Kanabis in kanabinoidi v medicini – zakonodajni vidik

The discovery of the endocannabinoid system has raised public interest in the medicinal use of cannabis, phytocannabinoids, and synthetic cannabinoids, which has always been closely regulated due to their psychotropic effects and potential abuse. The review takes a quick look at the current legal framework in the European Union, which regulates cannabis use and cultivation for medicinal purposes in line with the United Nations Conventions on the production, trade, and use of cannabis, phytocannabinoids, and synthetic cannabinoids. And while the EU legislation precisely defines requirements and marketing authorisation procedures for medicinal products for all EU member states, there is no common regulatory framework for magistral and officinal preparations containing cannabinoids, as they are exempt from marketing authorisation. Instead, their regulation is left to each member state, and it is quite uneven at this point, mainly due to cultural and historical differences between the countries, leading to different access to non-authorised medicinal products. Therefore, to meet great public interest, harmonised approaches on cannabinoid-containing products without marketing authorisation would be welcome to level the playing field in the EU.Odkritje endokanabinoidnega sistema je vzbudilo zanimanje javnosti za medicinsko uporabo konoplje, fitokanabinoidov in sintetičnih kanabinoidov, ki je bila zaradi psihotropnih učinkov in morebitne zlorabe že od nekdaj natančno regulirana. V prispevku je predstavljen pravni okvir Evropske unije, ki ureja uporabo in gojenje konoplje v medicinske namene, v skladu s konvencijami Združenih narodov o proizvodnji, trgovini in uporabi konoplje, fitokanabinoidov in sintetičnih kanabinoidov. Medtem ko zakonodaja Evropske unije natančno določa zahteve in postopke izdaje dovoljenja za promet za avtorizirana zdravila, ni skupnega regulatornega okvira za magistralne in oficinalne pripravke, ki so izvzeti iz avtorizacijskih postopkov. Njihova ureditev je prepuščena vsaki državi članici in se zaradi tega razlikuje, predvsem zaradi kulturnih in zgodovinskih razlik med državami, to pa vodi do različne dostopnosti do tovrstnih zdravil. Zaradi tega bi bili dobrodošli nekateri usklajeni pristopi držav članic EU, s katerimi bi zmanjšali razlike na trgu neavtoriziranih zdravil s kanabinoidi