Don’t bite off more than you can chew : Quality and regulatory umbrella for HTC and food market
Cannabis products are used for medicinal and industrial purposes, as well as for intoxication. At least four US states and one EU Member State now have two separate distribution systems...
Published on: 07/08/2020
Cannabis products are used for medicinal and industrial purposes, as well as for intoxication. At least four US states and one EU Member State now have two separate distribution systems for intoxicating cannabis running in parallel, besides any industrial use of the non-psychoactive parts of the plant.
Clarity is needed when discussing the laws involved. Cannabis products that are used for medicinal purposes — whether the psychoactive THC or the non-psychoactive cannabidiol (CBD) — are generally referred to as ‘medical cannabis’. Cannabis products used in manufacturing are commonly referred to as ‘industrial hemp’. Cannabis products used for nonmedical intoxication have been variously referred to as non-medical cannabis, retail cannabis and recreational cannabis. The term ‘non-medical’ cannabis does not make clear that it may not be for industrial purposes, while ‘retail’ refers to the form of distribution, rather than the motive for use such as ‘medical’ and ‘industrial’. Therefore, this short blog post uses the term ‘recreational’ for the psychoactive cannabis products intended for non-medical
intoxication
What sort of cannabis is controlled?
The cannabis plant is usually legally controlled when it is capable of producing a useable
amount of the psychoactive substance delta-9-tetrahydrocannabinol (THC), but some countries control all strains, even those where the THC content is negligible. The plant has been grown for several hundred years for fibre, oil, medicines and drugs. Since 1961, international law has defined the cannabis plant as ‘any plant of the genus Cannabis’, to cover the species Cannabis indica and Cannabis sativa and any variety discovered in the future (United Nations, 1961). The roots and seeds have no THC, dried stem material will
typically contain 0.3 % or less, and the lower leaves less than 1 %. However, in the female flowers, and the resin-producing trichomes (plant hairs) that grow among them, THC concentration can reach 20 % or more. In the European recreational cannabis market, the flowers may be sold still coated with the resin (‘herbal cannabis’), or the resin may be extracted and sold by itself (‘cannabis resin’). By 2015, the mean potency of samples analysed around
Europe had risen by 90 % for resin and 80 % for International law does not prevent cannabis, or cannabisbased products, being used as a medicine to treat defined indications. According to the UN conventions, the drugs under international control should be limited to ‘medical and
scientific purposes’.
Article 28 of the 1961 Convention of Narcotic Drugs describes a system of controls required if a country decides to permit the cultivation of cannabis that is not for industrial or horticultural purposes, while the 1971 Convention controls THC. In European countries, authorised medicines may include THC in capsules, cannabis extract as a mouth spray, and dried cannabis flowers for vaporising or making ‘tea’ .
By contrast, no country authorises the smoking of cannabis for medical purposes. There are two main reasons for this. First, there are many strains of cannabis plants, and each variety has the capacity to produce a range of chemicals. The range and concentration of chemicals may also vary within one plant, for example depending on light levels during growth or maturity at harvest. If these factors are not strictly controlled, it is very difficult for a prescriber and pharmacist to judge the content and thus the delivery of the particular chemicals needed for the patient. Second, inhaling smoke from burning plant material is not a healthy method of delivery of those chemicals to the bloodstream, as the patient will also inhale harmful tars and particles.
When the required chemicals are not psychoactive, such as CBD, it is also very difficult for the user to measure the dose correctly. A medicine based on cannabis extracts has been authorised in some European countries, and at the time of writing four EU countries have specific legal processes governing the distribution and use of medical cannabis. A medicinal product marketed in a number of European countries under the brand name ‘Sativex’ contains
approximately equal quantities of THC and CBD from two cannabis extracts. This product, which is sprayed inside the cheek or under the tongue, has been authorised in 17 EU Member States and Norway for the treatment of muscle spasticity from multiple sclerosis.
In some of these countries, national health insurance systems will reimburse the cost under certain conditions, such as prior approval or prescription by specialists.
Since 2001, the Office of Medicinal Cannabis (OMC) has been the Netherlands government agency with a monopoly on supplying medical cannabis to pharmacies and general
practitioners in accordance with the terms of the 1961 UN Convention. Producers are licenced by the Dutch government and must sell all produce to the OMC, which then distributes it to pharmacies. The OMC offers varieties of medical cannabis, with different levels of THC (ranging from less than 1 % to approximately 22 %) and CBD (ranging from less than 1 % to approximately 9 %). These products cater for different patient needs at a cost of about EUR 45 for 5 grams. These may be prescribed for relief of symptoms arising from multiple sclerosis, HIV/ AIDS, cancer, long-term neurogenic pain, and tics associated with Tourette’s syndrome. Smoking is not recommended by the manufacturer, and the preferred methods of use include inhalation from a vaporiser and infusion in tea. In theory any doctor may prescribe medical cannabis, but in practice only a limited number do so. As of March 2015, about 1 200 patients get their medical cannabis, with a prescription from their doctor, through the pharmacy.
There is no reimbursement from the national healthcare system, but there may be some partial reimbursement by supplementary health insurance. In the Czech Republic, the State Agency for Medical Cannabis was established as a special department of the State Institute of Drug Control. It set rules for e-prescription, pharmacies and so forth, but a special register only started operating in November 2014.
Use of medical cannabis products is only possible in line with the Ministerial Notice of 2013, and the prescription should state the mode of use and THC level (up to 21 %). Initially patient limits were 30 grams per month, but these were raised to 180 grams per month in October 2015. Currently only 16 specially qualified doctors, such as oncologists and psychologists, are authorised to prescribe cannabis, and only 26 pharmacies can dispense it. Patients must be aged over 18 years.
The first domestic harvest was distributed to pharmacies in March 2016, with the final price to the patient being about EUR 3.70/gram (the average price of illicit cannabis in the Czech Republic was about EUR 7.40/gram in 2014).
In Italy, the Ministry of Health is the coordinating body for medical cannabis. From November 2015, the ministry can issue permits for cultivation, production, possession and use, and herbal cannabis may be prescribed with a nonrepeatable prescription; the use of cannabis is only for symptomatic treatment supporting standard treatments, where results cannot be achieved with traditional treatments. Eligible conditions are primarily spasticity, chronic pain, nausea from chemotherapy or HIV treatments, loss of appetite from cancer or AIDS, glaucoma, and Gilles de la Tourette syndrome. Licensed farmers deliver the cannabis to the ministry, which then allocates it for production. The pharmacist buys the active substance from the ministry with vouchers, and prepares magistral (2) preparations accordingly.
Doctors should prescribe the most appropriate genetic strain, dispensing amount and consumption method (vaporising or infusion in hot water only) for each patient.
In Croatia, new regulations entered into force in October 2015 that amended the Ordinance on classifying, prescribing and dispensing medicines, to allow the use of cannabis for medical purposes. Following the recommendation of certain neurology, infectious diseases or cancer specialists, medicines containing THC, dronabinol or nabilone can be prescribed, on nonrepeatable prescription, by physicians working in general and family practice, health protection of preschool children and women’s healthcare. These medicines may be prescribed to relieve the symptoms of multiple sclerosis, cancer, epilepsy and AIDS.
They may be in various forms such as teas, ointments and other extracts including galenical preparations; smoking or vaping herbal cannabis is not permitted. The prescription should state the amount of THC in a single dose, the number of individual doses, drug form, dosage and method of use; also if applicable the type of herbal drugs and herbal preparation which will make the main composition. Medicines containing THC can be prescribed in the quantity necessary for treatment up to 30 days. The total amount of prescribed THC in 30 days of treatment must not be greater than 7.5 grams.
As at January 2017, no domestic cannabis was being grown for this purpose, but medicines were being imported.
In the European Union, it is legal to cultivate and supply cannabis plants for hemp fibre if they have low levels of THC. The granting of payments under the Common Agricultural Policy is conditional upon the use of certified seeds of specified hemp varieties; only varieties with a THC content not exceeding 0.2 % may be used (EU Regulation 1307/2013). Payments are
therefore granted only for areas sown with varieties of hemp offering certain guarantees with regard to their psychotropic content. There is a procedure for the determination of hemp varieties and the verification of their tetrahydrocannabinol content. Imports of hemp are also subject to certain conditions to ensure the above-mentioned THC limit is respected (EU Regulation 1308/2013). According to the European Court of Justice, case C-207/08 (Babanov), the cultivation of hemp fulfilling the strict conditions above by farmers respecting all the other conditions established by the EU legislation cannot be prohibited in any Member State, if this prohibition conflicts with provisions of EU law or undermines the aims and objectives of these provisions.
New countries joining the European Union, in which it was illegal to grow any cannabis plant under the narcotic control law, have sometimes needed to change their law in order to permit this exception.
