Switzerland lifted the general prohibition of the use of cannabis (i.e. more than 1% tetrahydrocannabinol ["THC"], "Cannabis") for medical purposes by August 1, 2022 ("Medical Cannabis") in the course of the revision of the Swiss Narcotics legislation.
The liberalization for the use of Medical Cannabis makes it easier for physicians to prescribe medicinal products containing Cannabis to patients. Furthermore, the commercial cultivation and export of Medical Cannabis is now permitted subject to authorization , which creates new commercial opportunities for domestic manufacturers, distributors and cultivators.
Reclassification of Medical Cannabis
Under the former law, Cannabis was qualified as a prohibited narcotic (such as e.g. opium, heroin, lysergide [LSD] etc.; Art. 8 Narcotics Act). Therefore, as a rule, any use of Cannabis was prohibited. Use of Cannabis was only exceptionally authorized on the basis of an exceptional permit from the Federal Office of Public Health ("FOPH"), if it served (i) scientific research, (ii) the development of medicinal products or (iii) limited medical use, which permit could only be obtained for patient-specific use and consequently only through bureaucratic hurdles. Under the now revised Narcotics regulation, Medical Cannabis is no longer classified as a prohibited narcotic, but as a so-called controlled substance (narcotics list a). The reclassification as a controlled substance means that the (commercial) handling of Medical Cannabis is subject to the regular control measures for controlled substances of Swissmedic and no longer requires an exceptional permit by the FOPH. This concerns all forms of Medical Cannabis such as plants, extracts, resins, oils and tinctures and combinations of dronabinol with THC. Accordingly, anyone who intends to (i) manufacture, (ii) obtain, (iii) broker, (iv) import, (v) export, (vi) dispense or (vii) trade in Medical Cannabis requires an operating license by Swissmedic for the handling of controlled substances (Art. 11 Narcotics Control Ordinance, "NCO").
The operating license requires (Art. 12 para 1 NCO):
- an entry in the Commercial Registry;
- the designation of a responsible person for narcotics with the required medical or scientific education; and
- securing the storage of Medical Cannabis protected from theft (Art. 54 NCO), e.g. by a surveillance system and entry restrictions.
Furthermore, any person handling Medical Cannabis must comply with certain duty of care obligations at all times. Accordingly, when Medical Cannabis is distributed, it must be ensured that the recipients are authorized to use the Medical Cannabis, and any potential misuse must be reported to the relevant cantonal authorities.
The competent cantonal authorities periodically examine compliance with the permit requirements and duty of care obligations, including by means of on-site inspections. Please note that for export/import and transit as well as cultivation of Medical Cannabis further licenses are required (cf. below).
The use of Cannabis for non-medical purposes (recreational use) remains generally prohibited and may only be permitted based on the limited scope of an exception permit from the FOPH.
What changes for manufacturers and distributors of Medical Cannabis products?
Under the former law, the commercial export of Medical Cannabis had no legal basis and was therefore prohibited (as recently decided by the Federal Administrative Court C-4772/2019 of September 6, 2021). This restricted the commercial trade of Medical Cannabis products and slowed innovation efforts in the development of such products.
With the revision of the Swiss Narcotics regulation, a legal basis has been established according to which Medical Cannabis can be imported and exported now also for commercial purposes. This allows Swiss manufacturers and distributors of Medical Cannabis products to expand their activities and may incentivize innovation in this area..
Please note that each individual cross-border delivery requires an import or export license to be obtained by Swissmedic in addition to the operating license (Art. 23 NCO). When applying for an export license the applicant must provide the import license of the recipient country (Art. 32 para. 1 NCO). Each import or export of Medical Cannabis is to be notified to Swissmedic within ten days (Art. 30 and 34 NCO).
What changes for cultivators of Cannabis?
The revision of the Narcotics regulation also simplified the cultivation of Medical Cannabis by the introduction of a two-stage approval procedure:
On the one hand, companies contemplating to cultivate Medical Cannabis need an operating license for the cultivation of Medical Cannabis, requiring (Art. 12 para. 2 NCO):
- an entry in the Commercial Registry;
- the designation of a responsible for narcotics with the required medical or scientific education;
- securing the storage of medical cannabis and protection from theft and from use for other purposes, e.g. surveillance system and entry restrictions; and
On the other hand, a supplemental one-time cultivation license is needed for each cultivation of Medical Cannabis, requiring (Art. 22b NCO):
- a system of traceability of medical Cannabis products;
- a quality assurance system and respective documentation; and
- a written agreement with precise information on the type and quantity of cultivation and the commitment of the recipient party to accept the harvest in its entirety.
The cultivation license authorizes the permit holder (i) to obtain seeds and plants required for the cultivation within Switzerland, (ii) to supply the harvested Medicinal Cannabis to the purchaser as specified in the purchase agreement subject to the one-time cultivation permit, and (iii) to carry out simple post-harvest treatments of medicinal cannabis not subject to the medicinal product regulation. However, it does not include the import and export of Medical Cannabis or the manufacture of Medical Cannabis products, for which the respective additional licenses must be obtained.
What changes for physicians?
In contrast to the exception permit system, physicians are now allowed to prescribe and dispense Medical Cannabis products on own responsibility (so-called narcotic prescription) according to the rules for narcotic prescription (Art. 46 NCO). The amount prescribed may not exceed the need for one month, except where the circumstances justify it a quantity sufficient for treatment for a maximum of six months may be prescribed (Art. 47 and 48 NCO). In the context of the permitted self-dispensation, physicians can also stock Medical Cannabis products themselves in their practice pharmacy.. They are responsible for the correct storage and have to document the usage (Art. 44 NCO).
For the purpose of monitoring the development of the prescription of Medical Cannabis in practice, physicians are required to provide the FOPH data about their usage of Medical Cannabis in treatments. The data gathering is aimed at creating a basis for the scientific evaluation of the revision of the Narcotics legislation and to monitor the efficacy and suitability of medical treatments with Medical Cannabis. The data include information on the indication, the preparation of the Medical Cannabis substance, the side effects and other relevant data in connection with the treatment with Medical Cannabis, as well as the age, sex, weight and canton of residence of the patient treated with Medical Cannabis. However, patient data will only be processed and shared on a pseudonymized basis (Art. 65b NCO).
What changes for patients?
The removal of the exemption permit system, significantly shortens the access to Medical Cannabis for patients. The decision as to whether Medical Cannabis should be used for medical treatment rests now solely with the prescribing physician and is no longer dependent on the granting of an exception permit by the FOPH. In particular, patients with severe chronic conditions (spasticity and spasms in multiple sclerosis) and pain (cancer treatment) will benefit from the simplified access to Medical Cannabis.
However, Medical Cannabis is still not covered by mandatory health insurance scheme. Currently, the evidence on the efficacy and suitability of Medical Cannabis products is still insufficient to satisfy the requirements for reimbursement under the mandatory health insurance scheme. Patients must therefore pay for prescribed medical cannabis out of pocket.