The importance of a standardised cannabis product
A standardised cannabis product enables doctors to monitor the dose and the effect of medicinal cannabis in the same way as for other certified medication.
Unlike other medication, the cannabis plant does not have a fixed chemical/molecular composition. Cannabis contains hundreds of different substances and each individual plant is different in terms of its composition. THC and CBD are the best known substances, but there are dozens to hundreds of other known and unknown substances in the plant that may have an effect. No two cannabis plants are the same. Even if the levels of THC and CBD are the same, the substances around them can produce a different effect for the patient; this known as the ‘entourage effect’. There have been various studies of this entourage effect. Ultimately, the complete ‘fingerprint’ of the plant determines its effect.
Four crucial reasons why cannabis should be standardised
Bedrocan produces five medicinal cannabis varieties. Each variety has a unique, fully standardised genetic composition that is and remains the same each time, for every batch, year in, year out, because of the unique production process. The result is that the CBD and THC levels are always the same, but the other substances are also always present in the same ratio. The reproducible chemical profile enables doctors to monitor the dose and the effect on the disorder in the same way as for other certified medication. Furthermore, it makes these varieties suitable for carrying out scientific medical research.
Standardised cannabis is extremely important to the patient
Just like ‘normal’ medication, all patients are ‘set’ on a certain variety. Sometimes it can take a long time to get patients on the right variety with exactly the right dose on the basis of the existing five varieties. The same applies to the use of cannabis oil. Changing the dose or administering medication with a different genetic composition can have adverse consequences for individual patients.
Standardised cannabis is extremely important to the doctor
Quite rightly, doctors want to know exactly what they give to their patients and what its effects are. It takes a lot of time and effort for doctors to become used to prescribing cannabis. The reproducible chemical profile of standardised medicinal cannabis enables doctors to monitor the dose and the effectiveness in the same way as for other certified medication. As this medicinal cannabis is also produced in accordance with pharmaceutical standards (GMP), quality and safety are guaranteed as much as possible. As doctors have prescribed the same products from the Office of Medicinal Cannabis for years, they know what it does and they feel comfortable with it. The same applies to the pharmacists who ultimately hand over the product.
Standardised cannabis is extremely important to researchers
For the first time, there is now larger scale serious clinical research into the effect of medicinal cannabis. In December 2018, the first results were published of a placebo-controlled, comparative study of 3 of the 5 varieties available in the Netherlands, carried out by the Leiden University Medical Centre. Different doctors, pharmacists, and study groups are now preparing further clinical research. They prefer to work with standardised medicinal cannabis that has a guaranteed quality, safety and availability.
In order to obtain permission for medical scientific research with humans, you need a detailed statement of the product that is studied. At the end of the study, the outcomes only say something about the specific plant, and its unique genetic composition, that was used in the study. Clinical research that is carried out with an existing product, can only be carried out with that product. Changing variety in the meantime is not possible from a substantive point of view, it is legally impossible, and certainly not desirable. If there were to be a change to a plant variety with only comparable THC and CBD levels, permission for the research would have to be applied for again. THC and CBD may well be comparable, but the chemical and genetic composition of the plant and the presence of other substances changes. So therefore, in essence the product used for the research changes too. It means the outcomes that were gathered up to that point are no longer usable, because they do not apply to this new, different plant.
4. MEDICINE DEVELOPERS
Standardised cannabis is extremely important to developers of medication and medical devices
At the moment, medicinal cannabis only applies as a medical raw material, i.e. an API or Active Pharmaceutical Ingredient. Various companies around the world are working on developing medication or medical devices on the basis of this active pharmaceutical ingredient. One example is an extremely advanced inhaler, which was developed by using standardised products from the Netherlands from the beginning. This inhaler is so advanced that it detects even the slightest change in the form and composition of the product to be administered. For the device to work correctly, the same percentage of THC and CBD and exactly the same genetic and chemical composition of the product are important. Any change in plant will produce high modification costs and months, if not years, of delay in its further development.
Scientific research with standardised cannabis
The importance of standardising the complete chemical composition of the plant is supported by various scientific studies. Below is a list of a number of studies into other substances in the cannabis plant and the entourage effect they cause: