Written by Tamara Attard
When one reads or hears the word, ‘cannabis’, the illegal drug comes to mind; marijuana or hashish, which is displayed as a trend in older movies and old rock bands. Cannabis sativa and other related Cannabis species are generally termed cannabis plants. The cannabis plant mainly exists in separate male and female forms. The unfertilised flowerheads of the female plants are generally rich in an interesting group of substances, called cannabinoids, with tetrahydrocannabinol (THC) and cannabidiol (CBD) representing the two major classes of cannabinoids. THC has psychoactive effects, meaning that it crosses the blood-brain barrier and exerts its effects on the brain. It is also highly intoxicating.
CBD within Europe
CBD is not psychoactive and is a therapeutic agent for inflammation, pain and nausea, amongst others. Due to the illicit use of cannabis ever since it was discovered, in 1961, there was an agreement within the United Nations that cannabis has to be regulated worldwide, through the Single Convention on Narcotic Drugs. This was amended in 1972.
Two other treaties that regarded the regulation of cannabis include the Convention on Psychotropic Substances of 1971 and the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988. Within the European Union, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) was established in 1993 to support the Member States by providing science-based information on drug use and to facilitate drug debates.
Legislators and competent authorities worldwide are constantly facing problems when dealing with the use of cannabis outside its categorisation as a drug of abuse or as a psychotropic substance. Consequently, although cannabis has been scientifically proven to exert important therapeutic effects, it cannot be categorised as a medicinal product. Because of its long-standing status, no official clinical studies have been carried out to fully support its therapeutic activities and therefore it cannot be granted marketing authorisation for its use as a medicine. On the other hand, whereas some herbal medicinal products have a long-standing history of medicinal use, this is not the case with cannabis and so it cannot be either registered as a herbal medicine with traditional use.
Within the European Union, this led to competent authorities of the Member States to provide a legal framework for the use of cannabis for medicinal purposes. As yet, there is no harmonisation between the Member States in this regard. In 2018, the Maltese Government issued “The Production of Cannabis for Medicinal and Research Purposes Act” placing cannabis within a category of its own. Under these circumstances, any cannabis product for medicinal use has to be manufactured in line with the Good Manufacturing Practices as applied to pharmaceutical products. Furthermore, due to the lack of clinical proof, there are no indications listed for cannabis-based medicines. Consequently, the registered physician should take full responsibility for the prescribing of cannabis-based products to patients. These products are prescribed on a named patient basis.
The situation is even more complex when manufacturers promote cannabis as industrial hemp
It is well known that there are cannabis varieties that may be practically devoid of the psychoactive THC but rich in CBD and therefore these are promoted for food use amongst other uses such as fibre and animal bedding. In food products, hemp can be either incorporated in foods such as cookies and biscuits or else formulated in food supplements. However, this raises a question as to whether CBD-based products should be considered for their medicinal use.
Competent authorities that allow this type of categorisation are facing problems as to where they should draw the line between the food and medicinal uses of hemp. The question is: should hemp rich in CBD be allowed in food supplements and the psychoactive cannabis rich in THC considered in medicines? The obvious answer is that psychoactive cannabis has to be regulated as a medicine. The situation with hemp is less clear. Some authorities tend to avoid disputes over this, by stating that since hemp is derived from Cannabis species, then it should be considered for its therapeutic uses and therefore no food use is allowed.
This current situation leaves cannabis at a cross-road. Competent authorities within the different Member States will have to face several legal and scientific debates so as to harmonise the situation within the European Union. The first issue to be tackled is the harmonisation of the definitions of several cannabis products, from the legal and scientific points of view, prior to their placement on the European market.