Current legislation on medical cannabis in the European Union: historical background, movements, trends, and counter-trends lessons for Brazil
Legislação atual sobre cannabis medicinal na União Europeia: históricos, movimentos, tendências e contratendências. Lições para o Brasil
Ricardo Ferreira de Oliveira e Silva; Emilio Nabas Figueiredo
Abstract
Keywords
Resumo
JUSTIFICATIVA E OBJETIVOS: O crescente interesse no uso medicinal da cannabis e fitocanabinoides tem levado os países da União Europeia (UE) a regulamentarem a produção e acesso a produtos canábicos para seus cidadãos. Esta regulamentação se baseia em convenções internacionais, orientações da Agência Europeia de Medicamentos (EMA) e brechas legais que concedem autonomia aos países-membros da UE para autorizar a produção e comercialização de fármacos e alimentos à base de cannabis. Este estudo teve o objetivo de apresentar a situação atual da legislação sobre cannabis medicinal na UE, destacando a autorização de fármacos, os processos de regulamentação e a autonomia dos estados-membros na produção de fórmulas magistrais.
CONTEÚDO: A maioria dos países da UE permite, de alguma forma, o uso legal da cannabis e seus derivados como fármaco. Desde 2019, três fármacos contendo nabiximols, dronabinol ou nabilona foram autorizados nos mercados dos estados-membros da UE. Além do procedimento centralizado da EMA para a autorização de comercialização, os produtos à base de canabinoides também podem ser autorizados por meio de processos regionais ou nacionais dos países da UE. Essa autonomia se estende à produção de fórmulas magistrais em farmácias de manipulação, permitindo que os farmacêuticos preparem fórmulas contendo cannabis para uso de acordo com prescrição médica específica e, em algumas situações, em escala.
CONCLUSÃO: Embora não seja possível concluir qual é a abordagem ideal para a regulamentação da cannabis medicinal que deve ser adotada por todos os países, a experiência da UE fornece lições valiosas. A autonomia concedida aos estados-membros permite a ampliação do uso medicinal da cannabis por meio da autorização de fármacos e da produção de fórmulas magistrais. Essas experiências podem ser utilizadas como base para reformulações na regulamentação brasileira, visando ampliar o acesso e uso medicinal da cannabis no país.
Palavras-chave
References
1 European Monitoring Centre for Drugs and Drug Addiction. Medical use of cannabis and cannabinoids: questions and answers for policymaking. Luxembourg: Publications Office of the European Union; 2018.
2 Congressional Research Service. Report R44742. Defining Hemp A Fact Sheet. 2019.
3 Zuardi AW. History of cannabis as a medicine: a review. Braz J Psychiatry. 2006;28(2):153-7.
4 Abuhasira R, Shbiro L, Landschaft Y. Medical use of cannabis and cannabinoids containing products - Regulations in Europe and North America. Eur J Intern Med. 2018;49(1):2-6.
5 Schurman LD, Lu D, Kendall DA, Howlett AC, Lichtman AH. Molecular mechanism and cannabinoid pharmacology. Handb Exp Pharmacol. 2020;258:323-53.
6 Lowe H, Toyang N, Steele B, Bryant J, Ngwa W. The endocannabinoid system: a potential target for the treatment of various diseases. Int J Mol Sci. 2021;22(17):9472.
7 N, Steele B, Bryant J, Ngwa W. The endocannabinoid system: a potential target for the treatment of various diseases. Int J Mol Sci. 2021;22(17):9472.
8 Di Marzo V, Piscitelli F. The Endocannabinoid system and its modulation by phytocannabinoids. Neurotherapeutics. 2015;12(4):692-8.
9 Rock EM, Parker LA. Constituents of Cannabis Sativa. Adv Exp Med Biol. 2021;1264:1-13.
10 Pertwee RG. Targeting the endocannabinoid system with cannabinoid receptor agonists: pharmacological strategies and therapeutic possibilities. Philos Trans R Soc Lond B Biol Sci. 2012;367(1607):3353-63.
11 Tsang CC, Giudice MG. Nabilone for the management of pain. Pharmacotherapy. 2016;36(3):273-86.
12 Castaneto MS, Gorelick DA, Desrosiers NA, Hartman RL, Pirard S, Huestis MA. Synthetic cannabinoids: epidemiology, pharmacodynamics, and clinical implications. Drug Alcohol Depend. 2014;144:12-41.
13 Aizpurua-Olaizola O, Elezgarai I, Rico-Barrio I, Zarandona I, Etxebarria N, Usobiaga A. Targeting the endocannabinoid system: future therapeutic strategies. Drug Discov Today. 2017;22(1):105-110.
14 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
15 European Medicines Agency. Orphan designation: Cannabidiol for: the treatment of Dravet syndrome. 2019.
16 European Medicines Agency. Epidyolex. EPAR. 2019.
17 Electronic Medicines Compendium (EMC). Sativex Oromucosal Spray. SmPC. 2018.
18 Danish Medicines Agency. Medicinal use of Cannabis, 3rd ed. Copenhagen: Medicines Control & Inspection;; 2015
19 Cesamet. 2020. Drugs.com
20 Álvares M. After legalisation, what next for medical cannabis in Portugal? Health Europa. 2020.
21 Státní agentura pro konopí pro léčebné použití (SAKL). 236/2015 Coll. Decree of 4 September 2015 stipulating the conditions of prescribing, preparation, distribution, dispensing, and use of magistral formulas containing medical cannabis.
22 Federal Institute for Drugs and Medical Devices. Annual Report 2017/2018. Bonn: Federal Institute for Drugs and Medical Devices; 2018.
23 Office of Medicinal Cannabis. Medicinal cannabis. The Hague: Institute for Responsible Medicine Use and the Office of Medicinal Cannabis of the CIBG; 2011.
24 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001.
25 Zakon o lekarniški dejavnosti [Pharmacy Practice Act, in Slovenian] Uradni list RS, št. 2020;85(16)
26 Čufar A. Regulatorni vidik predpisovanja kanabinoidov [Prescribing of cannabinoids - a regulatory view, in Slovenian] Farm Vestn. 2016;67:91-6..
27 Partners P, The European Cannabis Report Edition 4. January. 2019.
28 Krcevski-Skvarc N, Wells C, Häuser W. Availability and approval of cannabis-based medicines for chronic pain management and palliative/supportive care in Europe: A survey of the status in the chapters of the European Pain Federation. Eur J Pain. 2018;22(3):440-54.
29 Dobush G. Why can’t Germany get its medical marijuana industry going? Das Handelsblatt. 01/02/2019.
30 Pascual A. Germany’s medical cannabis market prioritizes efficacy over unfettered access. June 12th. 2019.
31 Da Cas R, The use and safety of Cannabis for medical use in Italy. Presentation given at the 2nd International Annual Congress on Controversies on Cannabis-Based Medicines. May 23rd-24th. 2019 Barcelona, Spain.
32 National Institute for Heath and Care Excellence (NICE) Cannabis-based medicinal products. NICE Guidelines [NG144] November 2019.
33 United Patient´s Alliance (UPA) UPA Patients’ Survey. 2018.
34 Health Canada Market data under the Access to Cannabis for Medical Purposes Regulations. 2019.
35 Convenção Única de 1961 sobre Narcóticos - Alterado pelo Protocolo de 1972 para modificar a Convenção Única de 1961 sobre Estupefacientes
36 World Health Organization (WHO). WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants. Geneva: WHO; 2003.
37 European Medicines Agency. Guidelines on Good Agricultural and Collection Practices (GACP) for starting materials of herbal origin. 2006.
38 Malta Medicines Authority. General Guidelines on the Production of cannabis for medicinal and research purposes. 2018.
39 Manifava D. Greece grants country’s first medical cannabis licenses. 2018.
40 Nanaimo BC. Tilray® Increases International Export Capacity with New Outdoor Cultivation Site in Portugal. 2019.
41 Agency for Medicinal Products and Medical Devices of the Republic of Slovenia. Andreja Čufar. Stališče JAZMP v zvezi s predlogom o spremembi razvrstitve konoplje in ureditvi gojenja konoplje [JAZMP’s position on the proposal to amend the classification of cannabis and the regulation of cannabis cultivation, in Slovenian]
42 Publications Office of the EU. C/2017/4132 Common catalogue of varieties of agricultural plant species - fifth supplement to the 35th complete edition.
43 European Commission. EU Novel food catalogue.
Submitted date:
07/09/2022
Accepted date:
06/21/2023
Facebook
Google+
Twitter
LinkedIn
Mendeley
Email