The following is a summary of questions and responses put at the July 2016 Consultation and Information Sessions about the medicinal cannabis scheme, grouped loosely by theme. These information sharing and consultation sessions and three state and territory working groups covering cultivation, patient access and law enforcement issues are our primary consultation mechanisms. We are likely to run a second round of information sessions in September/October.

Acquiring seeds

Consistent with Australia's obligations under the Single Convention on Narcotic Drugs 1961, seeds can only be sourced from lawful cultivation, including Australian growers of industrial hemp and anywhere globally where the industry is regulated, compliant with the Single Convention, and willing to export to Australia.

The Department of Agriculture and Water Resources (DAWR) advises that the hot water treatment required for import of cannabis seeds (50°C for 20 minutes) is a standard quarantine treatment for seeds for horticultural use and is not known to prevent seed germination. Importers are advised to undertake their own trials of imported seeds before importing large quantities. As an alternative to hot water treatment, DAWR has developed import conditions that allow cannabis seed to enter Australia subject to exporting government certification for disease freedom in conjunction with a fungicide treatment.

To import cannabis seed for sowing, all importers require an import permit issued by DAWR prior to import into Australia. Import permits can be lodged through BICON.

Yes. Seeds must be imported from a legal source (for example Canada, where medicinal cannabis is regulated) and can include global industrial hemp exporters. Further consideration regarding accessing seeds is underway. Information on import requirements is available on the Importers, Exporters & Travellers page.

You will be able to undertake research for medicinal cannabis purposes, which would include strain development.

Cultivation

This is controlled by the Commonwealth Department of Agriculture and Water Resources (DAWR) and relevant state and territory departments and agencies. Conditions on the importation of cannabis seeds have been developed to ensure seeds are not carrying pests or diseases with them. You will need to apply for and receive an import permit from DAWR before you can import seed.

DAWR has completed a pest risk analysis for seeds, and has published the import conditions on their import conditions system, BICON. To import cannabis seed for sowing, all importers require an import permit issued by DAWR. Import permits can be lodged through BICON.

DAWR is also working on an import protocol for tissue cultures and other forms of nursery stock. Until import conditions are published, import permit applications for tissue culture and nursery stock will not be accepted by DAWR.

Your buyers will be the manufacturers of medicinal cannabis products or manufacturers licensed to manufacture drugs for the purpose of research relating to medicinal cannabis products. The quantity of cannabis allowed to be cultivated will depend on the supply contract with the manufacturer which in turn will depend on the requirements of the medical professionals and patients.

All applications for cultivation licences will be assessed for compliance with legislative requirements and either granted or rejected on those grounds. The amount to be grown by individual licensees will be based on the capabilities of the cultivator and requirements of the manufacturer. Cultivation locations and organisations have not been pre-determined as all applications will be assessed on a case-by-case basis against the legislated criteria.

It is difficult to assess the predicted tonnage of cannabis required until we know more about patient numbers and likely dosage requirements. Various estimates suggest somewhere between 5 and 10 tonnes is likely to satisfy Australian patients which could be fulfilled with approximately 2 hectares of greenhouses or 10 hectares of broad acre crop. Under the Single Convention stockpiling is not allowed. However, there will be allowances for storage of material to satisfy peaks and troughs in demand, potentially up to 6 months' worth. We will be avoiding stockpiling by linking permits to product quantity required by the patient group.

No; that would not be consistent with the Single Convention.

It is unlikely that the growing environment will be mandated; however, there are a range of security and other conditions (including satisfying your manufacturing partner on quality) that you will have to be able to comply with. In addition, cultivators must prevent spread of their crop or cross-pollination of their crop, either from a legal industrial hemp crop or from illegal crops grown nearby.

This, together with the relatively small amounts required to meet patient needs, is likely to make growing outdoors difficult.

This will be determined by what the manufacturer requires to fulfil patient needs.

It depends on what the manufacturer requires to meet patient needs. The limits will then be set out in the permit.

If GMO seed is to be used, it would have to satisfy all regulatory requirements in Australia, including those of the Office of the Gene Technology Regulator and states and territories. We are not aware of any countries using genetically modified cannabis crops.

All applicants will need to be able to demonstrate they have an interested manufacturer and specific processes in place to meet the legislative requirements (including physical security) and would be able to adhere to the regulations and guidelines. Before providing a permit we would undertake an inspection of the facilities to ensure the applicant has fulfilled the provisions of the licence.

Licences and permits

The Office of Drug Control will assess all applications on their ability to meet the legislated requirements and their clear connection to manufacturer demand. This process may require inquiries to third parties and physical site inspections to satisfy the delegate for the purpose of a decision. As such, there are no statutory requirements regarding processing times.

No. A cultivation licence and associated permits will allow for propagation as part of the cultivation process. New strain development would need a research licence.

This is necessary to ensure there is annual review of compliance with the licence. Any licence holder who has been compliant could generally expect to have a further licence granted. As the system matures, the licence periods may be subsequently increased to 2 or 3 years, but it would depend on the circumstances of the individual licensee.

The only grounds on which a licence can be rejected is if the legislative requirements are not met or one of the specific instances when a licence must not be granted exists. For instance, the Secretary must not grant a licence if not satisfied that the applicant (natural person or body corporate) or a business associate of the applicant is a fit and proper person or that the proposed location is not suitable. Other instances include if the supply of cannabis produced under a cultivation/production licence is not for supply to a licensed manufacturer.

Any applicant for a research licence will need to be able to demonstrate that it is either for research relating to medicinal cannabis or research relating to medicinal cannabis products.

It is the responsibility of the applicant to determine what strain is to be grown. This will be determined by the needs of the patient groups, through medical professionals and manufacturers. If the permit nominates that particular strain then the grower would be restricted to growing that strain under that permit.

The permit can indicate both the weight and number of plants permitted to be grown. Manufacturing permits will designate the weight of product in line with the requirements on Australia to report to the International Narcotics Control Board.

Any consideration of other applications is a matter for Government to consider. At this time, this is only for human therapeutic use.

The legislation requires licensees and their business associates to be 'fit and proper'. The 'fit and proper' requirements are set out in the legislation. Someone who has recently spent time in prison for drug offences would be unlikely to meet this requirement. Licences can be issued to individual persons or body corporates - all directors of a body corporate must be considered fit and proper.

Other matters that are taken into account in determining fit and proper include the applicant's financial background and circumstances, their capacity and capability to operate a medicinal cannabis enterprise and whether they are considered of 'good repute'.

Licensees can only employ suitable staff. It is the responsibility of the licensee to ensure that all employees meet the requirements of a 'suitable person' set out in the legislation and the regulations. Suitable staff must, as a minimum, be over 18 years old and have no conviction for a serious offence in the last 5 years.

Industrial hemp growers who plan to grow a crop for medicinal purposes must do so under the medicinal cannabis scheme. This means that plants grown for medicinal purposes must be kept separate from those grown for other purposes. Under the Single Convention the same rules apply irrespective of the amount of THC or CBD in a plant.

Manufacture

The manufacture of medicinal cannabis products will be determined by reference to patient need, therefore the products authorised to be manufactured will be those supported by clinical evidence. The determining factor will be the products that approved medical prescribers are willing to prescribe, noting that state/territory and TGA approvals will then be required for their supply.

Yes. The definition of 'manufacture' under the Single Convention refers to the carrying out of any process by which a drug may be obtained and includes refining as well as the transformation of one drug into another drug. Extraction is the removal of the cannabinoids from the plant.

Yes, it is possible but the necessary approvals under customs legislation would be required.

Yes, provided both licences are obtained.

The nature of medicinal cannabis products manufactured under a licence will be determined by patient need and what medical practitioners are authorised to prescribe based on supporting clinical evidence. It is up to the manufacturer to deliver those products using the raw materials that licensed cultivators can provide.

Compliance

We will be developing our own in-house inspection process. We will require regular reporting so we know how much is being produced and to satisfy our obligations to report to the International Narcotic Control Board. It will be a condition of your licence that you advise us of any breaches of conditions or of the licence. Records required to be kept will be viewed when inspectors visit.

We expect industry to have systems in place to undertake internal auditing and ensure compliance with the licence conditions and the legislation.

Medicinal cannabis products will be prescription medicines. Under the Therapeutic Good Act, companies are not permitted to advertise prescription medicines to the public.

Patients

Currently no specific conditions have been established by the Commonwealth. The states and territories have a key role in this area and a number are setting up advisory committees for that purpose. Several are also coordinating clinical trials of specific medicinal cannabis products. Unique to Australia is our model of availability only under a prescription and dispensing through pharmacists, so medical conditions that may potentially be amenable to treatment with medicinal cannabis remain largely a question for the medical profession. Both the states and territories and the TGA will have a role in approving patient access.

States and territories have general responsibility under existing legislation regulating the supply of drugs.

Cost-recovery

Currently, the cost model is being developed and no final decisions on fees and any charges have been made.

Import and export

Yes, there are existing arrangements for the importing of cannabis. There is, currently, not a significant supply of cannabis or medicinal cannabis products available for import, which is why the Government decided to legalise the cultivation for this purpose. Finished products can be imported subject to customs and therapeutic goods legislative requirements as well as any applicable state and territory requirements.

Imports, exports and domestic production are limited internationally through 'consumption estimates' that are controlled by the United Nations' International Narcotic Control Board. These are estimated on likely demand for a given narcotic annually. Estimates are varied if legitimate demand exceeds initial estimates.

The scheme is limiting supply to domestic purposes only for an initial period. This is necessary to establish the system of controls and to ensure they are robust, demonstrating to the international community, in particular the International Narcotics Control Board and potential trading partners, that Australia has an appropriate system for managing the risks of diversion. Under the Act it will be possible to provide for exports at some further date.