17 June 2019

The Australian Advisory Council on the Medicinal Use of Cannabis, Communiqué #8

The Australian Advisory Council on the Medicinal Use of Cannabis (the Council) met on Wednesday 28 November 2018 in Canberra for its eighth meeting.

The meeting was chaired by Professor James Angus AO. Council members represent professional organisations, specialist areas of the medical profession and patient groups. The Minister for Health, the Hon Greg Hunt MP was also in attendance.

The Minister addressed the Council and thanked them for their service and leadership over the last two years. The Minister also reflected on the Council's importance as a qualified and impartial communication channel from the Australian Government through to the wider community.

Regulatory updates

The Council 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, permits and applications.

The Council was advised of the emerging issues relating to licencing and permits, including rejection rates, trends in unintended consequences, international investment and the delivery of a new guidance document regarding Good Manufacturing Practice. The Council also noted the Thai Government's request for the Australian Government’s expertise and assistance in the medicinal cannabis arena.

Special Access Scheme (SAS) Online Portal

The department announced that applications for the Special Access Schemes were able to be lodged through the online portal from 30 July 2018 in QLD, NSW and VIC and from 30 September 2018 in SA, QA and NT and noted that the online portal is not yet available in ACT or TAS. The department further advised that over 900 applications have been lodged (to end November 2018) using the online portal since 30 July 2018.

The Council noted its support of the national uptake of the SAS online portal and the portals ability to further improve national access.

Guidance regarding medicinal cannabis products

The Council discussed the stability of medicinal cannabis, particularly given reports that expiry date extension stickers are being applied to some unapproved therapeutic products. The Council considered the scrutiny of Australian manufactured products and the requirements of the Therapeutic Goods Order #93: Standard for Medicinal Cannabis, and discussed the advantages of medicinal cannabis products being registered on the Australian Register of Therapeutic Goods (ARTG). The Council expressed its view that the quality of medicinal cannabis products would be supported through registration on the Australian Register of Therapeutic Goods (ARTG).

Update on developments in the United Kingdom and the European Union

The Council discussed recent developments on cannabis in the United Kingdom (UK) and the European Union (EU). Members noted that Australia had received positive feedback on its regulatory reviews and guidance, at a recent neuroscience conference in London. Members also discussed the International Narcotic Control Board’s (INCB) Annual Report which is due to be released in the first quarter of 2019 and the review of cannabidiol by the World Health Organisation Expert Committee on Drug Dependence.

Next meeting

The Advisory Council agreed to meet again in Melbourne in March 2019 for the last meeting of the current tenure.