Office of Drug Control - Regulating cannabisJuly 2017

Thomas StoddartOffice of Drug ControlCommonwealth Department of Health

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

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Regulating cannabis - the medicinal cannabis scheme

• Prior to 2016, cannabis was an illegal narcotic, and it remains sooutside 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.

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Regulating cannabis - licence types

• The Narcotic Drugs Act 1967 allows the ODC to issue four types oflicences: 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.

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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.

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Regulating cannabis - why licence?

• The medicinal cannabis scheme is designed to ensure that Australiacan satisfy its international obligations under the United NationsSingle 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 formedical and scientific purposes only.

• Under the Single Convention, cultivation for medicinal purposes can onlyoccur under licence issued by the Australia Government. Permits allow theGovernment to restrict how much is cultivated (and manufactured), thusmeeting a key obligation of preventing accumulation of narcotic material.

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Regulating cannabis - how many licences are required?

• ODC does not limit the grant of licences, if your application iscomplete and satisfies the key issues, you will get a licence.

• But… 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.

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Regulating cannabis - how many licences are there?

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• 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.

Regulating cannabis - inspections and compliance

• The Narcotic Drugs Act 1967 includes provision for inspections andcompliance 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.

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Regulating cannabis - bulk import of medicinal cannabis

• The Therapeutic Goods Regulations 1990 allow the import ofmedicinal 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.

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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

Import) 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.

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Regulating cannabis - exporting medicinal cannabis

• ODC is now seeking industry comment on options to allow the exportof medicinal cannabis products while simultaneously ensuringsufficient 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.

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Regulating cannabis - exporting medicinal cannabis (2)

• Maintaining adequate domestic supply is an important considerationin 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 canbe supplied.• Increasing the available supply pathway options under 11k(2)(b) of the

Narcotic Drugs Act 1967 for those interested.

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Regulating cannabis - nowhere near the end

• The first 9 months of the medicinal cannabis scheme have beeninteresting and rewarding in working with industry entrants andapplicants in establishing cultivation and manufacture models.

• There will be some minor regulatory changes coming forward incoming months to reflect what we have learnt from the initial stages ofthe medicinal cannabis scheme.

• Given the time required to see changes to medical prescribingpractice based on the outcomes of clinical trials and development ofevidence, we have a way to go yet!

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Regulating cannabis - the end

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Questions? General contact: MCS@health.gov.au

Comments on export: DCS@health.gov.au