Definitive global law guides offering

comparative analysis from top-ranked lawyers

Medical Cannabis
& Cannabinoid
Regulation 2022
Switzerland: Law & Practice and Trends & Developments
Daniel Haymann and Daniel Donauer
MLL Meyerlustenberger Lachenal Froriep Ltd

practiceguides.chambers.com
 SWITZERLAND
Law and Practice
Germany
France
Bern

Contributed by: Switzerland

Daniel Haymann and Daniel Donauer
MLL Meyerlustenberger Lachenal Froriep Ltd see p.18
Italy

CONTENTS
1. Legal/Regulatory Framework p.2
1.1 Source of Regulations p.2
1.2 Regulatory Authorities p.10
1.3 Self-Regulation p.12
1.4 Key Challenges p.13
1.5 Level of Regulation p.14
1.6 Legal Risks p.15
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.16
3.3 Decriminalisation or Recreational Regulation p.17

1
SWITZERLAND Law and Practice
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

1 . L E G A L / R E G U L AT O R Y Cannabis Products with a THC content of

FRAMEWORK Above 1%
Narcotics Act, NarcA
1.1 Source of Regulations The use of narcotics is primarily regulated by the
In Switzerland, products containing hemp, or NarcA. The implementation of the NarcA is today
Cannabis sativa L. (cannabis), are regulated by governed by four ordinances on the control of
a set of laws and regulations that are intertwined, narcotics (BetmKV), the addiction to narcotics
complex, and create a level of legal uncertain- (BetmSV), the register of narcotics, psychotropic
ty that lawmakers have realised needs to be substances, precursors and auxiliary chemicals
addressed. The main tenets surrounding can- (BetmVV-EDI), and the Ordinance on Pilot Trials
nabis are regulated in the narcotics, therapeutic under the NarcA (BetmPV).
products, health insurance, foodstuff, chemical,
cosmetic, utility articles, tobacco substitutes as The BetmKV governs the activities of the Swiss
well as plant varieties and seeds laws and regu- Agency for Therapeutic Products (Swissmedic) in
lations. the area of granting authorisations for the legally
permitted handling of controlled substances and
To facilitate matters, this chapter will provide the associated controls, and is of importance for
an overview of only the most important aspects the industrial use of these substances.
of cannabis laws and regulations, and draw a
distinction between (i) cannabis products con- The BetmSV regulates the measures for pre-
taining a tetrahydrocannabinol (THC) content vention, therapy and harm reduction as well as
of above 1%, which are considered prohibited the exemptions for the restricted medical use of
narcotics under the Federal Act on Narcotics cannabis-containing medical products and the
and Psychotropic Substances (Narcotics Act, corresponding controls. The BetmVV-EDI lists all
NarcA), and (ii) products with a THC content controlled narcotics and psychotropic substanc-
below 1%, which have been popularised and es and determines to which control measures
aggregated in a somewhat untechnical jargon they are subjected. Lastly, the BetmPV regu-
as “CBD products”, which stands for products lates the requirements for conducting scientific
containing cannabidiol, and which are not sub- pilot trials with narcotics of the cannabis type in
ject to the NarcA so are more freely marketable. accordance with Article 8a NarcA.

Due to recent developments, also regarding the Cannabis is classified as a prohibited narcotic if
use of other cannabinoids (CBG, for example), its THC content exceeds 1%. An amendment to
the following statements, insofar as they relate the NarcA in force since 1 July 2011 provides for
exclusively to CBD, can in principle also be a restricted decriminalisation of the preparation
applied to other – non-psychotropic – cannabi- of a negligible quantity of cannabis for one’s own
noids. Both THC and CBD have garnered noto- consumption (10 g). Cannabis products with a
riety as the most prominent cannabinoids over THC content lower than 1%, on the other hand,
the last years; however, research has shown that can be legally produced and marketed. This
well over 140 cannabinoids, which are naturally holds true for all cannabis products except for
occurring compounds found in the cannabis cannabis resin.
plant, can be identified (THC, THCV, CBD, CBG,
CBT, CBN, CBL, CBE, etc). Cannabis resin is separately listed in the Betm-
VV-EDI and is considered a controlled narcotic

2
 Law and Practice SWITZERLAND
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

independent of its THC content. This classifica- • to use prohibited narcotics for limited medical
tion of cannabis resin as a narcotic drug, which purposes; and
was confirmed by the Swiss Federal Tribunal in • to use an authorised medical product with
2019, is considered rather unfortunate by the prohibited narcotics for any purpose other
local cannabis industry as it limits the commer- than the approved indication.
cial exploitation of the most cannabinoid-dense
part of the cannabis plant, drives a wedge of An exceptional licence for restricted medical use
unequal treatment between cannabis extracts, is issued to the attending physician. The physi-
which are legal if their total THC content remains cian then goes on to prescribe the medical can-
below 1%, and cannabis resin, and creates a nabis product (in the form of oils and tinctures
whole range of other legal issues (eg, in cosmet- for ingestion). Based on this prescription, the
ics regulation). corresponding medical product may be dis-
pensed to the patient within the framework of
However, in its statement of 16 February 2022 the Therapeutic Products Law. The granting of a
on a respective motion, the Federal Council licence for the restricted medical use of prohib-
announced the amendment of the ordinance ited narcotics also requires a prior written dec-
so that the THC-threshold of 1% will also be laration by the patient stating that they consent
applicable for cannabis resin in the future. There- to the use. An exceptional licence for restricted
fore, in the future, the regulation of cannabis as medical use may only be granted if the following
a narcotic drug will commonly be connected conditions are cumulatively fulfilled:
(no matter what part or form of the plant) to the
threshold of 1% THC content. Hence, the afore- • the patient suffers from a generally incurable
mentioned issues with regard to cannabis resin disease;
(and the currently missing limitation of 1% THC • the suffering can be alleviated by taking the
content) will soon be resolved. prohibited narcotic;
• the existing treatment options have been
Pursuant to the NarcA, the Federal Office of exhausted or there are no alternative treat-
Public Health (FOPH) may issue exceptional ment options; and
licences for cultivating, importing, producing • the administration of the prohibited narcotic
and placing on the market narcotics contain- enables the patient to live more indepen-
ing an effective concentration of cannabinoids, dently (eg, in case inpatient treatment can be
where this is not prohibited by an international avoided).
agreement and these narcotics are needed for
scientific research, the development of medical Applying for a special permit at the FOPH is
products or for restricted medical use. The pre- therefore quite cumbersome, and a revision to
scription for medical purposes of unauthorised the NarcA, which was adopted on 19 March
cannabis-based medical products which contain 2021, will provide long-sought relief, as will
a THC level of above 1% is permitted under cer- be described in detail in the adjacent Trends &
tain circumstances. Such an exemption permit Developments article.
from the FOPH is required:
On 24 June 2020, the Federal Council submitted
• to develop medical products with prohibited to Parliament a dispatch on the amendment of
narcotics; the Narcotics Act (BetmG), which provides for
the facilitation of the handling of cannabis for

3
SWITZERLAND Law and Practice
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

medical purposes. The bill was largely uncon- The application for obtaining a market authorisa-
troversial in parliamentary deliberations and was tion for medical cannabis products with indica-
adopted by both Chambers of Parliament on 19 tion must include, for example, detailed docu-
March 2021. The adopted amendment to the mentation on the results of physical, chemical,
law facilitates access to cannabis medicines for galenic and biological or microbiological tests,
thousands of patients as part of their treatment. as well as the results of pharmacological and
This mainly affects cases of cancer or multiple toxicological tests and clinical trials. The appli-
sclerosis, where cannabis-containing medicines cant must also prove that the medical products
can alleviate chronic pain. are of high quality, safe and effective and that
the medical product in question does not pose
According to the new legal situation, which is a risk to the safety of consumers.
expected to come into force in the autumn of
2022, special authorisation from the Federal Only one ready-to-use medical product with
Office of Public Health will no longer be required. a THC content above 1%, Sativex®, is fully
In other words, doctors will be able to prescribe approved in Switzerland. Sativex can be pre-
cannabis to their patients in the future as part of scribed without special permit for spastic con-
their regular treatment – ie, without the require- vulsions in multiple sclerosis patients only (ie, its
ment of a special licence. application is very limited in scope).

Therapeutic Products Law In the context of cannabis-based medicinal

Legal basis products, reference can also be made to Epidy-
The regulations on the use of medical products olex®, a ready-to-use medicinal product without
and medical devices are mainly set forth in: THC but including cannabidiol. Epidyolex® was
approved by Swissmedic on 10 February 2021,
• the Federal Act on Medicinal Products and and is used as adjunctive therapy for seizures
Medical Devices (Therapeutic Products Act, associated with Lennox-Gastaut syndrome
TPA); (LGS) or Dravet syndrome (DS) in patients two
• the Ordinance on Pharmaceutical Products years of age and older.
(VAM);
• the Ordinance on Advertising of Pharmaceuti- The manufacture of medical products and
cal Products (AWV); pharmaceutical excipients whose manufacture
• the Ordinance on the Approval of Medicinal requires a licence must conform to the recog-
Products (AMZV); nised rules of Good Manufacturing Practice
• the Products Licensing Ordinance (MPLO); (GMP). The Medicinal Products Licensing Ordi-
and nance (MPLO) refers to the GMP guidelines of
• the Medical Devices Ordinance (MedDO). the EU (Annex 1). Thus, in Switzerland the GMP
guidelines of the EU are applicable.
These laws and regulations apply to therapeutic
products according to the TPA, which include The GMP guidelines provide the minimum
medical cannabis products. requirements that a manufacturer of medical
products must meet to ensure that their prod-
Authorisation ucts are consistently of sufficiently high quality
Ready-to-use medical products may be placed for their intended use. This includes risk man-
on the market only if authorised by Swissmedic. agement, documentation, continuing improve-

4
 Law and Practice SWITZERLAND
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

ment processes as well as internal and external pensed for an indication other than the one for
audit requirements. Each manufacturer must which it has been approved. However, as men-
determine and document in writing how it com- tioned above, this legal situation will change in
plies with and implements the GMP guidelines. autumn 2022, when cannabis-prescribing doc-
tors will no longer require a special authorisation
An audit must verify whether all the required from the FOPH.
boxes of the GMP standard were ticked and
thus the products meet the safety and quality The reason for this exemption from authorisation
standards. Swiss-domiciled companies with a is, according to the legislator, that the training of
valid establishment licence for the manufacture the physician and the cantonal supervision of the
of medical products may apply to Swissmedic to professional licences guarantee that the physi-
obtain a GMP certificate through its eGov GMP- cian issues the prescriptions correctly and the
GDP online portal. pharmacist prepares the prescriptions according
to the law.
Exemption from authorisation
The Therapeutic Products Act also provides for The provisions of the TPA apply to narcot-
the market placement of medicinal products that ics used as therapeutic products even if they
are exempt from authorisation. These include are placed on the market with an exceptional
medical cannabis products manufactured as authorisation under the NarcA. The provisions
an extemporaneous preparation (“magistral for- of the NarcA are applicable to these narcotics
mula”) – that is, medicinal products prepared insofar as the TPA does not provide any regu-
according to a doctor’s prescription by a public lation or provides a less far-reaching regulation
pharmacy or a hospital pharmacy for a given than the NarcA. In other words, narcotics used
person or group of persons. The conditions for as medicinal products that are exempt from an
the use of medicinal products that are exempt exceptional authorisation by Swissmedic must
from authorisation are restrictive. Such use is also comply with the minimum standards of the
mainly considered in order to ensure the supply TPA.
if no authorised drug is available for this pur-
pose. Due to these requirements, extemporane- Health Insurance Law
ous preparations can and may only be produced The reimbursement of costs for medicinal prod-
in small quantities. Their prior authorisation is ucts by the compulsory health insurance (OKP)
impossible for time reasons and also not neces- generally requires that the medicinal product
sary, because the protection of public health is is included in the list of specialties (SL) of the
ensured by the fact that the prescribing physi- FOPH. To be included in that list, the medici-
cian and the pharmacist preparing the drug (or nal product requires both a licence from Swiss-
the manufacturer) have appropriate training and medic and proof of its efficacy, usefulness and
are controlled by the authorities. cost-effectiveness (WZW).

Medical cannabis products as a formula mag- In Switzerland, it is considered that there is lim-
istralis, produced by a pharmacy based on a ited evidence for the efficacy of cannabis in the
medical prescription, require an exceptional treatment of chronic pain, nausea in chemo-
authorisation from the FOPH under the NarcA. therapy and spasms in multiple sclerosis, etc.
An exceptional authorisation is also required Accordingly, no medicinal product, not even
for an approved drug (ie, Sativex®) that is dis- Sativex®, is on the FOPH’s list of specialties for

5
SWITZERLAND Law and Practice
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

reimbursement by the compulsory health insur- plant, CBD stands out as the most prominently
ance. marketed cannabinoid in the cannabis mar-
ket. On 21 April 2021, Swissmedic, the FOPH,
Only in cases of hardship, and upon request for the Federal Food Safety and Veterinary Office
a cost approval by a physician, is reimbursement (FSVO) and the Federal Office for Agriculture
by the OKP of a medicinal product not listed in (FOAG) jointly released an updated version of
the SL possible. It is considered a case of hard- Products containing cannabidiol (CBD): Over-
ship if the use of the product is expected to pro- view and implementation guide, the main ele-
vide a major therapeutic benefit against a dis- ments of which are set out below.
ease that may be fatal for the insured person or
result in severe and chronic health impairments, CBD products can only be marketed legally if they
and no other effective and approved treatment comply with the Swiss legislation that is applica-
method is available due to a lack of therapeutic ble to their respective classification. The range
alternatives. It remains to be seen whether an of CBD-containing products is extensive and
amendment to the NarcA, which was adopted by includes raw materials such as cannabis buds
the Swiss Parliament on 19 March 2021, will pro- or flowers with a high CBD content, extracts in
vide relief in terms of reimbursement by the OKP. the form of oils or pastes, ready-to-use products
Unfortunately, the adopted amendment does not such as capsules, food supplements, liquids for
envisage an adjustment to the reimbursement e-cigarettes, tobacco substitutes, scented oils,
requirements. chewing gums and ointments, some of which
are offered as personal care products.
A Health Technology Assessment report (HTA)
that was published on 30 April 2021, on behalf of In order to determine the applicable legisla-
the FOPH, was prepared to clarify the scientific tion, the product must be assigned to the cor-
evidence regarding the efficacy and cost-effec- responding product category based on the rel-
tiveness of medical cannabis products and to evant factors such as composition, intended use
differentiate between the various patient groups. and dosage.
Unfortunately, the HTA ultimately decided that
the efficacy data on medical cannabis use for As an initial step, however, it must be determined
chronic pain and spasticity was inconsistent (ie, whether the CBD product is a raw material or
studies with comparable patient populations ready-to-use product. CBD products considered
and similar type of medical cannabis did not as raw materials are governed by the Chemicals
show consistent results pointing in the same Act and the Chemicals Ordinance. If no intended
direction) and inconclusive (ie, none of the stud- use can be determined for a cannabis-based
ies was able to draw a definitive conclusion on raw material, it should be placed on the mar-
the efficacy of medical cannabis). As a result, ket in accordance with the legislation governing
the WZW criteria for medical cannabis have not chemicals. Lastly, the Federal Act on Product
been confirmed. Safety (PrSG) acts as a fallback catch-all leg-
islation for products for which there is no other
Cannabis Products with a THC content of specific applicable law.
Below 1%
Cannabis products with a THC content below CBD offered as chemicals
1% are not captured by the scope of the NarcA. CBD-containing products may be marketed
Of all the known cannabinoids in the cannabis legally as scented oils. Manufacturers must clas-

6
 Law and Practice SWITZERLAND
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

sify, package and label the product in accord- ready-to-use CBD medicinal product has been
ance with the provisions of the Chemicals approved anywhere in the world. Recently, on
Ordinance (ChemO) after having assessed that 10 February 2021, the same preparation was
substances or preparations they intend to place approved in Switzerland under the name of
in the market do not endanger human life, health Epidyolex®.
or the environment.
Pharmacies can also prepare and dispense
However, if the presentation of the products indi- CBD containing medicinal products as extem-
cates, or suggests, other uses that are covered poraneous preparations (ie, as a magistral for-
by other legal provisions, their marketability must mula), based on a prescription of a specialised
be assessed according to these provisions. This physician in Lennox-Gastaut syndrome and
may be the case, for example, if a “scented oil” Dravet syndrome or other treatment-resistant
is sold in a cartridge for e-cigarettes, in which forms of epilepsy. The medicinal product must
case foodstuffs/utility articles legislation applies be prepared with CBD that has been produced
for the assessment of marketability. The same in compliance with GMP to a quality standard
would apply if cannabis oils containing full spec- that, as a minimum, satisfies the requirements
trum hemp extracts would be labelled as having of monograph C-052 cannabidiol of the current
a specific nutritional value, for example. German Drug Codex DAC/NRF and the prepa-
ration itself at the pharmacy level must comply
The requirements of the general ruling issued by with the GMP requirements of the current Phar-
the Swiss Chemicals Notification Authority on 24 macopoea Helvetica (Ph. Helv.).
March 2022, must also be taken into account.
According to this general ruling, CBD-containing CBD sold as cosmetics
scented oils (ie, ready-to-use products) may now According to the Ordinance on Foodstuffs and
only be placed on the market or sold to con- Consumer Products (LGV), cosmetic products
sumers if they contain a denaturant in a suitable are broadly defined as “substances or prepa-
concentration to prevent misuse (ie, oral appli- rations intended to come into external contact
cation). 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
medical intended use are regarded as medicinal the sole or predominant purpose of cleaning
products under the TPA, which require authori- them, perfuming them, changing their appear-
sation by Swissmedic to be placed on the mar- ance, protecting them, keeping them in good
ket. Companies that manufacture, distribute or condition or influencing body odour” (unofficial
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-
Epidiolex®, a ready-to-use CBD monoprepa- ed in a safety report. References of any kind to
ration prescribed for the adjuvant treatment of disease-curing, disease-soothing or disease-
two rare forms of epilepsy, was approved by preventing effects of cosmetics (eg, medicinal
the United States Federal Drug Administration or therapeutic properties) are prohibited.
(FDA) on 28 June 2018. This was the first time a

7
SWITZERLAND Law and Practice
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

CBD has gained widespread popularity as an used to introduce CBD into cosmetics. Seeds
ingredient in cosmetic products in recent years and leaves not accompanied by the flowering or
(skin care oil, skin cream, lip care oil, mouth- fruiting tops, however, can be used to produce
wash, toothpaste, bath capsules, mouth spray, cosmetics.
dental gum, etc). The use of synthetic CBD is
not specifically regulated and can be used in the On 19 November 2020, the European Court of
formulation of cosmetic products if the require- Justice (ECJ) concluded in its judgment C-663-
ments set forth in the LGV are met. /18 (the Kanavape case) that CBD extracted
from the fruiting or flowering tops of the can-
Regarding the use of naturally derived CBD in nabis plant, and not only from the seeds and
cosmetics – ie, CBD derived from the cannabis leaves, “is not a drug within the meaning of the
plant – the Implementation Guide provides as Single Convention”. The ECJ clarified that “since
follows. CBD does not contain a psychoactive ingredient
in the current state of scientific knowledge […]
Article 54 (1) LGV refers to the list of substanc- it would be contrary to the purpose and general
es prohibited in cosmetic products in Annex II spirit of the Single Convention to include it under
of Regulation (EC) No 1223/2009 on Cosmetic the definition of ‘drugs’ within the meaning of
Products, Entry No 306, which reads: “Narcot- that convention as a cannabis extract”. It is to be
ics, natural and synthetic: All substances listed expected that a similar/analogous decision will
in Tables I and II of the single Convention on also be made by the Federal Supreme Court of
narcotic drugs signed in New York on 30 March Switzerland in the near future.
1961”.
Cosmetic ingredients have an international des-
Schedule I of the signed Single Convention on ignation, an INCI term (International Nomencla-
Narcotic Drugs of 1961 (the Single Convention) ture for Cosmetic Ingredients). Each ingredient
lists cannabis, cannabis resin, cannabis extracts is also listed in the Central European Register
and cannabis tinctures. According to the defini- of Cosmetic Ingredients (CosIng) either with or
tion in Article 1 of the Single Convention, “can- without restriction. Following the publication of
nabis” means “the flowering or fruiting tops of the decision in the Kanavape case and upon
the cannabis plant (excluding the seeds and request of the European Industrial Hemp Asso-
leaves when not accompanied by the tops) from ciation (EIHA) to lift the existing restriction on the
which the resin has not been extracted, by what- use of cannabis extracts in cosmetic products,
ever name they may be designated”. “Cannabis the European Commission has lifted the restric-
resin” is further defined in the Single Convention tion on CBD and has revised the entry as follows:
as “the separated resin, whether crude or puri- “Cannabidiol – derived from extract or tincture
fied, obtained from the cannabis plant”. or resin of cannabis”. It recently did the same for
cannabigerol, or CBG, which is another known
The Implementation Guide goes on to con- minor constituent of cannabis. While the Cos-
clude that, therefore, the use of “cannabis” or Ing database is not legally binding, the listing of
non-deresinated flowering or fruiting tops of the ingredients is regarded by authorities and courts
cannabis plant and products made from them in the EU member states as a strong indication
(eg, hemp extracts, CBD) are prohibited in cos- of their legality in cosmetic products.
metic products. Cannabis resin obtained from
any part of the cannabis plant can also not be

8
 Law and Practice SWITZERLAND
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

While cannabis resin is clearly defined as a nar- land (and, at the latest, after the new Tobacco
cotic under Swiss law, cannabis extracts are Products Act enters into force in summer 2023).
exempt from the NarcA if their THC content is
1% or above. (However, this qualification will Refill containers for e-cigarettes containing CBD
change due to the approved interpellation of are subjected to the provisions of the chemicals
Ms Léonore Porchet, a member of the Swiss legislation. Distributors must carry out self-reg-
Parliament, and so cannabis resin will also fol- ulation and implement labelling and reporting
low the typical limitation requirement of 1% THC obligations (product registration for chemicals).
content.)
On a side note, it may be added that parapher-
In view of a harmonisation with recent practice nalia and smoking accessories such as bongs,
in the EU, as well as the ECJ’s conclusion that vaporisers, grinders (without CBD) may be sold
“it would be contrary to the purpose and general without restriction if they comply with the FSA,
spirit of the Single Convention to include CBD the LGV and the PrSG.
under the definition of ‘drugs’ within the mean-
ing of that convention as a cannabis extract”, CBD sold as tobacco substitutes
it would be desirable and, in the authors’ view, Hemp with a total THC content of less than 1%
in line with current legislation to reconsider the does not fall under the NarcA and can be sold
described practice in the Implementation Guide as a tobacco substitute for smoking. Tobacco
to the effect that CBD derived from cannabis substitutes are a part of Swiss food legisla-
extracts from the flowering and fruiting tops tion and are subject to the Tobacco Ordinance
should also be allowed in cosmetic products. (TabV), independent of the Swiss Federal Tribu-
nal’s decision that hemp containing CBD is not
CBD sold as utility articles considered a tobacco substitute according to
CBD-containing liquids for e-cigarettes are clas- the Tobacco Tax Act (TStG).
sified as utility articles that come into contact
with mucous membranes under the Federal Act Therefore, it is lawful to sell tobacco substitutes
on Foodstuffs and Utility Articles (Foodstuffs containing CBD or other cannabinoids as dried
Act, FSA) as well as the LGV, may be sold unless flower, buds, or as cigarettes/cigars, for exam-
they release substances in quantities that pose a ple. However, existing food legislation must be
risk to health. It is further not permitted, in prin- observed, which includes the obligation to self-
ciple, to add CBD to liquids for e-cigarettes in regulate and to notify the FOPH before placing
pharmacologically effective doses. products on the market.

However, this rule is superseded by the require- According to the TabV, tobacco substitutes
ments of the Cassis De Dijon principle, accord- must satisfy the prerequisites applicable to the
ing to which CBD-containing liquids may be sold smoked tobacco products they replace (eg,
in Switzerland if they have been lawfully placed herbal cigarette packaging must contain pho-
on the market in an EEA or EU state. In addi- tographic warnings). The substitutes must not
tion, since the regulations on technical barriers pose a direct or unexpected threat to health.
to trade aim to prevent discrimination against
domestic suppliers compared to internation- In summer 2023, the new Tobacco Products Act
ally operating suppliers, CBD-containing liquids (TobPA) will enter into force. Under the TobPA,
may currently be lawfully marketed in Switzer- all tobacco-based and similar products (ie, with

9
SWITZERLAND Law and Practice
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

a similar purpose) will therefore be regulated As discussed in 1.1 Source of Regulations,

under the TobPA and Swiss food law (accord- regulations affecting the cannabis market span
ing to the LMG, LGV, etc) will no longer apply to a very wide spectrum of the law. It would go
such products. beyond the scope of this guide to describe the
authorities responsible for enforcement on both
CBD sold as foodstuffs a federal and cantonal level for each area of law.
The use of non-controlled cannabinoids in food- However, a short overview will be provided of
stuffs will be discussed in 3.2 Use of Non-con- the enforcement authorities in the laws related to
trolled Cannabinoids in Food, which will also narcotics, therapeutic products, foodstuffs and
include some comments on the consumption of utility articles (which includes cosmetics) and
THC. chemicals.

Reform of Switzerland’s hemp seed Enforcement of the NarcA

legislation As a result of Switzerland’s federal political sys-
As of 1 January 2021, all provisions of the seed tem, the cantonal law enforcement agencies (ie,
legislation relating to the production and sale of the public prosecutor’s office) are principally
hemp seed and seedlings, which includes can- charged with enforcing the NarcA, with the help
nabis with a THC content of below 1%, were of the police.
repealed. Previously, only approved varieties of
hemp grown for oil and fibre that were listed in The clear statement of the law that the enforce-
the Federal Office of Agriculture’s (FOAG) varie- ment of the NarcA lies within the competence
ties ordinance or the EU’s Common Catalogue of of the cantonal law enforcement agencies was
Varieties, which is still in force, could be placed relativised by the fact that it had always been
on the market for commercial use in agriculture. assumed that the narcotics sector was subject
This is a significant competitive advantage for to special supervision by the Confederation.
Switzerland as an innovation hub for the devel- Consequently, the Office of the Attorney Gen-
opment of hemp seeds and varieties as com- eral of Switzerland could, under certain circum-
pared to the EU. stances, order investigations itself if the criminal
acts were committed in whole or in part abroad
For the agricultural production of hemp, the or in several cantons. This competence contin-
provisions of the plant health legislation and the ues to exist. Thus, there is a parallel investigative
direct payments legislation must be respected; competence of the Confederation in this area.
for the use of hemp as animal feed, the provi-
sions of the Animal Feed Law must be observed. The Confederation exercises oversight over the
implementation of the NarcA. It conducts con-
1.2 Regulatory Authorities trols at the border (import, transit and export)
Switzerland is a federal state, which means that and in customs warehouses and bonded ware-
powers are divided between the Confederation, houses. The Confederation and the cantons
the cantons, and the communes, according to work together to fulfil their tasks under the NarcA
the principle of subsidiarity. The Confedera- and co-ordinate their work; they may call on the
tion, in principle, only undertakes tasks that the assistance of other organisations concerned.
cantons are unable to perform, or which are
expressly allocated to the Confederation by the Non-compliance with the NarcA is a crimi-
Federal Constitution. nal offence. Under the NarcA any person who

10
 Law and Practice SWITZERLAND
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

without authorisation, among others, cultivates, In simplified terms and on a cantonal level, the
produces, stores, sends, transports, imports, Cantonal Office for the Control of Therapeutic
exports, or carries in transit narcotic substances, Products (Kantonale Heilmittelbehörde) in Zurich
possesses, keeps, buys, acquires or otherwise for example is divided in three operative units: the
obtains narcotic substances, etc, is liable to a inspectorate, the laboratory and the administra-
custodial sentence not exceeding three years or tion. The Kantonale Heilmittelbehörde in Zurich
to a monetary penalty. is responsible for the control of the production,
wholesale trade and dispensing of therapeutic
As mentioned in 1.1 Source of Regulations, products, the market surveillance of therapeutic
medicinal cannabis products with a THC content products (which includes marketability reviews
of 1% and above may be prescribed with a spe- and conformity tests in accordance with recog-
cial authorisation by the FOPH, which develops nised pharmacopeias), the granting of cantonal
Switzerland’s health policy and works to ensure licences for the dispensing of medicinal prod-
that the country has an efficient and affordable ucts (pharmacies, drugstores etc), the issuance
healthcare system in the long term. of professional and narcotic licences and other
tasks. The cantonal pharmacy is mandated to
Enforcement of the TPA secure a high quality and economical supply of
Swissmedic is responsible for the duties therapeutic products to hospitals, a wide range
assigned to it by the TPA. It is involved in the of institutes and the general population. In the
entire life cycle of a medicinal product through Canton of Zurich, the cantonal pharmacy is also
its duties in the areas of authorisation, approval responsible for the production of a wide range
and monitoring of medicinal products. Swiss- of pharmaceutical products. Other cantons have
medic is run by the Confederation with the co- similar structures.
operation of the cantons, as an institution under
public law with its own legal personality. In terms of enforcement, non-compliance with
the TPA may lead to a series of administrative
It is important to note that Swissmedic’s areas (including disciplinary) and penal actions on both
of responsibility are closely related to those of the federal and cantonal level.
other authorities or implementing bodies. For
example, when it comes to the delimitation Enforcement of the FSA
between medicinal products and cosmetics or According to the LGV, business operators who
between medicinal products and foods, where manufacture, process, treat, distribute, import,
the FOPH and the Federal Food Safety and Vet- or export food, food additives or utility arti-
erinary Office (FSVO) are involved – all areas rel- cles must exercise self-control and designate
evant for the emerging cannabis market. a responsible person who appropriately docu-
ments compliance with the requirements of the
Furthermore, Swissmedic has, among oth- FSA/LGV. This includes the obligation to secure
ers, the competence to authorise ready-to- good manufacturing procedures, the implemen-
use medicinal cannabis products and to grant tation of quality management systems as well as
a licence for imports of therapeutic products the obligation to withdraw or recall unsafe food,
(including medicinal cannabis) if the applicant if applicable.
complies with the requirements of the Medicinal
Products Licensing Ordinance. On its website, the Swiss Association of Can-
tonal Chemists (ACCS) published a useful list

11
SWITZERLAND Law and Practice
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

of local law enforcement authorities for food • to guarantee absolute traceability throughout
and utility articles in Switzerland. In Zurich, for the production chain;
example, the Cantonal Laboratory is responsible • to ensure highest security for consumers and
for the implementation of food safety regulation, customers;
including the control of reporting and permit- • to build trust with consumers, customers and
ting obligations, as well as the implementation authorities;
of special protective regulations of non-food or • to protect against economic damage or loss
utility articles such as cosmetics. of reputation.

Authorities charged with the implementation of The Swiss Certified Cannabis label can only be
the FSA and its many ordinances have a wide used by certified companies. The application
range of administrative measures they can process includes:
impose on non-compliant market participants.
• training by a qualified auditor;
1.3 Self-Regulation • a certification audit on site by an independent
While there are numerous organisations that and qualified auditor;
act as self-regulatory bodies to the cannabis • a decision on the granting of the certificate
industry in Switzerland, three groups stand out based on the audit report by the board of
in particular. directors of IG Hanf.

The Interest Group Hemp (IG Hanf) The guidelines of Swiss Certified Cannabis set
Interest Group Hemp (IG Hanf) is an associa- standards on quality policy, production, pack-
tion representing the Swiss hemp industry and aging, storage, safety, control, work safety and
its members in politics, before authorities and hygiene, labour, environment and infrastructure.
in public. It is by far the largest interest group of
market participants in the cannabis industry in Swiss Society of Cannabis Medicine
the country. The association’s goal is to promote The Swiss Society of Cannabis in Medicine’s
exchange and co-operation among its members (SGCM-SSCM) goal is to promote the accept-
and thus strengthen the hemp industry in Swit- ance of cannabis as a therapeutic product, its
zerland. Its mission is to establish cannabis in legal regulation, as well as its clinical implemen-
society in a sustainable manner and to create tation in close co-operation with the FOPH. As
a regulated cannabis market in order to ensure an umbrella organisation for professionals from
that Switzerland plays a leading role in the global medicine, pharmacy, pharmacology, research
cannabis industry. and industry, its declared goal is to foster the
scientific, rational and destigmatised use of
To secure quality control among its members, medicinal cannabis as well as the simplified,
the IG Hanf established the quality label “Swiss unbureaucratic access to therapies with medici-
Certified Cannabis”. The label guarantees prod- nal cannabis.
ucts and consumer safety and determines qual-
ity standards (in accordance with ISO 9001). Its task is to serve as the Swiss interdisciplinary
Specifically, the goals of the label as stipulated knowledge and information platform for the
in the guidelines of Swiss Certified Cannabis are: medical use of cannabis and cannabinoids and
as a networking platform for a wide range of pro-
fessionals, care-givers, interest groups, etc. The

12
 Law and Practice SWITZERLAND
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

organisation further promotes basic and clini- linate”. As mentioned in 1.1 Source of Regu-
cal research and collects valuable data, based lations, cannabis resin is defined in the Single
on which it elaborates medical recommenda- Convention as “the separated resin, whether
tions for the most relevant treatment principles. crude or purified, obtained from the cannabis
SGCM-SSCM is the Swiss ambassador of the plant”. Cannabis resin is further separately listed
IACM (International Association for Cannabinoid in the BetmVV-EDI and is considered a controlled
Medicines). narcotic independent of its THC content. (How-
ever, this will be adjusted in 2022 and aligned
Medcan with the overall limitation of 1% THC content.)
Medcan advocates for the interests of patients
in Switzerland who take cannabis as a medicine, In contrast to cannabis resin, however, pollinate
and provides information on the use and effects (hemp flower pollinate) consists of fine CBD
of the medicinal plant. The association pursues hemp flower components that fall off when the
the goal of ensuring that patients in Switzerland biomass is shaken into drums (known as pol-
have legal access to cannabis without a great linators). The production of hemp flower polli-
deal of bureaucracy and can use it medically in nate is based exclusively on a process where the
tested quality and at reasonable prices. Moreo- flower components of the cannabis plant, which
ver, it demands from the FOPH to further edu- are freely marketable, are intensively refined and
cate physicians regarding possible indications extracted, resulting in a powder called hemp
and dosages and to minimise the bureaucratic flower pollinate. At no point in this process is
effort to obtain medicinal cannabis. Medcan the resin content explicitly increased. The resin
advocates on a political and on a public level for content (consisting of trichomes) of these prod-
people who use cannabis for medical purposes. ucts is the same as in CBD flowers. The resin is
thus not secreted from the flower but is still in the
1.4 Key Challenges very small flower components. Yet, many mar-
The cannabis market faces tremendous chal- ket participants had significant quantities of their
lenges such as inconsistent cannabis and can- pollinate production confiscated and destroyed,
nabinoids terminology, significant differences in which has caused widespread legal insecurity
enforcement between cantons as well as a con- and economic damage.
stantly changing regulatory environment.
The classification of pollinate as cannabis res-
The most obvious challenge market partici- in is debatable and remains to be clarified by
pants face is that cannabis is considered a higher instance courts or, ideally, by lawmakers.
narcotic drug if the THC content exceeds 1%. CBD pollinate is often exported into the EU and,
Consequently, all efforts by market participants in most cases, has a THC content of less than
to legally bring products to market are biased 0.2%. This is just one example of how confusing
by the default assumption that cannabis is an it can potentially be to bring cannabis products
illicit drug. This negative bias leads to height- to market.
ened scrutiny by enforcement agencies and is
not particularly conducive to the success of an Furthermore, some of the most challenging
emerging new industry. aspects of the cannabis market come to the sur-
face where various areas of the law overlap. The
A practical example of a wide-spread confusion development of a new product can be very chal-
in the market is the classification of “CBD pol- lenging when it is unclear, for example, whether

13
SWITZERLAND Law and Practice
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

it is governed by therapeutics or cosmetics law. international trade of medicinal and recreational

A chewing gum containing CBD could be many cannabis products, and a whole range of other
things – for example, a therapeutic product, a issues and uncertainties that participants in the
cosmetic product or a foodstuff. Defining the cannabis market must deal with.
product category and abiding by all regulatory
requirements while considering pertinent case 1.5 Level of Regulation
law can only be managed with a detailed techni- Cannabis-specific regulations in Switzerland are,
cal and legal assessment. with few exceptions, limited to narcotics and
criminal law. Legal uncertainty is still prevalent
Reference can be made to two very useful guides in production, trade and consumption of canna-
that can help, to some extent, navigate these bis products of all kinds (cosmetics, foodstuffs,
complexities. Firstly, the guide on Demarcation medicines, recreational use), as is inconsistent
criteria therapeutic products – foodstuffs with cantonal enforcement.
regard to products to be taken orally published
jointly by Swissmedic and the FSVO; secondly, In other jurisdictions – such as in many US states
the guide on Criteria for the demarcation of cos- where medical and recreational cannabis has
metic products from therapeutic products and been legalised – the cannabis market is meticu-
biocidal products, jointly issued by Swissmedic, lously regulated. Other countries are following
the FOPH and the FSVO. suit with various regulatory models (eg, Canada,
Uruguay).
Another main challenge in the CBD market is
the classification of cannabis extracts or tinc- Considering these developments, a revision of
tures (CBD oils). They can be qualified as raw Switzerland’s approach to cannabis regulation
materials or as ready-to-use products. While in appears warranted, as was recently proposed in
practice, most consumers are ingesting CBD a postulate submitted to the Council of States on
oils, such oils cannot be marketed as foodstuff 18 March 2021 by Thomas Minder, a member of
or nutritional supplements without authorisation the Council of States. Specific cannabis-related
of its components as novel food by the FSVO legislation could bring legal certainty through-
or the European Commission (EC). No company out the value chain and secure efficient quality
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, particularly for
medical cannabis industry 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 con-
described in the Trends & Developments article, cerning THC limits in Switzerland is considered
and the lifting of the export ban for cannabis rather progressive if compared to the EU and
for medicinal purposes, the market for medicinal the USA, where the threshold from legal can-
cannabis should be more accessible for compa- nabis (or hemp in the USA) to a narcotic drug
nies 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

14
 Law and Practice SWITZERLAND
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

for significantly higher values of THC intake from 1.7 Enforcement

food than the THC values in the EU. Switzerland Please refer to 1.4 Key Challenges.
has further repealed all provisions of the seed
legislation relating to the production and sale
of hemp seed and seedlings and is no longer 2. CROSS-
bound by the EU’s Common Catalogue of Vari- JURISDICTIONAL ISSUES
eties.
2.1 Cross-Jurisdictional Standards
In view of the latest developments in legislative In Switzerland, only cannabis with a THC content
reform of the NarcA regarding medicinal can- below 1% can be exported. The cannabis legis-
nabis, as well as cannabis trials for recreational lation of the importing country must therefore be
purposes, Switzerland is well positioned to fur- complied with. Generally, in the EU, cannabis-
ther expand its regulatory edge in the emerging products with a THC content of 0.2% and above
European cannabis industry. are considered narcotic drugs and thus cannot
be imported, except for medical purposes with
1.6 Legal Risks a special permit from local authorities.
Companies and individuals in the cannabis
market must navigate a complex web of inter- A revision of the NarcA which was adopted on
related, constantly changing areas of law. Non- 19 March 2021 will allow for exports of medical
compliance with existing laws and regulations cannabis with a THC content of 1% and above.
may lead to indictments for criminal offences, It is estimated that the revised law will be enact-
to administrative penalties and potentially to civil ed in the autumn of 2022. Further details can
damage claims. be found in the Trends & Developments article.

Recent enforcement measures by authorities Importers of cannabis products with a THC con-
were, for example, the shutdown of a retailer’s tent of 1% and below must be able to provide
website for publishing health claims in connec- proof in the form of a batch-specific analytical
tion with CBD products, and the imposition of a certificate for the delivery in question issued by
marketing ban for specific CBD oils. a laboratory accredited to ISO/IEC 17025 or by
a GMP laboratory.
However, special attention must be paid to the
compliance with the NarcA. Cannabis resin is
illegal independent of its THC content. Further- 3. FUTURE
more, cannabis products with a total THC con- DEVELOPMENTS
tent below 1% must meet the specific require-
ments of the Therapeutic Products Act, the 3.1 Legal Elements Affecting Access to
Foodstuffs Act, the Ordinance on Foodstuffs and Medical Cannabis
Utility Articles, the Chemicals Ordinance and the The main elements affecting medical cannabis
Tobacco Ordinance, among others, depending in Switzerland are described in the Trends and
on the classification of the product placed on Developments article, along with an overview
the market. It should be noted that not only the of impending changes to the current regulatory
NarcA but also other acts such as the TPA pro- framework.
vide for penal provisions.

15
SWITZERLAND Law and Practice
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

3.2 Use of Non-controlled Cannabinoids considered novel foods in Switzerland provided

in Food they originate from an approved plant of Can-
The FSA sets forth the rules on the safety and nabis sativa L. This is particularly the case for
transparency of foodstuffs and utility articles. hemp seeds, hemp seed oil, hemp seed flour
According to the FSA, foodstuffs are all sub- and defatted hemp seeds.
stances or products that are intended (or may
reasonably be expected) to be consumed by Furthermore, in Switzerland, herbal tea made
human beings in a processed, partly processed, from leaves of the hemp plant Cannabis sativa
or unprocessed state. Medical products, nar- L. is also not considered a novel food. However,
cotics and psychotropic substances do not fall the production, import or market placement of
under the definition of foodstuffs, and the other herbal teas obtained from the herb of the can-
way around. nabis plant is possible if one furnishes proof
that the herbal tea was already consumed as
Except for a few reservations (eg, novel foods), a foodstuff to a significant degree prior to 15
non-described foods without an authorisation May 1997, and is therefore not classified as a
can be placed on the market, provided they novel food. Novel foods that do not require an
meet all the requirements of food law. authorisation are listed in the FDHA Ordinance
on Novel Foods.
Under certain circumstances, which will be
described below, cannabis products may also Authorisation
be used in foodstuffs. The main tenet in food- As part of the authorisation procedure for novel
stuffs law is that foodstuffs must be safe – in foods, the FSVO examines whether the product
other words, they must neither be harmful to is safe and not deceptive. The basic prerequisite
health nor unsuitable for human consumption. for approval is that the product is classified as
a foodstuff and is not covered by the legislation
Novel Foods on medicinal products. In the case of foodstuffs
For foodstuffs that have not been used for containing cannabis, the Ordinance on the Maxi-
human consumption to any significant extent, mum Levels of Contaminants (VHK) is relevant. It
either in Switzerland or in an EU member state regulates the maximum permissible levels of del-
before 15 May 1997 – so-called “novel foods” ta 9-tetrahydrocannabinol in foodstuffs (which
– an authorisation by the Federal FSVO or an are generally higher than in the EU).
approval by the European Commission (EC) is
required. This applies to extracts of Cannabis It is important to note that all foods which, in
sativa L. that contain cannabinoids such as can- accordance with the Novel Food Regulations
nabidiol (CBD) and food products enriched with (EC) No 258/97 and (EU) 2015/2283, may be
extracts of Cannabis sativa L. or with cannabi- placed on the market in the EU are fundamen-
noids such as CBD (eg, hemp seed oil with add- tally also marketable in Switzerland (except for
ed CBD, food supplements with CBD), which are genetically modified foods). To place foodstuff
classified as novel foods and therefore require with CBD on the European market presupposes
an 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-

16
 Law and Practice SWITZERLAND
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

tage that the foodstuff can be placed on both A whole range of cannabinoids containing ingre-
the European and the Swiss markets. However, dients will be tested to ensure all food products
the reverse situation does not apply. Foodstuffs using these ingredients will be covered by the
that are not novel foods in Switzerland or have joint application. For the purpose of the appli-
been authorised as such in Switzerland and are cation, a corporation under German law was
classified as a novel food in the EU require an founded (EIHA projects GmbH), which collects
authorisation from the European Commission for the special contributions to finance the project
market placement in the EU. and ultimately acquires the rights for the distri-
bution of the approved products. EIHA projects
Lastly, authorisations are generally not issued GmbH will manage these rights and transfer
for composite foods. The authorisation require- them to EIHA members, with an established
ment always relates to a substance, not to a sublicensing system for white label (retail) trad-
composite product containing a novel food as ing companies.
an ingredient.
Swiss companies aspiring to develop and bring
The EIHA Consortium cannabis-based food products to market are
The European Industrial Hemp Association advised to evaluate a participation in the EIHA
(EIHA) is Europe’s largest association that rep- Consortium.
resents the common interests of hemp farm-
ers, producers, and traders working with hemp 3.3 Decriminalisation or Recreational
fibres, shives, seeds, leaves and cannabinoids. Regulation
The latest developments regarding a potential
In 2019, EIHA created a Novel Food Consor- legalisation of cannabis use for recreational pur-
tium with the aim of submitting a joint novel poses can be found in the Trends and Develop-
food application both to the UK Food Safety ments article.
Authority for the British market as well as to the
European Food Safety Authority (EFSA) for the
EU market (which, as mentioned above, would
include Switzerland), the costs of which will be
shared among its members. It is estimated that
the consortium will invest up to EUR3.5 million
for financing all relevant and unprecedented
toxicological studies on CBD and THC with the
help of a qualified service provider (ChemSafe).

17
SWITZERLAND Trends and Developments
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

MLL Meyerlustenberger Lachenal Froriep the country. Two offices abroad, in London and
Ltd is a leading Swiss law firm with a history Madrid, also provide local contact points for cli-
dating back to 1885. The firm has grown both ents seeking advice on Swiss commercial law.
organically and through strategic mergers, the Today, the firm has a strong international pro-
most recent of which was completed on 1 July file and a long-established global network. MLL
2021 between Meyerlustenberger Lachenal and combines recognised leadership and notable
Froriep. Through this merger, MLL has become expertise in all areas of Swiss and international
one of the largest commercial law firms in Swit- business law.
zerland, with over 150 lawyers in four offices in

AUTHORS

Daniel Haymann heads MLL’s Daniel Donauer is an attorney

cannabis practice. He in MLL’s Zurich office and a
specialises in corporate and member of the product
commercial law, with a focus on regulation, IP, and litigation/
M&A, private equity and venture arbitration practice groups. He
capital transactions, and advises clients in the life
regulatory matters. He advises investors, sciences sector on regulatory and litigation
start-ups, and vertically integrated companies issues of health and medical law, particularly
in the cannabis industry along the value chain. on product regulation and product
Prior to embarking on a career as an attorney, implementation for pharmaceuticals and
Daniel gained over 12 years of experience in medicinal products, medical devices, food,
the trading, mining and energy industries, alcohol and tobacco products, consumer
working for multinational corporations as a goods and chemicals. Additionally, he advises
trader and in managerial positions. He is a and litigates in IP matters. His advice often
member of the Zurich and Swiss Bar focuses on the areas of health insurance and
Associations and co-chair of the European healthcare law. Furthermore, he assists clients
Chapter of the International Cannabis Bar with medical law matters in the area of human
Association (INCBA Europe). research, reproductive medicine and genetic
engineering.

MLL Meyerlustenberger Lachenal

Froriep Ltd
Schiffbaustrasse 2
Postfach
8031
Zürich
Switzerland

Tel: +41 58 552 08 00

Email: [email protected]
Web: mll-legal.com

18
 Trends and Developments SWITZERLAND

Trends and Developments

Contributed by:
Daniel Haymann and Daniel Donauer
MLL Meyerlustenberger Lachenal Froriep Ltd see p.26

Introduction consuming “medical” cannabis illegally – that is,

The current regulatory environment surrounding sourced from the black market – which exposes
cannabinoid-based products in Switzerland is them to significant health risks due to the lack of
still marked by a high degree of uncertainty, due quality control and a growing number of cut and
both to vague legislative requirements and het- contaminated products in circulation. This num-
erogenous, sometimes arbitrary, enforcement. ber does not include the number of recreational
However, with the rise of public awareness of cannabis consumers, which is, by a conservative
the general benefits of the cannabis plant as a estimate, a threefold of the FOPH figure.
result of the cannabidiol (CBD) boom, as well as
the increasing use of cannabigerol (CBG) dur- Cannabis with a THC (tetrahydrocannabinol)
ing the last few years – plus growing anecdotal content of 1% and above is considered a prohib-
evidence from liberalised recreational markets ited narcotic in Switzerland. Under very restric-
such as Canada, Uruguay and certain US states tive circumstances, cannabis with a THC con-
– recent legislative developments are presenting tent above 1% may be prescribed for medical
an opportunity for Switzerland to establish itself purposes, but it requires an exceptional permit
as a role model for an innovative, pragmatic, from the FOPH. However, the Swiss Parliament
safe and comprehensively regulated cannabis approved an amendment to the law to facilitate
market. access to cannabis medicines on 19 March
2021, which essentially states that in the future
Medical Cannabis Reform (ie, from autumn 2022, as expected) cannabis for
The status quo medical purposes will be possible without any
A study conducted by the Institute for Addiction exceptional permit from the FOPH. The adopted
and Health Research on behalf of the Federal amendment to the law facilitates access to can-
Office of Public Health (FOPH), the findings of nabis medicines for thousands of patients as
which were published in February 2020, con- part of their treatment. This mainly affects cases
cluded that for over 96% of the participants of cancer or multiple sclerosis, where cannabis-
questioned, the consumption of medical canna- containing medicines can alleviate chronic pain.
bis has led to an improvement of their symptoms.
Half of the participants reported an “extreme As the currently most-researched cannabinoid,
improvement”. A large part of the participants THC is predominantly used for chronic pain con-
who already had prescriptions for cannabinoid- ditions, spasticity and spasms, as well nausea
based medicines reported that they were able and loss of appetite (mostly in the context of
to either completely abandon other prescribed chemotherapy). Ready-to-use medicinal prod-
drugs, or at least strongly reduce their consump- ucts may only be marketed in Switzerland if they
tion. are approved by Swissmedic, the Swiss Agency
for Therapeutic Products.
Around 3,000 patients are legally prescribed
medical cannabis in Switzerland today. The At present, in Switzerland, only two ready-to-
FOPH estimates that over 110,000 patients are use medicinal products based on cannabis have

19
SWITZERLAND Trends and Developments
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

been approved by Swissmedic, one of which is The amendment of the NarcA

Sativex®, with a THC content of above 1%. The main features of the legislative amendment
Sativex can be prescribed without special per- are as follows.
mit for spastic convulsions in multiple sclerosis
patients. For any other indication, an exception • The ban on marketability of medical cannabis
permit by the FOPH must be obtained (ie, for will be lifted. Medical cannabis will be reclas-
“off-label-use”). sified as a controlled narcotic with restricted
marketability. Cultivation, processing, produc-
The second medicinal product is Epidyolex, a tion and trade will be subject to the authorisa-
CBD-based drug that was approved by Swiss- tion and control system of Swissmedic, in the
medic on 10 February 2021. Epidyolex contains same way as other narcotics that are used in
the active substance cannabidiol, which can be a medical context, (eg, morphine).
used for the treatment of seizures (epilepsy). • A special permit by the FOPH will no longer
Epidyolex is an oral solution. It is used in com- be required to prescribe medical cannabis. In
bination with other medicines in patients aged other words, every doctor in Switzerland will
two years and older with Lennox-Gastaut syn- be able to prescribe medical cannabis.
drome or Dravet syndrome; both syndromes are • During the first few years after the coming
rare diseases associated with seizures and fits into force of the amendment, doctors will
(epilepsy). have to regularly report to the FOPH a whole
range of data regarding the therapies. The
If an approved preparation is unsuitable, physi- data collection will serve as a basis for the
cians can prescribe cannabis as a drug which is scientific evaluation of the revision as well as
exempt from approval by Swissmedic, but which guidance to the responsible cantonal enforce-
still requires a special permit by the FOPH. The ment authorities and the prescribing physi-
drug is then usually produced by a pharmacy on cians.
a doctor’s prescription as a so-called “extempo- • Commercial exports of medical cannabis will
raneous preparation” – ie, a “formula magistra- be made possible.
lis” – which is how most cannabis is prescribed
in Switzerland today. Apart from the Narcotics Act, executive ordi-
nances will also be amended. According to the
Applying for a special permit at the FOPH is bur- current wording of Swiss law, cannabis resin
densome, both for the physician and the patient. (hashish) is considered a narcotic drug that is
Although most applications are granted, the subjected to the Narcotics Act independent of
surge of applications in the last few years no its THC content, (ie, even if the THC content is
longer justifies the special treatment of medical below 1%). However, in its statement of 16 Feb-
cannabis as a prohibited narcotic. This realisa- ruary 2022 on a respective motion, the Federal
tion has led to a revision of the current regime Council announced the amendment of the ordi-
and the required amendments to the Federal nance so that the THC threshold of 1% will also
Act on Narcotics and Psychotropic Substances be applicable for cannabis resin in the future.
(NarcA), which the Swiss Parliament recently
adopted (on 19 March 2021). Reimbursement by compulsory health
insurance
Unfortunately, treatment with medical can-
nabis products is not covered by the compul-

20
 Trends and Developments SWITZERLAND
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

sory health insurance (OKP) due to insufficient • cultivation of medical cannabis in Switzerland
scientific evidence regarding the efficacy and (with a special permit by Swissmedic when
cost-effectiveness of these medicines (and this the amendment has been enacted);
will not change after the entry into force of the • further research into new plant varieties and
aforementioned revision), especially for extem- traits as well as cannabinoid development;
poraneous preparations. Such medicines are • innovative research and development of
reimbursed by the health insurance providers in cannabinoid-based drugs;
consultation with the physician on an exception • development of new delivery methods,
basis only. including vaporisers, dry powder inhalers,
slow-release tablets, etc;
The major challenge regarding the adopted • establishment of a cross-border medical can-
amendment is that the law does not envisage nabis marketplace with a surge in imports as
adjusting the current requirements for reim- well as exports;
bursement by the OKP. According to Medcan, • development of software tools for quality
Switzerland’s largest medical cannabis patient’s assurance, seed-to-sale traceability solutions
association, the costs of treatment with medi- as well as documentation standards (GACP,
cal cannabis can range from CHF450 to over GMP, etc);
CHF10,000 per month. • education platforms for physicians, patients
and the general public.
A Health Technology Assessment report (HTA)
that was published on 30 April 2021, on behalf of Many more opportunities will arise in this grow-
the FOPH, was prepared to clarify the scientific ing and fast-moving industry. The success of the
evidence regarding the efficacy and cost-effec- adopted amendment, the purpose of which is
tiveness of medical cannabis products and to first and foremost a facilitated access to medi-
differentiate between the various patient groups. cal cannabis for patients, will hinge on whether
Unfortunately, the HTA ultimately decided that these patients will be able to obtain reliable,
the efficacy data on medical cannabis use for quality-controlled, safe and affordable medical
chronic pain and spasticity was inconsistent (ie, cannabis products.
studies with comparable patient populations
and similar type of medical cannabis did not Tiptoeing in Cannabis Legalisation: the
show consistent results pointing in the same Recreational Pilot Trials
direction) and inconclusive (ie, none of the stud- Cannabis is the most frequently consumed ille-
ies was able to draw a definitive conclusion on gal substance in Switzerland. Around one-third
the efficacy of medical cannabis). As a result, of people aged 15 years and over have already
the WZW criteria for medical cannabis have not had experience with the drug. According to the
been confirmed, which leaves the issue of reim- FOPH and Addiction Monitoring Switzerland,
bursement by healthcare insurance unresolved. approximately 7.7% of the population used can-
nabis at least once during the last 12 months,
Commercial opportunities and 4% in the last 30 days.
The amendment to the NarcA presents entre-
preneurs with a range of new and exciting com- Repression has never been effective in curb-
mercial opportunities, such as: ing cannabis consumption or in eliminating the
black market. Legislators in Switzerland arrived
at the conclusion that alternative regulatory

21
SWITZERLAND Trends and Developments
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

options must be examined. At its meeting on 31 practice (GACP) of the European Medicines
March 2021, the Federal Council adopted the Agency (EMA), and be, in principle, organi-
Ordinance on Pilot Trials as per the NarcA, which cally produced according to the Organic
sets a detailed framework for the dispensing of Farming Ordinance of 22 September 1997;
cannabis products for non-medical use. On 15 only outdoor or greenhouse production that
May 2021, the amendment to the NarcA has is soil-bound is permitted (ie, indoor-grown
come into effect. It now allows pilot testing of cannabis is excluded).
the controlled dispensing of cannabis for recrea- • Regarding product quality, the total THC
tional purposes. From that point onwards, appli- content may not exceed 20%; in products for
cations to conduct such trials can be submitted oral intake, the THC content may not exceed
to the Federal Office of Public Health. 10 mg per serving. Cannabis products must
not contain levels of contaminants that give
The amendment to the NarcA, which will remain rise to health concerns and must be limited
in effect for ten years (ie, until 14 May 2031), to specified amounts of foreign components,
provides the legal basis for the implementation microbial contaminants, mycotoxins, heavy
of local and time-limited scientific pilot trials with metals, pesticides and solvent residues from
cannabis. The pilot trials will allow consumers extraction. Notably, the maximum levels of
to legally purchase a wide range of cannabis- delta-9-THC content, as per Annex 6 of the
based products. The cannabis offered must Contaminants Ordinance of 16 December
meet high quality standards, with strict seed- 2016, do not apply to edibles.
to-sale transparency, and must originate from • Cannabis products must abide by a whole set
organic cultivation. of safe packaging and labelling requirements.
• Advertising for cannabis products remains
The aim of the studies is to expand knowledge prohibited.
on the advantages and disadvantages of con- • Minors under the age of 18 are excluded from
trolled access to cannabis. They should facilitate the pilot trials and participants must already
the examination and documentation of the con- be consumers of cannabis products.
sequences on health and consumption habits of • The maximum amount of dispensed cannabis
users in a scientific framework and provide data per participant per month may not exceed 10
on the effects on the local illicit drug market, as g of total THC.
well as on the protection of minors and public • Cannabis products may only be dispensed at
safety. points of sale with trained staff and adequate
infrastructure, and at a price that is in line
In more detail, the pilot trials must meet the fol- with the black market. Distribution will there-
lowing main requirements. fore be made possible in both pharmacies
and social clubs, for example.
• Pilot trials are limited in time (five years, with • Both public and private organisations can
an option to extend by another two years), apply to the FOPH to conduct cannabis trials.
location (one or several municipalities), as • Outside of the pilot trials, the existing can-
well as number of participants (maximum nabis prohibition with the associated penal
5,000 participants per trial). provisions for violations of the law will con-
• Cannabis supplied to the pilot trials has to tinue to apply.
originate in Switzerland, be in line with the
Guideline on good agricultural and collection

22
 Trends and Developments SWITZERLAND
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

A long list of further requirements is detailed in data gathering of recreational cannabis products
the Ordinance on Pilot Trials as per the NarcA of in the context of the trials as well as the black-
31 March 2021. market pricing ceiling will leave very limited room
for extracting meaningful margins for suppliers
While the adoption of the pilot trial legislation has or distributors of the pilot programme. While the
been positively received by the cannabis indus- pilot trials allow for up to 5,000 participants, the
try and is recognised as a possible further step first impressions obtained by universities and
towards a controlled liberalisation, the require- cities planning to conduct such trials is that the
ments for the cannabis products to be used in actual number of participants will be significantly
the trials poses some major challenges of which lower – ie, in the hundreds at best – mostly for
law-makers may not have been fully aware. funding reasons.

Most of the cannabis from the black market However, the trials may well be a first step
that is consumed today is produced indoors. towards a trend in further liberalisation of the
In general, the indoor cannabis flower grown recreational cannabis market. Companies with a
in a controlled environment tends to be denser, reliable, quality-controlled supply chain may be
contain a higher trichome count and provide well-positioned to use the pilot trials to establish
a more potent high than cannabis grown out- brand equity, create innovative new products
doors or in greenhouses, although this point is and gather valuable experiences in a new and
subject to repeated debate within the cannabis developing market.
community. Concerns have been raised that the
requirements set with regard to organic farming, Further Political Developments
which limits suppliers of the cannabis trials to Parliamentary Initiative: “Siegenthaler”
soil-bound outdoor production or greenhouse On 25 September 2020, Heinz Siegenthaler, a
operations, may thwart obtaining reliable data member of the Swiss National Council, filed a
from the trials by failing to attract enough partici- parliamentary initiative which was signed by a
pants willing to try a new avenue with products total of 40 members of the Swiss National Coun-
to which they are not accustomed. cil, in an attempt to force a new and compre-
hensive regulation for the cultivation, production,
Other challenges may be to abide by a precise trade and consumption of cannabis containing
THC limit of 20% when growing outdoors where THC in line with the recommendations of the
weather conditions cannot be controlled, as Federal Commission on Narcotic Drugs (EKSF).
well as the use of clones only, as opposed to The main objectives of the initiative are the con-
“feminised” seeds which are not compliant with trol of production and trade by governmental
the Organic Farming Ordinance but have grown bodies, the separation of the medical and the
popular as they can be relied on to produce non-medical markets, the drying up of the black
female plants only and increase yield. It should market by lifting the prohibition, the regulation of
be noted that no such restrictions have been taxation and advertising as well as cultivation for
imposed on cultivation of cannabis for medical personal use.
purposes.
The reasoning accompanying the original text of
Commercial opportunities the initiative describes a general moral and legal
The high bar set regarding the application pro- inconsistency in cannabis prohibition, based on
cess, cultivation, production, distribution and current scientific research, especially if contrast-

23
SWITZERLAND Trends and Developments
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

ed with other harmful substances such as tobac- have liberalised the use of cannabis, ought to
co and alcohol. The Federal Council, in a state- be considered.
ment made on 23 May 2018, candidly admitted
that the NarcA has failed to fulfil its purpose of According to the text of the postulate, there is
protecting the population, considering the more still a great deal of legal uncertainty in the area
than 300,000 regular cannabis consumers in of production, trade and consumption of hemp
Switzerland. A flourishing black market, the lack products of all kinds (cosmetics, foodstuffs,
of quality controls, effective protection of youth medicines, recreational use), as well as extreme-
and reliable information, as well as a growing risk ly inconsistent cantonal enforcement, and even
of “cut” cannabis products containing artificial arbitrariness.
and toxic substances, warrant the replacement
of the current prohibition with a fully regulated The postulate refers to the findings in a compre-
cannabis market that meets the requirements of hensive report issued by the Federal Commis-
Swiss addiction policy, according to the initia- sion on Narcotic Drugs (EKSF) in 2019, accord-
tive. ing to which a revision of the NarcA regarding
cannabis is warranted, as is a general reorgani-
On 28 April 2021, Switzerland’s Health Commis- sation of the approach towards cannabis. The
sion of the National Council voted in favour of EKSF highlights familiar argumentation, such as
a controlled legalisation of cannabis. This was the assumption that market control with a regu-
a first important political hurdle the Siegent- lated supply chain is likely to reduce health risks
haler parliamentary initiative has passed. On 19 for consumers and that taxation would unlock
October 2021, the equivalent commission in the much-needed capital to increase preventative
Council of States with an overwhelming majority measures in vulnerable populations (eg, minors
of nine to two followed suit and gave the Health and persons under guardianship).
Commission of the National Council the green
light to prepare draft legislation as proposed by The text concludes that it is the right time for
the initiative. a political discussion on a comprehensive can-
nabis reform, also in view of the significant eco-
Postulate: “Minder” nomic potential of hemp in general. On 17 June
On 18 March 2021, Thomas Minder, a member 2021, the Council of States concurred with this
of the Swiss Council of States, filed a postulate view, and passed the motion.
mandating the Federal Council to evaluate in a
report how the various forms of cannabis could The latest political developments surrounding
be made more economically usable and how cannabis legislation are proof that the urgency
a contemporary and comprehensive cannabis to comprehensively regulate this growing market
regulation could be enacted (including health, has manifested itself in the general public con-
food, cosmetics, medicinal products, reason- sciousness. The limited view of cannabis as an
able thresholds for driving, tobacco products allegedly harmful narcotic drug and the stigma-
and customs regulations). The goal would be to tisation of its consumers is making way for the
achieve more legal certainty and a more uniform recognition of its significant medical potential, as
enforcement throughout Switzerland regard- well as the promising economic growth it could
ing the production, trade and use of cannabis generate in terms of recreational and industrial
products. In doing so, the experience of other use.
countries, such as the USA or Canada, which

24
 Trends and Developments SWITZERLAND
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

With an already progressive regulatory frame-

work regarding THC thresholds compared to the
rest of Europe and the liberalisation of cannabis
for medical purposes, Switzerland is in an excel-
lent position to expand its leading role in Europe
as an innovative, responsible and attractive hub
for cannabis entrepreneurs all along the value
chain.

25
SWITZERLAND Trends and Developments
Contributed by: Daniel Haymann and Daniel Donauer, MLL Meyerlustenberger Lachenal Froriep Ltd

MLL Meyerlustenberger Lachenal Froriep the country. Two offices abroad, in London and
Ltd is a leading Swiss law firm with a history Madrid, also provide local contact points for cli-
dating back to 1885. The firm has grown both ents seeking advice on Swiss commercial law.
organically and through strategic mergers, the Today, the firm has a strong international pro-
most recent of which was completed on 1 July file and a long-established global network. MLL
2021 between Meyerlustenberger Lachenal and combines recognised leadership and notable
Froriep. Through this merger, MLL has become expertise in all areas of Swiss and international
one of the largest commercial law firms in Swit- business law.
zerland, with over 150 lawyers in four offices in

AUTHORS

Daniel Haymann heads MLL’s Daniel Donauer is an attorney

cannabis practice. He in MLL’s Zurich office and a
specialises in corporate and member of the product
commercial law, with a focus on regulation, IP, and litigation/
M&A, private equity and venture arbitration practice groups. He
capital transactions, and advises clients in the life
regulatory matters. He advises investors, sciences sector on regulatory and litigation
start-ups, and vertically integrated companies issues of health and medical law, particularly
in the cannabis industry along the value chain. on product regulation and product
Prior to embarking on a career as an attorney, implementation for pharmaceuticals and
Daniel gained over 12 years of experience in medicinal products, medical devices, food,
the trading, mining and energy industries, alcohol and tobacco products, consumer
working for multinational corporations as a goods and chemicals. Additionally, he advises
trader and in managerial positions. He is a and litigates in IP matters. His advice often
member of the Zurich and Swiss Bar focuses on the areas of health insurance and
Associations and co-chair of the European healthcare law. Furthermore, he assists clients
Chapter of the International Cannabis Bar with medical law matters in the area of human
Association (INCBA Europe). research, reproductive medicine and genetic
engineering.

MLL Meyerlustenberger Lachenal

Froriep Ltd
Schiffbaustrasse 2
Postfach
8031 Zürich
Switzerland

Tel: +41 58 552 08 00

Email: [email protected]
Web: mll-legal.com

26
Chambers
Global Practice Guides
Chambers Global Practice Guides bring you up-to-date, expert
legal commentary on the main practice areas from around the
globe. Focusing on the practical legal issues affecting busi-
nesses, the guides enable readers to compare legislation and
procedure and read trend forecasts from legal experts from
across key jurisdictions.

To find out more information about how we select contributors,

email [email protected]

practiceguides.chambers.com