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.

As stipulated in the Ordinance on Pilot Trials under the Narcotics Act (BetmPV), pilot trials may only be conducted if they are intended and designed to gain scientific knowledge in the areas specified under BetmPV Article 2. In accordance with BetmPV Article 23, Paragraph 2, the FOPH will reject any requests for pilot trials which are unlikely to produce any new or further findings. The FOPH enjoys a certain discretionary scope when making the corresponding assessments.

New pilot trial requests will only be considered if it can be convincingly argued that the issues they address have not been covered by existing projects. It is the responsibility of the requesting party to adequately assess this in advance.

From a regulatory perspective, further pilot trials which are expected to produce new or further findings are of primary interest in the areas of:

• Pricing actions (incentive taxes), e.g. what incentive taxes might lower consumption without demand migrating to black-market sources, and what taxes might encourage a shift to lower-risk products and forms of consumption?
• Online sales channels, e.g. how can consumers be effectively sensitised, advised and protected from health harm in this sales environment, and what restrictions would this require?
• Road safety (as part of supplementary studies): e.g. can more reliable indicators be found than the level of THC in blood to determine fitness to drive following cannabis consumption, and what other actions could be taken to enhance road safety?
• Distribution models in rural areas, e.g. what sales models could be cost-effectively adopted in rural areas, and how acceptable are these likely to be among consumers and the broader population?

The FOPH reserves the right to reject any requests for pilot trials which are unlikely to provide significant new findings.

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.

Further information

• Documents

  • Form: Disclosure of vested interests BetmPV

    PDF234.09 kB19 February 2024

  • Checklist: Authorisation of pilot trials under Art. 8a NarcA – Application requirements

    PDF702.30 kB22 July 2021

  Legal basis

  • Explanatory report on NarcA

    in French

    PDF275.41 kB14 July 2021

  • FOPH standard questionnaire for participants in the pilot trials with cannabis

    German version Federal Office of Public Health, 2023

    PDF959.16 kB20 March 2023

  • Instruction to the use of FOPH standard questionnaire for participants in the pilot trials with cannabis

    German version Federal Office of Public Health, 2023

    PDF320.16 kB20 March 2023

  • Instruction to the module "competency in lower-risk cannabis use”

    German version Federal Office of Public Health, 2023

    PDF463.03 kB20 March 2023

  Scientific and technical basis

  • Health protection, youth protection and prevention: Orientation framework for the pilot tests with cannabis

    Infodrog, 2021 in French

    PDF846.37 kB1 June 2021

  • A research agenda for the regulation of non-medical cannabis use in Switzerland

    in English, executive summary in German, French, Italian Roman Zwicky et al. Universität Zürich, Institut für Politikwissenschaft, Forschungsbereich Policy-Analyse & Evaluation, 2021

    PDF2.79 MB18 August 2021

• Legislation

  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