Published on 13 March 2024
FAQs on cannabis pilot trials
This page provides answers to frequently asked questions relating to the cannabis pilot trials. It also contains information on the objectives, participation and organisation of the trials
Aims of the cannabis pilot trials
The aim is to increase knowledge of the advantages and disadvantages of controlled access to cannabis, and to provide a sound scientific basis for possible decisions on the way the approach to cannabis is regulated.
Growing, importing, producing and selling cannabis is prohibited in Switzerland. Despite this ban, consumption is widespread, the black market is thriving, and users’ safety is not guaranteed.
In view of this unsatisfactory situation, parliament decided to amend the Narcotics Act (NarcA) to create the possibility for a limited period of ten years to test the impact of new regulatory approaches to the way cannabis is handled. The new legislation allows pilot trials to be conducted on non-medical cannabis use in adults. The aim is to provide a sound scientific basis for possible decisions on the design of cannabis regulation.The pilot trials look at the use of cannabis by adults for recreational purposes. They do not cover medically prescribed cannabis use for medicinal purposes.
The pilot trials are designed to give us a better understanding of the effects of controlled access to cannabis on the physical and mental health of users and on behaviour linked to cannabis consumption. In addition, the study will look at socio-economic aspects, such as the effects on users’ work capacity (absenteeism) and on their family and social relationships. These scientific studies may also examine the impact on the local black market and the protection of young people and public safety. However, the specific research questions will be decided by the relevant research projects.
As part of these scientific studies, users will be able to legally purchase various cannabis-based products, the quality of which will be highly regulated. As well as receiving product information, participants will be made aware of the risks of cannabis consumption by staff at the points of sale who will be trained accordingly. Resort to the black market will thus be ruled out, because the supply chains, from seed to product distribution, will be monitored and strictly controlled. The pilot trials are subject to strict requirements in terms of the protection of minors and health protection, and a total ban on advertising.
The aim of these trials is to provide a sound scientific basis for any future decision-making on the design of cannabis regulation. The research is independent and open-ended. Outside these pilot trials, the ban on cannabis remains in force.
The aim is to provide a solid scientific basis for any future decision-making on cannabis regulation. In no way does this determine the outcome of any future political decisions. The trials are not merely examining the question of whether a ban or the legal sale and use would basically be more expedient. Rather, they are intended to also gain insights into how concrete alternatives to the prohibition of cannabis could be designed to minimise the social and health costs for society.
Protection of minors
Only adults will take part in the pilot trials. Not only that, but the implementing ordinance (NarcPT) sets forth a range of measures to protect minors, including childproof packaging for cannabis products for oral use, the safe storage of cannabis products, and labelling with appropriate warnings. The passing on of trial-related cannabis will be sanctioned with appropriate measures and in the event of a repeat offence will result in exclusion from the pilot trial.
Information to the public
The projects will provide information on the conduct of the various pilot trials on an individual basis. The licence holders for pilot trials will be required to provide the FOPH with an annual progress update and record the results of the trials in a research report. The FOPH will inform the public periodically about ongoing pilot trials.
Timeframe for the trials
This depends on the planning of those responsible for organising the pilot trials. The FOPH itself will not be conducting any pilot trials. Trials require FOPH approval. For this reason the time taken for the FOPH to review applications must be taken into account.
Applications for pilot trials can be submitted once the legislation governing them (Art. 8a NarcA and NarcPT) enter into force on 15 May 2021.
That depends on when the various pilot trials actually start and what questions they are looking into. The first findings are not likely to appear before 2024. The FOPH will inform the public periodically about ongoing pilot trials. Once all the pilot trials are completed, the FOPH will draw up a report for the attention of the Federal Council evaluating the experience gained in the course of the pilot trials.
Participation in the pilot trials
People may take part in the pilot trials if they:
- are of age and capable of judgement;
- prove that they already consume cannabis;
- are resident in the canton where the relevant pilot trial is being conducted;
- agree to the terms of the scientific study and provide written consent to participation in the pilot trial.
The following are excluded from participation:
- minors and people not capable of judgement;
- women who are pregnant or breastfeeding;
- persons suffering from a disease diagnosed by a doctor where cannabis is contraindicated.
- are of age and capable of judgement;
Pilot trials will be planned and conducted by private or public organisations. People interested in taking part can contact these organisations. Those managing the projects will inform the public about the timeframe and terms of participation as soon as they have received authorisation to conduct the trial. The FOPH itself will not be conducting any pilot trials.
No. The pilot trials will only be researching the use of cannabis by adults for non-medicinal purposes. A separate revision of the law is currently under way with regard to the medicinal use of cannabis.
No. The FOPH grants authorisation to conduct pilot trials. It is up to the private or public organisers to provide information on their pilot trial and approach participants potentially interested in taking part, as appropriate.
Participants must comply with the requirements set out by the organisers of the trial in which they are participating. The cannabis products they purchase may only be for their own use. It is prohibited to pass them on to third parties and to consume them in publicly accessible places.
No. Participant data cannot be passed on to third parties such as the authorities or the employer. The data received by the FOPH are anonymised. The relevant data protection provisions apply.
Organisation of the pilot trials
Pilot trials can be conducted by private or public organisations such as universities, local authorities, research institutes, associations or foundations. A recognised research institute must be involved in each pilot trial.
In order to implement a pilot trial, authorisation must be obtained from the FOPH. Before submitting an application, potential organisers should contact the cantonal and municipal authorities to clarify aspects relating to maintaining public order, safety, and the protection of minors. The planned points of sale must also be approved by the relevant municipal authorities.
The FOPH will grant authorisation if all the requirements in the ordinance on pilot trials are met and the competent ethics committee has approved the trial.
The pilot trials must be limited geographically to one or several communes. The duration is limited to five years. A one-off extension of a maximum of two years is possible upon justified request. The legislation governing pilot trials will apply for a limited ten-year period, from 15 May 2021 (their entry into force) to 14 May 2031. Participants must be limited to the number necessary required for the trial to be scientifically significant. The number may not exceed 5,000 per pilot trial.
Both unprocessed products such as cannabis flowers and processed products such as hashish and cannabis extracts may be dispensed. Also possible are cannabis products mixed with additives, for example solutions containing cannabis. Cannabis products may be designed to be smoked, inhaled, vaporised, or eaten or drunk (e.g. edibles). To protect the health of participants the cannabis products dispensed as part of pilot trials are subject to stringent quality requirements. For example, the cannabis product offered must, whenever possible, originate from organic farming and must not contain any contaminants such as pesticides that pose a health risk.
The price set will have to factor in the levels of THC contained in the product in question. In other words, “stronger” products should also be more expensive. The price should also be roughly in line with prices on the local black market. To avoid creating incentives to use more or resell on the black market, the selling price should not be substantially lower than the local black market price. However, to avoid the possibility of making the purchase appear unattractive to participants, the price should not be substantially higher either.
Funding
There is no legal basis allowing projects to be funded by the FOPH. The FOPH is responsible for granting approval for applications. The pilot trials must therefore be funded by third parties (cantons, communes, universities, associations, foundations, etc.). In principle, Swiss National Science Foundation funding is also possible.
Participants must pay for the cannabis they receive as part of the trials themselves
No tobacco tax will be levied on the cannabis within the framework of the pilot trials. Imposing a tobacco tax on the sale of cannabis products as part of a scientific trial would not be fitting and would prejudice any definitive regulation.
Traceability and data collection
A track and trace system records the work steps in the production of cannabis. Producers can use it to document all plants, plant parts, substances, additives and work steps. Complete traceability is required by law. It ensures that only cannabis products that meet the legal quality requirements are dispensed. In the event of undesirable side effects, the origin of the product can be traced.
The track and trace system from Vigia AG, which was expanded on behalf of the FOPH to include a module for pilot trials with cannabis, is recommended for documenting cannabis cultivation and dispensing to participants in a pilot trial. Given that its operation is funded by the FOPH, those managing pilot trials can use it free of charge.
The various organisations involved in the pilot trial can use this system not only to collect data relevant to their studies, but also to comply with the documentation, reporting and documentation obligations that are legally required for pilot trials. Those who do not use the software must document fulfilment of these obligations in other ways.
When cannabis is dispensed, the amount dispensed and the person it was dispensed to are documented. Anonymity is guaranteed, as each participant is assigned a coded number in the system. This anonymised data is used primarily for the scientific evaluation of the pilot trials. The data is also used to ensure that participants do not exceed the maximum monthly amount of cannabis they can obtain.
The data on dispensing are made available to the project managers for their scientific work. Personal data is anonymised so that no conclusions can be drawn about the user. Neither the FOPH nor other enforcement authorities have access to the data; only the study secretariats can assign the recorded data to a specific person.
There is a system in place to warn of double registrations. If the first name, surname, gender, date of birth and place of origin match, the people managing the pilot projects must consult with each other and check whether or not it is actually the same person.
On registration, each participant receives an individual QR code which is scanned at the dispensaries. This means that cannabis can only be dispensed under the corresponding pilot project.
In the IT infrastructure of the service provider (Vigia AG, based in Zurich). The servers are located in Germany.
A support group for the cannabis pilot trial control and reporting system meets regularly, provides information on the status of development of the track and trace system and, together with Vigia AG, offers both technical and organisational support. To participate, please contact us by email at pilotversuchecannabis@bag.admin.ch.
Cannabis products
Both unprocessed products such as cannabis flowers and processed products such as hashish and cannabis extracts may be dispensed. Also possible are cannabis products mixed with additives, for example solutions containing cannabis. Cannabis products may be designed to be smoked, inhaled, vaporised, or eaten or drunk (e.g. edibles). To protect the health of participants the cannabis products dispensed as part of pilot trials are subject to stringent quality requirements. For example, the cannabis product offered must, whenever possible, originate from organic farming and must not contain any contaminants such as pesticides that pose a health risk.
The following diagram illustrates the processes in the production and distribution chain of cannabis products for the pilot trials:
Cannabis products will be made available at suitable points of sale. The type of point of sale (pharmacy, specialist shop, cannabis social club, etc.) will be determined within the framework of the pilot trials and communicated to participants by the project organiser responsible. The points of sale must employ competent and appropriately trained staff, have adequate infrastructure in place, and keep the products secure from theft.
Cultivation of cannabis for the pilot trials
The cultivation of cannabis and the manufacture of cannabis products require an exceptional licence from the FOPH. Those responsible for a concrete pilot trial select their growers, producers and manufacturers themselves. In this connection interested growers, producers and manufacturers must contact an organisation conducting a pilot trial.
The FOPH will keep a list of interested producers that may potentially be suitable for producing cannabis for pilot trials. Interested growers, producers and manufacturers can contact the FOPH. On request this list may be handed out to those responsible for conducting a pilot trial. However, as the licensing authority, the FOPH cannot make any recommendations.
The requirements for cultivation and product quality as set down in the implementing ordinance (NarcPT) must be taken into account. This includes the requirement that whenever possible, the cannabis must be cultivated in accordance with the organic farming regulations and good agricultural practice for the cultivation of medicinal plants. Cultivation and manufacture also require an exceptional licence from the FOPH.
Federal Office of Public Health FOPH
Schwarzenburgstrasse 157
Switzerland - 3003 Bern