28 June 2017

The Australian Advisory Council on the Medicinal Use of Cannabis, Communique #2

The Australian Advisory Council on the Medicinal Use of Cannabis (the Council) met on Wednesday 7 June 2017 in Melbourne for its second meeting.

The meeting was chaired by Professor James Angus AO and 13 of the 16 members were in attendance.

Members received an update on the status of the regulatory scheme for the cultivation, production and manufacture of medicinal cannabis, and then the meeting focused on the following areas:

  • Patient access
  • Jurisdictional approval processes
  • Update on clinical trials and clinical guidance development
  • Stakeholder engagement and education initiatives

Patient access

Members were provided with data regarding use of the special access schemes in place to ensure that patients are able to access unapproved therapeutic goods under certain circumstances.

The Council noted that there is some potential for the misuse of Special Access Scheme Category A (SAS Cat A) as this scheme is based on a notification process by a medical practitioner to the Therapeutic Goods Administration (TGA). The Council requested that the TGA investigate whether there is an opportunity to perform data analytics on SAS Cat A to determine the potential level of misuse of the schemes. Doing so would allow for a better understanding of the risks involved with that pathway.

The Council went on to discuss Special Access Scheme Category B (SAS Cat B), which requires a practitioner to obtain authorisation from the TGA before an unapproved medicine can be administered. Generally the medicines associated with SAS Cat B are established medicines with known purposes and dosages. As there are few registered medicinal cannabis products overseas, a thorough assessment of the application is required; however; the TGA is processing these applications within 48 hours - when all required information is provided upfront.

Jurisdictional approval processes

The distinct and important roles of each jurisdiction in the regulation of patient access to medicinal cannabis were discussed. State and territory health departments have a role through medicine scheduling and requirements on how medicinal cannabis may be authorised for use by specified patient groups in their jurisdiction. The Commonwealth regulates medicinal cannabis products through the licensing of manufacture and importation of controlled substances (the Office of Drug Control) and the regulation of the quality, safety and efficacy of medicines and provision of access to unapproved medicines (TGA).

The Council noted some duplication of effort between the Commonwealth and the states and territories in approval processes for patient access, and that the TGA is investigating opportunities to streamline those processes.

Update on clinical trials and clinical guidance development

The Council was provided with an update on the clinical trials currently underway in New South Wales and Queensland and noted the long term benefit to the community of rigorous, well designed clinical trials. The members also acknowledged the pioneering nature of the trials, particularly the outcomes that determine the ideal doses and frequency of use of medicinal cannabis.

The TGA is developing five clinical guidance documents aimed at assisting doctors in the prescription of medicinal cannabis products and help identify suitable products. These documents will be guidance only and thus are not legally binding. The Council asked to be provided drafts of the guidance as it is developed and for a report on the status of the development of the documents at the next Council meeting.

Stakeholder engagement and education initiatives

Engagement and education of stakeholders regarding medicinal cannabis is of great interest to the Council and is a standing agenda item. Stakeholders are diverse and include patients and their advocates, medical practitioners, pharmacists, and the general community.

The Council was informed of patient advocate meetings hosted by the TGA in a number of cities. Patient advocates stated that access pathways to medicinal cannabis are confusing for the general public and the TGA agreed to work on case studies that demonstrate how individuals may practically access medicinal cannabis. These case studies will be provided to the Council for comment at the next meeting.

Members of the Council with roles in representative bodies updated the Council on the manner in which their organisations are educating their members or stakeholders on matters relating to medicinal cannabis. This includes development of fact sheets, publication of position statements and collaboration between organisations.

Next meeting

The Council agreed to meet again in late September 2017 in Sydney.