Australian Health Review Australian Health Review Society
Journal of the Australian Healthcare & Hospitals Association
RESEARCH ARTICLE

Mapping regulatory models for medicinal cannabis: a matrix of options

Vendula Belackova A , Marian Shanahan A and Alison Ritter A B
+ Author Affiliations
- Author Affiliations

A Drug Policy Modelling Program, National Drug and Alcohol Research Centre, UNSW, 22–32 King Street, Randwick, NSW 2052, Australia. Email: vendulabelackova@gmail.com; m.shanahan@unsw.edu.au

B Coresponding author. Email: Alison.ritter@unsw.edu.au

Australian Health Review - https://doi.org/10.1071/AH16257
Submitted: 17 November 2016  Accepted: 4 April 2017   Published online: 30 May 2017

Abstract

Objective The aim of the present study was to develop a framework for assessing regulatory options for medicinal cannabis in Australia.

Methods International regulatory regimes for medicinal cannabis were reviewed with a qualitative policy analysis approach and key policy features were synthesised, leading to a conceptual framework that facilitates decision making across multiple dimensions.

Results Two central organising dimensions of medicinal cannabis regulation were identified: cannabis supply and patient authorisation (including patient access). A number of the different supply options can be matched with a number of different patient authorisation options, leading to a matrix of possible regulatory regimes.

Conclusions The regulatory options, as used internationally, involve different forms of cannabis (synthetic and plant-based pharmaceutical preparations or herbal cannabis) and the varying extent to which patient authorisation policies and procedures are stringently or more loosely defined. The optimal combination of supply and patient authorisation options in any jurisdiction that chooses to make medicinal cannabis accessible will depend on policy goals.

What is known about the topic? Internationally, regulation of medicinal cannabis has developed idiosyncratically, depending on formulations that were made available and local context. There has been no attempt to date in the scientific literature to systematically document the variety of regulatory possibilities for medicinal cannabis.

What does this paper add? This paper presents a new conceptual schema for considering options for the regulation of medicinal cannabis, across both supply and patient authorisation aspects.

What are the implications for practitioners? The design of regulatory systems in Australia, whether for pharmaceutical or herbal products, is a vital issue for policy makers right now as federal and state and territory governments grapple with the complexities of medicinal cannabis regulation. The conceptual schema presented herein provides a tool for more systematic thinking about the options.


References

[1]  United Nations Office on Drugs and Crime. World drug report. United Nations Publication, No. E.16.XI.7. Vienna: United Nations; 2016.

[2]  Belendiuk KA, Baldini LL, Bonn-Miller MO. Narrative review of the safety and efficacy of marijuana for the treatment of commonly state-approved medical and psychiatric disorders. Addict Sci Clin Pract 2015; 10 10
Narrative review of the safety and efficacy of marijuana for the treatment of commonly state-approved medical and psychiatric disorders.CrossRef |

[3]  Whiting PF, Wolff RF, Deshpande S, Di Nisio M, Duffy S, Hernandez AV, Keurentjes JC, Lang S, Misso K, Ryder S, Schmidlkofer S, Westwood M, Kleijnen J. Cannabinoids for medical use: a systematic review and meta-analysis. JAMA 2015; 313 2456–73.
Cannabinoids for medical use: a systematic review and meta-analysis.CrossRef | 1:CAS:528:DC%2BC2MXht1Ojtr7K&md5=a91f33ee497e03d2d6a6869c1d6016b6CAS |

[4]  Freckelton I. Medicinal cannabis law reform in Australia. J Law Med 2016; 23 497–515.

[5]  Pacula RL, Boustead AE, Hunt P. Words can be deceiving: a review of variation among legally effective medical marijuana laws in the United States. J Drug Policy Anal 2014; 7 1–19.
Words can be deceiving: a review of variation among legally effective medical marijuana laws in the United States.CrossRef |

[6]  Pacula RL, Powell D, Heaton P, Sevigny EL. Assessing the effects of medical marijuana laws on marijuana use: the devil is in the details. J Policy Anal Manage 2015; 34 7–31.
Assessing the effects of medical marijuana laws on marijuana use: the devil is in the details.CrossRef |

[7]  Pacula RL, Sevigny EL. Marijuana liberalizations policies: why we can’t learn much from policy still in motion. J Policy Anal Manage 2014; 33 212–21.
Marijuana liberalizations policies: why we can’t learn much from policy still in motion.CrossRef |

[8]  Hasin DS, Wall M, Keyes KM, Cerdá M, Schulenberg J, O’Malley PM, Galea S, Pacula R, Feng T. Medical marijuana laws and adolescent marijuana use in the USA from 1991 to 2014: results from annual, repeated cross-sectional surveys. Lancet Psychiatry 2015; 2 601–8.
Medical marijuana laws and adolescent marijuana use in the USA from 1991 to 2014: results from annual, repeated cross-sectional surveys.CrossRef |

[9]  Scott C. Privatization and regulatory regimes. In: Moran M, Rein M, Goodin RE, editors. The Oxford handbook of public policy. Oxford: Oxford University Press; 2006. pp. 651–68.

[10]  International Association for Cannabis as Medicine. Law and politics. 2017. Available at: http://www.cannabis-med.org/index.php?tpl=page&id=41&lng=en [verified 15 March 2017].

[11]  Hazekamp A, Heerdink ER. The prevalence and incidence of medicinal cannabis on prescription in The Netherlands. Eur J Clin Pharmacol 2013; 69 1575–80.
The prevalence and incidence of medicinal cannabis on prescription in The Netherlands.CrossRef |

[12]  Mead AP. International control of cannabis. In: Pertwee RG, editor. Handbook of cannabis. Oxford: Oxford University Press; 2014. pp. 44–65.

[13]  World Health Organization (WHO). WHO Expert Committee on specifications for pharmaceutical preparations. Annex 12: guidelines on import procedures for pharmaceutical products. Geneva: WHO; 1996.

[14]  Belackova V, Zabransky T. Pěstování léčebného konopí – analýza zahraničních zkušeností z regulačního a ekonomického hlediska [Medicinal marijuana growing – analysis of international experience from regulative and economic perspective]. Adiktologie 2011; 11 28–39.

[15]  Russo EB. Taming THC: potential cannabis synergy and phytocannabinoid–terpenoid entourage effects. Br J Pharmacol 2011; 163 1344–64.
Taming THC: potential cannabis synergy and phytocannabinoid–terpenoid entourage effects.CrossRef | 1:CAS:528:DC%2BC3MXps1Sjtb4%3D&md5=5178c8d1de8f240a52e1e081b1dc5115CAS |

[16]  Hazekamp A, Grotenhermen F. Review on clinical studies with cannabis and cannabinoids 2005–2009. Cannabinoids 2010; 5 1–21.

[17]  Hazekamp A. An evaluation of the quality of medicinal grade cannabis in the Netherlands. Cannabinoids 2006; 1 1–9.

[18]  Pérez-Parada A, Alonso B, Rodríguez C, Besil N, Cesio V, Diana L, Burgueño A, Bazzurro P, Bojorge A, Gerez N, Heinzen H. Evaluation of three multiresidue methods for the determination of pesticides in marijuana (Cannabis sativa L.) with liquid chromatography–tandem mass spectrometry. Chromatographia 2016; 79 1069–83.
Evaluation of three multiresidue methods for the determination of pesticides in marijuana (Cannabis sativa L.) with liquid chromatography–tandem mass spectrometry.CrossRef |

[19]  Mravčík VCP, Grohmannová K, Nečas V, Grolmusová L, Kiššová L, Nechanská B, Sopko B, Fidesová H, Vopravil J, Jurystová L. Annual report on drug situation 2012 – Czech Republic. Prague: Office of Government, Czech Republic; 2013.

[20]  Mechoulam R. Cannabis – the Israeli perspective. J Basic Clin Physiol Pharmacol 2016; 27 181–7.
Cannabis – the Israeli perspective.CrossRef |

[21]  Fischer B, Kuganesan S, Room R. Medical marijuana programs: implications for cannabis control policy – observations from Canada. Int J Drug Policy 2015; 26 15–9.
Medical marijuana programs: implications for cannabis control policy – observations from Canada.CrossRef |

[22]  Carillo DE. A growing trend: policy diffusion of medical marijuana laws in the American states. San Diego: San Diego State University; 2013.

[23]  McKenna GJ. The current status of medical marijuana in the United States. Hawaii J Med Public Health 2014; 73 105–8.

[24]  NORML. Medical marijuana. 2016. Available at: http://norml.org/legal/medical-marijuana-2 [verified 15 March 2017].

[25]  NSW Government. Medicinal Cannabis Compassionate Use Scheme: fact sheet for adults with a terminal illness and their carers. 2015. Available at: https://www.medicinalcannabis.nsw.gov.au/regulation/medicinal-cannabis-compassionate-use-scheme [verified 15 March 2017].

[26]  World Health Organization (WHO). WHO guidelines on good manufacturing practices (GMP) for herbal medicines. Geneva: WHO; 2007.

[27]  Pacula RL, Kilmer B, Wagenaar AC, Chaloupka FJ, Caulkins JP. Developing public health regulations for marijuana: lessons from alcohol and tobacco. Am J Public Health 2014; 104 1021–8.
Developing public health regulations for marijuana: lessons from alcohol and tobacco.CrossRef |

[28]  Caulkins JP, Hawken A, Kilmer B, Kleiman MA. High tax states: options for gleaning revenue from legal cannabis. Oregon Law Rev 2012; 91 1041–68.

[29]  Hajizadeh M. Legalizing and regulating marijuana in Canada: review of potential economic, social, and health impacts. Int J Health Policy Manag 2016; 5 453–6.
Legalizing and regulating marijuana in Canada: review of potential economic, social, and health impacts.CrossRef |

[30]  Colorado Department of Revenue. Marijuana tax data. 2016. Available at: https://www.colorado.gov/pacific/revenue/colorado-marijuana-tax-data [verified 15 March 2017].

[31]  Kilmer B, MacCoun RJ. How medical marijuana smoothed the transition to marijuana legalization in the United States. Annual Rev Law Social Sci 2017; 13
How medical marijuana smoothed the transition to marijuana legalization in the United States.CrossRef |

[32]  Harper S, Strumpf EC, Kaufman JS. Do medical marijuana laws increase marijuana use? Replication study and extension. Ann Epidemiol 2012; 22 207–12.
Do medical marijuana laws increase marijuana use? Replication study and extension.CrossRef |

[33]  Schuermeyer J, Salomonsen-Sautel S, Price RK, Balan S, Thurstone C, Min S-J, Sakai JT. Temporal trends in marijuana attitudes, availability and use in Colorado compared to non-medical marijuana states: 2003–11. Drug Alcohol Depend 2014; 140 145–55.
Temporal trends in marijuana attitudes, availability and use in Colorado compared to non-medical marijuana states: 2003–11.CrossRef |

[34]  Gorman DM, Huber JC. Do medical cannabis laws encourage medical cannabis use? Int J Drug Policy 2007; 18 160–7.
Do medical cannabis laws encourage medical cannabis use?CrossRef |

[35]  Cerdá M, Wall M, Keyes KM, Galea S, Hasin D. Medical marijuana laws in 50 states: investigating the relationship between state legalization of medical marijuana and marijuana use, abuse and dependence. Drug Alcohol Depend 2012; 120 22–7.
Medical marijuana laws in 50 states: investigating the relationship between state legalization of medical marijuana and marijuana use, abuse and dependence.CrossRef |

[36]  Wen H, Hockenberry JM, Cummings JR. The effect of medical marijuana laws on adolescent and adult use of marijuana, alcohol, and other substances. J Health Econ 2015; 42 64–80.
The effect of medical marijuana laws on adolescent and adult use of marijuana, alcohol, and other substances.CrossRef |

[37]  Ritter A, Livingston M, Chalmers J, Berends L, Reuter P. Comparative policy analysis for alcohol and drugs: current state of the field. Int J Drug Policy 2016; 31 39–50.
Comparative policy analysis for alcohol and drugs: current state of the field.CrossRef |

[38]  Belackova V, Ritter A, Shanahan M, Hughes CE. Assessing the concordance between illicit drug laws on the books and drug law enforcement: Comparison of three states on the continuum from ‘decriminalised’ to ‘punitive’. Int J Drug Policy 2017; 41 148–57.
Assessing the concordance between illicit drug laws on the books and drug law enforcement: Comparison of three states on the continuum from ‘decriminalised’ to ‘punitive’.CrossRef |



Export Citation Cited By (1)

View Altmetrics