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Medical Cannabis & Cannabinoid Regulation GLOBAL PRACTICE GUIDES Definitive global law guides offering comparative analysis from top-ranked lawyers Medical Cannabis & Cannabinoid Regulation Switzerland Daniel Haymann Froriep practiceguides.chambers.com 2021 SWITZERLAND Law and Practice Contributed by: Daniel Haymann Froriep see p.18 CONTENTS 1. Legal/Regulatory Framework p.3 1.1 Source of Regulations p.3 1.2 Regulatory Authorities p.10 1.3 Self-Regulation p.11 1.4 Key Challenges p.12 1.5 Level of Regulation p.14 1.6 Legal Risks p.14 1.7 Enforcement p.15 2. Cross-Jurisdictional Issues p.15 2.1 Cross-Jurisdictional Standards p.15 3. Future Developments p.15 3.1 Legal Elements Affecting Access to Medical Cannabis p.15 3.2 Use of Non-controlled Cannabinoids in Food p.15 3.3 Decriminalisation or Recreational Regulation p.17 2 SWITZERLAND LAW AND PRACTICE Contributed by: Daniel Haymann, Froriep 1. LEGAL/REGULATORY governed by three ordinances on the control of FRAMEWORK narcotics (BetmKV), the addiction to narcotics (BetmSV) and the register of narcotics, psy- 1.1 Source of Regulations chotropic substances, precursors and auxiliary In Switzerland, products containing hemp, or chemicals (BetmVV-EDI). Cannabis Sativa L. (cannabis), are regulated by a set of laws and regulations that are intertwined, The BetmKV governs the activities of the Swiss complex and create a level of legal uncertain- Agency for Therapeutic Products (Swissmedic) ty that lawmakers have realised needs to be in the area of granting authorisations for the addressed. The main tenets surrounding can- legally permitted handling of controlled sub- nabis are regulated in the narcotics, therapeutic stances and the associated controls, and is of products, health insurance, foodstuff, chemical, importance for the industrial use of these sub- cosmetic, utility articles, tobacco substitutes as stances. The BetmSV regulates the measures well as plant varieties and seeds laws and regu- for prevention, therapy and harm reduction as lations, among others. well as the exemptions for the restricted medi- cal use of cannabis-containing medical products To facilitate matters, this guide will provide an and the corresponding controls. Lastly, the Bet- overview of only the most important aspects of mVV-EDI lists all controlled narcotics and psy- cannabis laws and regulations, and draw a dis- chotropic substances and determines to which tinction between cannabis products: control measures they are subjected. • containing a tetrahydrocannabinol (THC) Cannabis is classified as a prohibited narcotic if content of above 1%, which are considered its THC content exceeds 1%. An amendment to prohibited narcotics under the Federal Act the NarcA in force since 1 July 2011 provides for on Narcotics and Psychotropic Substances a restricted decriminalisation of the preparation (Narcotics Act, NarcA); and of a negligible quantity of cannabis for one’s own • containing a THC content below 1%, which consumption (10 g). Cannabis products with a have been popularised and aggregated THC content lower than 1%, on the other hand, (in somewhat untechnical jargon) as “CBD can be legally produced and marketed. This products” – which means products contain- holds true for all cannabis products except for ing cannabidiol – which are not subject to the cannabis resin. Cannabis resin is separately list- NarcA and are more freely marketable. ed in the BetmVV-EDI and is considered a con- trolled narcotic, independent of its THC content. THC and CBD have garnered notoriety as the This classification of cannabis resin as a nar- most prominent cannabinoids over the last cotic drug, which was confirmed by the Swiss years, but research has shown that over 140 Federal Tribunal in 2019, is considered rather cannabinoids (naturally occurring compounds unfortunate by the local cannabis industry as it found in the cannabis plant) can be identified. limits the commercial exploitation of the most cannabinoid-dense part of the cannabis plant, Cannabis Products with a THC Content drives a wedge of unequal treatment between Above 1% cannabis extracts, which are legal if their total Narcotics Act, NarcA THC content remains below 1%, and cannabis The use of narcotics is primarily regulated by resin, and creates a whole range of other legal the NarcA. The implementation of the NarcA is issues (eg, in cosmetics regulation). 3 LAW AND PracTICE SWITZERLAND Contributed by: Daniel Haymann, Froriep Pursuant to the NarcA, the Federal Office of • the administration of the prohibited narcotic Public Health (FOPH) may issue exceptional enables the patient to live more indepen- licences for cultivating, importing, producing dently (eg, in case inpatient treatment can be and placing on the market narcotics contain- avoided). ing an effective concentration of cannabinoids, where this is not prohibited by an international Applying for a special permit at the FOPH is agreement and these narcotics are needed for therefore quite cumbersome, and a revision to scientific research, the development of medical the NarcA, which was adopted on 19 March products or for restricted medical use. The pre- 2021, will provide long-sought relief. See the scription for medical purposes of unauthorised adjacent Trends & Developments article for cannabis-based medical products which contain further details. a THC level of above 1% is permitted under cer- tain circumstances. Such an exemption permit Therapeutic Products Law from the FOPH is required: Legal basis The regulations on the use of medical products • to develop medical products with prohibited and medical devices are mainly set forth in the narcotics; Federal Act on Medicinal Products and Medical • to use prohibited narcotics for limited medical Devices (Therapeutic Products Act, TPA), the purposes; and Ordinance on Pharmaceutical Products (VAM), • to use an authorised medical product with the Ordinance on Advertising of Pharmaceuti- prohibited narcotics for any purpose other cal Products (AWV) and the Products Licensing than the approved indication. Ordinance (MPLO). These laws and regulations apply to therapeutic products according to the An exceptional licence for restricted medical use TPA, which include medical cannabis products. is issued to the attending physician. The physi- cian then goes on to prescribe the medical can- Authorisation nabis product (in the form of oils and tinctures Ready-to-use medical products may be placed for ingestion). Based on this prescription, the on the market only if authorised by Swissmedic. corresponding medical product may be dis- The application for obtaining a market authori- pensed to the patient within the framework of sation for medical cannabis products must the Therapeutic Products Law. The granting of include, for example, detailed documentation a licence for the restricted medical use of pro- on the results of physical, chemical, galenic and hibited narcotics also requires a prior written biological or microbiological tests, as well as declaration by the patient stating that he or she the results of pharmacological and toxicologi- consents to the use. An exceptional licence for cal tests and clinical trials. The applicant must restricted medical use may only be granted if the prove that the medical products are of high qual- following conditions are cumulatively fulfilled: ity, safe and effective and that the medical prod- uct in question does not pose a risk to the safety • the patient suffers from an incurable disease; of consumers. • the suffering can be alleviated by taking the prohibited narcotic; Only one ready-to-use medical product with • the existing treatment options have been a THC content above 1%, Sativex®, is fully exhausted or there are no alternative treat- approved in Switzerland. Sativex can be pre- ment options; and scribed without special permit only for spastic 4 SWITZERLAND LAW AND PRACTICE Contributed by: Daniel Haymann, Froriep convulsions in multiple sclerosis patients – in or a hospital pharmacy for a given person or other words, its application is very limited in group of persons. scope. The conditions for the use of medicinal products The manufacture of medical products and phar- that are exempt from authorisation are restric- maceutical excipients (eg, colourings, preserv- tive. Such use is mainly considered in order to atives) whose manufacture requires a licence ensure the supply if no authorised drug is avail- must conform to the recognised rules of good able for this purpose. Medical cannabis prod- manufacturing practice (GMP). The Medicinal ucts produced as a formula magistralis, which Products Licensing Ordinance (MPLO) refers are produced by a pharmacy based on a medi- to the GMP guidelines of the European Union cal prescription, require an exceptional authori- (Annex 1). Thus, in Switzerland the GMP guide- sation from the FOPH under the NarcA. An lines of the European Union are applicable. exceptional authorisation is also required for an approved drug (ie, Sativex®) that is dispensed The GMP guidelines provide the minimum for an indication other than the one for which it requirements that a manufacturer of medical has been approved. products must meet to assure that their prod- ucts are consistently of sufficiently high quality The reason for this exemption from authorisation for their intended use. This includes risk man- is, according to the legislator, that the training of agement, documentation, continuing improve- the physician and the cantonal supervision of the ment processes as well as internal and external professional licences guarantee that the
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