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Presentation: Update on regulatory developments 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: Thomas Stoddart
- Presented at: Industry information and consultation sessions on medicinal cannabis, Adelaide and Brisbane
- Presentation date: July 2017
- Presentation summary: This presentation provides an overview of the current situation regarding research licences and manufacture licences in Australia.
Office of Drug Control - Regulating cannabis
Office of Drug Control
Commonwealth Department of Health
Industry information and consultation sessions on medicinal cannabis - Adelaide and Brisbane - July 2017
Slide 1 - Regulating cannabis - What does ODC do?
- Regulating cultivation and manufacture of medicinal cannabis
- Fit and proper persons requirements
- Security and inspections
- Controlling the import and export of narcotics
- Sponsored import of "bulk" medicinal cannabis products
- Patient by patient imports
- Personal importation and travelers exemption
- Export of manufactured medicinal cannabis products
Slide 2 - Regulating cannabis - the medicinal cannabis scheme
- Prior to 2016, cannabis was an illegal narcotic, and it remains so outside of the medicinal cannabis scheme.
- In early 2016, Government amended the Narcotic Drugs Act 1967, establishing the medicinal cannabis scheme:
- allowing cannabis to be treated as a medicine
- giving effect to the Single Convention on Narcotic Drugs 1961, and
- providing pathways for the supply of medicinal cannabis - cultivation, manufacture and trade.
Slide 3 - Regulating cannabis - licence types
- The Narcotic Drugs Act 1967 allows the ODC to issue four types of licences:
- Medicinal cannabis licence - allows for either or both the cultivation and production of medicinal cannabis for supply to the holder of a manufacture licence under this Act.
- Cannabis research licence - allows for either or both the cultivation and production of medicinal cannabis for research purposes
- Manufacture licence - provides for the creation of drugs from the raw cannabis material supplied under the above licences.
- Import licence - allowing the import of narcotics under certain conditions.
Slide 4 - Regulating cannabis - how to become licenced?
- Easy - just apply at <https://www.odc.gov.au/>
- There are a couple of issues though...
- you, and your business associates, must meet the fit and proper person test
- cultivation and manufacture security arrangements must be in line with the value of medicinal cannabis and the risk of criminal diversion, and
- supply pathways to patients must be clearly established.
Slide 5 - Regulating cannabis - why licence?
- The medicinal cannabis scheme is designed to ensure that Australia can satisfy its international obligations under the United Nations Single Convention on Narcotic Drugs 1961.
- Australia must ensure that the risk of diversion of narcotic drugs (such as cannabis) is minimised and that the use of cannabis is strictly reserved for medical and scientific purposes only.
- Under the Single Convention, cultivation for medicinal purposes can only occur under licence issued by the Australia Government. Permits allow the Government to restrict how much is cultivated (and manufactured), thus meeting a key obligation of preventing accumulation of narcotic material.
Slide 6 - Regulating cannabis - how many licences are required?
- ODC does not limit the grant of licences, if your application is complete and satisfies the key issues, you will get a licence.
- to obtain a permit to cultivate (non-research), you need a contract with a licensed manufacturer, and
- to obtain a permit to manufacture the drug, you need to demonstrate supply to patients.
Slide 7 - Regulating cannabis - how many licences are there?
- 17 licences have been granted as at 10 July 2017. These include:
- 8 Medicinal cannabis licences (cultivation and production)
- 5 Cannabis research licences (cultivation and production)
- 4 Manufacture licences
- Applications for licences are still being received and processed.
- Applications for permits under licences are now also being received.
Slide 8 - Regulating cannabis - inspections and compliance
- The Narcotic Drugs Act 1967 includes provision for inspections and compliance activity for all licence holders.
- ODC conducts two types of inspections:
- Licence and permit assessment inspections
- Inspections necessary to complete the assessment of licences or permits and ensure security undertakings are in place - arranged with the applicant.
- You are charged a fee for the pleasure.
- Compliance inspections
- Conducted under section 14 of the Act, and without prior warning at any time. These do not require your consent.
- These ones are free.
Slide 9 - Regulating cannabis - bulk import of medicinal cannabis
- The Therapeutic Goods Regulations 1990 allow the import of medicinal cannabis under bulk sponsored import arrangements.
- In early 2017 arrangements were put in place within this legislative framework to reduce the time it takes to get medicinal cannabis to patients - following prescription under the Special Access Scheme Category B or Authorised Prescriber pathways.
- Imports are subsequently allowed under the Customs (Prohibited Imports) Regulations 1956 and are subject to a number of strict conditions.
- State or Territory wholesaling and distribution licences are also required.
Slide 10 - Regulating cannabis - import of medicinal cannabis
- It is also possible to import medicinal cannabis on an individual basis.
- Medical practitioners can arrange for patient by patient importation to fill prescriptions issued using the Special Access Category A pathway. Importing for this purpose requires a licence under the Customs (Prohibited Imports) Regulations 1956 .
- Patients can alternatively utilise the traveler's exemption.
- This exemption allows travelers or their careers to carry their medicines with them on a ship or aeroplane entering into Australia with a valid prescription and in limited amounts.
Slide 11 - Regulating cannabis - exporting medicinal cannabis
- ODC is now seeking industry comment on options to allow the export of medicinal cannabis products while simultaneously ensuring sufficient product is available for domestic use.
- With 17 licences granted, and more under assessment, export allows for a broader market.
- It is important not to constrain the growth of an emerging domestic industry through restricting market opportunities.
- But – there must be domestically cultivated and manufactured medicinal cannabis products available to Australian patients.
Slide 12 - Regulating cannabis - exporting medicinal cannabis (2)
- Maintaining adequate domestic supply is an important consideration in any scheme which allows export.
- The ODC request for comment includes seeking industry suggestions on how to maintain that supply.
- The exports of finished medicinal products will require a regulatory change to expand the mechanisms whereby medicinal cannabis can be supplied.
- Increasing the available supply pathway options under 11k(2)(b) of the Narcotic Drugs Act 1967 for those interested.
Slide 13 - Regulating cannabis - nowhere near the end
- The first 9 months of the medicinal cannabis scheme have been interesting and rewarding in working with industry entrants and applicants in establishing cultivation and manufacture models.
- There will be some minor regulatory changes coming forward in coming months to reflect what we have learnt from the initial stages of the medicinal cannabis scheme.
- Given the time required to see changes to medical prescribing practice based on the outcomes of clinical trials and development of evidence, we have a way to go yet!
Slide 14 - Regulating cannabis - the end
General contact: MCS@health.gov.au
Comments on export: DCS@health.gov.au
- Regulating cultivation and manufacture of medicinal cannabis