POSITION PAPER
The Road Forward after Allard:
Creating Medical Cannabis Access Regulations
First Draft: March 23, 2016 Updated: May 24, 2016
Prepared by: Rosy Mondin, LL.B, B.A (Criminology) phone: 613-954-5031 / 604-346-8118 email: rmondin@gmail.com
“It is beyond my comprehension that any humane person would withhold such a beneficial substance from people in such great need simply because others use it for different purposes.” –Stephen Jay Gould, American paleontologist, evolutionary biologist and historian of science (Source: Marihuana, The Forbidden Medicine by Lester Grinspoon, M.D. & James B. Bakalar, Yale University Press, 1997)
Table of Contents Introduction
1
Policy Considerations
2
Current Policy
2
Patient Health and Safety
2
Evidence of Public Heath Benefits
3
Best Practices
3
Transition and Integration
3
Industry Participants and Licensing Categories
4
Recommendations for Medical Cannabis Access Regulations
6
Part 1:
Authorization to Possess
Part 2:
Production of Medical Cannabis for Personal Use
7 10
Introduction to Part 3, Part 4, Part 5 Commercial Production and Processing Licenses
13
Part 3:
Clone Production and Genetic Propagation
15
Part 4:
Medical Cannabis Grower
16
Part 5:
Medical Cannabis Processor
17
Part 6:
Licensed Laboratory
19
Part 7:
Authorized Retailers/Resellers
22
Regulatory Transparency
27
Creating Charter Compliant Regulations under the CDSA and NCA
28
For Additional Consideration: Remove Cannabidiol (CBD) from Schedule II CDSA
29
______________________________________
Appendix A – Public Health Benefits to Medical Cannabis Regulations Appendix B – Matrix of Medical Cannabis Laws in States that have Authorized Adult Use Appendix C – Removing Cannabis from Schedule II CDSA Appendix D – Cannabis Testing Without Strict Laboratory Standards Yields Inconsistent Results
The writer wishes to acknowledges the collaboration and valuable input from the wide spectrum of industry participants in helping craft these recommendations. These participants have many years of experience operating under the MMAR and MMPR, including medical cannabis dispensary owners, and other specialists in: business, academics, public health, drug policy, law, policy, research and science.
The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Introduction Canadians have a charter right to access cannabis for medical purposes. In Allard v. Canada1, Federal Court Justice Michael Phelan ruled that the Conservatives’ 2013 medical marijuana regulations – the Marihuana for Medical Purposes Regulations (MMPR)2 - violated the liberty and security interests of the Charter3. The Allard ruling extends an injunction granted to about 28,000 people licensed under the predecessor Marihuana Medical Access Regulations (MMAR)4 which permitted licensed patients to grow their own medical cannabis, or designate someone else to grow on their behalf 5. Allard primarily looked at the provisions contained in the MMPR which effectively banned individuals from growing their own medical cannabis. In his closing statements, Justice Phelan noted that “it is neither feasible nor appropriate to … reinstate the MMAR”6. In addition, he also noted that “it would not be feasible or effective to strike certain words or provisions [of the MMPR]”7 and “striking down the MMPR merely leaves a legislative gap where possession of marihuana continues as a criminal offence.”8 Justice Phelan concluded: “The appropriate resolution, following the declaration of invalidity of the MMPR, is to suspend the operation of the declaration of invalidity to permit Canada to enact a new or parallel medical marihuana regime.”9 Thus, rather than striking down the current law, the Allard decision gives the Federal government sixmonths (from February 24, 2016) to enact a new or parallel regulatory structure for medical cannabis access. This provides an opportunity to improve Canada’s medical cannabis access system, including matters of availability and affordability.10 This paper lays out a framework for an evidence-based medical cannabis regulatory structure, drawing on guidance from our courts (in Allard, and others) and the lessons from the regulation of medical cannabis in other jurisdictions. A robust medical purpose approach to regulation could form a base platform for a transition to a recreational model as rules and regulation continue to evolve.
These are preliminary recommendations – further research will be required – and final recommendations will be provided with supporting findings. We would be happy to provide further insights and recommendations throughout the process.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Policy Considerations A successful model for Canada’s cannabis industry must be built upon a foundation of evidence-based regulations and the Allard decision provides the government with a good opportunity to craft a new medical cannabis regulatory regime. As addressed in Allard, a constitutionally sound regime would allow the government to regulate commercial behaviour, but not criminalize individual non-commercial patient conduct, such as personal production of cannabis-based products.11 The current MMPR structure has been shown to be neither medically justifiable nor at all likely to eliminate the illegal market. The key to any constitutionally compliant new or parallel regulations must have at its foundation evidence-based policies which combine aspects of the MMAR and the MMPR, improving the way government protects the well-being of current and future medical cannabis patients, and permits an appropriate range of choice for medicinal users.
Current Policy Under Canada’s Controlled Drugs and Substances Act (“CDSA”)12 cannabis is a Schedule II substance, and its cultivation, sale, and possession are prohibited.13 In addition, under the Food and Drug Act, cannabis is defined as a “drug” to the extent that it is used for its medicinal value.14 However, if cannabis is produced, imported or exported by a producer licensed under the MMPR, it is expressly exempted from the application of the Food and Drug Regulations.15 The consumption and distribution of cannabis are largely governed by two sets of regulations: the Narcotic Control Regulations16, and the MMPR. From 2001 to 2016, the MMAR and MMPR have enabled legal access to medical cannabis and established the dominant regulatory regime for medical cannabis production and consumption in Canada. Over the years, and most recently in the Allard case, Canadian courts have found that access to medical cannabis is constitutionally required and that: ■■
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personal health and medical care are fundamental matters of personal choice,17 the market for medical cannabis is protected from undue or excessive regulation as access must be meaningful and timely,18 medical cannabis patients must not be required to prove life-threatening conditions or that they have exhausted all other treatment options before turning to medical cannabis,19 regulation cannot take the form of a blanket prohibition,20 and cannot exclude edibles, creams, and other non-inhaled means of administration.21
Patient Health and Safety An overriding theme in Allard is that not allowing individuals access to adequate supplies of medical cannabis harms an individual’s health and safety.22 The limitations imposed under the MMPR, restricting individuals to purchase only from MMPR Licensed Producers, diminished the health and safety of those individuals.23 In addition, the blanket prohibition on personal production, on possessing more than 150 grams of cannabis, and consuming forms other than dried marijuana is not proven to be connected to the objective of protecting health and safety.24 It was agreed by the experts in Allard “that there is no possibility of overdose death from cannabis consumption by humans, whether the consumption is oral, inhaled or topical.”25
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Evidence of Public Heath Benefits As cannabis has been legalized for medical use and more accepted in general, an increasing amount of research is emerging on its effects. Such research supports the medicinal value of cannabis. See Appendix A “Public Health Benefits to Medical Cannabis Regulations”.
Best Practices When crafting any new or parallel medical cannabis regulations, we strongly recommend Canadian legislators look to the United States for guidance. Oregon,(a) Colorado, Alaska and Washington state all had robust medical marijuana industries prior to full legalization (the path upon which Canada now finds itself), making the transition easier for government and its citizens. See Appendix B “Matrix of Medical Cannabis Laws in States that have Authorized Adult Use”.
Oregon and Alaska have the greatest degree of experience to date, recently conducting in-depth reviews of other US medical marijuana programs (particularly the successes and failures of Colorado and Washington), and making recommendations based on their analyses.
Transition and Integration In Canada, there already exists a diverse and well established licit and illicit private sector for medical cannabis. Canada is considered by many as a world leader in production, having developed thousands of different cannabis strains, including a plethora of medical cannabis oils, concentrates and infused products. The government must create a medical cannabis industry that will be sustainable without having to compete with the illicit market. This can only be achieved through policies that include those with a working knowledge of existing market infrastructure, often obtained through their participation in these illicit networks of production and distribution. The most efficient way to impede and eradicate the illicit-market is to provide these existing market players (and their products) an opportunity to participate in a new and more regulated economy, transitioning into the emerging legitimate market, without fear of injustice or persecution.
(a)
A 2016 report by Americans for Safe Access Foundation found that Oregon has one of the strongest medical cannabis programs for patients in the USA: “Medical Marijuana Access in the United States – A Patient-Focused Analysis of the Patchwork of State Laws”, 2016, online: http://www.safeaccessnow.org/
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Industry Participants and Licensing Categories The following table provides an overview of the existing industry participants and how they may be included in the new proposed medical cannabis regulations.
MMAR
Participant
MMPR
New Regulations
Individual (Patient)
Authorization to Possess
In accordance with a medical document
Authorization to Possess
Home Growing (personal production or production by a designate)
Personal Use Production License and Designated Person Production License
None
Personal Use Production & Processing License
Producer: Starting Material (seeds, mother plants, clone cultivation/ tissue culture)
Holder of a Personal Use Production or Designated Person Production license, Licensed Dealer (laboratory)
Licensed Producer
Clone Production and Genetic Propagation (CPGP) license
Producer: Growing, Flowering and Harvest
None
Licensed Producers
Medical Cannabis Grower license
Processor: extraction and processing into value-added products
None
Licensed Producers (limited to the production of oils)
Medical Cannabis Processor license
Laboratory
Not licensed under the MMAR - licensing is done as an exemption under the Controlled Drugs and Substances Act (Licensed Dealer)
Not licensed under the MMPR - licensing is done as an exemption under the Controlled Drugs and Substances Act (Licensed Dealer)
Laboratory license
Retailer/Reseller and Dispensary
None
None
Authorized Retailer/ Reseller
Health Care Practitioner
Medical Practitioner (authorized to practice medicine)
Health Care Practitioner (medical practitioner or nurse practitioner)
Authorized Practitioner (authorized to practice medicine, nursing or naturopathic doctors)
Caregiver Production and Processing License
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
The transition from the MMAR to the MMPR in 2014 took cannabis production away from small and medium-sized growers, to the tightly regulated ‘Fort Knox’ commercial operations of today – a result of the strict and rigorous application process which became cost prohibitive for many applicants. At the time of transition, the MMAR licensed approximately 40,000 patients, of which approximately 30,000 held growing licenses. In contrast, under the MMPR, only 31 producers have been licensed (as at May, 2016), from a pool of over 1,800 applications. This is not inclusion, but rather the creation of a federal oligopoly.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Recommendations for Medical Cannabis Access Regulations The Allard decision gives the Federal government six-months (from February 24, 2016) to enact a new or parallel regulatory structure for medical cannabis access. The federal government now has the opportunity to create a regulatory structure that protects patient rights, balancing the rights of individuals to grow for medical purposes with other forms of distribution. We recommend a medical cannabis regulatory regime which: ■■
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works in harmony with, and protects the well-being of current and future Canadian medical cannabis patients facilitates and leverages the knowledge base of the existing medical cannabis industry facilitates registration for individuals requiring access to medical cannabis for therapeutic or medical purposes includes the right for individuals to grow their medical cannabis or have a designated caregiver produce on behalf of an individual integrates mandatory laboratory testing of medical cannabis products (potency and contaminants) – this is a critical step in the seed to sale process and should be the main objective in any public health framework grants more licenses to increase the quantity and variety of the available supply chain to promote affordability of the end product for patients. The supply chain consists of the following distinct industry segments: -
Producers of starting material (seeds, mother plants, and cultivation of clones)
-
Production (growing, flowering and harvest)
-
Processor (extraction and processing into sub products)
-
Laboratories (required for analytical services for all medical cannabis products)
-
Authorized Retailers (i.e. dispensaries - can sell to ATP holders)
-
Authorized Resellers (wholesalers – can sell to other licensees)
does not penalize health-care practitioners under federal or provincial law, in any manner, or deny any right or privilege, for: -
advising a patient about the risks and benefits of the medical use of cannabis; or
-
providing a patient with a written recommendation, based upon a full assessment of the patient’s medical history and condition, that the use of cannabis may prove beneficial for the patient’s condition(s).
Our recommendations for constitutionally compliant new or parallel evidence-based regulations follow under each Part below.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Part 1
Authorization to Possess There are already a significant number of Canadians possessing and consuming cannabis for therapeutic and medical purposes. The objective of any new structure is to provide individuals with meaningful and timely access to medical cannabis without undue or excessive regulation26, and without the individual having to prove that they have exhausted all other treatment options.27 Pursuant to the Allard ruling, it is clear that any new medical cannabis access regulations cannot constitute another form of prohibition. The MMAR and MMPR allowed for the possession of medical cannabis to certain authorized individuals. These individuals must have the ability to maintain their status to access and possess medical cannabis while transitioning from their validly existing authorization to a new authorization under the new regulations (proposed transitionary period: 18 months from the date of effect of the new regulations). There will be three types of individuals who may seek an Authorization to Possess (ATP) under the new medical cannabis regulations: 1)
MMAR ATP holders,
2)
Holders of a medical document under the MMPR, and
3)
New Applicants. Many Canadians currently purchase medical cannabis through the illicit or ‘grey’ market without a valid license. Providing these individuals, the opportunity to obtain a Provisional ATP (outlined below), seamlessly transitions this segment of consumers away from accessing medical cannabis from the illicit market, to accessing through a properly regulated supply chain. This is an important industry segment to capture.
Recommendations 1.1
Provisional Authorization to Possess a) Eligibility
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i)
Holders of a valid ATP (valid under the Allard injunction), or a valid medical document (submitted to a licensed producer under the MMPR) will be granted an 18-month extension, from the date the new regulations come into force. This 18-month extension grants these patients a Provisional ATP. Such ATP holders must, during the term of this 18-month extension period, apply for, and obtain an ATP under the new regulations.
ii)
Other individuals seeking to obtain a Provisional ATP may submit an application containing a Declaration made by the applicant, declaring the applicant requires access to cannabis for medical purposes. Applicants seeking a Provisional ATP must submit their application and Declaration within 6-months from the date the new regulations come into force. A Provisional ATP will only be granted to applicants 18 years of age or older, unless with the consent of a parent or guardian.
The Road Forward after Allard: Creating Medical Cannabis Access Regulations
b)
Permitted Use. A Provisional ATP will allow the holder to legally purchase and possess medical cannabis product from Authorized Retailers/Resellers without threat of criminal sanctions, from the date the new regulations come into force, and for a period of 18-months thereafter. (within this 18-month period the applicant must apply for, and obtain, an ATP)
c)
Proof of Provisional ATP Status. An authorization letter from Health Canada would be suitable to identify Provisional ATP holders.
d) Expiration
1.2
1.3
1.4
i)
All Provisional ATPs expire 18-months from the date the new medical cannabis regulations come into force.
ii)
Provisional ATP holders must apply for an ATP (under para 1.2 below), to legally access medical cannabis after the expiration of the Provisional ATP.
Application for an Authorization to Posses a)
An individual seeking an authorization to access and possess cannabis for medical purposes will be required to apply for an Authorization to Possess (ATP) under the new medical cannabis access rules.
b)
An ATP application must contain a recommendation made by an Authorized Practitioner indicating the applicant requires access to medical cannabis for a medical purpose.
c)
An individual is eligible to be issued an ATP only if the individual is an individual who ordinarily resides in Canada.
Issuance of an Authorization to Possess a)
On receipt by the Minister of a recommendation from an Authorized Practitioner (under paragraph 1.7 below) that the applicant requires access to medical cannabis for a therapeutic or medical purpose, and if all other requirements are fulfilled, the Minister will grant to the applicant an ATP under the new medical cannabis regulations.
b)
Proof of ATP Status. An ATP card should be issued to qualifying ATP applicants, indicating certain information about the holder, such as: a randomly generated unique ID number, photograph of the holder, effective date and expiration date, and the name of the Authorized Practitioner.
Expiry and Renewal of Authorization to Possess. An ATP is valid for a period of two years, and must be renewed every two years thereafter.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
1.5
General Provisions a)
Application fees, if any, must be reasonable to be constitutionally valid, not a barrier to access, and should be set to meet reasonable administrative costs of the ATP program.
b)
Maintain the 150g possession limit. As stated by Justice Phelan in Allard, the 150g possession cap “still allows one to possess more than their necessary amount of marihuana.”28 Anyone requiring more than the allowed limit will need to apply for a variance. A variance application method will need to be implemented.
c)
Regulations must allow for submission of address changes.
Guidance 1.6
1.7
The Provisional ATP structure: a)
improves (not hinders) access to cannabis for medical purposes without having to remove cannabis from Schedule II (until such time that legalization occurs) – and, in keeping with Allard, does so without undue interference29 and without threat of criminal sanctions (see also “Creating Charter Compliant Regulations under CDSA and NCA” at page 26),
b)
allows an easy transition for individuals currently accessing medical cannabis from the illicit market, to purchase through a properly regulated and tested supply chain,
c)
allows the applicant time to find an Authorized Practitioner to write a recommendation for medical cannabis, and allows time for Authorized Practitioners to transition to the new regulations to allow for writing recommendations for medical cannabis, (also see paragraph 1.7 below)
d)
establishes a voluntary and confidential medical cannabis authorization database which will permit Health Canada to verify the applicant’s identity and age, as well as the medical purpose of the individual interested in obtaining a provisional ATP, and
e)
will provide Health Canada with the number and demographic data of individuals seeking to obtain an ATP -- having this information will aid to build adequate information technology systems associated with the transition into a proper infrastructure for processing applications.
Authorized Practitioners a)
Practitioners authorized to recommend medical cannabis for medical or therapeutic purposes should include physicians, psychiatrists, nurse practitioners and naturopathic doctors.
b)
Under the MMPR, physicians were made the gatekeepers of the program and they were handed the full responsibility for deciding who would get medical cannabis. However, lack of guidance has made those willing to prescribe few and far between.30
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Part 2
Production of Medical Cannabis for Personal Use The court in Allard found that cannabis can be produced safely and securely, with limited risk to public safety and with the promotion of public health.31 In addition, the court stated that if in compliance with electrical standards, indoor home growing facilities are “just as safe as any other electrical installation at any other type of facility�32, and with proper ventilation, any mold concerns are extinguished.33 Allowing opportunities for eligible Canadians to grow limited amounts of cannabis for their own personal use is a key strategy to prevent an illicit cannabis market from continuing, or re-emerging.34 Furthermore, home production also addresses the issue of affordability, strain availability (access) and price flexibility, all of which are hindered under the MMPR.35 There will be three groups of individuals who may seek a license for the production of medical cannabis for personal use under the proposed new medical cannabis regulations: 1)
MMAR Personal Use Production licensees (valid under Allard injunction),
2)
MMAR Designated-person Production licensees (valid under Allard injunction),
3)
New Applicants. In accordance with the Allard decision, any new cannabis access regulations must include an allowance for personal home production.
Recommendations 2.1 Transition a)
Holders of a valid MMAR License to Produce (Personal-use Production or Designatedperson Production licenses, valid under Allard injunction) will be granted a 10-month extension, from the date the new regulations come into force. During this period, valid MMAR license holders must apply for, and obtain, one or more valid licenses under the new regulations (as outlined in paragraph 2.1(c) below).
b)
All MMAR licenses (under paragraph 22.1(a) above) automatically expire 10-months from the date the new regulations come into force, and are no longer be legally valid for producing or processing personal use medical cannabis.
c)
All holders of a valid MMAR license (under paragraph 1.1(a) above) will be required to apply for one or more of the following licenses in order to continue to produce and process medical cannabis under the new regulations: i)
Personal Use Production and Processing license,
ii)
Caregiver Production and Processing license,
iii)
Clone Production and Genetic Propagation license
iv)
Medical Cannabis Grower license
v)
Medical Cannabis Processor license
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
2.2
2.3
2.4
2.5
Licensing Categories. We recommend two licensing categories for the production of medical cannabis for personal use: a)
Personal Production and Processing (PPP) licenses, and
b)
Caregiver Production and Processing (CPP) licenses. Caregiver means any individual designated by a patient to produce and process medical cannabis for that patient.
Permitted Activities - PPP License a)
The PPP license should allow the licensees to produce, process, store and transport medical cannabis products in accordance with the PPP licence.
b)
Two (2) PPP licenses should be allowed at one address. A variance application may be made in the event more licenses are required.
c)
PPP licensees should be issued an ATP concurrently with the PPP license allowing patients access to medicinal cannabis from other sources.
d)
PPP Licensees may donate at no charge or cost a certain portion of their personal medical cannabis to another ATP holder (within their allowable limits).
e)
PPP Licensees are specifically prohibited from selling any portion of their personal medical cannabis.
Permitted Activities - CPP license a)
The CPP license should allow Caregivers to possess, cultivate, produce, process and transport medical cannabis.
b)
Caregivers should be allowed to grow for up to four (4) patients at any one time. A variance application may be made if more licenses are required.
c)
CPP licensees would have to apply for, and obtain, an ATP should they require medical should have to obtain an ATP – an ATP should not be inherent in the CPP license.
d)
CPP licensees are specifically prohibited from selling a patient’s medical cannabis to any person other than the patient. A CPP should be able to cultivate and provide medical cannabis to patients for remuneration.
e)
An individual is eligible to be issued a CPP only if the individual is an individual who ordinarily resides in Canada and has reached 18 years of age.
Plant / Canopy Limits. Recommend: a)
a total growing area of up to 500 sq ft,(46.45 sq-m) - or any other allowable size limits established by the PPP or CPP license – and may include outdoor growing36 and greenhouses,
b)
if based on number of plants, up to 12 mature plants in flower (i.e. showing buds), or
c)
a combination of both.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
2.6
Patients requiring greater plant / canopy limits under para. 2.5 (above) may apply for a Variance (see Guidance paras. 2.8 – 2.11 below).
2.7
General Provisions a)
Recommend a small application fee, if any, to meet reasonable administration costs and to allow patients access to grow or process their own medicine. The application fee should assist in funding the infrastructure needed to process PPP and CPP licenses.
b)
Regulations must allow for submission of address changes including changing an authorized Caregiver.
c)
PPP and CPP licensees must adhere to all applicable federal, provincial/territorial and municipal laws and bylaws, including, but not limited to, zoning laws, building codes and strata by-laws (to address condo living safety).
d)
New CPP applicants may be required to provide notice to their municipality in advance of submission of their application – confirmation of notice must be provided with the application. CPP licensees and new CPP applicants may be subject to inspections and compliance with the new regulations and local by-laws.
Guidance 2.8
Different medical patients may require greater plant limits (i.e. for the production of Rick Simpson Oil / Phoenix Tears, or for juicing).
2.9
To maintain proper access and constitutionally valid regulations, it is recommended that a variance application method be implemented. PPP Licensees and CPP licensees must have the ability to apply for a variance for patients requiring more than the allowable plant/canopy limits.
2.10
Restricting personal production to a low plant limit number will open the door to further litigation and possibly a continuation of the current injunction. It has been suggested that no Allard plaintiff could make do with any low or restrictive plant numbers, such as 6 or 8 plants.
2.11
In Allard, Justice Phelan found the government’s reasons for plant restrictions to be arbitrary. Lack of access to a readily accessible supply for purchase gave rise to the constitutional flaws in the MMAR regulations; personal production under the MMAR has never been impugned by the courts. The MMAR was established by the Liberal government, and as such, the MMAR regime should not conflict with the Liberal’s current views on access to cannabis. A recommended response would be to bring back personal production as established under the MMAR.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Introduction to Part 3, Part 4, and Part 5
Commercial Production and Processing Licenses Commercial production and processing of medical cannabis was not contemplated under the MMAR. With the introduction of the MMPR, MMAR personal use production licenses were to be suspended, and all patients were to access their medical cannabis through a system of licensed commercial producers. However, as noted in Allard, the current MMPR regulations are excessive and do not provide meaningful, affordable and timely access to medical cannabis.37 In accordance with Allard, any new or parallel regulatory regime must facilitate a healthy, regulated environment while fostering patient choice. A robust medical purpose approach to regulation could form a base platform for a transition to a recreational model as rules and regulation continue to evolve. Therefore, we recommend three licensing categories for commercial medical cannabis production and processing. Applicants interested in obtaining a commercial production license may apply under any one or all production categories: 1)
Clone Production and Genetic Propagation (CPGP) – license for growing seeds, mother plants, and cultivation of clones
2)
Medical Cannabis Grower (MCG) – license for growing, cultivating and producing medical cannabis, and
3)
Medical Cannabis Processor (MCP) – license for processing medical cannabis.
General Recommendations - Applicable to all Commercial Producers Address Changes. New regulations must allow for submission of address changes. Additional Information. Health Canada may request additional information from new applicants in support of their application, which may include: building location map, site plan, environmental information about the proposed site, confirmation of access to necessary municipal services, and confirmation that the site passed an electrical safety inspection. Adherence to Applicable Laws. Licensees must adhere to all applicable federal, provincial/territorial and municipal laws and by-laws, including municipal zoning by-laws and zoning restrictions. Licensees are also required to communicate with local authorities whenever there is a change in the status of their licence. New applicants must provide notice to their municipality in advance of submission of their application – confirmation of notice must be provided with the application. Licensees and new applicants will be subject to inspections and compliance with the new regulations and local by-laws. Application Fees. Application fees should provide additional funding allowing government to hire additional support staff to manage this new infrastructure. Laboratory Testing. All medical cannabis and medical cannabis products must be (i) analyzed and certified as to the safety and potency; and/or (ii) identify ingredients, nutritional content, and/or potentially harmful contaminants in cannabis or cannabis products (as defined in Part 6 – “Licensed Laboratories”, below).
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Odour Control. Licensees must adhere to local bylaws with respect to odour abatement. Quality Assurance. The qualifications for the quality assurance person for each commercial producer should be defined clearly in the regulations and enforced consistently across the board. A Bachelor of Science in chemistry, bio-chemistry, plant biology or pathology, agriculture, forest science, or equivalent, or as may be determined under the new regulations. Security Cameras. Security (web) camera coverage should be limited to the following areas: i) entrances to the exterior of the perimeter of the facility, ii) entrances to areas where plant material will be present, iii) coverage of areas where dried plant material is stored, and any other such additional measures as determined appropriate. Data storage for camera footage should be limited by motion and light when activity is present in the area (CCTV storage space is expensive and there is no point saving footage of a black screen when it is dark with no activity). Security camera protocols are subject to revision and specific to each category of commercial producer. Security Clearance. Streamline the security clearance process, with clear, specific, and transparent criteria for security clearances and processing time. Licenses will only be granted to applicants 18-years of age or older. All applicants must submit an Electronic Criminal Records Check performed by The Canadian Corps of Commissionaires (https://www.commissionaires.ca). Reasonable, clear and unambiguous guidelines should be set forth indicating eligibility and ineligibility of an applicant for licensing. Security Requirements. The excessive security requirements under the MMPR are cost prohibitive, creating barriers to access for many small and medium applicants. Access control requirements should be reasonable and practicable (access control requirements are disproportionate to the level of security they actually provide under the MMPR). Facility security features should focus on real and appropriate levels of threat. MMPR regulations themselves are contradictory – they dictate ‘Fort Knox’ level security requirements on one-hand, yet dictate delivery of cannabis product by mail, on the other hand. Storage. Medical cannabis product should be stored in a secure area. Security (web) cam coverage, if needed, would be sufficient.
Transition MMPR Licensed Producers. MMPR Licensed Producers will be granted a 10-month extension from the date the new regulations come into force, to transition to the new regulations. During this period, MMPR Licensed Producers must apply and obtain any license the Licensed Producer may require to continue to operate their business. All MMPR LP licenses should automatically expire 10-months from the date the new regulations come into force. MMPR Applicants. Applicants with an MMPR application submitted and under review by Health Canada should have, within a set-period of time, the opportunity to amend their application to meet the requirements under the new regulations. New Applicants. New applicants will be required to apply under the new regulations.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Part 3
Clone Production and Genetic Propagation Medical cannabis products derived from pest-free and disease-free plants are the biggest factors in ensuring a safe supply chain for patients. Clones and tissue propagation of a genetically strong medical cannabis mother plant (grown from seeds, and free of harmful pesticides or fungicides) ensures disease free growth and a healthy root system, creating a more robust medical cannabis plant. Strong genetics are the root of a sustainable medical cannabis industry – neither the MMAR nor the MMPR contained sufficient provisions for legally reliable sources of seeds with suitable genetics. The inclusion of Clone Producers and Genetic Propagators ensures the supply chain has a much needed variety of contaminant-free starting plant material. Seed cultivation, clone production and genetic propagation of medical cannabis should be a full-scale production activity in its own category.
Recommendations 3.1
Licensing Structure. We recommend a new and separate licensing category for producers interested in obtaining a Clone Production and Genetic Propagation (CPGP) license. Allow for a graduated licensing structure based on square footage of the production (nursery) facility.
3.2
Permitted Activities. The CPGP license allows a licensee to possess, produce, transport, store and sell: seeds, seedlings, tissue culture, and other propagation materials used specifically in the cultivation of medical cannabis. Genetics, breeding and cloning only involve immature plants. CPGP licensees can sell to the following licensees: Medical Cannabis Growers, Authorized Retailers/Resellers, and other CPGP licensees.
3.3
Limits. The number of immature cannabis plants that may be possessed is subject to the limits established by the CPGP license.
3.4
Testing. CPGP licensees must observe good practices and periodically test mother plants and clones to ensure plants are of the proper genetic material and do not contain contaminates.
3.5
Public Health and Safety. CPGP licensees must meet any public health and safety standards and industry best practices established by the new regulations related to: a)
The propagation of immature cannabis plants and the seeds of the plant Cannabis family Cannabaceae.
b)
The growing of cannabis plants to the extent necessary for the production of mother plants and seeds.
3.6
Inventory Tracking. It is recommended that CPGP licensees follow good production practices such as tagging and tracking of plants throughout the facility, and tracking the number of plants sold.
3.7
Application Fee. Recommend an application fee $5,000 – $10,000 or other such amount as may be determined. Fees should be in the form of a schedule (sliding-scale) that imposes a greater fee for premises with more square footage.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Part 4
Medical Cannabis Grower A Medical Cannabis Grower license allows the licensee to produce, harvest, trim, dry, cure, and package dry cannabis. The growing and cultivating of medical cannabis is a production activity.
Recommendations 4.1
Licensing Structure. We recommend a graduated licensing structure for the Medical Cannabis Grower (MCG) license. Graduated licensing should be based on the allowable number of mature medical plants grown, or on square footage of the production facility.
4.2
Permitted Activities. The MCG license allows a licensee to possess, cultivate, produce, store and transport medical cannabis. MCG licensees can sell, distribute and deliver medical cannabis to the following licensees: Medical Cannabis Processors, Authorized Retailers/Resellers and other MCG licensees.
4.3
Public Health and Safety. MCG licensees must meet any public health and safety standards and industry best practices established by the new regulations related to the production, cultivation and storage of medical cannabis.
4.4
Limits. The number of immature and mature cannabis plants that may be possessed by a MCG licensee is subject to the limits established by the CPGP license.
4.5
Testing. MCG licensees must observe good practices. All medical cannabis and medical cannabis products must be (i) analyzed and certified as to the safety and potency; and/or (ii) identify ingredients, nutritional content, and/or potentially harmful contaminants.
4.6
Inventory Tracking. Tagging and tracking of plants throughout the facility is a good production practice. For weighing and recording inventory purposes, focus should be on number of plants and weight. A standardized weight method should be adopted and applied generally. Dried plants material should be weighed into inventory tracking as they come out of the dry rooms and into storage.
4.7
Production Equipment. If growing indoors, equipment used should be commercially manufactured and approved by third-party standards bodies (UL, CSA).
4.8
Security Cameras. Addition of security camera coverage of areas where plant material is dried and or cured. Note: Drying rooms are highly mechanized spaces requiring heating, cooling, humidification and dehumidification. Under the MMPR, a bank vault is specified for storing medical cannabis. This is not necessary for the drying process. The cost of adding secured storage (vault) specifications to a dry room is a barrier for potential applicants.
4.9
Packaging: All medical cannabis products for distribution/sale through Medical Cannabis Growers must have proper labelling and child-safe, air-tight packaging.
4.10
Application Fee. Recommend an application fee of $2,000 – $10,000 or other such amount as may be determined. Fees should be in the form of a schedule that imposes a greater fee for premises with more square footage or on which more mature medical cannabis plants are grown (sliding-scale).
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Part 5
Medical Cannabis Processor A medical cannabis processor license allows the licensee to convert medical cannabis into cannabis extracts, concentrates and cannabis-infused products. We recommend a graduated licensing structure for this category of producers based square footage of the production facility. The processing of medical cannabis is a production activity.
Recommendations 5.1
Licensing Structure. We recommend a new and separate licensing category for producers interested in obtaining a Medical Cannabis Processor (MCP) license, with a graduated licensing structure based on square footage of the production facility.
5.2
Permitted Activities. The MCP license allows the licensee to: a)
possess, extract and process medical cannabis for the purpose of producing the following medical cannabis products: i) extracts, ii) concentrates, iii)
cannabis-infused lotions, balms, and oils that are absorbed through the skin (topicals),
iv)
edibles, and
v)
tinctures, capsules, suppositories, and transdermal patch processor.
b)
produce edible products in food safe kitchens, following food safe production practices and meet the processing standards for other health food products in the marketplace
c)
store, distribute, transport, deliver and sell processed medical cannabis products to the following licensees: Authorized Retailers/Resellers and other MCP licensees.
5.3
Public Health and Safety. Processors must meet any public health and safety standards and industry best practices established by the new regulations.
5.4
Inventory Tracking. Tagging and tracking of sourced medical cannabis, and processed medical cannabis products throughout the facility is a good production practice.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
5.5 Testing: a)
Edible products must indicate product doses. 10mg is a standard medical dose for new consumers (or such other amount established under the new regulations)
b)
all processed medical cannabis must be clearly labelled, indicating cannabinoid profile, testing analytics, and warnings.
c)
Labels must clearly indicate product doses, warnings/contraindications, ingredients, and nutritional content.
5.6
Packaging: All medical cannabis products for distribution/sale through Medical Cannabis Processors must have proper labelling and child-safe, air-tight packaging.
5.7
Production Equipment. Equipment used should be commercially manufactured and approved by 3rd party Standards bodies (UL, CSA).
5.8
Security Cameras. Addition of security camera coverage of areas where medical cannabis material is extracted, and where medical cannabis derivative products are produced and stored.
5.9
Application Fee. Recommend an application fee of $2,000 – $10,000, or other such amount as may be determined. Fees should be in the form of a schedule that imposes a greater fee for premises with more square footage (sliding-scale).
Guidance 5.10
Not all processors want to be involved in the production (growing of medical cannabis). Therefore, the new regulations should allow and include processor-only licenses. This ensures patients have access to a wider variety of alternative products, particularly in non-smokable forms, and thus should be included as part of a harm reduction strategy.
5.11
Allowing the entrance of small businesses to operate with a processor only license will encourage the migration of currently operating processors from extracting cannabis in an unregulated market into a regulated one. Eliminating the unregulated use of solvent and pressurized equipment should also be included as part of a harm reduction strategy.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Part 6
Licensed Laboratory Product testing and quality assurance is of critical importance within any new medical cannabis regulatory structure. Many medical cannabis patients have suppressed immune systems that make them particularly susceptible to many common contaminants. As stated in Allard, “rigorous regular testing conducted by trained individuals is necessary to detect the presence of microbial contaminants and address other safety concerns.”38 Therefore, to ensure consistent quality and potency of all cannabis products throughout the medical cannabis supply chain, it is crucial that the new regulations provide for regulated laboratory testing and quality control standards. See also Appendix D “Cannabis Testing Without Strict Laboratory Standards Yields Inconsistent Results”.
Recommendations 6.1
Transition. Laboratories holding a valid exemption under Section 56 of the Controlled Drugs and Substances Act Dealer’s License) must submit, within a set-period of time, a Declaration that the stating Licensed Dealer (laboratory) meets the requirements under the new regulations. Applications are subject to review, and facilities will be subject to inspection.
6.2
Licensed Laboratory Applications a)
All new and existing applicants for a Licensed Laboratory must submit an Electronic Criminal Records Check performed by The Canadian Corps of Commissionaires (https://www.commissionaires.ca). Reasonable, clear and unambiguous guidelines should be set forth indicating eligibility and ineligibility of an applicant for licensing.
b)
New applicants may be asked to submit certain additional information in support of their application.
6.3
Application Processing. Licensed laboratories are a vital and critical component to any regulated medical cannabis supply chain. Applications for a Licensed Laboratory must be processed within a prescribed timeframe (see “Regulatory Transparency” on page 25).
6.4
Permitted Activities. Verification of medical cannabis and medical cannabis products must be conducted by independent third party laboratories as licensed under the new regulations. Note: Since cannabinoid potency and lack of impurities are value drivers for end-products, Medical Cannabis Growers and Medical Cannabis Processors should be required to engage third party laboratories for proper testing to avoid any conflict of interest that may be created by using their own in-house analytical lab testing.
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6.5
Testing Facilities. Laboratory testing facilities must develop and implement standard operating procedures and protocols to ensure regulatory compliance and worker safety.
6.6
Testing Methods. Acceptable methods for testing impurities and contaminants, including microbial, aflatoxin, pesticides and heavy metals, already exist and are available in the British, European or US Pharmacopoeia. Note: For potency analysis there is currently no widely accepted methodology for quantifying cannabinoid potency (THC, CBD and others). Standards should be developed within a set-period of time. In the interim, other test methods should be accepted. In addition, Terpene profiles are key to understanding the nuances of the therapeutic value of different strains, and would be a valuable addition to the testing regime.
6.7
Cannabis Potency Assay Development. Recommend that existing licensed testing companies work together to develop a cannabinoid potency assay suitable for inclusion in the selected pharmacopoeia (indicated in paragraph 7.3 above) and adopt this method industry wide. This pharmacopeia should be implemented as a baseline binding thread that will steadfastly assure consumers of an expectant consistency of all cannabis products. Encourage a review and revision process for the pharmacopoeia on a periodic base (i.e. annually for the first 5-years and every 3 to 5 years thereafter). Note: Engage leaders from the growing, processing, testing and packaging elements of the industry, along with government regulators to draft a Canadian monograph for cannabis – akin to a Pharmacopeia. The Canadian monograph would describe the quality, purity, strength, and identity standards for cannabis. Use the draft US monograph and Canadian Herbal Pharmacopoeia as starting points for the Canadian Cannabis Monograph. Alternatively, aim for inclusion in the US or EU Pharmacopeia.
6.8
Standardized testing methods outlined by government: a)
Government inspectors should conduct randomized sampling of licensed Medical Cannabis Growers, Medical Cannabis Processors and Authorized Retailers/Resellers. If, upon this sampling, a deficiency is found then an inspection would be undertaken.
b)
Create an Inspectors’ Matrix & Point System as per the Canadian Food Inspection Agency (CFIA).
c)
In addition to third party testing, recommend Third Party Government contracted labs that do government inspection – this would be at arm’s length and would minimize conflicts of interest. Contracted labs are relatively inexpensive for the government and they are frequently used in other industries (i.e. Pest Management Regulatory Agency ‘PRMA’ http://www.hc-sc.gc.ca/cps-spc/pest/index-eng.php)
Note: In the federal government (CFIA and PMRA as examples), inspectors are government employees and conduct the inspection, or sampling of a product. The inspector will then organise with a third party contracted lab for the lab testing (some tests are done in government labs, but the third party labs can be throughout Canada as it will be more economical – this is almost always the case for PMRA and pesticide tests).
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
6.9
General Provisions: a)
Application fees should be reasonable so as not to increase the overall cost of the medical cannabis product through the supply chain. This Application fee provides additional funding allowing government to hire additional support staff to manage this new infrastructure.
b)
Regulations must allow for submission of address changes.
c)
Adherence to Applicable Laws. Licensees must adhere to all applicable federal, provincial/ territorial and municipal laws and by-laws, including municipal zoning by-laws and zoning restrictions. Licensees are required to communicate with local authorities whenever there is a change in the status of their licence. New applicants must provide notice to their municipality in advance of submission of their application – confirmation of notice must be provided with the application. Licensees and new applicants will be subject to inspections and compliance with the new regulations and local by-laws.
d)
Licensees must maintain proper client records (as established by Health Canada).
“Cannabis is becoming increasingly understood that it is a very interesting and versatile medicine with much less toxicity than some of the pharmaceutical products it replaces.” –Dr. Lester Grinspoon, Associate Professor Emeritus of Psychiatry, Harvard Medical School; former senior psychiatrist, Massachusetts Mental Health Center
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Part 7
Authorized Retailers/Resellers In Allard, Justice Phelan writes that: “Dispensaries are at the heart of cannabis access,” and that “Current trends in dispensary growth suggest a connection between the restrictions to access under the MMPR and the need for patients to obtain their medical marihuana from illicit sources.”39 Medical cannabis retailers are the access points for authorized individuals to obtain their medical cannabis product. They are the critical final piece in the medical cannabis supply chain. Justice Phelan stated that under MMPR there is “no guarantee that the necessary quality, strain and quantity will be available when needed at some acceptable level of pricing.”40 To ensure better variety and consistent supply of product, Authorized Resellers (wholesalers) should also be a category for licensing in any new medical cannabis structure.
Recommendations 7.1
Licensing Structure. We recommend two new and separate licensing categories: Authorized Retailer (dispensary) and Authorized Reseller (wholesaler).
7.2
Application and Licensing Process
7.3
a)
Transition. Currently operating medical cannabis retailers, where permitted by municipal regulations, should have the opportunity to submit an application for an Authorized Retailer/ Reseller license. The application should include a declaration stating that the medical cannabis retailer meets the new requirements under the new regulations. Applications are subject to review, and facilities will be subject to inspection. This process would be done in parallel to ensure compliance with any relevant municipal bylaws (time, place and manner restrictions).
b)
New Applicants. New applications for authorization as an Authorized Retailer/Reseller must apply pursuant to the new regulations and provide all information and related documents as required under the new rules. Such documents should include, but not limited to: incorporation documents, architectural diagrams of the site, and proof that the proposed use of the site is in compliance with any business license issued, or will be issued by the municipality in which the proposed Authorized Retailer/Reseller is located (this must be provided prior to final authorization to operate).
c)
All applicants must submit an Electronic Criminal Records Check performed by The Canadian Corps of Commissionaires (https://www.commissionaires.ca). Reasonable, clear and unambiguous guidelines should be set forth indicating eligibility and ineligibility of an applicant for licensing.
Issuance of Authorized Retailer/Reseller License. The licence should be processed once the pre-opening inspection has been completed, a business licence has been received, and the Authorized Retailer/Reseller is authorized to open.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
7.4
Permitted Activities a)
An Authorized Retailer license allows a licensee to acquire, package, store, deliver, transport and sell medical cannabis and medical cannabis products, subject to the provisions of the license.
b)
An Authorized Reseller license allows a licensee to acquire, store, transport and deliver medical cannabis products to other licensees. Health Canada may want to establish different tiers of Authorized Reseller license.
c)
Authorized Retailers should be permitted to apply for an Authorized Reseller license. Authorized Resellers should be permitted to apply for an Authorized Retailer license.
7.5
Prohibition on Purchasing. Authorized Retailers/Resellers are specifically prohibited from purchasing medical cannabis product from unlicensed propagators, growers, cultivators or processors.
7.6
Staff and Training a)
Individuals 18-years of age or older should be authorized to work with, or in connection to, an Authorized Retailer/Reseller.
b)
Licensees must make best efforts to provide proper and adequate training so that staff best understand the medical cannabis products they sell, and be able to provide patients with the best up-to-date information. Proper training of employees is essential to deliver safe, quality cannabis products to patients and caregivers. Note: Look to “bud-tender” certification courses offered in the U.S. states (or any other similar certification programs), the “Start Low and Go Slow” campaigns, and brochures that are on every dispensary counter.
7.7
Intake Recommendations. Authorized Retailers/Resellers can sell medical cannabis products to individuals with proof of valid ATP (including Provisional ATP).
7.8
Supply Chain. All medical cannabis products for sale/distribution through any Authorized Retailers/ Resellers must: a)
be purchased from the following licensees: Clone Production and Genetic Propagation Medical Cannabis Grower, Medical Cannabis Processor, other Authorized Retailers/ Resellers,
b)
have proper testing,
c)
be dispensed into properly labelled child-safe packaging prior to leaving the premises, and
d)
be stored securely off hours.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
7.9
Dispensing. Maximum purchase amounts should be within the parameters specified on an individual’s ATP. Restrictions on Provisional ATP maximum purchase amounts will be in accordance to the new regulations.
7.10
Packaging: All medical cannabis products for distribution/sale through Authorized Retailers/ Resellers must have proper labelling and child-safe, air-tight packaging:
7.11
a)
dry cannabis flower must be dispensed into child safe containers with cautionary labels
b)
concentrates, baked goods, tinctures - to be sold in pre-weighed, pre-packaged with child safety top of mind. Concentrates be tested and dosed accordingly. Warning labels in place similar to e-cigarettes.
Inventory Tracking a)
Inventory control protocols should be implemented to ensure the integrity of the supply chain and prevent diversion of medical cannabis for non-medical use.
b)
The inventory tracking system should include a continuous chain of custody for medical cannabis products, periodic inventory counts, and a procedure for dealing with lost or stolen product.
c)
Point of Sale (POS) systems should be in place to ensure seed to sale tracking of all inventory: i)
POS system to be compliant with applicable federal, provincial/territorial privacy laws to ensure patient privacy
ii)
Ensure that POS system tracks all dispensary recommendations for treatment so that they can be shared with Authorized Practitioners upon patient’s request.
Note: Currently used POS systems (such as THC Bio-Track, MJ Freeway, Indica On-Line) are not Canadian-based products. There exist opportunities for Canadian companies to develop tech-based products which can engineer current POS challenges. 7.12
Public Health and Safety. Authorized Retailers/Resellers must meet any public health and safety standards and industry best practices established by the new regulations. Licensees must conduct their operations in sanitary conditions, using existing sanitation standards for food packaging, storage, and distribution, as well as herbal medicine handling and storage standards, as models for sensible regulations.
7.13
Allow Authorized Retailers/Resellers and Dispensaries to sell and deliver via online (mail-order) sales.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
7.14
7.15
Security Measures a)
adequate security measures and loss control procedures should be implemented to prevent theft or robbery and detect shrinkage.
b)
medical cannabis products should be stored in a manner that is sanitary, preserves the integrity of the product, and is secure. This is important to protect patients from mold, mildew, and other contaminants that may be harmful.
General Provisions a)
Application Fee. The application fee should be reasonable so as not to increase the overall cost of the medical cannabis product through the supply chain or create a barrier to access. This application fee provides additional funding allowing government to hire additional support staff to manage this new infrastructure.
b)
Regulations must allow for submission of address changes.
c)
Authorized Retailers/Resellers must maintain proper patient information, books, and accounting records.
d)
Adherence to Applicable Laws. Authorized Retailers/Resellers must adhere to all applicable federal, provincial/territorial and municipal laws and by-laws, including municipal zoning by-laws and zoning restrictions. Licensees are also required to communicate with local authorities whenever there is a change in the status of their licence. New applicants must provide notice to their municipality in advance of submission of their application – confirmation of notice must be provided with the application. Licensees and new applicants will be subject to inspections and compliance with the new regulations and local by-laws.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
“As far as cannabis is concerned, only behaviour causing demonstrable harm to others should be prohibited: illegal trafficking, selling to young people under the age of sixteen and impaired driving.” –Cannabis: Our Position for a Canadian Public Policy Report of the Senate Special Committee on Illegal Drugs, September 2002 Online: http://www.parl.gc.ca/SenCommitteeBusiness/CommitteeReports.aspx?parl=37&ses=1&comm_id=85
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Regulatory Transparency Regulatory bodies must be specific in drafting of new or parallel cannabis access guidelines and regulations. Clear, unambiguous criteria should be used.
Recommendations 1.
Application Processing a)
Provide timelines for application processing and disposition. For example, under the Natural Health Product Regulations, the Minister shall dispose of applications within 60-days.41
b)
Specific and measureable pre-license requirements should be set forth and implemented consistently across jurisdictions. Whether it is the quality assurance qualifications, the personnel and site security requirements, or distances from schools and daycares, criteria should be the same for all participants.
c)
Each applicant should be assigned a case manager who is responsible for processing files in a transparent, fair and considerate manner. This is not currently occurring with the MMPR. Every communication from Health Canada should have a proper tracking mechanism (i.e. software, preferably one which is interactive to allow the applicant to view the status of their file) and an appropriate method of contact and access in response, ensuring effective processing of application in a consistent and transparent manner.
2.
Regular Review of Licensees. Regular reviews of commercial productions licensees (Clone Production and Genetic Propagation, Medical Cannabis Growers, Medical Cannabis Processors) should include operational security, and quality assurance.
3.
Periodic Review of Rules. Encourage use of best practices and review enacted policies, regulations and legislative requirements on an annual basis for the first 5-years following implementation of the new cannabis access regulations, and every 3 to 5 years thereafter. Such review should be conducted pursuant to a proper assessment procedure as established by Health Canada.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
Creating Charter Compliant Regulations under CDSA and NCA If the Federal government chooses to continue with a new or parallel regulatory structure for medical cannabis under the Controlled Drugs and Substances Act and the Narcotic Control Act, we believe these recommendations provide a way to do so which does not criminalize Canadians for possession of small amounts of cannabis, while still restricting access to young people and impeding the illicit market. By crafting evidence-based regulations, and looking to states such as Oregon and Colorado as examples, Canada has the opportunity to create the foundation for a robust and sustainable medical cannabis industry, making the transition to full legalization easier for government and its citizens.
Further Discussion There are further options available to the government if it were to remove cannabis from the Schedule II list of controlled substances under the CDSA. See Appendix C “Removing Cannabis from Schedule II CDSA�.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
For Additional Consideration
Remove Cannabidiol (CBD) from Schedule II CDSA Cannabidiol (CBD) is a naturally occurring constituent of industrial hemp/cannabis. Unlike tetrahydrocannabinol (THC), CBD is a non-psychoactive cannabinoid compound, and thus is not associated with the mind-altering effects of the cannabis plant.42 CBD works through a number of complex mechanisms and is considered to have a wider scope of potential medical and therapeutic applications than THC. Pre-clinical studies (including cell culture and animal models) has shown CBD have analgesic (pain-relieving)43 44, antioxidant45, anticonvulsant46, anti-psychotic47, anti-tumor48, anti-anxiety49 and neuroprotective effects.50 However, because CBD is a component of the cannabis plant, CBD is an illegal substance under the Controlled Drugs and Substances Act.
Recommendations 1.
Remove Cannabidiol (CBD) from Schedule II of the CDSA - CBD would then be regulated under the Natural Health Product Regulations (NHPR) and issued a product license along with a Natural Health Product (NPN) number or an exemption number (EN-XXXXXX), so that CBD can be legally sold in Canada.51 Note: Under the NHPR, this would deem CBD as safe for consideration as a non-prescription product. Natural health products are available for self-care and self-selection, and do not require a prescription to be sold.
2
Amend the Industrial Hemp Regulations52 to allow authorized hemp producers to cultivate, produce and process hemp for extracting CBD. Hemp resin is rich in CBD content, but federal law forbids hemp farmers from saving or using any of the resins from the plants.
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The Road Forward after Allard: Creating Medical Cannabis Access Regulations
“I mistakenly believed the [DEA] listed marijuana as a Schedule I substance because of sound scientific proof … They didn’t have the science to support that claim, and I now know that when it comes to marijuana neither of those things are true. It doesn’t have a high potential for abuse, and there are very legitimate medical applications. In fact, sometimes marijuana is the only thing that works.” –Dr. Sanjay Gupta, Assistant Professor of Neurosurgery, Emory University Associate Chief of Neurosurgery, Grady Memorial Hospital.
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Appendix A
Public Health Benefits to Medical Cannabis Regulations As cannabis has been legalized for medical use and more accepted in general, an increasing amount of research is emerging on its effects. Canadian doctors prescribe marijuana to more than 20,000 people to treat conditions ranging from Alzheimer’s, premenstrual syndrome, seizures and migraines to glaucoma, MS, OCD, ADD and HIV/AIDS.53
The Medicinal Value of Cannabis is Supported by Research In addition to long-understood benefits of cannabis for treatment of pain, glaucoma, nausea, and side effects of chemotherapy, recent studies from the University of California’s Center for Medical Cannabis Research54 have shown positive results for: ■■
Spasticity from multiple sclerosis
■■
Neuropathic pain from HIV
■■
Severe disease through immunosuppressive effect of cannabinoids
■■
General pain management through analgesic effect of smoked cannabis
■■
Diabetic peripheral neuropathy
■■
Treatment-resistant neuropathic pain through use of vaporized cannabis at low doses
In addition, the Center for Medical Cannabis Research has begun looking into: ■■
Repeated use on driving impairment, showing that regular users experience less impairment to driving abilities as compared to infrequent users
■■
Treatment of mild occasional pain, such as headaches
■■
Long-term use on the body’s natural endocannabinoid system
■■
Efficacy of alternative delivery methods, such as vaporization and ingestion
A McGill University study published in 2015 showed that cannabis used for long-term pain management by experienced users leads to little adverse effects, and has a reasonable safety profile.55 A survey conducted by the New England Journal of Medicine found that 76% of doctors supported medical marijuana use for medical purposes.56
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Appendix A
Cannabis May Have Other Public Health Benefits Not Yet Fully Understood 2015 meta-analysis in the Journal of the American Medical Association showed mixed results from studies performed to date on the efficacy of medical cannabis for certain conditions. Moderate-quality evidence supported suggested benefits for pain management of chronic and neuropathic pain, and spasticity from multiple sclerosis. Low-quality evidence supported suggested benefits for anxiety, insomnia, and appetite stimulation in patients with HIV. The conclusion was that more studies needed to be performed with large robust, randomized clinical trials, but that these would be difficult with substantial regulatory hurdles still in place.57 One potential benefit that requires more study is in the treatment of Post-Traumatic Stress Disorder suffered by veterans. Anecdotal reports abound regarding the efficacy of cannabis for this condition, particularly among those experiencing suicidal thoughts. Two researchers have been attempting to study these effects, but have after six years only received institutional review board approval that is conditional on Drug Enforcement Administration approval.58 Part of the difficulty in performing this research is due to strain unavailability from the only federally-approved cultivation center, while sources of the needed strains can be found in many states that have authorized medical and adult use.
Cannabis mitigates chronic pain, reduces patients’ need for opioids Daily use of cannabis provides pain relief and reduces opioid use in patients with treatment-resistant chronic pain conditions, according to clinical trial data: ■■
■■
■■
■■
Investigators with Hebrew University in Israel evaluated the use of cannabis on pain in a cohort of 176 patients, each of whom had been previously unresponsive to all conventional pain medications. Subjects inhaled THC-dominant cannabis daily (up to 20 grams per month) for a period of at least six months. A majority of the study’s participants (66 percent) experienced improvement in their pain symptom scores after cannabis therapy, and most reported “robust” improvements in their quality of life. Subjects’ overall consumption of opioid drugs declined 44 percent by the end of the trial, and a significant percentage of participants discontinued opioid therapy altogether over the course of the study.59 The Israeli results are similar to those reported in a 2015 Canadian trial which concluded that chronic pain patients who use herbal cannabis daily for one-year experienced reduced discomfort and increased quality of life compared to controls, and did not possess an increased risk of serious side effects.60 Separate data published in 2014 in The Journal of the American Medical Association determined that states with medical marijuana laws experience far fewer opiate-related deaths than do states that prohibit the plant.61 Investigators from the RAND Corporation reported similar findings in 2015, concluding, “States permitting medical marijuana dispensaries experience a relative decrease in both opioid addictions and opioid overdose deaths compared to states that do not.62
Appendix A
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Appendix B
Matrix of Medical Cannabis Laws in States that have Authorized Adult Use Oregon Personal Possession Limit Jointly between cardholder/caregiver: ■■ ■■
■■
Home Grow Limit ■■
24 oz. usable marijuana
■■
No limit on cannabinoid products
■■
Grower may possess harvest up to 12 lb. usable marijuana per outdoor plant, 6 lb. per indoor plant
Plant/Canopy Limit
No limit on immature plants
■■
6 mature plants per cardholder Cardholder may designate a grower to produce
Each grower may grow for up to 4 cardholders, multiple growers may be registered to one address
Driving Law ■■
■■
For newly registered grow sites: ■■
■■
No change to existing law. Illegal to drive under influence of controlled substance Implied consent to testing, but no limit established
If in residential zone within city limits 12 plants Any other location 48 plants
For grow sites registered prior to Jan. 1, 2015, allowed to have number of plants registered at that time, up to: ■■
■■
If in residential zone within city limits 24 plants Any other location 96 plants
Alaska Personal Possession Limit ■■ ■■
■■
Home Grow Limit
1 oz. usable marijuana
■■
No dispensary system established
■■
No specific allowance or possession limit for medical marijuana products
6 plants per person, no more than 3 mature legal to possess yield of plants at grow location
Plant/Canopy Limit ■■
No separate license or registration for medical cultivators
Driving Law ■■
No change to existing law. Illegal to drive under influence of controlled substance
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Colorado Personal Possession Limit ■■
■■
2 oz. usable marijuana, though patient can raise as affirmative defense to charge for excess that more is needed to treat debilitating condition
Home Grow Limit ■■
6 plants per patient, no more than 3 mature
Plant/Canopy Limit ■■
Or equivalent in marijuana products ■■
Dispensaries must register patients, and cultivation is tied to the dispensary, so plant counts calculated based on number of patients registered to dispensary that cultivation facility will serve Plant counts do not include immature plants
Driving Law ■■
■■
■■
■■
Permissible inference of impairment of 5ng/ ml whole blood Delta-9 THC Driver can be charged with impairment regardless of results of test based on officer’s judgment Implied consent to blood test Unlawful to have open marijuana container in passenger area of vehicle
Washington Personal Possession Limit Jointly between cardholder/caregiver: ■■ ■■
■■
■■
24 oz. usable marijuana No more marijuana product than what could reasonably be produced from 24 oz. of marijuana Combined total of usable marijuana and product not to exceed 24 oz. or equivalent
Home Grow Limit ■■ ■■
Plant/Canopy Limit
15 plants per patient
■■
After July 1, 2016, 6 plants per patient for personal medical use, up to 15 plants per housing unit
■■
Until July 1, 2016, collective garden may be established for up to 10 patients, limit of 45 plants per garden
Driving Law ■■
■■
After July 1, 2016, cooperative for up to 4 patients may be established ■■
Per se guilt of impairment at 5ng/ml whole blood Delta-9 THC Driver can be charged with impairment regardless of results of test based on officer’s judgment Implied consent to blood test
After July 1, 2016, limits increase to 3 times adult use limit, and authorizing health care provider may specify that patient requires higher limit
Appendix B
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Appendix C
Remove Cannabis from Schedule II CDSA The CDSA gives the government broad regulation-making authority,63 including the power to add or delete a particular drug or substance from the schedules to the CDSA where it deems such an amendment to be “necessary in the public interest”64. Since this change would be regulatory, rather than legislative, the government could effect it without the legislature’s approval. However, to avoid total deregulation of cannabis, there are options available to the government if it were to remove cannabis from the Schedule II list of controlled substances.
Recommendations C-1
C-2
C-3
Remove cannabis from Schedule II of the CDSA and create a new regulatory structure for medical cannabis under the Food and Drugs Act (FDA)65 a)
Contraventions of the new medical cannabis regulatory regime would be enforced under the FDA.
b)
The FDA has enforcement powers under Section 3166, and such powers can be extended by amendment to include enforcement for contraventions of any of the provisions of the FDA or its regulations (such as any new Medical Cannabis Access Regulations).
Alternatively, amend the Natural Health Product Regulations (NHPR) to allow for the personal production of medical cannabis: a)
In the NHPR there already exists provisions governing: product licensing, evidence requirements for safety and efficacy, labelling, site licensing, good manufacturing practices, adverse reaction reporting, clinical trials, related advisories, warnings and recalls, transparency in the regulatory licensing process, books and record keeping, suspension and cancellation of licenses, and inspections.67
b)
Given that the NHPR fall under the FDA, the enforcement powers under the FDA (as outlined in point 1 above) would automatically be applicable to medical cannabis.
c)
Alternatively, cannabis could be granted an exemption, in the form of an exemption number (EN), by the Minister under the provisions of the Natural Heal Products (Unprocessed License Applications) Regulations.68
Any new regulations created under the FDA, or amendments made to the NHPR, will also require corresponding amendments to the Excise Act 69 The Excise Act imposes a federal taxation system for alcohol and tobacco products manufactured in Canada and includes extensive control provisions relating to the production and distribution of these commodities.
Page 35 of 39
Appendix C
Appendix D
Cannabis Testing Without Strict Laboratory Standards Yields Inconsistent Results D-1
Standardization through laboratory accreditation procedures used by other industries can help to minimize risk from inconsistent results. Oregon has instituted accreditation through its Oregon Environmental Laboratory Accreditation (ORELAP) program.70 ■■
D-2
2015 study in the Journal of the American Medical Association tested potency of edible products purchased at dispensaries in California and Washington. It found that of 75 products from 47 different brands, only 17% were accurately labeled for potency. 23% of tested products understated the content of THC and CBD, and 60% overstated this potency.71
The need for testing standardization is not limited to pesticides. Other contaminants, such as heavy metals and microbiological agents like Aspergillus, other molds, powdery mildew, and bacteria represent significant public health threats if present in consumer products.72 ■■
■■
2013 study showed that up to 60-70% of pesticides used on cannabis flower may be present in smoke.73 2015 paper from the Cannabis Safety Institute (US) showed a wide range of pesticides present on cannabis available in Oregon medical dispensaries, and at unsafe levels. Only 7% of flower and 24% of concentrates that were tested would have failed Oregon Health Authority standards, yet 14% of flower and 46% of concentrates would have failed comparable EPA standards for detectable levels of pesticide residue. This paper suggested a list of analytes to test for that would alleviate this problem, and recommended the use of pesticides that are exempt from set EPA tolerances, those that are generally not considered to be significantly harmful.74
72%
Appendix C
79%
80%
81%
82%
Page 36 of 39
Endnotes 1
Allard v. Canada, 2016 FC 236
2
Marihuana for Medical Purposes Regulations, SOR/2013-119, online http://www.laws-lois.justice.gc.ca/eng/ regulations/SOR-2013-119/ [MMPR]
3
Canadian Charter of Rights and Freedoms, Part 1 of the Constitution Act, 1982, being Schedule B to the Canada Act 1982 (UK), 1982, c 11
4
Marihuana Medical Access Regulations, SOR/2001-227 [Repealed, SOR/2013-119 s.267] – 2014-03-31 [MMAR]
5
Laanela, Mike “Ban on medical marijuana patients growing own pot struck down by Federal Court”, February 24, 2016, online: http://www.cbc.ca/news/canada/british-columbia/medical-marijuana-federalcourt-ruling-1.3461694
6
Allard, supra, note 1 at para. 293
7
Ibid., at para. 292
8
Ibid., at para. 294
9
Ibid., at 296
10 11
Ibid., at paras. 147 and 204
Ibid., at para. 174
12
Controlled Drugs and Substances Act, SC 1996, c 19 [CDSA]
13
Ibid., at s.4-7.1
14 15
Food and Drugs Act, RSC 1985, c F-27, s 2 [FDA] Marihuana Exemption (Food and Drugs Act) Regulations, SOR/2013-120, online: http://laws-lois.justice.gc.ca/eng/regulations/SOR-2013-120/index.html, s 2
16
Narcotic Control Regulations, CRC, c 1041 [NCR]
17
Wakeford v. Canada (1998), 166 DLR (4th) 131 (ONSC) at paras. 28-29 and 35-36 [Wakeford]
18
Ibid., at para. 31 (also see R. v. Mernagh, 2013 ONCA 67)
19
Ibid., at para. 25
20
R. v. Parker (2000),188 DLR (4th) 385 at paras. 156 and 178 [Parker]
21
R. v. Smith, 2015 SCC 34 at paras. 25-26 and 31
22
Allard, supra, note 1 at paras. 33, 230, 258 and 274 and 274
23
Ibid., at para. 236
24
Ibid., at para. 259
25
Ibid., at para. 67
26
Wakeford, supra, note 17 at para. 13
27
Ibid., at para. 25
28
Allard, supra, note 1 at paras. 210 and 288
29
Ibid., at paras. 47-49
30
Hagar, Mike, “On a mission to change how family doctors view medical marijuana”, July 30, 2015, online: http://www.theglobeandmail.com/news/british-columbia/on-a-mission-to-change-how-family-doctors-viewmedical-marijuana/article25791287/
31
Allard, supra, note 1 at para. 282
32
Ibid., at para. 244
33
Ibid., at para 245
Page 37 of 39
Endnotes
34
Legalization of Marijuana – Policy Paper 2013 – Liberal Party of Canada in BC, at page 12
35
Allard, supra at note 1, at para. 171
36
Allard, supra at note 1, at para. 270
37
Ibid., at para. 31 (also see R. v. Mernagh, 2013 ONCA 67)
38
Ibid., at para. 266
39
Ibid., at para. 162
40
Ibid., at para. 15
41
Natural Health Product Regulations, SOR/2003-196, s.6 “Sixty-Day Disposition”
42
Volkow, Nora “The Biology and Potential Therapeutic Effects of Cannabidiol”, June 24, 2015, online: https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2016/biology-potentialtherapeutic-effects-cannabidiol
43
Russo, Ethan B “Cannabinoids in the management of difficult to treat pain” Therapeutics and Clinical Risk Management, 2008 Feb; 4(1): 245-249, online: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2503660/
44
Manzanares, J. et al. “Role of the Cannabinoid System in Pain Control and Therapeutic Implications for the Management of Acute and Chronic Pain Episodes”, Current Neuropharmacology, 2006 Jul; 4(3) 239-257, online: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2430692/
45
Volkow, supra, at note 42
46
Devinksy, O et al. “Cannabidiol: pharmacology and potential therapeutic role in epilepsy and other neuropsychiatric disorders”, Epilepsia, 2014 Jun; 55(6) 791-802, online: http://www.ncbi.nlm.nih.gov/pubmed/24854329
47
Zuardi, AW et al. “A critical review of the antipsychotic effects of cannabidiol: 30 years of a translational investigation”, Current Pharmaceutical Design, 2012; 18(32):5131-40, online: http://www.ncbi.nlm.nih.gov/pubmed/22716160
48
Volkow, supra, at note 42
49
Ibid.
50
Pazos, MR et al., “Mechanisms of cannabidiol neuroprotection in hypoxic-ischemic newborn pigs: role of 5HT(1A) and CB2 receptors”, Neuropharmacology, 2013 Aug;71:282-91, online: http://www.ncbi.nlm.nih.gov/pubmed/23587650
51
Health Canada website: “About Natural Health Product Regulation in Canada”, online: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php
52
Industrial Hemp Regulations (SOR/98-156)
53
Legalization of Marijuana – Policy Paper 2013 - Liberal Party of Canada in BC
54
Center for Medicinal Cannabis Research, Completed Studies, online: http://www.cmcr.ucsd.edu/index.php/2015-11-20-20-52-15/completed-studies
55
McGill University, “Medical cannabis in the treatment of chronic pain”, last updated 2015-10-07, online: https://www.mcgill.ca/channels/news/medical-cannabis-treatment-chronic-pain-255706; Ware, Mark et al. “ Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS)” The Journal of Pain, Vol 16, No 12 (December), 2015: pp 1233-1242, online: http://www.jpain.org/article/S1526-5900(15)00837-8/pdf
56
Adler, Jonathan N. & James A. Colbert. “Medicinal Use of Marijuana — Polling Results,” New England Journal of Medicine, 368 (2013)
57
Penny F. Whiting, et al. “Cannabinoids for Medical Use: A Systematic Review and Meta-Analysis.” Journal of the American Medical Association (June 2015); http://jama.jamanetwork.com/article.aspx?articleid=2338251
Endnotes
Page 38 of 39
58
http://www.maps.org/research/mmj/marijuana-us
59
Haroutounian S et al. “The Effect of Medicinal Cannabis on Pain and Quality of Life Outcomes in Chronic Pain: A Prospective Open-label Study”, online: http://www.ncbi.nlm.nih.gov/pubmed/26889611 reported online ahead of print in The Clinical Journal of Pain
60
McGill study, supra note 55
61
Bachhuber, Marcus A et al. “Medical Cannabis Laws and Opiod Analgesic Overdose Mortality in the United States, 1999-2010”, October, 2014, online: http://archinte.jamanetwork.com/article.aspx?articleid=1898878
62
Powell, David et al. “Do Medical Marijuana Laws Reduce Addictions and Deaths Related to Pain Killers?”, July 2015, online: http://www.nber.org/papers/w21345
63
CDSA, supra note 12 at s. 55
64
Ibid., at s. 60
65
FDA, supra, note 14
66
Ibid., at s.31
67
Health Canada, supra, note 51
68
Natural Health Products Regulations (SOR/2003-196), s.103.2 and s.103.3
69
Excise Act, R.S.C., 1985, c. E-14
70
Oregon Health Authority, online: https://public.health.oregon.gov/LaboratoryServices/ EnvironmentalLaboratoryAccreditation/Pages/cannabis-info.aspx; Farrer, David (Public Health Toxicologist), “Technical Report: Oregon Health Authority’s Process to Determine Which Types of Contaminants to Test for in Cannabis Products and Levels for Action”, online: https://public.health.oregon.gov/PreventionWellness/ marijuana/Documents/oha-8964-technical-report-marijuana-contaminant-testing.pdf
71
Ryan Vandrey, et al. “Cannabinoid Dose and Label Accuracy in Edible Medical Cannabis Products.” Journal of the American Medical Association (June 2015).
72
Mowgli Holmes, et al. “Microbiological Safety Testing of Cannabis.” Cannabis Safety Institute (2015); http://cannabissafetyinstitute.org/wp-content/uploads/2015/06/Microbiological-Safety-Testing-of-Cannabis.pdf
73
Sullivan, N., Elzinga, S. & Raber, J. C. Determination of pesticide residues in cannabis smoke. J Toxicol 2013, 378168 (2013)
74
Rodger Voelker and Mowgli Holmes. “Pesticide Use on Cannabis.” Cannabis Safety Institute (2015); online: http://cannabissafetyinstitute.org/wp-content/uploads/2015/06/CSI-Pesticides-White-Paper.pdf
Page 39 of 39
Endnotes
There are chemicals in our bodies that act like cannabis, and they target the same sites as THC. It begs the question of why on Earth we have these receptors in our bodies –Mark Ware, MD, MSc, Director of Clinical Research, Alan Edwards Pain Management Unit, McGill University Health Centre, Associate Professor, Family Medicine and Anesthesia, McGill University Publications: http://www.ncbi.nlm.nih.gov/ pubmed/?term=%22ware+ma%22%5Bau%5D+AND+%28mcgill%5Bad%5D+OR+montreal%5Bad%5D%29