12 May 2020

The Australian Advisory Council on the Medicinal Use of Cannabis, Communiqué #12

The Australian Advisory Council on the Medicinal Use of Cannabis (the Council) met for its twelfth meeting, via teleconference, on Tuesday 21 April 2020.

The meeting was chaired by Professor James Angus AO. Council members represent professional organisations, specialist areas of the medical profession and patient groups.

Senate Inquiry: Current barriers to patient access to medicinal cannabis in Australia

Representatives from the Department of Health provided Council members with a detailed update on the Senate Inquiry: Current barriers to patient access to medicinal cannabis in Australia, held in November 2019, including the Inquiry report which was released on 26 March 2020. Council members considered and discussed the draft Australian Government response and indicated support of the content.

Regulatory updates

The Council received a detailed update on the status of the regulatory scheme for the cultivation, production and manufacture of medicinal cannabis, including application processing and inspection activity for licences and permits.

Members were advised that, in response to the impacts of COVID-19 and the pandemic, all licenses for cultivation and production, research and manufacture due to expire by 30 June 2020 had been extended for a period of six months to facilitate business continuity. The Council noted that although Parliament is in recess for several more months, work continues to progress the legislative reforms recommended in the Review of the Narcotic Drugs Act 1967 conducted by Professor John McMillan AO.

Special Access Scheme (SAS) Online Portal

The Council was provided with an update on the Special Access Schemes (SAS), including an overview of data relating to patient access to medicinal cannabis products via different access pathways. Members noted a 300% increase in approvals over the last 12 months. Of note was that over 38,000 prescriptions have been written for unapproved medicinal cannabis products with over 28,000 patients receiving authorisation through the SAS or Authorised Prescriber Schemes. Members were advised of initiatives undertaken in various states and territories to address processing issues related to COVID-19.

Guidance

The Council noted there had been a number of activities occurring in the regulatory education space, including a refresh of the bibliographies published on the Therapeutic Goods Administration's website.

Stakeholder engagement

Representatives from the Department of Health advised the stakeholder sessions held in Brisbane, Melbourne and Sydney during November 2019 and January and February 2020, were well attended and the principles of cost recovery and changes to fees and charges were generally supported. Council members that attended the stakeholder sessions noted attendees had been engaged and eager to move forward and reach a positive consensus.

The Council noted the department had conducted a formal consultation process on the Medicinal Cannabis Cost Recovery Framework, resulting in the receipt of multiple written submissions.

Next meeting

The Advisory Council agreed to meet again in late June 2020 with a venue to be determined closer to the date.