UK

The UN Single Convention on Narcotic Drugs (1961, amended 1972) classifies cannabis and its derivatives as a narcotic drug.¹ The UK and EU member states are required to have measures in place to control narcotics. However, national regulations vary depending on the type of cannabis-based product in question, based on the risk of exposure to narcotic substances and therefore risk to public health.

Regulatory approved cannabis-based medicines

In the UK, cannabis-based medicines are prescription-only medicines, and can only be prescribed by a specialist for the indications that particular medicine is licensed for through the Medicines and Healthcare products Regulatory Agency (MHRA).^2,3 They are classified as ‘controlled drugs’ and are allocated into one of five schedules according to their potential for medical use and risk of abuse.⁴ This scheduling is in place to protect public health.

Non-regulatory approved cannabis-based products

These products are called unlicensed ‘cannabis-based products for medicinal use in humans’ (CBPMs).⁵ In November 2018, CBPMs were reclassified from Schedule 1 to Schedule 2, and therefore became legal with a prescription.⁵ They can only be prescribed by a specialist doctor as an unlicensed ‘special’, and must only be supplied to meet the special clinical need of an individual where no other licensed options are suitable.⁵ One aim of this rescheduling was to facilitate clinical research into CBPMs.⁶

CBD-containing consumer/food products

These are available for purchase in shops and online.⁷ These products are not medicines, and any claims about medical benefits should not be made unless they have been authorised by government bodies.^7,8

CBD itself is not subject to controlled drugs regulations, however the Home Office considers products containing CBD as controlled drugs (Schedule 1) due to the potential for contamination with other cannabinoids (e.g. THC).⁸ This is because it is technically difficult to remove other cannabinoids during manufacturing. To be exempt from these regulations, such products may only contain a maximum of 1 mg of controlled cannabinoids (including THC, ^Δ8THC, THCV and CBN) per bottle or pack.⁸

Ingestible CBD products are classed as ‘novel foods’. Those already on the market must have a ‘validated’ novel food application (as of March 2021).⁹ Cosmetic products fall under separate cosmetics regulations; CBD is a listed authorised ingredient.^10–12 Under UK regulations that involve the MHRA, it is prohibited to give the impression that e-cigarettes and vaping products containing CBD alongside nicotine provide any health benefit.¹³

Recreational cannabis

In the UK, recreational cannabis is a Class B drug and is illegal. Possession can result in 5 years in prison, an unlimited fine, or both. Supplying can result in 14 years in prison, an unlimited fine, or both. Unlike other Class B drugs, cannabis comes under the discretionary warning scheme, whereby a police officer can choose to issue a street warning only in cases where an individual is caught with only a small amount of cannabis for personal use, has no previous record of offence and behaves compliantly.¹⁴

CBD, cannabidiol; CBN, cannabinol; ^Δ8THC, delta-8-tetrahydrocannabinol; THC, delta-9-tetrahydrocannabinol; THCV, delta-9-tetrahydrocannabivarin

References:

1. European Monitoring Centre for Drugs and Drug Addiction. Classification of controlled drugs. Available at: https://www.emcdda.europa.eu/publications/topic-overviews/classification-of-controlled-drugs/html_en. Accessed February 2022
2. National Institute for Health and Care Excellence (NICE). Cannabis-based medicinal products. NICE guideline [NG144]. 2019. Available at: https://www.nice.org.uk/guidance/ng144. Accessed February 2022
3. Medicines and Healthcare products Regulatory Agency. Medicines: reclassify your product. May 2021. Available at: https://www.gov.uk/guidance/medicines-reclassify-your-product. Accessed February 2022
4. Release. Schedules. 2020. Available at: https://www.release.org.uk/law/schedules. Accessed February 2022
5. Medicines and Healthcare products Regulatory Agency. The supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans ‘specials’. March 2020. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/869284/Cannabis_Guidance__unlicensed_CBPMs__updated_2020.pdf. Accessed February 2022
6. NHS England and NHS Improvement. Barriers to accessing cannabis-based products for medicinal use on NHS prescription. August 2019. Available at: https://www.england.nhs.uk/publication/barriers-to-accessing-cannabis-based-products-for-medicinal-use-on-nhs-prescription/. Accessed February 2022
7. European Monitoring Centre for Drugs and Drug Addiction. Low-THC cannabis products in Europe. December 2020. Available at: https://www.emcdda.europa.eu/publications/ad-hoc-publication/low-thc-cannabis-products-europe_en. Accessed February 2022
8. Home Office. Cannabis, CBD and other cannabinoids: drug licensing factsheet. June 2020. Available at: https://www.gov.uk/government/publications/cannabis-cbd-and-other-cannabinoids-drug-licensing-factsheet. Accessed February 2022
9. Food Standards Agency. Deadline for CBD novel food applications approaching. January 2021. Available at: https://www.food.gov.uk/news-alerts/news/deadline-for-cbd-novel-food-applications-approaching. Accessed February 2022
10. The European Parliament and the Council of the European Union. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Official Journal of the European Union 2009. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32009R1223&from=EN. Accessed February 2022
11. European Commission. Ingredient: Cannabidiol – synthetically produced. Cosmetic ingredient database (CosIng). Available at: https://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.details_v2&id=93486. Accessed February 2022
12. European Commission. Ingredient: Cannabidiol – derived from extract or tincture or resin of cannabis. Cosmetic ingredient database (CosIng). Available at: https://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.details_v2&id=96287. Accessed February 2022
13. Home Office. E-cigarettes: regulations for consumer products. Available at: https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products. Accessed February 2022
14. FRANK. Cannabis. Available at: https://www.talktofrank.com/drug/cannabis#how-do-people-take-it. Accessed February 2022

Germany

EU member states and the UK are required to have measures in place to control narcotics; however, national regulations vary by country and depending on the type of cannabis‑based product.

• In Germany, controlled substances are listed in the German Narcotic Drugs Act, known as the Betäubungsmittelgesetz (or BtMG)^1,2
• Cannabis is listed in Annexe I of the BtMG, which includes narcotics that are not eligible for trade and which are non-prescribable^1,2
• Cannabis for medical purposes is listed in Annexe III of the BtMG, which includes narcotics that are eligible for trade and are available on a special prescription^1,2

Regulatory approved cannabis-based medicines

• Physicians of any specialty can prescribe cannabis-based medicines with marketing authorisation, per Annexe III of the BtMG^1,2

Non-regulatory approved cannabis-based products

• Physicians of any specialty can prescribe medicinal pharmaceutical-grade cannabis extract or cannabis flowers, per Annexe III of the BtMG^1,3,4
• Medicinal cannabis products can be prescribed for any serious indication,⁴ so long as:³
  • There are no other drugs available to treat the disease or symptoms
  • A noticeably positive effect on disease course or severe symptoms is expected

CBD-containing consumer/food products

• Consistent with EU law,CBD-containing consumer/food products are considered ‘novel foods’ (they can be plant based or products enriched with CBD); this means they can only be marketed if authorised by the European Commission^5–7

• It is important to note that some consumer products derived from hemp pre-date the Novel Foods Act (1997),⁵ and therefore not all edible products should be considered ‘novel foods’⁸

• In Germany there are currently no cases in which CBD is marketable in food and dietary supplements (i.e. no approved marketing authorisations),⁷ but there is ongoing confusion around their sale, with no coordinated national approach⁹

• In some federal states, sometimes (e.g. due to a lack of enforcement or avoidance tactics like re-labelling as a non-food product) consumers are able to purchase a range of CBD products from various retail outlets^10–12
• In other states, their sale is banned in certain cities and municpalities¹⁰

• CBD can be used in cosmetics if the product complies with EU Cosmetics Regulations,^13–15 contains less than 0.2% THC, and can’t be easily ingested¹⁶

Recreational cannabis

• Possession of cannabis that is not for medical purposes may result in a fine or prison sentence of up to 5 years,² withpolice or prosecutors directed to use non‑custodial penalties or powers of dismissalfor minor ‘personal use’ offences^2,17

CBD, cannabidiol; THC, delta-9-tetrahydrocannabinol

References:

1. European Monitoring Centre for Drugs and Drug Addiction Drugs. Legal framework. GERMANY 2018 Report of the National REITOX Focal Point to the EMCDDA (Data year 2017 / 2018). Available at: https://www.dbdd.de/fileadmin/user_upload_dbdd/05_Publikationen/PDFs/REITOX_BERICHT_2018/REITOX_BERICHT_2018_ENG/02_Legal_Framework_2018_eng.pdf. Accessed February 2022
2. European Monitoring Centre for Drugs and Drug Addiction. Penalties for drug law offences in Europe at a glance. 2019. Available at: https://www.emcdda.europa.eu/publications/topic-overviews/content/drug-law-penalties-at-a-glance. Accessed February 2022
3. Federal Institute for Drugs and Medical Devices. Annual Report 2017 | 2018. 2018. Available at: https://www.bfarm.de/SharedDocs/Downloads/EN/BfArM/Publikationen/AnnualReport2017-18.pdf?__blob=publicationFile. Accessed February 2022
4. European Monitoring Centre for Drugs and Drug Addiction. Medical use of cannabis and cannabinoids: Questions and answers for policymaking. 2018. Available at: https://www.emcdda.europa.eu/system/files/publications/10171/20185584_TD0618186ENN_PDF.pdf. Accessed February 2022
5. European Commission. Novel food. Available at: https://ec.europa.eu/food/safety/novel-food_en. Accessed February 2022
6. European Commission. EU Novel Food Catalogue online (‘cannabinoids’ entry). Available at: https://ec.europa.eu/food/safety/novel_food/catalogue/search/public/index.cfm?ascii=Cannabinoids#. Accessed February 2022
7. Bundesamt für Verbraucherschutz und Lebensmittelsicherheit. Sind Nahrungsergänzungsmittel mit Cannabidiol (CBD) (CBD) verkehrsfähig? Available at: https://www.bvl.bund.de/SharedDocs/FAQ/DE/02_Unternehmer/01_Lebensmittel/03_FAQ_Hanf_THC_CBD/00_FAQ_Cannabidiol_CBD.html. Accessed February 2022
8. Bundesamt für Verbraucherschutz und Lebensmittelsicherheit. Ist das Cannabis-Produkt ein neuartiges Lebensmittel? Available at: https://www.bvl.bund.de/SharedDocs/FAQ/DE/02_Unternehmer/01_Lebensmittel/03_FAQ_Hanf_THC_CBD/03_FAQ_Cannabidiol_CBD.html. Accessed February 2022
9. Verbraucherzentrale. Vorsicht bei Lebensmitteln mit dem Hanf-Inhaltsstoff Cannabidiol (CBD). 2020. Available at: https://www.verbraucherzentrale.de/wissen/lebensmittel/nahrungsergaenzungsmittel/vorsicht-bei-lebensmitteln-mit-dem-hanfinhaltsstoff-cannabidiol-cbd-43455. Accessed February 2022
10. Verbraucherzentrale. CBD-Öl legal auf dem Markt? Available at: https://www.verbraucherzentrale.de/wissen/lebensmittel/nahrungsergaenzungsmittel/cbdoel-legal-auf-dem-markt-37660.  Accessed February 2022
11. McGregor et al. Int J Drug Policy 2020;85:102935.
12. European Monitoring Centre for Drugs and Drug Addiction. Low-THC cannabis products in Europe. 2020. Available at: https://www.emcdda.europa.eu/publications/ad-hoc-publication/low-thc-cannabis-products-europe_en. Accessed February 2022
13. The European Parliament and the Council of the European Union. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Official Journal of the European Union. 2009. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32009R1223&from=EN. Accessed February 2022
14. European Commission. Ingredient: Cannabidiol – synthetically produced. Cosmetic ingredient database (CosIng). Available at: https://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.details_v2&id=93486. Accessed February 2022
15. European Commission. Ingredient: Cannabidiol – derived from extract or tincture or resin of cannabis. Cosmetic ingredient database (CosIng). Available at: https://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.details_v2&id=96287. Accessed February 2022
16. Bundesinstitut für Arzneimittel und Medizinprodukte. Betäubungsmittel: Häufig gestellte Fragen. Available at: https://www.bfarm.de/DE/Bundesopiumstelle/_FAQ/Cannabis/faq-liste.html?cms_fid=566334. Accessed February 2022
17. European Monitoring Centre for Drugs and Drug Addiction. Cannabis legislation in Europe: An overview. 2018. Available at: https://www.emcdda.europa.eu/system/files/publications/4135/TD0217210ENN.pdf. Accessed February 2022

Spain

EU member states and the UK are required to have measures in place to control narcotics; however, national regulations vary by country and depending on the type of cannabis‑based product.

• Spain has specific legislation that establishes that drug schedules are determined by the UN Single Convention on Narcotic Drugs (1961, amended 1971)^1–3
• Consistent with the 1961 convention, cannabis is listed as a Schedule I narcotic (subject to very strict control)^1,3

Regulatory approved cannabis-based medicines

• Regulatory approved cannabis-based medicines are available on prescription for their licensed indication^4,5
• They are categorised as ‘Diagnóstico hospitalario’,^4,5 meaning they can only be used in patients who have been diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, or by particular specialists⁶

Non-regulatory approved cannabis-based products

• The use of non-regulatory approved cannabis-based products for medical purposes is not legal, and there is no clear regulatory framework in this setting⁷
• Access to medicinal cannabis may be possible via Cannabis Social Clubs,^7,8 but the legality of these organisations has been disputed^7,9–13

CBD-containing consumer/food products

• Consistent with EU law,¹⁴ CBD-containing food products are considered ‘novel foods’; this means they can only be marketed if authorised by the European Commission¹⁵
• Although there are currently no examples where CBD is marketable in food,¹⁶ Spanish regulations make a distinction for products, including CBD oils and sweets, derived from hemp kernels (i.e. seeds not intended for sowing)
  • The hemp kernels must be from plant varieties with a THC content of ≤0.2%^17,18
  • Such ingredients are not considered novel foods per EU law since they have ‘a history of safe and significant consumption’^17,18
• CBD can be used as an active ingredient in cosmetics if the product complies with EU Cosmetics Regulation^19–21 and Spanish law,²² and is for external use¹⁹

Recreational cannabis

• Cannabis is decriminalised for personal cultivation, possession, and use, so long as this does not occur in a public place²
• Possession or consumption of cannabis in public places is punishable by a fine,while supply is punishable by imprisonment (typically 1–3 years)²

CBD, cannabidiol; THC, delta-9-tetrahydrocannabinol

References:

1. United Nations. Schedules of the Single Convention on Narcotic Drugs of 1961. 2021. Available at: https://www.unodc.org/pdf/convention_1961_en.pdf. Accessed February 2022
2. European Monitoring Centre for Drugs and Drug Addiction. Penalties for drug law offences in Europe at a glance. 2019. Available at: https://www.emcdda.europa.eu/publications/topic-overviews/content/drug-law-penalties-at-a-glance. Accessed February 2022
3. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Estupefacientes y Psicótropos. Available at: https://www.aemps.gob.es/medicamentos-de-uso-humano/estupefacientes-y-psicotropos/. Accessed February 2022
4. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Medicine Online Information Center (CIMA). SATIVEX 2,7 MG/2,5 MG SOLUCION PARA PULVERIZACION BUCAL. Available at: https://cima.aemps.es/cima/publico/detalle.html?nregistro=72544. Accessed February 2022
5. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Medicine Online Information Center (CIMA). EPIDYOLEX 100 MG/ML SOLUCION ORAL. Available at: https://cima.aemps.es/cima/publico/detalle.html?nregistro=1191389001. Accessed February 2022
6. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Medicine Online Information Center (CIMA). Glossary. Available at: https://cima.aemps.es/cima/publico/glosario.html. Accessed February 2022
7. Arana X, The Transnational Institute. Cannabis Regulation in Europe: Country Report Spain. 2019. Available at: https://www.tni.org/en/publication/cannabis-regulation-in-europe-country-report-spain. Accessed February 2022
8. Decorte et al. Int J Drug Policy 2017;43:44–56.
9. Ley 13/2017, de 6 de julio, de las asociaciones de consumidores de cannabis. 2018. Available at: https://www.boe.es/buscar/act.php?id=BOE-A-2017-9367. Accessed February 2022
10. Ley 1/2016, de 7 de abril, de Atención Integral de Adicciones y Drogodependencias. 2016. Available at: https://boe.es/diario_boe/txt.php?id=BOE-A-2016-4170. Accessed February 2022
11. Ley Foral 24/2014, de 2 de diciembre, reguladora de los colectivos de usuarios de cannabis en Navarra. 2018. Available at: https://www.boe.es/buscar/act.php?id=BOE-A-2014-13626. Accessed February 2022
12. Tribunal Constitucional, Sentencia 144/2017, de 14 de diciembre de 2017. 2018. Available at: https://hj.tribunalconstitucional.es/HJ/docs/BOE/BOE-A-2018-606.pdf. Accessed February 2022
13. Tribunal Constitucional, Sentencia 100/2018, de 19 de septiembre de 2018. 2018. Available at: http://hj.tribunalconstitucional.es/docs/BOE/BOE-A-2018-13998.pdf. Accessed February 2022
14. European Commission. EU Novel food catalogue. Cannabinoids. Available at: https://ec.europa.eu/food/safety/novel_food/catalogue/search/public/index.cfm. Accessed February 2022
15. Agencia Española de Seguridad Alimentaria y Nutrición. Uso del cáñamo y cannabinoides en alimentación. 2019. Available at: http://www.aecosan.msssi.gob.es/AECOSAN/docs/documentos/noticias/2019/CANIAMO_CANNABINOIDES_ALIMENTACION.pdf. Accessed February 2022
16. Agencia Española de Seguridad Alimentaria y Nutrición. Tabla Resumen de los Nuevos Alimentos Autorizados Para la Elaboracion de Complementos Alimenticios. 2021. Available at: https://www.aesan.gob.es/AECOSAN/docs/documentos/seguridad_alimentaria/gestion_riesgos/TABLA_RESUMEN_NUEVOS_ALIMENTOS_AUTORIZADOS_CA.pdf. Accessed February 2022
17. European Commission. EU Novel food catalogue. Cannabis sativa L. Available at: https://ec.europa.eu/food/safety/novel_food/catalogue/search/public/index.cfm. Accessed February 2022
18. Ministerio de Agricultura, Pesca y Alimentación. Nota Informativa Sobre el Cultivo del Cáñamo. Available at: https://www.mapa.gob.es/es/agricultura/temas/producciones-agricolas/notainformativasobreelcultivodecanamo_tcm30-560351.pdf. Accessed February 2022
19. The European Parliament and the Council of the European Union. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Official Journal of the European Union 2009. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32009R1223&from=EN. Accessed February 2022
20. European Commission. Ingredient: Cannabidiol – synthetically produced. Cosmetic ingredient database (CosIng). Available at: https://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.details_v2&id=93486. Accessed February 2022
21. European Commission. Ingredient: Cannabidiol – derived from extract or tincture or resin of cannabis. Cosmetic ingredient database (CosIng). Available at: https://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.details_v2&id=96287. Accessed February 2022
22. Real Decreto 85/2018, de 23 de febrero, por el que se regulan los productos cosméticos. 2018. Available at: https://boe.gob.es/boe/dias/2018/02/27/pdfs/BOE-A-2018-2693.pdf. Accessed February 2022

France

EU member states and the UK are required to have measures in place to control narcotics; however, national regulations vary by country and depending on the type of cannabis-based product.

• In France, cannabis is a List I narcotic substance, along with heroin and cocaine¹

Regulatory approved cannabis-based medicines

• Regulatory approved cannabis-based medicines need a marketing authorisation (European and/or national), and in France, medicines awaiting a decision on their reimbursement by the health insurance system may be available via special access schemes (i.e. Autorisation d’accès précoce [AAP], autorisation d’accès compassionnel [AAC] or cadre de prescription compassionnelle [CPC])^2,3

Non-regulatory approved cannabis-based products

• The use of cannabis, including in a therapeutic capacity, is currently prohibited⁴
• In December 2018, a multidisciplinary scientific committee called for medical cannabis ‘experimentation’ to be established⁵
  • The experiment, which will include 3000 selected volunteers, was initiated in March 2021 and will run for 2 years⁶
  • Participants must be referred by physicians who specialise in the indications that have been chosen for inclusion⁴
  • Cannabis formulations will include cannabis flowering tops for inhalation (i.e. vaporisation) and orally administered oils⁵

CBD-containing consumer/food products

• CBD-containing consumer/food products are available for sale under strict conditions⁷
• This covers the fibres and seeds of specific varieties of cannabis, provided the THC content is <0.2% as quantified by gas chromatography following extraction with a suitable solvent⁷

Recreational cannabis

• Possession and use of cannabis are criminal offences, punishable by imprisonment and a fine;^1,8 however, police or prosecutors are directed to use non-custodial penalties or powers of dismissal for minor personal use offences⁸
• Supply of cannabis is punishable by imprisonment¹

CBD, cannabidiol; THC, delta-9-tetrahydrocannabinol

References:

1. European Monitoring Centre for Drugs and Drug Addiction. Penalties for drug law offences in Europe at a glance. 2019. Available at: https://www.emcdda.europa.eu/publications/topic-overviews/content/drug-law-penalties-at-a-glance. Accessed February 2022
2. Ministère des Solidarités et de la Santé. Autorisation d’accès précoce, autorisation d’accès compassionnel et cadre de prescription compassionnelle. 2021. Available at: https://solidarites-sante.gouv.fr/soins-et-maladies/medicaments/professionnels-de-sante/autorisation-de-mise-sur-le-marche/article/autorisation-d-acces-precoce-autorisation-d-acces-compassionnel-et-cadre-de. Accessed February 2022
3. Agence nationale de sécurité du médicament et des produits de santé (ANSM). Demande d'autorisation d’accès précoce. 2021. Available at: https://ansm.sante.fr/vos-demarches/industriel/demande-dautorisation-dacces-precoce. Accessed February 2022
4. Agence nationale de sécurité du médicament et des produits de santé (ANSM). Nous répondons à vos questions sur le cannabis médical. 2021. Available at: https://ansm.sante.fr/dossiers-thematiques/cannabis-a-usage-medical/nous-repondons-a-vos-questions-sur-le-cannabis-medical. Accessed February 2022
5. Agence nationale de sécurité du médicament et des produits de santé (ANSM). Cadre et mise en oeuvre de l'expérimentation du cannabis médical. 2021. Available at: https://ansm.sante.fr/dossiers-thematiques/cannabis-a-usage-medical/cadre-et-mise-en-oeuvre-de-lexperimentation-du-cannabis-medical. Accessed February 2022
6. Agence nationale de sécurité du médicament et des produits de santé (ANSM). L’expérimentation du cannabis médical en bref. Available at: https://ansm.sante.fr/uploads/2021/03/16/infographie-cadre-general.pdf. Accessed February 2022
7. Légifrance. Arrêté du 22 août 1990 portant application de l'article R. 5132-86 du code de la santé publique pour le cannabis. 2021. Available at: https://www.legifrance.gouv.fr/loda/id/JORFTEXT000000351447/. Accessed February 2022
8. European Monitoring Centre for Drugs and Drug Addiction. Cannabis legislation in Europe: An overview. 2018. Available at: https://www.emcdda.europa.eu/system/files/publications/4135/TD0217210ENN.pdf. Accessed February 2022

Italy

EU member states and the UK are required to have measures in place to control narcotics; however, national regulations vary by country and depending on the type of cannabis-based product.

• In Italy, the use of cannabis-based products is regulated according to national legislation known as Presidential Decree n.309 of 1990¹
• This consolidated law covers the cultivation, production, trade and use of narcotics and other psychoactive substances¹

Regulatory approved cannabis-based medicines

• Regulatory approved cannabis-based medicines are available on prescription for their licensed indications; these are classified as Class H (to be dispensed at a hospital)or Class A-PHT (to be directly distributed through territorial pharmacies or public health facilities)^2–4

Non-regulatory approved cannabis-based products

• Medical use of non-regulatory approved cannabis preparations is legal on a
  non-repeatable prescription for specific conditions^5,6
  • Prescription has been possible since 2013,⁷ per the provisions of Law n.94 of 1998 relating to off-label use of drugs⁸
  • Medical cannabis can be prescribed as an adjunct to standard treatments to relieve symptoms for which traditional therapies have failed⁶
  • Physicians of any specialty can prescribe cannabis for medical use for individual patients⁵
  • Magistral preparations can be made in any pharmacy and must be administered either orally (i.e. by infusion or in oil) or by inhalation (but not by smoking)⁵

CBD-containing consumer/food products

• CBD-containing products are available for purchase at various outlets, and include oils, leaves, extracts, food and beverages⁹
• The sale of these products followed changes in legislation in 2016 that were intended to assist hemp farmers, but which, by virtue of a broad interpretation, have unintentionally encouraged the large-scale marketing of cannabis-based products with ≤0.6% THC,* e.g. online and in ‘cannabis light’ shops^9–11

*While 0.2% remains the legal THC limit, 0.6% is the tolerated limit following an audit of hemp crops¹¹

Recreational cannabis

• Possession of small quantities of cannabis for personal use is a non-criminal offence punishable by administrative sanctions (e.g. suspension of driving licence);¹²the law does not typically allow for imprisonment in this setting
• The supply of drugs, including cannabis, is punishable by imprisonment and a fine¹²

CBD, cannabidiol; THC, delta-9-tetrahydrocannabinol

References:

1. Mario Di Luca et al. Ann Ist Super Sanita 2020;56:76–89
2. Italian Medicines Agency. Lists of Class A and Class H medicinal products. Available at: https://www.aifa.gov.it/en/liste-farmaci-a-h. Accessed February 2022
3. World Health Organization. Italy: European Region. 2017. Available at: https://www.who.int/health-laws/countries/ita-en.pdf. Accessed February 2022
4. Garattini et al. Expert Rev Pharmacoecon Outcomes Res 2016;16:331–2
5. European Monitoring Centre for Drugs and Drug Addiction. Medical use of cannabis and cannabinoids: Questions and answers for policymaking. 2018. Available at: https://www.emcdda.europa.eu/system/files/publications/10171/20185584_TD0618186ENN_PDF.pdf. Accessed February 2022
6. European Monitoring Centre for Drugs and Drug Addiction. Cannabis legislation in Europe: An overview. 2018. Available at: https://www.emcdda.europa.eu/system/files/publications/4135/TD0217210ENN.pdf. Accessed February 2022
7. Gazzetta Ufficiale Della Repubblica Italiana, Venerdì, 8 febbraio 2013. DECRETO 23 gennaio 2013. Available at: http://www.gazzettaufficiale.it/eli/gu/2013/02/08/33/sg/pdf. Accessed February 2022
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