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Presentation: Legislation and patient access schemes for medicinal cannabis
TGA presentations: Industry information and consultation sessions on medicinal cannabis - Adelaide and Brisbane - July 2017
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.
- Presented by: Adjunct Prof John Skerritt, Deputy Secretary, Health Products Regulation Group, Commonwealth Department of Health
- Presented at: Industry information and consultation sessions on medicinal cannabis - Adelaide and Brisbane
- Presentation date: July 2017
- Presentation summary: This presentation provides an update on the current progress of the development of clinical guidance on the use of medicinal cannabis products in Australia.
Legislation and patient access schemes for medicinal cannabis
Adjunct Prof John Skerritt
Health Products Regulation Group
Commonwealth Department of Health
Industry information and consultation sessions on medicinal cannabis - Adelaide and Brisbane - July 2017
Slide 1 - 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
Slide 2 - This afternoon's program
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
- What information do patients and their doctors need?
- How should information best be communicated?
Slide 3 - 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
- Cultivation and manufacture through Office of Drug Control
- Product GMP, product scheduling and patient access through the Therapeutic Goods Administration (TGA)
- States also have a significant role in regulation
"Home made" cannabis extracts are from illegally sourced materials, often of varying strengths and may contain contaminants
Slide 5 - Many cannabinoids in marijuana – the most studied are THC and CBD
Therapeutic Goods Administration,
States and Territories
Patient Access Medical Professionals
Special Access Scheme or
Manufacture Manufacturing Licence
Therapeutic Goods Act
States and Territories
Narcotic Drugs Act
Office of Drug Control Cultivation & Production Cultivation Licence
Narcotic Drugs Act
Slide 7 - 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
Slide 8 - Overview of legislation
- Licence required to cultivate cannabis for medicinal purposes
- 13 licences have been issued as of 6 July 2017
- 8 commercial and 5 research licences
- Permits that set out the amounts and strains of cannabis needed before cultivation can begin
- 3 permits have been issued as of 6 July 2017
- Licences required for manufacturing
- Narcotic Drugs Act (security and prevention of diversion)
- Therapeutic Goods Act (quality of the products)
- 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
Slide 9 - 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
Slide 10 - 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
Slide 11 - 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
Slide 12 - Bulk "sponsored" imports of products
- Some importers and products listed at:
- Products available in Australia "ex stock" include
- THC and CBD oils
- oromucosal solutions
- CBD capsules
- raw cannabis for vaporisation
Slide 13 - 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
Slide 14 - 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
Slide 15 - 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
Slide 16 - 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
Slide 17 - 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
- Dosage, Route of administration, Duration of treatment
- 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
Slide 18 - Access assistance for doctors
Access to medicinal cannabis products in Australia
Resource for doctors
Doctor has consultation with patient
- Is a medicinal cannabis product appropriate for my patient?
- Do I have the appropriate expertise/qualifications? Should I consider specialist involvement?
- Review evidence for potential products in the context of the patient’s condition.
- Use this information to guide specific product selection.
Depending on the circumstances, you may need to seek approval/authorisation from the TGA, your state/territory health department and/or the ODC before you can prescribe, access or arrange importation of medicinal cannabis products.
Seeking approval/authorisation for a specific medicinal cannabis product
- Gather product details – trade name, formulation, dosage form, route of administration, dose and product specifications.
- Follow steps 2A and 2B then:
- if imported stock is already in Australia or Australian manufactured stock is available, follow Step 3A.
- if stock must be imported into Australia, follow Step 3B. ***
For further information, see the TGA’s Access to medicinal cannabis products webpage.
For assistance call 1800 020 653 (or 02 6232 8866) or email firstname.lastname@example.org
TGA access schemes
For individual patients:
Special Access Scheme Category B (SAS B)
Complete application - SAS B form (include supporting evidence, product details).
Submit paperwork to the TGA.
Timeframe: Max. 6 working days*
For a class of patients:
Authorised Prescriber (AP)
Complete application - Agreement to Treatment Directions form, treatment protocol (include supporting evidence, product details), HREC/College endorsement.
Submit paperwork to TGA.
Timeframe: Max. 10 working days*
* Timing dependent on applications containing all necessary information.
Check your state/territory requirements
Rules relating to medicinal cannabis products may vary between states and territories.
Contact your state/territory health department to confirm requirements (contact details below).
Obtain prescribing approval if required (may not be required if schedule 4, for example cannabidiol entry)
Timeframe: Max. 20 working days
If stock available in Australia
Pharmacist or medical practitioner:
- Contact supplier.
- Provide supplier SAS B approval or AP authorisation and state/territory approval if required.
- Supplier releases product.
If product must be imported
Pharmacist or medical practitioner:
- Determine importer.
- Importer must hold an ODC licence. ***
- Send SAS B approval/AP authorisation and state/territory approval to importer.
*** Import licence and permit (from the ODC)
If intending to import product from overseas (Step 3B):
- Check import licence status of importer.
- If no licence is held, importer must apply for a licence from the ODC. (Max. 30 working days)
- Import permit is a later step - issued on a case by case basis after TGA and state/territory approval.
- Importer applies to ODC for an import permit (per shipment). Timeframe: Max. 20 working days
- Liaise with overseas supplier.
- Exporter supplies product.
- Importation of product.
- Supply of product.
Slide 19 - 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
Slide 20 - Can patient access processes be better aligned
Slide 21 - 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
Slide 22 - 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
Slide 23 - 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: email@example.com
Slide 24 - 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 group