Medicinal Cannabis and the Law in Ireland

Niall Neligan
Barrister-at-Law

Medicinal Cannabis and the Law in Ireland.

Niall Neligan, Barrister-at Law.
Lecturer, Department of Law, Dublin Institute of Technology.


Abstract

The purpose of this article is to give a brief overview of the law relating to medicinal cannabis in Ireland in light of recent scientific and medical discoveries. This article will critically evaluate the nature of cannabis prohibition under Irish law in the context of international legal requirements derived from Ireland’s adherence to the United Nations Single Convention on Narcotic Drugs 1961 as amended by the 1972 protocol, the Convention on Psychotropic Substances 1972 and the United Nations Convention against illicit traffic in Narcotic Drugs and Psychotropic Substances 1988.The author will then evaluate the nature of domestic regulation and licensing of cannabinoids for medicinal use under the Misuse of Drugs Acts 1977-2015. Finally, the article will conclude with a comparative analysis of legal regulation of medicinal cannabis in the United States and Germany for the treatment of cancer, multiple sclerosis, chronic pain syndrome and other illnesses.

Historical evolution of medicinal cannabis
Hemp has been cultivated by humans for much of the last 12,000 years. However use of wild hemp dates back a lot further with evidence of hemp cordage during palaeolithic times. Anthropologists believe hemp was first cultivated near the Irtysh River in the central Asian steppes of Kazakhstan from where it spread east through China. Its residue has been found among pottery belonging to Tapenking culture excavated at Yangmingshan near Taipei on the island of Taiwan. Cannabis is the generic name for hemp the name given to it by Carl Linaeus deriving the name from the classical Greek word Kannabis which in turn emanated from the Sanskrit word Cana. Throughout the course of its long and varied history, hemp fibres have been used as a food source, for paper, roping, and of course for the manufacture of textiles used in clothing. Moreover, and somewhat lost, is the fact that hemp fibres can be synthesised for oil and plastics.

Aside from the industrial use of hemp, the plant has a long tradition of medicinal use in ancient, indigenous and non western societies. Recorded medicinal use of cannabis in China can be traced as far back as 2737 BCE. In the subcontinent of India stretching from the foothills of the Hindu Kush to Bangladesh, there is recorded use of medicinal cannabis during the Vedic period which lasted from 1500 – 500 BCE. Herodotus in histories recorded use of hemp by the Scythians for incense and medicine in the 5th century BCE, making it the first recorded reference of use in classical antiquity.
It is well recognised that Cannabis is among the oldest and most widely used forms of medicine by mankind; used predominantly for the treatment of pain and spasm as well as other recognised conditions. However, notwithstanding its long recorded history and the fact that it was used both by indigenous and non-western societies, cannabis and its medicinal benefits were not popularised in modern Western medicine until the 1840s largely thanks to research findings of Irish physician William Brooke O’Shaughnessy.

Sir William Brooke O’Shaughnessy
In August 1833 O’Shaughnessy joined the Bengal army as an assistant surgeon and shortly after arriving in India was appointed professor of chemistry and medicine at the Calcutta medical college. For a time he was also employed as first assistant in the government’s opium factory at Bihar and as physician to Sir Charles Metcalfe. Early in his tenure, he observed the potential therapeutic value of cannabis. After studying oriental texts he carried out a number of experiments with cannabis on both animals and humans; specifically focusing on patients suffering from Rheumatism, Epilepsy, Tetanus and Cholera. He subsequently published his findings in a paper to the Medical and Physical Society of Bengal entitled On the Preparation of Indian Hemp or Gunjah In his conclusion O’Shaughnessy made the following observation
‘In hemp the profession has gained an anti-convulsive remedy of greatest value. I deem it my duty to publish it without any avoidable delay in order that the most extensive and speediest trial may be given to the proposed remedy.’ Aside from his contribution to our knowledge of medicinal cannabis, O’Shaughnessy is best remembered as the inventor of the intravenous drip.


Nature of Cannabis
Cannabis belongs to a genus of flowering plants which includes three recognised species: Cannabis Sativa, Cannabis Indica and Cannabis Ruderalis all of which are indigenous to Eurasia and south Asia respectively. The Eurasian Cannabis Sativa and the Indian variety Cannabis Indica were first classified in 1753 by Carl Linnaeus in his Species Planatarum.. The third recognised species of Cannabis, Ruderalis was classified in 1924 by a Russian botanist DE Janischewski and is largely found in north eastern Europe and the Volga region. Cannabis Sativa represents the largest category in cultivation and use, followed by Indica.

Varieties of Cannabis
Notwithstanding the medicinal as well as the numerous industrial uses of the plant, cannabis is better known among the wider population as a recreational drug. In terms of recreational use, there are a variety of cannabis byproducts which may be used psychoactively, however the most common can be broadly divided between the resin based hash and the leaf based marijuana. Hash which is made from resin is known by many names, including bhong and ganja, and is traditionally more potent than the herbal based marijuana.

The name Marijuana itself is derived from Spanish slang used widely in Mexico in the late 19th century to refer to cannabis. Indeed up until the early part of the 20th century, the words cannabis or hemp were more widely used in the United States to refer to the plant rather than marijuana which found its way into the lexicon courtesy of Mexican immigrants who settled in the south western United States after the revolution of 1910.

Unlike hash, marijuana is made from the dried flowering tops, leaves, stems and seeds of the cannabis plant which are more popularly used in the United States. In more recent years, synthetic cannabinoid products have emerged and have added a new dimension to the cannabis market. According to the European Drug Report (2015) over 130 synthetic cannabinoids have been identified, and they appear to be largely manufactured in China before being shipped to Europe in powder form and subsequently added to plant material before being repackaged as synthetic highs.

Chemical Composition
There are approximately 470 known chemical constituents in the average cannabis plant which include compounds that have both medicinal as well as psychoactive use. Cannabinoids are unique chemical structures that can only be found in the cannabis plant. The main psychoactive constituent of cannabis is tetrahydrocannabinol or THC, however it is not the only important cannabinoid found in the plant, which also includes cannabidiol (CBD) and cannabinol (CBL) respectively. It is generally believed that CBD the most abundant cannabinoid in the plant has anti-anxiety effects, and would appear to have the potential to prevent psychotic symptoms having been used in clinical trials on patients with schizophrenia. The evidence as published seems to support the view that CBD operates in the same way that regulated pharmaceutical drugs do when it comes to treating certain disorders such as schizophrenia.

Cannabinol (CBN) is a cannabinoid and an oxidation product of THC it is normally only found in aged samples of cannabis and cannabis resin. CBN is only very weakly psychoactive and not unlike CBD interacts with THC to reduce its effects. CBN was first isolated in 1899 with CBD being identified in 1949 . However, it wasn’t until 1964 when Israeli scientist Raphael Mechoulum isolated THC as the main psychoactive component of cannabis. Notwithstanding, Mechoulum’s discovery of THC, it wasn’t until the discovery of the endocannabinoid system in the human brain and the peripheral nervous system in the 1980s did scientists begin to comprehend the full extent to which each person has their own cannabinoid processing system which is now known as the endocannabinoid system.

The Endocannabinoid system
The endocannabinoid system is a lipid signalling system that has been with humans since early in our evolution and serves important regulatory functions throughout the human body. The system consists of a family of cannabinoid receptors; G-protein-coupled receptors, endoligands which activate these receptors; and in addition two enzymes, amide hydrolase and monoacylglycerol lipase to metabolise the endoligands. The endoligands of the cannabinoid receptor system, are small molecules derived from arachidonic acid, are called endocannabinoids.

What this suggests is that these naturally found receptors have developed in tandem with human evolution and physiology receptors which are naturally activated by the use of cannabis, in short humans may have been using cannabinoids far longer than was originally perceived.

In terms of taking cannabis there are two main ways (whether medicinal and/or recreational) inhaling or ingestion resulting in THC entering the bloodstream through the brain. Inhaling THC takes less time to absorb and its effects pass more quickly through the system than ingestion which can take up to an hour before absorption into the bloodstream and consequently its effects last longer. Pharmacologically speaking, cannabis is a mild hallucinogen which depending on the strength gives the user a mild euphoric lift or ‘high’. Unlike opiate based drugs, cannabis while it may give rise to psychological dependence in some people with addictive personalities it is highly unusual for users to become physiologically dependent in the same manner as habitual users of heroin or cocaine would.

Distinctions in use and effect
One of the major distinctions between opiate derived drugs and cannabis derivatives is that the later is less toxic, in so far that there is no scientific evidence that a user can overdose in the same way users of heroin, cocaine and other synthetic drugs can. Moreover, cannabis is less toxic and harmful than alcohol and tobacco, as evidenced in research published by The Lancet in which the researchers ranked twenty drugs on 16 criteria, nine of which related to individual harm and seven on harm to others; each drug was scored out of 100 with alcohol scoring 72, heroin 55, crack cocaine 54, Tobacco 26 and Cannabis with 20.

A long established myth about cannabis use is that it serves as a ‘gateway drug,’ which has been rejected by medical and scientific research which notes that there is no sequential or progressive pattern discernible in leading one drug use to another. The gateway drug advocates suggest that beginning with tobacco and alcohol, the user progresses to cannabis and other illicit drugs as a matter of cause and effect, but there is no evidence to back this up. Rather if as research suggests a gateway pattern exists (and that remains in doubt) then it reflects unmeasured causes rather than causal effects of specific drugs on subsequent use of others. This implies that successful efforts to prevent use of specific ‘gateway’ drugs’ may not themselves lead to major reduction in the use of later drugs’

Global prohibition and the accompanying War on Drugs has for many years done significant damage to the reputation of cannabis as a therapeutic drug. Notwithstanding the difficulties created by global prohibition and the hurdles placed in the way of carrying out clinical research, a significant body of research demonstrates that ‘Cannabinoids have many distinct pharmacologic properties. These include analgesic, antiemetic, antioxidative, neuroprotective, and anti-inflammatory activity, as well as modulation of glial cells and tumor growth regulation.‘.


Drug Regulation Ireland
Regulation of Drugs in this jurisdiction dates back to The Poisons (Ireland) Act, 1870 which placed controls on opium, morphine, cocaine, heroin and preparations containing these drugs. After 1870 several substances were added to the schedule, including the barbiturates and certain of the amphetamines. This Act imposed labelling and recording requirements and provided that certain of the scheduled substances could only be sold to a person known , etc.to the seller. The sale of the scheduled substances was confined to authorised persons (i.e., registered pharmaceutical chemists , etc.) by virtue of the operation of the Pharmacy Act (Ireland) 1875 (as amended).

Cannabis Prohibition
The circumstances of how cannabis became prohibited at the League of Nations 2nd Conference on Opium in 1925 has long been a subject of controversy. The focus of the conference was supposed to be opium and cocaine, however a dispute arose between the United States delegation and the British /Indian representatives over the scope of restrictions on opium; the Americans sought to curtail supply, the British on the other hand favoured moderating demand. The Americans tabled a motion which went beyond what was already agreed should be the objective of the conference and it was into this void that a resourceful prohibitionist from Egypt, Mohammad El Guindy suggested that cannabis should be included on the list of prescribed drugs.
Initially perceived as diplomatic posturing, El Guindy cleverly exploited the differences between the American and British delegations over the agenda and the nature of the proposals concerning controls on opium. With some backing from the Americans but more particularly from the Turks and Chinese who were only too happy to have attention shifted away from Opium, El Guindy managed, with the assistance of questionable scientific data and puritanical zeal to have cannabis listed as a controlled substance.
Thus, it was by virtue of El Guindy hijacking the agenda and gaining support from small nations to pass the motion, that the United Kingdom (and by extension Ireland) was obliged to introduce regulations to prohibit the production, supply and possession of Cannabis, something which the British

The Dangerous Drugs Acts 1920-1925
In light of these development, the Parliament of the United Kingdom passed the Dangerous Drug Act in August of 1925 amending two previous acts passed in 1920 and 1923 respectively. The net effect of the 1925 Act was the inclusion of ‘Indian hemp’ and all resins associated with Indian hemp. As Mills notes that by taking into account international obligations arising from the Opium Convention, coupled with domestic ignorance on the nature and effect of cannabis, the Dangerous Drug Bill passed through Parliament ‘despite the opinions of experts, because of little more than innuendo…and without anything approaching well-informed debate.’

On 28th September 1928 cannabis first became illegal in the United Kingdom, and most of the rest of the world, when as already noted the Second Geneva Convention took effect. The 1928 Amendment to the 1925 Dangerous Drugs Act criminalised possession of cannabis. The Dangerous Drugs Act 1920 formed part of Irish Law until 1934 when the Irish equivalent to the 1925 Dangerous Drugs Act was passed. the Dangerous Drugs Act 1934 was passed in order to fulfil Ireland’s obligations under the League of Nations Convention for Limiting the Manufacture and Regulating the Distribution of Narcotic Drugs, 1931

The Dangerous Drugs Act 1934
The 1934 Dangerous Drugs Act firstly repealed the 1920 Act and secondly allowed the Minister to make regulations for controlling or restricting the production, possession, sale and distribution of Indian Hemp and resins obtained from Indian hemp and all preparations of which such resins form the base. Under the definition section, Indian Hemp was described as the dried flowering or fruiting tops of the pistillate plant known as cannabis sativa from which the resin has not been extracted.

United Nations Single Convention on Narcotic Drugs 1961.
Already noted above, the circumstances in which cannabis was prohibited under the 1925 convention was quite controversial.
Little was done to change the text of the convention in the years before the 2nd World War with the exception of the 1936 Convention for the Suppression of the Illicit Traffic in Dangerous Drugs. Interestingly, the United States did not sign this convention which was only signed by thirteen member states. After World War II, international drug control transferred from the now defunct League of Nations to the newly founded United Nations, from 1946 onwards responsibility for multilateral control became vested in that organisation. The piecemeal approach towards international drug control initiated back in 1909 was revisited in 1961 by the UN Single Convention on Narcotic Drugs. The guiding principal of the 1961 convention was to limit the use of drugs exclusively to medical and scientific purposes. The preamble of the convention declared that whilst recognising the medical use of narcotics as indispensable for the relief of pain and suffering, addiction to narcotic drugs constituted a serious evil for the Individual.

The convention marked an important milestone in global prohibition, requiring signatory states to enshrine in their domestic law

‘such legislative and administrative measures as may be necessary (a) to give effect to and carry out the provisions of this Convention within their own territories’

The provisions governing cannabis set out under earlier conventions were re-enacted under Article 28 (3) which provided that

“The Parties shall adopt such measures as may be necessary to prevent the misuse of, and illicit traffic in, the leaves of the Cannabis plant.”

Quite inexplicably and again controversially, cannabis was included in Schedule IV of the convention, reserved for the most dangerous drugs, alongside heroin; whereas cocaine on the other hand appeared in the 1st Schedule Article 2 (5) of the convention provided that special measures of control should be adopted in relation to drugs listed on Schedule 4 which are necessary having regard to the particularly dangerous properties of a drug so included.

Irrespective of the wording of the convention, the drugs listed in the schedule were not made ‘illegal’ in the strict sense of the word, rather their cultivation, production and distribution were placed under strict control so that their use could be limited to medical, scientific and other legitimate purposes. Notwithstanding the fact the United States had been the driving force behind the Single Convention, the Americans proved again to be quite reticent in signing the treaty when it came into force in December 1964. The Americans had previously signed off on the 1953 New York Opium Protocol and particular the enforcement measures under Article 12 which provided for an embargo mechanism against states which failed its obligations. The Americans argued that the 1961 convention should be amended to make it more effective before it came into force. When that did not occur the Americans refused to sign, and did not accede to the convention until 1967.
The provisions of the 1961 Convention were augmented by the 1972 Protocol Amending the Single Convention on Narcotic Drugs and that in turn was supplemented on two further occasions by the Convention on Psychotropic Substances 1971, and the 1988 Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.

In response to the 1961 convention and increased drug usage towards the end of the 1960s the United Kingdom introduced the Misuse of Drugs Act 1971 providing for the first time a classification system for controlled drugs. In the United Kingdom before 1971, it was not a criminal offence for a Doctor to prescribe cannabis, and Doctors were still allowed to prescribe drugs such as cannabis for treatment or addiction under the 1928 Act.

In 1969 aware of development in the United Kingdom the Irish Minister for Health, Sean Flanagan, appointed a Working Party on Drug Abuse. Their report in 1971 makes for interesting reading, and demonstrates some familiarity with the arguments why cannabis should not be criminalised under Irish Law. However the opinions of the committee under paragraph 3.4 of the report are largely a replication of similar findings under the UK’s Wooton Report 1968. In respect of cannabis the report recommended the following:

(a) In the light of present knowledge it cannot be said that cannabis is harmless, especially in regard to long-term and frequent use. Therefore, it should remain subject to control. However, the legal and medical status of cannabis should be kept under review in the light of experience and research;

(b) Possession of a small amount of cannabis otherwise than for peddling or pushing should not normally be regarded as a crime to be punished by imprisonment.


Misuse of Drugs Acts 1977-2015
The Irish equivalent of the Misuse of Drugs Act 1971 was introduced in 1977 and remains the bedrock of drug prohibition alongside the Misuse of Drugs Act 1984 and the accompanying regulations. Interestingly, Ireland was not a signatory to the Single Narcotics Convention 1961 and only acceded to the treaties in 1980, and the convention on Psychotropic substances in 1992.

Under the Acts, Cannabis and cannabis resin, Cannabinol (except where contained in cannabis or cannabis resin) and Cannabinol derivatives are scheduled. The definition of Cannabis was amended by Section 2 of the Misuse of Drugs Act 1984 and means

‘any plant of the genus Cannabis or any part of any such plant (by whatever name designated) but includes neither cannabis resin nor any of the following products after separation from the rest of any such plant, namely—
(a) mature stalk of any such plant;
(b) fibre produced from such mature stalk; or (c) seed of any such plant;

Section 4 of the Misuse of Drugs Act 1977-2015 provides

that the Minister may make regulations enabling any person, or persons of a prescribed class or description, in prescribed circumstances or for prescribed purposes, to possess a controlled drug subject to such conditions (if any), or subject to and in accordance with such licence, as may be prescribed.

(2) Subject to section 13 of this Act, the Minister shall exercise his power to make regulations under this section so as to secure that it is not unlawful under this Act for a practitioner or pharmacist to have a controlled drug in his possession for the purpose of his profession or business.
(3) It shall be lawful for any person, or a person of a class or description specified in regulations under this section, to have in his possession in prescribed circumstances or for prescribed purposes, as may be appropriate, a controlled drug specified therein, provided that any conditions specified in the regulations or attached to a Licence granted under this Act and applicable in the particular case are complied with by him.

The Misuse of Drugs Acts 1977-2015 distinguishes between possession (for personal use) and possession for sale or supply. Possession of cannabis for personal use is punishable by a fine on first or second conviction; from a third offence onwards, it may be punished by fines, up to one year imprisonment, or both, on summary conviction, and imprisonment for up to three years on indictment

Prohibition of Cultivation

Under Section 17

“a person shall not cultivate any plant of the genus Cannabis or except under and in accordance with a Licence issued under Section 14 from the Minister. In respect of Section 14, regulation 5 of the Misuse of Drugs (Scheduled Substances) Regulations 1993 (SI No. 339 of 1993) provides that a person so authorised by a License granted by the Minister may, under and in compliance with any conditions attached thereto, produce, supply, offer to supply, import, export or have in his possession any scheduled substance to which the License relates.”

Under Section 21 (6)

Any person who contravenes a condition attached to a Licence, permit or authorisation granted or issued by the Minister under this Act (other than section 24) or under regulations made under this Act shall be guilty of an offence.

Cultivation of Industrial Hemp

Irrespective of the prohibition of cannabis cultivation, under Irish law hemp may be cultivated to produce fibre and seeds provided that it fulfils certain requirements. Currently only cultivars with less than 0.2% tetrahydrocannabinol (THC), the narcotic component of cannabis, may be grown for fibre and seed oil production in the EU.

A Licence for the cultivation of certain varieties of hemp (Cannabis sativa L.) for fibre use will only be granted by the Minister for Health under the Misuse of Drugs Acts 1977-2015, to persons who are entitled to and intend making application to the Department of Agriculture, Food and the Marine for a subsidy under the EU Aid Scheme for the production of hemp under Council Regulation (EC) No. 1251/1999 (as amended) and who occupy and farm not less than 3 hectares (7.4 acres) of utilised agricultural land (including rough grazing, commonage and/or mountain grazing).

The provisions regarding Section 21(6) of the Misuse of Drugs Acts 1977-2015 apply – namely if the License to grow hemp for fibre, grows hemp which exceeds the maximum amount of 0.2% tetrahydrocannabinol permitted.

Medicinal Cannabis Regulations

Article 4 (c) of the Single Convention on Narcotic Drugs as amended limits production, manufacture, export, import, distribution of, trade in, use and possession of Cannabis to Medical and Scientific purposes. This provision is implied within the Misuse of Drugs Acts 1977-2015 and the accompanying regulations.

On the 11th of July 2014, Minister of State for Primary Care, Alex White T.D. signed S. I. No 323 Misuse of Drugs (Amendment) Regulations to enable authorised cannabis-based medicinal products to be legally prescribed by medical practitioners and used by patients. The regulations removed legal impediments to the provision of cannabis based pharmaceuticals to ease the symptoms of spasticity for Multiple Sclerosis sufferers.

The Misuse of Drugs Regulations, made under the Misuse of Drugs Act 1977, are the primary legislative instrument regulating the import, export, manufacture, production, prescribing, supply, possession and administration of controlled drugs within the Irish health system.  The granting of approval enabling this product to be used in Ireland was dependent on changes to the Misuse of Drugs Regulations.

On the 18th July 2014,The Health Products Regulatory Authority granted a marketing authorisation for the cannabis-based medicinal product Sativex manufactured by GW Pharma to be marketed in this State. Sativex contains’ cannabinoids’, which are extracted from cannabis sativa plants grown and processed under strictly controlled conditions. Its formulation is unique and standardised and, like any other medicine, it has undergone the corresponding research, clinical development, toxicology testing and regulatory approval processes. Sativex is administered as an oral spray (to be applied under the tongue or inside the cheek) enabling flexible dosage, always in accordance with healthcare professional’s advice.

In September 2014, the Health Service Executive received an application for inclusion of Sativex under the community drugs schemes high-tech arrangements. The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the GMS and community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Decisions on which medicines are reimbursed by the taxpayer are made the HSE on the advice of the National Centre for Pharmacoeconomics, NCPE.

A health technology assessment report on Sativex was completed by the National Centre for Pharmacoeconomics, however it did not recommend reimbursement of Sativex at the submitted price. Consequently as of May 3rd of 2016, Sativex is not available to the many patients suffering from MS who cannot afford the drug while it is not listed on the community drug scheme, however the listing of Sativex remains under consideration.

Global position regarding Medicinal Cannabis
The international drug control treaties have defined the parameters within which medicinal cannabis is permissible. It is worth noting that in 2014 the World Health Organisation’s expert committee on drug dependence, which is the designated body to develop scheduling recommendations observed the following.

“A review of cannabis and cannabis resin by the World Health Organisation is necessary for multiple reasons, the foremost being that the medical use of cannabis appears to have increased in recent years. Cannabis and cannabis resin has not been scientifically reviewed by the Expert Committee since the review by the Health Committee of the League of Nations in 1935. An increasing number of countries are adopting varying policies on cannabis and cannabis resin different from prohibition to mitigate the harm due to cannabis.”

Subsequent to that observation, The Expert Committee on Drug Dependence undertook to collect more evidence on medical use of cannabis and cannabis resin for a future comprehensive review. A point noted by the Commission on Narcotic Drugs which stated that “… looks forward to an updated report on cannabis by the Expert Committee, subject to the availability of extra budgetary resources”

The review is long overdue and the delay to date is highly questionable considering that there has been important medical and scientific breakthroughs such as the discovery made by researchers at the Department of Oncology, Division of Clinical Sciences, St George’s, University of London in 2014 that Cannabinoids have been shown to specifically inhibit glioma growth as well as neutralise oncogenic processes such as angiogenesis. In plain language what this means is that a combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) when used along side radiotherapy reduces the growth of tumours in brain cancer.

At the time of writing, twenty-eight of the fifty states in America have made provision for medicinal cannabis (medical marijuana) the first being California in 1996, and the most recent being Florida, Arkansas and North Dakota on November 9th 2016.

On the 4th May 2016 the German government announced that is was relaxing the rules governing medicinal cannabis enabling patients to purchase dried cannabis flower buds on prescription from pharmacies in 2017. In contrast to the position in Ireland, health insurance will cover the cost. Presently under German Federal Regulations, there are three-forms of medical cannabis available to patients: Dronabinol, Sativex and cannabis buds. Dronabinol which is taken orally and prepared by pharmacists from a synthetic Δ9-Tetrahydrocannabinol which is mixed in sesame oil giving it the appearance of a light yellow resinous oil. Dronabinol is used to treat patients with HIV and helps patients undergoing chemotherapy with the side-effects of nausea and vomiting.

Illnesses and cannabis based treatments
Internationally, there are a number of diseases which cannabinoids have been prescribed to treat and include Alzheimer’s disease, Dravet’s syndrome, Glaucoma, Crohn’s disease, Tourette’s syndrome, and Amyotrophic Lateral Sclerosis, Anorexia and Fibromyalgia. Nabilone although principally developed to treat the side-effects of chemotherapy has been used also been used to treat patients suffering from Fibromyalgia or chronic pain syndrome as it is also referred to. In research carried out by the University of Heidelberg in 2006 nine patients with fibromyalgia were treated with Nabilone over a 3-month period resulting in a significant reduction in daily recorded pain and electronically induced pain.

Conclusions
Research findings concerning medicinal value of cannabis in the treatment of illness and its positive use in palliative care has contributed significantly to the debate in favour of legal regulation and the end of global prohibition of cannabis. While cannabis and its derivatives remains a scheduled substance within the meaning of the Misuse of Drugs Acts 1977-2015 and it’s accompanying regulations, the Irish government has made some progress towards allowing for cannabis based treatments, most notably allowing Sativex, to be marketed in this jurisdiction On a critical note, the Irish Government’s approach to medicinal cannabis has been painstakingly slow, conservative and largely reactive. This is worth bearing in considering that other countries in the European Union and elsewhere are taking a more progressive approach towards regulation, instituting policies which allow patients the option to grow their own medication or at least acquire organic cannabinoids as opposed to purely synthetic versions. The German approach of allowing patients to purchase cannabis buds under prescription from pharmacies warrants serious consideration. At this juncture, the scientific and medical evidence is sufficiently strong to warrant significant reform of the law and accompanying regulations to allow for a more progressive approach to the production, use and supply of cannabis for medicinal purposes.

Niall Neligan, Barrister-at-Law
© 2016


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Endnotes

1.Chang, Kwang-chih (1969). Fengpitou, Tapenking, and the Prehistory of Taiwan. Yale University Publications in Anthropology, no. 73. New Haven: Yale University, Department of Anthropology.

2.Booth, Martin (2003) Cannabis: A History. Picador

3. The origin of the word ‘hemp’ is Middle English, from the Old English word ‘hænep’; akin to Old High German word ‘hanaf’

4. Indeed, in 1941, Henry Ford manufactured a plastic chassis entirely from a combination of soya bean and cellulose hemp fibre long before the motor industry eventually moved away from metal to carbon fibre in the manufacture of motor carsWoodyard, Chris (June 29, 2010). “Mystery Car 40: Henry Ford’s soybean car”. USA TODAY.

5. The History by Herodotus” — Translated from the Greek by Isaac Littlebury [1737] at page 380.

6. Republished in the Provincial Medical Journal, No 123 J – London February 4, 1843.

7. Of the three recognised taxonomic species there is still some disagreement over the classification of Ruderalis,

8. von Linné, Carl (1753) Species Plantarum, Sections II

9. No 3 at pag107

10. With the exception of Alcohol and Tobacco.

11. Hash is derived from the arabic word ḥashīsh and is composed of compressed or purified preparations of stalked resin glands from the female plant, called trichomes.

12. There have been a number of suggestions that the name Marijuana is the diminutive slang of the Spanish name Maria Juana or Mary-Jane.

13. Drug Fact Sheet (2015) National Institute of Drug Abuse, Washington D.C.

14. European Drug Report – Trends and Developments 2015 at p 21 – European Monitoring Centre For Drugs and Drug Addiction.

15. Zuardi AW et al – A critical review of the antipsychotic effects of cannabidiol: 30 years of a translational investigation. Cure Pham Des .2012 18(32):5131-40. Department of Neuroscience and Behavior, Faculty of Medicine, University of São Paulo and National Institute for Translational Medicine, Ribeirão Preto, SP-Brazil.

16. Wood TB, Spivey WTN, Easterfield TH. Cannabinol Part I. J Chem Sic (1899) 75; 20-36

17. Adams R, Hunt M, Clarck JH. Structure of Cannabinol III Synthesis of cannabinol.. J Am Chem Soc 1940

18. Di Marzio and Pop. Cannabinoids, Chapter 1 The Chemical Constituents of Cannabis Sativa and the Endocannabinoid system. Wiley-Blackwell 1st Edition (2014)

19. CB1 found in the brain and many peripheral tissues, and CB2, primarily found in immune cells

20. Outside the brain, the endocannabinoid system has been found to be activated in virtually every physiological system researchers have investigated, playing a critical role in the modulation of the autonomic nervous system, the immune system, reproductive and gastrointestinal tracts, sympathetic ganglia, arteries, lung, heart and endocrine glands. New Developments in Cannabinoid-Based Medicine: An Interview with Dr. Raphael Mechoulam
by Lara Pizzorno, MDiv, MA, LM

21. David J Nutt, Leslie A King, Lawrence D Phillips Drug harms in the UK: a multicriteria decision analysis Lancet 2010; 376: 1558–65.

22. Degenhardt, L., L. Dierker, W. T. Chiu, M. E. Medina-Mora, Y. Neumark, N. Sampson, J. Alonso, et al. “Evaluating the Drug Use “Gateway” Theory Using Cross-National Data: Consistency and Associations of the Order of Initiation of Drug Use among Participants in the Who World Mental Health Surveys.” [In eng]. Drug Alcohol Depend 108, no. 1-2 (Apr 1 2010): 84-97. Harvard Medical School – Department of Health Care Policy.

23. Dosing Medical Marijuana: Rational Guidelines on Trial in Washington State, MedGenMed. 2007; 9(3): 52 Suni K. Aggarwall, Muraco Kyashna and Professor Gregory T. Carter Conjoint Professor of Rehabilitation Medicine and Principal Researcher in the Centre for Translational Neuroscience and Mental Health (CTNMH), University of Newcastle, Australia.

24. The League became the the custodian of the Opium Convention following its establishment in 1920.

25. The United States proposal was ‘that contracting parties shall enact laws or regulations for the control of the production and distribution of raw opium and coca leaves so that there will be no surplus available for purposes not strictly medical or scientific. International Opium Conferences at Geneva, 1924-25.

26. Extension of Part I. of Dangerous Drugs Act, 1920, to coca leaves and Indian hemp. (1) Part I. of the Dangerous Drugs Act, 1920 , (which restricts the importation and exportation of, and gives power to regulate dealings in, raw opium), shall, as amended by this Act, apply to coca leaves, Indian hemp, and resins obtained from Indian hemp and all preparations of which such resins form the base, as it applies to raw opium.

27. Largely stemming the Pharmaceutical Society wrongly placing Cannabis on the Poisons Schedule in the face of opposition from policy makers at the Home Office and drugs experts like Professor Dixon at Cambridge University.

28. With a notable exception that doctors were able to prescribe any drugs as treatments for general medicine or for addictions.

29. The Convention was ratified by Ireland on January 4th 1938.

30. The United States believed that the convention did not go far enough in terms of punishment for all non-medicinal forms of cultivation, production and distribution. The thirteen countries which signed the convention were Belgium, Brazil, Canada, China, Colombia, Egypt, France, Greece, Guatemala, Haiti, India, Romania and Turkey. Both Germany and Japan had left the League of Nations in 1933.

31. The UN Economic and Social Council established the Commission on Narcotic Drugs as the central policy-making body.

32. Work on a single or unified treaty had begun in 1948 when the Economic and Social Council adopted a resolution for the Commission on Narcotic Drugs. This requested the UN Secretary General to prepare a draft convention to replace the existing treaties which had been agreed since 1912.

33. Cannabis for the purpose of the 1961 convention was defined under Article 1 to mean the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted.

34. It should be noted that Cannabis also appears on the 1st Schedule.

35. As to what other ‘legitimate purposes’ was, gave rise to much debate and no firm solution was arrived at in defining the scope of this provision.

36. Article 12 of the New York Opium Convention provided for a Recommendation of embargo If the Board finds: (1) as a result of its study of the estimates and statistics furnished under articles 8 and 9, that a Party has failed substantially to carry out its obligations under this Protocol or that any other State is seriously impeding the effective administration thereof, or (2)in the light of the information at its disposal, that excessive quantities of opium are accumulating in any country or territory or that there is a danger of any country or territory becoming a centre of illicit traffic, it may recommend to the Parties an embargo on the import of opium, the export of opium, or both, from or to the country or territory concerned, either for a designated period or until it shall be satisfied as to the opium situation in such country or territory. The State concerned may bring the matter before the Council, in accordance with the relevant provisions of article 24 of the 1925 Convention.

37. Section III Cannabis in the United Kingdom, Report by the Advisory Committee on Drug Dependence, 1st November 1968 – The Wooton Report.

38. The 1977 Act was a copy of the British equivalent introduced by Reginald Maudling MP and which received Royal assent, 27 May 1971.

39. The power to schedule drugs Ministerial order under Section 2(2) of the Misuse of Drugs Act 1977 was declared unconstitutional by the Supreme Court in the case of Director of Public Prosecutions v Bederev [2015] IECA 38, the Irish Court of Appeal declared that Section 2(2) of the Misuse of Drugs Act 1977 unconstitutional in so far that it vested unlimited power of regulation in the Government to declare what “substances, products or preparations” should be controlled drugs. The consequence of the decision for a brief time, was that substances which were not originally scheduled under the 1977 Act were briefly legalised including MDMA and benzodiazepines.

40. The Misuse of Drugs Regulations 1988 (S.I. No. 328 of 1988), the Misuse of Drugs (Amendment) Regulations 1993 (S.I. No. 342 of 1993), the Misuse of Drugs (Amendment No. 1) Regulations 1999 (S.I. No. 273 of 1999), the Misuse of Drugs (Amendment) Regulations 2006 (S.I. No. 53 of 2006), the Misuse of Drugs (Amendment) Regulations 2007 (S.I. No. 200 of 2007), the Misuse of Drugs (Amendment) Regulations 2009 (S.I. No. 63 of 2009), the Misuse of Drugs (Amendment) (No. 2) Regulations 2009 (S.I. No. 122 of 2009), the Misuse of Drugs Regulations 2010 (S.I. No. 200 of 2010), the Misuse of Drugs (Amendment) (No. 2) Regulations 2010 (S.I. No. 607 of 2010), the Misuse of Drugs (Amendment) Regulations 2011 (S.I. No. 552 of 2011) and these Regulations may be cited together as the Misuse of Drugs Regulations 1988 to 2014 and shall be construed together as one.

41. Medical Marijuana supporters would argue that Sativex is not unique, and fear that cannabis would be cordoned off by the FDA and patents which favour pharmaceutical companies.

42. The process of creating Cannabis or hemp oil is centuries old. Indeed, William Brooke O’Shaughnessy wrote about the production process back in the 19th century. Sativex is produced in much the same way albeit using more up to date techniques. Cannabis buds are dried, and a liquid CO2 technology borrowed from the perfume industry dissolves everything but their essence. The essence is then washed with cold alcohol, and glycol is added. GW mixes the essences from the high-THC and high-CBD strains in a 25:27 ratio, and adds some peppermint flavour.

43. Reply to question raised by Senator Colm Burke from the Minister for State at the Department of Jobs, Enterprise and Innovation, Damien English. Seanad Éireann Debate Vol. 245 No. 8 – 28th January 2016.

44. Cannabis and cannabis resin: Information Document, WHO Expert Committee on Drug Dependence, 36th Meeting, Geneva, 16-20 June 2014.

45. The Combination of Cannabidiol and Δ9-Tetrahydrocannabinol Enhances the Anticancer Effects of Radiation in an Orthotopic Murine Glioma Model – Katherine A. Scott, Angus Dalgleish and Wai M Liu published November 14th 2014 Journal of Molecular Cancer Therapeutics.

46. In the United States it is prescribed under the name Marinol which is produced by Unimed Pharmaceuticals, Inc. Marinol has been approved by the FDA. Medical cannabis patients argue that Dronabinol is less effective than naturally grown cannabis.

47. After oral administration, dronabinol has an onset of action of approximately 0.5 to 1 hours and peak effect at 2 to 4 hours. Duration of action for psychoactive effects is 4 to 6 hours, but the appetite stimulant effect of dronabinol may continue for 24 hours or longer after administration.

48. Information acquired from the Mayo Clinic website section – Consumer Health, Medical Marijuana. http://www.mayoclinic.org/healthy-lifestyle/consumer-health/in-depth/medical-marijuana/art-20137855

49. Fibromyalgia (FM) is a chronic pain syndrome of unknown etiology. The disease is characterised by widespread musculoskeletal pain, fatigue and multiple tender points in the neck, spine, shoulders and hips. Nabilone is similar to Dronabinol which the FDA approved for the treatment of nausea and vomiting associated with chemotherapy in 1985. Nabilone is marketed under the trademark Cesamet Capsules and contains the synthetic cannabinoid Nabilone as the active ingredient.

50. Schley et al. 2006. Delta-9-THC based monotherapy in fibromyalgia patients on experimentally induced pain, axon reflex flare, and pain relief. Current Medical Research and Opinion 22: 1269-1276.