Medical cannabis: pilot trials versus medical treatment

27 October 20264 min read

Pilot trials under Art. 8a BetmG are non-medical studies with their own participation rules. How they differ from medical treatment by a physician.

The Narcotics Act draws a clear line between medical treatment with cannabis medicines and scientific pilot trials. The two have different legal bases, different purposes and different rules for taking part. This article sets them side by side.

Two legal bases

Medical treatment. Since 1 August 2022, the Narcotics Act prohibits the cultivation, import, production and placing on the market of cannabis-type narcotics only insofar as they are not used for medical purposes (Art. 8 para. 1 let. d BetmG). Physicians may prescribe medical cannabis, where medically indicated, without an exceptional authorisation from the BAG (BAG).
Pilot trials. After consulting the cantons and communes concerned, the BAG may authorise scientific pilot trials. They are meant to provide findings on how new rules affect the handling of cannabis for non-medical purposes (Art. 8a BetmG). Consumption for medical reasons is not part of the trials (Art. 2 BetmPV).

Pilot trials in detail

Limited in place. A pilot trial is limited to one or more communes (Art. 5 para. 1 BetmPV).
Limited in time. It lasts at most five years and may be extended once, on request, by at most two years (Art. 5 para. 2 BetmPV). Art. 8a BetmG and the pilot trials ordinance (BetmPV) apply until 14 May 2031 (Art. 35 BetmPV).
Limited number of participants. The number of participants must be limited to what the scientific validity of the trial requires and may not exceed 5,000 people (Art. 6 BetmPV).
No advertising. Advertising for the cannabis products of the trials is prohibited (Art. 12 BetmPV).

The BAG lists the authorised trials in its overview; the list can change. Our canton pages name the trials in each canton, for example for Zurich.

Who can take part in a pilot trial

Participation is governed by the pilot trials ordinance (Art. 14 BetmPV). People can take part who

can show that they already consume cannabis,
live in the canton in which the trial is conducted, and
agree to the conditions of the study and give their written consent.

Excluded are people who are minors or lack capacity of judgement, who are pregnant or breastfeeding, or who have a medically diagnosed illness for which cannabis use is contraindicated. There is no entitlement to take part, and consent can be withdrawn at any time (Art. 14 para. 2 to 4 BetmPV).

Participants may use the products only for their own use, must not pass them on to others and must not consume them in publicly accessible places (Art. 15 and 17 BetmPV). Those running the trial issue participants with an identity document that shows they are study participants (Art. 18 let. b BetmPV).

Medical treatment in detail

Different rules apply to medical treatment:

The physician decides. Narcotics may be prescribed only to the extent required by the recognised rules of medical science (Art. 11 para. 1 BetmG). There is no entitlement to a prescription; the physician decides on the basis of the medical assessment.
An official form. Where medically indicated, the medicine is prescribed on the narcotics prescription form, and only for patients the physician has examined herself (Art. 46 BetmKV).
Dispensing at the pharmacy. Pharmacies dispense narcotics to the public only on a medical prescription (Art. 13 BetmG). You choose the pharmacy freely (Art. 26 para. 2bis let. b HMG).
Reporting to the BAG. Treating physicians record pseudonymised treatment data in the MeCanna system (Art. 8b and 18f BetmG).

Two routes that do not mix

Pilot trials are not a route to medical treatment and are kept separate from it. Equally, medical treatment is not participation in a trial: participation is governed by the conditions of the BetmPV, and there is no entitlement there either (Art. 14 para. 3 BetmPV).

In our practice

Our practice is not involved in any pilot trial. Our physician Oxana Smagulova works only on the medical route: she decides individually during the consultation whether treatment is an option. The free ten-minute information call answers questions on the process, the legal situation and the costs.