AACMC meeting 4, 12 December 2017

In addition to receiving briefings on the progress of the regulatory scheme for the cultivation, production and manufacture of medicinal cannabis in Australia, members discussed a number of issues, including:

• Endorsing the final drafts of clinical guidance documents and discussion of evidence reviews around the use of medicinal cannabis for five major groups of conditions (epilepsy, multiple sclerosis, nausea and vomiting, palliative care and pain)
• Supporting the Government's position around the use of the Special Access Scheme Category B as the primary mechanism for prescription of medicinal cannabis, including noting recent statistics around the increasing numbers of SAS Cat B applications being turned over in under 1 working day.
• Considering the clinical trials previously or currently underway in relation to medicinal cannabis in Australia (36 such since 2003), and discussing further opportunities for new research directions.

Clinical guidance on the use of medicinal cannabis

The Council reviewed the five clinical guidance documents presented; documents aiming to provide guidance to health professionals who may choose to prescribe medicinal cannabis in Australia under current access schemes for epilepsy, multiple sclerosis, nausea and vomiting, palliative care and pain.

The Council noted and commended the extraordinary amount of consultation that was conducted with clinical and patient representative groups in the preparation of the documents, in addition to the review of clinical literature.  The Council supported the view within the guidance that medicinal cannabis is not a 'first line' treatment and that the documents provide suggestions for the potential use of medicinal cannabis in particular medical conditions/symptoms, rather than providing recommendations for the specific management of medical conditions.

Members further noted that there is a need to ensure that the general community and medical practitioners understand that these documents will be revised and updated with emerging data on safety and efficacy as further medical evidence comes to hand.

Following review and discussion, the Council unanimously endorsed the clinical guidance documents.  The final versions of the five clinical guidance documents will be made available on the Therapeutic Good Administration website: tga.gov.au.

Prescription of medicinal cannabis

The Council discussed existing issues around access to medicinal cannabis, including the use of prescriptions under Special Access Scheme Category B (SAS Cat B) and under Special Access Scheme Category A (SAS Cat A).

Data presented shows that there has been a ten-fold increase in applications in 2017 (from 38 in 2016 to 380+ in 2017). Where approval is given, it is given in 1 working day or less in a third of cases and three-quarters of approvals are given in 10 working days or less. Terminally ill patients are accessing medicinal cannabis through SAS Cat B in a timely fashion. Where there are delays, this rest entirely with doctors who are not responding for requests for basic medical information in a timely fashion.

Clinical trials

The Council noted 36 clinical trials found involving medicinal cannabis products have been notified to the Therapeutic Good Administration since 2003.  These trials have included a wide range of conditions and issues, covering 20 indications (including schizophrenia, epilepsy, insomnia and chemotherapy induced nausea and vomiting) and seven products (including nabilone, sativex, cannabidiol and vaporised cannabis bud).

The Council noted the range of trials, and sought assistance from the Department of Health to work with state and territory governments to achieve a better understanding of current and planned government sponsored or supported clinical trials across Australia.

The Council then went on to discuss what future clinical trials might cover, including areas such as primary care collaboration, plant phenotyping and methods of delivering a safe and high quality medicinal cannabis product, and epilepsy in adults.

Next meeting

The Council agreed to meet again in February 2018.