Medical Cannabis Industry

Medical Cannabis history

Cannabis, also known as marijuana, a family of plants called Cannabaceae. There are over 700 varieties of cannabis that have been described to date. Based on characteristics such as shape, colour, height, smell, etc., usually recognised by two main types: Cannabis Sativa, which originated in the Western hemisphere and Cannabis Indica, which originated in Central and South Asia.

The first evidence of the use of cannabis was found in China, where archeological and historical findings indicate that that plant was cultivated in 4,000 B.C. Cannabis use as a medicine can be found as early as 2737 BC. Indications for use included malaria, rheumatic pain, constipation, disorders of reproductive system and many others.

Scientific research into the medical value of cannabis started in the early 19th century, with the structure of the active components, and their pharmacological properties, being characterised in the latter half of the 20th century. It was the discovery of the binding sites for these cannabis components, starting in 1988, that has led to our current understanding of the medical properties, and possibilities, using cannabis as a therapeutic intervention.

There are more than 480 natural components found within the cannabis plant. In 2016, researchers reported at least 113 different cannabinoids can be isolated from cannabis. Cannabinoids are chemicals unique to the plant, including delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) however there are many more including: CBG, CBC, CBN CBDL, CBL, CBE, CBT.

From research done in the field it was concluded that the THC acts on 2 types of cannabinoid receptors: CB1 and CB2. CB1 receptors are mainly found in the brain, peripheral nerves, and nervous system, whereas CB2 are found both in the neurons and immune cells.

Evidence suggests that THC helps alleviate symptoms suffered both by AIDS patients and by cancer patients undergoing chemotherapy, by increasing appetite and decreasing nausea.

The other main ingredient is CBD, a non-psychoactive component of cannabis which accounts for more than 50% of the known therapeutic applications. CBD is considered to have a wider scope of medical applications. A range of clinical studies indicated that CBD appears to relieve convulsions, inflammation, anxiety, nausea and short term memory loss.

Medical Indications and Benefits

Based on clinical, research and other medical literature the following are only part of the indications that cannabis has therapeutics benefits:

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Current Regulation

Australia

Legislation came into effect on 30 October 2016 to allow legal cultivation, production and manufacturing of medicinal cannabis products in Australia. This scheme is administered by the Commonwealth Department of Health through the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC). This legislation is designed to work together with the therapeutic goods legislation, and state and territory legislation, to make medicinal cannabis products available to certain patients. The term 'medicinal cannabis products' covers a range of cannabis preparations intended for therapeutic use, including pharmaceutical cannabis preparations, such as oils, tinctures and other extracts. Medicinal cannabis products are regulated as medicines in Australia. Generally, medicines imported into, supplied in, and exported from Australia must be entered in the Australian Register of Therapeutic Goods (ARTG), which is administered by the TGA. However, there are other mechanisms for access to medicines that are not registered on the ARTG (“unapproved therapeutic goods”). Medicinal cannabis products supplied in Australia will use these alternative supply pathways while evidence to support registration is gathered through clinical trials. The Therapeutic Goods Act 1989 establishes the regulatory framework for all medicines in Australia. The Act provides a number of mechanisms to enable access to unapproved therapeutic goods. For medicinal cannabis products these include: • access for individual patients through either: o Authorised Prescriber Scheme o Special Access Scheme • access as part of a clinical trial. These mechanisms maintain the same standards for medicinal cannabis products that apply to any other experimental or emerging medicine.

Canada

Canada introduced replacement medical marijuana regulations in June 2013 that came into effect in April 2014. The Marihuana for Medical Purposes Regulations (MMPR) regulated the production, distribution and use of medical marijuana and replaced the previous legislation, Marihuana Medical Access Regulations (MMAR), that had been in effect since July of 2001. The implementation of the MMPR was met with a constitutional challenge with respect to the rights to grow medical marijuana under a personal cultivation license that was part of the MMAR program. In what was known as ‘The Allard Case’ those patients that held a personal cultivation license prior to March 24, 2014 were allowed to continue to do so while the courts heard the arguments surrounding the constitutional challenge. On August 11, 2016, Health Canada announced the new Access to Cannabis for Medical Purposes Regulations (ACMPR). The ACMPR came into force on August 24, 2016. These regulations replaced the Marihuana for Medical Purposes Regulations (MMPR) as of August 24, 2016, and are being implemented as a result of the Federal Court ruling in the case of Allard v. Canada. Under the ACMPR, Canadians who have been authorised by their health care practitioner to access cannabis for medical purposes will continue to have the option of purchasing safe, quality-controlled cannabis from one of the producers licensed by Health Canada. Canadians will also be able to produce a limited amount of cannabis for their own medical purposes, or designate someone to produce it for them. Only producers who are authorized to produce and sell to the public may sell or provide dried marijuana, fresh marijuana, cannabis oil, or starting materials to eligible persons. As at June 2017, 50 licences had been issued by Health Canada.

USA

In June 2017, twenty-nine states and the District of Columbia currently have laws broadly legalising marijuana in some form. Seven states and the District of Columbia have adopted the most expansive laws legalising marijuana for recreational use. Most recently, California, Massachusetts, Maine and Nevada all passed measures in November 2016 legalising recreational marijuana. California’s Prop. 64 measure allows adults 21 and older to possess up to one ounce of marijuana and grow up to six plants in their homes. Other tax and licensing provisions of the law will not take effect until January 2018. A number of states have also decriminalised the possession of small amounts of marijuana. Some medical marijuana laws are broader than others, with types of medical conditions that allow for treatment varying from state to state. Several states have passed narrow laws allowing residents to possess cannabis only if they suffer from certain rare medical illnesses. These numbers are expected to rise towards 40 states by 2020 as pending legislation in a number of states is expected to be put into practice in the next several years. However, medical marijuana is still not legal at the federal level. Recently, new Senate legislation have passed, shielding medical marijuana patients, from federal prosecution in states that have legalised marijuana for medical purposes. Other pending legislation is calling to reclassify marijuana from a Schedule I drug, which has no medical benefit and includes recreational drugs (like LSD and heroin), to a Schedule II drug, which has an accepted medical use.

Europe

Europe is a small market but growing. It is served primarily by the Dutch company Bedrocan and imported by individual patients from across Europe. The Czech Republic is about to launch a national medical cannabis program with a number of local growers. Italy is joining the trend and the military has taken the role to grow in a secure location. The estimated compounded annual growth rate through 2018 is approximately 15% for the European market as a whole. Patients require prescriptions, in some cases from neurologists rather than GP’s, while distribution is conducted through pharmacies or other types of regulated dispensaries.

Israel

Israel was among the first countries to legalise medical marijuana – it remains illegal for recreational use – and is one of just three countries with a government-sponsored cannabis program, along with Canada and the Netherlands. The Israeli parliament recently took steps towards legalising the export of medical marijuana. Furthermore, Israel is at the forefront of research around medical cannabis. At present, there are more than 110 clinical trials involving cannabis are underway in Israel, more than any other country. Many of those studies are funded by the Israeli government. PhytoTech Therapeutics Limited is a subsidiary of MMJ PhytoTech Limited that has a license agreement with Yissum Research Development Company and research cooperation with Hadassah University Hospital in Jerusalem. These place the company at that forefront of medical cannabis R&D worldwide.