Medical Cannabis & Cannabinoid Regulation - GLOBAL PRACTICE GUIDES Switzerland Daniel Haymann Froriep
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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
2SWITZERLAND Law and Practice
Contributed by: Daniel Haymann, Froriep
1 . L E G A L / R E G U L AT O R Y 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).
3Law 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
4SWITZERLAND 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 physi-
audit requirements. Each manufacturer must cian issues the prescriptions correctly and the
determine and document in writing how it com- pharmacist prepares the prescriptions according
plies with and implements the GMP guidelines. to the law.
An audit must verify whether all the required
boxes of the GMP standard were ticked and thus The provisions of the TPA apply to narcot-
that the products meet the safety and quality ics used as therapeutic products even if they
standards. are placed on the market with an exceptional
authorisation under the NarcA. The provisions
Swiss-domiciled companies with a valid estab- of the NarcA are applicable to these narcotics
lishment licence for the manufacture of medical insofar as the TPA does not provide any regu-
products may apply to Swissmedic to obtain lation or provides a less far-reaching regulation
a GMP certificate through its eGov GMP-GDP than the NarcA. In other words, narcotics used
online portal. as medicinal products that are exempt from an
exceptional authorisation by Swissmedic also
Exemption from authorisation must comply with the minimum standards of
The Therapeutic Products Act also provides for the TPA.
the market placement of medicinal products that
are exempt from authorisation. These include Health Insurance Law
medical cannabis products manufactured as an The reimbursement of costs for medicinal prod-
extemporaneous preparation (“magistral formu- ucts by the compulsory health insurance (OKP)
la”) – ie, medicinal products prepared according generally requires that the medicinal product is
to a doctor’s prescription by a public pharmacy included in the so-called list of specialties (SL) of
the FOPH. To be included in that list, the medici-
5Law and Practice SWITZERLAND
Contributed by: Daniel Haymann, Froriep
nal product requires both a licence from Swiss- Cannabis Products with a THC Content
medic and proof of its efficacy, usefulness and Below 1%
cost-effectiveness. Cannabis products containing a THC content
of below 1% are not captured by the scope of
In Switzerland, it is considered that there is lim- the NarcA. Of all the (known) cannabinoids in
ited evidence for the efficacy of cannabis inter the cannabis plant, CBD stands out as the most
alia in the treatment of chronic pain, nausea in prominently marketed cannabinoid in the can-
chemotherapy and spasms in multiple sclero- nabis market. On 21 April 2021, Swissmedic, the
sis. Accordingly, no medicinal product, not even FOPH, the Federal Food Safety and Veterinary
Sativex®, is on the FOPH’s list of specialties for Office (FSVO) and the Federal Office for Agri-
reimbursement by the compulsory health insur- culture (FOAG) jointly released an updated ver-
ance. sion of an “Overview and implementation guide”
regarding “Products containing cannabidiol
Only in cases of hardship, and upon request for (CBD)” (the “Implementation Guide”), the main
a cost approval by a physician, is reimbursement elements of which are set out below.
by the OKP of a medicinal product not listed in
the SL possible. It is considered a case of hard- CBD products can only be marketed legally if
ship if the use of the product is expected to pro- they comply with the Swiss legislation that is
vide a major therapeutic benefit against a dis- applicable to their respective classification. The
ease that may be fatal for the insured person or range of CBD-containing products is extensive
result in severe and chronic health impairments, and includes, among others, raw materials such
and no other effective and approved treatment as cannabis buds or flowers with a high CBD-
method is available due to a lack of therapeutic content, extracts in the form of oils or pastes,
alternatives. ready-to-use products such as capsules, food
supplements, liquids for e-cigarettes, tobacco
It remains to be seen whether an amendment substitutes, scented oils, chewing gums and
to the NarcA, which was adopted by the Swiss ointments, some of which are offered as per-
Parliament on 19 March 2021, will provide relief sonal care products.
in terms of reimbursement by the OKP. Unfortu-
nately, the adopted amendment does not envis- In order to determine the applicable legislation,
age an adjustment to the reimbursement require- the product must be assigned to the corre-
ments. However, a so-called Health Technology sponding product category based on the rele-
Assessment (HTA) report is being prepared on vant factors such as composition, intended use,
behalf of the FOPH to clarify the scientific evi- dosage, etc.
dence regarding the efficacy and cost-effective-
ness of medical cannabis products and to differ- As an initial step, it must be determined whether
entiate between the various patient groups. The the CBD product is a raw material or ready-to-
HTA will form the basis for the reimbursement use product. CBD products considered as raw
decision on medical cannabis products that do materials are governed by the Chemicals Act
not require a marketing authorisation. It may be and the Chemicals Ordinance. If no intended
published later in 2021. use can be determined for a cannabis-based
raw material, it should be placed on the mar-
ket in accordance with the legislation governing
chemicals. Lastly, the Federal Act on Product
6SWITZERLAND Law and Practice
Contributed by: Daniel Haymann, Froriep
Safety (PrSG) acts as a fallback catch-all leg- Epidiolex®, a ready-to-use CBD monoprepa-
islation for products for which there is no other ration prescribed for the adjuvant treatment of
specific applicable law. two rare forms of epilepsy, was approved by
the United States Federal Drug Administration
CBD offered as chemicals (FDA) on 28 June 2018. This was the first time a
CBD-containing products may be marketed ready-to-use CBD medicinal product has been
legally as scented oils. Manufacturers must clas- approved anywhere in the world. Recently, on
sify, package and label the product in accord- 10 February 2021, the same preparation was
ance with the provisions of the Chemicals approved in Switzerland under the name of
Ordinance (ChemO) after having assessed that Epidyolex®.
substances or preparations they intend to place
in the market do not endanger human life, health Pharmacies can also prepare and dispense CBD
or the environment. containing medicinal products as extemporane-
ous preparations – ie, as a magistral formula,
However, if the presentation of the products indi- based on a prescription of a specialised physi-
cates, or suggests, other uses that are covered cian – in Lennox-Gastaut syndrome and Dravet
by other legal provisions, their marketability must syndrome or other treatment-resistant forms of
be assessed according to these provisions. This epilepsy. The medicinal product must be pre-
may be the case, for example, if a “scented oil” pared with CBD that has been produced in com-
is sold in a cartridge for e-cigarettes, in which pliance with GMP to a quality standard that as
case foodstuffs/utility articles legislation applies a minimum satisfies the requirements of mono-
for the assessment of marketability. The same graph C-052 Cannabidiol of the current Ger-
would apply if, for example, cannabis oils con- man Drug Codex DAC/NRF and the preparation
taining full spectrum hemp extracts would be itself at the pharmacy level must comply with the
labelled as having a specific nutritional value, or GMP requirements of the current Pharmacopoea
is sold under the banner of a therapeutic prod- Helvetica (Ph. Helv.).
uct.
CBD sold as cosmetics
The authorities are applying a holistic approach According to the Ordinance on foodstuffs and
in their assessment of product classification, consumer products (LGV), cosmetic products
which also includes a detailed analysis of how are broadly defined as “substances or prepa-
CBD-containing products are marketed through rations intended to come into external contact
company websites and other sales channels. with certain parts of the human body, such as
the skin, the hair system, the nails, the lips or
CBD sold as medicinal products external intimate regions, or with the teeth and
Ready-to-use CBD-containing products with a the mucous membranes of the oral cavity, for the
medical-intended use are regarded as medicinal sole or predominant purpose of cleaning them,
products under the TPA, which require authori- perfuming them, changing their appearance,
sation by Swissmedic to be placed on the mar- protecting them, keeping them in good condi-
ket. Companies that manufacture, distribute or tion or influencing body odour” (the author’s
dispense medicinal products containing CBD translation).
always require a corresponding authorisation
from Swissmedic or the respective canton. Cosmetic products must be safe, and the safety
of the individual ingredients must be document-
7Law and Practice SWITZERLAND
Contributed by: Daniel Haymann, Froriep
ed in a safety report. References of any kind to be used to introduce CBD into cosmetics. Seeds
disease-curing, disease-soothing or disease- and leaves not accompanied by the flowering or
preventing effects of cosmetics (eg, medicinal fruiting tops, however, can be used to produce
or therapeutic properties) are prohibited. cosmetics.
CBD has gained widespread popularity as an It should be noted that, on 19 November 2020,
ingredient in cosmetic products in recent years. the European Court of Justice (ECJ) concluded
The use of synthetic CBD is not specifically in its judgment C-663-/18 (the Kanavape case)
regulated and can be used in the formulation of that CBD extracted from the fruiting or flowering
cosmetic products if the requirements set forth tops of the cannabis plant, and not only from
in the LGV are met. the seeds and leaves, “is not a drug within the
meaning of the Single Convention”. The ECJ
Regarding the use of naturally derived CBD in clarified that “since CBD does not contain a
cosmetics, (ie, CBD derived from the cannabis psychoactive ingredient in the current state of
plant), the Implementation Guide provides as scientific knowledge […] it would be contrary
follows: to the purpose and general spirit of the Single
Convention to include it under the definition of
Article 54 (1) LGV refers to the list of substanc- “drugs” within the meaning of that convention
es prohibited in cosmetic products in Annex II as a cannabis extract”.
of Regulation (EC) No 1223/2009 on Cosmetic
Products, Entry No 306, which reads: “Narcot- Cosmetic ingredients have an international des-
ics, natural and synthetic: All substances listed ignation, a so-called INCI term (International
in Tables I and II of the single Convention on Nomenclature for Cosmetic Ingredients). Each
narcotic drugs signed in New York on 30 March ingredient is also listed in the Central European
1961”. Schedule I of the signed Single Conven- Register of Cosmetic Ingredients (CosIng) either
tion on Narcotic Drugs of 1961 (the Single Con- with or without restriction. Following the publica-
vention) lists cannabis, cannabis resin, cannabis tion of the decision in the Kanavape case and
extracts and cannabis tinctures. According to upon request of the European Industrial Hemp
the definition in Article 1 of the Single Conven- Association (EIHA) to lift the existing restriction
tion, “cannabis” means “the flowering or fruiting on the use of cannabis extracts in cosmetic
tops of the cannabis plant (excluding the seeds products, the European Commission has lifted
and leaves when not accompanied by the tops) the restriction on CBD and has revised the entry
from which the resin has not been extracted, as follows: “Cannabidiol – derived from extract
by whatever name they may be designated”. or tincture or resin of cannabis”. It recently did
“Cannabis resin” is further defined in the Sin- the same for cannabigerol, or CBG, which is
gle Convention as “the separated resin, whether another known minor constituent of cannabis.
crude or purified, obtained from the cannabis While the CosIng (cosmetic ingredients) data-
plant”. The Implementation Guide goes on to base is not legally binding, the listing of ingredi-
conclude that, therefore, the use of “cannabis” ents is regarded by authorities and courts in the
or non-deresinated flowering or fruiting tops of EU member states as a strong indication of their
the cannabis plant and products made from legality in cosmetic products.
them (eg, hemp extracts, CBD) are prohibited
in cosmetic products. Cannabis resin obtained While cannabis resin is clearly defined as a nar-
from any part of the cannabis plant can also not cotic under Swiss law, cannabis extracts are
8SWITZERLAND Law and Practice
Contributed by: Daniel Haymann, Froriep
exempt from the NarcA if their THC content tion and are subject to the Tobacco Ordinance
does not exceed 1%. In view of a harmonisa- (TabV), independent of the Swiss Federal Tribu-
tion with recent practice in the European Union nal’s decision that hemp containing CBD is not
(EU) as well with the ECJ’s conclusion that “it considered a tobacco substitute according to
would be contrary to the purpose and general the Tobacco Tax Act (TStG).
spirit of the Single Convention to include CBD
under the definition of ‘drugs’ within the mean- It is therefore lawful to sell tobacco substitutes
ing of that convention as a cannabis extract”, it containing CBD or other cannabinoids as dried
would be desirable – and, in the author’s view, flower, buds, or as cigarettes/cigars, for exam-
in line with current legislation – to reconsider the ple. However, existing food legislation must be
described practice in the Implementation Guide observed, which includes the obligation to self-
to the effect that CBD, as well as all other can- regulate and to notify the FOPH before placing
nabinoids, derived from cannabis extracts from products on the market.
the flowering and fruiting tops should also be
allowed in cosmetic products. According to the TabV, tobacco substitutes
must satisfy the prerequisites applicable to the
CBD sold as utility articles smoked tobacco products they replace (eg,
CBD-containing liquids for e-cigarettes are clas- herbal cigarette packaging must contain pho-
sified as utility articles that come into contact tographic warnings). The substitutes must not
with mucous membranes under the Federal Act pose a direct or unexpected threat to health.
on Foodstuffs and Utility Articles (Foodstuffs
Act, FSA) as well as the LGV, may be sold unless CBD sold as foodstuffs
they release substances in quantities that pose Please see 3.2 Use of Non-controlled Cannab-
a risk to health. It is further not permitted to add inoids in Food, which includes some comments
CBD to liquids for e-cigarettes in pharmacologi- on the consumption of THC.
cally effective doses.
Reform of Switzerland’s hemp seed
Refill containers for e-cigarettes containing CBD legislation
are subjected to the provisions of the chemicals As of 1 January 2021, all provisions of the seed
legislation. Distributors must carry out self-reg- legislation relating to the production and sale of
ulation and implement labelling and reporting hemp seed and seedlings, which includes can-
obligations (product registration for chemicals). nabis with a THC content of below 1%, were
repealed. Previously, only approved varieties of
On a side note, it may be added that parapher- hemp grown for oil and fibre that were listed in
nalia and smoking accessories such as bongs, the Federal Office of Agriculture’s (FOAG) varie-
vaporisers, grinders (without CBD), etc, may be ties ordinance or the European Union’s Com-
sold without restriction if they comply with the mon Catalogue of Varieties, which is still in force
FSA, the LGV and the PrSG. in the EU, could be placed on the market for
commercial use in agriculture. This is a signifi-
CBD sold as tobacco substitutes cant competitive advantage for Switzerland as
Hemp with a total THC content of less than 1% an innovation hub for the development of hemp
does not fall under the NarcA and can be sold seeds and varieties as compared to the EU.
as a tobacco substitute for smoking. Tobacco
substitutes are a part of Swiss food legisla-
9Law and Practice SWITZERLAND
Contributed by: Daniel Haymann, Froriep
For the agricultural production of hemp, the investigative competence of the Confederation
provisions of the plant health legislation and the in this area.
direct payments legislation must be respected.
For the use of hemp as animal feed, the provi- The Confederation exercises oversight over the
sions of the Animal Feed Law must be observed. implementation of the NarcA. It conducts con-
trols at the border (import, transit and export)
1.2 Regulatory Authorities and in customs warehouses and bonded ware-
Switzerland is a federal state, which means that houses. The Confederation and the cantons
powers are divided between the Confederation, work together to fulfil their tasks under the NarcA
the cantons and the communes, according to and co-ordinate their work. They may call on the
the principle of subsidiarity. The Confedera- assistance of other organisations concerned.
tion, in principle, only undertakes tasks that the
cantons are unable to perform, or which are Non-compliance with the NarcA is a crimi-
expressly allocated to the Confederation by the nal offence. Under the NarcA any person who
Federal Constitution. without authorisation, among others, cultivates,
produces, stores, sends, transports, imports,
As discussed in 1.1 Source of Regulations, exports or carries in transit narcotic substances,
regulations affecting the cannabis market span possesses, keeps, buys, acquires or otherwise
a very wide spectrum of the law. It would go obtains narcotic substances, etc, is liable to a
beyond the scope of this guide to describe the custodial sentence not exceeding three years or
authorities responsible for enforcement on both to a monetary penalty.
a federal and cantonal level for each area of law.
However, a short overview will be provided of the As mentioned in 1.1 Source of Regulations,
enforcement authorities in narcotics, therapeu- medicinal cannabis products with a THC content
tic products, foodstuffs and utility articles (which of 1% and above may be prescribed with a spe-
includes cosmetics) and chemicals law. cial authorisation by the FOPH, which develops
Switzerland’s health policy and works to ensure
Enforcement of the NarcA that the country has an efficient and affordable
As a result of Switzerland’s federal political sys- healthcare system in the long term.
tem, the cantonal law enforcement agencies (ie,
the public prosecutor’s office) are principally Enforcement of the TPA
charged with enforcing the NarcA, with the help Swissmedic is responsible for the duties
of the police. The clear statement of the law assigned to it by the TPA. It is involved in the
that the enforcement of the NarcA lies within entire life cycle of a medicinal product through
the competence of the cantonal law enforce- its duties in the areas of authorisation, approval
ment agencies was relativised by the fact that and monitoring of medicinal products. Swiss-
it had always been assumed that the narcotics medic is run by the Confederation with the co-
sector was subject to special supervision by the operation of the cantons, as an institution under
Confederation. Consequently, the Office of the public law with its own legal personality.
Attorney General of Switzerland could, under
certain circumstances, order investigations itself It is important to note that Swissmedic’s areas
if the criminal acts were committed in whole or in of responsibility are closely related to those of
part abroad or in several cantons. This compe- other authorities or implementing bodies – for
tence continues to exist. Thus, there is a parallel example, when it comes to the delimitation
10SWITZERLAND Law and Practice
Contributed by: Daniel Haymann, Froriep
between medicinal products and cosmetics or Enforcement of the FSA
between medicinal products and foods, where According to the LGV, business operators who
the FOPH and the Federal Food Safety and Vet- manufacture, process, treat, distribute, import or
erinary Office (FSVO) are involved, all areas rel- export food, food additives or utility articles must
evant for the emerging cannabis market. exercise self-control and designate a responsi-
ble person who appropriately documents com-
Furthermore, Swissmedic has, among oth- pliance with the requirements of the FSA/LGV.
ers, the competence to authorise ready-to- This includes the obligation to secure good
use medicinal cannabis products and to grant manufacturing procedures, the implementation
a licence for imports of therapeutic products of quality management systems as well as the
(including medicinal cannabis) if the applicant obligation to withdraw or recall unsafe food, if
complies with the requirements of the Medicinal applicable.
Products Licensing Ordinance.
The Swiss Association of Cantonal Chemists
In simplified terms and on a cantonal level, the (ACCS) published a useful website listing local
Cantonal Office for the Control of Therapeu- law enforcement authorities for food and utility
tic Products (Kantonale Heilmittelbehörde) in articles in Switzerland; see www.kantonsche-
Zurich, for example, is divided in three operative miker.ch. In Zurich, for example, the Cantonal
units: the inspectorate, the laboratory and the Laboratory is responsible for the implementa-
administration. The Kantonale Heilmittelbehörde tion of food safety regulation, including the con-
in Zurich is responsible for the control of the trol of reporting and permitting obligations, as
production, wholesale trade and dispensing of well as the implementation of special protective
therapeutic products, the market surveillance of regulations of non-food or utility articles such
therapeutic products (which includes marketa- as cosmetics.
bility reviews and conformity tests in accordance
with recognised pharmacopeias), the granting of Authorities charged with the implementation of
cantonal licences for the dispensing of medicinal the FSA and its many ordinances have a wide
products (pharmacies, drugstores, etc), the issu- range of administrative measures they can
ance of professional and narcotic licences and impose on non-compliant market participants.
other tasks. The cantonal pharmacy is mandated
to secure a high quality and economical sup- 1.3 Self-Regulation
ply of therapeutic products to hospitals, a wide While there are numerous organisations that act
range of institutes and the general population. as self-regulatory bodies to the cannabis indus-
In the canton of Zurich, the cantonal pharmacy try in Switzerland, three groups stand out in par-
is also responsible for the production of a wide ticular, as detailed below.
range of pharmaceutical products. Other can-
tons have similar structures. The Interest Group Hemp (IG Hanf)
The association Interest Group Hemp (IG Hanf)
In terms of enforcement, non-compliance with represents the Swiss hemp industry and its
the TPA may lead to a series of administrative members in politics, before authorities and in
(including disciplinary) and penal actions on both public. It is by far the largest interest group of
the federal and cantonal level. market participants in the cannabis industry in
the country. The association’s goal is to promote
exchange and co-operation among its members
11Law and Practice SWITZERLAND
Contributed by: Daniel Haymann, Froriep
and thus strengthen the hemp industry in Swit- uct, its legal regulation as well as its clinical
zerland. Its mission is to establish cannabis in implementation in close co-operation with the
society in a sustainable manner and to create FOPH. As an umbrella organisation for profes-
a regulated cannabis market in order to ensure sionals from medicine, pharmacy, pharmacolo-
that Switzerland plays a leading role in the global gy, research and industry, its declared goal is to
cannabis industry. foster the scientific, rational and destigmatised
use of medicinal cannabis as well as the sim-
To secure quality control among its members, plified, unbureaucratic access to therapies with
the IG Hanf established the quality label “Swiss medicinal cannabis.
Certified Cannabis”. The label guarantees prod-
ucts and consumer safety and determines qual- Its task is to serve as the Swiss interdisciplinary
ity standards (in accordance with ISO 9001). knowledge and information platform for the
Specifically, the goals of the label as stipulated medical use of cannabis and cannabinoids and
in the guidelines of Swiss Certified Cannabis are: as a networking platform for a wide range of pro-
fessionals, care-givers, interest groups, etc. The
• to guarantee absolute traceability throughout organisation further promotes basic and clini-
the production chain; cal research and collects valuable data, based
• to ensure highest security for consumers and on which it elaborates medical recommenda-
customers; tions for the most relevant treatment principles.
• to build trust with consumers, customers and SGCM-SSCM is the Swiss ambassador of IACM
authorities; (International Association for Cannabinoid Medi-
• to protect against economic damage or loss cines).
of reputation.
MEDCAN
The Swiss Certified Cannabis label can only be MEDCAN advocates for the interests of patients
used by certified companies. The application in Switzerland who take cannabis as a medicine
process includes: and provides information on the use and effects
of the medicinal plant. The association pursues
• training by a qualified auditor; the goal of ensuring that patients in Switzerland
• a certification audit on site by an independent have legal access to cannabis without a great
and qualified auditor; deal of bureaucracy and can use it medically in
• a decision on the granting of the certificate tested quality and at reasonable prices. Moreo-
based on the audit report by the board of ver, it demands from the FOPH to further edu-
directors of IG Hanf. cate physicians regarding possible indications
and dosages and to minimise the bureaucratic
The guidelines of Swiss Certified Cannabis set effort to obtain medicinal cannabis. MEDCAN
standards on quality policy, production, pack- advocates on a political and on a public level for
aging, storage, safety, control, work-safety and people who use cannabis for medical purposes.
hygiene, labour, environment and infrastructure.
1.4 Key Challenges
Swiss Society of Cannabis Medicine The cannabis market faces tremendous chal-
The goal of the Swiss Society of Cannabis in lenges such as inconsistent cannabis and can-
Medicine (SGCM-SSCM) is to promote the nabinoids terminology, significant differences in
acceptance of cannabis as a therapeutic prod-
12SWITZERLAND Law and Practice
Contributed by: Daniel Haymann, Froriep
enforcement between cantons as well as a con- higher instance courts, or ideally by lawmak-
stantly changing regulatory environment. ers. CBD-pollinate is often exported into the EU
and contains in most cases a THC content of
The most obvious challenge market participants less than 0.2%. This is just one example of how
face is that cannabis is considered a narcotic confusing it can potentially be to bring cannabis
drug if the THC content exceeds 1%. Conse- products to market.
quently, all efforts by market participants to
legally bring products to market are biased by Furthermore, some of the most challenging
the default assumption that cannabis is an illicit aspects of the cannabis market come to the sur-
drug. This negative bias leads to heightened face where various areas of the law overlap. The
scrutiny by enforcement agencies and is not par- development of a new product can be very chal-
ticularly conducive for an emerging new industry. lenging when it is unclear, for example, whether
it is governed by therapeutics or cosmetics law.
A practical example of a widespread confusion A chewing gum containing CBD could be many
in the market is the classification of “CBD-pol- things – for example, a therapeutic product, a
linate”. As mentioned in 1.1 Source of Regu- cosmetic product or a foodstuff. Defining the
lations, cannabis resin is defined in the Single product category and abiding by all regulatory
Convention as “the separated resin, whether requirements while considering pertinent case
crude or purified, obtained from the cannabis law can only be managed with a detailed techni-
plant”. Cannabis resin is further separately list- cal and legal assessment.
ed in the BetmVV-EDI and is considered a con-
trolled narcotic independent of its THC content. Reference can be made to two very useful
In contrast to cannabis resin, however, pollinate guides that can help, to some extent, navigate
(hemp flower pollinate) consists of fine CBD these complexities:
hemp flower components that fall off when the
biomass is shaken into drums (known as pol- • Demarcation criteria therapeutic products –
linators). The production of hemp flower polli- foodstuffs with regard to products to be taken
nate is based exclusively on a process where the orally (published jointly by Swissmedic and
flower components of the cannabis plant, which the FSVO); and
are freely marketable, are extremely refined and • Criteria for the demarcation of cosmetic prod-
extracted, resulting in a powder called hemp ucts from therapeutic products and biocidal
flower pollinate. At no point in this process is products (jointly issued by Swissmedic, the
the resin content explicitly increased. The resin FOPH and the FSVO).
content (consisting of trichomes) of these prod-
ucts is the same as in CBD flowers. The resin is Another main challenge in the CBD market is
thus not secreted from the flower but is still in the the classification of cannabis extracts or tinc-
very small flower components. Yet, many mar- tures (CBD oils). They can be qualified as raw
ket participants had significant quantities of their materials or as ready-to-use products. While in
pollinate production confiscated and destroyed, practice, most consumers are ingesting CBD
which has caused widespread legal insecurity oils, such oils cannot be marketed as foodstuff
and economic damage. or nutritional supplements without authorisation
of its components as novel food by the FSVO
The classification of pollinate as cannabis res- or the European Commission (EC). No company
in is debatable and remains to be clarified by
13Law and Practice SWITZERLAND
Contributed by: Daniel Haymann, Froriep
in Switzerland, or in the EU, has obtained such control measures. An allocated taxation of can-
authorisation to date. nabis products could generate state revenues
and secure the financing of already necessary
Another key challenge for participants in the prevention and health measures, in particular for
medical cannabis market is to place a medici- the protection of youth.
nal cannabis product on the market. In view of
the revision of the NarcA – which is thoroughly At the same time, cannabis legislation concern-
described in the adjacent Trends & Develop- ing specifically THC limits in Switzerland is con-
ments article – and the lifting of the traffic ban sidered rather progressive if compared to the
for cannabis for medicinal purposes, the market EU and the USA, where the threshold from legal
for medicinal cannabis should be better acces- cannabis (or hemp in the USA) to a narcotic drug
sible for companies in the future. (which in some states in the USA is legalised) is
passed when the THC levels surpass 0.2% or
The above examples of key challenges do not 0.3%, respectively. Also, the Ordinance on the
touch on the many complexities surrounding maximum levels of contaminants (VHK) allows
international trade of medicinal and recreational for significantly higher values of THC intake from
cannabis products, and a whole range of other food than the THC values in the EU. Switzerland
issues and uncertainties participants in the can- has further repealed all provisions of the seed
nabis market must deal with. legislation relating to the production and sale
of hemp seed and seedlings and is no longer
1.5 Level of Regulation bound by the European Union’s Common Cata-
Cannabis-specific regulations in Switzerland are, logue of Varieties.
with few exceptions, limited to narcotics and
criminal law. Legal uncertainty is still prevalent In view of the latest developments in legislative
in production, trade and consumption of canna- reform of the NarcA regarding medicinal can-
bis products of all kinds (cosmetics, foodstuffs, nabis as well as cannabis trials for recreational
medicines, recreational use, etc), as is inconsist- purposes, Switzerland is well positioned to fur-
ent cantonal enforcement. ther expand its regulatory edge in the emerging
European cannabis industry.
In other jurisdictions, such as in many US states
where medical and recreational cannabis have 1.6 Legal Risks
been legalised, the cannabis market is thor- Companies and individuals in the cannabis
oughly regulated. Countries such as Canada market must navigate a complex web of inter-
and Uruguay are following suit with their own related, constantly changing areas of law. Non-
regulatory models. compliance with existing laws and regulations
may lead to indictments for criminal offences,
Considering these developments, a revision of to administrative penalties and potentially to civil
Switzerland’s approach to cannabis regulation damage claims.
appears warranted, as was recently proposed in
a postulate submitted to the Council of States on Recent enforcement measures by authorities
18 March 2021 by Thomas Minder, a member of were, for example, the shutdown of a retailer’s
the Council of States. Specific cannabis-related website for publishing health claims in connec-
legislation could bring legal certainty through- tion with CBD products, or the imposition of a
out the value chain and secure efficient quality marketing ban for specific CBD oils.
14SWITZERLAND Law and Practice
Contributed by: Daniel Haymann, Froriep
It should be noted that special attention must a laboratory accredited to ISO/IEC 17025 or by
be paid to compliance with the NarcA. Cannabis a GMP laboratory.
resin is illegal independent of its THC content.
Furthermore, cannabis products with a total
THC content below 1% must meet the specific 3. FUTURE
requirements of the Therapeutic Products Act, DEVELOPMENTS
the Foodstuffs Act, the Ordinance on Foodstuffs
and Utility Articles, the Chemicals Ordinance and 3.1 Legal Elements Affecting Access to
the Tobacco Ordinance, among others, depend- Medical Cannabis
ing on the classification of the product placed The main elements affecting medical cannabis
on the market. It should be noted in this context in Switzerland are described in the adjacent
that not only the NarcA but also other acts such Trends and Developments article, along with
as the TPA provide for penal provisions. an overview of impending changes to the current
regulatory framework.
1.7 Enforcement
Please see 1.4 Key Challenges. 3.2 Use of Non-controlled Cannabinoids
in Food
The FSA sets forth the rules on the safety and
2. CROSS- transparency of foodstuffs and utility articles.
JURISDICTIONAL ISSUES According to the FSA, foodstuffs are all sub-
stances or products that are intended or may
2.1 Cross-Jurisdictional Standards reasonably be expected to be consumed by
In Switzerland, only cannabis with a THC content human beings in a processed, partly processed
below 1% can be exported. The cannabis legis- or unprocessed state. Medical products, nar-
lation of the importing country must therefore be cotics and psychotropic substances do not fall
complied with. Generally, in the EU, cannabis- under the definition of foodstuffs, and the other
products with a THC content of 0.2% and above way around.
are considered narcotic drugs and thus cannot
be imported, except for medical purposes with Except for a few reservations (eg, “novel foods”),
a special permit from local authorities. non-described foods without an authorisation
can be placed on the market, provided they
A revision of the NarcA which was adopted on meet all the requirements of food law.
19 March 2021 will allow for exports of medi-
cal cannabis with a THC content of 1% and Under certain circumstances, which will be
above. It is estimated that the revised law will be described below, cannabis products may also
enacted in the summer/autumn of 2022. Further be used in foodstuffs. The main tenet in food-
details can be found in the adjacent Trends and stuffs law is that foodstuffs must be safe – that
Developments article. is, they must neither be harmful to health nor
unsuitable for human consumption.
Importers of cannabis products with a THC con-
tent of 1% and below must be able to provide Novel Foods
proof in the form of a batch-specific analytical For foodstuffs that have not been used for
certificate for the delivery in question issued by human consumption to any significant extent
either in Switzerland or in an EU member state
15Law and Practice SWITZERLAND
Contributed by: Daniel Haymann, Froriep
before 15 May 1997, so-called “novel foods”, an ta 9-tetrahydrocannabinol in foodstuffs (which
authorisation by the Federal FSVO or an approv- are generally higher than in the EU).
al by the European Commission (EC) is required.
This applies to extracts of Cannabis sativa L. It is important to note that all foods which in
that contain cannabinoids such as cannabidiol accordance with the Novel Food Regulations
(CBD) and food products enriched with extracts (EC) No 258/97 and (EU) 2015/2283 may be
of Cannabis sativa L. or with cannabinoids such placed on the market in the EU are fundamen-
as CBD (eg, hemp seed oil with added CBD, tally also marketable in Switzerland (except for
food supplements with CBD), which are clas- genetically modified foods). To place foodstuff
sified as novel foods and therefore require an with CBD on the European market presupposes
authorisation. the application for authorisation to the European
Commission. If the application is granted, food-
Products of Cannabis sativa L., or parts of plants stuff containing CBD can be also placed on the
that had a safe and documented significant use Swiss market. Hence, the authorisation from
as food in the EU before 15 May 1997, are not the European Commission entails the advan-
considered novel foods in Switzerland provided tage that the foodstuff can be placed on both
they originate from an approved plant of Can- the European and the Swiss markets. However,
nabis sativa L. This is particularly the case for the reverse situation does not apply. Foodstuffs
hemp seeds, hemp seed oil, hemp seed flour that are not novel foods in Switzerland or have
and defatted hemp seeds. been authorised as such in Switzerland and are
classified as a novel food in the EU require an
Furthermore, in Switzerland, herbal tea made authorisation from the European Commission for
from leaves of the hemp plant Cannabis sativa market placement in the EU.
L. is also not considered a novel food. However,
the production, import or market placement of Lastly, authorisations are generally not issued
herbal teas obtained from the herb of the can- for composite foods. The authorisation require-
nabis plant is possible if one furnishes proof ment always relates to a substance, not to a
that the herbal tea was already consumed as composite product containing a novel food as
a foodstuff to a significant degree prior to 15 an ingredient.
May 1997, and is therefore not classified as a
novel food. Novel foods that do not require an The EIHA Consortium
authorisation are listed in the FDHA Ordinance The European Industrial Hemp Association
on Novel Foods. (EIHA) is Europe’s largest association that rep-
resents the common interests of hemp farm-
Authorisation ers, producers, and traders working with hemp
As part of the authorisation procedure for novel fibres, shives, seeds, leaves and cannabinoids.
foods, the FSVO examines whether the product
is safe and not deceptive. The basic prerequisite In 2019, EIHA created a Novel Food Consortium
for approval is that the product is classified as with the aim of submitting a joint Novel Food
a foodstuff and is not covered by the legislation application both to the UK Food Safety Authority
on medicinal products. In the case of foodstuffs for the British market as well as to the European
containing cannabis, the Ordinance on the maxi- Food Safety Authority (EFSA) for the EU mar-
mum levels of contaminants (VHK) is relevant. It ket (which, as mentioned above, would include
regulates the maximum permissible levels of del- Switzerland), the costs of which will be shared
16SWITZERLAND Law and Practice Contributed by: Daniel Haymann, Froriep among its members. It is estimated that the 3.3 Decriminalisation or Recreational consortium will invest up to EUR3.5 million for Regulation financing all relevant and unprecedented toxico- The latest developments regarding a potential logical studies on CBD and THC with the help of legalisation of cannabis use for recreational pur- a qualified service provider (ChemSafe). A whole poses can be found in the adjacent Trends and range of cannabinoids containing ingredients Developments article. will be tested to secure all food products using these ingredients will be covered by the joint application. For the purpose of the application, a corporation under German law was founded (EIHA projects GmbH), which collects the spe- cial contributions to finance the project and ulti- mately acquires the rights for the distribution of the approved products. EIHA projects GmbH will manage these rights and transfer them to EIHA members, with an established sublicensing system for white label (retail) trading companies. In its press release dated 23 March 2021, EIHA informed its members that the UK Food Safety Authority has confirmed that both applications for the regular/full-spectrum and the natural iso- late products were considered to be compliant with the administrative requirements. By grant- ing the pre-validation status, the Food Stand- ards Agency recognises and supports the strong will of the hemp sector, and particularly of the EIHA Consortium, to evaluate and determine the safety levels of its novel food products. Swiss companies aspiring to develop and bring cannabis-based food products to market are advised to evaluate a participation in the EIHA Consortium. 17
Law and Practice SWITZERLAND
Contributed by: Daniel Haymann, Froriep
Froriep is a Swiss law firm with a unique inter- qualified attorneys. Clients include cultivators,
national presence and perspective. Founded in extractors, product developers, distributors,
Zurich in 1966, the firm is one of the leading law retailers, pharmaceutical companies and inves-
firms in Switzerland, with offices in Zurich, Ge- tors from Switzerland and abroad. Froriep is
neva and Zug, as well as foreign offices in both also the first Swiss law firm to join the European
London and Madrid. Froriep is a first mover in Industrial Hemp Association as a member. Fro-
new areas of law and was the first law firm to riep is in the process of merging with Meyer-
establish a dedicated cannabis practice cover- lustenberger Lachenal, creating a new top-tier
ing the regulatory and commercial aspects of commercial law firm in Switzerland with a total
the cannabis industry in Switzerland. The can- of 155 lawyers.
nabis team consists of three partners and five
AUTHOR
Daniel Haymann heads second career as an attorney, Daniel gained
Froriep’s cannabis practice. He over 12 years of experience in the trading,
specialises in corporate and mining, energy and related industries based
commercial law, with a focus on out of Switzerland, Singapore and Hong Kong,
private equity and venture working for multinational corporations as a
capital transactions, as well as trader and in managerial positions. He is a
on regulatory matters in the cannabis industry. member of the Zurich and Swiss Bar
He advises investors, start-ups, and vertically Associations, the International Cannabis Bar
integrated companies in the cannabis industry Association and is a co-founder of the network
along the value chain. Prior to embarking on a of European Cannabis Lawyers.
Froriep Legal AG
Bellerivestrasse 201
8034 Zurich
Switzerland
Tel: +41 44 386 60 00
Fax: +41 44 383 60 50
Email: zurich@froriep.ch
Web: www.froriep.ch
18SWITZERLAND Trends and Developments
Trends and Developments
Contributed by:
Daniel Haymann
Froriep see p.24
The current regulatory environment surround- patients are consuming “medical” cannabis ille-
ing cannabinoid-based products in Switzerland gally (ie, sourced from the black market), which
is unfortunately still marked by a high degree exposes them to significant health risks due to
of uncertainty, due both to vague legislative the lack of quality control and a growing number
requirements and heterogenous, sometimes of cut and contaminated products in circulation.
arbitrary, enforcement. However, with the rise This number does not include those who con-
of public awareness of the general benefits of sume cannabis for recreational purposes, which
the cannabis plant as a result of the cannabid- is, by conservative measures, three times that of
iol (CBD) boom of the last few years, as well the FOPH estimate.
as by actual and growing anecdotal evidence
from local and liberalised recreational markets Cannabis with a tetrahydrocannabinol (THC)
such as Canada, Uruguay and certain states in content of 1% and above is considered a pro-
the USA, recent legislative developments are hibited narcotic in Switzerland. Under very
presenting an opportunity for Switzerland to restrictive circumstances, cannabis with a THC
establish itself as a role model for an innovative, content above 1% may be prescribed for medi-
pragmatic, safe and comprehensively regulated cal purposes, which requires an exceptional
cannabis market. permit from the FOPH. As the currently most-
researched cannabinoid, THC is predominantly
Medical Cannabis Reform used for chronic pain conditions, spasticity and
The status quo spasms, as well as nausea and loss of appe-
A study conducted by the Institute for Addiction tite (mostly in the context of chemotherapy).
and Health Research on behalf of the Federal Ready-to-use medicinal products may only be
Office of Public Health (FOPH), the findings of marketed in Switzerland if they are approved by
which were published in February 2020, came Swissmedic, the Swiss Agency for Therapeutic
to the conclusion that, for over 96% of the par- Products. Only one ready-to-use medicinal prod-
ticipants questioned, the consumption of medi- uct with a THC content above 1%, Sativex®, is
cal cannabis has led to an improvement of their fully approved in Switzerland. Sativex can be
symptoms. Half of the participants reported an prescribed without special permit for spastic
“extreme improvement”. A large part of the par- convulsions in multiple sclerosis patients. For
ticipants who already had prescriptions for can- any other indication, an exception permit by the
nabinoid-based medicines reported that they FOPH must be obtained (ie, for so-called off-
were able to either completely abandon other label use).
prescribed drugs, or at least substantially reduce
their consumption. See Cannabiskonsum: If an approved preparation is unsuitable, physi-
Rekreative oder medizinische Beweggründe? cians can prescribe cannabis as a drug which is
exempt from approval by Swissmedic but which
Around 3,000 patients are legally prescribed still requires a special permit by the FOPH. The
medical cannabis in Switzerland today. Mean- drug is then usually produced by a pharmacy
while, the FOPH estimates that over 110,000 on a doctor’s prescription as a so-called extem-
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