The Ministry of Health has issued a decree stipulating the rules of proper farming practice, which includes terms for growing and processing medical cannabis.
27 August 2022 saw the coming into force of decree No. 35/2022 Coll. by the Ministry of Health, on growing and processing cannabis plants for medical purposes (the “Decree”), implementing the relevant provisions of Act No. 167/1998 Coll., on addictive substances and on the amendment of certain other laws, as amended (the “Narcotics Act”). The Decree is built around the general idea that growing medical cannabis requires a special grower’s license, issued by the State Institute for Drug Control, and at the same time a concession for handling addictive substances (which is subject to the fulfillment of certain duties under the Narcotics Act).
The Decree provides precise rules as to how to proceed in handling cannabis plants, including rules for their storage and transport, but above all rules subsumed under what the Decree calls “proper farming practice”. These include e.g. rules for a quality management system to ensure the quality of the crop, employee qualification and training, public-health standards, requirements as to the growing premises, record-keeping rules, and rules for growing, harvesting, and packaging cannabis. In terms of their substance, these rules of proper farming practice for the cultivation of medical cannabis match the parameters set out in the Narcotics Act. At first glance, therefore, these rules are essentially not new or unprecedented.
The Decree is strict in determining how cannabis-growing facilities must be secured. Specifically, the facilities must be comprised of a coherent complex of buildings in one location (or a set of premises within one building), made of materials which discourage trespassing, and the entrance must be under CCTV surveillance. Also, growers must draft an internal policy in which the security system for each growing facility is laid out, which among other things means implementing a system whereby keys or access cards are only made available to designated personnel. These strict parameters for buildings and cannabis-growing facilities are indispensable for ensuring qualified and safe access to the various stages of the growing process, so as to minimize the degree of risk of intrusion by unwanted pests or unauthorized persons. In practice, this means roofed buildings with regular checks by qualified personnel as to the physical integrity of the growing facility.
In developing a cannabis-growing system, all activities and processes must take place under managed and standardized conditions which have been precisely configured and described and are regularly being monitored and documented. Cannabis growers must enter into a contract with all suppliers whose activities may have impact on the quality of intermediate products, and this contract must define the responsibilities and duties of the parties.
All activities related to the growing, harvesting, and primary processing of cannabis must be carried out in accordance with the managed documents, and must be recorded or entered in logs and protocols. The Decree sets forth the preferred time period for harvesting the cultivated medical cannabis plants, chosen such as to ensure that the plants will contain the desired concentrations of THC and CBD (i.e., the active substances under consideration), and each harvest must be labeled with a serial number as a separate batch.
The Decree will doubtlessly have significant impact on the business environment in the Czech medical cannabis industry, seeing as it imposes fundamental terms which need to be observed to be allowed to cultivate the plant in the first place, and to consummate the commercial intentions of the farmers.
In closing, we should note that the stringent rules for growing medical cannabis set out in the Decree are legitimate considering the very nature of cannabis: The product has narcotic effects and broad potential for abuse, including its marketability on the black market.