The current legal status of medicinal cannabis in Australia

Lana Lakofski of L&M Law provides an insight into the current legal status of medicinal cannabis products in Australia.

The legal framework around medicinal cannabis products in Australia is unfolding and remains tightly restricted. Australia’s regulatory bodies have complex laws, rules and criteria which must be followed regarding licensing requirements to set up a cannabis facility and also for patient access to medicinal cannabis. Broadly, the law in Australia has two main components:

Component one – licensing and permits

Regulated and administered by the Office of Drug Control (ODC) in conjunction with the The Narcotic Drugs Act 1967 (Cth) (the ND Act) contains the legal framework for the licensing and permit scheme to regulate cannabis cultivation, production and manufacture for medicinal and scientific purposes. The ND Act restricts the cultivation, manufacture, supply and use of narcotic drugs in accordance with international obligations to act against drug abuse. The ND Act implements the United Nations Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol (the Single Convention), to which Australia is a party. The Single Convention details the obligations of the parties thereto.

The ND Act was amended in February 2016 to establish a regime authorising the cultivation and production of cannabis and cannabis resin in Australia. This allows for a supply of medicinal cannabis products to be available for therapeutic purposes and furthermore to facilitate scientific research in the area.

There are 3 different licences that can be granted under the ND Act:

1. Medicinal Cannabis Licence may authorise:
   a) the cultivation of cannabis plants for producing cannabis or cannabis resin for medicinal purposes and the obtaining of cannabis plants for that purpose; or (b) the production of cannabis or cannabis resin for medicinal purposes; or (c) all the above;¹
   A licence can be granted to an applicant who has not yet established a growing facility.
2. Cannabis Research Licence may authorise:
   a) the cultivation of cannabis plants for producing cannabis or cannabis resin for research relating to medicinal cannabis and the obtaining of cannabis plants for that purpose; or
   b) the production of cannabis or cannabis resin for research relating to medicinal cannabis; or
   c) all the above.
   A research licence can be granted prior to research commencing. A cannabis research licence may authorise cultivation or production only for research purposes.
3. Manufacture Licence may authorise one or more of the following activities:
   a) the manufacture of a drug in accordance with one or more manufacture permits; (b) activities relating to such manufacture, including but not limited to the following: (i) the supply of the drug;(ii) the packaging, transport, storage, possession and control of the drug (iii) the disposal or destruction of the drug.²

Before a licence holder can cultivate cannabis plants, or produce cannabis or cannabis resin, the licence holder must obtain a cannabis permit. Permits deal with matters such as the types of cannabis plants that can be cultivated and the quantities of cannabis and cannabis resin that can be produced.³

Licences and permits are interrelated, and both are required to be granted before any cultivation, production, research or manufacture can be undertaken. The export of cannabis and cannabis resin produced under a medicinal cannabis licence has been permitted since February 2018.

According to the ODC the following can be exported:

• Medicinal cannabis products manufactured in Australia under a GMP Licence;
• Medicinal cannabis products listed as export only or registered in the Australian Register of Therapeutic Goods;
• Extracts of cannabis (or cannabis resin) manufactured under a Narcotic Drugs Act 1967 Licence that are not in the final dosage form.⁴
  What cannot be exported under the amendments?
• Cannabis (e.g. flowers, leaves) or cannabis resin.

When applying for an ODC export licence for medicinal cannabis, the applicant will need to demonstrate that they will be able to supply medicinal cannabis in Australia for supply under the special access scheme, to authorised prescribers or for clinical trials. The policy is to ensure that export is not detrimental to the supply to Australian patients.⁵

Review of the ND Act in 2019

The 2016 amendments to the ND Act include a requirement being Section 26A that the Minister cause a review of the operation of the Act to be undertaken as soon as possible after the second anniversary of the commencement of the 2016 amendments. The report of the review is to be tabled in both houses of Parliament before the third anniversary – in effect, by 29 October 2019.

The review is to consider the new regulatory framework for the cultivation, production and manufacture of medicinal cannabis in Australia taking into account the parameters imposed on licensing, availability for therapeutic and research purposes amongst other potential conflicts and compliance issues. Once the review is finalised, a report will be tabled in both houses of Parliament. The report may contain recommendations regarding the operations of the Act and regulations and whether Parliament should consider future changes to legislation, regulation or its operation.

Component 2 – Access to medicinal cannabis products:

Patient access to medicinal cannabis is provided under the Therapeutic Goods Act 1989 (TGA) which establishes the regulatory framework for all medicines in Australia. This Act provides the mechanisms that enable access to unapproved therapeutic goods for appropriate patients. The pathways through which Australian patients have access to medicinal cannabis products is known as the Authorised Prescriber and Special Access Schemes, Category A, B and C.

Authorised Prescriber

A medical practitioner who has been approved under the TGA Act as an Authorised Prescriber is able to prescribe unapproved therapeutic goods for a condition or class of patients in their immediate care without further TGA approval.

To become an Authorised Prescriber the medical practitioner must:

• Have the training and expertise appropriate for the condition being treated and the proposed use of the product;
• Be able to best determine the needs of the patient and;
• Be able to monitor the outcome of therapy.

Special Access Scheme

• Category A is a notification pathway which can be accessed by a prescribing medical practitioner for patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
• Category B is an application pathway which can be accessed by health practitioners for patients that do not fit the Category A definition and where the unapproved good is not deemed to have an established history of use and cannot therefore be accessed through Category C. An approval letter from the TGA is required before the goods may be accessed. Approvals for medicines accessed through this pathway are typically only issued to medical and dental practitioners.
• Category C is a notification pathway which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval. The goods deemed to have an established history of use will be specified in a list along with their indications and the type of health practitioner authorised to supply these products for their respective indications. There is a separate list for medicines, medical devices and biologicals.⁶

The Special Access Scheme provides doctors with a way of seeking the Commonwealth Government’s permission for their individual patients to have access to unapproved medicines. The TGA has introduced an online system allowing Special Access Scheme applications to be lodged online which streamlines the process to the advantage of patients.

Up until 30 April 2019, the TGA has approved over 6400 SAS Category B applications for unapproved medicinal cannabis products.⁷

With the medicinal cannabis industry being an evolving industry, the legislation and legal compliance requirements are continually changing. There are many who criticise the current legislation.

L & M Law

L& M Law is a bespoke full-service legal firm that delivers exceptional service and a wealth of expertise in a way that’s accessible to the community. We’re based in the heart of Sydney and have clients from all over Australia. We represent new entities and businesses seeking to enter and flourish in the medicinal cannabis industry. There are several significant and complex hurdles to overcome. We help our clients understand how best to structure their needs and ensure compliance with the stringent rules and regulations in this ever-changing legislative climate.

We advise patients on how best to navigate the legal pathways to access medicinal cannabis through the Federal Government’s Special Access Scheme. We can assist clients navigate through the regulatory compliance, licensing and permit applications and administrative matters.

We collaborate with a large Colorado law firm namely Feldmann Nagel Cantafio
providing our clients with access to the complex USA regulatory regime in this space. https://www.colo-lawyers.com/

Disclaimer: The authors have used all due care and skill to ensure the material is accurate as at the date of this report, however, the authors do not accept any responsibility for any losses that may arise by anyone relying upon its contents.

References

1. Section 8D of Narcotic Drugs Act 1967
2. Section 11G of Narcotic Drugs Act 1967
3. Section 8D of Narcotic Drugs Act 1967
4. https://www.odc.gov.au/publications/export-medicinal-cannabis
5. https://www.odc.gov.au/sites/default/files/guidance-on-export-of-medicinal-cannabis.pdf
6. https://www.tga.gov.au/special-access-scheme-frequently-asked-questions
7. https://www.tga.gov.au/access-medicinal-cannabis-products-1

Lana Lakofski
Partner
L&M Law
+61 2 8322 3856
lana@auscannabis.law
www.l-mlaw.com.au

Please note, this article will appear in issue 10 of Health Europa Quarterly, which is available to read now.