A HANDBOOK GUIDE ANALYZING MEDICAL CANNABIS REGIMES, AND THEIR IMPACTS. CONTENTS QUALITY ISSUES 2 Introduction ISSUE 1: Quality Issues 3 PRODUCT QUALITY • Issue 1: Product quality 4 Comparing• Issue Overseas 2: Contaminants Jurisdictions 5 and/or raw cannabis. At the most expensive end of the spectrum are the pharmaceutical GMP (Good AManufacturing key consideration Practice) that allstandards, jurisdictions as adhered face is de�ining to by GW an Pharma,acceptable the quality manufacturers standard forof Sativex;cannabis the products Dutch company Bedrocan; and top tier Canadian manufacturers who have recently attained or are pursuing these • Scoring System 6 of time and money to attain. It is the standard most closely aligned with our current pharmaceutical model. A patchwork of state successes, hampered by federal law. standards,However, the such impact as Tilray, on the CanniMed cost to patients and Canopy is immense. Growth. The GMP standard requires a signi�icant investment The United States: 7 At the other end of the scale, as an early legaliser of medical cannabis, California initially had no product standards for its medical regime, allowing dangerous pesticides and plant growth regulators to be used. • California: First to reform 8 However, decent product standards were recently enacted via the adult use law in California. • Alabama: CBD only 9 As a compromise solution, Canada has set up a regime known as GPP (Good Production Practices) [1], where products are made to a high standard. Under GPP, variation between batches based on the potency of the • Arizona: Massive patient uptake 10 costs, as batches that vary in potency no longer need to be discarded. Multiple products made to this GPP United Kingdom: Hypocrisy abounds 11 plantsstandard is haveallowed, been so accepted long as and each approved batch is for labelled individual accurately. patients This in New has Zealand.enormous We bene�its term this for standard production ‘near pharmaceutical’. Israel: Powerhouse of research 12 Canada: Exporter extraordinaire 14 Many American states set safety standards for products in lieu of de�ining an industry standard regime. The Australia:MCANZ’s Comprehensive Cart before the horseSolution 15 safety standards de�ine tolerable levels of contaminants to ensure that the product is safe to consume, without demanding proof of ef�icacy. References 16 Pharmaceutical Near Pharmaceutical INTRODUCTION Cannabis remains a prohibited drug throughout much of the world. However, countries throughout Food Grade the developed world are grappling with how to regulate medical cannabis and the compromises that must be made to ensure patient access. This guide is designed to inform the public on the various regimes that have been set up worldwide, and the positive and negative aspects of each. Despite the growing pool of countries that have regulated medical cannabis, there is no consensus on which method offers a gold standard for other countries to follow. Even at an international level, QUALITY there has been a lack of discussion of this burning issue. The United Nations General Assembly Special Session (UNGASS) on the “world drug problem” in 2016 was effectively silent on the issue. It should be noted that at the international level, medical cannabis is not prohibited. The 1961 Single Convention on Narcotic Drugs restricts medical research and use, but does not ban it. In effect, until very recently, most countries banned medical use despite the fact that it has been allowed under international treaties since 1961. 3 2 MCANZ: Medical Cannabis Around the World - mcanz.org.nz/ ISSUE 2: CONTAMINANTS COMPARING OVERSEAS JURISDICTIONS Scoring system pesticides and other additives; moulds and associated toxins; and heavy metals. There are three types of contaminants that can be a cause for concern with cannabis: In order to compare different overseas medical cannabis regimes, we propose the following scoring Pesticides and other addititives system by which to compare different jurisdictions. Each jurisdiction is given a score between 0 and 5 for the following parameters, with a score of 5 being optimal. When cannabis is cultivated on a larger scale, there is an increased risk of pest infestations such as spider mites. While a personal grower with a handful of plants can generally keep Prescriber freedom: This score represents the potential barriers that prescribers face, either on top of such things, larger operations, such as the enormous greenhouses currently from regulations or from formal medical bodies, and the level of support and education provided to being put into production, can much more easily harbour an infestation. To combat this, prospective prescribers to ensure that they feel comfortable to prescribe as appropriate. some commercial growers turn to pesticides. There are some pesticides that are safe to use on cannabis; however most are not, particularly due to the breakdown of the chemicals Patient access: This speaks to the cost to the patient and the range of options available to patients once cannabis is heated and inhaled. [2] through legal channels. Every patient has different preferences, whether it is oil capsules or raw dried cannabis to be used with a vaporiser. One pesticide that should be banned for use on cannabis is myclobutanil, which is freely available in New Zealand. It is banned in most medical cannabis jurisdictions, as when Product quality: The various states and nations that have implemented medical cannabis regimes have on price for patients. Set the standards too high, and businesses struggle, costs remain high, Mouldsheated under and associated�lame it degrades toxins to hydrogen cyanide. haveand patients all been are forced left resortingto confront to thethe issueblack ofmarket product as before.quality Setand the the standards impact that too quality low, and standards patient safety is put at risk. succumb to mould if grown in damp conditions. Some types of mould give off toxins that Cannabis �lowers, which harbour the plant’s concentrated medicinal compounds, can posecause a liver harm damage) to health. [3]. Aspergillus moulds, The mould-susceptibility for example, of cannabis give meansoff ochratoxin that the (alargest suspected legal carcinogenmedicinal cannabis which is producers toxic to thetend kidneys) to cultivate and either a�latoxin indoors (a orknown in high-tech carcinogen greenhouses, that can in order to control the variables that allow moulds to develop. This is in stark contrast to Support for research: Various countries have regulations that either support or inhibit research. opium poppies, which are hardy in comparison and lend themselves to massive outdoor The ability for private companies and universities to conduct research is critical to furthering our knowledge on cannabis, both medically and otherwise. based medicines. �ields. This is why cannabis-based products are likely to always cost more than opium- Industry development: How supportive is the regime of industry development? Is there competition Heavy metals and innovation? What is the bar for entry to newcomers? Cannabis is a bioaccumulator, and in fact, industrial hemp has been researched and trialled Diversion: As with other drugs such as opioids, some people may try to game the system and soils. This novel property of cannabis may not be as problematic in New Zealand as it is in widespread diversion could be within a regulatory regime, and what controls the regulators have for site remediation bene�its such as removing heavy metal contaminants like lead from receiveover this. prescriptions for conditions that are not genuine. This criterion assesses how frequent and environmental exploitation is more likely to accumulate high levels of lead or cadmium, otherposing post-industrial a severe health countries. risk. The Forrisk example, on many hempNew Zealand grown in soils a country is likely with to be a historylower; but of risks can still exist here based on land use, including past use of agrichemicals. 5 4 MCANZ: Medical Cannabis Around the World - mcanz.org.nz/ THE UNITED STATES: CALIFORNIA: A PATCHWORK OF STATE SUCCESSES, HAMPERED BY FEDERAL LAW FIRST TO REFORM Currently, 29 of the 50 US states have legal medical cannabis regimes. However, these regimes are constrained in some ways by a prohibitionist federal law. Proposition 215, the Compassionate Use Act, passed with 56% of the vote. The bill allowed for the Californiause, possession �irst andintroduced cultivation medical of cannabis cannabis on ain physician’s 1996, after recommendation a voter-initiated for referendumpatients with called a list At the federal level, in the United States cannabis is a Schedule 1 controlled drug. Schedule 1 is of severe conditions, as well as including the catch-all clause, “any other illness for which marijuana designated for drugs that have a high potential for abuse and no accepted therapeutic purpose. This provides relief”. is an archaic designation as far as cannabis is concerned. To compare, methamphetamine, which is available on prescription, is Schedule 2. Because this bill was so early, there were large holes in the regulations. Initially, there were no Various attempts have been made to reschedule cannabis through the US courts. To date, many court decisions have accepted that cannabis does not belong in Schedule One, but the courts haven’t qualityuse cannabis standards bill. set for medical cannabis, as it was not intended for commercial production to had jurisdiction to force the Drug Enforcement Agency to reschedule. occur. The lack of quality standards was remedied two decades later with the passing of the adult Because of the federal scheduling, many state regulations get around doctors prescribing cannabis by stipulating that doctors can instead “recommend” cannabis to patients. This impacts on patients, California’s product range, price and quality control is now going from strength to strength. However, in that prescribers are constrained from providing advice and support and directing patients someAn additional regulations concern are now until squeezing recently out was the the smaller, access longer-established process; a single medical10-minute growers.