2016 FC 236, 2016 FC 236

[2016] 3 F.C.R. 303 T-2030-13 2016 FC 236 Neil Allard, Tanya Beemish, David Hebert and Shawn Davey ( Plaintiffs ) v. Her Majesty the Queen in Right of Canada ( Defendant ) Indexed as: Allard v. Canada Federal Court, Phelan, J.—Vancouver, February 23, 24, 25, 26, March 2, 3, 4, 5, 9, 10, 11, 12, 13, April 30 and May 1, 2015; February 24, 2016.

Food and Drugs — Action under Canadian Charter of Rights and Freedoms, s. 7 challenging constitutionality of medical marihuana regime under Marihuana for Medical Purposes Regulations (MMPR) — MMPR reforming medical marihuana access regime by, inter alia, mandating that dried marihuana be produced by licensed producer (LP), limiting amount authorized for possession to 150 grams — Plaintiffs arguing, inter alia, that by taking away patients’ ability to produce marihuana for themselves, MMPR forcing them to choose between their liberty, health in order to access adequate supply of medicine; that personal production of medical marihuana involving individual autonomy, dignity, right to make fundamental personal choices free from state interference, thereby impacting or engaging liberty — Whether Canada limiting rights of plaintiffs in manner not complying with Charter — Liberty interest engaged — Liberty at risk for those who cannot access LP regime, who stray outside conditions set for possession by MMPR — Scheme also standing between plaintiffs, right to make decision of fundamental importance unimpeded by state action — Case law decided under previous regulatory scheme (Marihuana Medical Access Regulations (MMAR)) applying herein — Security interest also engaged — MMPR undermining health, safety of medical marihuana users through severe restrictions on access to medical marihuana — These restrictions not in accordance with principles of fundamental justice — Objective of MMPR to reduce risks to public health, security, safety of Canadians, significantly improve access to marihuana for medical purposes — Access to medical marihuana not improved under MMPR — MMPR forcing plaintiffs to choose between medication, other basic necessities without rational connection to objective — With respect to health, safety risks, evidence insufficient, risks not proved to exist — No direct evidence on how MMPR improving access compared to MMAR — MMPR arbitrary, overbroad — Infringement not justified under Charter, s. 1 — As to 150-gram restriction, cap not overbroad, grossly disproportionate — Possession cap still allowing one to possess more than necessary amount of marihuana — Action allowed.

Constitutional Law — Charter of Rights — Life, Liberty and Security — Charter, s. 7 challenge of constitutionality of medical marihuana regime under Marihuana for Medical Purposes Regulations (MMPR) — Plaintiffs arguing, inter alia, that by taking away patients’ ability to produce marihuana for themselves, MMPR forcing them to choose between their liberty, health in order to access adequate supply of medicine; that personal production of medical marihuana involving individual autonomy, dignity, right to make fundamental personal choices free from state interference, thereby impacting or engaging liberty — Whether Canada limiting rights of plaintiffs in manner not complying with Charter — Plaintiffs’ s. 7 Charter rights infringed by MMPR — Right not to have one’s physical liberty endangered by risk of imprisonment, to make decisions of fundamental personal importance engaged herein — Liberty at risk for those who cannot access LP regime, who stray outside conditions set for possession by MMPR — Scheme also standing between plaintiffs, right to make decision of fundamental importance unimpeded by state action — Case law decided under previous regulatory scheme (Marihuana Medical Access Regulations (MMAR)) applying herein — Security of person interest engaged by establishment of regulatory regime severely restricting access to medical marihuana — MMPR thus undermining health, safety of medical marihuana users — These restrictions not in accordance with principles of fundamental justice — Objective of MMPR to reduce risks to public health, security, safety of Canadians, significantly improve access to marihuana for medical purposes — Access to medical marihuana not improved under MMPR — MMPR forcing plaintiffs to choose between medication, other basic necessities without rational connection to objective — Government cost savings resulting from licensed producer regime cannot trump plaintiffs’ Charter rights, form Charter-compliant justification for MMPR — With respect to health, safety risks, evidence insufficient, risks not proved to exist — No direct evidence on how MMPR improving access compared to MMAR — MMPR arbitrary, overbroad; limits imposed on s. 7 interests bearing no rational connection to objective — Infringement not justified under Charter, s. 1 — Plaintiffs demonstrating, on balance of probabilities, that cannabis can be produced safely, securely with limited risk, consistently with promotion of public health — Complete restriction not minimal impairment.

This was an action under

section 7 of the Canadian Charter of Rights and Freedoms (the Charter) challenging the constitutionality of the medical marihuana regime under the Marihuana for Medical Purposes Regulations (MMPR). The previous regulatory scheme under the Marihuana Medical Access Regulations (MMAR) permitted individuals to obtain an authorization to possess (ATP) marihuana for medical purposes. The MMAR did not set a daily dosage limit, but it did impose a cap on the amount of marihuana that an ATP holder could possess.

ATP holders could obtain marihuana through a personal-use production licence (PUPL), a designated person production licence (DPPL), or from Health Canada. The MMPR completely reformed the medical marihuana access regime, most substantially invalidating all PUPLs and DPPLs and the amount an individual is authorized to possess. It dispossessed licensees of the ability to control the medical marihuana they consumed. The MMPR, inter alia , mandates that dried marihuana be produced by a licensed producer (LP).

Individuals who formerly were or could be issued an ATP must register the prescription of a medical practitioner with a LP to obtain dried marihuana. If they do so,

section 3 of the MMPR authorizes them to obtain and possess marihuana produced by that LP. The amount authorized for possession under

section 5 is lower than under the MMAR: either 150 grams or 30 times the amount prescribed for daily consumption. Sections 12 to 101 of the MMPR require a LP to meet various quality and security measures. The plaintiffs argued, inter alia , that the MMPR takes away the ability of the patient to produce marihuana for themselves, compelling them to purchase from a LP, placing them in the position of having to choose between their liberty and their health in order to have access to an adequate supply of medicine; that

section 7 permits the government to regulate commercial behaviour in this area but does

not permit the government to criminalize individual non-commercial patient conduct such as personal production of cannabis-based products; and that the personal production of medical marihuana involves individual autonomy, dignity and the right to make fundamental personal choices free from state interference, thereby impacting or engaging liberty. At issue was whether Canada has limited the rights of the plaintiffs in a manner that does not comply with the Charter . Held , the action should be allowed. The plaintiffs’

section 7 Charter rights were infringed by the MMPR. The liberty interest in this case was engaged in two distinct ways: the right not to have one’s physical liberty endangered by the risk of imprisonment, and the right to make decisions of fundamental personal importance. Liberty is at risk for those who cannot access the LP regime if they cultivate or purchase outside the regime for any reason, including affordability, dosage and strain preference, as they risk conviction and imprisonment.

The risk is also manifested if they stray outside the conditions set for their possession by the MMPR—possessing more than 150 grams. The scheme also stands between the plaintiffs and their right to make a decision of fundamental importance unimpeded by state action. The case law decided under the MMAR applied to the analysis of the constitutionality of the MMPR as the case law addressed the limitations and prohibitions imposed on medical marihuana, finding such limitations to engage

section 7 rights. The decision of fundamental importance was about access to marihuana for medical purposes, and that access, while not prohibited, is restricted. The issue was the scope of the restrictions to access. The security of the person interest was engaged, even independently of criminal sanction, by the establishment of a regulatory regime that restricts access to marihuana. This was true of the MMAR and is true of the MMPR. The Ontario Court of Appeal’s analysis in Hitzig v. Canada applied in the present case, albeit the regime in Hitzig —the MMAR—is distinguishable from the MMPR.

The common and significant factor is that constraints are imposed in both regimes. In the present case, one cannot cultivate for oneself or purchase the marihuana from a supplier that is not registered as a LP. As a result of these restrictions, if one cannot access a LP for any reason, that person’s security is engaged as there would be no access to their medication resulting in physical or psychological suffering. The MMPR has undermined the health and safety of medical marihuana users by diminishing the quality of their health care through severe restrictions on access to medical marihuana.

It is the restriction that engages

section 7 interests. The next question was whether these limitations are in accordance with the principles of fundamental justice. The objective of the MMPR is “to reduce the risks to public health, security and safety of Canadians, while significantly improving the way in which individuals access marihuana for medical purposes”. Access to cannabis for medical purposes is not improved for the plaintiffs under the MMPR. By limiting their access to purchasing from LPs, the health and safety of the plaintiffs is also diminished.

Although the plaintiffs may not resort to the black market and break the law, the MMPR forces them to choose between their medication and other basic necessities without a rational connection to the objective. With respect to health and safety risks, the evidence was insufficient. The only consequence of the MMPR remaining unchallenged was that of government cost savings. The regulatory cost burden has been transferred to the LPs. Cost savings cannot trump the plaintiffs’ Charter rights and form a Charter-compliant justification for the MMPR. The MMPR is arbitrary as the limits it imposes on

section 7 interests bear no rational connection to their objective. Many of the risks purported to be significant were not proved to exist, including fire, home invasion and community impacts. The MMPR goes too far and interferes with some conduct that bears no connection to its objectives. Even if there were some rational connection between the purposes of the MMPR and some, but not all, of its impacts, the restriction on personal cultivation of marihuana would still be overbroad. There was no direct evidence on how the MMPR has improved access compared to the MMAR.

The restriction catches those whose health and safety were never at risk. Therefore, in addition to being arbitrary, the law is overbroad. The infringement of

section 7 was not justified under

section 1 of the Charter . The objective of the prohibition is the same in both

section 7 and

section 1 Charter analyses. The same disconnect between the prohibition and its object that renders the restrictions arbitrary or overbroad under

section 7 frustrates the requirement under

section 1 that the limit on the right be rationally connected to a pressing objective and minimally impairing. As to “minimal impairment”, it was demonstrated, on a balance of probabilities, that cannabis can be produced safely and securely with limited risk to public safety and consistently with the promotion of public health. Accepting that fire, mould, diversion, theft and violence are risks that inherently exist to a certain degree, this significant restriction punishes those who are able to safely produce by abiding with local laws and taking simple precautions to reduce such risk. A complete restriction is not minimal impairment. For these reasons, the infringement of

section 7 is not justified under

section 1 of the Charter. Finally, as to the 150-gram restriction, the cap is not overbroad or grossly disproportionate because it bears a connection to the objective —it reduces the implied risk of theft, violence and diversion. The 150-gram restriction is significantly different than the restriction on cultivation, which was a complete ban. The possession cap still allows one to possess more than their necessary amount of marihuana. There is nothing stopping Parliament from legislating cultivation in a similar way that ensures that significant measures are taken to reduce risk. STATUTES AND REGULATIONS CITED Canadian Charter of Rights and Freedoms , being

Part I of the Constitution Act, 1982 ,

Schedule B, Canada Act 1982 , 1982, c. 11 (U.K.) [R.S.C., 1985, Appendix II, No. 44], ss. 1, 7 . Controlled Drugs and Substances Act , S.C. 1996, c. 19, ss. 4, 5 , 7 , 56 . Food and Drugs Act , R.S.C., 1985, c. F-27. Marihuana for Medical Purposes Regulations , SOR/2013-119. Marihuana Medical Access Regulations , SOR/2001-227, s. 41( b . 1 ) (rep. by SOR/2009-142, s. 1). Narcotic Control Act , R.S.C., 1985, c. N-1. Narcotic Control Regulations , C.R.C., c. 1041. Natural Health Products Regulations , SOR/2003-196.

Safety Standards Act, S.B.C. 2003, c. 39. CASES CITED APPLIED: R. v. Parker, , 49 O.R. (3d) 481 (C.A.); R. v. Smith, 2015 SCC 34, [2015] 2 S.C.R. 602; Hitzig v. Canada, , 231 D.L.R. (4th) 104 (Ont. C.A.); R. v. Mernagh, 2013 ONCA 67, 295 C.C.C. (3d) 431; Johnson v. Milton (Town), 2008 ONCA440, 91 O.R. (3d) 190; R. v. Mohan, (SCC), [1994] 2 S.C.R. 9, (1994), 114 D.L.R. (4th) 419; R. v. Abbey, 2009 ONCA624, 97 O.R. (3d) 330; White Burgess Langille Inman v. Abbott and Haliburton Co., 2015 SCC 23, [2015] 2 S.C.R. 182; Canada(Attorney General) v. Bedford, 2013 SCC 72, [2013] 3 S.C.R. 1101. CONSIDERED: Sfetkopoulos v.

Canada (Attorney General), 2008 FC 33, [2008] 3 F.C.R. 399; R. v. Beren and Swallow, 2009 BCSC 429, 192 C.R.R.(2d) 79; Canada (Attorney General) v. PHS Community Services Society, 2011 SCC 44, [2011] 3 S.C.R. 134; Allard v. Canada, 2014 FC280, 451 F.T.R. 45; R. v. Morgentaler, (SCC), [1988] 1 S.C.R. 30, (1988), 44 D.L.R. (4th) 385; Chaoulli v. Quebec(Attorney General), 2005 SCC 35, [2005] 1 S.C.R. 791; Blencoe v. British Columbia (Human Rights Commission), 2000 SCC 44, [2000]2 S.C.R. 307; Carter v. Canada (Attorney General), 2015 SCC 5, [2015] 1 S.C.R. 331; R. v. Malmo-Levine; R. v.

Caine, 2003 SCC 74,[2003] 3 S.C.R. 571; Newfoundland (Treasury Board) v. N.A.P.E., 2004 SCC 66, [2004] 3 S.C.R. 381. REFERRED TO: Rodriguez v. British Columbia (Attorney General), (SCC), [1993] 3 S.C.R. 519, (1993), 107 D.L.R. (4th) 342; Alfano v.Piersanti, 2012 ONCA 297, 291 O.A.C. 62; R. v. J.-L.J., 2000 SCC 51, [2000] 2 S.C.R. 600; Re B.C. Motor Vehicle Act, (SCC), [1985] 2 S.C.R. 486, (1985), 24 D.L.R. (4th) 536. AUTHORS CITED Boyd, Susan and Connie Carter. Killer Weed: Marijuana Grow Ops, Media and Justice. Toronto: University of Toronto Press, 2014. Regulatory Impact Analysis Statement, C. Gaz. 2012.I.3422.

Walsh, Zachary. Cannabis Access for Medical Purposes: Patient Characteristics, Patterns of Use and Barriers to Access. action under

section 7 of the Canadian Charter of Rights and Freedoms challenging the constitutionality of the medical marihuanaregime under the Marihuana for Medical Purposes Regulations. Action allowed. APPEARANCES John W. Conroy, Q.C., Kirk Tousaw, Tonia Grace, Bibhas Vaze, and Matthew Jackson for plaintiffs. B. J. Wray, Jan Brongers, Carl Januszczak, Melissa Nicolls and Philippe Alma for defendant. SOLICITORS OF RECORD Conroy & Company, Abbotsford, British Columbia, for plaintiffs. Deputy Attorney General of Canada for defendant. TABLE OF CONTENTS Sections: Paragraph I. Introduction 1–5 II.

Summary/Overview 6–16 III. Background 17 A. Regulatory Scheme 17–18 B. MMAR 19–29 C. MMPR 30–39 IV. Judicial Context 40–64 V. Factual Background 65 A. Medical Marihuana Use 66

(1) Dosage 67–78

(2) Methods of Consumption 79–84

(3) Strains 85–93 B. Marihuana Cultivation 94–100 C. Risk of Cultivation 101–109 D. Mould and Other Contamination 110–115 E. Fire 116–122 F. Home Invasion/Violence/Diversion123–126

G. Community Impacts 127–128 H. Other Witnesses 129–130 VI. The Plaintiffs 131 A. Neil Allard 132–134 B. Shawn Davey and Brian Alexander135–139 C. Tanya Beemish and Dave Hebert 140–147 D. Affordability 148–157 E. Access/Availability 158–163 F. Cost of Cultivation 164–171 VII. Analysis 172 A.

Section 7 Rights and Interests 172–175

(1) Liberty Interest 176 (

a) Law 176–180 (

b) Positions —

Summary 181–186 (

c) Analysis 187–196

(2) Security Interest 197 (

a) Law 197–199 (

b) Positions—Summary 200–201 (

c) Analysis 202–203

(3) Affordability and Access Discussion204–213 B. Principles of Fundamental Justice 214

(1) Objective of the Legislation 215–221

(2) Section 1 v.

Section 7 222–224

(3) Arbitrariness 225 (

a) Law 225–227 (

b) Positions—Summary 228–232 (

c) Analysis 233–235 (

d) Impact on the Plaintiffs 236–238 (

e) Response to Defendant’s Position 239–254

(4) Overbreadth 255 (

a) Law 255–257 (

b) Positions—Summary 258–266 (

c) Analysis 267–271

(5) Grossly Disproportionate 272 (

a) Law 272 (

b) Positions—Summary 273–277 (

c) Analysis 278 C.

Section 1 279–285 D. Possession Limits—Specific Issue 286–288 VIII. Conclusion 289 IX. Disposition and Remedy 290–298 The following are the reasons for judgment rendered in English by Phelan J.: I. Introduction [1] This is a Charter challenge to the current medical marihuana regime under the Marihuana for Medical Purposes Regulations,SOR/2013-119 (MMPR) brought by four individuals. It is important to bear in mind what this litigation is about, and equally, what it isnot about. [2] This case is not about the legalization of marihuana generally or the liberalization of its recreational or life-style use.

Nor is itabout the commercialization of marihuana for such purposes. This case is about the access to marihuana for medical purposes by persons who are ill, including those suffering severe pain, and/orlife-threatening neurological conditions. Such persons also encompass those in the very last stages of their life. [3] This is another decision in a line of cases starting with R. v. Parker, , 49 O.R. (3d) 481 (C.A.) (Parker), andculminating in R. v.

Smith, 2015 SCC 34, [2015] 2 S.C.R. 602 (Smith), that have examined, often with a critical eye, the efforts ofgovernment to regulate the use of marihuana for medical purposes and the various barriers and impediments to accessing this necessarydrug. [4] Like other cases, this most recent attempt at restricting access founders on the shoals of the Canadian Charter of Rights and

Freedoms , being

Part I of the Constitution Act, 1982 ,

Schedule B, Canada Act 1982 , 1982, c. 11 (U.K.) [R.S.C., 1985, Appendix II, No. 44] (the Charter), particularly

section 7, and is not saved by

section 1 : Rights and freedoms in Canada 1. The Canadian Charter of Rights and Freedoms guarantees the rights and freedoms set out in it subject only to such reasonable limits prescribed by law as can be demonstrably justified in a free and democratic society. … Life, liberty and security of person 7.

Everyone has the right to life, liberty and security of the person and the right not to be deprived thereof except in accordance with the principles of fundamental justice. [ 5 ] The Court has concluded that the plaintiffs’ liberty and security interest are engaged by the access restrictions imposed by the MMPR and that the access restrictions have not been proven to be in accordance with the principles of fundamental justice. II.

Summary/Overview [ 6 ] The plaintiffs are four individuals, who have a medical requirement for marihuana to deal with certain physical conditions from which they suffer. Their lives have been adversely impacted by the imposition of the relatively new regime to control the use of marihuana for medical purposes. [ 7 ] The focus of this litigation is the most recent response of the federal government to the teachings of Parker that effectively mandated a regime to make marihuana available for medical purposes to persons in need. The Court in Parker held that the criminal prohibition against the possession of marihuana in

section 4 of the Controlled Drugs and Substances Act , S.C. 1996, c. 19 (CDSA), was of no legal effect absent a constitutionally acceptable medical exemption from that prohibition. [ 8 ] The federal government previously put in place the Marihuana Medical Access Regulations , SOR/2001-227 (MMAR) in 2001, repealed the MMAR on March 31, 2014 [ SOR/2013-119, s. 267 ], and put in place a substantially different regime under the MMPR . For purposes of this case, the terms “cannabis” and “marihuana” (marijuana) are used interchangeably. [ 9 ] The fact finding process in this case was challenging due to volume and relevancy. The case, on consent, proceeded as a

summary trial where affidavit evidence was taken as “read” into the record and only those witnesses whom a party wished to cross- examine appeared in Court. There was a large volume of evidence, not subject to cross-examination, which nevertheless had to be assessed with a critical focus on relevancy and weight. A list of the witnesses for the parties, both lay and expert, is attached as

Schedule A. [ 10 ] The previous jurisprudence on marihuana for medical purposes under the MMAR was extremely helpful in establishing the relationship between

section 7 interests and the consumption of marihuana for medical purposes. After the trial concluded, the Supreme Court rendered its decision in Smith (discussed more fully later). That decision held that the former medical access regime’s limitation to the use of only dried marihuana unjustifiably violated the guarantees in

section 7. This trial was reopened to permit the parties to make submissions on the effect of the Smith decision on the present case. [ 11 ] That decision reaffirms the connection between

section 7 rights and the restrictions on the use of marihuana and disposes of the question of the methods of consumption issue raised as one of the numerous issues in this trial. The restriction to dried marihuana under the MMPR is void for the same reasons it was held to be void under the MMAR in Smith . [ 12 ] On the issue of the proper dosages and the alleged therapeutic effects of different strains of marihuana, there remains significant scientific debate on this topic.

A clear theme running through the evidence of this trial is that despite the lengthy period for which marihuana for medical purposes has been available, there is a paucity of evidence, particularly from government, in respect of its use and effects. Marihuana is not treated as a “medicine” by statute, regulation or policy, and the information gap posed a significant problem.

In addition to methods of consumption, the evidence adduced during the course of the litigation focused on the plaintiffs’ access to marihuana considering dosages, strains, cultivation, cost economics and the administration of the drug in other jurisdictions. [ 13 ] The anecdotal evidence of the plaintiffs on the impact of different strains is accepted but its weight is not significant. The Court is not in any position to prescribe or condone different medical treatments.

The defendant asks the Court to conclude that, given the high level of use of medical marihuana (significantly more than some other countries), Canadian medical practitioners are, in effect, overprescribing medical marihuana. There is insufficient evidence for the Court to reach that conclusion much less ground a

section 1 finding on that basis. [ 14 ] To the extent that affordability was advanced as a ground of

section 7 violation, it has not been made out. More importantly, it is not necessary to make such a finding. Affordability can be a barrier to access, particularly where it is a choice made to expend funds on medical treatment to the detriment of other basic needs.

However, this case does not turn on a right to “cheap drugs”, nor a right “to grow one’s own”, nor do the plaintiffs seek to establish such a positive right from government. [ 15 ] The evidence does establish that under the single source system of a licensed producer (LP) there is no guarantee that the necessary quality, strain and quantity will be available when needed at some acceptable level of pricing (through such mechanisms as flexible pricing or discount pricing)—due to the structure of the regulations and the characteristics of the market. [ 16 ] Ultimately, considering that liberty and security interests are engaged, the Court has found that the evidence of each plaintiff’s individual circumstances was sufficient to demonstrate that the regulatory restrictions in the MMPR upon the individuals (including but

not limited to the prohibitions against certain methods of consumption and plant growth by a patient or his or her delegate) does not bear a connection to the objective of the legislation and is therefore arbitrary. The access restrictions did not prove to reduce risk to health and safety or to improve access to marihuana—the purported objectives of the regulation. In the alternative, even if some connection is found, the restriction is still overbroad and does not minimally impair

section 7 rights. III. Background A. Regulatory Scheme [ 17 ] Drugs and controlled substances are primarily regulated by the CDSA , the Food and Drugs Act , R.S.C., 1985, c. F-27 (FDA) and their related regulations.

Cannabis (marihuana) is a controlled substance scheduled under the CDSA and a narcotic subject to the Narcotic Control Regulations , C.R.C., c. 1041 (NCR). [ 18 ] Subsequent to the Ontario Court of Appeal’s decision in Parker referred to earlier, which in practical terms mandated a constitutionally acceptable medical exemption for the use of marihuana, the federal government (Canada) enacted the MMAR . These regulations have been amended numerous times in response to decisions from various courts. B.

MMAR [ 19 ] The MMAR , prior to its repeal and replacement with the MMPR , permitted individuals who had the support of a medical practitioner to obtain an authorization to possess (ATP) marihuana for medical purposes from Health Canada. [ 20 ] The MMAR did not set any limit on the daily dosage a doctor could authorize—however, it did impose a cap on the amount of marihuana that an ATP holder could possess at 30 times one’s daily dosage. [ 21 ] Under the MMAR, ATP licence holders could obtain lawful access to marihuana in one of three ways: 1. through a personal-use production licence (PUPL), which permitted the individual ATP licence holder to grow a certain quantity of marihuana for his or her own use; 2. through a designated person production licence (DPPL) that permitted a person designated by an ATP licence holder to produce marihuana for up to two ATP licence holders; or 3. through purchasing dried marihuana directly from Health Canada which had contracted with a private company to produce and distribute medical marihuana. [ 22 ] The production of marihuana under a PUPL or DPPL could only be conducted at the site designated on that licence.

Cultivation could be indoors or outdoors, although not both at the same time. [ 23 ] There were no restrictions as to the location of the production facility beyond the fact that if outdoors, it could not be adjacent to a school, public playground, day care facility or other public place frequented mainly by persons less than 18 years of age.

There were mandatory compliance requirements that licence holders had to meet including compliance with all local by-laws. [ 24 ] The number of plants that could be grown by a person with a production licence was calculated using a formula set out in the MMAR based primarily on the ATP licence holder’s authorized daily dose. The MMAR permitted up to four production licences to be issued in respect of the same site. [ 25 ] There was significant growth in ATPs between 2002 and the end of 2013 from 455 to 37 151, and in PUPLs from 326 to 28 228.

Growth was expected to continue. [ 26 ] As of December 31, 2013, the average daily dosage was 18.22 grams per day, which permitted an individual to grow 89 plants. This level of daily dosage was significantly higher than in Israel or the Netherlands—two countries used in this case by Canada as comparators to suggest that daily dosage is a problem in this country. [ 27 ] The MMAR provided for an inspection system under which Health Canada inspectors were required to either obtain consent to enter a dwelling or secure a warrant.

As part of the defendant’s justification for the new system, Health Canada estimated that the inspection of all residential growing operations in existence in 2013 would cost $55 million. The number has little relevance in the absence of evidence to show that the inspection of all sites annually is reasonably justified. Health Canada produced no evidence of the amount of inspections necessary to ensure compliance with the regulations. [ 28 ] As evident in the justification for the new MMPR , program costs were a significant, if not dominant, priority.

The administrative cost of operating the MMAR program and supplying dried marihuana became significant as demand increased. [ 29 ] In 2005-2006 the cost of that program was $5 million per year. By 2012 that cost was projected to increase to over $15 million per year. As Health Canada subsidized the cost of the marihuana it sold to the extent of 50 percent of product cost, the annual $15 million cost included this subsidy. C.

MMPR [ 30 ] The defendant, through the evidence of the then Director of the Bureau of Medical Cannabis/Director of Medical Marihuana Regulatory Reform (Director) contended that concerns about the MMAR led to government reform. She was the defendant’s key

witness on the rationale for changes in the medical marihuana regime as incorporated in the MMPR. A series of decisions including Hitzig v. Canada, , 231 D.L.R. (4th) 104 (Ont. C.A.) (Hitzig); Sfetkopoulos v. Canada(Attorney General), 2008 FC 33, [2008] 3 F.C.R. 399 (Sfetkopoulos); R. v.

Beren and Swallow, 2009 BCSC 429, 192 C.R.R. (2d) 79(Beren), had required changes to the regulatory regime to lessen the restrictions on cultivation and facilitate access to marihuana formedical purposes. [31] The Director contended that the concerns arising from the MMAR included: the rapid increase in the number of individualsauthorized to possess and produce increasing amounts of marihuana; the fact that the majority of medical marihuana was grown indwelling houses, which were not constructed to support large scale production; and the unintended negative impacts on public health,safety and security (which covered such matters as mould, fires, thefts, harms from fertilizers, odours and diversion to the black market).

She further contended that some MMAR program participants had expressed dissatisfaction due to regulatory wait times. Finally, she stated that the program was becoming an administrative and financial burden for the federal government. [32] While the Director asserted that Health Canada had received complaint letters from certain B.C. and Ontario districts, fireofficials and neighbours of PUPL holders, these references were vague and not extensive.

The reference to municipality feedbackconsisted of eight instances: a B.C. fire chief, a B.C. mayor, a B.C. municipality, an Ontario municipal fire authority, an administrativeofficer in a B.C. district, a large B.C. community, a B.C. district and an Ontario Police Services official. [33] Against this background, the Director acknowledged in cross-examination that: • Health Canada, despite having data for the kilograms of marihuana produced by MMAR licensees, had no data with respect topublic safety issues including fires, thefts, harms arising from fertilizers or other chemicals used in gardens and no effort had been madeto collect such data; • Health Canada had no statistics relating to incidents in which people who produced their own marihuana became sick from it; • the federal government was and would continue to be the major beneficiary of the move to the MMPR in terms of cost savings,and the persons who were and would continue to be most impacted were the patients due to the increase in cost; • Health Canada had no information that the plaintiffs or a substantial number of licensees ever over-produced their licences,diverted marihuana to the black market, produced unsafely, caused smells, had any fires, produced any mouldy marihuana or sufferedany negative health consequences from consuming their medicine. [34] Despite this lack of data and information, Health Canada began the process to develop a new medical marihuana regime by 2010.The key principles of this new regime included: • treat marihuana as much as possible like any other medication (but not as a pharmaceutical drug); • restore Health Canada’s role as a regulator and eliminate the government role in supplying and distributing marihuana formedical purposes; • create a new supply and distribution system using fully regulated, inspected and audited LPs; • phase out personal and designated production and institute mechanisms for compliance and enforcement; • reduce the risk of abuse and exploitation of the regulatory regime and improve access to marihuana for medical purposes; • address the public health and safety risks that police, fire authorities and municipalities had expressed to Health Canada; and • provide physicians with up-to-date information on the use of marihuana for medical purposes. [35] Health Canada examined different possibilities and issues.

It also engaged in a consultation process that included onlineconsultation, meetings with stakeholders and consultations following a draft publication in the Canada Gazette. However, the particularsof the policy process are not particularly relevant to the Court’s consideration of the impact of the MMPR on the plaintiffs’ Charterrights. [36] The Court’s role is only to determine if the policy or regulations comply with the Charter, not if their development was adequate.Even a bad policy may be Charter compliant. The Supreme Court of Canada in Canada (Attorney General) v.

PHS Community ServicesSociety, 2011 SCC 44, [2011] 3 S.C.R. 134 (PHS), at paragraph 105, stated the following on the role of the Court: … It is for the relevant governments, not the Court, to make criminal and health policy. However, when a policy is translated into law orstate action, those laws and actions are subject to scrutiny under the Charter: Chaoulli, at para. 89, per Deschamps J., at para. 107, perMcLachlin C.J. and Major J., and at para. 183, per Binnie and LeBel JJ.; Rodriguez, at pp. 589-90, per Sopinka J.

The issue before theCourt at this point is not whether harm reduction or abstinence-based programmes are the best approach to resolving illegal drug use. Itis simply whether Canada has limited the rights of the claimants in a manner that does not comply with the Charter. [37] Similarly, the issue before the Court is not whether the LP regime (MMPR) or the personal cultivation regime (MMAR) is thebest approach for access to medical cannabis.

It is simply whether Canada has limited the rights of the plaintiffs in a manner that doesnot comply with the Charter. [38] In the end, the MMPR completely reformed the medical marihuana access regime, most substantially invalidating all PUPLs andDPPLs and the amount an individual is authorized to possess. It dispossessed licensees of the ability to control the medical marihuana

they consumed. [39] Justice Manson in his March 21, 2014 order (the Manson order) (in which he kept the MMAR largely in place for qualifiedpersons) (Allard v. Canada, 2014 FC 280, 451 F.T.R. 45) summarized the situation as follows (at paragraphs 15 and 16): The MMPR mandates that dried marihuana be produced by a Licensed Producer [LP], pursuant to

section 12 of the MMPR. Individualswho formerly were or could be issued an ATP must register the prescription of a medical practitioner with an LP to obtain driedmarihuana. If they do so,

section 3 authorizes them to obtain and possess marihuana produced by that LP. The amount authorized forpossession under

section 5 is lower than under the MMAR: either 150 grams or 30 times the amount prescribed for daily consumption bythe individual’s medical practitioner, whichever is less. An LP is required to meet various quality and security measures as per sections 12-101. This includes provisions in sections 13 and 14which state that the production site may not be outdoors or in a dwelling-place. IV. Judicial Context [40] As of 1999, it was only possible for individuals in Canada to possess marihuana for medical purposes by way of

section 56 of theCDSA which allows the Minister of Health to exempt any person or class of persons from the application of the CDSA or its regulationsif necessary for a medical or scientific purpose or if it is otherwise in the public interest. [41] In 2000, the Ontario Court of Appeal, in Parker, dealt with an accused charged with cultivation of marihuana under the formerNarcotic Control Act, R.S.C., 1985, c. N-1, and with possession of marihuana under the CDSA. He needed the marihuana to control hisepilepsy.

As there was no legal source of the type of marihuana he required, Parker grew his own. [42] The Ontario Court of Appeal upheld the trial finding that the prohibition against marihuana in

section 4 of the CDSA infringedParker’s

section 7 Charter rights. The [Ontario] Court of Appeal declared the prohibition on the possession of marihuana in the CDSA tobe of no force and effect, but suspended the declaration for one year. Based on the principles established by the Supreme Court of Canada in R. v. Morgentaler, (SCC), [1988] 1 S.C.R. 30(Morgentaler) and Rodriguez v. British Columbia (Attorney General), (SCC), [1993] 3 S.C.R. 519, the Court concludedthat forcing Parker to choose between his health and imprisonment violated his right to liberty and security of the person.

This violationdid not accord with the principles of fundamental justice nor was the unfettered discretion of the Minister to provide an exemption undersection 56 of the CDSA consistent with the principles of fundamental justice. [43] Following upon Parker, the federal government promulgated the MMAR, outlined earlier in these reasons. [44] In Hitzig, the Ontario Court of Appeal dealt with three civil applications challenging the constitutionality of the MMAR.

By thetime the government brought in the MMAR in 2001, it had decided that government-supplied marihuana from its Prairie Plant Systems(the only authorized grower of marihuana), which typically supplied marihuana to those who could not grow their own or have adesignate, would be available only for research purposes. [45] The Court, in declaring certain provisions of the MMAR invalid, allowed all DPPL holders to be compensated to grow for morethan one ATP holder and to combine their growing with more than two other DPPL holders.

The Court also acknowledged that thegovernment could choose to address the constitutional difficulty of marihuana supply by an approach fundamentally different from thatcontemplated by the MMAR. [46] This Court in Sfetkopoulos heard a judicial review application to declare invalid paragraph 41(b.1) [repealed by SOR/2009-142, s.1] of the MMAR, which restricted a designated licensee to producing medical marihuana for only one user.

The substantive issue waswhether the remedial steps taken by Canada had brought the MMAR into conformity with the Charter requirements identified in Parkerand Hitzig. [47] As those cases held, the Charter requires that government not hinder access to marihuana for no good reason for those with ademonstrated need to obtain and use this substance. Justice Strayer, following the reasoning in those two decisions, concluded that paragraph 41(b.1) constituted an impermissible restrictionon

section 7 liberty and security rights of the applicants. The comments of Justice Strayer are prescient to this case. [48] The “liberty interest” identified by Justice Strayer would include: • the right to choose, on medical advice, to use marihuana for the treatment of serious conditions (which right implies a right ofaccess to marihuana); and • the right not to have one’s physical liberty endangered by the risk of imprisonment from having to access marihuana illegally.

The “security interest” included similar rights for those with a medical need to have access to medication without undue interference (thisCourt’s emphasis). [49] With respect to the “principles of fundamental justice”, Justice Strayer held that the limitation on DPPLs and therefore thelimitation on access did little or nothing to enhance the state’s interest. As such, it was arbitrary. [50] The Court critically examined the limitations on DPPLs and found them lacking justification. The government’s justification—tosome extent similar to the Regulatory Impact Analysis Statement (RIAS) [C.

Gaz. 2012.I.3422] in the present case—included: the needto control distribution of an unapproved drug; the desire to minimize risk of diversion to non-authorized use; consistency withinternational obligations; and movement toward a supply model where there would be product standards and regulated production with

the advice of physicians. [ 51 ] The government’s concern about the risk of diversion had to be justified, and it was found not to be. [ 52 ] On the issue of the movement to a supply model, the Court stated that (in Sfetkopoulos , at paragraph 18 ): … That may well be a laudable goal and if ever reached would make unnecessary litigation such as the present case. But we do not know when this new age will dawn and in the meantime the courts, in their wisdom, have concluded that persons with serious conditions for which marihuana provides some therapy should have reasonable access to it.

It is no answer to say that someday there may be a better system. Nor does the hope for the future explain why a designated producer must be restricted to one customer.

In the present case, one of the issues is why a customer must be restricted to a single supply. [ 53 ] The restraint on access was not in accordance with the principles of fundamental justice because it did not respond to the concerns motivating the Hitzig decision and left ATP holders, who are unable to grow for themselves and who cannot engage a designated producer due to MMAR restrictions, to seek marihuana in the black market. [ 54 ] In Justice Strayer’s view (one which could with slight adaption be replicated here) (at paragraph 19): … it is not tenable for the government, consistently with the right established in other courts for qualified medical users to have reasonable access to marihuana, to force them either to buy from the government contractor, grow their own or be limited to the unnecessarily restrictive system of designated producers.

At the moment, their only alternative is to acquire marihuana illicitly and that, according to Hitzig , is inconsistent with the rule of law and therefore with the principles of fundamental justice. As seen earlier, the MMPR limits a patient to a single government-approved contractor and eliminates the ability to grow one’s own marihuana or to engage one’s own designated producer.

That system is likewise not tenable. [ 55 ] The Court found paragraph 41 ( b .1) to be arbitrary, contrary to the principles of fundamental justice, not rationally connected to its objectives and a disproportional restraint to any state interests promoted. The decision was upheld on appeal. The Federal Court of Appeal agreed in law and fact with the Federal Court’s decision. [ 56 ] In 2009, the B.C.S.C. [British Columbia Supreme Court] rendered its decision in Beren , dealing with a challenge to sections 5 and 7 of the CDSA .

It focused on the failure of the MMAR to provide practical access to medical marihuana for those whose medical conditions would appear to fall within the exemption provided, despite the amendments following Hitzig and a change in policy with respect to the availability of medical marihuana for qualified patients through government supply. [ 57 ] The Court in Beren largely adopted the Court’s reasoning in Hitzig in respect of “fundamental justice” and Justice Strayer’s reasoning in Sfetkopoulos in respect of impediments to supply.

Following Sfetkopoulos and Beren , the MMAR was amended to further facilitate access to medical marihuana. [ 58 ] In the context of the MMAR at the time of its replacement by the MMPR , the judicial teachings were that access for approved medical patients was mandated by the Charter and that restrictions on access, use and supply were to be strictly limited. It is evident that Canada struggled with these two conflicting notions of access and control, as well as the direction toward greater access.

As seen in its structure and evident from a review of its operation, the MMPR moved in the opposite direction. [ 59 ] Even after the MMPR had been enacted, significant developments affecting the MMAR moved through the Court system. In Smith , first decided by the British Columbia Supreme Court, the accused argued that the CDSA and MMAR could not constitutionally prohibit rendering dried cannabis into oils and other substances. The case was an attack on the MMAR provision (also found in the MMPR) that only dried cannabis can be used.

The trial Judge found against the limitation to dried marihuana. [ 60 ] The matter moved through to the Supreme Court in Smith . The appeal required the Court to decide whether a medical access regime that only permits access to dried marihuana unjustifiably violates the guarantee of life, liberty and security of the person contrary to

section 7 of the Charter . [ 61 ] The Supreme Court reaffirmed the lower court decision that the medical marihuana regime engaged

section 7 rights. More specifically, the legislative scheme’s restriction of medical marihuana to dried marihuana limited

section 7 rights in several ways: • the prohibition on possession of cannabis derivatives infringed Smith’s liberty interest by exposing him to the threat of imprisonment on convictions under the CDSA ; • the prohibition engages the liberty interests of medical marihuana users as they could face criminal sanctions if they produce or possess cannabis products other than dried marihuana; • the prohibition on possession of active cannabis compounds for medical purposes limits liberty by foreclosing reasonable medical choices through the threat of criminal prosecution.

Specifically, the state prevents people who have already established a legitimate need for marihuana—a need the legislative scheme purports to accommodate—from choosing the method of administration; • the right to security of the person is infringed by forcing a person to choose between a legal but inadequate treatment and an illegal but more effective choice of administration of marihuana; and • the prohibitions on non-dried medical marihuana were also arbitrary because they undermined the health and safety of medical marihuana users by diminishing the quality of their medical care.

The effect of the prohibition, which in reality limited usage to smoking

marihuana, contradicted the objective of the medical marihuana regime. [62] Germane to the present case, the Supreme Court accepted the trial court’s conclusion that the evidence did not establish aconnection between the restriction and the promotion of health and safety. A general proposition of the defendant is that the MMPR isjustified on health and safety grounds and addresses such concerns as diversion of medical marihuana into the illegal market—a fact notsupported by the evidentiary record in Smith. [63] On the matter of

section 1 justification, the Supreme Court in Smith stated (at paragraph 29): The remaining question is whether the Crown has shown this violation of s. 7 to be reasonable and demonstrably justified under s. 1 ofthe Charter. As explained in Bedford, the s. 1 analysis focuses on the furtherance of the public interest and thus differs from the s. 7analysis, which is focused on the infringement of the individual rights: para. 125. However, in this case, the objective of the prohibitionis the same in both analyses: the protection of health and safety.

It follows that the same disconnect between the prohibition and itsobject that renders it arbitrary under s. 7 frustrates the requirement under s. 1 that the limit on the right be rationally connected to apressing objective (R. v. Oakes, (SCC), [1986] 1 S.C.R. 103). Like the courts below, we conclude that the infringementof s. 7 is not justified under s. 1 of the Charter. [64] The Smith decision confirmed the teachings of the prior jurisprudence in respect of improving access to medical marihuana butdealt specifically with one aspect of the challenge to the MMPR—the restriction to dried marihuana.

The current challenge to the MMPR is more broadly based and attacks the very foundation and operation of the MMPR as an integratedregulatory scheme. V. Factual Background [65] In the context of the earlier background, the medical marihuana regime under the MMPR and the trial evidence must be assessed. A. Medical Marihuana Use [66] The medical benefits of marihuana were largely undisputed at trial and have been recognized in previous cases. It is therefore notnecessary to exhaust all the medical evidence that was adduced in the course of this litigation.

It is important to note, however, thataspects of the therapeutic benefit and dosage remain disputed for particular illnesses and individuals. The following is a brief overview ofsome of the medical findings: • Marihuana has medicinal value for certain individuals, particularly in terms of pain relief, reducing nausea and stimulatingappetite; • Conditions that allow for medical marihuana use, inter alia, include: chronic neuropathic pain, HIV, multiple sclerosis,Parkinson’s disease, Tourette syndrome and Fibromyalgia.

It is also used in the context of palliative care for end-of-life patients; • There is limited research and scientific knowledge on marihuana as a medicine; and • Although disputed, there are risks with consuming marihuana. Accordingly, there is a need for studies of adverse effects in long-term users of marihuana for medical purposes.

(1) Dosage [67] It was agreed by the experts that there is no possibility of overdose death from cannabis consumption by humans, whether theconsumption is oral, inhaled or topical. Conversely, medically appropriate dosages of cannabis were an issue of significant debate. Thedefendant suggested that overdosing pursuant to over-prescription was a serious problem. Dosages were also relevant when determiningmethods of consumption. The position of the experts regarding dosage more generally is summarized below. [68] Dr.

Pate—plaintiffs’ expert on botany and pharmacology—stated that there is little scientific research on the efficacy ofmarihuana products or the medically appropriate dosages. He agreed that marihuana overdoses can produce side effects that are“extremely unpleasant” and postulated that orally ingesting “cannabis-based medicines” may require “lesser dosages” —one reason whyoral ingestion results in the amelioration of unwanted side effects.

Pate further admitted that this was difficult to confirm because itwould depend on the case at hand including the route of administration, the effect desired and the individual patient tolerance. [69] Dr. Baruch—defendant’s expert on cannabis use in Israel—gave evidence based on his research and experience in Israel. Hestated that physicians in Israel may recommend medical marihuana starting at 20 grams per month and the dose can be increased, withthe support of another physician, up to a maximum dose of 100 grams per month. Medically appropriate maximum dosage should notexceed 5 grams per day.

Dosages beyond this amount do not provide any additional therapeutic benefit and may result in adverse effects.Consumption amounts to 1 gram per day in Israel and only 86 permits for an amount of marihuana exceeding 100 grams have beenissued, which represents less than 0.5 percent of authorized patients. Of these 86 exemptions, none exceed 200 grams per month. [70] Dr.

Baruch noted that “there is cumulating evidence that the response to escalating doses of cannabis has an inverted U shape …as the dose increases above a certain point the effectiveness of cannabis decrease and risk side effects increase ….This is one morereason why physicians prescribing cannabis should be extra cautious when using escalating doses especially when reaching high doses(above 2 g per day)” (as written). Finally, Dr. Baruch commented on the growing literature concerning the development of tolerance, dependence and withdrawal fromcannabis use, especially among heavy cannabis users. [71] Dr.

Daenick—defendant’s expert on cannabis use and dosage—stated that in his experience, most of his patients generally use 3-

5 grams a day, only when necessary, with some patients using much less. He noted that there are no medical indications for the use of amounts in excess of 5 grams a day. The College of Family Physicians of Canada agrees that 1-3 grams per day is a medically appropriate dosage. In his expert report, Dr. Daenick states that despite the fact that there is no medical reason for dosages over 5 grams per day, only a quarter of patients under the MMAR were approved for 1-5 grams per day. The majority were approved for over 10 grams per day. [ 72 ] Dr.

Daenick opined on several reasons for these high dosages, these reasons were not factually supported. [ 73 ] Dr. Ferris—plaintiffs’ rebuttal expert on use and dosage—generally agrees that doses of 3-5 grams of cannabis per day are adequate for most patients. However, the dose for oral consumption is 2.5 times the inhaled consumption dose, thus the prescribed range for patients consuming marihuana via edibles can easily be 10-12.5 grams per day. Tolerance, genetics and access to low or high-potency strains, also needs to be considered to determine dosage.

Dosage is determined through doctor patient interactions and dialogues that result in a dosage that works for the particular patient’s medical issues. [ 74 ] Dr. Kalant—defendant’s expert on medical marihuana use—opined that dosages beyond 5 grams per day do not provide any additional therapeutic benefit and may result in adverse effects. Specifically, he testified that a number of studies of medical marihuana have found that progressive increases in dosage at first increase the therapeutic effect, but further increases lead to loss of therapeutic effect and replacement by adverse effects.

He accepted and elaborated on the inverted U-shape phenomenon described by Dr. Baruch. [ 75 ] Dr. Kalant touched upon a problem that has run throughout this case—that despite the government having exerted control over medical marihuana, there is a surprising lack of research to justify many of the assumptions relied on by government. He acknowledged that there is insufficient evidence on which to base scientifically reasoned dosage ranges for different medical uses and acknowledged that patients can develop significant levels of tolerance to the effects of particular dosages. [ 76 ] Dr.

Clarke—plaintiffs’ rebuttal expert on cannabis use—commented that high potency of cannabis in the medical context means that a patient needs to consume less to achieve medical efficacy, lowering the chances of adverse side effects. Medical users do not want to overconsume and they want to avoid side effects. [ 77 ] Finally, the Bureau of Medical Cannabis in the Netherlands estimates that the average daily dosage of medical marihuana in that country is about 0.68 grams per patient.

However, this data must be approached with caution considering the particulars of that regime including the access to coffee shops selling marihuana.

The availability of marihuana in that generally unenforced environment calls into question the weight given to some of the evidence from that Bureau. [ 78 ] In my view, the weight of the evidence presented in this Court is that: • the medically appropriate dose may depend on individual tolerance, particular potency of strains (e.g. the CBD [cannabidiol] and THC [tetrahydrocannabinol] rations), the route of administration and the content of the edibles; • Canada has an exceedingly high dosage and the reasons suggested for this were vastly speculative; • many of the experts agree that there is a U-shape effect, where after a certain amount, the medicinal effect of the cannabis is limited; • the recommended amount is largely agreed upon as 1-5 grams per day; and • there is insufficient evidence to determine why dosages in Canada are so high and what the effect on patients would be if they were to consume less than currently prescribed.

(2) Methods of Consumption [ 79 ] Much of the debate regarding methods of consumption and the legal prohibition against non-dried marihuana has been dealt with in Smith . The finding that the dry marihuana restriction was more dangerous to one’s health than other forms of consumption undermines the defendant’s position that the MMPR—which maintained the dried marihuana restriction—were focused on public health and safety. [ 80 ] It is useful to touch on some of the evidence on this issue presented in this case. Dr.

Pate provided evidence explaining how the cannabis plant is harvested for its medicinal resin compounds inside the glandular trichomes of the plant.

The glandular trichomes containing the therapeutically active chemical compounds can be isolated from the plant matter in different ways thus eliminating most of the plant matter in the final product, resulting in resin (“hash”, “kit” or “pollen”) or extracts (oil, butter). [ 81 ] There are multiple ways to ingest the active compounds of cannabis, which have different risks and benefits: inhalation (rapid onset with short-term relief), oral ingestion (gradual onset with longer-term relief), topical (assists skin conditions and joint pain with no psychoactive effects), and trans-mucosal (rapid onset with short-term relief, without smoking).

Ingesting the resin can be more effective than other forms of administration. As mentioned earlier, Dr. Pate also stated that an individual may consume less cannabis if in edible form depending on a number of factors, including intended benefit and tolerance. [ 82 ] Dr. Baruch stated that in Israel, licensed individuals may purchase marihuana in the form of cannabis buds or cannabis oil (extract), and children who require marihuana for medical purposes are provided with cannabis cookies made using dried cannabis. Cannabis oil was introduced for religious reasons.

There is little to no difference between the quantities of marihuana a patient must consume through inhalation compared to oral ingestion to obtain the same effect. [ 83 ] Dr. Kalant states that there is no scientific evidence that a particular method of consumption is required to treat a particular medical condition, or that certain forms of consumption are more efficacious than others. Dr. Kalant was unable to find a single scientific

study comparing the therapeutic effects of undried versus dried cannabis. [ 84 ] According to Dr. Kalant, the restriction to dried marihuana could not be justified. In like manner, there was insufficient evidence that other forms of consumption are particularly effective. Any such evidence was anecdotal. However, it was the defendant’s burden to justify restrictions to particular forms of consumption.

(3) Strains [ 85 ] In much the same vein as the issue of consumption, there is a lack of scientific research relating to medicinal uses of different strains. Thus, much of the evidence relied upon was anecdotal including the conclusions by the experts. [ 86 ] The Ontario Court of Appeal in R. v. Mernagh , 2013 ONCA 67 , 295 C.C.C. (3d) 431, at paragraphs 63–65 , stated the following on anecdotal evidence when commenting on a trial judge’s findings not being supported by evidence: Mr.

Mernagh, both on the application and on this appeal, fundamentally misconceived the nature of the evidentiary foundation required in a case of this kind. He relies on the passage at para. 9 of Hitzig , which states: “[T]he courts, relying on evidence of individuals’ personal experiences and anecdotal evidence have determined that some seriously ill persons derive substantial medical benefit from the use of marihuana.” He wrongly takes this to mean that anecdotal evidence of serious illness, and the relief of symptoms through marihuana use, is sufficient to establish a person's own medical need to use marihuana.

This

interpretation misunderstands the scope for anecdotal evidence in Charter analysis and over-reads the passage in Hitzig . The reference to anecdotal evidence in Hitzig recognizes nothing more than that for the purposes of judicial fact-finding, anecdotal evidence has been used to establish the general proposition that marihuana can have some medical benefit for some people. Anecdotal evidence, in a sense, compensates for scientific evidence that might otherwise have been used for that purpose.

In the absence of more and better studies about the therapeutic value of marihuana, anecdotal evidence may be a reasonable substitute. Mr. Mernagh’s lay evidence was sufficient to show that he was not a recreational user and that his s. 7 right to security of the person was engaged.

However, it was not sufficient to show that he fit the medical criteria in the MMAR , and was therefore entitled to a physician’s declaration in support of an application for an exemption. [Footnote omitted.] [ 87 ] In light of the above comments and in the absence of more and better studies about the therapeutic value of strain efficacy, anecdotal evidence is a reasonable substitute in this case. This is because there is a concordance between the anecdotal evidence and objective scientific evidence that different strains have a greater percentage of the active ingredient THC.

The issue is not without controversy. [ 88 ] Dr. Pate, on behalf of the plaintiffs, stated that cannabis has a number of phenotypes (strains) that are created by breeding different varieties of the plant with each other. Different strains produce differing effects and levels of efficacy on the patient, depending on the individual and the medical condition. The differing effects and levels of efficacy are probably caused by varying amounts, ratios and synergistic effects of the therapeutically active compounds. [ 89 ] I accept Dr.

Baruch’s statement that Israel is recognized as perhaps the leading country in the world in terms of cannabis research. Dr. Baruch has had great success in managing to create strains of cannabis that are significantly potent (24 percent THC). The medicine is stable, which means that if the strain is said to have certain levels of CBD or THC, it in fact does.

The average supply in Israel affects a high quality product. [ 90 ] However, according to the evidence of Catherine Sandvos, legal counsel and the Deputy Manager of the Bureau of Medicinal Cannabis (BMC), part of the Netherlands Department of Health Division, it is the understanding of the BMC that patient preference for a particular variety is a matter of taste that is unrelated to efficacy. There are currently five varieties of dried marihuana with differing levels of THC and CBD available for medical use for patients in the Netherlands. [ 91 ] The defendant’s witness, Dr.

Kalant, agrees that different strains may have different chemical compositions, but is of the view that there is a lack of scientific research as to whether different strains have different effects for particular patients and illnesses. Dr. Kalant states that “it is not at all clear that the large number of so-called strains advertised on the internet are in fact distinct strains as defined botanically”. These advertisements are not accompanied by any evidence that they meet the criteria or that they have been analysed chemically for their contents of various cannabinoids.

The alleged medical efficacy of particular strains is not the result of clinical testing or scientific research but is instead “based either on subjective anecdotal reports or promotional advertising by producers”. Dr. Kalant states that there is no scientific evidence to support the anecdotal claims that certain strains are useful for certain medical conditions.

All that is known is that THC to CBD ratios result in different levels of psychoactivity. [ 92 ] Zachary Walsh—the plaintiffs’ expert on affordability and access—also commented on strains based on the result of his survey, stating: • A large proportion of the respondents reported that access to specific strains of cannabis was very important to their symptom relief; • Whether or not the empirical work will correspond with the patient reports remains to be seen, but patients consistently, across samples, report that a diversity of strains is important.

There is basic science showing different cannabinoid levels across different strains; • There is a scientific reason to believe that different strains would have different physiological effects and there are also “entourage effects”, referring to the concurrent effects of these diverse cannabinoids that vary across strains.

The treatment of survey evidence is discussed later. [93] The evidence is that the use of medical marihuana has both physical and psychological effects on patients. The relief given isinfluenced in part by the patient’s perspective and cannot be callously dismissed as something akin to a placebo. The lack of access todifferent strains does appear to have an adverse effect on some patients including some of the plaintiffs in this matter. B. Marihuana Cultivation [94] Remo Colasanti was the plaintiffs’ expert witness in cannabis cultivation.

He opined on how to produce cannabis indoors invarious ways in a residential area without interfering with neighbours’ rights in relation to odour, public safety, fire and electrical safetyand mould, and without risks to the producer and those around them. His evidence is given less weight than might otherwise be the casebecause he, like a number of “expert witnesses”, was so committed to one side of the debate, that the objectivity which this Court neededwas undermined.

However, his evidence assisted the Court in relation to the details of how the cannabis plant is cultivated and providedcontext for some of the concerns asserted by the defendant to justify the MMPR’s provisions. It also touched upon the prohibitionagainst “growing one’s own” marihuana. [95] Cannabis needs light, water and nutrients to survive and grow. It can be grown outdoors or indoors. Lighting and physical spaceare the primary determinants for overall yield in indoor cannabis production, not the number of plants.

Small amounts of cannabis can beproduced in small spaces such as closets, grow tents and growth chambers. [96] There are two primary stages in the plant’s life cycle: vegetative growth and flowering. Each stage is characterized by differingamount of light. The sun provides the light needed to grow outdoors and in greenhouses. For indoor production, different types of lightsare used including (

a) fluorescent, (

b) LED, and (

c) high intensity lights designed for indoor plant cultivation. [97] Colasanti testified that larger plants are less work and can produce the necessary amount of cannabis. He also opined that withthe right lighting and physical space, an individual could obtain the same yield from 6 plants as from 600. [98] He also gave evidence regarding the infamous (at least in this litigation) “Bloom Box”. The Bloom Box is an example of a self-contained hydroponic grow box that can be used to safely and inexpensively grow cannabis without odour and does not use excessiveamounts of power. It costs $3 300 plus tax.

I find the purpose of this evidence was to illustrate that marihuana can be cultivatedeffectively, safely and cheaply without massive investment or the measures necessary to address the hazards associated with largegrowing operations. [99] Dr. Thomas Baumann—the plaintiffs’ expert witness on horticulture—is a horticulturist and Professor of Agriculture at theUniversity of the Fraser Valley.

He provided an expert opinion with respect to general and specific issues or concerns involved in theproduction or cultivation of plants for food, enjoyment, health purposes, personal use or family use, and limitations thereon. [100] On cultivation, Dr. Baumann states that the technology and equipment that exists today enables a person to grow any plant eitheroutside (in soil or in greenhouses) or indoors, safely with respect to themselves and others, and without damage to the building orstructure in which production takes place.

Use of proper electrical connections, water management, environmental controls (humidityand temperature) and compliance with all laws and regulations is required no matter the kind of plant being produced. (The cost ofcultivation is discussed below in affordability and access.) C. Risk of Cultivation [101] The risk of cultivation of marihuana was a major plank in the defendant’s case that any interference with

section 7 rights was inaccordance with principles of fundamental justice or otherwise justified in a free and democratic society (section 1). The defendant canvassed the risks of cultivation through “expert” witnesses. By way of overview, it is necessary for the Court to providesome context for its consideration of social science and other “non-hard” science expert witnesses.

Many “expert” witnesses were soimbued with a belief for or against marihuana—almost a religious fervour—that the Court had to approach such evidence with asignificant degree of caution and scepticism. [102] It is important to recognize the standard necessary for admission of expert opinion evidence (Johnson v. Milton (Town), 2008ONCA 440, 91 O.R. (3d) 190, at paragraph 50): Courts must be vigilant to guard against such impermissible evidence.

It is trite law that expert witnesses should not give opinionevidence on matters for which they possess no special skill, knowledge or training, nor on matters that are commonplace, for which nospecial skill, knowledge or training is required. [103] In the leading case, R. v. Mohan, (SCC), [1994] 2 S.C.R. 9 (Mohan), the Supreme Court provided criteria on theadmission of expert evidence that advances a novel scientific theory.

Although the experts in the present trial did not advance a novelscientific theory, and the expert qualifications were not objected to during the course of the trial, it is still necessary to evaluate theirprobative value. Since Mohan, the courts have provided guidance on this evaluation. [104] An expert witness should provide independent assistance to the court and should not assume the role of an advocate (Alfano v.Piersanti, 2012 ONCA 297, 291 O.A.C. 62, at paragraphs 96–120).

An expert should state the facts or assumptions upon which his orher opinion is based and should not omit to consider material facts which weaken his or her opinion. In R. v. Abbey, 2009 ONCA 624, 97O.R. (3d) 330 (Abbey), the Ontario Court of Appeal provided the following guidance when assessing the opinion of an expert witness inthis context (at paragraphs 119 and 120): As with scientifically based opinion evidence, there is no closed list of the factors relevant to the reliability of an opinion like that offeredby Dr. Totten.

I would suggest, however, that the following are some questions that may be relevant to the reliability inquiry where anopinion like that offered by Dr. Totten is put forward:

* To what extent is the field in which the opinion is offered a recognized discipline, profession or area of specialized training? * To what extent is the work within that field subject to quality assurance measures and appropriate independent review by others in the field? * What are the particular expert’s qualifications within that discipline, profession or area of specialized training? * To the extent that the opinion rests on data accumulated through various means such as interviews, is the data accurately recorded, stored and available? * To what extent are the reasoning processes underlying the opinion and the methods used to gather the relevant information clearly explained by the witness and susceptible to critical examination by a jury? * To what extent has the expert arrived at his or her opinion using methodologies accepted by those working in the particular field in which the opinion is advanced? * To what extent do the accepted methodologies promote and enhance the reliability of the information gathered and relied on by the expert? * To what extent has the witness, in advancing the opinion, honoured the boundaries and limits of the discipline from which his or her expertise arises? * To what extent is the proffered opinion based on data and other information gathered independently of the specific case or, more broadly, the litigation process?

The significance of testing the expert's methodologies against those accepted in the field was highlighted in Kumho Tire Co. at p. 152: The objective of that requirement [the gatekeeper function] is to ensure the reliability and relevancy of expert testimony.

It is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigour that characterizes the practice of an expert in the relevant field. [Emphasis added.] [ 105 ] The Supreme Court most recently applied the Abbey framework and extensively commented on expert opinion evidence in White Burgess Langille Inman v. Abbott and Haliburton Co. , 2015 SCC 23 , [2015] 2 S.C.R. 182 (at paragraphs 22–24 ): Abbey (ONCA) introduced helpful analytical clarity by dividing the inquiry into two steps.

With minor adjustments, I would adopt that approach. At the first step, the proponent of the evidence must establish the threshold requirements of admissibility. These are the four Mohan factors (relevance, necessity, absence of an exclusionary rule and a properly qualified expert) and in addition, in the case of an opinion based on novel or contested science or science used for a novel purpose, the reliability of the underlying science for that purpose: J.-L.J. , at paras. 33, 35-36 and 47 ; Trochym , at para. 27; Lederman, Bryant and Fuerst, at pp. 788-89 and 800-801.

Relevance at this threshold stage refers to logical relevance: Abbey (ONCA), at para. 82; J.-L.J. , at para. 47 . Evidence that does not meet these threshold requirements should be excluded. Note that I would retain necessity as a threshold requirement: D.D. , at para. 57; see D. M. Paciocco and L. Stuesser, The Law of Evidence (7th ed. 2015), at pp. 209-10; R. v. Boswell , 2011 ONCA 283 , 85 C.R. (6th) 290, at para. 13 ; R. v. C. (M.) , 2014 ONCA 611 , 13 C.R. (7th) 396, at para. 72 .

At the second discretionary gatekeeping step, the judge balances the potential risks and benefits of admitting the evidence in order to decide whether the potential benefits justify the risks. The required balancing exercise has been described in various ways. In Mohan , Sopinka J. spoke of the “reliability versus effect factor” (p. 21), while in J.-L.J. , Binnie J. spoke about “relevance, reliability and necessity” being “measured against the counterweights of consumption of time, prejudice and confusion”: para. 47.

Doherty J.A. summed it up well in Abbey , stating that the “trial judge must decide whether expert evidence that meets the preconditions to admissibility is sufficiently beneficial to the trial process to warrant its admission despite the potential harm to the trial process that may flow from the admission of the expert evidence”: para. 76. [ 106 ] The Court went on to discuss the nature of an expert’s duty to the court and where it fits into the framework (at paragraphs 27 and 32): One influential statement of the elements of this duty are found in the English case National Justice Compania Naviera S.A. v.

Prudential Assurance Co. , [1993] 2 Lloyd’s Rep. 68 (Q.B.) . Following an 87-day trial, Cresswell J. believed that a misunderstanding of the duties and responsibilities of expert witnesses contributed to the length of the trial. He listed in obiter dictum duties and responsibilities of experts, the first two of which have particularly influenced the development of Canadian law: 1. Expert evidence presented to the Court should be, and should be seen to be, the independent product of the expert uninfluenced as to form or content by the exigencies of litigation …. 2.

An expert witness should provide independent assistance to the Court by way of objective unbiased opinion in relation to matters within his [or her] expertise . . . . An expert witness in the High Court should never assume the role of an advocate. [Emphasis added; citation omitted; p. 81.] (These duties were endorsed on appeal: [1995] 1 Lloyd’s Rep. 455 (C.A.), at p. 496 .) … Underlying the various formulations of the duty are three related concepts: impartiality, independence and absence of bias.

The expert’s opinion must be impartial in the sense that it reflects an objective assessment of the questions at hand. It must be independent in the

sense that it is the product of the expert’s independent judgment, uninfluenced by who has retained him or her or the outcome of the litigation. It must be unbiased in the sense that it does not unfairly favour one party’s position over another. The acid test is whether the expert’s opinion would not change regardless of which party retained him or her: P. Michell and R. Mandhane, “The Uncertain Duty of the Expert Witness” (2005), 42 Alta. L. Rev. 635, at pp. 638-39. These concepts, of course, must be applied to the realities of adversary litigation.

Experts are generally retained, instructed and paid by one of the adversaries. These facts alone do not undermine the expert’s independence, impartiality and freedom from bias. As to admissibility or weight, the following comments were provided (at paragraphs 45 and 54): Following what I take to be the dominant view in the Canadian cases, I would hold that an expert’s lack of independence and impartiality goes to the admissibility of the evidence in addition to being considered in relation to the weight to be given to the evidence if admitted.

That approach seems to me to be more in line with the basic structure of our law relating to expert evidence and with the importance our jurisprudence has attached to the gatekeeping role of trial judges. Binnie J. summed up the Canadian approach well in J.-L.J. : “The admissibility of the expert evidence should be scrutinized at the time it is proffered, and not allowed too easy an entry on the basis

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