Authorisation of pilot trials under Art. 8a NarcA

The FOPH can grant authorisations for scientific pilot trials involving the controlled dispensing of non-medicinal cannabis that are limited in time, place and scope, provided new insights into cannabis use can be gained.

The FOPH authorises pilot trials under the Narcotics Act (NarcA) provided the submitted application is complete and the requirements for conducting the trial, as stipulated in Art. 8a NarcA and the Ordinance on Pilot Trials Conducted Under the Narcotics Act (NarcPT), (in German, French and Italian) are met.

Pilot trials are scientific studies designed to deliver insights on the impact of measures, usefulness of instruments and effectiveness of approaches regarding the use of non-medicinal cannabis.

You can find more information on pilot trials with cannabis on this page:

Pilot trials with cannabis

Pilot trial requirements

Pilot trials must be geographically limited to one or more communes and can be conducted by public or private organisations. The duration of pilot trials must be scientifically justified and is limited to a maximum of five years; a one-off extension of no more than two years may be granted if justified and reasons are given. Pilot trials must involve the minimum number of participants needed to be able to draw meaningful scientific conclusions, and may not exceed 5,000 participants.

You will find further requirements and guidance on conducting pilot trials in Articles 5-20 of the Ordinance on Pilot Trials Conducted Under the Narcotics Act (NarcPT).

Research questions and core questionnaire

Scientific pilot trials are designed to provide insights into one or more of the following impacts:

the physical and mental health of users and their performance and productivity;
consumption pattern;
socioeconomic aspects;
the drug market in a specific area;
youth protection; or
public order and public safety.

The pilot trials with cannabis choose their research questions primarily along these subjects. The FOPH provides a standard questionnaire for participants in the cannabis pilot trials (the links are under the section "Questionnaire for cannabis pilot trials" at the bottom of this page). We ask all trial partners to use this. The use of uniform questions will increase comparability and thus validity towards policy makers and the general public.

Documentation and reporting obligations

Authorisation holders must keep a record of all traffic of cannabis products and must report to the FOPH and cantonal authorities at the end of every year on the sale of cannabis products and on the quantity stored at individual points of sale. They must report any unforeseen events to the FOPH immediately (see Art. 27 NarcPT). The FOPH will ensure that the relevant processes are in place as part of the authorisation procedure.

These documentation and reporting obligations also apply to holders of exceptional licenses for the cultivation of cannabis and the manufacture of cannabis products for pilot trials.

The FOPH recommends that applicants use a digital system to document cultivation and distribution. The FOPH funds a track and trace system for pilot trials with cannabis for recording cannabis products cultivated and the dispensing of cannabis; pilot projects can use the system free of charge.

Inspection activities

To ensure compliance with the provisions of the NarcPT on cultivation and product quality and on packaging and product information, distributors are required to self-regulate (Art. 30 NarcPT).

The FOPH ensures that authorisation holders comply with the provisions of the NarcPT for pilot trials. It may consult the competent cantonal executing authorities for this purpose.

Compliance with the requirements for conducting pilot trials is primarily ensured through periodic inspections by the competent federal and cantonal authorities. Authorisation holders are required to grant inspectors access to sites and premises. This applies to all related areas, i.e. cultivation areas, production facilities, and sale and storage areas. The relevant stock and accompanying documents must be presented to inspection authorities upon request.

Coordination of applications

An exceptional licence from the FOPH, in accordance with Art. 8 para. 5 NarcA, is required for the cultivation, manufacture or import of narcotics with an effective concentration of cannabinoids that are used in the pilot trials. These activities are not covered by the pilot trial licence. Therefore, an application to conduct a pilot trial and for the cultivation, manufacture and/or import must correlate and being submitted to the FOPH in full. The FOPH coordinates the authorisation procedure.

Information on exceptional licences for the cultivation, production and import of cannabis for pilot trials can be found on these pages:

As scientific studies under the Human Research Act, pilot trials must be approved by the competent cantonal ethics committee. Applicants may submit the application to conduct the pilot trial to the FOPH and to the cantonal ethics committee at the same time.

Applications for a licence to conduct a pilot trial should be accompanied by proof that an application has been submitted to the competent ethics committee.

Submission of application

Applications must be signed by the person responsible for the pilot trial and submitted in full to the FOPH. Applications should be sent by post to the following address:

Confidential

Federal Office of Public Health
Prevention of Non-Communicable Diseases Division
Policy Bases and Implementation Section
Schwarzenburgstrasse 157
Postfach
3003 Bern

The FOPH can request additional information and documents at any time.

When submitting your application please take processing time into account.

Application requirements

Applications for a licence to conduct a pilot trial must contain at least the following information and supporting documents:

Information on the activity of the public or private organisation submitting the application
Designation of a responsible person who will supervise the pilot trial
Extract from the Swiss criminal record excerpt for the person responsible for conducting the trial that must have been issued within the last six months
Information on the aim and benefit of the pilot trial
Description of the trial (study protocol), particularly regarding the content, methodology and approaches, number of participants, what information participants will be given, funding and timeframe
Designation of the research management
Information on what type of cannabis products will be made available (see also product quality requirements: Art. 9 NarcPT)
List of points of sale that will dispense those cannabis products
Information on the involvement of relevant cantonal and communal authorities and consent from the relevant communes regarding the planned points of sale
Information on the envisaged quantities to be dispensed and sale price (Art. 16 NarcPT)
Information on cultivation, import, manufacture and distribution of cannabis products (applications in accordance with Art. 24 NarcPT)
A description of the precautionary measures taken to ensure participant safety and to protect public order and public safety
Information on the monitoring of participants’ state of health
Information on prevention, youth protection and health protection measures and strategies
Evidence that a licence application has been submitted to the competent ethics committee in accordance with Art. 45 of the Federal Act of 30 September 2011 on Research involving Human Beings (HRA), or that a confirmation has been requested stating that such an authorisation is not required. A decision/confirmation from the ethics committee should be enclosed with the application.

The authorisation procedure includes a comprehensive examination of the legal requirements, coordination of the decisions with the ethics committees and, last but not least, consultation with the cantons and communes concerned. Experience shows that several rounds of clarification with the applicants are necessary. Due to the complexity of the authorisation procedure, a processing period of at least 3 months is to be expected.

Documents
Legislation

Form: Disclosure of vested interests BetmPV (PDF, 228 kB, 19.02.2024)

Checklist: Authorisation of pilot trials under Art. 8a NarcA – Application requirements (PDF, 685 kB, 22.07.2021)

A research agenda for the regulation of non-medical cannabis use in Switzerland (PDF, 2 MB, 18.08.2021)in English, executive summary in German, French, Italian
Roman Zwicky et al.
Universität Zürich, Institut für Politikwissenschaft, Forschungsbereich Policy-Analyse & Evaluation, 2021

SR 812.121 Narcotics Act (NarcA) Art 8a

812.121.5 Ordonnance sur les essais pilotes au sens de la loi sur les stupéfiants (OSPStup)

Further information

Pilot trials with cannabis

On 15 May 2021 an amendment to NarcA has come into force allowing pilot trials involving the dispensing of cannabis for non-medicinal (“recreational”) purposes. These studies are intended to create the basis for the future legal regulation of cannabis.

Exceptional licences related to pilot trials

After consulting with the relevant cantons and communes, the FOPH can authorise scientific pilot trials with narcotics containing an effective concentration of cannabinoids.

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