Focus on Medicinal Marijuana: The regulatory framework for supply and use of medicinal cannabis in Australia
The legalisation of medicinal cannabis in Australia was largely enabled by the Narcotic Drugs Amendment Act 2016 (Cth), which permits research, cultivation and production of medicinal cannabis and related products. Corresponding amendments have also been made to the Therapeutic Goods Act 1989 (Cth) to facilitate regulatory approvals and alternative access schemes for unapproved medicinal cannabis products. Although the production, cultivation and regulatory approval for the supply of medicinal cannabis are the subject of federal legislation, the power to regulate patient access to medicinal cannabis products remains with the states and territories. Ongoing lack of consistency between the jurisdictions has resulted in a complex web of legislative instruments for the prescription and use of medicinal cannabis across Australia.
In this third and final part of our series, we highlight the options available for companies seeking to market medicinal cannabis products and for patients to access this new class of therapeutics.
Entering the market – regulatory considerations for manufacturers and suppliers
The supply of medicinal cannabis is regulated under the Therapeutic Goods Act and the Office for Drug Control (ODC). Under the Act, medicinal products must be registered on the Australian Register of Therapeutic Goods (ARTG) before the product can be supplied in the Australian market. The Therapeutic Goods Administration (TGA) will enter a product into the ARTG where the product has been assessed as meeting the requirements for quality, safety, efficacy and/or performance.
Regulation of medicinal cannabis products by the TGA was made possible by a number of amendments to the Therapeutic Goods Act and the associated Poisons Standard to reschedule cannabis and THC for therapeutic use. Specifically, cannabis, including seeds, extracts, resins, plant and any plant parts and tetrahydrocannabinols (THC) extracted from cannabis were added to Schedule 8 of the Poisons Standard on 1 November 2016. This provides basis for the prescription of medicinal cannabis products in States and Territories where changes making medicinal cannabis a controlled drug have been adopted. Under the current regime, medicinal cannabis products can be prescribed as registered goods on the ARTG. Alternatively, non-registered products may be accessed by patients via Special Access Schemes and from Authorised Prescribers, the details of which are outlined below.
In the context of cannabis-derived compounds and formulations, these products will only be available with a prescription (Therapeutic Goods Act, Appendix D). As such, these products will have to satisfy the strict regulatory requirements for prescription medical products, supported by quality data (e.g., composition, batch consistency, stability, sterility (where applicable) and impurity content); non-clinical data (e.g., pharmacology and toxicology data); and clinical data (e.g., results from clinical trials). The data is evaluated by technical staff to determine if the product is suitable for registration. This is an iterative process, with technical staff having the ability to consult with the company or individual seeking registration (i.e., the sponsor) to resolve any questions about the data submitted.
All medicinal cannabis products derived from seeds, extracts, resins, plant and any plant part) must also conform to the Therapeutics Goods Order 93 (Standard for Medicinal Cannabis). According to these standards the active ingredients and cannabinoids in medicinal cannabis products must be manufactured from a cannabis plant. This means that the medicinal cannabis products cannot contain synthetic cannabinoids or active ingredients from any source other than the cannabis plant. This may restrict the use of genetically modified cannabis plants that express recombinant proteins that, for example, improve yields and increase pest resistance.
To ensure consistency between batches, the plants must be positively identified and tested for the presence of aflatoxins, foreign matter, heavy metals, ochratoxin A, pesticides and total ash in accordance with European Pharmacopoeia monographs. In addition, the contents of the active ingredients in the medicine’s final formulation (i.e., plant matter or extracts, such as oil or resin) must also be assessed.
Registration on the ARTG allows the sponsor to lawfully supply the registered goods in Australia. It should be noted, however, that export of medicinal cannabis is not permitted under the Narcotics Drugs Act unless the product is registered on the ARTG. Furthermore, exportation of medicinal cannabis will only be considered where this is consistent with Australia’s obligations under the Single Convention on Narcotic Drugs, which prohibits the production and supply of specific drugs.
At this stage, the standard process for registration of prescription therapeutics has been successfully used to register cannabis-derived compounds on the ARTG. For example, the TGA has registered a cannabis-derived product for nabiximols (Sativex™), an oromucosal spray for the treatment of symptoms associated with multiple sclerosis (MS). However, in view of the limited clinical data to support the efficacy of medicinal cannabis, the majority of patients will only be able to access medicinal cannabis via the alternative access pathways administered by the TGA or in clinical trials.
Patient access to medicinal cannabis
The TGA administers alternative schemes to allow for access to unapproved medicinal cannabis products in limited circumstances under the clinical trial, Special Access Scheme (SAS) and Authorised Prescriber provisions of the Therapeutic Goods Act. These alternative supply pathways allow for interim patient access to unapproved products while the evidence required to support registration on the ARTG is generated.
Clinical trials of new therapeutic goods or new uses of existing therapeutic goods may be conducted under the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) Schemes administered by the TGA. Any medicines that are approved for use in clinical trials under either of these schemes are exempt from registration or listing by either section 18 or 19 of the Therapeutic Goods Act, or regulation 12 and schedules 5 and 5A of the Therapeutic Goods Regulations 1990 (Cth).
A number of clinical trails are currently underway in Australia. As mentioned in our previous article (available here), these trials are seeking to assess the efficacy of medicinal cannabis from a number of different patient cohorts and indications. For example, trials are currently underway to assess the efficacy of cannabis-derived products and compounds (i.e. cannabis oil, CBD oil) for the treatment of children with severe, drug-resistant epilepsy and of vaporised cannabis flowers to provide relief for adult cancer patients in palliative care.
Special Access Scheme
Individual patients can also access unapproved medicinal cannabis products via the Special Access Scheme (SAS). Accordingly, an Australian registered medical practitioner with the appropriate qualifications and/or expertise for the medical condition requiring treatment may apply on a patient’s behalf to import and supply products through the SAS Category B.
SAS B is currently the TGA’s fastest access pathway for medicinal cannabis. This scheme is an application pathway which can be accessed by medical practitioners for patients that do not fall into the A category and where the unapproved good is not deemed to have an established history of use. An approval letter from TGA is required before the good may be accessed. Thereafter, medicinal cannabis products may be obtained from an Australian stockist or imported by the medical practitioner, a pharmacist or an importer under licence by the Office of Drug Control (ODC).
It should be noted that the TGA can also allow for medical practitioners to prescribe unapproved products under SAS Category A. SAS A is a notification pathway which is limited to 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. However, access to medicinal cannabis is not currently allowed through SAS A.
While it is not clear why the government has restricted access to medicinal cannabis to SAS B, in June this year a motion was moved in the Senate to allow patients to access medicinal cannabis through SAS A. Interestingly, however, the ODC blocked patient access via SAS A by notifying importers that they would be in breach of their permit and licence conditions if imported medicinal cannabis products are imported under SAS A. To counter the measures taken by the ODC, the Medicinal Cannabis Legislation Amendment (Securing Patient Access) Bill 2017 (Senator Di Natale) has recently been introduced into Parliament to prevent the government from using the contractual conditions of importers to block the import of medicinal cannabis under SAS A.
“Authorised Prescribers” are medical practitioners who can prescribe medicinal cannabis products for classes of patients with specific conditions without further TGA approval. To qualify as an Authorised Prescriber, a medical practitioner must have training and expertise that is appropriate for the condition being treated and the proposed use of the product. Furthermore, the practitioner must be in a position to best determine the needs of the patient and to monitor the outcome of the therapy. Where the practitioner satisfies these requirements, they will be authorised to prescribe unapproved medicinal cannabis products to the specified patients.
The TGA’s alternative access schemes have been recently criticised as unduly restrictive, with only a small number of patients being prescribed medicinal cannabis. The problems identified are two-fold – medical practitioners lack the requisite level of expertise to utilise the SAS or to become registered as an Authorised Prescriber; and medicinal cannabis products are not considered to be treatments of first choice because of the lack of safety, quality and efficacy data currently available. As a result, the legal prescription of medical cannabis products via the alternative access schemes has been low, and it has been suggested that patients will inevitably have to resort to the black market to obtain cannabis for therapeutic use (Lateline, ABC, August 2017). Despite this suggestion, the TGA considers that the alternative access schemes work in a restricted manner to ensure that patients are provided with safe and effective medications that are supported by evidenced-based decision making by both medical practitioners and the TGA. However, the TGA is also working with states and territories to assist medical practitioners in assessing quality evidence on medicinal cannabis, particularly for the treatment of epilepsy and palliative care, to better support medical practitioners in making informed decisions about the use of medicinal cannabis.
It should also be recognised that the alternative access schemes operate in conjunction with state and territory laws, which dictate the patients who can access medicinal cannabis products. As it currently stands, there is little consistency in the state and territory legislation regarding the patients and indications for which it is legal to prescribe and use medicinal cannabis. Therefore, state and territory laws also operate to restrict patient access to medicinal cannabis.
State and Territory laws for the use and prescription of medicinal cannabis
We have previously outlined the differences in state and territory legislation (available here), however, since then, further legislative amendments have been made which impact the range of patients who can access medicinal cannabis across the states and territories.
- Queensland – As from 1 March 2017, it is legal for doctors to prescribe medicinal cannabis with the approval of Queensland Health and the TGA. Patients may be prescribed medicinal cannabis where there is clinical evidence or indication that the product will be beneficial for their condition or symptoms and where the patient has already tried conventional treatments without success. Currently, Queensland Health lists severe muscle spasms and other symptoms associated with MS, chemotherapy-induced nausea and vomiting, some types of epilepsy with severe seizures and palliative care as conditions that medicinal cannabis may be suitable to treat.
- WA – Under strict conditions, as from 1 November, 2016 it is legal for specifically authorised doctors to prescribe and for pharmacists to dispense medicinal cannabis. Whilst there are presently no locally grown or produced cannabis products available, it is not intended that there will be any restrictions on the conditions for which medicinal cannabis can be prescribed.
- Victoria – Under the Access to Medicinal Cannabis Act 2016, from early 2017, it will be legal to prescribe cannabis for children with certain categories of epilepsy.
- New South Wales – It is currently legal for doctors to prescribe medicinal cannabis using the TGA alternative access schemes once approved by NSW Health and the TGA. A compassionate use scheme also operates to allow for the use of medicinal cannabis by adults with certain “end of life” conditions. Accordingly, police officers can exercise discretion as to whether or not to charge adults who have been certified to have a terminal illness, and their carers, with use or possession of cannabis.
- Tasmania – From 1 September 2017, patients will be able to access medicinal cannabis, particularly patients with severe epilepsy, under a “controlled access scheme”. The scheme permits authorised medical specialists to prescribe medicinal cannabis to patients for specific conditions. Cultivation, possession and use of cannabis in Tasmania outside the “CAS” will remain illegal.
- ACT – As from 1 November 2016, medicinal cannabis can be prescribed with the authorisation of the ACT Chief Health Officer under the SAS or Authorised Prescriber schemes. The same process currently applied to other controlled medicines such as opiates and amphetamines.
- South Australia – As from 1 November, 2016, medicinal cannabis can be prescribed by authorised medical practitioners and dispensed by pharmacists.
- Northern Territory – With the re-classification of cannabis as a Schedule 8 item under the Poisons Standard, it appears that prescription and use of medicinal cannabis in the Northern Territory is regulated in the same way as any other Schedule 8 item. Under this regulation, the prescriber need only be locally qualified (e.g., excluding an interstate prescriber) and the supplier can be a qualified pharmacist.
Although the federal government has passed legislation facilitating the supply of, and access to, medicinal cannabis products in Australia, there are a number of regulatory obstacles for both suppliers and patients, which means that access to medicinal cannabis products in Australia remains laborious and difficult to achieve. Not only do regulatory obstacles inhibit market access, inconsistencies in state and territory legislation make it difficult for patients to assess their eligibility to access medicinal cannabis products.
We recognise that the regulatory framework for the supply and access of medicinal cannabis in Australia is a complex and rapidly changing area. The IP and legal specialists at DCC and DCCL can assist you in navigating the path to commercialisation of your medicinal cannabis and cannabis-derived products.