131 The Draft Bill appears to leave scope for highly varying licence conditions for different licensees, with the CHO deciding on a case-by-case basis the maximum number of plants that may be under cultivation and the maximum amount of cannabis that may be kept under the licence at any time.

9.132 ATODA highlighted to the Committee that the approval conditions for medicinal cannabis patients should be limited to trafficable quantity as per the cultivation licence provisions.468

9.133 The ACT Government also noted to the Committee that specifying the number of plants that

461 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 79. 462 Dr Peggy Brown, Transcript of Evidence, 9 April 2015, p. 80. 463 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 85. 464 Draft Bill, s16(1). 465 Submission 23, ACT Government, p. 7. 466 Submission 23, ACT Government, p. 7. 467 A trafficable quantity of cannabis in the ACT is 300 grams of cannabis, 25 grams of cannabis oil or resin, or 10 cannabis

plants. 468 Submission 24, ATODA, p. 10.



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can be cultivated risks yielding amounts of cannabis in excess of the trafficable quantity and could put the licensed cultivator in a position where they are considered to be trafficking cannabis.469

9.134 A number of submissions proposed limiting cultivation up to ten plants, which is just below a trafficable quantity.470 The Committee heard that a medicinal user may use quite a bit more over a period of time than a recreational user, noting that different plant varieties, application and different dosages would alter the number of plants a medicinal user may need.471 In some cases patients may require more than 10 plants such as where leaves are being juiced.472

9.135 Other evidence to the Committee suggested that a licence to cultivate up to ten plants is excessive, suggesting that ‘medical marijuana patients require no more than 370 grams a year’.473

9.136 Whilst cultivation licences are limited to less than the trafficable quantity, the Committee notes that this limit appears to be substantially higher than other proposed medicinal cannabis schemes and in comparison to the current ACT decriminalisation of simple cannabis offences.

9.137 The ACT’s current Simple Cannabis Offence Notice Scheme applies to the cultivation of one or two cannabis plants or possession of not more than 50 grams of cannabis. The scheme does not apply to hydroponically grown cannabis or cannabis resin or cannabis fibre.474

9.138 In comparison, the NSW Terminal Illness Cannabis Scheme limits possession and use to 15 grams of cannabis, one gram of cannabis oil or 2.5 grams of cannabis resin for registered patients and carers.

9.139 The ACT’s trafficable quantities are also much greater than the maximum allowance for possession in Canada under its new ‘Marihuana for Medical Purposes Regulation’ regime, which came into operation in April 2014.475 Under that regime, the amount of dried marijuana that a person can possess is the lesser of 150 grams or 30 times the daily quantity of dried marijuana stipulated by the person’s health care practitioner.476

469 Submission 23, ACT Government, p. 8. 470 Submission 7, Prof David Penington, Att A – MJA, 2 February 2015, p. 75; Submission 19, p. 2; Submission 28, p. 14;

Mr Marc Pengryffyn, Transcript of Evidence, 13 March 2015, pp. 8; 11-12. 471 Mr Marc Pengryffyn, Transcript of Evidence, 13 March 2015, p. 9. 472 Submission 22, Mr Justin Sinclair, pp. 10-11. 473 Mr Gary Christian, Transcript of Evidence, 31 March 2015, p. 56. 474 ACT Policing, Drugs and the Law. 475 The Regulations were made in June 2013, to operate from April 2015. Details at: http://www.hc-sc.gc.ca/dhp-

mps/marihuana/index-eng.php, accessed 30 July 2015. 476 Health Canada, ‘Accessing Marijuana for Medical Purposes – Information Bulletin’, at http://www.hc-sc.gc.ca/dhp-

mps/marihuana/info/licencedproducer-producteurautorise/access-usage-eng.php, accessed 3 August 2015.

http://www.hc-sc.gc.ca/dhp-mps/marihuana/index-eng.php


http://www.hc-sc.gc.ca/dhp-mps/marihuana/info/licencedproducer-producteurautorise/access-usage-eng.php

http://www.hc-sc.gc.ca/dhp-mps/marihuana/info/licencedproducer-producteurautorise/access-usage-eng.php



9.140 The Committee notes that the quantity of cannabis required by patients may vary depending on the method of application and the condition or symptom being treated. The wide range of viewpoints presented to the Committee about how much cannabis is appropriate reinforces arguments for more clinical evidence on plant varieties, dosages and the best modes of administration for different conditions.

LICENSING AND PHOTO ID

9.141 The discussion paper notes that ‘it is expected that the CHO will issue approved patients and nominated persons with a photo identity card, which will allow authorities to easily verify a patient’s, or nominated person’s eligibility.’477

9.142 This detail is not specified in the Draft Bill, however the ACT Government believes this needs to be included in the legislation ‘to assist with enforcement and regulatory activities’.478

9.143 ACT Policing note that licensing would also need to be done by a statutory body that has the same access and information as the RTA.479 The Committee heard that there are a lot of safeguards behind the RTA issuing drivers licences and a medicinal cannabis licensing scheme would need similar safeguards. If issuing a licence, it would need to identify things like when cannabis was prescribed, for what use and period of time and whether the medical practitioner provided advice to the patient on whether they should be driving a motor vehicle or not.480

INTERSTATE USE

9.144 The ACT Government submission raised the implications of an approved applicant needing to transport their medicinal cannabis interstate when travelling. At present, a patient would be subject to the laws of the State or Territory they are travelling in and may be charged for possession and/or use. The Government submission notes that this cannot be addressed within the Draft Bill itself but must be considered in the implementation phase.481

9.145 This issue is pertinent to arguments for a national approach as discussed in Chapter 10 of this report.

477 ACT Greens Discussion Paper, p. 4. 478 Submission 23, ACT Government, pp. 5, 11. 479 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 100. 480 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 100. 481 Submission 23, ACT Government, p. 10.



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DIVERSION

9.146 The Committee was advised that the Draft Bill does not appropriately manage the risk of diversion of crude cannabis to the recreational market, particularly due to the grow-your-own supply option.

9.147 DFA highlighted to the Committee that the risks of diversion under the Draft Bill are high, particularly given the proposed limits on quantities of cannabis that can be cultivated. They note that ‘one plant is like giving an open chequebook to all and sundry...only naivety would believe that no-one will ever exploit that trust’.482

9.148 The Committee was advised that the Draft Bill ‘does not provide for any penalty provisions for misuse of therapeutic cannabis’.483 The CPO highlighted that the Draft Bill:

does not necessarily point to what penalty provisions and what sorts of things are in place that would dissuade a person from using not only the process in producing but also the distribution and the prescription unlawfully, which to some extent might go to answering your questions around what would be the consequences and how would we find out if it was used in a manner that was outside the process or a scheme.484

AFFORDABILITY

9.149 The discussion paper accompanying the Draft Bill asks readers if other factors should be relevant for decisions to allow applications under Category 3, such as if a suitable alternative treatment is unaffordable.

9.150 ATODA does not support this criterion, noting that decisions to use medicinal cannabis should be made in the context of a patient’s health needs.485


9.151 Whilst the affordability of medications is an important concern for many patients, given the commentary from officials on the need for clearly specified indications the Committee does not feel it is appropriate to include affordability as a reason for an application under Category 3.

482 Mr Gary Christian, Transcript of Evidence, 31 March 2015, p. 56. 483 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 103. 484 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 103. 485 Submission 24, ATODA, p. 10.


REVIEW OF THE BILL

9.152 The Draft Bill includes requirements for review of the Cannabis for Medical Conditions provisions as soon as practicable after three years of its operation.486

9.153 ATODA highlighted that:

The discussion paper refers to a review of the legislation after three years, but section 25 of the exposure draft of the bill refers to two years. In ATODA’s view, two years is too short a time for the initiative to be fully implemented and bedded down. A review after three years seems appropriate.

With respect to the composition of the review committee (s. 25(3)) ATODA suggests that it also include a person with expertise in the evaluation of social policy initiatives. Too often committees that review these types of interventions, within a legislative framework, lack evaluation expertise and, as a consequence, apply evaluative methodologies that do not reflect contemporary standards of evaluation practice.487

9.154 The Committee notes the lapsed NSW Bill included provisions for a review after one year of operation for parts relating to the use of cannabis by children with intractable childhood epilepsy and after two years for the use of cannabis by adults to relieve serious medical conditions.488

9.155 The Committee also received comments in support of a three-yearly review.489

OTHER

9.156 The Committee noted a range of other issues that are not adequately addressed in the Draft Bill.

CANCELLATION OF APPROVALS OR L ICENSES

9.157 The provisions around cancellation of an approval (cl 15) do not require the CHO to inform the medical practitioner/s that provided a medical declaration for that applicant under section 8 or section 9 that the approval has been cancelled.

9.158 Similarly the provisions around cancellation of a cultivation licence (cl 23) do not require the

486 Draft Bill, s25. 487 Submission 24, ATODA, p. 11. 488 NSW Bill, s30Q. 489 Submission 22, Mr Justin Sinclair, p. 11; Submission 24, ATODA; Submission 28, p. 14.



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CHO to inform the approved patient, if a nominee cultivating on their behalf has had their licence cancelled.

CONFIDENTIALITY

9.159 The Draft Bill does not specify whether the register of approved patients or the register of licensed cultivators (cl 24) and associated information will be public or confidential. This raises additional risks such as information about cultivating locations becoming public, along with privacy considerations.

PUBLIC PLACES

9.160 The Draft Bill does not address the use of medicinal cannabis in public places. It is unclear if that detail would be provided in the approval conditions for each user, in which case consistency of conditions across approved patients may be of concern.

PRINCIPLE PLACE OF RESIDENCE

9.161 The Draft Bill does not require the applicants’ principle place of residence to be in the ACT. Depending on whether medicinal cannabis schemes are established in other Australian States and Territories, there are risks of the ACT becoming a centre for interstate patients creating increased burden for registrations, compliance as well as a range of legal issues. These may in turn raise issues of priority for ACT applicants. 490


9.162 The Committee notes that a number of submissions and statements to the Committee support the Draft Bill. The Committee also notes that the support expressed was, in many cases, in-principle support for the establishment of a medicinal cannabis scheme in a timely fashion, rather than for the specific scheme set out in the Draft Bill.

9.163 Whilst the Committee supports the principle for a compassionate approach to medicinal cannabis for those suffering from terminal illness or serious medical conditions, the Draft Bill does not provide a workable regulatory framework. In particular it does not adequately address more significant medical and legal risks, notably the need for a quality medicinal cannabis supply.

Recommendation 5 490 Submission 22, Mr Justin Sinclair, pp. 9-10.


9.164 The Committee recommends that the ACT Legislative Assembly reject the proposed Drugs of Dependence (Cannabis Use for Medical Purposes) Amendment Bill 2014.



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I N Q U I R Y I N T O T H E E X P O S U R E D R A F T O F T H E D R U G S O F D E P E N D E N C E ( C A N N A B I S U S E F O R M E D I C A L P U R P O S E S )

A M E N D M E N T B I L L 2 0 1 4 A N D R E L A T E D D I S C U S S I O N P A P E R

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10 AM E NDE D, A LT E RNATIVE AND P REF E RRE D

M O DE LS 10.1 In this chapter the Committee analyses proposed amendments to the Draft Bill, and then

considers alternative regulatory approaches to medicinal cannabis, including supply options.

AMENDMENTS AND ALTERNATIVES

10.2 In his submission to the Committee, Mr Shane Rattenbury MLA advised that, if the Committee did not wish to support the scheme as outlined in the Draft Bill, amended versions of the scheme and/or alternative approaches should be considered.491 Mr Rattenbury suggested the Committee consider one, or a combination of, the following:

a scheme that provides patients with indemnity from prosecution for cannabis possession and use but not permitting cultivation, leaving patients to source their own cannabis;

limiting the scheme to terminally ill patients only (Category 1); and

inclusion of a sunset clause, after three years of operation to enable the scheme to operate as a trial. 492

INDEMNITY FROM PROSECUTION

10.3 Mr Rattenbury advised in his submission to the Committee that the scheme outlined in the Draft Bill should be considered more as an amnesty from criminal laws for genuinely ill people using cannabis. 493 He highlights that doctors are not expected to prescribe or recommend taking cannabis under the scheme and therefore arguments for a formal TGA approved medicine with known quality and dosage need to be put aside and the unique situation of cannabis be considered in a different light.494

10.4 Noting the concerns of the Deputy CHO around what he described in the Draft Bill as the ‘ceremonial use of the medical profession to endorse something,’ the Committee heard that a scheme without medical profession involvement would be similar to what the ACT

491 Submission 32, Mr Shane Rattenbury MLA, pp. 7-8. 492 Submission 32, Mr Shane Rattenbury MLA, pp. 7-8. 493 Submission 32, Mr Shane Rattenbury MLA, p. 5. 494 Submission 32, Mr Shane Rattenbury MLA, p. 5.

1 0 2 S T A N D I N G C O M M I T T E E O N H E A L T H , A G E I N G , C O M M U N I T Y A N D S O C I A L S E R V I C E S

currently has in place through Simple Cannabis Offence Notices. The Deputy CHO noted that the Bill is essentially seeking ‘legal relief for the compassionate use of illicitly obtained cannabis’.495

10.5 The Committee heard that in place of the proposed legislation, a simple licensing scheme could be created, with a register maintained by law enforcement and perhaps an identification card for registered individuals to make it clearer when questioned by law enforcement that they are entitled to possess and use cannabis.496


10.6 Given the concerns discussed in the previous chapter, the Committee notes that a scheme focusing on an amnesty from prosecution for patients would appear to be a preferable interim approach to medicinal cannabis rather than the scheme proposed in the Draft Bill.

10.7 A scheme that does not permit cultivation by patients or carers is similarly preferred to one that is in contradiction to international conventions or that endorses the use of unknown and potentially dangerous cannabis supplies. As identified by Mr Rattenbury, patients would be left to source their own cannabis, which is also not ideal. The Committee discusses preferred supply models later in this chapter.

LIMITING THE SCHEME

10.8 With regard to Mr Rattenbury’s alternative proposal to limit the scheme to terminally ill patients, Winnunga suggested that a limited approach could be considered:

Limited compassionate decriminalisation of cannabis specifically for palliative care might be a reasonable short term option. This is consistent with community opinions voiced at the ATODA public forum on the issue in 2014. Winnunga would support allowing Category 1 patients (those with a terminal illness) from the proposed Greens Bill Amendment access to medicinal cannabis.497


10.9 The Committee believes that limiting the scheme to terminally ill patients, without significant additional amendment to the Draft Bill, does not address the majority of concerns raised by the medical profession and by law enforcement, particularly if private cultivation is still being sanctioned.

495 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 78. 496 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, pp. 82-83. 497 Submission 21, Winnunga.



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10.10 The Committee notes that the current NSW Terminal Illness Cannabis Scheme (TICS) is effectively a combination of Mr Rattenbury’s first and second alternative proposals (limiting the scheme and indemnity from prosecution) and provides this type of interim, limited approach.

10.11 As outlined in Chapter 3, TICS provides amnesty from prosecution for possession and use of cannabis by registered terminally ill patients without addressing cultivation and supply issues.

SUNSET CLAUSE

10.12 The Committee supports the inclusion of a sunset clause in legislation for a medicinal cannabis scheme. However, the Committee notes that there are too many outstanding concerns with the Draft Bill that need to be addressed and these will not be overcome by the inclusion of a sunset clause.

SU PE RSE DI NG TH E DRAFT BI LL

10.13 Citing recent changes to the Canadian medicinal cannabis scheme, Mr Rattenbury also proposed, in his submission to the Committee, that the scheme in the Draft Bill could be superseded if a formal supply model was developed.498 He stated that ‘once the basic scheme is in place we can, over time, improve the scheme as required, and adapt to any evolving circumstances.’499

10.14 The Committee notes that a ‘fix it later’ approach comes with its own risks such as extended legal proceedings. Changes to the Canadian scheme to remove provisions for private, individual cultivation (alongside government licensed cultivation) and move to solely commercial cultivation by government licensed firms has been the subject of legal proceedings [case of Allard et al. v. Her Majesty the Queen in Right of Canada, 2014 FC 280].

10.15 On 31 March 2014 the Canadian MMPR500 replaced the Marihuana for Medical Access Regulations (MMAR) which had been in place (with some amendments) since 2001. Possession and use of marihuana is illegal in Canada unless authorised under the regulations ‘the courts have required reasonable access to a legal source of marijuana when authorized by a healthcare practitioner.’501

10.16 As a result of the Allard case and interim Canadian Federal Court Orders from March 2014:

498 Submission 32, Mr Shane Rattenbury MLA, pp. 2-3. 499 Submission 32, Mr Shane Rattenbury MLA, p. 2. 500 Marihuana for Medical Purposes Regulations (SOR/2013-119). 501 Health Canada, ‘Medical Use of Marijuana’, at http://www.hc-sc.gc.ca/dhp-mps/marihuana/index-eng.php.



individuals who were previously authorized to possess and produce marijuana under the MMAR, and who meet the terms of the Federal Court order, will be able to continue to do so on an interim basis until the Court reaches a final decision.502

10.17 There does not appear to have been a decision rendered yet in the Allard case.

GROWERS’ COLLECTIVES AND CLUBS

10.18 The Committee heard evidence both in support and against growers’ collectives or co-ops as possible supply alternatives to the grow-your-own or illegal supply options in the Draft Bill.

10.19 One submission proposed that cannabis social clubs or collectives be considered as a supply approach. The submission proposes that clubs could be registered as not for profit organisations ‘that supply and distribute Cannabis among its members all of which must be over twenty one.’ Members smoke the cannabis at a private residence for leisure or therapeutic reasons. With strict operating guidelines, they aim to prevent cannabis users from being involved in illegal activity or interacting with the criminal element of the illicit market by organising cultivation within the club. The model also aims to provide education and information to its members as well as a peer support system. Clubs would also need to maintain an open dialogue and collaboration with authorities. The submission notes that ‘at present, CSCs [Cannabis Social Clubs] are effectively operating in the United States, Canada, Spain and Switzerland.‘503

10.20 The Committee heard that a cooperative growing approach short-circuits the black market which is beneficial for patients and the community.504

10.21 The Committee was advised that cannabis clubs or collectives have developed in jurisdictions where, like the Draft Bill, the regulatory schemes allow for patients to nominate third parties to grow cannabis for their medicinal use.505 This is particularly relevant to jurisdictions with medical endorsement not prescription. However, the Committee heard concerns that in many cases the clubs have grown into a substantial industry which appear ‘to be marketing to consumers despite the technical requirement to obtain a medical endorsement to use the product’ which has led to regulatory failure and defacto legislation for all uses.506

10.22 Another submission advised that medicinal cannabis supply is best kept as a ‘cottage industry’, limiting the size of producers/growers to reduce the likelihood of a ‘Big Tobacco’

502 Health Canada, ‘Medical Use of Marijuana’. 503 Submission 33, Cannabis Social Club, p. 1. 504 Mr Marc Pengryffyn, Transcript of Evidence, 13 March 2015, p. 8. 505 Submission 23, ACT Government, p. 10. 506 Submission 23, ACT Government, p. 10; Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 77.



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type of industry dominance.507


10.23 Like a grow-your-own approach, the Committee notes that a supply model based on cannabis growers’ collectives would not be in accordance with the requirements of the 1961 Convention and is therefore not a viable option.

PREFERRED APPROACH

CRUDE CANNABIS AS A PHARMACEUTICAL

10.24 The AMA notes that in the absence of suitable, accessible pharmaceutical products a quality controlled source of crude cannabis is the next best option, like those in Canada and the Netherlands where it is produced through a pharmaceutical company with research, development and monitoring.508

10.25 Similarly, the Committee heard from the Deputy CHO that a gold standard system would ‘regularise the supply with a normal prescription process.’509 He advised that:

The only way you could make it medicinal cannabis, or medicinal cannabis in the way the medical profession understands it, is to have a known product that runs through very similar lines to the normal prescription process. 510

...

If you look at areas that have prescription supply, such as the Netherlands, they have actually controlled the THC component of what is available.511

10.26 The Committee notes the comments made by Emeritus Professor David Pennington on crude cannabis:

Cannabis can never be a pharmaceutical agent in the usual sense for medical prescription, as it contains a variety of components of variable potency and actions, depending on its origin, preparation and route of administration. Consequently, cannabis has variable effects in individuals. It will not be possible to determine universally safe dosage of cannabis for individuals based on a clinical trial.512

507 Submission 19, Nimbin HEMP Embassy, p. 2. 508 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, pp. 35-36. 509 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 81. 510 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 78. 511 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 78. 512 Submission 7, Prof David Penington, Att A – MJA, 2 Feb 2015 pp. 74-75.


10.27 However, the Deputy CHO advised that arguments claiming a plant cannot be a pharmaceutical are not correct. He noted that such statements are:

only true if you grow the plant and do not test it. You can do quite detailed chemical tests to say, “This has exactly this much THC and this much cannabinoid and it is this many grams.” And if that is the case, then the fact that it is a plant is kind of irrelevant. It is a certain amount of product.513

GOVERNMENT SUPPLY AND DISTRIBUTION

10.28 A number of the submissions that support a medicinal cannabis scheme based on crude cannabis indicated a preference for a government controlled supply and distribution scheme.514

10.29 AMA, for example, advised that ‘... if we are going to introduce legislation it needs to be tight, it needs to be scientifically rigorous and it needs to be controlled.’515 They told the Committee:

if we can come up with a good product and a good model of distribution then we are very happy to support it for those conditions where there is rigorous scientific evidence to support it.516

10.30 Winnunga also supported the availability of medicinal cannabis with a preference for a highly regulated program with government supply and product quality control in the model of systems which exist in the Netherlands or Canada.517

10.31 FFDLR told the Committee that:

You want a system that provides a product you can rely upon and that requires a central growing system. Our concern is that you do not want commercial interests to push the boundaries of what is a desirable extent to which the cannabis should be allowed.518

...

We favour control centrally—some sort of central control, whether in the ACT or a unified one in Australia as a whole, just as exists in relation to the poppy straw industry in Tasmania. That is a relevant example. Or we can import from countries

513 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 87. 514 Submission 21, Winnunga; Submission 22, Mr Justin Sinclair, p. 11; Submission 18, Mr Nicholas Christodoulou;

Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 38; Mr William Bush, Transcript of Evidence, 31 March 2015, p. 49.

515 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 38. 516 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 40. 517 Submission 21, Winnunga. 518 Mr William Bush, Transcript of Evidence, 31 March 2015, p. 47.



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where it is controlled.519

NATIONAL APPROACH

10.32 A national approach to a medicinal cannabis scheme was strongly supported in the evidence received by the Committee.520

10.33 The AMA is supportive of a national approach in order to ensure a consistent and coordinated approach to the management of medicinal cannabis, which will offer better support and effective policy. They noted that ‘We do not want to see different states having different standards and different laws’,521 which would also create cross-border issues.522

10.34 The Committee heard from the AMA that the NSW trials are not contrary to a national approach as the finding can be rolled out nationally. They note that it would be ideal to have an Australia-wide trial.523

10.35 ACT Policing supports a national approach, regardless of whether trials are run in the ACT or NSW. The CPO stated that:

the view of ACT Policing is that whatever is introduced needs to have some commonality right across every border in Australia—so a national approach...524

...it would be unreasonable and counterproductive if different laws and different regulations applied to different states.525

10.36 The Deputy CHO advised that ‘a national approach would be ideal...as it is with prescription medicines in general.’526

REG UL ATO R OF ME DI CI NA L CA NN AB IS BI LL 2014

10.37 The Committee was advised that the Commonwealth’s Regulator of Medicinal Cannabis Bill 2014 ‘offers a more practical and viable option for reform than the Draft Bill because it overcomes barriers associated with the TGA and addresses Australia’s international

519 Mr William Bush, Transcript of Evidence, 31 March 2015, p. 49. 520 Submission 16, AMA; Submission 18, Mr Nicholas Christodoulou; Submission 24, ATODA; Submission 35; Dr Elizabeth

Gallagher, Transcript of Evidence, 31 March 2015, pp. 34-40; Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 91; Adjunct Prof Michael Moore, Transcript of Evidence, 31 March 2015, p. 73; Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 104.

521 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 34. 522 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 40. 523 Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, p. 35. 524 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 104. 525 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 104. 526 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 91.


obligations’.527

10.38 The PHAA advised that the Commonwealth Bill addresses many of the issues and concerns with the Draft Bill in a national way.528 They note that:

there are some really significant benefits of being part of a national scheme where negotiations are going on between jurisdictions and the national scheme, particularly in regard to supply.529

10.39 PHAA further advised that:

The bill that is currently being considered by the Senate I think really does relieve quite a number of [ACT Health’s] concerns. One of the most attractive things about the commonwealth bill is that it envisages a partnership between the commonwealth and the states, and that there will not be a national system of medicinal cannabis unless it is done on a partnership basis because of the different constitutional responsibilities of the states and territories compared with the commonwealth.

The idea that the commonwealth bill is drafted in such a way as to be in strong compliance with the international treaties, the two key conventions, is a very attractive aspect. The fact that it separates therapeutic cannabis from the TGA system and therefore does not impact adversely on the integrity of our medicine system, that it is setting up a parallel approach, and the fact that it applies only to participating jurisdictions mean that there is a real opportunity now for us to move here in the ACT, within our own constitutional provisions, knowing that there is this overarching support through the commonwealth framework if that bill goes ahead in anything like its current form... 530

It would also allow, basically, the particular supply of appropriate cannabis for an appropriate need.531

10.40 ATODA proposed that:

The ideal policy setting is one which combines the approach of the Bill currently before the Commonwealth Parliament to introduce a legal regime managed by a Regulator of Medicinal Cannabis, on the one hand, and the development of cannabis pharmaceuticals that meet the therapeutic goods standards of the TGA. Unfortunately, it will be many years before we will be in such a position.532

527 Submission 18, Mr Nicholas Christodoulou, p. 9. 528 Adjunct Prof Michael Moore, Transcript of Evidence, 31 March 2015, p. 65. 529 Adjunct Prof Michael Moore, Transcript of Evidence, 31 March 2015, p. 73. 530 Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 73. 531 Adjunct Prof Michael Moore, Transcript of Evidence, 31 March 2015, p. 73. 532 Submission 24, ATODA, p. 6.



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Recommendation 6 10.41 The Committee supports a national approach to medicinal cannabis and encourages the

ACT Government to continue to work with the Commonwealth, States and Territory on a national medicinal cannabis scheme.

REGULATORY APPROACH - INTERNATIONAL EXPERIENCE

10.42 When considering a preferred regulatory approach, the Committee was advised to take into account the experiences and evidence of both the efficacy of medicinal crude cannabis and regulatory approaches internationally.533 The former Director-General, ACT Health advised that:

Notwithstanding Dr Pengilley’s comments about the evidence around the efficacy of these—and I support what he said—I would make the point that we do not necessarily have to generate that evidence in Australia either. I think we should be looking at the international evidence. There is a growing body of evidence in this space and I think we should be prepared to embrace that, as we do in most other fields.534

10.43 The Deputy CHO added:

Particularly the evidence of the different kinds of regulatory schemes that have been used. There are good systems approaches. The clinical evidence is one issue but the approach by government is actually quite a lot of experience.535

10.44 In addition to learnings from international experiences, the CPO advised that Australia could consider broader trials:

Putting in place a trial that simply talks about its production, distribution and use is one thing, but certainty around the quality of the drug produced and the consistency in quality of the drug produced through a number of different manufacturers has to be well considered, so that you know that if you are getting it from two or three pharmacies under the same prescription, each and every time you are getting exactly the same drug.536

533 Submission 24, ATODA, p. 5; Submission 23, ACT Government. 534 Dr Peggy Brown, Transcript of Evidence, 9 April 2015, p. 91. 535 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 91. 536 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 102.


THE NETH ER LA N DS MO DE L

10.45 The Netherlands national regulatory model for medicinal cannabis was discussed by a number of witnesses and in submissions as one of the better-framed regulatory models internationally.537

10.46 In the Netherlands production and supply of cannabis for medicinal and scientific purposes is regulated through the Office for Medicinal Cannabis, which provides a contaminant-free range of cannabis plant strains with varying levels of THC and CBD to pharmacies, hospitals and veterinarians.538

10.47 The cultivation and distribution of medicinal cannabis in the Netherlands has been described as follows:

The Netherlands Ministry of Health, Welfare and Sport procures medicinal grade cannabis from an authorised agricultural company that cultivates the plant in compliance with current European standards and is subject to strict quality control. It is dispensed by a qualified pharmacist in its raw botanical form (milled vegetable matter) by prescription. Patient information includes instructions for use with a vaporiser or preparation as a tea. A short video illustrates the entire process.539

10.48 The ACT Government expressed a preference for a Netherlands style scheme to address supply concerns:

So it would allow you to quantify what was being supplied, as a basis for education, as a basis for doctors knowing what they are doing. I guess the issue of liability, just because they do not know what they are prescribing, would be controlled. I think it would increase the confidence of the medical profession, or at least those who wish to pursue training in using this pharmaceutical, in knowing what to train in. There is a body of evidence on that much of a known substance having this much effect, not an unknown quantity of an unknown subject having a certain effect...540

10.49 It was highlighted for the Committee that marijuana is still illegal in the Netherlands. The Deputy CHO noted that ‘They get around that by having this agency model and by having a fairly broad tolerance for people using it illicitly. But it is not actually legalisation; it is just a supply system.’541

537 Mr William Bush, Transcript of Evidence, 31 March 2015, p. 50; Mr Ross O’Donoughue, Transcript of Evidence, 9 April

2015, p. 88; Submission 23, ACT Government, pp. 10-11; Submission 21, Winnunga, p. 1; Submission 20, PHAA, Att A, p. 2; Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, pp. 35-36; Adjunct Prof Michael Moore, Transcript of Evidence, 31 March 2015, p. 73; Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, pp. 78, 87.

538 Assoc Prof Jonathon Arnold, Specialist Adviser Report, 16 March 2015, p. 21. 539 Submission 30, FFDLR, p. 6 [quoting Mather et al 2013: Laurence E Mather, Evert R Rauwendaal, Vivienne L Moxham-

Hall and Alex D Wodak, “(Re)introducing medicinal cannabis”, (MJA 199 (11) 16 December 2013, p. 760.] 540 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, pp. 86-87. 541 Mr Ross O’Donoughue, Transcript of Evidence, 9 April 2015, p. 88.



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10.50 FFDLR noted that the Dutch scheme is a fairly effective way of controlling quality and could be a source of import for cannabis.542

10.51 The Deputy CPO told the Committee that, in regard to the Dutch scheme:

the evidence is that they have fewer prescriptions, in an older patient group. That would suggest it is being targeted appropriately and with less diversion. So that sort of systems evidence is done.543

10.52 The ACT Government further highlighted in its submission that reviews of the Netherlands scheme indicated a higher proportion of prescriptions for cancer and non-chronic pain indications and for older patients, ‘which are more likely to be indicative of use in serious medical conditions’. The Netherlands scheme also has a lower overall use compared to schemes in the US, suggesting it is a strong regulatory scheme.544

10.53 The Committee was advised that a scheme like the one in the Netherlands also seems more consistent with the 1961 Convention than the Draft Bill545 and is similar to the model proposed in the Commonwealth Bill.

ACT - UNILATERAL APPROACH

10.54 The Committee received commentary in support of the ACT progressing with a local medicinal cannabis scheme ahead of a national scheme, noting that agreement by the States, Territories and Commonwealth to a national approach may be a long way off.546

10.55 FFDLR, for example, noted that the Commonwealth Bill would answer a lot of the concerns about quality and control but ‘the platoon should not march at the pace of the slowest person’. They note that some jurisdictions will move faster than others to establish medicinal cannabis schemes.547

10.56 The PHAA concurred, advising that:

We should be keeping pressure on the federal parliament and the federal government to make that sort of legislation. But in the meantime there is no reason why the ACT cannot make that first step with regard to just ensuring there is no penalty for somebody—I think it is a simple piece of legislation—who is in palliative

542 Mr William Bush, Transcript of Evidence, 31 March 2015, p. 50. 543 Dr Andrew Pengilley, Transcript of Evidence, 9 April 2015, p. 90. 544 Submission 23, ACT Government, p. 10. 545 Mr Ross O’Donoughue, Transcript of Evidence, 9 April 2015, p. 88. 546Submission 24, ATODA, p. 6; Submission 23, ACT Government pp. 3-4; Mr William Bush, Transcript of Evidence,



care548 and is using cannabis, or for their carer who is supplying very small amounts. We already have personal amounts defined for our expiation notice system.549

SUPPLY OPTIONS

10.57 As identified in evidence to the Committee, a reliable, consistent supply of crude cannabis with known quality and chemical makeup is essential for any cannabis scheme to truly be able to be considered medicinal. 550

10.58 The Committee notes there are two cannabis supply options that could be considered without breaching Australia’s international obligations:

importation by a government agency; and

government controlled cultivation in Australia.

IMPORTATION

10.59 The Committee received evidence in support of importation of pharmaceutical-standard crude cannabis from overseas.551

10.60 The Committee notes that, whilst not impossible, importation, exportation and distribution of medicinal cannabis for scientific or medical purposes requires compliance with a number of conditions under Commonwealth legislation and the 1961 Convention.552

10.61 The Customs Act 1901 would be applicable if importation or exportation of cannabis is considered. The Committee was advised that ‘if external importation was deem the only viable option, s50(3)(a), provides that the ‘importation of [illicit] goods is prohibited unless a licence, permission, consent or approval to import goods’ is provided.553

10.62 The Committee was further advised that:

The Customs (Prohibited Imports) Regulations list cannabis as a prohibited item under schedule 4. However, under reg[ulation] 5(1)(a), importation of a prohibited drug is possible if a licence or permission is granted by the Secretary of the Department of Health and Aged Care (DHAC) or other authorised person. The ACT would be expected to comply with several conditions provided for in reg[ulation] 5(9) in order

548 PHAA note that they use the term Palliative care as meaning the relieving of symptoms without necessarily curing or

treating the cause, as opposed to palliation as in end-of-life palliation. Mr David McDonald, Transcript of Evidence, 31 March 2015, p. 72.

549 Adjunct Prof Michael Moore, Transcript of Evidence, 31 March 2015, p. 73. 550 Submission 22, Mr Justin Sinclair, pp. 14-15; Submission 23, ACT Government, pp. 3, 11; Mr Rudi Lammers, Transcript

of Evidence, 9 April 2015, pp. 95-96; Dr Elizabeth Gallagher, Transcript of Evidence, 31 March 2015, pp. 35-36. 551 Submission 20, PHAA; Submission 30, FFDLR, p.6. 552 Submission 30 FFDLR, p. 6; Submission 18, Mr Nicholas Christodoulou, pp. 4-5. 553 Submission 18, Mr Nicholas Christodoulou, pp. 4-5.



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to obtain a licence to import cannabis, such as the safe custody of the drug. Cannabis is listed as a Schedule I drug, and reg[ulation] 5(12) of the Customs (Prohibited Imports) Regulations specifies that a maximum amount of the drug that is to be imported into Australia must be determined by the DHAC ‘in accordance with Australia’s obligations under the 1961 Convention and be notified annually to the International Narcotics Control Board’.554

CULTIVATION IN AUSTRALIA

10.63 The Committee also received evidence in support of cultivation within Australia.555

10.64 The PHAA, for example, supports further exploration on the feasibility of licensing medicinal cannabis production in Australia.556

10.65 The ACT CPO also advised that ‘ACT Policing strongly supports federally regulated cultivation.’557

10.66 Interstate importation could also be possible for the ACT if the government or another Australian jurisdiction opted to make the necessary legislative changes to enable it to produce and supply crude cannabis for medicinal purposes. The Committee was advised, for example that if NSW and ACT had similar legislation, the ACT could look to import medicinal cannabis from NSW, assuming the NSW government was growing it.558

10.67 FFDLR highlighted that a national approach to cultivation would enable the costs of selective plant breeding to be shared between jurisdictions.559

10.68 Professor David Penington advised, in an article written for the Medical Journal of Australia, that ‘any proposal for commercial production should be subject to strict control, with analysis of THC, THC-A and CBD content by a government toxicology laboratory for both cannabis oil and the leaf product.’560

ACT GOVERNMENT CONTROLLED PRODUCTION

10.69 The Committee was advised that there are approaches to growing and supplying medicinal cannabis within the ACT that are compliant with Australia’s international obligations should

554 Submission 18, Mr Nicholas Christodoulou, p. 5. 555 Submission 20, PHAA; Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 93; Submission 30, FFDLR, pp. 5-6. 556 Submission 20, PHAA. 557 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, p. 93. 558 Mr Nicholas Christodoulou, Transcript of Evidence, 13 March 2015, p. 23. 559 Submission 30, FFDLR, p. 6. 560 Submission 7, Prof David Penington, Att A – MJA, 2 February 2015, p. 75.


the ACT Government choose a unilateral approach:

To comply with Australia’s international obligations under art[icle] 28 of the 1961 Convention, the ACT Government itself ought establish a ‘system for selling or supplying cannabis’, similar to the cultivation of opium....

... A scheme must provide for the ACT Government to take ‘physical possession’ of the cannabis, for distribution to wholesalers in the ACT.561

10.70 Growing cannabis within the ACT would also ‘circumvent any Commonwealth importation legislation’562 and possibly be a cheaper option for patients.563

10.71 However, the Committee heard that any proposed scheme must resolve the need for registration of cannabis on the ARTG,564 which is highly unlikely given earlier arguments around safety and efficacy:565

Registration of crude cannabis on the ARTG can only be achieved ‘on application by a pharmaceutical company’; this is unlikely, because ‘of the difficulties patenting cannabis in its crude form’..., making it less attractive as a viable product for a pharmaceutical company.566

10.72 The Committee was advised that there are ways to operate within the TGA 1989 framework including relying on the Australian orphan drug scheme, relying on section 19(1) of the TGA 1989 which provides ‘exemptions for special and experimental uses’ or relying on section 19(5) of the TGA which permits a specified medical practitioner to supply therapeutic goods to be used as treatment. These options rely on the discretion of the Secretary of the Commonwealth Department of Health and Aged Care or on pharmaceutical companies seeking to register cannabis products or raw cannabis on the ARTG. 567

10.73 Alternatively, the Committee heard that the ACT could undertake a similar approach to the draft Commonwealth Bill, disassociating the ACT from the TGA in relation to medicinal cannabis only by amending section 157 of the Medicines, Poisons and Therapeutic Goods Act 2008 (ACT) ‘thereby creating the possibility of a separate therapeutic register in the ACT that provides specifically for the registration of medicinal cannabis’.568

561 Submission 18, Mr Nicholas Christodoulou, p. 11. 562 Submission 18, Mr Nicholas Christodoulou, p. 11. 563 Mr Nicholas Christodoulou, Transcript of Evidence, 13 March 2015, p. 20. 564 Submission 18, Mr Nicholas Christodoulou, pp. 11-12. 565 Submission 18, Mr Nicholas Christodoulou, p. 11. 566 Submission 18, Mr Nicholas Christodoulou, p. 6. 567 Submission 18, Mr Nicholas Christodoulou, pp. 11-12; Mr Nicholas Christodoulou, Transcript of Evidence, 13 March

2015, p. 18. 568 Submission 18, Mr Nicholas Christodoulou, p. 12; Mr Nicholas Christodoulou, Transcript of Evidence, 13 March 2015,

p. 21.



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10.74 The Committee was advised that establishing its own regulated supply of cannabis would, however, create an onerous administrative burden.569

GOVERNMENT SUPPLY ALONGSIDE GROW-YOUR-OWN

10.75 Some evidence to the Committee proposed that a government supply could be made available alongside a grow-your-own approach.570

10.76 FFDLR, for example, advised that:

the ACT should adopt a system that permits access to cannabis from a centralised source while at the same time removing penalties from those who have managed to cultivate their own supply for their medical needs.571


10.77 The Committee notes, however, the Canadian experience providing two supply options (government and grow-your-own) and the resulting legal cases arising from Canada’s attempt to remove personal cultivation provisions.

10.78 The Committee also notes that an individual grow-your-own approach to supply remains contradictory to Australia’s international obligations under the 1961 Convention.

OTHER CONTROLS

10.79 In addition to a suitable supply, the Committee received evidence that an effective regulatory regime for medicinal cannabis requires other important controls to be effectively implemented including prescribing requirements, dispensing methods, appropriate pricing, professional development for medical practitioners, and an oversight role for the government.

PRESCRIPTION AND DISPENSING

10.80 The Committee received evidence in support of a prescribing process like any other prescription drug and limited to registered dispensaries.572

569 Submission 30, FFDLR, p. 5. 570 Submission 30, FFDLR, p. 5; Dr Karen Downing, Transcript of Evidence, 13 March 2015, p. 3; Submission 5. 571 Submission 30, FFDLR, p. 5. 572 Mr Nicholas Christodoulou, Transcript of Evidence, 13 March 2015, p. 22; Submission 5; Submission 7, Prof David

Penington.


10.81 Professor David Penington advised in an article written for the Medical Journal of Australia that ‘venues for sale, presumably pharmacies or health food shops, should be registered’.573

10.82 The Committee also heard from the CPO for these controls:

ACT Policing supports a regulatory framework for persons accessing medical cannabis, with medical cannabis available only on prescription and dispensed through pharmacies.574

PRICING

10.83 At the ATODA-organised forum on 10 March 2015, attended by some members of the Committee, professor Beau Kilmer advised that one feature of a medicinal cannabis scheme that can assist in preventing diversion into the recreational market is to keep the price of medicinal cannabis above black market prices.575

10.84 The Committee heard from the CPO that the price point needs to be carefully considered:

If the cost of cannabis that is prescribed through a pharmacy is so high that a parent is forced to find a different method of supply, I think that would be a tragedy. The price of cannabis already is relatively low; it does not cost much to grow and produce cannabis. Therefore, in my view, the cost of providing lawful cannabis through a chemist ought to be sufficiently priced to make it accessible to those who need to use it. History has shown that when we price things beyond the reach of people, we drive the problem underground and we encourage purchasing through black markets. 576

10.85 As noted earlier, the cost of pharmaceutical cannabis products, and comparatively cheap cost to grow-your-own cannabis was a key factor for those advocating a medicinal crude cannabis scheme.


10.86 The Committee is conscious of patient concerns about the cost of pharmaceutical cannabis products. It is also aware that, should a medicinal cannabis scheme be implemented based on crude cannabis, the costs need to be commensurate to the cultivation, distribution and administration costs of the scheme and not profit driven.

573 Submission 7, Prof David Penington, Att A – MJA, 2 February 2015, p. 75. 574 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, pp. 90-94. 575 Professor Kilmer, presentation: ‘What will we need to do to keep a legal therapeutic cannabis market separate from

the illegal market? The implications of the USA experience for ACT policy, legislation and practice’, ATODA forum, 10 March 2015.

576 Mr Rudi Lammers, Transcript of Evidence, 9 April 2015, pp. 105-106.



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10.87 A regulated crude supply should not be priced prohibitively. The Committee notes that further research is needed to establish an appropriate price-point.

CHO OVERSIGHT, MEDICAL PRACTITIONER REGISTRATION AND PROFESSIONAL

DEVELOPMENT

10.88 In light of discussion in Chapter 9 around the role of the CHO, the Committee notes that the role of the CHO should not be to approve access to medicinal cannabis to individual users, but rather be an oversight and monitoring role.

10.89 The CHO’s role could primarily be to monitor prescribing patterns, through an electronic system and be responsible for registration of medical practitioners who are approved to prescribe medicinal cannabis.

10.90 As discussed in Chapter 9 relation to the Draft Bill, any medicinal cannabis scheme also needs a strong focus on ongoing professional development for medical practitioners. Registration should therefore include requirements for ongoing professional development and be subject to a 12 month renewal process.

COMMUNITY EDUCATION

10.91 The Committee notes that any medicinal cannabis scheme would also require enhanced community education.577

10.92 The AIDS Action Council, for example, notes that more reliable information and education would be of value to those communities likely to utilise and benefit from medicinal cannabis. Such material would best be produced and provided in collaboration with the community, service providers and doctors.578

10.93 The Committee also heard that appropriate education is needed for patients around the cannabis product itself, including advice around dosage requirements and that not one strain suits all.579

10.94 Education on the harms of recreational cannabis use would also need to be proliferated to reduce risks of ‘normalising’ cannabis use.

577 Submission 9, AIDS Action Council ACT; Submission 13; Submission 16, AMA; Submission 35. 578 Submission 9, AIDS Action Council ACT. 579 Mr Grant Beale, Transcript of Evidence, 13 March 2015, p. 30.



10.95 The Committee notes that the following features should be a part of any medicinal cannabis scheme:

Government-sourced or controlled cannabis (either through a multi-state cultivation trial or importation of suitable product from the Netherlands);

Require a prescription from a medical practitioner;

Permit for medical practitioners who are registered to prescribe with a 12-monthly renewal;

Hospital pharmacy dispensing;

CHO oversight of prescribing patterns by medical practitioners;

Price should be greater than street cannabis with a special scheme for low income earners;

Continued professional development for medical practitioners;

Community education; and

Sunset clause.

Recommendation 7 10.96 The Committee recommends that if the ACT acts independently of the Commonwealth or

other State and Territory jurisdictions on a medicinal cannabis scheme it needs to address the regulatory concerns raised in this report.

I N Q U I R Y I N T O T H E E X P O S U R E D R A F T O F T H E D R U G S O F D E P E N D E N C E ( C A N N A B I S U S E F O R M E D I C A L P U R P O S E S ) A M E N D M E N T

B I L L 2 0 1 4 A N D R E L A T E D D I S C U S S I O N P A P E R

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11 CO NCL US IO N 11.1 The Committee believes that there is evidence that cannabinoids have medicinal potential.

PH AR MA CE UTI CA L CA N NA BIS P RO DU CTS

11.2 The Committee notes that a small range of pharmaceutical cannabinoid products exist and that there is scope in Australia for additional indications and reduced cost, where appropriate.

11.3 The Committee believes there are opportunities to improve the guidance available to medical practitioners to help them understand and utilise Special Access Arrangements and off-licensing prescribing.

MEDI C AL R ESE AR C H

11.4 The Committee notes that barriers to medical research and development remain, particularly in relation to the scheduling of cannabis.

11.5 The Committee supports making crude cannabis and pharmaceutical cannabinoid products available for the purposes of medical research and clinical trials.

MEDI C IN AL C R U DE CA N NA BIS

11.6 The Committee also notes that there is not unanimous community support, in principle, for a medicinal cannabis scheme.

11.7 The Committee understands that some individuals suffering from terminal and/or chronic conditions are seeking immediate access to crude cannabis and associated indemnity from prosecution.

11.8 The Committee notes concerns about the known health risks of crude cannabis, including risks associated with smoking.

11.9 The Committee notes the long term effects of crude cannabis use are relatively unknown.

REG UL ATIO N

11.10 The risk of diversion and creating a catalyst for legalising recreational cannabis use are also noted and the Committee believes these risks need to be managed with appropriate controls.

11.11 The Committee notes community calls for a medicinal cannabis scheme; however it should not be implemented without suitable regulatory controls to manage known risks and harms.


DR AFT B IL L

11.12 The Committee does not support the Draft Bill, primarily as it does not adequately address supply concerns, public health and safety concerns or include suitable controls to minimise diversion.

11.13 The Committee acknowledges that any scheme involving the medical profession needs to provide enhanced outcomes for patients. The knowledge of medical professionals and administrators regarding cannabis and cannabinoid products also needs to be bolstered.

SU PPL Y

11.14 The Committee notes that creating cannabis supplies through a grow-your-own approach, growers clubs and collectives do not meet the requirements imposed by the 1961 Convention, in addition generating many practical, legal and health concerns.

11.15 The Committee notes a medicinal cannabis scheme should rely upon a strictly regulated and consistent supply of high quality medicinal cannabis which may be imported or grown in Australia.

NATIO N AL AP PR OA CH

11.16 Although the Committee notes that the ACT could act independently of the Commonwealth and other State and Territory jurisdictions, the Committee believes that a national approach is preferred to ensure consistency across Australia and avoid cross-border importation concerns. There are also cost-sharing benefits to a national approach including research and development of appropriate strains of cannabis and administrative costs for managing a scheme.

11.17 The Committee notes that the Commonwealth’s Regulator of Medicinal Cannabis Bill 2014 currently before the Senate appears to provide a suitable framework for a national medicinal cannabis scheme.

11.18 The Committee also notes that the Regulator of Medicinal Cannabis Bill 2014 (Cwlth) may not be passed and so a national approach may be delayed.

11.19 The Committee therefore supports an interim approach in the ACT, if the Commonwealth Bill is not passed, similar to the NSW Terminal Illness Cannabis Scheme.

Dr Chris Bourke Chair 10 August 2015



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Appendix A Submissions

Submission No.

Name/Organisation

1 Professor Jan Copeland

2 Ms Barbara Mummery

3 Directions ACT

4 Mr Justin Kander

5 Name Suppressed

6 Name Suppressed

7 Emeritus Professor David Penington, The University of Melbourne

8 Name Suppressed

9 AIDS Action Council of the ACT

10 Withdrawn

11 Mrs June Garfit

12 Name Suppressed

13 Name Suppressed

14 Dr Karen Downing

15 Drug Free Australia

16 Australian Medical Association (ACT)

17 Name Suppressed

18 Mr Nicholas Christodoulou

19 Nimbin HEMP Embassy and Australian HEMP Party

20 Public Health Association of Australia (PHAA)

21 Winnunga Nimmityjah Aboriginal Health Service


22 Mr Justin Sinclair

23 ACT Government

24 Alcohol Tobacco & Other Drug Association ACT (ATODA)

25 MS Australia & MS Research Australia

26 Mr Grant Beale

27 Name Suppressed

28 Name Suppressed

29 Name Suppressed

30 Families & Friends for Drug Law Reform (FFDLR)

31 Name Suppressed

32 Mr Shane Rattenbury MLA

33 Mr Shaun Kay (Krstic), CSC Australia

34 ACT Medicare Local

35 Name Suppressed



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Appendix B SPECIALIST ADVISER REPORT

Report on the medical applications of cannabis and cannabinoids

Legislative Assembly for the Australian Capital Territory Standing Committee on Health, Ageing, Community and Social Services

Inquiry into the Exposure Draft of the Drugs of Dependence (Cannabis use for Medical Purposes) Amendment Bill 2014

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Report on the medical applications of cannabis and the cannabinoids.

Jonathon Arnold Associate Professor in Pharmacology at the University of Sydney Director of the Cannabinoid Research Group About the author. Jonathon Arnold is an Associate Professor in Pharmacology at the University of Sydney. He is Director of the Cannabinoid Research Group and has 20 years of experience in cannabinoid pharmacology with 36 publications in this area. He has published papers on both the therapeutic and adverse effects of the cannabinoids. He co-authored a recent paper that reported for the first time the potency of street level cannabis in Australia. He has appeared on national television and radio commenting on cannabis and provides expert testimony in pharmacology, recently at the NSW Coroners Court and the Supreme Court of NSW.

Introduction

Cannabis has been used for thousands of years for medicinal and recreational

purposes. It was used as a medicinal herbal tincture in Europe and the United States in

the 19th century, and was prescribed for various conditions including birth labour,

menstrual cramps, asthma, insomnia, and migraine. Prohibition of its use began in the

early 20th century with the inclusion of cannabis under international drug control

treaties which deemed it a dangerous drug with no medical value. Since the discovery

over 20 years ago of the endocannabinoid system (a naturally occurring cannabinoid

biological system found in our brain and bodies), there has been a resurgence of

interest the potential therapeutic applications of cannabis. A wealth of both preclinical

and small scale clinical studies suggest that cannabis or its cannabinoid constituents

may be useful in combating various disease states. In recent times cannabis has been

legalized for medicinal use, particularly in the US where now 21 and 5 states allow its

medicinal and recreational use respectively, which generated 2.6 billion in sales

revenue in 2014 [1]. Thus, there is an urgent need to characterize the medicinal and

toxicological effects of cannabis and cannabinoid preparations. In Australia, the

debate about the legalisation of cannabis for medicinal or recreational purposes is

heating up, with many in the community arguing for its medical benefits and the need

to loosen access restrictions, while others argue of its harms and the need to maintain

its prohibited status.

Cannabis and cannabinoid pharmacology

Cannabis is a plant of the common varieties of Cannabis sativa, Cannabis



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indica and Cannabis ruderalis. There are 100 cannabinoid (cannabis-like) molecules

found in the plant material [2], being most abundant in the leaves and flowering tops

of the female plant. Δ9-tetrahydrocannabinol (THC), the main psychoactive ingredient

in cannabis, was one of the first active molecules isolated from the cannabis plant,

and its molecular structure became the template for all similar molecules

characterised thereafter (cannabinoids). Molecules were originally classed as

cannabinoids if they had similar behavioural or physiological effects as THC

including “tetrad” effects in rodents such as motor depression, catalepsy, analgesia,

and hypothermia. The term now applies beyond this narrow definition as many

cannabinoids, particularly cannabidiol are not psychoactive, while having a similar

chemical structure to THC. Further, endocannabinoids have a distinct chemical

structure to THC, as do many synthetic cannabinoids that have been synthesized by

chemists and have recently found there way into recreational use as herbal “spice”

incense.

THC acts upon the endocannabinoid system which naturally regulates a

diverse range of important physiological functions, including learning, mood, the

extinction of aversive memories, appetite and pain regulation [2-4]. The study of the

natural physiological role of endocannabinoids then provides a useful indication of

what disease states cannabinoid therapies might be useful in treating. The

endocannabinoid system was relatively recent discovered in the 1990s [5] and is a

complex network of receptors (proteins found in different tissues of the body that

mediate chemical communication) called cannabinoid CB1 and CB2 receptors. CB1

receptors are distributed throughout the brain [5], but are also present in peripheral

tissues including the gonads, the gut and glands. CB2 receptors are expressed in the

immune system in organs such as the spleen, tonsils, and thymus gland [2]. CB2

receptors are also present to a lesser extent in the brain where they are most densely

expressed on microglia cells (the brain’s immune cells), and there is controversial

evidence of their existence on neurons [6]. There is a possibility that CB2 receptors

are not appreciably expressed in healthy tissues but that physiological challenges and

disease states may increase their expression [7]. Additional as yet unidentified

cannabinoid receptors, such as GRP55, have also been postulated [8]. THC mimics

the action of cannabinoid chemicals such as anandamide and 2-AG which are lipid

messengers (ie. they are fat-derived compounds) [9, 10].



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Cannabidiol and other phytocannabinoids

One component of cannabis that might make a useful therapeutic due to its

lack of psychoactivity is CBD. This drug exhibits broad spectrum therapeutic

potential [11, 12], with evidence for it having anxiolytic, antipsychotic and

anticonvulsant effects. CBD levels vary across cannabis types, and there has been a

historical trend for decreasing CBD levels in street cannabis as THC concentrations

have increased [13, 14]. We conducted Australia’s first potency analysis which

showed that street cannabis contained THC concentrations averaging 15%, however

CBD was virtually absent from most samples [14]. The trend toward greater

THC:CBD ratios is of significant public health concern given evidence that CBD may

protect against the deleterious effects of THC such as cognitive impairment and

psychosis, supporting the viewpoint that CBD should be bred back into cannabis [13,

15-19]. More research is needed on the interplay of cannabinoid components, as it

may be that strains bred with a more balanced level of THC to CBD will be more

effective and safer therapeutics than street cannabis. Companies specializing in

medical marijuana in Europe and the US have developed various strains with some

providing a 1:1 THC:CBD ratio. However it is often argued that that these medical

strains still provide problems for regulatory approval as they would also contain other

cannabinoid components, as well as various phytochemicals whose toxicity might

need to be established.

Unlike THC, CBD doesn’t induce classic cannabinoid tetrad effects

(locomotor suppression, catalepsy, analgesia and hypothermia) [20] and has relatively

poor affinity for CB1 and CB2 receptors [12]. CBD behaves as an indirect

cannabinoid receptor agonist, meaning that it stimulates these receptors indirectly by

increasing levels of the natural occurring endocannabinoids [11]. CBD’s indirect

agonism may explain why studies have shown CBD can hinder the effects of

cannabinoid drugs like THC. CBD affects numerous other drug targets including

receptors important to the antipsychotic and anxiolytic effects of conventional drugs

[11]. CBD is also a potent antioxidant drug, dampening levels of reactive oxygen

species induced by various toxins and disease states [21].

There is also emerging preclinical evidence for the efficacy of a variety of

other plant-based non-intoxicating cannabinoids in treating a wide variety of disease

states. These include cannabidiolic acid (CBDA), cannabidivarin (CBDV),



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tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarin (THCV),

tetrahydrocannabivarin-acid (THCVA), cannabichromene (CBC), cannabinol (CBN),

cannabigerol (CBG) and cannabigerolic acid (CBGA). These agents require further

more extensive characterization, however there is preclinical evidence showing that

they may have analgesic, anticonvulsant, anti-inflammatory, and anti-cancer

properties [22, 23]. These chemicals can be isolated as pure substances and therefore,

if found effective in treating a medical condition, might be more easily progressed to

clinical trials.

Cannabis as medicine

Most research on medicinal cannabinoids has administered pharmaceutical

formulations of THC and/or CBD [24]. Pharmaceutical cannabinoid formulations that

have been approved for use in Australia and in other countries include Marinol,

Cesamet, Cannador, and Sativex. At present only Sativex is registered with the

Therapeutic Goods Administration’s (TGA) Australian Register of Therapeutic

Goods, where it is indicated for symptomatic relief of spasticity and neuropathic pain

in treatment resistant multiple sclerosis patients. Marinol (generic name dronabinol),

is an oral synthetic THC preparation that has been used since 1985 for nausea and

vomiting induced by cancer chemotherapy, as well as for anorexia in acquired

immunodeficiency (AIDS) patients. Cesamet (nabilone) is a synthetic cannabinoid

analogue of THC. Cannador is an oral capsule containing a cannabis extract, with

reportedly a 2:1 ratio of THC to CBD. Sativex (nabiximols) is a botanical

cannabinoid mouth spray which delivers in each spray 2.7 mg THC and 2.5 mg CBD.

While studies examining the effects of smoked cannabis preparations on

disease states are less prevalent, clinical studies employing the gold standard design

of a randomized controlled trial (RCT) do exist. One limitation of these studies

though is that they are often small in scale, so larger trials are needed to provide more

definitive information. The limitation in the number and size of medical cannabis

trials has been restricted by its strict regulation (it is a Schedule 9 and Schedule 1 drug

in Australia and the US respectively, which deems it as a prohibited drug with no

medicinal value). Large scale phase III, therapeutic trials are necessary for drugs to

make it to the market place. Many professional medical associations in the US like the

American Medical Association and the American College of Physicians have called

for the reclassification of cannabis to facilitate research into its medical properties



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[25]. Below I will provide a brief overview of the most important indications of

cannabinoid medicines and the strength of the evidence that is used to support the

application of cannabinoid medicines to these disease states.

Pain. Cannabinoid drugs have been used to treat various pain states

including neuropathic pain, postoperative pain, chronic pain, fibromyalgia,

rheumatoid arthritis, and the pain associated with multiple sclerosis and cancer.

Preclinical research strongly supports the basis for this therapeutic indication, with

cannabinoids being analgesic in animal models, and research showing that the

endocannabinoid system is distributed in classical pain neuronal pathways. A recent

review of relevant RCTs of legal pharmaceutical cannabinoid analgesics found 38

published trials in which 71% found the drugs to be effective and well tolerated [25].

Most only assessed efficacy in the short term, and longer trials are required, especially

given that cannabinoids induce tolerance (ie. a reduced drug effect with repeated use)

and dose escalation may be required.

The efficacy of smoked cannabis in treating pain states has also been

examined in various RCTs. These studies administered cannabis cigarettes containing

between 0% and 9.4% THC [26]. The number of participants were low (between 21-

50) but despite this improvements in pain were observed in post-traumatic/post-

surgical neuropathic pain, neuropathic pain associated with HIV, and general

neuropathic pain [26]. There is particular interest in cannabinoid efficacy in treating

neuropathic pain, as this pain condition is not well managed by current therapies. A

systematic review of 14 RCTs of HIV-related neuropathic pain showed that smoked

cannabis was more effective than currently available therapies such as amitriptyline

and gabapentin [27]. Cannabis therapies might also be used as adjunctive treatments,

and a recent Australian study surveying 1514 people with chronic pain showed that

many felt they gained greater benefit when cannabis use was combined with opioid

drugs [28]. This makes sense given the considerable overlap between endogenous

opioid and endocannabinoid systems in pain pathways of the body and evidence of

supra-additive interactions [28]. Future clinical studies could examine whether

synergistic interactions occur between cannabinoid and conventional analgesics, as

this has the promise of maximizing analgesia while reducing dose-related side effects

of the individual drugs.



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Nausea and vomiting. The ability of cannabinoids to treat nausea has long been

known [29, 30]. Synthetic cannabinoid preparations have been used to treat

chemotherapy-induced nausea and vomiting since their regulatory approval in the

1980’s. The development of the cannabinoids as anti-emetic agents at this time came

due to a lack of effective agents. Many RCTs showed that synthetic cannabinoids like

dronabinol and nabilone were more effective than placebo. However the cannabinoids

were at best equally as effective [29], but with worse side-effects, than the gold

standard anti-emetic drug used at that time, prochlorperazine. Since the 1980’s an

abundance of highly effective anti-emetics have been introduced that are far more

effective than dopamine antagonists like prochlorperazine. These include ondansetron

as well as combination therapies (ondansetron, dexamethasone and aprepitant). To the

best of my knowledge only one trial has compared a cannabinoid drug against the

current mainstays of anti-emetic treatment. This study showed that dronabinol was as

effective as ondansetron in treating chemotherapy-induced nausea and vomiting [31].

While dronabinol was more effective in treating mild to moderate nausea,

ondansetron was more effective than dronabinol for severe nausea and vomiting.

Dronabinol combined with ondansetron was no more effective in treating nausea than

either drug administered alone [31]. Cannabinoids have never been compared against

the current first-line combination treatments. Nabiximols (which combines THC and

CBD) may prove to be effective, as a small scale phase II RCT (7 patients received

the cannabinoid therapy and 9 received placebo) showed when combined with

ondansetron, this cannabinoid therapeutic was more effective than placebo [32]. It

may be that cannabinoids are useful in rare cases where patients are resistant to

current anti-emetic therapies, so while there doesn’t appear to be an urgent need for

cannabinoid therapy in this area, it would be humane to allow patients access,

especially if they perceive a benefit over other drugs they have tried.

Appetite stimulation. The “munchies”, the insatiable desire to eat, is widely reported

following recreational cannabis ingestion. Preclinical evidence supports the view that

cannabinoids may be effective in stimulating appetite, although this may be selective

for food with high calories (junk foods), rather than staple foods [33]. The ability of

cannabis and cannabinoid drugs to stimulate appetite has been exploited in the

treatment of conditions in which there is a loss of appetite and associated wasting

[34]. This is commonly observed in cancer patients and also in individuals with



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AIDS. An RCT in 139 AIDS patients showed that a low oral dose of dronabinol (5

mg) improved appetite, as well as benefiting mood and promoting weight gain [35].

The beneficial effects of dronabinol were maintained for 1 year of use and the drug

had relatively few side-effects [36]. Although, compared to other appetite stimulants

like megestrol, the increases in weight gain were modest, and in most cases the drug

only stabilized weight (ie. they prevented weight loss). Dronabinol when combined

with megestrol did not augment appetite stimulation or weight gain [37]. Two placebo

controlled laboratory studies suggest that higher doses of dronabinol may be required

to enhance weight gain, especially if the patient already uses cannabis [38, 39].

The results are more mixed for the use of cannabinoids in stimulating appetite

in cancer patients. While effective in stimulating appetite, THC (2.5 mg twice daily)

was less effective than the comparator medication megestrol. Although, the use of

megestrol in males was associated with impotence, implying cannabinoids might have

a place in treating the male population [40]. A large phase III RCT of 243 cancer

patients could not show any appetite stimulant action of THC, however this study

only administered 2.5 mg daily which may be too low a dose [41]. Preliminary

evidence suggests THC was efficacious in stimulating appetite in Alzheimer’s

patients [42]. Given preclinical evidence that cannabinoids may be effective appetite

stimulants, more research is needed to advance this application. Higher doses than

that normally approved by regulatory bodies may also be considered.

Relief from symptoms associated with multiple sclerosis and other neurological

disorders. Multiple sclerosis (MS), a neurodegenerative disorder, is associated with

muscle spasticity, spasm, neuropathic pain, tremor, ataxia, and bladder problems.

Conventional treatments may be effective in treating these symptoms, however many

patients remain resistant to treatment. Preclinical studies using animal models of MS

have proven cannabinoids to be effective in ameliorating MS-associated symptoms

[43, 44]. A large RCT in this area with 630 participants funded by the United

Kingdom Medical Research Council showed that dronabinol or the cannabis extract

preparation Cannador didn’t improve the primary outcome measure of spasticity after

15 weeks but did after one year of treatment [45, 46]. Although, the cannabinoids

improved rating scale measures of spasticity, spasm, pain and sleep, and the mobility

of the patients improved. Another RCT of 277 MS patients being treated with

Cannador reported similar findings [47]



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Sativex (nabiximols) has been approved in 19 different countries including

Australia for the treatment of spasticity associated with MS in instances where the

patient was unresponsive to conventional treatments. The drug is not covered by the

Pharmaceutical Benefits Scheme limiting its affordability and therefore use by

patients in Australia. Many clinical studies support the regulatory approval of Sativex,

with many showing benefits for spasticity, pain, muscle spasms, sleep and bladder

dysfunction. The effectiveness of Sativex in treating spasticity associated with MS

was supported by a meta-analysis of 3 major studies that examined 666 patients [48]

and a more recent phase III RCT [49]. Sativex was very well tolerated in all of these

studies.

Convincing clinical evidence is not yet available for symptomatic relief in

other neurological disorders such as Parkinson’s disease, Huntington’s disease,

Tourette’s syndrome, amyotrophic lateral sclerosis and Alzheimer’s disease.

However, many preclinical animal models of these conditions support the view that

cannabinoids have potential that should be examined in greater detail [21, 50, 51].

Epilepsy. Epilepsy affects about 50 million people word-wide but approximately one

third of patients remain resistant to treatment. There is conflicting evidence regarding

the efficacy of THC in treating epilepsy, with reports of both anticonvulsant and

proconvulsant actions of the drug. There has been considerable interest in the

potential of CBD in recent times given its lack of psychoactivity and limited side-

effect profile. Preliminary human studies support CBD being effective in reducing

seizures in treatment-resistant epilepsy [52]. The only double-blind placebo controlled

study of 15 patients with treatment-resistant epilepsy reported positive outcomes, with

7 of 8 patients receiving CBD showing a benefit (4 of the 7 remained seizure free for

the 8-18 week duration of the study) and only 1 of 7 improved on placebo [53]. The

efficacy of cannabinoids, particularly CBD, CBDV and THCV has been demonstrated

in preclinical animal models of epilepsy [52]. One area of promise for cannabinoid

drugs is in the treatment of the intractable forms of pediatric epilepsy such as Dravet

syndrome. There are abundant reports of epileptic children showing dramatic

improvements in their health following the use of medical marijuana formulations

[54]. One compelling case study reported that a cannabis extract reduced seizure

frequency in a girl with Dravet sydnrome from nearly 50 seizures/day to 2–3

nocturnal seizures/month [55]. However, no RCTs have evaluated the efficacy of



Page 9 of 24

cannabinoid therapies in intractable pediatric epilepsy. There are currently trials

underway assessing CBD for the management of severe early-life seizure disorders

such as Dravet and Lennox-Gastaut syndrome in the US, and the NSW Government

has recently committed $5 million to conduct a therapeutic RCT. My own laboratory

is commencing preclinical evaluations of the efficacy of the cannabinoids in mouse

models of Dravet syndrome.

Schizophrenia. Schizophrenia is a mental disorder characterized by positive

symptoms (hallunications, delusions), negative symptoms (poverty of speech, social

withdrawal) and cognitive dysfunction. THC may provoke symptoms in certain

individuals that resemble a psychotic episode [13] and there are concerns street

cannabis, which now predominantly contains THC [14], may increase ones risk of

developing the chronic mental disorder schizophrenia (see Deleterious effects of

cannabis section below). However, studies have shown that the CBD content in the

plant may be protective against the development of schizophrenia, and preclinical and

small-scale clinical studies suggest cannabidiol is an effective antipsychotic drug [13,

56]. In a landmark phase II RCT in 42 patients, CBD was equally as effective as the

antipsychotic amisulpride in reducing positive and negative symptoms of

schizophrenia [57]. Conventional antipsychotic drugs like amisulpride, while clearly

effective in managing the core symptoms of the disorder, are very toxic and promote

sedation, motor problems, metabolic disturbance and significant weight gain. CBD

was also shown to have none of these side-effects. This result is extremely promising

and there are current phase III therapeutic trials underway overseas. Moreover, the

former Australian of the Year Professor Patrick McGorry is leading a trial that will

occur in Australia.

Inflammatory bowel disease. Inflammatory bowel diseases like Crohn’s disease and

ulcerative colitis are chronic, relapsing conditions that are poorly managed by current

treatments. Many patients out of desperation turn to herbal remedies to treat these

conditions [58]. There is ample preclinical evidence that shows various cannabinoids

have anti-inflammatory properties [59]. Some preclinical studies report that drugs that

activate the cannabinoid CB2 receptor, like THC, protect against experimental colitis

in mice [60]. Only one small scale RCT in 22 participants has been performed which

showed that smoking cannabis cigarettes decreased disease severity and improved



Page 10 of 24

quality of life, but failed to cure the disorder [61]. The drug was well tolerated as the

rate of adverse effects was similar to the placebo control group. However, the active

subjective effects of cannabis unblinded the patients to their experimental condition,

rendering the study unreliable. There is a need for larger and more rigorous RCTs to

establish the efficacy of cannabinoids in inflammatory bowel diseases.

Other potential uses: cancer and PTSD. New evidence for the potential

applications of cannabis and the cannabinoids in the treatment of medical conditions

are reported each day. Apart from modulating the endogenous cannabinoid system,

cannabinoids also have anti-inflammatory and antioxidant actions that may confer

medicinal benefits. Cannabinoids including THC, CBD and CBG have been shown to

reduce the proliferation and spread of various forms of cancer (e.g. cancers of the

brain, breast, prostate and blood) [62]. Further, cannabinoids inhibit proteins that

mediate resistance to anticancer drugs, and thus have potential in reversing multidrug

resistance, which is a major stumbling block in the successful treatment of cancer [63,

64]. More recent studies show that cannabinoids such as THC and CBD may help

people with post-traumatic stress disorder (PTSD) to forget traumatic events and

reduce anxiety [65]. There is a real need for funding to support the translation of these

findings to the clinical treatment of patients. Strict regulatory restrictions on the use of

cannabinoids, even if they are non-psychoactive and have no addictive liability,

impedes the development of novel cannabinoid medicinal agents.



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Deleterious effects of cannabis

Cannabis is a relatively safe drug and it is not associated with fatal overdoses. In fact

in its millenia of use there has not been one case report of cannabis overdose.

Lethality studies in animals show the dose needed to induce mortality are well beyond

what could possibly be consumed by a human [66]. The most robust evidence

supporting cannabis toxicity can be grouped into acute and chronic effects. Acute

cannabis intoxication, which lasts for 3-6 hours, impairs psychomotor skills, short-

term memory, attention, perception of time and diminishes driving performance [67,

68]. However it is well known that cognitive and performance deficits are less

apparent in experienced cannabis users due to tolerance (a the diminished effect of a

drug that comes with repeated exposure to it) [69]. The US Institute of Medicine in

1999 concluded that the acute adverse effects of medicinal cannabinoids were “within

the risks tolerated for many medications” [70]. A more recent review of the

deleterious effects observed in numerous RCTs and laboratory studies on

cannabinoids concluded that 97% of the adverse effects of cannabinoids were minor,

with the most common being that 20% of patients experienced dizziness [71]. Chronic

effects of cannabis are of much more serious concern but these appear in only a small

proportion of users, nevertheless they remain risks to anyone smoking cannabis. The

evidence is strongest for cannabis causing drug dependence, psychosis, chronic

bronchitis, increased risk of heart attack in middle to old age users, and testicular

cancer.

Driving performance. The introduction of medical cannabinoids might increase the

number of people on the roads under the influence of cannabis. Laboratory and

epidemiological evidence support the notion that people under the influence of

cannabis are more likely to have a car crash. Although, the level of risk is not as great

as with alcohol (2-3 times for cannabis, 6-15 times for equivalent intoxicating doses

of alcohol [72]). This may be due to cannabis users overestimating their level of risk

[73], and in doing so recruit strategies to compensate for the impairing effects of

cannabis on their driving ability. By contrast alcohol intoxicated individuals

underestimate their level of impairment. Some studies suggest that drivers under the

influence of cannabis drive more slowly, make fewer attempts to overtake, and leave

greater distances between themselves and the vehicle in front [74]. However other



Page 12 of 24

studies show that cannabis use impairs reaction time, lane control, speedometer

monitoring, hand and body steadiness, braking stop time, and promotes inappropriate

responses in an emergency scenario [75-78]. At present Australia has zero tolerance

laws for testing positive to THC when driving; these laws may need revision to

account for the increasing use of medical cannabinoids in the community. New

formulations of cannabinoids may have less or no psychoactivity which would need

to be examined for their effects upon driving or driving-related tasks. If the medical

cannabinoid preparation did impair driving patients would need to be advised to avoid

driving. Furthermore, cannabinoids are fat-soluble drugs that remain in the body for

long periods of time. People may test positive to THC a week or more after they last

used cannabis [79, 80], making interpretation of blood THC levels problematic when

trying to infer impairment. We have also recently shown that exercise and stress may

artificially elevate blood THC levels due to fat-stored THC being liberated back into

the blood stream [81-83]. Interpretation of blood cannabinoid levels therefore has

major limitations due to the fat-soluble nature of these compounds. The logic of

inferring impairment based on a blood alcohol level cannot be straightforwardly

extended to the cannabinoids.

Cognitive impairments. There is evidence that long-term use of cannabis from

adolescent age may produce impairments in cognitive function, with consistent

findings of deficits in verbal learning, memory and attention [84, 85]. A small

proportion of people who initiate cannabis use in adolescence and consume the drug

for decades show reductions in IQ (as much as an 8 point reduction in those who

started as early as 13 and used to the age of 38) [86], although those who commenced

in early adulthood and had not used the drug for a year did not display any reduction

in IQ. It remains unclear whether cannabis-induced cognitive impairments are

irreversible. Some studies report that long-term cannabis users show structural

abnormalities in brain regions important to cognitive function, mood and addiction

[87-89]. Although a recent study, that better controlled for confounds such as alcohol

use, gender, age and other variables, showed that no such structural changes [90].

Reductions in the odds of completing high-school have been associated with

adolescent cannabis use, but the evidence is contentious, as are links to increased rates

of suicide, depression and use of other illicit drugs [72]. The implication of these

findings is that adult prescription of cannabis is unlikely to have a long-term impact



Page 13 of 24

on cognitive function, but dependent on the dose, patients acutely intoxicated on the

drug may display cognitive impairments.

Drug dependence. Cannabis is used as a recreational drug and has habit-forming

qualities. Some recreational cannabis users may seek out professional treatment to

assist in abstaining from the drug (about 1-2% of adults have been diagnosed with

cannabis dependence in the past year). It is estimated that approximately 10% of

people that have used cannabis will become dependent on it at some point in their life

[72]. To put this in perspective, approximately 30% become dependent on tobacco,

20% on heroin and cocaine, and 15% on alcohol [91]. Cannabis dependent

individuals crave the drug and lose control of their drug use, consequently using

cannabis for longer periods than intended. Cannabis dependent individuals may also

experience a cannabis withdrawal syndrome, although this is mild compared to

syndromes observed with alcohol, benzodiazepines or heroin. Cannabis withdrawal

promotes symptoms of insomnia, depression, anxiety and gastrointestinal disturbance

that may last 48-72 hours [92]. There is recent evidence that nabiximols alleviate

cannabis withdrawal [93]. Patients treated with nabiximols didn’t report psychotropic

effects and its use assisted in retaining patients in addiction treatment. Overall,

cannabis has mild to moderate addictive liability, but for those who become

dependent it can take a strong hold over their life and cause significant distress.

Psychosis and schizophrenia. One of the more concerning adverse effects of

cannabis is psychosis, where the user experiences disordered thinking, hallucinations

and delusions. There have been frequent reports of cannabis intoxication precipitating

a short-lasting psychotic state which reverses once the effects of the drug have abated

[94]. More alarming is the link between cannabis and the psychotic mental disorder

schizophrenia, which is a chronic, disabling condition where the patient suffers

hallucinations, delusions, and cognitive dysfunction. Human population studies have

reported that cannabis use increases the risk of developing schizophrenia by around 2-

fold [94]. This equates to regular cannabis use increasing rates of schizophrenia from

7 in 1000 to about 14 in 1000 [72]. There is also evidence that adolescent cannabis

use may accelerate the age of onset of schizophrenia [95]. The argument that cannabis

causes schizophrenia is contentious though, as some have observed that sharp

increases in cannabis use did not increase the incidence of schizophrenia [96].



Page 14 of 24

However, some recent studies have shown that increased prevalence of cannabis use

has increased the incidence of schizophrenia [97, 98]. It has been argued that reducing

the incidence of cannabis-induced schizophrenia would be difficult, because it has

been estimated that 4700 young people would need to be dissuaded from cannabis use

to prevent a single case of schizophrenia [99]. Moreover, most of the evidence for

cannabis causing schizophrenia comes from studies of those who used the drug during

adolescence, the period of highest risk for developing schizophrenia. The rates of

cannabis-induced psychosis are likely to be much lower in patients who commence

medicinal use of cannabinoids in adulthood. While the vast majority of people who

smoke cannabis will never develop a psychotic disorder, it is likely that those who do

have some genetic vulnerability to cannabis-induced psychosis [13]. Understanding

which genes confer this increased vulnerability may assist in future pharmacogenetic

approaches to cannabinoid therapeutics where genetic screening may predict

individuals who should not be prescribed cannabis. At this point though medicinal

cannabinoid preparations that contain THC should not be prescribed to individuals

who have a family history of psychosis.

The adverse effects of smoking cannabis. Smoking is the predominant route of

cannabis administration because of efficient cannabinoid uptake by the lungs and

distribution to the CNS. Cannabis if often mixed with tobacco and smoked using a

water pipe (bong) or cannabis cigarette (joint). Regular cannabis users may

experience higher rates of chronic bronchitis (cough, increased sputum production,

wheezy airways) due to the irritant effects of smoking on the airways, rather than

cannabinoids per se damaging the airways. In fact, THC has bronchodilatory effects

(it opens the airways), and has been considered as a therapeutic agent in the treatment

of asthma [100]. The largest study to date on cannabis and respiratory function

followed 5000 people over 20 years and reported a dose-response relationship: those

using low levels of cannabis (3-5 joints per month) had improved respiratory function,

whereas heavy users displayed clear reductions in function [101]. The link between

cannabis use and increased rates of respiratory cancer is confounded by the general

effects of smoking and it is unlikely that cannabinoids themselves increase

tumourogenicity. Similarly, cannabis smoking has been reported to increase the risk

of testicular cancer by 2-3 fold, however this might be accounted for by carcinogens

produced via the smoking process rather than cannabinoids themselves being



Page 15 of 24

responsible [102-104]. This study did control for tobacco and alcohol use, however it

was a small population study, so more research is needed in the area to provide more

definitive evidence. Studies also suggest that cannabis smoking may trigger

myocardial infarction in adults [105]. Medical marijuana may be advanced then by

developing alternate modes of drug administration than smoking.

Modes of administration

The preferred mode of delivery of recreational cannabis users is smoking. The main

reason for this is that smoking introduces cannabinoids to the vasculature of the lungs,

which then quickly and efficiently provide passage of THC to the brain [100].

Smoking cannabis avoids the slowed absorption and first pass metabolism that occurs

with swallowing THC, and thus allows users to better titrate their dose. THC taken

orally is rapidly broken down into inactive chemicals through exposure to gut acids

and enzymes. The actions of cannabis on the brain following oral administration may

take hours to take effect. Oral THC absorption is unpredictable, taking between 1 and

5 hours to reach peak blood concentrations. This is why for some medical

applications, the oral mode of delivery is impractical (e.g. for rapid pain relief). Of

course, oral applications may be useful in some contexts and novel synthetic

cannabinoids are being developed that display less variability in absorption into the

body. One oral THC formulation known as Namisol is being developed that promotes

less variability in blood THC concentrations than other oral THC preparations such as

dronabinol [106]. Moreover, new methods of delivery that allow better dose titration

and a rapid onset of action are being developed that avoid the toxicity associated with

smoking. These include the use of vaporisers, which allow cannabinoids to be

ingested without the need to combust plant material which gives rise to toxic bi-

products such as carbon monoxide, irritants and tar [107, 108]. Another is buccal

administration, where the cannabinoids are applied in the mouth and are absorbed

through oral membranes (as is the case for Sativex). Drugs are also in development

which do not cross into the brain and, and thus are not psychoactive, and remain in

the peripheral tissues (so called peripherally active cannabinoid drugs) which may be

appropriate for some therapeutic indications like inflammatory bowel disease [109].

The future of medical cannabis versus medicinal cannabinoids

Medical cannabis. Recently in NSW, medical cannabis was approved for patients



Page 16 of 24

with terminal illnesses. The use of medical cannabis has been introduced more

broadly in the UK, US, Israel, Czech Republic, Uruguay, Spain, Canada, and the

Netherlands, with different models of regulation. For example, medical cannabis in its

current form in the US is concerned with medical applications of unregulated plant

material that will most often be smoked. By contrast, in the Netherlands the supply of

cannabis is heavily regulated and the advised modes of administration are either in a

tea or via a vapouriser. Numerous problems have arisen due to the policy

inconsistencies that come with decriminalization of medical cannabis. An analysis of

the experience of countries that have introduced medical cannabis has been discussed

in more detail by other commentators [110, 111]. One problem that has been raised is

that the demand for medical cannabis outstrips supply. In the US this has been

overcome somewhat by allowing patients to use street cannabis via buyer’s clubs,

whereas in Canada, government supply cannot meet demand. Another problem is that

the unregulated use of street cannabis may be suboptimal therapeutically and give rise

to greater toxicity. Street cannabis contains high THC content, toxic contaminants

(e.g. pesticides, heavy metals, fungi or bacteria) and is most often smoked. Moreover,

variability in the amount of cannabinoids found in the plant may undermine optimal

dosing and therapeutic efficacy. It should be noted here that this issue has been

somewhat overcome in the Netherlands, which has an Office for Medicinal Cannabis

that regulates the production and supply of cannabis for medicinal and scientific

purposes. The Office provides various cannabis strains to pharmacies, hospitals and

veterinarians that contain varying levels of THC to CBD (e.g. high THC/low CBD,

low THC/high CBD, moderate THC and CBD) and are free of contaminants

(pesticides etc). Following the lead of the Dutch system, the Australian Government’s

Senate Standing Committee on Legal and Constitutional Affairs will soon examine a

Regulator of Medicinal Cannabis Bill that seeks to introduce a national regulator for

the medicinal and scientific use of cannabis and cannabinoids. Another major issue

for medical cannabis is that many doctors will not prescribe cannabis as they are

confused about its specific indications and are concerned about litigation from

patients who may experience toxicity. Indeed, for health professionals to be able to

genuinely recommend or ‘prescribe’ a product, they need to be able to present the

patient with usual information such as what is/are the exact active medical

component/s, the doses and duration of dosing required, for which specific condition

is the medication approved to treat, and its potential adverse effects. Such information



Page 17 of 24

is generally not available for the vast majority of potential clinical indications for

medical cannabis, and as such, the experience is that even in countries where medical

cannabis access schemes are available, most health professionals avoid participation.

A final problem is that the medical cannabis supply system has been exploited by

recreational users to maintain their habit, rather than treat a medical condition.

Some have argued that most of these problems would dissolve if cannabis

were made legal for both recreational and medical applications. E.g. there would be

no issue of supply and the user would then take personal responsibility for any

adverse effects of the drug. However, this doesn’t counter the issue of suboptimal

therapeutic endpoints and increased toxicity that would come with an unregulated,

self-medication by the population with cannabis. In addition, if cannabis was

completely legalized it would still have to be restricted for use for those greater than

21 years of age, to avoid the health issues of cannabis exposure during adolescence.

Arguments have also been made that the level of cannabis use may increase if it were

legalized for both recreational and medicinal use, therefore exposing more people to

the potential harms of cannabis.

Medicinal cannabinoids. The recent debate concerning medical cannabis though

should not be confused with the advancement of medicinal cannabinoids. Medicinal

cannabinoids deals with the scientific and medical development of cannabis-like

compounds, whether they be: 1) pure phytocannabinoids, 2) synthetic analogues of

phytocannabinoids, 3) synthetic drugs that modulate the activity of the

endocannabinoid system, 4) pure phytocannabinoid drug combinations or, 5)

cannabinoid extract formulations like Sativex that contain consistent doses of THC

and CBD that have been manufactured according to Good Manufacturing Practice

(GMP). Medicinal cannabinoid development first aims to provide preclinical evidence

for biological plausibility, therapeutic efficacy and toxicology of cannabinoid

pharmaceutical drugs before examination at various stages of the clinical trial process.

The ultimate aim is to test in a phase III therapeutic trial that could provide sufficient

evidence to support the marketing and sale of the product. The cannabinoid would be

administered via a safe non-smoking route of administration using a formulation

abiding by GMP.

Conclusion.



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Research and development of medical cannabis and medicinal cannabinoids has also

been stymied by its illegal status and prohibited drug scheduling [112]. This has

placed roadblocks in the way of obtaining the required plant strains and compounds

for conducting research. Moreover, funding for cannabinoid research and clinical

trials on cannabinoids has been limited and is sorely needed. Much of the current

evidence concerning the therapeutic efficacy of the cannabinoids has focused on THC

which is psychoactive, and to a lesser extent cannabidiol (CBD) which is non-

intoxicating and holds much therapeutic potential. However there are 100’s of other

non-intoxicating cannabinoids from the plant with promising therapeutic potential yet

to be examined for their medical properties, for example CBDA, CBDV, THCV,

THCA, THCVA, CBG and CBC. Current legislation groups all of these cannabinoids

under Schedules 8 or 9 in Australia, even though these drugs do not have

psychoactive properties, have no addictive potential, and yet have promising

therapeutic benefits in preclinical and early stage human explorations. The future of

medical cannabinoids looks bright it but could be brighter with a relaxation of legal

restrictions on research and development. One suggested way to move forwards with

this could be to move the non-psychoactive, non-addictive cannabinoids into a lesser

schedule (for instance a Victorian bill currently under consideration would reschedule

CBD into Schedule 4, making it much easy for researchers and clinicians to work

with). This is a positive step and should be supported, and followed up with all of the

non-addictive cannabinoids, leaving only THC in Schedule 8. Cannabis itself also

should be moved from Schedule 9 to Schedule 8 along with Sativex, reflecting the

plants immense therapeutic potential.

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