THE GREEN GUIDEINTRODUCTION BY MR BRIAN WHITE

A CBD RICH FLOWERING HEAD WITH RESINOUS TRICHOMES

1.0 The Cannabis PlantCannabis originated in Central Asia either side of the Himalaya mountains region of India and China. Local “races” or cultivars developed over time under the care and cultivation of humans for a range of uses including food, fibre and medicine.

The utility of Cannabis for the manufacture of rope, clothes, lamp oil, food and as a recreational drug and medicine is likely to have been sufficient to ensure its establishment in prehistoric times on all inhabited continents by the agency of humans. The current explosion of cannabis varieties and types is an expression of the enormous impact humans have had on cannabis through the se-lective breeding for desirable traits.

Medicinal cannabis is derived from the flowering tops of the female cannabis plant. The resin con-taining the active ingredients of cannabis is formed in hairlike follicles called trichomes, present in varying density throughout the plant, but concentrated in the flowering buds.

In selected varieties with high resin production these trichomes can easily be seen with the naked eye and have a sticky oily feel with piny aroma.

“The current explosion of cannabis varieties and types is an expression of the enormous impact humans have had on

cannabis through the selective breeding for desirable traits.“

LARGE FEEDER LEAF FROM A CHINESE HEMP VARIETY SIMPLE LEAF FORM

1.1 Plant MorphologyCannabis has enormous diversity in its morphology, ranging from prostrate “creeper” forms to upright giants over 6m tall. Generally cannabis is an upright annual herb from 1 to 3 metres tall, depending on the variety. It can be either a dioecious (male and female plants) annual or a moneocious (hermaphrodite) annual. Rarely, individuals have been induced to survive for several years, but this is not a common occurrence.

There is also variation between strains or varieties in terms of photoperiod, that is the day length at which flowering is initiated – typically 12 hours plus or minus, and the relative duration of the growing and flowering seasons.

Cannabis can be grown from seed or from cuttings. Generally in medicine the cannabis plant is produced from elite mother plants by cuttings taken during the vegetative growth phase.

The cannabis growth cycle is divided into vegetative growth and flowering. Vegetative growth gener-ally requires 40-65 days of days longer than 12 hours, flowering is initiated by day length (photoperi-od) being less than approximately 12 hours, and the flowering period can be 35-60 days.

Some varieties have a photoperiod longer than 12 hours, some are shorter. Most cannabis varieties show photoperiodism around 12 hours, although some “autoflowering” types can flower seemingly independent of day length.

Leaves are typically compound in the recognisable hand-shaped form, these may range in size from under 20mm from side to side, or they may stretch over 30cm in the feeder leaves of Chinese Hemp.

The leaves may be narrow, or they may be “webbed”. In some plants and varieties, the leaves exist as simple leaves, further confounding the image of a “typical” cannabis plant.

The Cannabis plant starts producing cannabinoids as soon as it germinates and commences photo-synthesis. Concentrations tend to increase steadily through the growth of the plant and reaches its peak at the end of the flowering stage.

The female flowers are where the highest concentrations of cannabinoids are found, and these are the parts that are harvested and dried for preparation of cannabis as a drug.

TENDING THE HOLY QUNUBU - ASSYRIAN 650BC (ASSYRIANGC.COM 2013)

THE FIRST OPIUM WAR – THE BRITISH ROYAL NAVY SINKING THE IMPERIAL CHINESE FLEET IN THE PEARL RIVER DELTA 1839

1.2 Ethnobotany of CannabisEthnobotany describes the relationship between plants and humans, and the relationship humans have had with Cannabis goes back into deep time. This plant has had great cultural, economic and industrial significance throughout most of human history.

What is Cannabis? Is it a drug? Is it a poison? In our society and our law perhaps. More correctly, cannabis in its raw form is a non-toxic herbal material and has historically been classified as a grain, an oil, an herb, or a spice.

Its vast global distribution is testament to the travels of humans, and its usefulness to us over the millennia. Cannabis appears in the most an-cient of holy texts, and its use has been depicted in stone and art for thousands of years. To this day primitive economies exist in the Congo re-gion of Africa where pygmies trade hunted meat in exchange for grain and cannabis. This tradi-tion is likely to represent a continuation of trade since the dawn of agriculture.

The physical evidence that Cannabis has had an important role in human civilisation can be traced as far back as organic remains can be preserved.

The famous “Ice Man” mummy “Ötzi” found on the border of Switzerland and Italy in a retreat-ing glacier proved to be 5300 years old, and had a bag of cannabis seeds around his neck. We can only assume he was not just going to grow some rope with it.

Caucasian mummies of similar or greater age to found from as far east as Qinjiang province of China through to the Steppes of Eastern Europe

have proven the ancient importance of this plant to their life and economy. Cannabis formed a cen-tral and vital part of Temple life for the Jews, and was one of the most important spices traded by the Levites in their role as Custodians of the Temple Gardens up until Roman times.

Cannabis provided oil for lamps and food, shelter, clothing and medicine. Hemp polymer plastic was used in the wheels and axles of the Hittite chariots that defeated Ramses II in war. This polymer, which has recently been rediscovered, proves to be four times stronger than steel for its weight, and is made from three ingredients: charcoal, hemp pulp and water.

Wars were fought over access to hemp, for example the Crimean War which was about access to Ukrainian hemp. Hempen rope enabled tiny Britain’s navy to project its war, aggression and con-quest around the globe. Cannabis was widely traded as a drug and medicine from the Middle East into Europe from ancient times.

Australia was literally founded with and for the production of Cannabis. The Colony in Terra Novae Hollandiae - New Holland and later to become better known as Australia, was founded on a proposal put forward by Sir Joseph Banks, the man who financed Cook’s Voyage of discovery. Banks, a philanthropist and great pa-tron of science of his age, argued that the “Criminals” clogging the assizes, jails and hulks of England were not bad people, but good people caught by bad circumstance.

Banks proposed a more humane treatment aimed at rebuilding self-worth and health, a second chance for the damned, as it were. He proposed a relatively short period no longer than seven years of corrective incarceration in a healthful climate. During which

A FRESH TERMINAL BUD OF CANNABIS SATIVA

time the men and women convicts would be engaged in whole-some empire-building activities under the lash and for no pay to repay their debt to British society. After this the convicts could contribute to the wealth of England by growing hemp for the pro-vision of naval stores.

There were some early successes and many failures as settlers struggled with spoiled seed, inappropriate varieties and lack of farming knowledged. Steadily its production grew until it was a regular mainstay for fibre and medicine in a number of early co-lonial production areas.

Whilst hemp proved a reliable standby crop until the 1920’s in Australia, and a mainstay for compounding pharmacists through-out the country, Britain’s hunger for land, wealth and resources took cannabis production in another direction entirely.

Implementing its audacious plan on a massive scale through its Possessions in the Subcontinent and its depredations into China, Britain devised a three way drug trade cartel involving cannabis, opium and tea. The market was carefully divided, the plan was carefully conceived and skilfully executed for nearly a century.

Under this arrangement, India was permitted and indeed re-quired to grow cannabis for its own consumption, the taxation collected from this went directly to Whitehall. India was required to grow Opium for supply to China, traded in exchange for tea, which in turn was sold in the UK. Thus on the trade of three social drugs of regular use and abuse were Empires built.

The trade was enforced with perfidy, espionage, invasion, mas-sacre, enslavement through addiction, gunpowder and hot lead. Meanwhile the gentle folk of Old Blighty reaped the rewards of wealth and development, most blissfully unaware of the ugly me-chanics of Empire.

For at least 50 years until 1947, Great Britain drained the wealth of India by way of cannabis taxation. All other taxation for exam-ple income tax, land tax, capital gains tax, death duties, sales tax, customs duties and excise went to pay for the running of India, Britain took the cannabis tax. It was the main game in town.

When India was “granted independence” in 1947, it was forced to become a member of the newly formed United Nations, thus being bound to cannabis prohibition and therefore unable to raise the very tax that made Britain Great.

Cannabis was an important part of the pharmacopoeia of colonial Australia up until the mid 1920’s when the first restrictions and prohibitions came in for compounding pharmacists. Cannabis cig-arettes and cannabis tincture were noted to provide relief from a very wide range of maladies and diseases and formed the backbone of many a station medicine chest.

Prohibition was complete in law if not in civil fact from 1932 onwards in Australia. Cannabis prohi-bition became an international obligation when Australia ratified the Single Convention of Narcotic Drugs in 1961. Any current use of medicinal cannabis in Australia must comply with the terms of the Single Convention.

“Australia was literally founded with and for the production of Cannabis.”

1.3 Cannabis Taxonomy.Historically, the taxonomy of Cannabis has been determined by purely morphological traits, and it is generally accepted to consist of three species. However there is a problem with this. All three species freely “hybridise” and produce offspring with genetically predictable traits from both parents. In taxonomic terms the differences between these three reasonably arbitrary phenotypes can be better explained as being local expressions of genetic elasticity and diversity rather than separate distinct plant species.

Cannabis is characterised by considerable genetic elasticity in its ability to quickly undergo epigen-etic change to adapt to local conditions, and pass these changes on to the next generation perma-nently through seed.

Cannabis produces a unique array of chemical defences - a group of plant chemicals collectively known as phytoalexins. Phytoalexins are defined as a substance that is produced by plant tissues in response to contact with a parasite, disease or environmental stress, and specifically protects the plant from damage from these stressors.

It is this profile of chemicals specific for each individual plant that gives the cannabis plant its so-called whole-plant cannabinoid profile, or if referring to the chemical make-up of a particular strain, its chemotype.

The different cannabis phenotypes are typified by particular chemotypes, that is the variable ratios of cannabinoids and plant terpenes and flavonoids present in the flowering heads of the female plants. These compounds are significant in medicine, because terpenes and flavonoids interact with the cannabinoids present to enhance or alter the overall effect on the body and its immune system.

Many botanists feel it is more accurate to describe cannabis in terms of phenotype and chemotype groupings within a genetic continuum rather than genetically discrete species. Here we will instead classify Cannabis broadly as “industrial” or “medicinal” types, although even here there may be some overlap.

Dioecious (male and female plants) taller (up to 6m) phenotype with palmate leaves typically not webbed. Industrial varieties can have very low THC levels ap-proaching 0ppm. Some Industrial cultivars have quite high levels of CBD and selections with 20% plus CBD have been reported. Photoperiod around 12 hours. Vegetative Growing period 60-85 days flowering period 60-70 days. These plants are typically grown for grain, fibre and biomass. High CBD strains are bulk extracted in Europe, Canada and China for use in medicine.

THC content greather than 3% and up to 4m in height. Cannabis sativa can have natural THC levels up to and over 25%, typically in the range of 5% to around 18%. Some sativa varieties are clearly indica hybrids and display both THC and CBD in their profile. Sativa/indica hybrids show promise for the treatment of a wide range of serious illnesses.

Evolved in the far northern latitudes of Europe. Adapted to a very short growing season. It is typically monoecious that is it has both male and female flowers (hermaph-rodite), and short in stature from 30 to 120cm tall. Ruderalis types have very low CBD and THC levels. Photoperiod 12.5 - 13.5 hours, Vegetative period 40-65 days flowering 40-50 days.

Dioecious (male and female plants) shorter phenotype with palmate leaves typically webbed. Cannabis indica typically has high natural THC levels up to and over 25% and little or no CBD in their profile. High THC are used for the treatment of chronic pain, epilepsy, rheumatoid arthritis, MS, Parkinsons, Alzheimers, Dementia,ADHD and PTSD, and as an anti-emetic and relaxant for chemo-therapy patients.

Cannabis Sativa / Industrial Hemp

Industrial Type Medicinal Type

Cannabis Sativa / Marijuana

Cannabis Rudealis Cannabis Indica

(SOURCE: THE GREEN BOOK, ISRAELI DEPARTMENT OF HEALTH)

SATIVA SOURCE/PROPERTIES INDICA SOURCE/PROPERTIES

Increase in Thought Processes Increased physical effect (“couch-lock”)

Stimulates the mind, digestion and body Soothing – relaxes smooth muscle

Increases appetite Axiolytic - Relieves anxiety

Increases creativity Soporific – mild sedative

Anxiolytic - Increases Self-Confidence and Fights Depression Analgesic and Anti Inflammatory - Relieves pain

Recommended for use during the day Recommended for use at night

CANNABIS IS CLASSIFIED INTO THREE SPECIES:

SATIVA

SATIVA INDICA RUDEALIS

INDICA RUDEALIS

Recreational Cannabis generally utilises Sativa or Indica strains or - most often - a hybrid of these two.

Rudealis is not used for consumption but is crossbred with Indicas or Sativas to produce “auto�owering” hybrid strains - which will produce �owers (buds) based on age, rather than light cycles like Sativa or Indica strains.

Indica strains tend to a�ect the perceptions of the body and are ideal fo night-time dosing. Typical e�ects include: mellowness, a carefree state, calm, couch-lock, sleepyness, and relaxation.

Sativa strains tend toward daytime focusing on mental activation and producing e�ects of: euphoria, creativity, alertness, sociability, cheefulness and energy.

- Flowering time 10-16 weeks- Very tall- Long branches with large distances

between nodes- Expansive root system

- Flowering time 6-8 weeks- Small, compact size- Robust stalks- Condensed root system- Dense heavy buds

- Flowering time 3-4 weeks- Small in size- Wild looking- Conical shape- Fewer branches than Sativa or Indica

Light colourLong, thin leaves

Deep ColourWide, broad leaves Low THC content

Wild strain

8-15 ft.

2-6 ft.

1-3 ft.

THC CBD CBN ALL OTHER CANNABINOIDS

0%

25%

50%

75%

100%

“THC and CBD are the two main, but not the only clinically and pharmacologically active cannabinoids in the cannabis plant.”

ANALYSIS OF CANNABIS SEIZURES IN NSW, AUSTRALIA: CANNABIS POTENCY AND CANNABINOID PROFILE (2013). (PLUS ONE VOL 8. ISSUE 7 2013)

1.4 Cannabinoids.Cannabis is best known producing a family of prophenolic terpenes known as cannabinoids. These are responsible for the medicinal and psychoactive effects of cannabis in humans and animals.

Each Cannabis seedling has a cannabinoid profile, taste and smell which is unique to that particular plant. The range of combinations and permutations of chemicals in the profile of a strain or plant are of great interest to both the plant breeder and to the medical practitioner.

There are more than 100 cannabinoids identified, but of these, the main psychoactive ingredient is Δ9 Tetrahydrocannabinol (THC), ligating both the CB1 receptors in the Central Nervous System, reproductive organs, liver, kidneys, bones and brain, and the CB2 receptors in the immune system.

The other main cannabinoid of interest is Cannabidiol or CBD, which is not psychoactive and ligates only the CB2 receptors in the immune system. CBD interacts with and mediates the uptake of THC. CBD acts as a CB1 antagonist to the uptake of THC in the early stages of medication, then acts as to promote the ligation of CB1 receptors by THC, as THC levels drop in the body. This has the effect of moderating the psychoactive effects of THC, then prolonging its effect over time. This phenomenon is of great interest in medicine.

THC and CBD are the two main, but not the only clinically and pharmacologically active canna-binoids in the cannabis plant. The effects of THC and CBD are mediated via other cannabinoids, which also have a unique set of effects of their own.

There are other psychoactive Cannabinoids such as Tetrahydrocannabivirin THC-V, which is an antagonist of the CB-1 receptor and a partial agonist of the CB-2 receptor. THC-V is the subject of current research into its use against Type 2 Diabetes and other auto-immune diseases. No doubt we will learn more of these “other” cannabinoids in due course as science catches up with cannabis.

1.5 Is Cannabis stronger now than it was in the 1960’s?No. Only a very few varieties of Cannabis have significant quantities of THC, out of the many thousands of landraces still in existence. Some varieties will go above 20% THC. In fact these high THC varieties make up a small percentage of the illicit market in Australia.

In Australia, high THC cannabis has been rarely detected in street seizures by police. Most cannabis available on the illicit market in Australia and the US has THC levels between 6 and 18%.

What has changed is a selection for THC production alone, to the possible neglect of other active cannabinoids.

That’s changing fast, as the understanding improves of how the Endocannabinoid system functions in our bodies, and its interac-tions with the terpenes and cannabinoids of cannabis, we will see some very interesting developments in this field.

1.6 Cannabis TerpenesThe chemical profile of Cannabis is testament to its unique immune system. It has the ability to produce a dazzling array of chemical defences against pests, herbivores, diseases and parasites. Many terpenes have been identified as the active ingredients in herbs and spices. These terpenes have long been used in medicine, and are undergoing further exploration using modern science to determine their mode of action within our own immune systems.

All culinary herbs contain volatile oils that give them their flavour and value in cooking. These es-sential oils have a high percentage of plant terpenes, terpenoids and flavonoids. Cannabis is unique in the plant world in that it has the largest known range of terpenes present of any plant species.

It seems remarkable that one plant can independently synthesise and possess so many phytoalexins. Does Cannabis have the ability to “smell” the phytoalexins produced by other plants and then re-cre-ate them for its own use, or is this ability pure coincidence? The unique genetic elasticity of cannabis means any new epigenetic changes are readily passed on to subsequent generations through seed.

Cannabis terpenes include most of those found in culinary herbs and spices. Terpenes detected in-clude some very exotic ones such as eucalyptol, normally only associated with the genus Myrtaceae, particularly Australian Eucalypts, melaleucas and callistemons.

As with all herbs, cannabis has its own essential oil made up primarily of terpenes that is non-psy-choactive, and has a clear, slightly green tint and grassy herbal smell. These chemicals provide pow-erful protection for the plant’s immune system, and contribute to the distinctive aroma of the plant.

Plant terpenes have different actions on and within the human body. In some cases they assist the uptake of cannabinoids by the body, in other cases they inhibit or antagonise the uptake at the CB1 and/or CB2 receptor sites.

Patients become “immune” to their regular strain after a while, and this tolerance can be minimised by changing strains from time to time. The different terpene profile of the new strain overlying the Cannabinoid profile is sufficient to break the immunity for a time.

Most plant terpenes are biologically inert and non-toxic, but have been given a “notional” LD-50 - that is a dose sufficient to kill 50% of the population - of over 4000mg/kg bodyweight. In fact there is no such thing as an LD-50 for most plant terpenes and all cannabinoids as they are not cytotoxic. Most botanical terpenes found in culinary herbs are regarded as biochemically safe, and most have been granted GRAS status (Generally Regarded As Safe).

Terpenes and Cannabinoids interact in what has been termed by Dr Ethan Russo as “the Entourage Effect” where the components work synergistically with the user’s endocannabinoid profile to pro-vide an overall effect unique to each individual user.

For example, The sedative effects of over 40 terpenoids were assayed upon inhalation by mice by Buchbauer et al. (1993). The study found that linalool found in cannabis and particularly associated with lavender, had the most powerful effect of the terpenoids tested.

Mouse motility was reduced 73% after 1 hour of inhalation, indicating powerful sedation. This study showed other cannabis terpenoids such as α-terpineol and citronellol are also deeply sedating upon inhalation, even in low concentrations. It was also found that combinations of these terpenoids were synergistic in their sedative effects.

It is known that pure THC can have undesirable psychological side-effects in certain individuals, brought on by extreme and sudden anxiety. The significance of terpenes in cannabis medicine is that the presence of these substances that occur naturally in some cannabis strains may mitigate anxiety effects brought on in some individuals by THC.

Komori et al. (1995) showed that nasal inhalation of certain terpenes, in particular β-caryophyllene found in black pepper can provide antidepressant effects, alleviating possible anxiety brought on by high levels of THC, and Inouye et al (2001) proved the antibacterial and antiviral properties of gas-phase plant terpenes at concentrations as low as 12.5ppm.

Botanical terpenes are known to be active within the body at very low concentrations. Their seeming synergism with the other chemicals present in cannabis suggests they may have an important role to play in cannabis medicine.

“In addition to the likely beneficial effects of CBD in the diet, cannabis oil is unique among plant seed oils in having the

“perfect” balance of Omega 3,6 and 9 fatty acids. “

1.7 Cannabis as Food.Cannabis as food falls outside the scope of Medicinal Cannabis, but the unique chemical profile of hemp as food makes it a functional food. Functional foods may be defined as foods that have an effect on the body over and above their simple nutritional value. The evidence supporting the value of hemp to our diet has been sufficient to overturn nearly 90 years of prohibition.

Hemp as a food has up to 30% high quality oil, 30% protein, which includes all 20 essential amino acids in the perfect ratio, and complex carbohydrate. Hemp is a high quality, complete food. In March 2017 Cannabis hemp seed was approved for use as a food in Australia and New Zealand. This legislative change took nearly 30 years and three separate attempts to pass through the cumbersome and dysfunctional formal processes of approval.

Many vested interests within the business and religious community did not want a hemp industry to take place in Australia in any shape or form. Despite their constant interference and 29 years of abuse of process, the approval was eventually granted. This milestone is a testament to the validity of the science backing the use of hemp for food, and the dedication of a small group of people working for sensible hemp laws both in the broader community and essentially, from within government at all levels.

Under the changes, dehulled hemp seed can be used for foodstuffs, provided it complies with strict safety guidelines and falls within the defined maximum limits for CBD and THC. During the FSANZ approval process, a hazard analysis was conducted for CBD. The Executive Summary of this report states:

“Cannabidiol (CBD), which is structurally related to delta 9-tetrahydrocannabinol (THC), is typically present in low THC hemp seed foods at levels in the low mg/kg range. The pharmacological properties of CBD, and its safety profile, have been the subject of extensive research, including studies in humans. In contrast to THC, CBD binds weakly to cannabinoid receptors and does not cause psychoactive effects.

Studies in laboratory animals indicate that the oral toxicity of CBD is low. CBD administered by the oral route has been investigated in clinical trials in healthy subjects and in patients with various medical conditions. CBD has been shown to be well tolerated at doses greater than 1000 mg per day. No reports of adverse effects attributable to oral CBD were located in the published literature. Regarding efficacy in these studies, the lowest oral dose in humans for which potential therapeutic effects have been reported is 120 mg/day.” (Food Standards Australia and New Zealand - Cannabidiol Hazard Profile – Proposal P1042 Low THC Hemp Seeds as Food, 2015).

In addition to the likely beneficial effects of CBD in the diet, cannabis oil is unique among plant seed oils in having the “perfect” balance of Omega 3,6 and 9 fatty acids. It is reputed to be a viable replacement for fish oil, calamari oil or krill oil in the human diet.

Final objections brought through the FSANZ process were eventually resolved in April 2017, and hemp food that meets the strict quality and safety criteria is legally available to all Australians from 1 November 2017.

DRIED CANNABIS FLOWER BUDS

1.8 Plant Breeding: Towards Standardised Medicines.The interaction between the terpenes, CBD and THC becomes a vital consideration in matching patients to the appropriate medicine. Hybridisation, the process of cross-breeding varieties and strains to develop new stable strains, is an important part of developing appropriate CBD:THC ratios for medicine.

Given the predictable heritability of desirable traits, and the relative ease with which cross-breeding can occur, the development of new strains is a dynamic and ongoing process. In recent times the internet has greatly accelerated this development around the world, and arguably has done an enor-mous amount of good in spreading the Truth about Medicinal Cannabis.

As medical science builds its knowledge base of the Endocannabinoid System, focus will be placed on the development of specific cannabinoid profiles to treat specific illnesses. This is not as straight-forward as it may seem.

Medicinal cannabis interacts with the individual’s own endocannabinoid system, no two of which are exactly the same. Therefore, no two individuals respond in exactly the same way to the same medication. This gives rise to the concept that medicinal strains must not only be developed for specific illnesses and disorders, but also to suit individuals suffering from those ailments.

Cannabis medicine is one that requires the input of both the patient and the medical practitioner to fine-tune and get things right. Even so, the patient may become “immune” to his medici-nal strain of preference and may need to jump to other strains from time to time to break im-munity. The process of cannabis medication is therefore highly individual and it must remain a dynamic process to maintain its usefulness over time.

Once suitable strains are developed, they can be maintained via vegetative propagation for decades or even centuries. Examples of ancient horticultural clones we enjoy to this day would include the Rhine Riesling grape reputed to have been developed during Roman times, and the Shiraz grape, which originated in Iran again pos-

sibly in pre-Roman times. These varieties have survived through the ages via cuttings transported through time and across the globe by humans.

A more modern example is the Granny Smith apple. This was a sport or mutation on a backyard tree in Sydney first propagated in 1868. It provides the pollination for all modern apple orchards, every seventh tree planted is a Granny Smith. Yet another is the Cavendish Banana, was collected from native cultivation in 1829, and forms the mainstay of the international banana trade today.

The point to remember is this: once a selection is made, a clonal mother plant can be kept going for generations. Its chemotype and potency remains the same from generation to generation, enabling the production of standardised medicines.

CANNABIS PROCESSING

1.9 Drying and Curing.After the cannabis has been grown, the next critical step is drying and curing. It is at this point that microbial contamination can occur, seriously affecting the safety and quality of the herbal material. Bacterial contaminants include Klebsiella, E.coli, Pseudomonas, Acinetobacter, and fungi that have been implicated in fungal lung infections in immune compromised individuals.

Great care must be taken during harvest not to touch the flowering heads, or let them come in contact with unhygienic surfaces. Some exposure to UV light in the form of sunlight serves as an efficient surface sterilization technique for drying herbal material. However, THC is reactive to UV light and is degraded upon excessive repeated exposure.

Excessive exposure to ultraviolet light degrades THC into Cannabinol – CBN – which is a powerful sedative. This can impact the usefulness of medicinal cannabis if it causes the user to be too sleepy to continue normal daily activities. Great care must be taken in the drying, curing and storage to en-sure that exposure to UV light is kept to the minimum necessary for safe preparation of the material.

The drying process is by necessity slow, requiring surface drying and case hardening of the outer cuticle of the leaf material, followed by curing, allowing inner moisture to redistribute through the harvested material, then daily repeated careful and slow drying until the herb is sufficiently dry to minimise the possibility of damage by fungi.

During this process certain metabolic processes continue within the plant, under the action of en-zymes in the ever increasingly concentrated plant material as it dries. Precursor molecules continue to convert via enzyme-mediated pathways into active cannabinoids. In this way, cured cannabis improves in its potency and effect over the first six months from harvest, if stored and cured prop-erly. However, all the hard work put into growing and harvesting can easily be thrown away with incautious and unhygienic drying and curing.

“There is no requirement for medicines containing cannabis to be registered with the ARTG, unless they are patent medicines. “

1.10 Production of Medicinal Cannabis in AustraliaLegislation in Australia enabling the cultivation of cannabis for medicinal and related research purposes was passed by the Australian Parliament on 29 February 2016, with amendments relating to licensing coming into effect on 30 October 2016. The regulatory framework is in place to enable applications for licences and permits for the cultivation, production and manufacture of medicinal cannabis products. A number of research and grower licences have been issued at the time of writing.

Under the new Law, medicinal cannabis products are only available under medical supervision for specific patient groups. Cannabis grown for medicinal purposes, as well as the resulting product, is subject to stringent security and quality control measures. Cannabis cultivated for other purposes (other than for industrial hemp) remains illegal in Australia.

Therapeutic Goods Order 93 from the Australian TGA is in place, specifying the rigid quality criteria required of medicinal cannabis. The order amongst other things specifies the maximum permissi-ble limits of heavy metals, aflatoxins and bacterial contamination. The cannabis must be subjected to macroscopic, microscopic examination and chromatographic procedures to ensure safety prior to sale.

It is anticipated that domestic cultivation of medicinal cannabis will enable sufficient quantities of raw materials to meet the needs of local manufacturers. The stringent health and safety guidelines ensure that quality control on medicinal cannabis-produced under the new License system protect patient safety.

There are three types of licences relating to the supply of medicinal cannabis products in Australia:

› Medicinal cannabis licence authorising cultivation or production or both

› Cannabis research licence authorising similar process for research purposes

› Manufacturing licence authorising the manufacture of a drug or product.

All applicants for licences under the Medicinal Cannabis framework are subject to regulations. These regulations include detail on the “fit and proper person” test, which involves consideration of the applicant’s criminal history, financial viability, business history and capacity to comply with licensing requirements.

Before any activity under a licence can commence, the licensee must obtain a permit, which sets out the types and amount of cannabis that can be grown and/or produced and the types and quantities of medicinal cannabis products that can be manufactured under the licence.

Medicinal Cannabis is treated differently to all other drugs in Australian Law. There is no require-ment for medicines containing cannabis to be registered with the ARTG, unless they are patent medicines. The Medicinal Cannabis is considered “fit for purpose” if the protocols of production (Good Agricultural Practice – GAP), processing (Good Manufacturing Practice – GMP), and disribu-tion (Good Distribution Practice – GDP) are followed.

For medical practitioners who are concerned about liability issues relating to the prescription of un-listed medicines, State enacted legislation indemnifies practitioners from any claims that may arise from the prescription of medicinal cannabis. This is unique in Australian Legal history.

The Australian Medicinal Cannabis legislation opens the door for the treatment of a wide range of diseases with this versatile and safe natural product.