Easier prescription of medical cannabis

The Federal Council wants to make it easier for sick people to access these medicines. It therefore proposed the lifting of the ban on cannabis for medicinal purposes and submitted the dispatch on the amendment of the Narcotics Act to parliament on June 24, 2020. In the consultation period from June 26 to October 17, 2019, the amendment was welcomed by the cantons, political parties and other interested parties.

 

I. Regulation in force today

In Switzerland, cannabis is currently considered a prohibited narcotic and is subject to a comprehensive traffic ban. Cannabis may therefore not be cultivated, produced, imported, exported or distributed. Currently, the medical use of cannabis ("medical cannabis") is therefore only possible to a limited extent and with an exceptional permit from the FOPH.

The active ingredient tetrahydrocannabinol (THC) is used in medical practice primarily for: chronic pain conditions (e.g., neuropathic or cancer-induced pain); spasticity and convulsions caused by multiple sclerosis or other neurological diseases; and nausea as well as loss of appetite as a result of chemotherapy.

Research into the efficacy of the medical use of medical cannabis is still in its infancy, which is why its effect is still insufficiently proven scientifically. For many applications, there are field reports, but no clinical studies that prove the quality, safety and efficacy of medicinal cannabis. Systematic clinical research is primarily the responsibility of the pharmaceutical industry.

In Germany, medical cannabis has been marketable and prescribable since 2011. Since 2017, doctors in Germany have also been able to prescribe cannabis flowers and cannabis extracts to their patients, and health insurance companies may even cover the costs. Other European countries such as Italy, Croatia and the Netherlands have also long since legalized medicinal cannabis.

In recent years, demand for cannabis treatments has also risen sharply in Switzerland. In 2019 alone, the FOPH has issued almost 3,000 exceptional licenses. This is administratively burdensome, delays the individual treatments and no longer corresponds to the exceptional character that the legislator originally envisaged with the Narcotics Law.

Currently, Sativex® is the only medical cannabis approved in Switzerland. It can already be prescribed without an exceptional license from the FOPH, but only for the treatment of spastic convulsions in multiple sclerosis.

 

II. Revision of the narcotics law

With the upcoming revision of the law, the Federal Council wants to make better use of the scientifically proven potential of cannabis as a medicine. Sick people should have access to cannabis medicines without much bureaucracy.

The Council of States unanimously adopted the proposed amendment to the law after the National Council had already approved it in the winter session. Compared to the Federal Council's proposal, the upper chamber added that the FOPH should also collect data on side effects during monitoring. The Council of States agreed to this.

The amendment was approved in the final vote on 19 March 2021 and is expected to come into force in 2022. The amendment also regulates the cultivation, production, processing and trade of medicinal cannabis. Swissmedic is envisaged as the licensing authority.

In concrete terms, the revision of the law will have the following effects:

  • The traffic ban on cannabis for medical purposes is to be lifted. The use of cannabis for non-medical purposes, on the other hand, remains prohibited without exception.
  • The amendment to the law will make the cultivation, processing, production and trade of medical cannabis subject to Swissmedic's licensing and control system - as is the case with other narcotics used for medical purposes (for example methadone or morphine).
  • Treatment with medical cannabis no longer requires an exemption from the FOPH - freedom of therapy is guaranteed, and responsibility for treatment lies exclusively with physicians.
  • The commercial export of cannabis for medical purposes is to be legalized. This will create economic prospects for domestic growers of the raw materials and specialized manufacturers of herbal medicines. In parallel, the regulations for seed and planting material are to be revised. This should also simplify the cultivation of medical cannabis in agriculture.
  • Safety and quality requirements for the production of medical cannabis products were included in the Swiss Pharmacopoeia in 2019. An amendment to the Therapeutic Products Act is therefore not necessary.
  • In order to monitor the prescription of medical cannabis and obtain more evidence on their effects, an accompanying data collection is to be carried out. Prescribing doctors are to be obliged to provide the FOPH with certain information on treatment during the first few years after the amendment to the law comes into force. The data collection should serve as a basis for the scientific evaluation of the revision and provide guidance to the responsible cantonal enforcement bodies and prescribing doctors.


III. Cost reimbursement still unclear

The amendment to the law is not expected to change the requirements for social insurance reimbursement of the costs of medical cannabis. At the moment, these are only covered by compulsory health insurance in exceptional cases. However, the FOPH is currently having a review carried out to determine whether there is a need for action. In the process, the evidence on the efficacy and cost-effectiveness of medical cannabis is being comprehensively assessed.

 

Our specialized and experienced team will be happy to assist you in all legal matters related to medical cannabis. We advise you in connection with the prescription, use and distribution of medical cannabis products.

March 2021 | Authors: Prof. Dr. Juana Vasella, David Meirich

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