Philippe Reich, partner, and Tiziana Hongler, associate, supported by Tanya Adams and Anna Bachmann at Baker McKenzie in Zurich, investigate a significant development in modernising Switzerland’s legislation on cannabis
On August 1, 2022, Swiss National Day, Switzerland’s revised Narcotics Act (NarcA) entered into force. The revision aims at facilitating medical treatments and improving research and development of cannabis.
Prior to the revised law, patients and physicians had to apply for special authorisation from the Federal Office of Public Health (FOPH) if they wanted to access cannabis for medical purposes. The amendment will allow numerous patients safe and timely access to cannabis medicines as part of their treatment regime.
According to a study by the Institute for Addiction and Health Research carried out on behalf of the FOPH, 96% of participants reported that the consumption of medicinal cannabis led to an improvement of their symptoms. In light of cannabis’s potential as a medical treatment and the surge in applications and high approval rates of the FOPH in the last few years, the costly and time-consuming procedure physicians and patients had to undergo to obtain authorisation for treatment with medicinal products containing cannabis was no longer justified. This led to the latest revision of the NarcA, which focuses on the legalisation of medicinal cannabis, making cultivation, processing, production and trade thereof subject to the authorisation procedure of Swissmedic in the same way as other narcotics that are used in a medical context.
The main features of the amendment include the following:
- Every licensed physician is now able to prescribe medicinal products containing cannabis as part of the general principle of therapeutic freedom, and special authorization by the FOPH is no longer required
- The cultivation, production, processing and trade of medicinal cannabis is now subject to the authorisation procedure of Swissmedic
- A two-stage authorisation procedure has been established for the cultivation of cannabis plants for medicinal purposes
Prior to the enactment of the revised law, cannabis with tetrahydrocannabinol (THC) levels of 1% and above were classified as prohibited narcotics in Switzerland. As a result, cannabis with THC levels of 1% and above could not be cultivated, produced, imported or placed on the market. This limited the medicinal use of cannabis, which was subject to a case-by-case authorisation requirement from the FOPH.
Products containing cannabis with THC levels below 1% and products containing cannabidiol (CBD) are not subject to the NarcA and therefore were not prohibited even before the revision. The use of cannabis for non-medicinal purposes, however, remains prohibited.
Removal of ban on medicinal cannabis
According to the revised NarcA, cannabis is classified as a controlled narcotic with restricted marketability. Therefore, the cultivation, production, processing and trade of medicinal cannabis will be subject to the authorization and control system of Swissmedic and a special authorisation from the FOPH will thus no longer be required. The revision aims to maximise the full potential of cannabis as a medicinal product and to ease access to medicinal cannabis for physicians and patients alike.
As a result of the removal of the ban on medicinal cannabis, the following is now possible in Switzerland:
- Licensed physicians may now prescribe medicinal products containing cannabis as part of the general principle of therapeutic freedom without the need to obtain special authorisation from the FOPH
- Public pharmacies and hospital pharmacies that have obtained a manufacturing license for medicinal products are authorised to manufacture and dispense medicinal products with cannabis
- The commercial export of cannabis for medicinal purposes is now generally possible with a license from Swissmedic. This creates economic opportunities for domestic growers and specialised manufacturers of these herbal medicines
In order to evaluate the effects of the revision, physicians are required to regularly report on medicinal cannabis-based therapies to the FOPH for the first few years after the revision of the law has taken effect The data collected will help guide cantonal enforcement authorities and prescribing physicians on further treatment using medicinal cannabis.
Reimbursement by the compulsory health insurance
As a general rule, the reimbursement of costs for medicinal products by the compulsory health insurance (OKP) requires that the medicinal product is included in the FOPH’s list of specialties (SL). In order for a medicinal product to be included in the SL, it is required that a marketing authorisation is obtained for the medicinal product and that scientific proof of the efficacy, usefulness and cost-effectiveness of the product has been established. Whether or not a medicinal product is ultimately included in the SL is determined by the FOPH.
The evidence of cannabis’s efficacy for medicinal purposes was long considered insufficient. On April 30, 2021, a Health Technology Assessment (HTA) report was published on behalf of the FOPH to provide additional information and to clarify the scientific evidence of the use of cannabis for medicinal purposes. However, the HTA report ultimately found no sufficient evidence for the efficacy of the use of medicinal cannabis. Therefore, an inclusion of medicinal products containing cannabis in the SL and the correlating reimbursement by the OKP is not possible under the general regime of reimbursement by the OKP.
By way of exemption, the reimbursement of a medicinal product not listed in the SL by the OKP is possible in case of hardship and upon request for cost approval by the treating physician. A case of hardship is defined as a case in which the use of the product is expected to provide a major therapeutic benefit against a disease that may be fatal for the insured person or result in severe and chronic health impairments, and no other effective and approved treatment method is available due to a lack of therapeutic alternatives.
The latest revision of the NarcA does not affect the current rules on reimbursement of medicinal products containing cannabis. Therefore, as was the case before the revision, the only way to obtain reimbursement by the OKP is by way of seeking reimbursement based on hardship.
Two-stage authorisation procedure for the cultivation of cannabis
As a result of the removal of the ban on medicinal cannabis, a license from Swissmedic can be obtained for the cultivation of cannabis plants by passing the following two-stage authorisation procedure:
In a first step, the applicant must obtain an establishment license, which is granted under the following conditions:
- The applicant is registered in the commercial register
- The correct storage of the controlled substance is ensured
- A person responsible for compliance with the NarcA is appointed
Furthermore, the applicant must show that measures have been taken to provide sufficient protection against theft and to prevent the misuse of the plants.
In a second step, the applicant must obtain an individual cultivation license, which is granted under the following conditions:
- The applicant has obtained the above-mentioned establishment license
- The applicant has demonstrated that a system is in place that enables the traceability and quality of the substances supplied
- The applicant has submitted a written purchase agreement with a purchaser who is in possession of a corresponding establishment license
- The applicant has provided detailed information on the type of cultivation intended
Once the applicant has obtained the individual cultivation license, it must comply with reporting obligations within ten working days for each case.
Global context and outlook
There is little consistency among European countries when it comes to the use of cannabis as a medicinal product. By legalising medicinal cannabis, Switzerland has followed the UK, the Netherlands, Italy and Germany, which already have systems in place that allow access to medical treatment with cannabis and, simultaneously, protect people by containing and combating the black market for cannabis. On the other hand, countries including Sweden, Latvia, Belgium and Albania strictly prohibit the use of medicinal cannabis while France, Ireland and Denmark are running trial periods for medicinal cannabis.
The potential for the emerging global market for cannabis-based medicines and supplements is estimated at US$50bn to several hundred billion US dollars.
It is a complex market that is growing very fast, but the revision of the NarcA has created a clear route through the complexity for Swiss farmers and pharma pioneers looking to make sizeable profits by getting in early. This allows for a good opportunity for Swiss producers to serve a part of the rapidly developing world market.
For many Swiss farmers, this could mean additional earnings of around CHF 10,000 per acre. As with any new change in law, legal uncertainty may arise.