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Table 1 Current legal status of Cannabis and CBMs in selected countries

From: Cannabis-based medicines and the perioperative physician

Continent

Country

Year approved

Notes

North America

America (United Nations Office on Drugs and Crime 2019; Mead 2017; US Food and Drug Administration 2016; Aguilar et al. 2018)

1996-2017

Cannabis illegal under federal law, individual states have legalised to varying degrees

Medical use:

-Legalised by 33 states

-FDA has approved dronabinol (Marinol ®, Syndros® ), nabilone (Cesamet ®,) and cannabidiol (Epidiolex ®) (CBMs) for specific indications, but cannabis plant not FDA approved

Recreational use:

-Legalised by 10 states (Alaska, California, Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont, Washington) and District of Colombia for recreational use

-Illinois to be legalised January 1 2020

-Multiple states have bills in session to legalise recreational and medicinal cannabis and its products

-“Decriminalised” in numerous states (ie avoid jail term)

Canada (United Nations Office on Drugs and Crime 2019; Aguilar et al. 2018; Government of Canada 2018b; Health Canada 2018)

1999/2018

Medical use:

-Regulated by federal government

-Healthcare practitioner authorisation required

-Patients can access cannabis through federally licensed seller, designate someone to produce, or grow their own.

Recreational use:

-Cannabis for recreation legalised October 2018 under Cannabis Act

-Cannabis act permits sale of cannabis oil, fresh cannabis, dried cannabis, cannabis plants and seeds

-Retailers must be authorised to sell cannabis

Mexico (Aguilar et al. 2018; Government of Mexico 2018a; Government of Mexico 2018b; Government of Mexico 2018c)

2017

Medical use:

Cannabis use allowed for medical and scientific purposes

Application required for import and use of cannabis and CBMs for medical purposes

Products with < 1% THC recently marketed under Government authorisation with no prescription required

South America

Uruguay (United Nations Office on Drugs and Crime 2019; Aguilar et al. 2018; Uruguay Government 2018)

2013

Medical use:

-Prescription required for CBM for medicinal use

-Medicinal cannabis not authorised to be sold

-CMs accessible via specialist prescription

Recreational Use:

-Cannabis legalised and market regulated from December 2013 with strict controls

Chile (Aguilar et al. 2018)

2015

Medical use:

-Medical prescription required for medicinal cannabis

-CBM can be imported under special license

Brazil (Aguilar et al. 2018; Brazilian Government 2016)

2014

Medical use:

-Imports of medications based on CBD oil for medical and therapeutic use for patients with prescription allowed

-Nabiximols (Sativex ®) licensed for MS

-Cannabis plant prescription prohibited

Argentina (Aguilar et al. 2018; Argentinian government 2018; Government of Argentina 2019)

2017

Medical use:

-Prescription and government authorisation required through ministry of health

-State produced pharmaceuticals for domestic market

-Cannabis oils legal for import

Oceania

Australia (Aguilar et al. 2018; Australian Government Department of Health 2018; Therapeutic Goods Administration 2017)

2016

Medical use:

-cultivation, manufacture, prescribing and dispensing of medicinal cannabis products for patients now legal

-Access via authorised prescriber program, or special access scheme on individual patient basis. Must be prescribed

-Cannabis, THC, nabiximols (Sativex ®), dronabinol (Marinol ®), nabilone (Cesamet ®, Canemes ®) listed under schedule 8, require prescription

-Cannabidiol listed under schedule 4, requires prescription

New Zealand (Aguilar et al. 2018; New Zealand Parliament 2018; New Zealand Ministry of Health 2018)

1977

Medical use:

-Prescription required for most cannabis-based products, some require ministerial approval

-Nabiximols (Sativex ®)and CBD based products available without ministerial approval

-Bill currently passing through NZ parliament to improve access

Europe

Netherlands (Aguilar et al. 2018; Office of Medicinal Cannabis 2018; Government of the Netherlands 2019; Office of Medicinal Cannabis Government of the Netherlands 2019)

2000

Medical use:

-Medicinal use legalised in 2000

-Office of Medicinal Cannabis government agency responsible for supplying medicinal cannabis to pharmacies, prescription required

-5 compositions produced, with varying strengths of THC and CBD

Recreational use:

-Illegal, but smoking cannabis under strict conditions allowed

Germany (Aguilar et al. 2018; Broich 2018)

2017

Medical use:

-Medicinal cannabis products able to be prescribed by physician

-CBMs included in range of medications covered by public and private health insurance

Poland (Aguilar et al. 2018)

2017

Medical use:

-Medicinal cannabis sold in registered pharmacies.

-Patients need permission from pharmaceutical inspector and physician

France (Aguilar et al. 2018; National Agency for the Safety of Medicines and Health Products 2013)

2013

Medical use:

-Law changed to allow marketing authorisation of products containing cannabis or its derivatives

-Dronabinol (Marinol ®) approved and marketed

-Nabiximols (Sativex ®) approved but not marketed due to price disagreements

Ireland (Aguilar et al. 2018; Department of Health Ireland 2018; Health Products Regualtory Authority 2017)

 

Medical use:

-Cannabis for medical use access programme enables prescribing of Cannabis for medical use by Medical Consultant

-Authorised CBMs (nabiximols (Sativex ®) , dronabinol (Marinol ®), nabilone (Cesamet ®, Canemes ®) should be used in first instance with prescription

-Cannabis (plant or extracts not authorised as medicine) considered as treatment option

-Cannabidiol (Epidiolex ®) not currently authorised

 

UK (National Institute for Health and Care Excellence 2019; Dame Sally Davies 2018; National Health Service 2019)

2018

Medical use:

-CBMs recently rescheduled, only available via prescription from doctor on the specialist register

-Nabilone and Nabiximols (Sativex ®) currently licensed but the latter is not approved by NICE

-Dronabinol not available as a licensed medicine

-Cannabidiol not classed as CBM, and not controlled. Epidiolex® currently in licensing process.

-NICE draft guidance for prescription of CBMs currently open for public consultation

Middle East

Israel (Aguilar et al. 2018)

1992

Medical use:

-Medical Cannabis Unit established for the regulation of Cannabis

-Specialist physicians apply for Medical Cannabis permit on behalf of patient

- > 40,000 patients receiving medicinal cannabis

Asia

Japan (Aguilar et al. 2018)

 

Prohibited

Pakistan (Aguilar et al. 2018)

 

Prohibited

Philippines (Aguilar et al. 2018; Republic of Phillipines House of Representatives 2018)

2016

Medical use:

-Cannabis allowed with prior authorisation from a doctor and treatment delivered in dedicated centres

-Covers all forms of Cannabis, no specific mention CBMs

India (Aguilar et al. 2018; Indian Council of Medical Research 2018)

 

Medical use:

-Legal provisions for medicinal use yet to be implemented

-Council of Scientific and industrial research currently undertaking research into medical benefits

Africa

South Africa (Department of Agriculture, Forestry and Fisheries 2018; Constitutional Court of South Africa 2017; Medicines Control Council 2016)

2018

Medical use:

-Special authorisation from Medical Control Council by physician can be requested for prescription of medicinal cannabis products

-Cannabidiol preparations excluded from Medicines and related substances act