This presentation provides an update on the current progress of the development of clinical guidance on the use of medicinal cannabis products in Australia.

1. Legislation and patient access
schemes for
medicinal cannabis
Adj Prof John Skerritt
Deputy Secretary, Health Products Regulation Group
Commonwealth Department of Health
13 July 2017

2. This afternoon’s program
Government policy on medicinal cannabis and recent
regulatory developments
John Skerritt, Deputy Secretary, Commonwealth Department of Health
• Context of the Commonwealth government’s decisions
• The regulatory system for cultivation and manufacture
• Import of “bulk” supplies of a range of medicinal cannabis products
Patient access – current issues
• Special Access Scheme and Authorised Prescriber, import
Patient access schemes in Queensland
Sue Ballantyne and Greg Perry, Queensland Health
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3. Reviews of clinical evidence for efficacy of medicinal
cannabis
Tim Greenaway, Chief Medical Adviser, Commonwealth Dept of Health
• Findings in cancer nausea/vomiting, MS, epilepsy, palliative care and pain
Development of guidances for clinicians for the use of
medicinal cannabis
Tim Greenaway, Chief Medical Adviser, Commonwealth Dept of Health
Sue Ballantyne, Senior Medical Advisor, Queensland Health
• Content and structure of draft clinical guidances
• Involvement of patient groups and clinicians in finalising guidances
Consumer led-Discussion
• What information do patients and their doctors need?
• How should information best be communicated?
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4. The government’s intent
• Provide patient access to Australian-grown and
manufactured medicinal cannabis outside the standard
registered medicines route
• Provision of a quality medicine through a doctors prescription
is integral to the scheme
• At the same time encourage pathways to clinical trialling for
future TGA registration of suitable products
• The Health Products Regulation Group provides the two
commonwealth government “arms” of the scheme
o Cultivation and manufacture through Office of Drug Control
o Product GMP, product scheduling and patient access
through the Therapeutic Goods Administration (TGA)
• States also have a significant role in regulation
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5. “Home made” cannabis extracts are from
illegally sourced materials, often of varying
strengths and may contain contaminants
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6. Many cannabinoids in marijuana –
the most studied are THC and CBD
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7. 6

8. Medicinal cannabis legislation does not
involve legalisation of recreational cannabis
• The Single Convention on Narcotic Drugs 1961 aims to combat
drug abuse through coordinated international action
• The Narcotic Drugs Act 1967 provides the Commonwealth with
powers to meet Australia’s obligations under the Single Convention
• This includes regulation of narcotic drug manufacture and
cannabis cultivation for medicinal and related scientific purposes.
• The Act was amended in in February 2016 to permit cannabis
cultivation for medicinal and related scientific purposes in
accordance with the Single Convention
• The regulatory scheme being implemented needs to being line
with state, national and international commitments
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9. Overview of legislation
• Licence required to cultivate cannabis for medicinal purposes
o 13 licences have been issued as of 6 July 2017
o 8 commercial and 5 research licences
• Permits that set out the amounts and strains of cannabis needed
before cultivation can begin
o 3 permits have been issued as of 6 July 2017
• Licences required for manufacturing
o Narcotic Drugs Act (security and prevention of diversion)
o Therapeutic Goods Act (quality of the products)
o State/territory licences may be required in some cases
• To get a Narcotic Drugs Act licence, must be able to demonstrate
supply to meet a particular demand
• Permits are required for cultivation of individual crops 8

10. The Act imposes stringent requirements
• Persons and entities
involved in medicinal
cannabis cultivation or
manufacture must meet a “Fit
and Proper Persons Test”,
employee suitability
requirements and financial
viability requirements
• Location of, and security for
medicinal cannabis cultivation
or manufacturing sites
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11. The Act imposes stringent requirements
• Storage, handling, transport and
destruction of medicinal cannabis
• Record keeping and auditing of
medicinal cannabis activity
• Exporting of cannabis is not yet
permitted but the government has
asked us to consult on this
possibility and how access for
domestic patients can be
maintained
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12. Import of “bulk sponsors ” supplies of
medicinal cannabis products
• Processes changed early 2017
• Put in place to reduce the time it takes
to physically get medicinal cannabis to
patients following approvals of
prescription under the SAS B and
Authorised Prescriber pathways
– Under an import licence issued under the
Customs (Prohibited Imports) Regulations
and subject to strict conditions
– Allowed because there is a check on their
use by TGA prior to prescribing
– State or Territory wholesaling and
distribution licences are also required
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13. Bulk “sponsored” imports of products
• Some importers and products listed at:
www.odc.gov.au/importers-and-manufacturers-medicinal-cannabis-products
• Products available in Australia “ex stock” include
– THC and CBD oils
– oromucosal solutions
– CBD capsules
– raw cannabis for vaporisation
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14. Scheduling determines access controls
• A process of determining the levels of control on access that
can be applied to a substance, based on risk, e.g.:
– Schedule 3 – Pharmacy only medicines
– Schedule 4 – Prescription only medicines
– Schedule 8 – Controlled drug
– Schedule 9 – Prohibited substances
• Implemented under state not CTH law
• Each schedule has a different level of control about who can
dispense them, how prescriptions must be made, labelling
requirements etc
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15. Before 1 Nov 2016 medicinal cannabis was a
Schedule 9 prohibited substance
• “Substances which may be abused or misused, the manufacture,
possession, sale or use of which prohibited by law
…….except when required for medical or scientific research …
with approval of Commonwealth and/or State or Territory
Authorities
• This made prescribing and patient access very difficult and in
some states impossible
• States and territories had various/or no ability to approve for use
and prescribe S9 containing products to be used
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16. Scheduling as of July 2017
Schedule 8 – Controlled drug
• Cannabis and Tetrahydrocannabinols e.g. THC (extracts, or derivatives
of extracts, of cannabis) for human therapeutic use, only by prescription
from a medical practitioner authorised by states and territories
• Thus supply requires state S8 and/or medicinal cannabis approvals
• Other examples of controlled drugs are oxycodone, dexamfetamine
Schedule 4 – Prescription medicine
• Cannabidiol (CBD) in preparations for therapeutic use containing 2 per
cent or less of other cannabinoids found in cannabis.
• This is the same class as most prescription medicines like penicillin
• For CBD there is a requirement for state approvals in QLD and TAS, and
VIC in certain circumstances
• As it is scheduled as a prescription medicine, CBD is not legal in cosmetics
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17. SAS and Authorised Prescriber
Criteria depend upon the patients, product, prescriber
Authorised Prescribers must:
• have training and expertise appropriate for the
condition and the proposed use of the product, and
• be able to best determine the needs of the patient and
to monitor the outcome of therapy
Patient and clinical justification
• patient information, diagnosis and indication being
treated
• the seriousness of the condition
• details of past treatment
• expected benefits from the use of the product 16

18. Product details
• Trade name - Manufacturer/Company/Supplier
• Dose Form i.e. tablet, extract and active ingredients
• Shelf-life and Storage Conditions
• Compliance with TGO 93 for composition / contamination
Administration details:
• Dosage, Route of administration, Duration of treatment
Monitoring Details:
• Efficacy of the treatment, adverse events/reactions
• Human studies to demonstrate efficacy and safety data
• Level of evidence required will depend on seriousness of
the condition
SAS B form is one page with an attachment
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19. Access assistance for
doctors
https://www.tga.gov.au/access-medicinal-cannabis-
products-steps-using-access-schemes
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20. Personal import and travelers’ exemption
• Patient import e.g. by courier under the personal importation scheme
is not possible because of prohibitions under the Customs Act 1901
• Medical practitioners can arrange for patient-by-patient importation
to fill prescriptions issued using the SAS Cat A (or B) pathway if they
obtain an import licence from the Office of Drug Control
• Traveller's exemption allows travellers / carers to carry medicines
with them on a ship or aeroplane into Australia with certain conditions:
– you must have a valid prescription, dispensed by a pharmacist
– medicine must remain in its original packaging with labelling intact, and
– you may only bring in 3 months supply.
States and Territories have additional requirements about prescription and
possession of schedule 8 medicines (and for some states cannabidiol)
So please contact your state health department before travel
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21. Can patient access processes be better
aligned?
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22. S8 Medicinal Cannabis Products
State / Territory Specialists GPs Process
ACT Yes Yes with specialist support Specific process
QLD – patient class (CINV, palliative
care, MS, resistant paediatric epilepsy)
Yes (certain
specialists)
No
Must follow QLD clinical
guidance; no application
needed
QLD – single patient Yes
Yes – with longitudinal treating
relationship with the patient
Application to DG of QLD
Health
NSW Yes Yes with specialist support
Specific process
VIC – Eligible patient (currently children
with intractable epilepsy)
Yes
Initial application made by specialist
then GP ongoing
Specific process
VIC – Exceptional circumstances
(under Vic legislation)
Yes Yes
Specific process
VIC – General S8
(imported or non VIC manufacture)
Yes Yes
Standard S8 process
TAS Yes No Specific process
SA standard Yes Yes with specialist support Standard S8 process
WA – notification (like TGAs AP) Yes
Initial application made by specialist
then GP ongoing
Specific process
WA - authorisation (like TGA SASB) Yes Yes with specialist support Specific process
NT Yes
Initial application made by specialist
then GP ongoing
Standard S8 process
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23. S4 Medicinal Cannabis Products
Most states do not have specific/ additional
requirements, except:
State / Territory Specialists GPs Process
QLD – patient class (CINV,
palliative care, MS, resistant
paediatric epilepsy)
Yes (certain
specialists)
No
Must follow QLD
clinical guidance; no
application needed
QLD – single patient Yes
Yes – with longitudinal treating
relationship with the patient
Application to DG of
QLD Health
TAS Yes Not eligible to prescribe Specific process
VIC – Eligible patient –
Currently children with
intractable epilepsy (under
Vic legislation)
Yes Initial application must be
made by specialist then GP
prescribes ongoing treatment
Specific process
VIC – Exceptional
circumstances (under Vic
legislation)
Yes Yes Specific process
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24. Assistance for Doctors re SAS and AP
Medicinal Cannabis Section at TGA
• call 1800 220 007 (or 02 6232 8866), or
• Access to medicinal cannabis products -
https://www.tga.gov.au/access-medicinal-cannabis-
products
• Access to medicinal cannabis products: steps to using
access schemes - https://www.tga.gov.au/access-
medicinal-cannabis-products-steps-using-access-schemes
• email to: medicinal.cannabis@health.gov.au
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25. Draft clinical guidance documents
• Draft “clinical guidance documents” for
the use of cannabinoids are being
developed for epliepsy, MS, pain types,
nausea and vomiting and palliative care
• Note that they will have no legal status
• Decisions on patient access to particular
cannabis products will be made by the
treating physician and patient with clinical
oversight from the state/territory health
departments and TGA
• Aim to complete guidance documents
during 2017 with input by Australian
clinical experts and patient groups
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26. Questions?
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