The Senate Community Affairs References Committee Current barriers to patient access to medicinal cannabis in Australia March 2020 © Commonwealth of Australia 2020 ISBN 978-1-76093-059-2 (Printed Version) ISBN 978-1-76093-059-2 (HTML Version) This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Australia License. The details of this licence are available on the Creative Commons website: http://creativecommons.org/licenses/by-nc-nd/3.0/au/. Printed by the Senate Printing Unit, Parliament House, Canberra Committee Members Chair Senator Rachel Siewert AG, WA Deputy Chair Senator Wendy Askew LP, TAS Members Senator Catryna Bilyk ALP, TAS (from 5 February 2020) Senator Raff Ciccone ALP, VIC (from 5 December 2019 to 5 February 2020) Senator Hollie Hughes LP, NSW Senator Malarndirri McCarthy ALP, NT Senator Anne Urquhart ALP, TAS Participating Members Senator Catryna Bilyk ALP, TAS (until 5 February 2020) Senator Richard Di Natale AG, VIC Former Members Senator Deborah O'Neill ALP, NSW (until 5 December 2019) Secretariat Jeanette Radcliffe, Committee Secretary Apolline Kohen, Principal Research Officer Kathleen McGarry, Acting Senior Research Officer Carol Stewart, Administrative Officer PO Box 6100 Parliament House Canberra ACT 2600 Phone: 02 6277 3515 Fax: 02 6277 5829 E-mail: [email protected] Internet: www.aph.gov.au/senate_ca iii Table of Contents Committee Members ........................................................................................................................ iii Terms of Reference ............................................................................................................................ ix Abbreviations ..................................................................................................................................... xi List of Recommendations .............................................................................................................. xiii Chapter 1—Introduction .................................................................................................................... 1 Purpose of the inquiry ......................................................................................................................... 1 Report structure ................................................................................................................................... 1 Conduct of the inquiry ........................................................................................................................ 2 Acknowledgements .................................................................................................................. 2 Note on terminology and references ...................................................................................... 2 Medicinal cannabis .............................................................................................................................. 2 Medicinal uses ........................................................................................................................... 3 The role of the Therapeutic Goods Administration (TGA) ............................................................ 3 Scheduling of medicines .......................................................................................................... 3 Registration of medicines ........................................................................................................ 4 Access pathways for medicinal cannabis .............................................................................. 5 The role of the Office of Drug Control (ODC) ................................................................................. 7 The role of state and territory governments ..................................................................................... 7 SAS online system ..................................................................................................................... 9 Chapter 2—Education and information ........................................................................................ 11 Education about medicinal cannabis .............................................................................................. 12 Medical cannabis efficacy ...................................................................................................... 12 Treatment of last resort .......................................................................................................... 13 Stigma ....................................................................................................................................... 14 Training ............................................................................................................................................... 15 Training available ................................................................................................................... 16 Training needs ......................................................................................................................... 16 Information about accessing medicinal cannabis .......................................................................... 17 Patients' perspectives ............................................................................................................. 17 Health practitioners' perspectives ........................................................................................ 18 v Medicinal cannabis products ................................................................................................ 19 Committee view ................................................................................................................................. 19 Chapter 3—Access pathways and regulatory hurdles ................................................................ 23 Introduction ........................................................................................................................................ 23 Special Access Scheme....................................................................................................................... 23 Use of SAS-A ........................................................................................................................... 24 Recent increase in SAS-B applications ................................................................................. 24 Concerns about using the SAS-B pathway .......................................................................... 26 Authorised Prescriber scheme ......................................................................................................... 31 Clinical trials ....................................................................................................................................... 35 Alternatives proposed to the current TGA pathways .................................................................. 36 Proposal for an independent regulatory framework ......................................................... 37 Committee view ................................................................................................................................. 39 Notification pathways ............................................................................................................ 39 Approval pathways ................................................................................................................ 40 Committee view ................................................................................................................................. 41 Jurisdiction-specific regulatory requirements ............................................................................... 43 The 'postcode lottery' ............................................................................................................. 44 Tasmania – the odd state out ................................................................................................ 46 Need for harmonisation ......................................................................................................... 47 International jurisdictions and their access models ...................................................................... 48 The Canadian model .............................................................................................................. 49 Committee view ................................................................................................................................. 50 Chapter 4—Products and supply ................................................................................................... 53 Regulating medicinal cannabis products ....................................................................................... 53 Scheduling in the Poisons Standard ..................................................................................... 54 Registration of medicinal cannabis products in the ARTG .............................................. 57 Regulating cannabinoids as complementary medicines ................................................... 62 Committee view ................................................................................................................................. 63 Medicinal cannabis supply in Australia ......................................................................................... 64 Locally-manufactured medicinal cannabis products .......................................................