FACTUM OWEN EDWARD SMITH, RESPONDENT (Pursuant to Rule 42)

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1 FILE NO IN THE SUPREME COURT OF CANADA (ON APPEAL FROM THE COURT OF APPEAL OF BRITISH COLUMBIA) BETWEEN: HER MAJESTY THE QUEEN - and- APPELLANT (Appellant) OWEN EDWARD SMITH -and' RESPONDENT (Respondent) SANTE CANNABIS, CRIMINAL LAWYERS' ASSOCIATION (ONTARIO), CANADIAN CIVIL LIBERTIES ASSOCIATION, BRITISH COLUMBIA CIVIL LIBERTIES ASSOCIATION, and CANADIAN AIDS SOCIETY, CANADIAN HIV/AIDS LEGAL NETWORK AND HIV & AIDS LEGAL CLINIC ONTARIO INTERVENERS FACTUM OWEN EDWARD SMITH, RESPONDENT (Pursuant to Rule 42) Tousaw Law Corporation 4768 Fairbridge Drive Duncan, Be V9L 7N8 Kirk 1. Tousaw John W. Conroy, Q.C. Tel: Fax: kirktousaw@gmailcom Counsel for the Respondent, Owen Edward Smith Gowling Lafleur Henderson LLP Elgin Street Ottawa ON KIP lc3 Jeffrey W. Beedell Tel: Fax: jeff.beedell@gowling.com Ottawa agent for the Respondent Owen Edward Smith

2 Public Prosecution Service Canada British Columbia Regional Office Howe Street Vancouver, BC V6Z 2S9 W. Paul Riley, Q.C., Kevin Wilson Tel: Fax: Counsel for the appellant Her Majesty the Queen Grey Casgrain 1155 Rene-Levesque Ouest, Suite 1715 Montreal, QC H3B 2K8 Julius H. Grey Tel: Fax: Counsel for the Intervener Sante Cannabis Ruby Shiller Chan Hasan 11 Prince Arthur Avenue Toronto, ON M5R 1B2 Nader R. Hasen Gerald Chan Tel: Fax: gcj Counsel for the Intervener Criminal Lawyers' Association (Ontario) Paliare Roland Rosenberg Rothstein LLP 155 Wellington Street, W. 35 th Floor Toronto, ON M5V 3H1 Andre K Lokan Tel: Fax: Andrew.lokan@paliareroland.com Counsel for the Intervener Canada Civil Liberties Association Brian Saunders, Q.C. Director of Public Prosecutions 160 Elgin Street, 12th Floor Ottawa, ON KIA OH8 Francois Lacasse Tel: Fax: flacasse@ppsc-sppc.gc.ca Ottawa agent for the appellant Her Majesty the Queen Gowling Lafleur Henderson LLP Elgin Street Ottawa ON KIP 1C3 Guy Regimbald Tel: Fax: guy.regimbald@gowlings.com Ottawa agent for the Intervener Sante Cannabis Gowling Lafleur Henderson LLP Elgin Street Ottawa ON KIP 1C3 Guy Regimbald Tel= Fax: guy.regimbald@gowlings.com Ottawa agent for the Intervener Criminal Lawyers' Association (Ontario) Gowling Lafleur Henderson LLP Elgin Street Ottawa ON KIP 1C3 D. Lynne Watt Tel: Fax: lynne.watt@gowlings.com Ottawa agent for the Intervener Canadian Civil Liberties Association

3 Gratl & Company West Hastings Street Vancouver, Be V6B 1L8 Jason B. Gratl Tel: 604'694'1919 Fax: 604'608' Counsel for the Intervener British Columbia Civil Liberties Association Burstein Bryant Barristers 6 Adelaide Street, E. 5 th Floor Toronto, ON M5C 1H6 Gowling Lafleur Henderson LLP Elgin Street Ottawa ON KIP 1C3 D. Lynne Watt Tel: Fax: lynne.watt@gowlings.com Ottawa agent for the Intervener British Columbia Civil Liberties Association Supreme Advocacy LLP Gilmour Street Ottawa, ON K2P OR3 Paul K. Burstein Ryan Peck Richard Elliott Tel: 416' Fax: pburstein@bursteinbryant.com Marie-France Major Tel: 613' Fax: mfmajor@supremeadvocacy.ca Ottawa Agents for Canadian AIDS Counsel for the Intervener Canadian AIDS Society, Society et al. Canadian HIV/AIDS Legal Netowrk and HIV & AIDS Legal Clinic Ontario

4 1 TABLE OF CONTENTS PART I. O\TERVIEW AND FACTS... 1 Overview... 1 The Lay Evidence... 2 The Crown Witness... 8 Respondent's Expert Evidence... 9 The Appellant's Expert Evidence Legislative Provisions Prior Decisions A. British Columbia Supreme Court (2012 BCSC 544) B. British Columbia Court of Appeal (2014 BCCA 322) PART II. ISSUES PART III. ARGUMENT... ' A. Standing B. The Section 7 Violations Liberty and Security of the Person Violations " The Rights Infringements Violate the Principles of Fundamental Justice The Object of the Restriction The Restriction Does Not Accord with the Principles of Fundamental Justice The Restriction is Arbitrary...,,;, The Restriction is Overbroad The Harms Caused are Grossly Disproportionate to any Benefits The Restriction is Arbitrary, Overbroad and Grossly

5 11 Disproportionate..., The Infringements are Not Justified Under s.l of the Charter PART IV. COSTS PARTV. ORDER SOUGHT PART VI. TABLE OF AUTHORITIES...41 PART VII. STATUTORY PROVISIONS...42

6 1 PART!. OVERVIEW AND FACTS OVERVIEW 1. The possession, distribution and production of cannabis, including all of its constituent components, is criminally prohibited. The MMARs provide, for those able to qualify, a limited medical exemption to the prohibition. That limited exemption applies to patients having the support of a physician and/or specialist and, in some circumstances, the patient's designated producer. 2. The exemption created by the MMARs applies only to cannabis plants and to dried marihuana. 3. The therapeutically active compounds in cannabis are found on trichomes; these are resin glands that grow primarily on the flowers of the female plant. The plant matter itself is inert and has no medical utility. 4. The trichomes can be removed from the plant matter in various ways. They can simply be shaken loose from the dried flowers. They can be extracted into alcohol or into fats such as olive oil or butter by soaking the dried flowers in the fat or alcohol and then removing the inert plant material. 5. Once extracted, the trichomes can be ingested in various ways. They can be put into capsules or cooked into foods and ingested orally. Lotions or balms can be made and applied topically. An alcohol extract can be taken as a tincture or a spray. 6. Orally ingesting the compounds is more effective than smoking dried marihuana for a variety of conditions and/or symptoms. Oral ingestion provides a slower onset of action and a longer period of therapeutic activity than inhalation. Inhalation gives nearly immediate effect but rapidly wears off. Oral ingestion does not require constant dosing/smoking to maintain therapeutic effect.

7 2 7. Topical administration provides therapeutic application directly to the site of pathogenicity but low levels of systemic absorption of the compounds and, as a result, does not produce any psychoactivity. 8. Smoking is the most harmful mode of ingesting cannabis. Most of the harms associated with consuming cannabis are a result of smoking, not consumption of the therapeutically active compounds themselves. 9. A patient qualifying for the MMARs exemption can lawfully produce plants, harvest them and then possess the dried marihuana, typically in the form of the flowers (or buds) of the female plants. The patient is not permitted to extract the trichomes from those flowers in any way. Doing so constitutes production and possession of cannabis resin and/or the various compounds and is a criminal offence punishable by severe deprivations of liberty. 10. Effectively, then, the MMARs constrain the ability of the patient to choose modes of ingesting cannabis other than smoking and vaporizing the dried plant matter. Thus, patients are forced under threat of criminal sanction into more harmful and less effective ways of consuming the therapeutically active compounds. THE LAy EVIDENCE 11. Constable Brewster of the Victoria Police Department testified to his attendance at 865 View Street, Apartment 204 in the City of Victoria on December 3, 2009 and the exhibits seized from that location. He provided the Court with a book of photographs depicting the scene (Exhibit 2) and the various products being produced there including medicinal cookies, topical oils and gel capsules filled with oil-based cannabis extracts.] 12. Mr. Ted Smith (no relation to Respondent Owen Smith) employed Respondent to make medicinal cannabis products for the CBCC, an entity that exists to provide 1 Admissions, Appellant's Record ("AR"), Part III, v.l, p.12-13

8 3 its members, all of whom suffer from a permanent physical disease or disability, with access to a supply of dried cannabis and cannabis-based products Prospective members demonstrate their eligibility for membership primarily by bringing in confirmation of their condition from their physician New members of the organization are given a 45-minute to one-hour orientation session. They are provided with information about the CBCC's rules, given a list of the medical cannabis products sold by the organization and advised that they should refrain from operating heavy machinery or driving while consuming the medications. Members are told that some strains of cannabis can increase heart rate and therefore persons with heart issues should pay attention to that possibility.4 With respect to the orally-ingested products, new members are advised to begin with very small doses and to gradually, over time, work their way up to a dose that provides adequate symptom relief without, or with minimal, side effects (a process known as "self-titration'') New members of the CBCC are also provided with information about Health Canada's MlMAR program and are encouraged to attempt to gain access to the legal protections afforded by the MMAR. Upon request they are given copies of application forms and the CBCC provides assistance with filling out those forms.6 The CBCC provides this service because a primary purpose of the organization is to protect vulnerable sick people from the criminallaw. 7 2 AR Part III, v.1, pa3, 27-36; p.44, 35 p.45, 18 3 AR Part III, v.1, p.45, 34-p.46, 1-8. In certain instances, membership can be granted to persons demonstrating their permanent physical disease or disability by other means including copies of their medical records or, rarely, a prescription issued to them for the treatment of a recognized qualifying condition (eg, prescription drugs used in the treatment of HIV/AIDS). AR Part III, v.l, p. 146, 29- p.147,4 4 AR Part III, v.1, p.46, 13-43; p.48, 13-24; AR Part III, v.2, p.6, AR Part III, v.2, p.124, AR Part III, v.1, p.48, 32-p.49, 3; p.145, 34-p.146, 4 7 AR Part III, v.1, p.145, 16-28

9 4 16. Ms. Gayle Quin testified to her personal use of medicinal cannabis and cannabis-based medicines, her personal medical conditions, her lay training in herbalism and her role in developing cannabis-based medical products for the CBCC and in dialoguing with its members about their experiences with the products. 17. Ms. Quin suffers from a range of serious medical conditions including chronic pam ansmg from injuries suffered in an automobile accident as a teenager, Hepatitis C, chronic fatigue syndrome, fibromyalgia and breast cancer. Her symptoms include chronic pain, fatigue, nausea, lack of appetite and insomnia. She provided a number of medical documents supporting her testimony on these points Ms. Quin holds an Authorization to Possess Dried Marihuana issued by Health Canada. She obtained that Authorization in 2011, after being diagnosed with breast cancer. Her successful application came only after many unsuccessful attempts, over a period of years, to convince various treating physicians to provide her with access to the legal protections of the M1\dARprogram She has essentially consumed cannabis, and cannabis products, to treat her conditions and the serious symptoms arising from those conditions since she was a teenager. She consumes cannabis by inhalation, orally and topically. She produced her own cannabis for a time and also produced her own cannabis-based oral medicines by extracting the active ingredients into olive oil (having previously attempted, unsuccessfully, to simply add dried leaf to batter).lo 20. Ms. Quin is a former long-term care aide, a self-taught herbalist and is responsible for developing and/or refining many of the CBCC's cannabis-based medicines.ll She trained Respondent Owen Smith in how to produce the various products offered by the CBCC. Ms. Quin, along with Mr. Ted Smith, authored the CBCC's Medicinal Cannabis Recipe Book. She also regularly consults with the S AR Part IV, v.1, p AR Part III, v.2, p.10s, and AR Part III, v.2, p.125, AR Part III, v.2, p.96, 25; p.97, 2S; p.99, 34; p.100, 4

10 5 members of the organization, providing information and advice about the CBCC's products, proper usage and taking feedback from the members related to the efficacy of the products for their particular symptoms and conditions.1 2 One piece of information she imparts to members planning to consume orally-ingested products is the need to self-titrate the dosage to avoid accidentally ingesting too much. 21. Ms. Gina Herman is a member of the CBCC. She testified to her personal medical history. Ms. Herman suffers from chronic pain, anxiety, insomnia and inflammation_ Her medical issues began in 2001 after suffering a workplace injury. She provided documents related to her medical condition and treatments Ms. Herman tes~ified to her history with prescription pharmaceuticals and the significant negative side effects she suffered as a result of consuming those drugs. These side effects included an inability to focus, mental fuzziness, social withdrawal and an inability to meaningfully participate in her family life. This caused her significant anxiety and depression as well as damaging her relationship with her husband and children. In her words, she went from an active wife and mother who enjoyed a variety of activities (camping, soccer, swimming) with her husband and children to having life as she and her family knew it stop, causing her to lose eight years of her life Ms. Herman began to consume cannabis and cannabis-based medicines with the full knowledge and support of her treating physician Dr. Sayad after moving from Ontario to British Columbia. She was able to significantly reduce her intake of pharmaceutical painkillers and anti-inflammatory drugs and, as a consequence, to minimize the serious negative side effects she had been experiencing without compromising her overall health. 12 AR Part III, v.2, p.98, 44, p.99, AR Part IV, v.2, pp AR Part III, v.3, p.13l, 31-p.132, 35

11 6 24. She consumes primarily cannabis-based cookies obtained from the CBCC. She also consumes the "Ryanol" gel capsules and uses the topical products including the massage oils and the Cannapatch. 15 Ms. Herman also consumes cannabis by inhalation (using a vaporizer) though it is not her preferred mode of ingestion. Ms. Herman has taken each product she obtains from the CBCC to her treating physician and has discussed the use of each with him. 25. She has not suffered any negative side effects from any of the products she obtains from the CBCC To the contrary, she testified that the use of the CBCC products has given her back her life and that she has been able to begin to rebuild the damaged relationships with her husband and children and to become more active in her daily life and social activities As a result of seeing the improvement in her life and her reduction in the intake of pharmaceuticals, Ms. Herman's treating physician completed the MMAR forms necessary for her to apply for an Authorization to Possess Dried Marihuana in December 2010, selecting "oral" as the method of ingestion Ms. Sandra Large testified to her serious medical conditions, the prescription drugs she takes and took to deal with those conditions and her use of cannabis and cannabis products obtained from the CBCC. 29. Ms. Large suffers from bone and joint problems along the entire left side of her body because of a motorcycle accident she had in She experiences chronic pain and is mobility impaired. In addition, she suffers from digestive problems due to damage to her digestive system from the accident. In 1995 she had a stroke that caused her nerve damage. She also suffers from migraine headaches, arthritis, 15 AR Part III, v.3, p.139, 19,21 16 AR Part III, v.3, p.140, AR Part III, v.3, p.140, 12-13; p.141, 1-S 18 AR Part IV, v.2, p.97

12 7 fibromyalgia, epilepsy and congenital heart failure. Her headaches are severe to the point of near blindness. Her epilepsy has caused her to have grand mal seizures. Finally, her heart issues have caused her to have a heart attack Ms. Large has been put through the gamut of prescription drugs and, in particular, narcotic painkillers such as morphine and cortisone, a steroidal antiinflammatory that she took by injection for a period of time. She also takes a prescription anti-seizure medication to combat her epileptic symptoms. 31. She testified that as a result of consuming medical cannabis and cannabis products obtained from the CBCC commencing in 2003, she has reduced her intake of opiate-based painkillers (to which she had become addicted) and the side effects associated with those drugs.2o She has also reduced her intake of Carbamazepine, a prescription anti-seizure drug that caused her unwanted side effects She finds cannabis based medicines such as the "Buddha Balls"22 meant for oral ingestion, the topical massage oils and the Cannapatch to be effective at reducing her pain, combatting her migraine headaches and reducing the frequency of her seizures with little or no side effects.23 She credits the ingestion of cannabis in the form oflozenges with assisting in the non-surgical resolution of a blockage in her lower intestine.24 Ms. Large has not experienced any significant negative consequences from her medicinal cannabis use. 33. Ms. Large's physician, Dr. Lenser, is aware of her consumption of cannabis based medicines but has not been willing to assist her in obtaining access to the legal protections of the NlMAR scheme AR Part III, v.3, pp AR Part III, v.3, p. 93, AR Part III, v.3, p.102, 39-p. 103, 3 22 AR Part III, v.1, p.105, 45-p.106, AR Part III, v.3, p.94, 26-44; p. 107, 43-p.108, 1 24 AR Part III, v.3, p.93, 47-p.98, AR Part III, v.3, p.99, 38'40

13 8 34. Ms. Ruth Arthurs testified that she suffers from chronic pain arising from a serious automobile accident including head trauma. She joined the CBCC and primarily consumes the Buddha Balls and Ryanol gel capsules, though she also inhales dried cannabis on occasion. She had not experienced any negative side effects from the use of the products obtained from the CBCC.26 THE CROWN WITNESS 35. Mr. Eric Ormsby, an employee of Health Canada, was called by the Crown. His evidence consisted primarily of explaining the process by which traditional drug products are brought to market in Canada and the government's rationale for that process. Mr. Ormby was qualified as an expert but offered little opinion evidence. 36. Mr. Ormsby conceded that the pharmaceutical drug approval process IS typically, though not exclusively, applied to single compound drugs. He admits further that dried cannabis produced either pursuant to the MMAR or under contract with Her Majesty was specifically exempted from the Food and Drugs Act by the government of Canada Mr. Ormsby also conceded that the Natural Health Product Regulation, promulgated pursuant to the Food and Drugs Act, is a comprehensive regulatory scheme designed to ensure the safety and quality control of natural health products and to govern their production, marketing and distribution in Canada and that this scheme would apply to cannabis and cannabis"based medicines if the NHP Regulation did not specifically exempt from its ambit all substances scheduled in the CDSA Mr. Ormsby agreed that a product obtaining approval for marketing and distribution in Canada pursuant to the Food and Drugs Act was not a guarantee of safety. Products that demonstrate safety and efficacy in clinical trials can 26 AR Part III, v.3, p.168, 39-p.169, 8 27 AR Part III, v.5, p.50, 31"41 28 AR Part III, v.5, p.63, 24 p.64, 1

14 9 sometimes produce very different, and dangerous, effects when released into the general population and some products obtaining FDA approval have later been linked to serious side effects up to and including large numbers of deaths Finally, Mr. Ormsby acknowledged that both the Food and Drugs Act and the Natural Health Product Regulation contain offence sections permitting prosecutions of individuals alleged to be in violation of the legislative scheme. 30 RESPONDENTS EXPERT EVIDENCE 40. Dr. David Pate was qualified as an expert in pharmacology and botany. He submitted an affidavit setting out his opinions and the facts upon which they are based He described the botany of the cannabis plant and explained that the medicinal compounds are located in resin glands produced on the plant surface. 32 The compounds include cannabinoids (THC and CBD being the most prevalent) and terpenes. 33 The plant matter itself has no medicinal value and consuming it, particularly by way of smoking, can produce negative health effects ranging from mild to serious Dr. Pate explained the varlous methods of extracting the therapeutically active compounds from the plant matter; this included the method of extracting into cooking oil use by Mr. Smith Dr. Pate also testified to certain principles of pharmacology. In particular, he opined that direct application of the medicinal compounds to the site of 29 AR Part III, v.5, p.60, AR Part III, v.5, p.65, 15-19; p.62, AR Part IV, v.2, p.1 32 AR Part III, v.2, p.144, 28-35; p.145, 31 p.146,46; p.148, 3 p.149, L p.164, 9-12; AR Part III, v.3, p.5, AR Part III, v.2, p.149, 2-29; p.150, 47-p.152, AR Part III, v.2, p152, 22-43; p.162, 21'31; p.l72, 10-p.173, 15; AR Part III, v.3, p.3, 30-p.4, 10; p.39, AR Part III, v.2, p.162, 38 p.163, 10; p.164, 13 p.166, 18; p.168, 25-45

15 10 pathogenicity was a standard practice, not just with cannabis"based medicines but with all medicines. This is the case because direct application can, in appropriate circumstances, provide the therapeutic benefits sought by the patient with less intake of the substance than necessary for systemic application. The end result is greater efficacy with reduced levels of unwanted side effects Dr. Pate testifed that cannabis and cannabis-based medicines are quite safe with no possibility oflethal overdose. 37 He underscored the importance of titration of dose, a principle of pharmacology not exclusive to medicinal cannabis products. 38 Titration is of particular importance when taking medicines orally because that mode of ingestion requires longer before experiencing the effects Because of the high safety profile of cannabis medicines, however, Dr. Pate testified that the negative consequences of an overdose - even of orally ingested cannabis products - were transient and relatively mild. This is in contrast to many prescription and some over-the-counter pharmaceutical medicines that can and do cause lethal overdoses. 4o 46. Dr. Pate explained that oral ingestion could be preferable because, in addition to direct application, oral ingestion results in longer systemic loads with a more stable plateau of the active ingredients. By contrast, smoking results in a rapid spike in the systemic load - potentially to levels much higher than required for therapeutic effect - followed by rapid decreases. According to Dr. Pate, inhalation is preferred for treating acute conditions requiring quick action whereas oral ingestion would be preferred for chronic conditions particularly where symptom relief over longer periods of time (eg, while sleeping) is desired AR Part III, v.2, p.170,12-p.171, 5; p.175, 7-15; p.179, 23-38; p.182, 6-23; AR Part III, v.3, pa, 32-45; p.62, AR Part III, v.2, p.180, 28-p.181, 3; p.188, 33-39; p.189, 24" AR Part III, v.2, p.160, 31-p.161, AR Part III, v.2, p.181, AR Part III, v.2, p.182, 24-p.183, See Pate Affidavit, paras. 30'34; AR Part III, v.2, p.176,47-p.178, 43; AR Part III, v.3, p.4, 11-31

16 11 THE APPELLANTS EXPERT EVIDENCE 47. Dr. Abramovici, an employee of Health Canada having no pre-employment experience, either in the academic or laboratory setting, with cannabis or cannabisbased medicines, testified as Appellant's expert Dr. Abramovici's sole expertise with cannabis comes as a result of a literature review conducted at the direction of his employer in connection with his work to update the government's document "Information for Health Care Professionals" (Exhibit 40, Tab G) When asked about input into his expert report by other Health Canada officials Dr. Abramovici admitted that the entire "Conclusions" section of his sworn affidavit was actually written by his superior at Health Canada Suzanne Dejardin Dr. Abramovici conceded that the dried plant matter itself had no medicinal value. 45 He conceded that smoking the dried cannabis created health risks that did not exist with oral or topical modes of ingestion. 46 He further conceded that the concept of applying medicine to the site of pathology was a general principle of drug delivery In terms of the risks of consuming cannabinoids, Dr. Abramovici conceded that apart from the issue of known dosages and potential risks unrelated to the nonmedicinal compounds themselves, the risks of conventional cannabis-based drug products Sativex and Marinol were similar to the products sold by the CBCC.48 He conceded that these risks were within the range generally accepted for medicines 42 AR Part III, v.4, p.9, 20-24; p.20, 39-p.21, 7; p.22, AR Part III, v.4, p.23, 26-p.27, 32; p.33, 44-p.34, 22; p. 36, AR Part III, v.4, p_39, 15-p.41, AR Part III, v.4, p.70, 12-36; p_74, 11-46; p.76, 7-28; p.114, 13-32; p.116, AR Part III, v.4, p.s1, 19-25; p.93, 35-p.95, 1; p. 110, 24-p.111, 3; 121, 19-p.122, 12; p.174, 45-p.175, 36; p.177, 12-28; AR Part III, v.5, p.17, AR Part III, va, p.80, 36-p.81, 3; p.140, 44-p.141, AR Part III, v.4, p.8s, 4-40; p. 95, 26-43; AR Part III, v.5, p.16, 43-p.17, 17

17 12 and that cannabis and cannabis products were as safe or safer than many prescription drugs and some over-the-counter drugs Dr. Abramovici's Information for Health Care Practitioners document sets out Health Canada's position on certain key points and corroborates the scientific and medical evidence of Dr. Pate and the patient witnesses: a. Inhalation by smoking can pose serious risk to health akin to, or greater than, risks associated with smoking tobacco (sections 1.2 and 8.2); b. CBD has anti-inflammatory, analgesic, antipsycotic, anti-ischemic, anxiolytic, and antiepileptic effects and may have potential therapeutic application for a host of serious conditions (section 2.1); c. Smoked cannabis results in rapidly absorbed and very variable levels of THC, and smokers often titrate dosage (sections , and 3.1); d. Oral ingestion of THC occurs by ingesting foods containing cannabis such as butters, oils, brownies, cookies, teas or capsules containing THC and topical administration can include compresses, creams and ointments (sections and 3.0); e. Oral ingestion can have a slower onset of effect but produces longerlasting effect than inhalation (sections , and 3.2); f. Orally administered cannabinoids are well-tolerated and, at least for use of extracts to treat MS like symptoms, clinical trials do not indicate serious adverse effects (section 4.3.1); g. Topical administration results in some systemic absorption of THC but in quantities significantly lower than either inhaled or orally ingested cannabis (section ); h. Cannabinoids are efficacious, or at least demonstrate potential efficacy in laboratory, animal and pre-clinical studies, for a variety of symptoms and conditions (section 4.0) AR Part III, v.4, p.97, 34-p.99, 6; p145, 25-p.146, 1; p.166, 6-29; p.179, 30-p,lS0, 4; AR Part III, v.5, p.ll, 1l p.12, 7 50 AR Part IV, v.3, p.66

18 13 LEGISLATIVE PROVISIONS 53. Section 7 of the Charter guarantees that "[e]veryone 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." Sections 4, 5 and 7 of the ControJIed Drugs and Substances Act criminally prohibit the possession, distribution and production of all Schedule II substances that include cannabis, its preparations, derivatives and similar synthetic preparations including: cannabis reslll,cannabis (marihuana), tetrahydrocannabinol (THC), cannabidiol (CDB) and a host of other cannabinoids found in the plant The Marihuana Medical Access Regulations were intended to provide a viable constitutional exemption from these CnSA prohibitions to ensure a reasonable continuous supply for medially approved patients However, that exemption applied only or was limited to only "dried marihuana" ("harvested marihuana that has been subjected to any drying process") and to marihuana plants in the production phase. "Marihuana" in the MMARs means "the substance referred to as 'cannabis (marihuana)' in subitem 1(2)" of Sched ule II to the CDSA Pursuant to the MMARs: a. patients able to qualify by virtue of having physician andlor specialist support for their medical use can obtain an Authorization to Possess (ATP) dried marihuana (this is an exemption from s. 4 of the CDSA); b. patients who also plan to produce marihuana plants to turn into dried marihuana for their own medical use can obtain a Personal-use 51 Canadian Charter of Rights and Freedoms, Part 1 of the Constitution Act, 1982, being Schedule B to the Canada Act 1982 (UK), 1982, c Controlled Drugs and Substances Act, SC 1996, c.19, ss. 4, 5, 7 and Schedule II (CDsA) 53 Manhuana Medical Access Regulations, SOR/ , as amended (MMARs) 54 MM4Rs, supra, s. 1(1)

19 14 Production License (PuPL) (this IS an exemption from s. 7 of -the CDSA); c. designated producers (persons specifically designated by a patient) can obtain a Designated-Person Production License (DPPL) permitting them to grow marihuana plants and to supply dried marihuana to a maximum of two patients and to charge for their services in doing so (this is an exemption from ss. 5 and 7 of the CDSA) In order to obtain an ATP (and thus obtain an associated PuPL or DPPL) a patient's physician had to confirm, in writing: a. The patient's medical condition and symptoms; b. The form and route of administration the patient intends to use; c. That conventional treatments have been tried or considered and found to be ineffective or medically inappropriate; d. That the medical practitioner is aware that no Notice of Compliance under the FDR has been issued concerning the safety and effectiveness of cannabis; e. And, for Category 2 conditions, that a specialist has been consulted and concurs that conventional treatments are ineffective or medically inappropriate The MMARs were available to any person ordinarily resident in Canada and applied to any medical condition, though conditions other than those in Category 1 required additional specialist support. Category 1 conditions were cancer, HIV/AIDS, multiple sclerosis, spinal cord injury/disease, epilepsy and severe arthritis The MMARs did not provide any exemption to the general prohibition on producing, distributing and possessing any Schedule II substance other than plants and "dried marihuana." 55 MMARs, supra, ss. 2, 24, MMARs, supra, s MMARs, supra, Schedule

20 The other legislative and regulatory provisions cited by Appellant are not relevant to the s. 7 analysis and are only relevant to the s. 1 analysis to the extent that they demonstrate that the government has other less intrusive means at its disposal than the CDSA criminal law power. In the words of the BCCA majority, those legislative provisions are "red herrings" as they relate to the s. 7 issues to be decided in this Court. PRIOR DECISIONS BRITISH COLUM:BIA SUPREME COURT (2012 BCSC 544) 62. After a lengthy voir di,re, Mr. Justice Johnston found that the JIiIMAR restriction to dried marihuana infringed the s. 7 rights of medical cannabis patients in a manner that neither complied with the principles of fundamental justice nor was justified pursuant to section 1. He found the restriction arbitrary and, due to that finding, declined to address other principles of fundamental justice. 63. In the result, by way of remedy he deleted the word "dried" from the MMARs and read in a definition of "marihuana" that included all Schedule II substances. He suspended his remedy for one year as it related to persons with DPPLs but declined to suspend the remedy as it related to persons with ATPs (and corresponding PuPLs) because he was unwilling to allow patients to have their s. 7 rights violated by the impugned restriction during the suspension period. 64. Appellant then declined to call evidence at Mr. Smith's trial and Mr. Smith was acquitted. 65. The Appellant did not respond legislatively within one year, instead seeking a further suspension. Mr. Justice Johnston declined to extend the suspension.

21 16 BRITISH COLUMBIA COURT OF APPEAL (2014 BCCA 322) 66. Madam Justice Garson, writing for the 2-1 majority, upheld Mr. Justice Johnston's decision. The majority found that the impugned restriction did not comport with s. 7 because it was arbitrary. While disagreeing with some of the application judge's reasoning, the majority determined that the evidence in the record was sufficient to demonstrate the arbitrariness of the impugned restriction. 67. The majority disagreed with the remedy imposed below and, instead, declared the restriction to be invalid, suspending any Order for one year in order to allow Appellant time to respond legislatively. PART II. ISSUES 68. The Court stated the following constitutional questions: (1) Do the MMARs infringe s. 7 of the Charter, insofar as they only allow for access to "dried marihuana" and (2) if so, is the infringement a reasonable limit prescribed by law as can be demonstrably justified in a free and democratic society under s. 1 of the Charter? PART III. ARGUMENT A. STANDING 69. Mr. Smith has standing to challenge the CDSA as modified by the M1kL4Rs on two grounds. First, he may challenge the law based upon his right not to be convicted pursuant to an unconstitutional legislative scheme Second, the issue before the Court is serious and justiciable and permitting Mr. Smith to advance the arguments he makes is a reasonable and effective means of putting those arguments before the courts, particularly as the matter has now 58 R v. Big M Drug Mart, [1985] 1 S.C.R. 295; Canadian Egg Marketing Agency v. Richardson [1998] 3 S.C.R. 157; R v. Morgentaler, [1988] 1 S.C.R. 30.

22 17. reached this Court for decision. He therefore meets the test for public interest standing Appellant urges this Court to deny Mr. Smith standing because he made no effort to comply with the MlIJARs. 72. This ignores that he could not comply with the MlIJARs because the MlVlARs did not allow for the production and distribution of anything other than "dried marihuana." 73. Appellant also suggests that: "quite apart from the restriction in the MlVlAR regime to dried marihuana alone, Mr. Smith would never have been in a position to legally produce and distribute the substance."go 74. This is legally incorrect. Had the MMARs permitted other cannabis medicines, Mr. Smith could have obtained a DPPL allowing him to legally produce and distribute those medicines to two patients. 75. Mr. Smith was not charged with an MMAR violation. He was charged with violating the CDSA. His pre-trial application challenged the CDSA provision under which he was charged. His liberty was at stake and he had standing to make his arguments. 76. Appellant's standing argument invites this Court to revisit and fundamentally alter two basic tenets of Charter jurisprudence: if a law is invalid as to anyone person, it is invalid as to all persons and no person should be convicted of violating an unconstitutionallaw This Court should decline that invitation. 59 Attorney General of Canada v. Downtown Eastside Sex Workers United Against Violence Society, [2012] 2 S.C.R Factum ofthe Appellant, para Big M Drug Mart, supra, 313; see also R v. Nguyen, [1990] 2 S.C.R. 906 at 945 (dissenting on the merits)

23 18 B. THE SECTION 7 VIOLATIONS 78. In order to demonstrate a violation of s. 7 at his voir dire, Mr. Smith showed that the law deprived medical cannabis patients of their liberty and security of the person. Once he established that s. 7 was engaged, he then showed that the deprivations in question were not in accordance with the principles of fundamental justice. 79. Appellant argues that a s. 7 inquiry is inapt because the Charter does not confer a right to obtain or produce drugs based upon a subjective belief in their therapeutic value, irrespective of medical need or lawfully available alternative trea tments. 80. Perhaps not. But that is not what this case is about. 81. The facts found below, and unchallenged on this appeal, are that the medicinal compounds that provide therapeutic benefit are the cannabinoids, not the dried plant matter. At issue in this case is the criminalization of patient choice of the modes of ingesting those compounds. 82. The criminal prohibition on non-di'ied forms of medicinal cannabis infringes the rights to liberty and security of the person of medical cannabis patients in a manner that is not in accordance with the principles of fundamental justice and therefore violates s. 7. LIBERTY AND SECURITY OF THE PERSON VIOLATIONS 83. This court recently explained that while liberty and security of the person are distinct interests, both rest on a foundation of protecting individual autonomy and dignity: Underlying both of these rights is a concern for the protection of individual autonomy and dignity. Liberty protects "the right to make fundamental personal choices free from state interference": Blencoe v. British Columbia

24 19 (Human Rights Commission), [2000] 2 S.C.R. 307, at para. 54. Security of the person encompasses "a notion of personal autonomy involving... control over one's bodily integrity free from state interference" (Rodriguez, at pp per Sopinka J., referring to R. v. Morgen taler, [1988] 1 S.C.R. 30) and it is engaged by state interference with an individual's physical or psychological integrity, including any state action that causes physical or serious psychological suffering (New Brunswick (Minister of Health and Community Services) v. G. (J.), [1999] 3 S.C.R. 46, at para. 58; Blencoe, at paras ; Chaoulli, at para. 43, per Deschamps J.; para. 119, per McLachlin C.J. and Major J.; and paras. 191 and 200, per Binnie and LeBel JJ.). While liberty and security of the person are distinct interests, for the purpose of this appeal they may be considered together In addition to protecting autonomy and individual dignity, the liberty interest protects against deprivation of freedom by the threat of criminal prosecution and incarcera tio n. 85. Patient autonomy in medical decision-making is a central tenet of both s. 7 and the common law right to informed consent, as this Court recently explained: The law has long protected patient autonomy in medical decision-making. In A. C. v. Manitoba (Director of Child and Family Services), [2009] 2 S.C.R. 181, a majority of this Court, per Abella J. (the dissent not disagreeing on this point), endorsed the "tenacious relevance in our legal system of the principle that competent individuals are - and should be - free to make decisions about their bodily integrity" (para. 39). This right to "decide one's own fate" entitles adults to direct the course of their own medical care (para. 40): it is this principle that underlies the concept of "informed consent" and is protected by s. 7's guarantee of liberty and security of the person (para. 100; see also R. v. Parker (2000), 49 O.R. (3d) 481 (C.A.». As noted in Fleming v. Reid (1991), 4 O.R. (3d) 74 (C.A.), the right of medical self-determination is not vitiated by the fact that serious risks or consequences, including death, may flow from the patient's decision. It is this same principle that is at work in the cases dealing with the right to refuse consent to medical treatment, or to demand that treatment be withdrawn or discontinued: see, e.g., Ciarlariello v. Schacter, [1993] 2 S.C.R. 119; Malette v. Shulman (1990), 72 O.R. (2d) 417 (C.A.); and Nancy B. v. H6tel-Dieu de Quebec (1992), 86 D.L.R. (4th) 385 (Que. Sup. Ct.) Carter v. Canada (Attorney General), 2015 sec 5 at para Carter, supra, para.67 (emphasis added)

25 In Carter, this Court determined that protecting choice in individual responses to grievous and irremediable medical conditions is critical to individual dignity.64 The law, post-carter, allows persons to "request palliative sedation, refuse artificial nutrition and hydration, or request the removal of life-sustaining medical equipment" and to engage in physician-assisted dying even where other treatments may be available. Section 7, thus, confers very broad decision-making authority on patients. 87. Mr. Smith submits that the CDSA as applied to persons consuming cannabis for medical purposes is a serious intrusion into those patients' liberty and security of the person. The MJl.JARs provide an exemption scheme. But the MMARs, too, are an intrusion into the patients' autonomy and are an infringement on s. 7 rights If able to comply with the M1l1ARs, the law allows persons to consume the medicinal compounds found in cannabis (by smoking or vaporizing the dried flowers) but denies them, under threat of severe criminal sanction, the choice of more effective and less harmful methods of ingesting it even where a physician has recommended such modes of ingestion. In this way, the restriction "interferes with their ability to make decisions concerning their bodily integrity and medical care and thus trenches on liberty." Put another way, and echoing this Court's language, security of the person is engaged because patients are denied more effective and safer modes of ingestion for a condition that is clinically significant to their current and future health This Court also made clear that patients would not be forced to first undertake treatments that the patient found unacceptable: "'Irremediable', it should be added, does not require the patient to undertake treatments that are not acceptable to the individual." Carter (supra) para Mr. Smith agrees with and incorporates the analysis of the Ontario Court of Appeal in Hitzig v. Canada, (2003) 177 CCC (3d) 449, at paragraphs concluding that the MMARs are themselves a limitation on a s.7 that must, to be valid, comply with the principles of fundamental justice. 66 Carter, supra, para Chaou}Jj v. Quebec, [2005] 1 S.C.R. 791, per McLachlin C.J.C. at paras. 116, 117, 121, 123; see also Appellant's Factum at para.83

26 Worth underscoring is that this right to autonomy in medical decision-making extends even to choices that could - or are intended to - result in the patient's death despite that s. 7 also protects the right to life. 91. The common thread running through this Court's jurisprudence is that patients' choices are to be respected. In the specific context of cannabis, this Court has suggested that consumption of cannabis for medical purposes would impact the security of the person right because prohibiting medical consumers could be considered serious state-induced psychological stress Against this backdrop, Appellant argues that the patient witnesses' choices "at their highest" should not be respected and s. 7 inquiry not triggered because: III This Court's jurisprudence has only protected autonomy in medical decision-making from restrictions that impede access to lawful treatments; III Medical autonomy only protects choices that are "reasonably necessary" for "serious or life-threatening conditions"; III The patients' choices are based solely on subjective preferences. 93. The record evidence and facts found below do not support Appellant, nor does the jurisprudence. This Court should reject Appellant's attempt to insulate the restriction from s. 7 challenge. 94. This Court's jurisprudence has long recognized the centrality of autonomy in medical decision making to our free and democratic society. Faced with this long jurisprudential history of protecting patient choice - even unto death - Appellant attempts to artificially limit the jurisprudence to cases involving only laws that restrict "approved" health care services R v. Malmo-Levin6' R v. Caine, [2003] 3 S.C.R. 571 at para Appellant's Factum para.84

27 Appellant's characterization must fail in light of this Court's decision in Carter. Physician-assisted dying was not an "approved health care service" that the Criminal Code prevented access to. Quite the opposite. 96. Ms. Quin and Ms. Herman had been approved to use cannabis as medicine by virtue of having ATPs. Ms. Herman's physician recommended oral ingestion. For them, and others similarly situated, cannabis is an approved medicine. It is their choice of how to ingest that medicine that is criminally prohibited. 97. Appellant also seeks to limit the scope of s. 7 protection by arguing that only restrictions on medical treatments that are "reasonably necessary" to treat "serious or life-threatening medical condition[s]" can ever engage liberty and security of the person Even if this Court accepts the Appellant's characterization on the evidence that the burden is met. The patient witnesses all suffered from serious and/or lifethreatening medical conditions. For at least Ms. Quin and Ms. Herman, their doctors agreed that cannabis (and in Ms. Herman's case, cannabis consumed orally) was necessary to treat those conditions because other conventional treatments had been tried or considered and found to be ineffective or medically inappropriate. 99. Choosing a mode of ingesting cannabis that is (a) more effective; (b) has potentially less unwanted side effects; and (c) is less harmful than smoking dried marihuana is reasonable In urging this Court to dramatically circumscribe autonomy, Appellant also argues that there was no "medical evidence" that the witnesses were unable to treat their serious health conditions with pharmaceutical drugs. Along these lines, Appellant suggests that any rights claimant would need objective evidence from a qualified and informed medical practitioner in order to trigger as. 7 inquiry. 70 Appellant's Factum, para.91.

28 The Courts below, however, found as fact that the objective evidence from Dr. Pate and Dr. Abramovici supported the increased medical efficacy and decreased risk profile of ingested versus smoked cannabis. Ms. Herman and Ms. Quin had doctors that declared that conventional treatments were "ineffective or medically inappropriate". And Ms. Herman had physician support and is therefore medically approved for an oral mode of ingestion. Appellant's argument fails on the facts Appellant also says that there was no medical evidence that dried marihuana was "any less effective" than other cannabis medicines, suggesting that the patients merely have a preference for an unlawful treatment over a lawful one Dr. Pate, Dr. Abramovic and Health Canada's publication all confirm that for certain conditions oral ingestion is more effective than smoking. The patients confirmed this with their own experiences Moreover all experts agreed that smoking was a more harmful mode of ingesting Finally, one can hypothesize many situations in which smoking dried marihuana is less effective than ingesting it in other ways. Smoking cannabis resin (made of trichomes that have been removed from the inert plant matter) delivers greater doses with less smoking. This is more effective and less harmful. Persons with asthma, or suffering from lung cancer or other respiratory conditions, may have smoking andlor vaporization contraindicated but would benefit from ingesting cannabis orally or topically. Persons working as bus drivers, construction workers, pilots and a host of other professions may benefit from cannabinoid medicine applied 71 Appellant's Factum, paras.92, 93. Appellant's myopic focus on the concept of preferring one treatment over another ignores the basic scientific fact: the cannabinoids are the treatment. The mode of ingestion is the way the patient uses the treatment. That mode of ingestion could (without the restriction) make the treatment more effective and less harmful or (with the restriction) less effective and more harmful to the patient. 72 This Court in Malmo-Levine noted the application judge's finding that even for chronic non-medical consumers the health risks associated with cannabis "arise primarily from the act of smoking rather than from the active ingredients in marihuana." Malmo-Levine) para.255.

29 24 topically while not experlencmg the unwanted side effect of psycho activity. Persons with chronic conditions that either do not want to, or are unable to, constantly ingest cannabis by smoking/vaporization but are able to ingest it orally for longer-lasting effect. THE RIGHTS INFRINGEMENTS VIOLATE THE PRINCIPLES OF FUNDAMENTAL JUSTICE 106. The infringements of the liberty and security of the person rights are not in accordance with the principles of fundamental justice 107. Three central principles are identified as fundamental m recent s. 7 jurisprudence: arbitrariness, overbreadth and gross disproportionality in effects All three can be seen as what Professor Hamish Stewart has described as "failures of instrumental rationality" in the sense that the means chosen by Appellant to achieve its objectives are intrinsically mismatched with that objective The first step in the fundamental justice analysis is to identify the object of the impugned restriction. THE OBJECT OF THE RESTRICTION 110. Mr. Smith submits the object of the restriction must be defined precisely and go no further than the restriction at issue. He submits that the objective is the protection of the health and safety of patients lawfully possessing and producing cannabis for medicinal purposes. This objective is broader than that found by the application judge and in line with that found by the court of appeal majority. Ill. The application judge determined that purpose of the impugned restriction Cbased on Appellant's submissions) was protecting health and safety in the sense of 73 Carter, supra, para Stewart, Hamish. Fundamental Justice: Section 7 of the Canadian Charter of Rights and Freedoms. Toronto: Irwin Law 2012.

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