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

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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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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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 3

“Home made” cannabis extracts are from illegally sourced materials, often of varying strengths and may contain contaminants

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Many cannabinoids in marijuana – the most studied are THC and CBD

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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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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

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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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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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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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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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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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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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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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

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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 17

Access assistance for doctors

https://www.tga.gov.au/access-medicinal-cannabis-products-steps-using-access-schemes

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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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Can patient access processes be better aligned?

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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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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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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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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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Questions?

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