AACMC meeting 6, 10 May 2018

The Australian Advisory Council on the Medicinal Use of Cannabis met on 10 May 2018 in Sydney for its sixth meeting.

The meeting was chaired by Professor James Angus AO. Members represent professional organisations, specialist areas of the medical profession and patient groups. The Council noted some changes to membership and to support roles provided by the department. Members thanked Professor Jennifer Martin on her resignation of her role on the Council, highlighting her ongoing work in medicinal cannabis trials and research.

Members received a detailed update on the status of the regulatory schemes for the cultivation, production and manufacture of medicinal cannabis - including the status of licences and applications.

Regulatory updates

The Council discussed the recent amendments to the Narcotic Drugs Regulations 2016 that allow:

• export of medicinal cannabis products
• supply of raw flower to a Good Manufacturing Practice (GMP) manufacturer authorised under the Therapeutic Good Act 1989 for processing.

The Council were advised of other minor amendments (largely around information requirements for licensing and application processes) and discussed the end to end process for medicinal cannabis from cultivation to prescription.

Report on the progress made at a departmental level regarding streamlining approval processes with the states and territories

The department noted that since the last meeting of Council, a meeting of the COAG Health Council had occurred, following which Minister Hunt announced that a single portal for applications would be created allowing a streamlined approval process.

It was reported that work on the streamlining process was underway, and that the combined process for the TGA and the NSW Health Department was 'live' with, in most cases, applications for access to medicinal cannabis being processed within 24 hours.

Noting the current burden on prescribers and consumers, the Council agreed that all jurisdictions should work together to streamline access through the national portal as soon as possible.

Clinical Trials

The Council discussed the current scale and number of clinical trials relating to medicinal cannabis. The Council also received an update on clinical trials funded by government entities which includes three NSW Government funded trials for paediatric epilepsy (a joint project with the QLD government), anorexia-cachexia in advanced cancer and chemotherapy induced nausea and vomiting.

In addition the Council noted the NSW Government has recently announced an additional $6.05M in funding for their clinical cannabis medical program; $3M will be allocated to the Australian Centre for Cannabinoid Clinical and Research Excellence. This funding is in addition to that already allocated to trials.

The Council noted it would continue to monitor the clinical trials underway and would consider encouraging further support.

Next meeting

The Advisory Council agreed to meet again in August 2018.