AACMC meeting 5, 7 February 2018

The Australian Advisory Council on the Medicinal Use of Cannabis met on 7 February 2018 in Melbourne for its fifth meeting.

The meeting was chaired by Professor James Angus AO.

Members received an update on the status of the regulatory scheme for the cultivation, production and manufacture of medicinal cannabis. Members additionally discussed four main areas of interest:

• Collaboration to streamline state and territory and Commonwealth approval processes
• Clinical trials
• National cannabinoid data collection and pharmacovigilance system
• Cannabis licences under the Narcotic Drugs Act 1967 (the Act)

Streamlining state and territory and Commonwealth approval processes for medicinal cannabis access

The Advisory Council discussed public frustration with access to medicinal cannabis, and noted the potential duplication in Commonwealth and state and territory approval processes as an area of concern.

Advisory Council members discussed the different requirements of the Commonwealth and the states and territories in approving the use of medicinal cannabis products, and acknowledged the complementary roles that each jurisdiction brings to patient access of medicinal cannabis.

It was noted that the Minister for Health, the Hon. Greg Hunt MP, has written to the state and territory health Ministers to seek support from his colleagues to address challenges faced by patients in accessing medicinal cannabis. The Department of Health provided an update on engagement with its state and territory counterparts and remains committed to the identification of opportunities to reduce duplication and the development of solutions to address the matter.

Clinical trials

Clinical trials remained an area of focus for the Advisory Council, and members were encouraged by the rigorous design and broad range of the 34 existing medicinal cannabis clinical trials. The results of these trials will contribute positively to the amount and quality of evidence to either support or contradict the use of medicinal cannabis as an approved treatment across a range of health conditions and symptoms.

Members noted the significant investment by both the Commonwealth and state and territory governments in both funding and facilitating the trials.

Members discussed potential opportunities for expansion in the clinical trial setting, such as primary care collaboration, plant phenotyping and intractable epilepsy in adults.

National cannabinoid data collection and pharmacovigilance system

Advisory Council members discussed data collection and pharmacovigilance, and identified the issue is broader than in its relevance to medicinal cannabis. Members provided in principle support for a national cannabinoid data collection and pharmacovigilance system and noted the potential of such a system to help overcome jurisdictional barriers and improve reporting of adverse event data more generally.

Cannabis licences under the Narcotic Drugs Act 1967 (the Act)

Advisory Council members noted that 29 licences have been granted under the Act to date, and that 5 permits to cultivate medicinal cannabis have also been granted. Members were encouraged to see these numbers, and expressed their support for the fledging industry.

The Advisory Council noted that processing licence applications is a time consuming and complex process, and that it is important to maintain  a strong regulatory posture when licencing drugs of potential harm and abuse, especially in terms of preventing diversion into the criminal market.

The Advisory Council has sought greater detail on licencing progress, and requested that the Department of Health continue to work closely with industry applicants to tailor the assessment processes for licences and permits.

Next meeting

The Advisory Council agreed to meet again in May 2018.