R. v. Smith Transcripts Volume 5

Court of Appeal CA040556
COURT OF APPEAL ON APPEAL FROM THE SUPREME COURT OF BRITISH COLUMBIA, FROM THE ACQUITTAL OF THE HONOURABLE MR. JUSTICE JOHNSTON, PRONOUNCED ON THE 10TH DAY OF JANUARY 2013.
REGINA
APPELLANT
v. OWEN EDWARD SMITH

RESPONDENT
TRANSCRIPT
Volume 5 (Pages 717 - 795)
Public Prosecution Service of Canada 900 - 840 Howe Street Vancouver, B.C. V6Z 2S9 Phone: (604) 775-7475 Fax: (604) 666-1599 Solicitors for the Appellant Kirk Tousaw 1135 Fisher Road Cobble Hill, B.C. V0R 1L4 Phone: (604) 836-1420 Solicitor for the Respondent
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Kirk I. Tousaw Counsel
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(BEFORE THE HONOURABLE MR. JUSTICE JOHNSTON) Victoria, B.C. January 16, 17, 18, 19, 20, 23, 24, 25, 26, 2012 February 1, 6, 7, 8, 27, 28, 29, 2012 March 1, 2012 April 13, 2012 January 10, 2013 REGINA v. OWEN EDWARD SMITH
PROCEEDINGS AT TRIAL
Crown Counsel:
P. Eccles K. Guest K. Tousaw
Defence Counsel:
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INDEX
VOLUME 1 PROCEEDINGS AT TRIAL - JANUARY 16, 2012 Proceedings .......................................................................................................... 1 WITNESSES FOR THE CROWN COLIN BREWSTER ................................................................................ 12 EXAMINATION IN CHIEF ON VOIR DIRE BY MR. ECCLES: ................. 12 CROSS-EXAMINATION ON VOIR DIRE BY MR. TOUSAW: .................. 35 WITNESSES FOR THE ACCUSED LEON EDWARD SMITH .......................................................................... 42 EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............... 43 PROCEEDINGS AT TRIAL - JANUARY 17, 2012 Proceedings ........................................................................................................ 76 WITNESSES FOR THE ACCUSED LEON EDWARD SMITH .......................................................................... 80 EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............... 80 CROSS-EXAMINATION ON VOIR DIRE BY MR. ECCLES: ................. 140 PROCEEDINGS AT TRIAL - JANUARY 18, 2012 Proceedings ...................................................................................................... 156 VOLUME 2 PROCEEDINGS AT TRIAL - JANUARY 19, 2012 Proceedings ...................................................................................................... 157 WITNESSES FOR THE ACCUSED LEON EDWARD SMITH ........................................................................ 158 CROSS-EXAM ON VOIR DIRE BY MR. ECCLES, CONTINUING: ....... 158 RE-EXAMINATION ON VOIR DIRE BY MR. TOUSAW:........................ 212 GAYLE QUIN ......................................................................................... 217 EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............. 218
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PROCEEDINGS AT TRIAL - JANUARY 20, 2012 Proceedings ...................................................................................................... 233 WITNESSES FOR THE ACCUSED GAYLE QUIN ......................................................................................... 242 EXAM IN CHIEF ON VOIR DIRE BY MR. TOUSAW, CONTINUING: ... 243 CROSS-EXAMINATION ON VOIR DIRE BY MR. ECCLES: ................. 270 PROCEEDINGS AT TRIAL - JANUARY 23, 2012 Proceedings ...................................................................................................... 288 WITNESSES FOR THE ACCUSED DAVID PATE ......................................................................................... 288 EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............. 291 VOLUME 3 PROCEEDINGS AT TRIAL - JANUARY 24, 2012 Proceedings ...................................................................................................... 352 WITNESSES FOR THE ACCUSED DAVID PATE ......................................................................................... 352 EXAM IN CHIEF ON VOIR DIRE BY MR. TOUSAW, CONTINUING: ... 352 CROSS-EXAMINATION ON VOIR DIRE BY MR. ECCLES: ................. 356 RE-EXAMINATION ON VOIR DIRE BY MR. TOUSAW:........................ 429 PROCEEDINGS AT TRIAL - JANUARY 25, 2012 Proceedings ...................................................................................................... 435 WITNESSES FOR THE ACCUSED SANDRA LARGE .................................................................................. 435 EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............. 435 CROSS-EXAMINATION ON VOIR DIRE BY MS. GUEST: ................... 459 GIOCONDA HERMAN ........................................................................... 471 EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............. 471 PROCEEDINGS AT TRIAL - JANUARY 26, 2012 Proceedings ...................................................................................................... 495
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WITNESSES FOR THE ACCUSED GIOCONDA HERMAN ........................................................................... 495 EXAM IN CHIEF ON VOIR DIRE BY MR. TOUSAW, CONTINUING: ... 495 CROSS-EXAMINATION ON VOIR DIRE BY MR. ECCLES: ................. 499 RUTH ARTHURS................................................................................... 511 EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............. 511 CROSS-EXAMINATION ON VOIR DIRE BY MS. GUEST: ................... 524 PROCEEDINGS AT TRIAL - FEBRUARY 1, 2012 Proceedings ...................................................................................................... 532 VOLUME 4 PROCEEDINGS AT TRIAL - FEBRUARY 6, 2012 Proceedings ...................................................................................................... 537 WITNESSES FOR THE CROWN HANAN ABRAMOVICI .......................................................................... 539 EXAMINATION IN CHIEF ON VOIR DIRE BY MR. ECCLES: ............... 539 CROSS-EXAMINATION ON VOIR DIRE BY MR. TOUSAW: ................ 556 PROCEEDINGS AT TRIAL - FEBRUARY 7, 2012 Proceedings ...................................................................................................... 619 WITNESSES FOR THE CROWN HANAN ABRAMOVICI .......................................................................... 619 CROSS-EXAM BY MR. TOUSAW ON VOIR DIRE, CONTINUING: ...... 619 VOLUME 5 PROCEEDINGS AT TRIAL - FEBRUARY 8, 2012 Proceedings ...................................................................................................... 717 WITNESSES FOR THE CROWN HANAN ABRAMOVICI .......................................................................... 717 CROSS-EXAM BY MR. TOUSAW ON VOIR DIRE, CONTINUING: ...... 717 RE-EXAMINATION BY MR. ECCLES ON VOIR DIRE: ......................... 738
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PROCEEDINGS AT TRIAL - FEBRUARY 27, 2012 Proceedings ...................................................................................................... 783 PROCEEDINGS AT TRIAL - FEBRUARY 28, 2012 Proceedings ...................................................................................................... 784 PROCEEDINGS AT TRIAL - FEBRUARY 29, 2012 Proceedings ...................................................................................................... 785 PROCEEDINGS AT TRIAL - MARCH 1, 2012 Proceedings ...................................................................................................... 786 PROCEEDINGS AT TRIAL - APRIL 13, 2012 Proceedings ...................................................................................................... 787 PROCEEDINGS AT TRIAL - JANUARY 10, 2013 Proceedings ...................................................................................................... 791
EXHIBITS
EXHIBITS ON VOIR DIRE EXHIBIT 1: Admissions filed January 16, 2012 ............................................. 3 EXHIBIT 1-A: Amended Admissions filed January 17, 2012 ........................... 76 EXHIBIT 2: Crown's Book of Photographs ................................................... 14 EXHIBIT 3: Victoria Police Department Exhibit Flow Chart .......................... 17 EXHIBIT 4.1: Original Analyst Report No. 09 14838 V ................................... 30 EXHIBIT 4.2: Original Analyst Report No. 09 14835 V ................................... 30 EXHIBIT 4.3: Original Analyst Report No. 09 14839 V ................................... 30 EXHIBIT 4.4: Original Analyst Report No. 09 14803 V ................................... 30 EXHIBIT 4.5: Original Analyst Report No. 09 14804 V ................................... 30 EXHIBIT 4.6: Original Analyst Report No. 09 14805 V ................................... 30 EXHIBIT 4.7: Original Analyst Report No. 09 14806 V ................................... 30 EXHIBIT 4.8: Original Analyst Report No. 09 14807 V ................................... 30 EXHIBIT 4.9: Original Analyst Report No. 09 14808 V ................................... 30 EXHIBIT 4.10: Original Analyst Report No 09 14809 V .................................... 30
EXHIBIT 4.11: EXHIBIT 4.12: EXHIBIT 4.13: EXHIBIT 4.14: EXHIBIT 4.15: EXHIBIT 4.16: EXHIBIT 4.17: EXHIBIT 4.18: EXHIBIT 4.19: EXHIBIT 4.20: EXHIBIT 4.21: EXHIBIT 4.22: EXHIBIT 4.23: EXHIBIT 4.24: EXHIBIT 4.25: EXHIBIT 4.26: EXHIBIT 4.27: EXHIBIT 4.28: EXHIBIT 4.29: EXHIBIT 4.30: EXHIBIT 4.31: EXHIBIT 4.32: EXHIBIT 4.33: EXHIBIT 4.34: EXHIBIT 4.35: EXHIBIT 4.36: EXHIBIT 4.37: EXHIBIT 4.38: EXHIBIT 4.39: EXHIBIT 4.40: EXHIBIT 4.41: EXHIBIT 5: EXHIBIT 6: EXHIBIT 7: EXHIBIT 8: EXHIBIT 9: EXHIBIT 10:
Original Analyst Report No. 09 14810 V ................................... 31 Original Analyst Report No. 09 14811 V ................................... 31 Original Analyst Report No. 09 14812 V ................................... 31 Original Analyst Report No. 09 14813 V ................................... 31 Original Analyst Report No. 09 14814 V ................................... 31 Original Analyst Report No. 09 14815 V ................................... 31 Original Analyst Report No. 09 14816 V ................................... 31 Original Analyst Report No. 09 14817 V ................................... 31 Original Analyst Report No. 09 14818 V ................................... 31 Original Analyst Report No. 09 14819 V ................................... 31 Original Analyst Report No. 09 14820 V ................................... 31 Original Analyst Report No. 09 14821 V ................................... 31 Original Analyst Report No. 09 14822 V ................................... 31 Original Analyst Report No. 09 14823 V ................................... 31 Original Analyst Report No. 09 14824 V ................................... 31 Original Analyst Report No. 09 14825 V ................................... 31 Original Analyst Report No. 09 14826 V ................................... 32 Original Analyst Report No 09 14827 V .................................... 32 Original Analyst Report No. 09 14828 V ................................... 32 Original Analyst Report No. 09 14829 V ................................... 32 Original Analyst Report No. 09 14830 V ................................... 32 Original Analyst Report No. 09 14831 V ................................... 32 Original Analyst Report No. 09 14832 V ................................... 32 Original Analyst Report No. 09 14833 V ................................... 32 Original Analyst Report No. 09 14834 V ................................... 32 Original Analyst Report No. 09 14836 V ................................... 32 Original Analyst Report No. 09 14837 V ................................... 32 Original Analyst Report No. 09 14840 V ................................... 32 Original Analyst Report No. 09 14841 V ................................... 32 Original Analyst Report No. 09 14842 V ................................... 32 Original Analyst Report No. 09 14843 V ................................... 32 DVD containing scene video images......................................... 34 City of Victoria Proclamation "International Medical Marijuana Day" ........................................................................................ 112 Letter from Office of the Mayor of Victoria, B.C. to Tony Clement dated March 20, 2006 ............................................... 116 Letter to Leon Smith from Susan Fletcher, July 27, 2005 ....... 117 Letter from Leon "Ted" Smith to Susan Fletcher dated January 4, 2006 ...................................................................... 119 Letter to Ujjal Dosanjh from Leon "Ted" Smith dated February 3, 2005 ..................................................................... 121
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EXHIBIT 11: EXHIBIT 12: EXHIBIT 13: EXHIBIT 14: EXHIBIT 15: EXHIBIT 16:
EXHIBIT 17: EXHIBIT 18: EXHIBIT 19: EXHIBIT 20: EXHIBIT 21: EXHIBIT 22: EXHIBIT 23: EXHIBIT 24: EXHIBIT 25: EXHIBIT 26: EXHIBIT 27: EXHIBIT 28: EXHIBIT 29:
EXHIBIT 30:
EXHIBIT 31: EXHIBIT 32:
Letter to Leon Smith from Beth Pieterson, dated February 24, 2006 ................................................................... 124 Letter to Tony Clement from Leon "Ted" Smith dated August 1, 2006 ........................................................................ 128 Letter to Leon Smith from Susan Russell dated September 26, 2006................................................................ 130 Letter to Tony Clement from Leon "Ted" Smith dated January 3, 2007 ...................................................................... 133 Letter to Leon "Ted" Smith from Ronald Denault dated 2008-06-03.............................................................................. 137 Letter to Tony Clement on International Hempology 101 Society letterhead dated December 4, 2007 (was Exhibit B for identification) ...................................................................... 139 Cannabis Buyers' Club of Canada informational pamphlet ..... 176 Cannabis Buyers' Club of Canada - Medicinal Cannabis Recipe Book............................................................................ 258 Breast imaging report - exam date 18-Apr-2011 ..................... 260 Histopathology Report for Gayle Quin..................................... 261 Prescription sheet from Dr. Roland Graham dated November 28, 1997................................................................. 261 Urine Toxic Metals report of Dr. Peter Nunn dated August 12, 2002 ...................................................................... 262 Letter from Dr. Kristen Bovee dated January 6, 2012 ............. 266 Package of documents including original affidavit of Dr. Pate, curriculum vitae, list of publications and two studies ............... 290 Colour photograph of close-up depicting female flower of cannabis plant ......................................................................... 301 Macro colour photograph of close-up of leaf surface .............. 302 Macro photograph depicting isolated trichomes ...................... 319 1 page photocopy of prescriptions prescribed to Sandra Large ....................................................................................... 455 5-page document from St. Joseph's Health Care entitled, "Regional Evaluation Centre Multidisciplinary Health Care Assessment ............................................................................ 472 Document from St. Joseph's Health Care, Regional Evaluation Centre Multidisciplinary Health Care Assessment - Final.................................................................. 476 Copy of report from St. Joseph's Health Care dated March 28, 2002 ....................................................................... 476 3-page letter dated May 7, 2004 addressed to Dr. Patricia Morley-Forster ......................................................................... 478
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EXHIBIT 33: EXHIBIT 34: EXHIBIT 35: EXHIBIT 36: EXHIBIT 37: EXHIBIT 38: EXHIBIT 39: EXHIBIT 40: EXHIBIT 41:
EXHIBIT 42: EXHIBIT 43: EXHIBIT 44:
1-page copy of document from London Health Services dated July 22, 2004 ................................................................. 484 1-page document from Vancouver Island Health Authority dated May 6, 2009 .................................................................. 485 3-page copy of fax dated May 11, 2005 from Dr. Laurence Jerome Re: Gina Herman ....................................................... 487 1-page document of Prescription Authorization Request printed on January 20, 2012 re Herman, Gioconda ................ 488 4-page copy of document entitled Form B1 ............................ 493 Copy of letter from Dr. Grimwood to Mr. Brooks re Ruth Ann Arthurs dated April 15, 2010 ................................................... 515 1-page copy of assessment form for Life Mark Physiotherapy re Ruth Arthurs dated March 17, 2010 ............ 517 Affidavit of Hanan Abramovici ................................................ 556 "Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain" ................................................................ 721 "Adverse effects of medicinal cannabinoids: a systematic review" .................................................................................... 726 Large cerlox bound volume, affidavit of Eric Ormsby .............. 755 Curriculum vitae of Eric Ormsby ............................................. 765
EXHIBITS FOR IDENTIFICATION ON VOIR DIRE EXHIBIT A: Cannabis Buyers' Club of Canada, Product Guide ................. 102 EXHIBIT B: Letter to Tony Clement on International Hempology 101 Society letterhead dated December 4, 2007 ........................... 136 EXHIBIT C: Binder of Health Canada MMAR information .......................... 194 EXHIBIT D: Affidavit of Dr. Harold Kalant sworn April 3, 2008 ................... 412
RULINGS
Plea ...................................................................................................................... 2 Ruling re re Ban on Publication .......................................................................... 10 Order re Exclusion of Witnesses......................................................................... 11 Ruling re admissibility of document .................................................................. 100 Ruling re admissibility of document .................................................................. 115 Ruling re admissibility of document .................................................................. 119 Ruling re admissibility of question on re-examination ....................................... 214 Ruling re Qualification of Witness re Pate ........................................................ 291
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[RULING RE ADJOURNMENT APPLICATION] ............................................... 533 Ruling re Qualification of Witness re Abramovici .............................................. 538 Ruling on Voir Dire ............................................................................................ 787 Ruling on Voir Dire ............................................................................................ 788 Re-Election ....................................................................................................... 791 Plea .................................................................................................................. 794 Reasons for Judgment re Acquittal ................................................................... 795
717 VOIR DIRE Proceedings
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Victoria, B.C. February 8, 2012 THE CLERK: In the Supreme Court of British Columbia, this Wednesday, the 8th day of February, 2012, calling the matter of Her Majesty the Queen against Owen Edward Smith. HANAN ABRAMOVICI recalled, warned. THE CLERK: Witness, I remind you, having been previously affirmed, you're still under affirmation. THE COURT: Be seated, Dr. Abramovici. Mr. Tousaw? MR. TOUSAW: Thank you, My Lord. CROSS-EXAM BY MR. TOUSAW ON VOIR DIRE, CONTINUING: Q Doctor, I'm going to pass you a study titled Volume 39, No. 2, February 2010, originally published in the Journal of Pain and Symptom Management, and the title of the study is "Multicenter, double-blind, randomized, placebocontrolled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancerrelated pain." Do you see that? I do. And you've read that study before, haven't you? I believe so. It's cited in the "Information for Health Care Practitioners" article at 190? Yes. And that is a study, just reading from the abstract, that compared the efficacy of a THC:CBD extract, essentially Sativex, with a THC extract and with placebo in relief of patients experiencing advanced cancer pain, correct? That's correct. According to the abstract, 177 patients with cancer pain who were not experiencing adequate analgesia despite their use of chronic opioid dosing entered the trial, and it was a two-week trial, correct? Yes. Sixty of those patients were given the THC:CBD
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718 VOIR DIRE Hanan Abramovici (for Crown) cross-exam by Mr. Tousaw
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extract, 58 were given the THC extract, and 59 were given placebo, correct? Yes. The abstract says that: The primary analysis of change from baseline in mean pain Numerical Rating Scale (NRS) score was statistically significantly in favor of THC:CBD compared with placebo . . .
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And then gives a ratio of improvement, correct? Yes. And that's essentially concluding that the THC:CBD extract worked in a manner that the placebo didn't work in a way that's significant, statistically significant? Yes. Outside of the margin of error of these types of tests, correct? Yes. It goes on to read that: . . . the THC group showed a nonsignificant change.
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Correct? Yes. The abstract continues that: Twice as many patients taking THC:CBD showed a reduction of more than 30% from baseline pain NRS score when compared with placebo . . .
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Correct? Yes. And this is a statistically significant ratio: . . . whereas the number of THC group responders was similar to placebo.
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Correct? That's what it says, yes. And that does not reach statistical significance, correct? Yes. This study provides some clinical evidence
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supporting the hypothesis that, at least for some patients, patients in this double-blind placebocontrolled study, the THC:CBD combination was more efficacious than both placebo and the THC alone combination, correct? That's what this study reports. Yes, and this study provides at least some level of support for the hypothesis advanced by Dr. Pate and Dr. Russo that there is potentially a synergistic or enhancing effect between THC and CBD that may not be experienced in people taking THC alone, correct? Partially. I believe the article by Dr. Russo was speaking about phytocannabinoid-terpenoid synergy. This is cannabinoid to cannabinoid interaction. And you're aware that the Sativex, the THC:CBD extract, the whole plant extract, it also contains terpenes, correct? Yes, that's my understanding. The conclusion of the study, however, is specific to THC:CBD and with respect to that particular interaction between THC:CBD this study provides some clinical scientific evidence that the hypothesis that CBD may have an enhancing effect on THC's analgesic properties or vice-versa, that has some support in the clinical evidence, according to this study, correct? I would be cautious about this study because it says on the bottom left-hand side the study was sponsored by GW Pharma, and sometimes that calls into question the value of the scientific article because it's supported by industry. As we talked about, there may be some bias depending on the source of information, correct? That's correct. Now, this was published in the Journal of Pain and Symptom Management, correct? That's what it says, yes. Are you aware of any suggestion that the Journal of Pain and Symptom Management is not a reputable publication? I wouldn't off the top of my head, no. And this appears to be a -- this would be a study that's been peer-reviewed, correct? Presumably, yes. Or it wouldn't be published in a journal of this
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nature, correct? That's what I would assume, yes. And, of course, the approval of Sativex with conditions in Canada is largely based on studies conducted by GW Pharmaceuticals, correct? A Yes. Q So this is part of the evidentiary backdrop, this and studies like it would be part of the evidentiary backdrop that Health Canada would accept in approving a substance for marketing and sale in Canada, correct? A Potentially. I don't have familiarity with that approval process, so I can't really comment meaningfully on it. Q Other than the caution, be careful of the source, I am correct in suggesting that this provides some clinical evidence supporting the hypothesis that THC and CBD in combination at least for some patients may be more efficacious in reducing analgesia? A Well, on the second page, on page 168 it actually says that THC and CBD showed a worsening in nausea and vomiting compared with placebo. Q Yes, but I'm speaking of analgesia, correct? A Well, for analgesia it may have had a beneficial effect, but it had a worsening effect on nausea and vomiting. Q Yes, but when I ask you about analgesia, I'm speaking of analgesia. You understand that to be not nausea and vomiting, correct? A I understand. Q Yes, and it's not that it may have, it did, it did have a statistically significant increased analgesic effect over both THC and placebo in this gold standard double-blind randomized placebocontrolled parallel group study, correct? A According to this study, yes. Q And you cited this study in your "Information for Health Care Practitioners" document, correct? A I did. MR. TOUSAW: Rather than take you through the document in great detail, I am going to ask that it be marked as Exhibit 41 in these proceedings. THE COURT: Exhibit 41. THE CLERK: Exhibit 41, My Lord. A Q
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EXHIBIT 41 (on voir dire): "Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancerrelated pain" MR. TOUSAW: Q Page 175 of Exhibit 41, Doctor, there -THE COURT: He doesn't have it. MR. TOUSAW: I apologize, My Lord. A I'm sorry, what page? Q Page 175. A Yes. Q There's a discussion of safety and tolerability, correct? A Yes. Q And the first sentence is: The active compounds were generally well tolerated, and no safety concerns were identified during this study. Correct? And it goes on to discuss some of the treatment related adverse effects being reported by about 60 percent of patients, that the common treatment related adverse effects were similar to those in other THC:CBD trials; sleepiness, dizziness, nausea, mostly mild to moderate severity, correct? A That's what it says there, yes. Q Some people died in the study group, but that was considered to be because of the progression of their disease, serious cancer, as opposed to the actual treatment being administered, that's correct, isn't it? A That's what it says, yes. THE COURT: Just before you go any further, there's somewhere in this document that identifies AE as adverse effect? MR. TOUSAW: There is, My Lord. I apologize. I'm not sure of the exact page. Q But you understand AE to be adverse effect? A I do. Q And that's a common usage of the term in the literature, correct? A It is. A
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THE COURT: Thank you. MR. TOUSAW: Thank you, My Lord. And I do see it's defined, My Lord, at page 170, right-hand column, first full paragraph. Q Now, on page 170 there's a figure, Figure 1, study design, that's essentially a flowchart? A Yes. Q And it explains the process of people moving through the study, for lack of a better word, correct? A That's correct. Q And they screened 192 people, they randomized, of that screening they randomized out and accepted into the study 177 people, split those into the three groups of the numbers we've advised, and then there's a completion number for the number of people that completed the study, correct? A That's correct. Q And it appears that there were essentially 12 people that withdrew from the THC:CBD portion, 13 people that withdrew from the THC potion, and eight that withdrew from the placebo portion, and the explanation for those withdrawals or at least general categories of the reasons for those withdrawals are given in those boxes, correct? A I believe so, yes. Q And we know that because a number of patients passed away during the course of the study, that was described that we just went over as an adverse event, not a treatment related adverse event, but that's going to explain a number of these withdrawals? A It could, yes. Q Those are my questions on Exhibit 41. I'll put another study in front of the witness. Doctor, I've put before you a study titled "Adverse effects of medical cannabinoids: a systematic review". At the bottom of page 1 it appears that this study appeared in the Canadian Medical Association Journal June 17, 2008, Volume 178. Do you see that? A I do. Q Have you seen this study before? A It looks familiar. Q And the Canadian Medical Association Journal is commonly referred to as CMAJ, correct? A That's correct.
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And that's a publication put out by the Canadian Medical Association, correct? A It is. Q And that's a publication that puts out peerreviewed research for the consumption by members of the CMAJ and others, correct? A I believe so, yes. Q I'll direct your attention to the abstract of this research paper, and this is on page 1, My Lord. It gives the background which is essentially that the therapeutic use of cannabis and cannabis-based medicines raises safety concerns for a variety of stakeholders and that most safety information comes from studies of recreational use. That's a fair assessment, isn't that correct? A I would say so, yes. Q And describes the methodology, and the methodology of this study appears to be a systematic review of safety studies published over the past 40 years, correct? A That's what it says, yes. Q And that's the kind of systematic review of the literature that we described earlier in your testimony, similar to what you conducted in putting together the "Information for Health Care Professionals" document, correct? A Correct. Q Under the "Results" category we see that they found 321 articles eligible for evaluation. They then excluded the ones that focused on recreational use and included in the final analysis 31 studies, 23 randomized controlled trials and eight observational studies, correct? A Mm-hmm, yes. MR. ECCLES: I'm sorry, My Lord, that's not quite what it says. What it says is: After excluding those that focused on recreational cannabis use, we included . . . So of the 321 articles, 31 were non-recreational use. That's not quite how my friend put it to the witness. MR. TOUSAW: Q I think that's precisely what I said, but if there's some confusion in my friend's mind about that, there were 321 articles that were eligible
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and they excluded the recreational cannabis ones, correct? That's what I understand. That's what they're saying. And they included 31 studies, presumably non-recreational cannabis use studies, correct? That's my understanding, yes. Twenty-three of those were randomized controlled trials. They describe the median duration of the exposure being two weeks, and the range being eight hours to 12 months, correct? Yes. And in the results they indicate that there were 4,779 adverse effects reported among participants and that most, 4,615 or 96.6 percent were not serious. Do you see that? That's what it says. You don't have any reason sitting here today to dispute that those were, in fact, the findings made by the authors of this study, correct? No, but I would want to know what "not serious" is defined as. And that may well appear in the study, correct? Yes. The abstract goes on to indicate that there were of the 164 serious adverse events, most common were relapse of multiple sclerosis, correct? Yes. Vomiting and urinary tract infections, correct? That's right. And that the rate of nonserious adverse events was higher among participants than among controls, correct? That's what it says. And then in terms of what they are describing at least as nonserious adverse events, dizziness was the most common such event? That's what it says, yes. This provides at least some scientific basis for interpreting some of the risks associated with cannabinoid therapy, correct? Short-term risks. And it's clear from the abstract that they're talking about studies of relatively short duration, correct? Yes, but it's important to look at the interpretation that they provide there as well.
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Table 1 describes -- and that's on page 1672, My Lord, numbered in the bottom left corner. Table 1 describes essentially the different randomized control trials that were reviewed. You see that, correct? I do, yes. And Table 2 which appears on page 1674 in the bottom left corner describes at least what these authors consider to be serious adverse effects, correct? Yes. And there were serious adverse effects reported not just among people exposed to cannabinoids but also amongst the control group, correct? That's right. And so just by way of example, in terms of one of the major headings, nervous system disorders, it's about halfway down the table, 25 out of 164 persons exposed to cannabinoids or 15.2 percent reported a serious adverse nervous system disorder, and 18 out of 60 or 30 percent of the controls reported a similar nervous system disorder, correct? That's right. And so what we don't have in this particular table at least is a determination of whether or not the serious adverse effects were necessarily caused by the cannabinoid exposure because, in fact, at least for nervous system disorders it appears that a greater percentage of persons in the control group experienced those serious adverse effects? Just for that particular heading. I don't propose to take you through each category. I think the document speaks for itself. I'm just a little confused because when I look at cannabinoid exposure under nervous system disorders, it reports 25 percent and under controls 18 percent. I think you're reading it perhaps incorrectly. It's 25 is the number, 15 percent in parenthetical and -Oh, I see, thank you. Does that clear that up for you? Thank you, yes. So at least with respect to that particular category, a greater percentage of people in the control group experienced a serious adverse
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nervous system disorder event than the people in the cannabinoid group? That's a fair interpretation of that particular category? A For that particular category, yes. Q And each category has varying numbers, and again I don't propose to take you to each of them, but it says what it says and you have no reason to dispute this, falsified or not accurate in any way? A No. Q Table 3 on page 1675 in the bottom right corner again speaks to the nonserious adverse events and same type of table, gives you the number of people experiencing it out of the group and the percentage in parentheticals afterwards, both for the people exposed to cannabinoids and for the control groups, correct? A That's right. MR. TOUSAW: My Lord, I'd ask that this be entered as Exhibit 42 in these proceedings. THE COURT: Exhibit 42. EXHIBIT 42 (on voir dire): "Adverse effects of medicinal cannabinoids: a systematic review" MR. TOUSAW: Q One of the studies that you cite in your affidavit is a study called "Science of Marihuana" from the year 2000, the author being Iversen, correct? A That's right. Q And that's a fairly lengthy document, some 302 pages, correct? A Potentially. It's a book. Q If I said to you -- yes, it's a book? A It's a book. Q One of the -- and I'm not going to put the book to you, I don't propose to enter it as an exhibit, My Lord, but one of the things that's reported in Iversen is a quote from the Institute of Medicine report from 1999, a report called "Marihuana and medicine". Are you familiar with that report? A I am. Q And the quote from Iversen, I'm just going to give you the quote, then I'm going to ask if you agree with it. The quote from Iversen, including the quote from the Institute of Medicine is [as read
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in]: In all instances including the use of smoked marihuana more properly controlled clinical trials are needed and research in improved means of delivering the drug is also a high priority. The Institute of Medicine (1999) in their report 'Marihuana and medicine' summarized the safety issues succinctly: And here is the quote that I'm going to ask you about: Marihuana is not a completely benign substance. It is a powerful drug with a variety of effects. However, except for the harms associated with smoking, the adverse effects of marihuana use are within the range of effects tolerated for other medications. A Q Do you have that quote? I remember -- I think I remember reading it or seeing it, yes. Do you agree with that quote from the Institute of Medicine that: . . . except for the harms associated with smoking, the adverse effects of marihuana use are within the range of effects tolerated for other medications. A I would agree with it generally, but I think that because we don't have enough -- we haven't carried out enough clinical studies, it's hard to say. We don't know. Because clinical studies tend to be of relatively short duration, correct? They can be. They can be a longer duration. There's -And at least as we -- excuse me. I didn't mean to interrupt you. I'm sorry. I think it's also what was lacking perhaps in 2000 were epidemiological studies looking at population-wide effects of the use of cannabis or specifically the medicinal uses of cannabis and their adverse effects on patient populations.
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In terms of the adverse effects that we know, even sitting here today, about the effects of marihuana use, cannabis use or cannabinoid use, those adverse effects are within the range of effects tolerated for other medications that are approved for sale in Canada, aren't they? Some of them, yes, some of the effects. And we've talked about many of the effects. I don't propose to go over it again. Are you aware of any studies analyzing the potential long-term effects of chronic medicinal cannabis use? I don't think there are that many studies out there. There's maybe one that I remember seeing about -- I think it was a study looking at chronic ingestion of cannabis by patients with MS and their cognitive -- the effect on cognition, I think, is probably the only study that comes to mind. In the course of your research in updating the Health Canada "Information for Health Care Professionals" document or in preparing to testify today, did you happen to come across and review a paper titled "Chronic cannabis use in the compassionate investigational new drug program. an examination of the benefits and adverse effects of legal clinical cannabis", authored by Dr. Russo, Mary Lynn Mathre, Al Byrne, Rob Velin, Paul Bach, Juan Sanchez-Ramos, and Kristin Kirlin? Are you familiar with that? Nothing comes to mind. And so if I said to you that that was essentially a study that examined -- well, are you aware of what the compassionate investigational new drug program is? I'm not. And if I indicated to you that the study that I'm referencing was an investigation into persons that had been receiving pre-rolled cannabis cigarettes for greater than 20 years from the U.S. government under the auspices of the National Institute for Drug Abuse and the compassionate investigational new drug program is the U.S. government's program that provides marihuana to a very limited number of patients and has done for a couple of decades, are you aware of that generally, that program? Not really, no. I will have no questions on that study. In terms
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of Exhibit 40 -THE COURT: Does he have Exhibit 40? THE CLERK: Yes, My Lord. MR. TOUSAW: Q I'm going to ask you to direct your attention to paragraph 44 of that study, and in paragraph -THE COURT: What part of Exhibit 40 are you -MR. TOUSAW: Paragraph 44, it's in the conclusory section, My Lord. It's the -THE COURT: His affidavit. MR. TOUSAW: The affidavit, yes, it's one of the paragraphs written by Suzanne Desjardins. THE COURT: Yes. MR. TOUSAW: Q In terms of paragraph 44, do you have that before you? A I do. Q Your superior at Health Canada, Suzanne Desjardins, wrote that [as read in]: Products made by persons who do not have the capacity to perform laboratory, pre-clinical and clinical studies such as those mentioned above . . . -- and she mentions some above in the previous paragraph -. . . are of unknown composition and quality and hence may pose additional risks to users. A Q A Q Do you see that? I do. That is a speculative statement, isn't it? I would agree with that statement. But it's a speculative statement? She uses what we described as careful language, that it may pose additional risks. It's a speculative statement, isn't it? Well, I think the reason that we carry out those tests, people and companies carry out those tests is to ensure that it's safe. Or to at least ensure that it's within the safety margins to the best of one's ability because there's no guarantees of safety, of course? Well, I think there are certain rules and regulations governing acceptable limits of certain
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contaminants or chemicals within certain products, and it's based on many years of research and rules and regulations and I think those -- you know, when you bring a product to market, I think, whether it's a toothpaste or something else, I think it has to conform to certain standards. That's my understanding at least. And those are the rules and regulations that a few moments ago you said you don't have any particular expertise in, correct? I don't, but it's -- I think it's general knowledge. But with respect to the statement that I'm asking about, that these products may pose additional risks, that's a speculative statement, that's not a definitive statement, is it? That's correct. And you sitting here today don't have any evidence that the products made and sold by the Cannabis Buyers' Club of Canada have caused any harm to any consumer, correct? I personally would not know. And in your conversations with Ms. Desjardins she didn't advise you that she had any personal knowledge of any harm that's come to the consumers of the baked goods and topical oils made by the Cannabis Buyers' Club of Canada, correct? That's correct. At paragraph 45 of Exhibit 40, the affidavit, again Suzanne Desjardins writes that essentially there are good reasons for pharmaceuticals to undergo lengthy and expensive processes that they undergo before being authorized for sale and that no cannabis-based products except for Sativex and no cannabinoid products except for Marinol and Cesamet have gone through those processes and received notices of compliance. Similarly, the cannabis being currently produced -- you see that quote, yes? I do. It's the case, isn't it, that the cannabis currently produced by persons with licences to produce cannabis issued by Health Canada, that cannabis does not go through any extensive analysis and is also not the subject of a notice of compliance, correct? That's because from my understanding marihuana is
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not an approved therapeutic product in Canada. Regardless of what your understanding is of why that's not occurring, it is the case that the cannabis that Health Canada authorizes people to grow or to grow for others does not go through the lengthy and expensive processes that are described in the affidavit and has not been issued a notice of compliance, correct? Yes. And the cannabis being produced under contract for the Government of Canada and being sold by Health Canada to authorized persons, that too has not received a notice of compliance, correct? It has not received a notice of compliance, no. Paragraph 46, the final paragraph in the affidavit Exhibit 40, Ms. Desjardins writes that: In the absence of any scientific evidence that cannabis-based products such as oils, ointments, baked goods, et cetera, bring any additional therapeutic benefits over those of marihuana (plant material) and in the presence of significant safety risks associated with the production of some of these products as well as the additional potential health risks associated to the unknown composition, characterization and effects of these products, authorizing their use in Canada would not be recommended.
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Do you see that quote? I do. That's an overstated conclusion, isn't it? Not in my opinion. There is scientific evidence, perhaps not clinical evidence, but there is scientific evidence derived from lab and animal studies that cannabis-based products can, in fact, be more effective with a lesser chance of negative side effects than smoked cannabis, isn't there? Not exactly. There's not clinical evidence of that, but there is laboratory evidence, there is animal study evidence that we've discussed over the last couple of days that supports cannabis-based products being more effective with a lesser chance of negative side effects than smoking cannabis,
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correct? I wouldn't agree. And just as you criticized Dr. Pate for you say not fully setting out possible negatives in his affidavit, paragraph 46 fails to note that there are significant negatives associated with smoking whole plant cannabis that do not exist when the compounds are ingested topically or orally, correct? There are different risks associated with smoking, yes. And that's not set out in paragraph 46, is it? No. And moreover, putting aside any risks associated with the quality control issues in the baking process, the risks of the compound themselves, the THC, the CBD, and the terpenes in a marihuana cookie, for example, are not qualitatively different for the cannabis cookies than for the approved drugs, Marinol, Cesamet, and Sativex, are they? I'm not sure I'm clear on your question. Putting aside risks involved in baking a marihuana cookie, contamination of food products, the fact of the matter is the pharmacologically active compounds in the marihuana cookie are the THC, the CBD, and possibly the terpenes, correct? That's correct. And the risks of those compounds, whether they're in the cookie or whether they're in Marinol, Cesamet, and Sativex are the same. It's the same compound and it carries the same risks, doesn't it? Not necessarily. Depends how much you're taking. Putting aside the dosing issue, it's the same compound, it has the same risks, doesn't it? Again, I disagree because we're talking about -- with pharmaceutical products we're talking about, in the case of Marinol and Cesamet, one compound or essentially one compound, with Sativex several compounds. It's comparing a little bit of apples and oranges. The risk of THC in Marinol, hundred percent synthetic THC in Marinol, there's no qualitative difference for the risk of THC in Marinol as compared to THC in a cannabis cookie, is there? It's the same compound.
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If you're comparing THC to THC then, yes. Similarly, Sativex is a whole plant extract, THC: CBD, and because it's a whole plant extract all the other things that are in the whole plant, correct? It's got the terpenes, it's got some of the other cannabinoids, that's in Sativex, isn't it? Yes, to my understanding. And the risks of those compounds, just the compounds, forget about dosing, forget about how the things are made, the risks of the compound themselves aren't any different for Sativex than they are for the marihuana cookie being produced at the CBC of C? It's the same compound, has the same risks, doesn't it? If we know the exact composition of those products and we're comparing them side by side, yes. And the use of cannabis-infused olive oil on a topical basis further reduces any potential risk because topicals eliminate any risk associated with the baking process and they eliminate any risk associated with the smoking process, don't they? They eliminate those particular risks, yes. And that's not in paragraph 46, is it? Not those particular risks that you mentioned, no. I'm going to suggest to you, Doctor, with the greatest of respect, that in coming to the facts and opinions set out in your affidavit you've overemphasized the potential risks and you've downplayed the potential benefits of cannabisbased medicines, haven't you? I've stated what I think. In drafting your affidavit and in including the sections written by Suzanne Desjardins, your use of the term "no scientific evidence" from critiquing Dr. Pate's opinions really means no clinical studies, doesn't it? Well, I'd have to look at exactly which paragraph and sentence you're talking about. And the reason, sir, that you use the term "no scientific evidence" when you really mean no clinical studies is because you in responding to Dr. Pate are prepared to discount anecdotal evidence, you're prepared to discount animal and laboratory research that supports Dr. Pate's opinions, but you are -- because the hypotheses
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developed in those studies plus what we have agreed are general pharmacological principles provide some scientific support for Dr. Pate's opinions, don't they? I think the scientific evidence is limited. But you don't say limited when you say no scientific evidence in your affidavit. You say no scientific evidence in portions of your affidavit. Well, with regards to oils, ointments, or baked goods, there isn't any scientific evidence. You're discounting animal studies and you're discounting laboratory research demonstrating hypotheses and general pharmacological principles of direct application to the site of pathology, and you're focusing, aren't you, on clinical studies, isn't that the case? With all due respect, Mr. Tousaw, it says cannabis-based products such as oils, ointments, and baked goods, and those have not been tested on animals or on humans, clinical or pre-clinical studies. What has been tested is single compounds. That's different from oils, ointments, and baked goods. There are citations in your "Information for Health Care Practitioners" document related to the use of baked goods by humans for therapeutic purposes, aren't there? Yeah, but that's anecdotal evidence. And that's evidence, isn't it? But it's anecdotal, it's not scientific. And you're prepared to discount that evidence, aren't you? I base it on the science. By contrast, when you set out your view of the risks and potential negatives of cannabis-based medicines, you are prepared to rely on laboratory research and animal studies, aren't you? I rely on the scientific evidence for therapeutic and adverse effects. You're even prepared to accept anecdotal evidence in the form of case studies based on self-reports when it comes to negatives which you're not prepared to accept when it comes to positives, aren't you? No, that's not necessarily the case. But you do so, and with specific reference you do so with self-reports of contact allergic
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reactions, you accept self-reports that the person came into contact with an allergen and that's what caused the rash, that's a self-report, isn't it? That's anecdotal evidence, isn't it? A Well, not necessarily anecdotal evidence. I also include in the "Information for Health Care Professionals" anecdotal evidence supporting and discounting. Q But not in your affidavit. In your affidavit you're prepared to accept anecdotal evidence, you're prepared to accept lab studies, you're prepared to accept animal studies when you're talking about risks, but you're not prepared to accept those studies when you're talking about benefits in your affidavit, isn't that the case? A With regards to the topical administration it was -- it was a report, anecdotal -- sorry, not an anecdotal report but a case report, yes, but there is no other evidence that suggests that it has an effect, a therapeutic effect. Q And the reason that you're prepared to accept lab and animal studies, highlight negatives but not to emphasize positives, is because you and your superior at Health Canada have a vested interest in defending the regulatory choices made by Health Canada, your employer and her employer, don't you? A Presenting the evidence, sir. Q It's much in the same manner that you say both today and yesterday and the day before that Dr. Russo's work can be called into question because he has a vested interest in promoting the positions adopted by his employer, GW Pharmaceuticals? That's the case, isn't it? A I don't know. Q The fact of the matter is that Health Canada through you and Ms. Desjardins, its employees, is attempting to restrict as much as possible Canadians' lawful access to cannabis and cannabisbased medicines, and that is why your affidavit consistently overemphasizes the potential and actual risks and consistently underemphasizes the potential and actual benefits that patients are obtaining from the use of these products, isn't it? A I'm basing it on -THE COURT: There were three questions there, weren't there?
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MR. TOUSAW: I think there was just one, but I can break it down. Q Health Canada through its employees, you and Ms. Desjardins, is attempting to restrict as much as possible the lawful access by Canadians to cannabis and cannabis-based medicines? MR. ECCLES: I'll object if that's the first question, My Lord. It's asking for a conclusion of law, and it is well beyond the area of expertise of this witness. Thats ultimately an issue for Your Lordship at the end of the day. My friend is asking -THE COURT: Well, who issues permits? MR. ECCLES: Health Canada does, My Lord, but this witness -THE COURT: So a question whether or not Health Canada restricts access, doesn't that go right to whether or not they are freely handing out permits or restricting permits? MR. ECCLES: It may well at the end of the day, My Lord. The question becomes how does Dr. Abramovici who is an expert in cannabis, its pharmacology, absorption, and distribution in the body, the pharmacological actions of cannabinoids and cannabis, therapeutic and adverse effects that can be consequence of its use, and the medicinal aspects of cannabinoids, how does that question fall within the expertise of this witness. THE COURT: As I said earlier, and that was a ruling, the fact that this witness is tendered as an expert does not mean his evidence is restricted to areas within his expertise. If he is an employee of Health Canada, he is fair game to be questioned on Health Canada policy, to the extent that he understands it or is familiar with it, or any other part of the workings of Health Canada. MR. ECCLES: Yes, My Lord, and if my friend wishes to ask policy questions of the witness, he can do so as policy questions, in my respectful submission -THE COURT: That's what he just did. MR. ECCLES: In my respectful submission, no, he did not, My Lord. He asked the witness his view of the legal approach, the word "legal" was packed into the question. That asked this witness to give a legal opinion. That is an area no witness can testify to, regardless of whether they're in
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direct or cross, unless they're called and qualified as an expert in law on an issues alive before the court. In my respectful submission, this witness has not been qualified in these areas. He can be asked as to whether that is the policy of Health Canada to his knowledge, but that is not what my friend is asking. My friend is asking whether Health Canada has a legal interest, is attempting to legally do things. That incorporates into the question an element this witness, in my respectful submission, cannot answer because his answer cannot be relevant. Generalized cross does not open up a witness who is not qualified to give legal opinions to be cross-examined on the law. That's my objection. Policy, yes; law, no. And my friend phrased the question as inviting a legal opinion, at least the portion that I heard. Perhaps he was going to put something at the end of it, but as soon as the word "legal" appears with a witness who's not here to give a legal opinion, the Crown will object. COURT: All right. I don't need to hear from you, Mr. Tousaw. The question, in my view, did not invite this witness to voice a conclusion of law or to give an opinion on a matter of law. I agree that if he were asked he would not be permitted to do so. The question, as I understood it or recall it, was whether or not Health Canada, as a matter of policy perhaps, was deliberately restricting access by the public to legal sources of marihuana. That is an entirely different matter than asking the witness for a conclusion of law. I think the question as phrased was entirely suitable. ECCLES: Thank you, My Lord. TOUSAW: Thank you, My Lord. Do you remember the question? I do not. The fact of the matter is that Health Canada through you and Ms. Desjardins, its employees, and in the affidavit you filed in these proceedings and then testimony that you've given is attempting to restrict as much as possible Canadians' lawful access to cannabis and cannabis-based medicines, and that reason is why your affidavit and the conclusions of Ms. Desjardins consistently -COURT: Now, Mr. Tousaw, that's two questions. Are
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they restricting deliberately is a question. If the answer is no, the second question becomes irrelevant. If the answer is yes, you can go into why they're doing it. But that was my problem the first time. If I get a yes, what is it, that they're restricting? TOUSAW: Understood, My Lord. The fact of the matter is that Health Canada through you and Ms. Desjardins, its employees, the filing of the affidavit in these proceedings is attempting to restrict as much as possible Canadians' lawful access to cannabis and cannabisbased medicines, isn't it? I can't comment on that. And that is why your affidavit consistently overemphasizes potential and actual risks and consistently underemphasizes potential and actual benefits that patients are obtaining from the use of these products, isn't it? The risks are better known than the benefits. TOUSAW: If I could have a moment, My Lord. COURT: Yes. TOUSAW: Doctor, we established two days ago that paragraphs 43 to 46 of the affidavit that you signed and filed in these proceedings were written by Suzanne Desjardins before she wrote and you inserted those paragraphs. Did you have different conclusions? Had you had something there that was replaced by Ms. Desjardins' language? No. TOUSAW: Those are my questions for this witness, My Lord. COURT: Re-examination? ECCLES: Thank you, My Lord.
RE-EXAMINATION BY MR. ECCLES ON VOIR DIRE: Q A Q A Q Dr. Abramovici, what if any impact will the results of this case have on your employment or your job duties? I have no idea. I don't know. In your affidavit material you include at Tab G of Exhibit 40 the "Information for Health Care Professionals", the entire document, don't you? Yes. And in that document you cite various studies at
739 VOIR DIRE Hanan Abramovici (for Crown) re-exam by Mr. Eccles
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various points throughout the document, correct? A That's right. Q Why? MR. TOUSAW: My Lord, doesn't arise or could've been asked in direct. Doesn't arise out of cross. MR. ECCLES: I'll refocus then. Q The information for health -THE COURT: It seems to me, Mr. Tousaw, that I may have throttled Mr. Eccles down in terms of his examination in chief when I presented him in effect with the consideration whether he would file the document or walk through examination in chief using the document as the template perhaps, but I'm not sure that it's a fair objection when I invited him not to spend a great deal of time going through each page of this document to say, well, he could have. I think I must have given Mr. Eccles the very clear impression that if he had tried to do it in chief, I'd have been a bit cranky. MR. TOUSAW: My Lord, that may well have been the case, but my recollection is that my friend did walk the witness through substantial portions of the affidavit in chief, whether that was a -- whether his decision not to walk him through every paragraph was one borne out of strategy or a desire to conform with the implied statements that Your Lordship made, I don't know, but he certainly did conduct direct examination on the affidavit. In any event, I'll withdraw my objection to that question. MR. ECCLES: And I'll rephrase the question, My Lord, and back it up. Perhaps before I turn to that, could Dr. Abramovici please be shown Exhibit 41 which is the article entitled "Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain." Q My friend asked you some questions about this, Dr. Abramovici. You have the Exhibit 41 in front of you? A I do. Q The abstract states: This study compared the efficacy of a tetrahydrocannabinol:cannabidiol (THC:CBD)
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extract . . . From that study do you know whether that extract was actually Sativex itself? I don't think the study says that it is Sativex per se. Now, does the study say whether the THC extract is Marinol, the synthetic THC extract? Does it identify what precise THC extract is being used in this comparison study? Not that I know of, no. Now, at the page 168 under the "Introduction", the second full paragraph under "Cancer pain is a common problem", there's a description of cannabis containing 60 or more cannabinoids, correct? Yes. Sixty or more -- my friend asked you a question in relation to your report in which you indicated there are more than 60 -- now more than 70 cannabinoids that are known, correct? Yes. And the health care practitioners' guide refers to more than 60, correct? I believe so. Just before you refer you to that, the use of "more than" indicates that 60 is the baseline and there's at least 60 and possibly more, correct? That would be my interpretation, yes. Now, in this particular document at this paragraph the main ones are identified and there's a cite 4.5, and I take it if we look to the end of the article we find a reference to correspond to that footnote at the back of the article which is 425, actually. It's the House of Lords Select Committee on Science and Technology, London U.K. House of Lords, 1988, and then a GW Pharmaceutical and product monograph for Sativex. Those are the two sources for that statement, correct? That's right. And the product monograph for Sativex is incorporated in your affidavit as an exhibit to it? It is. The report carries on: Sativex, an endocannabinoid system modulator, is produced by GW Pharma Ltd,
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United Kingdom. It is derived from strains of Cannabis sativa L. plants developed to produce high and reproducible yields of principal CBs . . . A And that would be cannabinoids, correct? Yes. . . . (THC and CBD), with minor amounts of other CBs and terpenes in a solution containing ethanol, propylene glycol, and peppermint oil flavoring. The named CBs constitute at least 90% of the total CB content of the extracts. And then a description of CBs. Does that assist at all in determining what it is they're actually giving to patients as part of this study, whether it's Sativex or something else? No. From your work in the area, your preparation of the health care practitioners' guide and your review of the literature, are the plant sources that are used to create Sativex, are they a known strain or are they just grabbing marihuana off the street? These are known strains. Now, at page 170 of the report there's an indication in this report under the study design that 33 individuals dropped out, correct, for various reasons that -- adverse event, consent withdrawal, other. So that's under the column of THC:CBD 12 withdrawn, THC extract 13 withdrawn, adverse event 7, consent withdrawal 2, sponsor decision 1, protocol violation 1, other 2. And then under the placebo, withdrawn 8, adverse event 3, consent withdrawal 2, other 3. Before we -- do you know whether anywhere in the paper they define what "other" is? Or would we just have to read the paper and see for ourselves? I'd have to read -- I'd have to look through the paper to see, yes. Thirty-three dropping out out of a total of 192, 16, 17 percent dropout rate, isn't it? I would assume, yes. From your review of the literature and from your review of clinical trials generally, is that a
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normal dropout rate or is that a high dropout rate? To be honest, I don't know. Now, could Dr. Abramovici please be shown Exhibit 42, please, which is the "Adverse effects of medical cannabinoids: a systematic review". Now, my friend put to you the abstract heading, the results. Under the heading "Interpretation": Short-term use of existing medical cannabinoids appeared to increase the risk of nonserious adverse events. The risks associated with long-term use were poorly characterized in published clinical trials and observational studies. High-quality trials of long-term exposure are required to further characterize safety issues related to the use of medical cannabinoids. Are you aware of the existence of high-quality trials of long-term exposure of medical -- to characterize safety issues for medical users? No, not generally. And if we turn to, well, the first paragraph on the first page: Cannabis is widely used as a recreational drug, with an estimated worldwide annual prevalence (defined as use at least once per year) of 160 million. That's the definition they use for recreational drug use. Do you know whether there is a consistency in the scientific literature as to the definition of recreational use, moderate use, heavy use, and chronic use? Are these terms defined within the literature? Is there an accepted definition across the literature for what constitutes chronic use? I don't think so, no. And if we look to the interpretation section of this article at page 1675, it states: In our review, we identified 8371 adverse events related to medical cannabinoid use, 4779 . . .
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That's the first paragraph. None of the reported adverse events was unexpected, according to the International Conference on Harmonisation criteria. And then it carries on: Although the randomized controlled trial is a powerful study design, several aspects of the quality of reporting of adverse events in published trials limited our results. And then it carries on to describe the difficulties: First, not all published cannabinoid trials provided safety information; we excluded 28 randomized controlled trials, including 2 trials that examined cannabis smoked by patients with HIV infection because they did not quantify adverse events or they reported events for only one intervention group. Is that a valid concern for a scientific -- for a scientist who's reviewing another scientist's work, these sorts of concerns? Yes. It carries on: The Jadad . . . A Q What is Jadad? I believe that that's a way of measuring the levels of evidence in scientific studies. And the authors of this study indicate: The Jadad score does not adequately reflect the quality of safety reporting in randomized controlled trials, which meant that rating by the Jadad scale indicated good methodologic quality for these studies, despite their poor reporting of safety. Is that a legitimate concern for a scientist when reviewing studies that have been done in the
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field? Yes. Second, most of the trials selected did not provide both the absolute number of adverse events and the number of participants reporting at least 1 event, as recommended by the Consolidated Standards of Reporting Trials (CONSORT) statement. Is that also a legitimate concern for a scientist reviewing another scientist's work or study, preclinical, clinical trials? Yes. This meant that we could focus only on the incidence of adverse events, rather than being able to analyze both the incidence rates of events and the risks for participants who had reported at least 1 event. Third, because of the lack of data on frequency of adverse events for each patient, we had to assume that the occurrence of adverse events was independent, which would not be a valid assumption if a patient had experienced more than 1 event. This assumption would result in generation of artificially narrow CIs around the RR estimates, which might have affected the results of significance testing. What is artificially narrow CIs, what does that mean? That refers to confidence intervals which is a measure of data reliability. And what's the RR estimates? I think they're risk ratios. And are the concerns expressed by the authors of this report in relation to the studies they've reviewed, are those valid concerns for any scientist to have regarding work in the field? Yes, very much so. And as is often the case with research papers of this sort, at the end of the paper there are references numbered 1 through 60 corresponding to the references within the article, correct? Yes.
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Now, my friend put to you there are different risks associated with smoking as opposed to oral ingestion and that information is not in the affidavit. Is that information in Exhibit G, "Information for Health Care Practitioners", the varying risks between smoking versus other methods of ingestion, smoking versus inhalation through vapour, smoking versus oral ingestion, is that dealt with in the info for health care practitioners? I believe so, yes. My friend put to you that you -- and that's part of your affidavit as an exhibit thereto, correct? That's correct. My friend put to you, you do not have any knowledge of harms to consumers of products made by the Cannabis Buyers' Club. If I was to suggest to you that one individual purchased, on the evidence of Mr. Smith, a hash oil product, apparently waited a month and then consumed the product, experienced a significant enough adverse event that he had to be admitted to the hospital for treatment of some kind of unidentified event arising out of his use of the substance. Would that be a harm to a consumer of a product made by CBC, assuming everything I've told you in hypothetical to be correct? Yes. You didn't receive a copy of the evidence of Mr. Smith to review before you gave your evidence in these proceedings? I did not, no. Now, my friend put to you that we now know tobacco is epidemiologically linked to cancer. You know that to be so, correct? Yes. Do you know how long it took to establish an epidemiological link between tobacco and consumption of cancer in smoked form? Probably three decades or so. Now, my friend put to you various portions of Tab G and certain sentences under the headings at page 8, for example, of that particular document, and it was in relation to the dosing, the smoking section. He took you through, then he turned to the sections dealing with the indications and use, nausea and vomiting and wasting symptom, and you
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advised the information presented in the previous and this section is a summary of the clinical and pre-clinical studies. Now, when you prepared the "Information for Health Care Practitioners", were you intending it to be read as a -- for example, the section on nausea and vomiting at the bottom of page 9, it's one sentence at the heading 4.1, and I believe my friend took you to one or two sentences within that paragraph. Was that paragraph intended for health care practitioners to read in its total? Are they to read the whole document or are they to just pluck a sentence out? No, it was for them to read in its entirety or as a whole, yes. And in each section under nausea and vomiting, for example, there's the first sentence, at the end of the first sentence, bracket 108, end bracket, period. What's that a reference to? TOUSAW: My Lord, I rise to object. My friend asked that question in direct. He took him to Tab G. He asked him what the numbers meant. I think we all know the answer is they're citations to studies, but this testimony has already been given. ECCLES: Then I'll move to the next question, My Lord: Why cite the studies? TOUSAW: My Lord, again, that question was asked in direct. COURT: Are we covering the ground again, Mr. Eccles, and, if so, is there a useful purpose in doing so? I mean, I'm prepared to accept that someone in Dr. Abramovici's position, when he cites through a footnote the source of the information, is doing that so that the reader will be able, if the reader wishes, to look at the cited material, or if the reader doesn't wish to spend a great deal of time reading all of it will have at least some comfort that there is some authority for the statement footnoted. Do we need to go any further? ECCLES: No, My Lord, I'll move on to a more general question. My friend put to you a number of times that -- the concept of systemic delivery of THC or CBD orally versus smoked. What exactly -- when you use the phrase "systemic delivery" and the measurement of
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nanograms per millilitre of blood or as an example of an indication of systemic delivery, what do you mean by systemic delivery? That it goes throughout the body. In relation to the systemic uptake of oral ingestion as set out in your answer to questions to my friend and in your report, you describe systemic uptake of oral ingestion as slow and erratic, and my friend put to you and that's a function of the first-pass effect, and your answer was, in part. What else is it a function of when one orally ingests and the systemic uptake tends to be slow and erratic? Is it purely a first-pass effect or is there something else playing in there? There are many variables which govern oral absorption of a drug. That can be differences in digestion between people, what kind of food you've eaten, when was the last time that you ate, genetic differences in metabolism. There are a whole host of factors. My friend put to you if one reduces the amount of cannabis ingested by smoking and if one can reduce that amount by offering oral ingestion, that would be a benefit to the health. Could Dr. Abramovici be shown Exhibit 18 in these proceedings, please. TOUSAW: My Lord, while the clerk is finding Exhibit 18, I'm going to rise to object. This was not put to the witness in direct. It could have been. I did not put it to the witness in cross. It does not arise out of cross. COURT: What is Exhibit 18? ECCLES: Exhibit 18 is the Cannabis Buyers' Club of Canada medicinal cannabis recipe book, My Lord. I have an extra copy for Your Lordship. COURT: I think I must have it somewhere. ECCLES: It may save Your Lordship a bit of time. I'm quite certain that one has no marking on it. My recollection was I actually did seek to put this to the witness in direct, and my friend objected on the basis that the witness was not called as a medical expert and it was beyond the scope of his expertise. Your Lordship upheld that objection. My friend proceeded in his crossexamination to ask the question that I've just put to the witness regarding health, a benefit to health through oral ingestion. What I propose to
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ask the witness is whether he is aware from his review of the literature of any literature to support any of the claims made at the second paragraph of the first page of Exhibit 18. TOUSAW: My Lord, that doesn't arise out of crossexamination. I didn't put this exhibit to the witness. I didn't ask him about health claims. He's not a medical doctor. My friend attempted to do this in direct. He was prevented from doing so by way of objection and Your Lordship's ruling. He's now attempting to back-door it in again. COURT: Well, but your friend says you did ask about the respective health benefits of oral ingestion versus smoking, and I do recall that was asked more than once. If that were a relevant line of inquiry in cross-examination, how does it become irrelevant in re-examination? TOUSAW: That's not the line of examination my friend proposes to embark upon. The paragraphs at paragraph 18 that he's made reference to don't speak to that particular issue, at least the paragraphs at page 1 that he's referred to. It talks about replacement of allopathic medicines. That's a medical issue. It's not an issue of oral versus smoking. It speaks to studies. It indicates that the recipe book is a guide to preparing and using cannabis. ECCLES: My Lord, I wasn't going beyond the single paragraph. My friend is going further into the materials. If he wants me to, I'm happy to reexamine in that area as well. COURT: All right, well, Mr. Eccles, maybe you can show me, now that I'm looking at the paragraph, how that arises out of the witness's answer to a question about oral ingestion versus smoking. ECCLES: And health benefits, My Lord, it's the -TOUSAW: My Lord, perhaps the witness could be excused for this discussion. COURT: I don't think Dr. Abramovici is going to be polluted by this discussion. I suspect he's a bit more resistant to suggestion than that. ECCLES: It's the second sentence, My Lord, that I respectfully submit the Crown is entitled to ask their expert about because my friend has opened the doors to smoked versus oral ingestion having health benefits. This is a specific reference of extracts in the context of a cannabis recipe book
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that my friend entered as an exhibit as part of his case that makes certain claims regarding the health benefits of those products. I would like to ask the expert whether he's aware of any material anywhere to support the sorts of claims advanced in that paragraph. COURT: Does that presuppose that I should be permitted to accept as true the claim in this paragraph, in the sentence in the paragraph, because I wasn't proposing to do so. ECCLES: I'm not suggesting it is true, My Lord. This may well impact on the proposed s. 7 remedy my friend seeks and the basis upon which he seeks it based on the line of cross-examination he's pursued with Dr. Abramovici. COURT: All right. Mr. Tousaw, final word? TOUSAW: My Lord, that sentence has nothing to do with health benefits of extracts versus smoking. It doesn't even reference smoking in any way. It's a paragraph that speaks to some medical claim that this witness, frankly, hasn't been qualified to respond to. COURT: I think it's relevant, and I think it arises out of the line of cross-examination, and I couldn't cite particular questions, but the general impression I have where this witness was asked about the existence or his awareness of whether or not there have been studies that demonstrate efficacy of cannabis products when applied directly to the site of the pathology, whether it's a skin lesion, a wound, or something internal. Seems to me that that sentence the Crown wants now to put to Dr. Abramovici goes directly to that subject canvassed at some length in cross-examination. I don't know whether it arises or it's connected in any way with smoking versus oral ingestion, but it seems to be related to other aspects of cross-examination, and before we get the answer we'll let Dr. Abramovici study on his answer over the break. Fifteen minutes. (WITNESS STOOD DOWN) (PROCEEDINGS ADJOURNED FOR MORNING RECESS) (PROCEEDINGS RECONVENED) HANAN ABRAMOVICI, recalled.
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RE-EXAMINATION BY MR. ECCLES ON VOIR DIRE, CONTINUING: Q A Q Doctor, do you have Exhibit 18 in front of you? I do. I direct your attention to the second full paragraph on the page and the two sentences that read: Cannabis can be used to replace almost any type of allopathic medicine, from diuretics to anti-depressants, ear oil; throat sprays and salves that reduce tumors. Extracts have been found to be effective on everything from bacteria and fungi, to the herpes virus and staphylococcus. Are you aware of any literature, clinical, preclinical studies to support the assertions that are made there? MR. TOUSAW: My Lord, I don't know if my friend is asking about any literature or just clinical and pre-clinical studies. MR. ECCLES: Q I'll start with pre-clinical or clinical studies. Are you aware of any pre-clinical or clinical studies to support these assertions? A Well, with regards to the second sentence, the only thing that I have to say is that certain cannabinoids have been found in vitro to have -- if I refer to my -Q And you're referring to Exhibit 40 at this point? A Yes, I am, yes. Q Are you referring to the text of your affidavit or to one of the exhibits to your affidavit, just so we're clear on the record. A Oh, I'm sorry, to the "Information for Health Care Professionals". Q That's at Tab G, Exhibit G to your affidavit, correct? A That's correct. Q And something has twigged your recollection? A Yes, I'm just trying to see if it's in here. Well, I would say to the sentence: Extracts have been found to be effective on everything from bacteria and fungi, to the herpes virus and staphylococcus.
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No, to that I know of. And the first sentence: . . . to replace almost any type of allopathic medicine, from diuretics to antidepressants, ear oil; throat sprays and salves that reduce tumors.
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No. Are you aware of any anecdotal studies that have been reported in recognized scientific literature to support either of those assertions? Not off the top of my head, no. ECCLES: Thank you. Those are my questions, My Lord. COURT: May this witness be excused? TOUSAW: Yes, My Lord. COURT: All right, thank you, Dr. Abramovici, for your assistance. You're now excused. WITNESS: Thank you very much, My Lord. (WITNESS EXCUSED)
MR. ECCLES: The Crown now calls Mr. Eric Ormsby to the stand. He's just out in the hall. And, My Lord, the Crown will be seeking to qualify Mr. Ormsby -I believe when we were last before Your Lordship I left a copy of his affidavit for Your Lordship's review, but I have an extra copy. THE COURT: Yes, I have it. MR. ECCLES: Thank you, My Lord. That simplifies it. I will be seeking to qualify Mr. Ormsby as an expert able to assist the court with opinion evidence in the following areas; the science-based drug regulatory processes for therapeutic and pharmaceutical products in Canada and as recognized for regulatory processes internationally, the approval process for new drugs brought to market in Canada, including the drug development and clinical trials process, the consequences -- thirdly, the consequences of noncompliance with this process and the failure to properly identify harms and benefits of new drugs or drugs for which new claims are advanced, and, finally; fourthly, the Health Canada drug review process and its exceptions. THE COURT: Mr. Tousaw?
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MR. TOUSAW: Yes, My Lord, I don't take issue with the witness's qualifications in those areas. Having reviewed the affidavit that's been presented to Your Lordship, it was difficult for me to discern which areas of the affidavit are opinions requiring this witness to be tendered as an expert. I'm unclear from the affidavit what the opinions are and why there's a need to qualify him as an expert to tender any of the evidence in the affidavit. I also have some concerns about the particular relevance of the material, but that's a matter for argument. THE COURT: Mr. Eccles, why is any of this a matter of opinion? I mean, presumably this man says I'm familiar with the processes and I can tell you how they work. MR. ECCLES: Yes, My Lord, and -THE COURT: There's no element of opinion in that, is there? MR. ECCLES: In my -- well, out of an abundance of caution I would say yes, there is, My Lord, because the witness is being asked to describe the science-based drug regulatory processes that govern the marketing of therapeutic and pharmaceutical products and what is required to comply with those particular processes. THE COURT: That's all presumably a matter of regulation, policy manual, or the practices of Health Canada or the Food and Drug Administration or anybody who licences. Why don't we do this: I'm reluctant to just in a vacuum say this fellow is an expert in this. I don't doubt that he has all of the expertise in the world in these areas. I just don't think it's a matter of opinion. If you get to that, Mr. Tousaw can object, but I propose to hear his evidence and if you run into a rock that says this requires an opinion and that opinion requires expertise, we'll deal with it then. MR. ECCLES: Certainly, My Lord. I was hoping to be able to expedite the tendering his evidence by filing his affidavit rather than taking him through it viva voce, but I'm quite content to take him through it. THE COURT: What is the -- I haven't read it. What is the affidavit and why is it coming in an affidavit form?
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MR. ECCLES: It comes in an affidavit form because from my review of the materials in the affidavit much of it is simply fact driven, but portions of it require an opinion as to whether what is required to meet the sections of the FDA, what steps have to be taken, the costs associated, the labours associated, the overview section, paragraphs 4, 5, 6 is some of the background. Paragraph 8(c), for example, does require, in my respectful submission, a drug with respect to which the manufacturer prescribes, recommends, proposes, or claims a use as a drug or condition of uses of a drug including dosage, et cetera, that is an area within the context of the paragraph. The FDR contains special rules, the term new drug is defined, how that definition works in practice, what the impacts are on, what if any impact that definition has on a grandfathered substance. Those are areas that do call for opinion. And in dealing with, for example, I have a very limited number of questions that I propose to ask Mr. Ormsby regarding the contents of his affidavit. That was one of the paragraphs that I was specifically going to ask him about. But there are very few. Paragraph 8 -- well, the final sentence of paragraph 4, how and why this is a concern. Paragraph 8, an example and what grandfathering -- how grandfathering a drug fits within the FDR scheme described or program described, paragraph 8. Paragraph 12 and 13, for example, what do you mean by manufacturing and quality control in order to ensure consistent product quality, how much of a concern is this in the process of regulating drugs and how does one address this concern. And the clinical trials section is an area that is not purely statute driven, it's a description of the clinical trial process and why it's important to follow it. Your Lordship has heard evidence from Dr. Pate on that, some evidence from Dr. Abramovici on that. This witness has further specific evidence to this area. And this is -THE COURT: But I assume that he is here because he is thoroughly familiar with the regulatory process, the licensing process, and why from his
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understanding both are necessary for public safety in Canada. ECCLES: Yes, My Lord, and the why portion is where he's being asked to render an opinion. COURT: It's not an opinion. It's patent. Unsafe drugs are dangerous to the public. There's no opinion in that. That's why the government regulates drugs. I'm not sure that we need to worry too much about this, Mr. Eccles. I am perfectly willing and you can lead this man through what he does for a living and how long he's done it and what his exposure is to the regulatory process and how long has he worked in it. I'm sure he's going to be a big help. I just don't see it's a matter of opinion. It's a matter of his experience, training, and what he does for a living and what he understands is the reason that these regulatory schemes exist. ECCLES: Yes, My Lord, and it may well be -COURT: I don't think you need to worry about the opinion and qualifying him. As I say, if we get to a point where either Mr. Tousaw gets concerned and objects or I think as the gatekeeper we need to get into the qualifications of this man as an expert in a particular field, I'll put my hand up and tell you we're there and we can go through it. ECCLES: Certainly, My Lord. The only other -- I don't know whether one calls it a caveat or direction that the Crown would -- caveat for my friend, direction from Your Lordship, is the Crown would propose to lead Mr. Ormsby through the report and lead quite heavily as to the content of the report. COURT: Well, maybe we can ask Mr. Tousaw. Mr. Tousaw, as unusual as it may be to receive the evidence of a witness in affidavit form in a criminal trial, even in a voir dire, are you content to have this witness's evidence in chief taken in affidavit form with such elaboration as Mr. Eccles wishes to pursue, or shall we simply read along as Mr. Eccles leads him through it? TOUSAW: My Lord, I am content to have it taken in affidavit format and have my friend lead him through the portions that he feels necessary to expand upon. I will potentially rise to object if we stray into areas of opinion evidence that I think require qualification or areas of opinion
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evidence for which the Crown has not provided notice. COURT: Well, Mr. Eccles, let us do it that way. We will mark the affidavit which I take it -- or to which I take it refers to all of these exhibits as an exhibit in this trial. And by agreement of the defence, the affidavit and exhibits will stand as Mr. Ormsby's evidence in chief, subject to any elaboration, qualification or clarification you wish to lead him through orally. And that will presumably get us to cross-examination in a somewhat more efficient fashion. ECCLES: Yes, My Lord. Thank you. COURT: What number are we at? ECCLES: And I thank my friend. CLERK: Forty-three. COURT: Exhibit 43? ECCLES: Thank you, My Lord. EXHIBIT 43 (on voir dire): Large cerlox bound volume, affidavit of Eric Ormsby
EXAMINATION IN CHIEF ON VOIR DIRE#1 BY MR. ECCLES: Q A Q Mr. Ormsby, you have your own copy -I have --- and perhaps I could just ask our clerk produce to you what is now marked as Exhibit 43. And if you could just confirm that what is placed in front of you as Exhibit 43 is identical to the materials you've [indiscernible] ECCLES: Oh, I am sorry, he hasn't been sworn yet, My Lord. COURT: Yeah. ECCLES: I am getting well ahead of myself. COURT: Well, we could probably just have a chat, but I don't think that would be terribly effective from the record point of view. CLERK: Would you like to swear on the Bible or have a solemn affirmation? Solemn affirmation. ERIC ORMSBY a witness called for the Crown, affirmed. THE CLERK: Please state your full name and spell your
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756 VOIR DIRE Eric Ormsby (for Crown) in chief on voir dire by Mr. Eccles
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last name for the record. A Eric Ormsby, O-r-m-s-b-y. THE CLERK: Thank you. THE COURT: Have a seat, Mr. Ormsby. Are you going to go through the CV, Mr. Eccles? MR. ECCLES: Briefly, My Lord. EXAM IN CHIEF ON VOIR DIRE BY MR. ECCLES, CONTINUING: Q Mr. Ormsby, you have Exhibit 43 before you and just before we get to your CV, can you just confirm for us that the Exhibit 43 that is in front of you is the same as the copy of the materials that you have? Yes, it is. Now, you are currently employed by Health Canada as the manager of the Office of Science Bureau Policy Science and International Programs, Therapeutic Products, Director of Health Products and Food Branch Health Canada, correct? That's correct. And you have had -- you filled that role since October of 2000, initially as the acting in the post and then you were formally appointed to the post in 2008, correct? Correct. And you have held it ever since? Yeah. And as the manager, you report to a Lisa Lange, who is the acting director of the department, correct? Yes. Your responsibilities at paragraph 3 of the affidavit are set out, correct? That's correct. And your background is as per your curriculum vitae which has been handed to His Lordship, do you have a copy of that document? I don't. Producing it to you now. And just -- and that sets out your background, your areas of particular work expertise, your knowledge and your experience, including 1982 is when you received your Masters of Science from the University of Guelph and Statistics, correct? That's correct.
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Previously, in 1979, you received your Honours Bachelor of Science from the University of Guelph, major in Genetics, minor in Statistics, correct? Correct. And in 1979, an Honours Bachelor of Science was a four-year degree instead of a three, is that correct? Oh, yes. Yes. And your membership is the Statistical Society of Canada, the biostatistics section of the Statistical Society of Canada and the Statistical Society of Ottawa are set out there, correct? Correct. What is biostatics? Biostatistics? Biostatistics, what -- what -- is that a sub-field or what? It is a branch of statistics where the subject matter is biological in nature as opposed to Statistics Canada or something like that. And you are also a member of the Drug Information Association, Canadian Society of Pharmaceutical Sciences and the American Association of Pharmaceutical Sciences, correct? That's correct. And then your employment history is set out October 2000 to present, the manager of the Officer of Science -- Office of Science initially as the acting manager for eight years and then appointed as the manager in October of 2008, correct? Right. And in 1997 to September 2000, you were the chief risk management methods officer for the Bureau of Policy and Coordination Therapeutic Products Program, Health Protection Branch, correct? That's correct. And the balance of your employment is as set out in your CV, correct? That's right. And then you have listed as well your publications in most recent first and back through until your -- your first publication comparison of fresh -- Number 20, Journal of Food Protection -Mm-hmm. -- comparison of fresh feces with lyophilize frozen cultures of feces as inoculate prevent
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salmonella infection in chicks, correct? That's correct. You have 20 publications. I note from reviewing the list, none of them are specific to cannabis or cannabinoids, correct? That's correct. And do you work with or for the medical marihuana -- Marihuana Medical Access Regulations Division of Health Canada? No, I don't. Do you provide advice or assistance to them? As a policy and when that was being developed, they had to sort of work with us in order to develop a process. Now, in your affidavit, you've -- you set out in the first three paragraphs, your employment, that you are the manager, what your role is. And then at paragraph 4 in the Overview section, the first question I will ask: who prepared the affidavit? It was -- I prepared that with help from our policy people. Which portions of the materials did the policy people specifically assist you with or can you recall? Just obtaining the actual regulations and some background information of how things were approved. So, for example, at tab A of your affidavit is a printout from the Internet made available by Health Canada, that is something that provided to you by the policy -Right. -- department or by your -- you -- you found on your own? The policy would access those for me. All right. And in your affidavit, you've -- we will find the reference to Exhibit A in the body of the affidavit, correct? That's correct. As far as the actual description of the sciencebased drug regulatory process, the safeguards that are part of that process and how the process operates under the legislation, is that material that you know from your employment or is that material that you needed to acquire from the policy direction? From my employment experience with, yes.
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Now, in the overview, you describe science-based drug regulatory processes at paragraph 4 in general. And in the last sentence of paragraph 4 of your affidavit, you refer to: In these ways, regulatory oversight increases the probability that drugs on the market will be safe and efficacious under their recommended conditions of use. And that is the conclusion to the paragraph. Is that a particular concern for you in your work and for Health Canada in the regulatory process? Yes. That's the basis of the whole approval process is to assess the risks and the benefits of a drug before allowing it on the market. Why? So that the safety of the patient, the physician can have an informed decision when trying to decide what drug a patient should have to treat them with. Now, paragraphs 5 and 6 are general overviews. Paragraph 7 deals with after you have discussed the general overview and then paragraph 6, s. 2 of the FDA is set out. Paragraph 7: Based on this definition, a distinguishing feature of a drug is its purpose. And you note, the source may vary. Typically they are associated with chemical manufacturing processes, but that is not always the case. They can also be biologically derived. And you give an example of: Reminyl . . . a drug used in the treatment of Alzheimer's disease . . . derived from the bulbs of a Narcissus plant.
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Correct? Correct. And purpose, distinguishing feature of a drug is its purpose. You then carry on at paragraph 8: The FDR contains special rules respecting the approval . . . of new drugs.
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And then the term "new drug" is defined in the Federal Drug Regulations. At paragraph 8(c), you give a definition, is that definition straight from the regs? That's right from the regulations, yes. Now, we have heard some evidence in these proceedings about drugs that are, and the expression that has been used is grandfathered. Aspirin is an example of, as I understand it from the evidence we have heard, a drug that was grandfathered in and accordingly, it did not need to go through the full clinical trial process that a new drug has to go through, does that accord with your understanding? That's correct. It was approved in the early 1900s actually before we even had the Food and Drugs Act. So when the Food and Drugs Act came in, what was on the market was sort of grandfathered. What happens if the manufacturers of Salicylic Acid, Bayer Aspirin, or any other manufacturer of that product, advances a new claim for what the drug will do, is there a process that must be followed as per 8(c)? So under the current regulatory approval, one would have to supply the government with a new drug submission. And in that, they must provide us with clinical trial data to show the drug is safe, it's effective and also that it has been made with high quality. Taking the example of Aspirin, did Aspirin, Acetylsalicylic Acid, was it required to comply with the new drug procedures, clinical trials and the like within the last 30 years or so? Yes. The new indication for heart -- heart disease had to come through with the full submission requirements under the new drug. So just so I'm clear, any -- any drug that is currently marketed for a specific treatment and has been approved for such, if they discover a secondary purpose to the use of the drug, they have to resubmit? They have to resubmit and get another notice of compliance. Yeah. On occasion, drugs may be developed for one purpose and found to be more effective for another, that accords with your experience,
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correct? That's correct. A classic example for men would be Rogaine, correct? Correct. Was initially a heart medication as I understand it? I'm not sure. But they discovered if you rub it on your head -It was --- it helps --- it was a side effect that they noticed, yes. -- hair grow? And the side effect is what it is currently marketed for? Correct. And it would need to -- if that side effect is something that the drug manufacturer wishes to market to the public for and it's not already licensed for that purpose, do they have to then submit? They'd have to submit a whole submission. Now, you described the -- the process at paragraphs 9, 10 and 11. And in 11, you -- you note Sativex and you have included as Exhibit D. So Exhibit A is the circular from Health Canada on health product, safe effective high quality pharmaceuticals. Exhibit B is the notice of compliance for Cesamet or Nabilone, correct? That's correct. And that's -- and in your affidavit, a notice of compliance, it is shorten down to a NOC, N-o-c, correct? That's correct. And then Exhibit C is the notice of compliance for Marinol, correct? That's correct. Both of those are marketed within Canada under the Food and Drug Acts -Yes. -- and can be prescribed by any physician? That's correct. And then D is Sativex, which is the authorization with conditions for Sativex, published by Health Canada. What is the purpose of that document? This is a -- since the drug obtained a notice of compliance with conditions, we publicly go out and let the -- usually the physician know exactly what
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the conditions are. And it's a notice of compliance with conditions because basically we find that it is safe and it has promising ethicacy, so we let it go out on the market before it even gets a full NOC. So we like to just let the public know that this is out as a notice of compliance with conditions. And then at paragraph 12, you discuss the -- what is required for marketing of a new drug and paragraph 13, you carry on recommending -recommending conditions of use. And in paragraphs 12 and 13, you refer to manufacturing in quality: In order to obtain approval for the . . . [paragraph 12] there must be substantial evidence of the safety and efficacy [of the] of the drug under its recommended conditions of use. . . . safety and efficacy in both animals and humans. In addition, a drug submission must also include sufficient data relating to chemistry, manufacturing and quality control in order to ensure consistent product and quality.
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What -- what does that mean? It means that the drug has to be manufactured in a consistent manner even in the clinical trial and when it is on the market so that it -- basically quality is the foundation and if it's not consistent batch to batch, the safety and ethicacy data is kind of questionable. So once we nail down the quality of the product, then you go in the clinical trials and establish the safety and the ethicacy of that specific dosage form. And what, if anything, is done regarding ensuring manufacturing or in quality control for a drug that is approved? What is required? Yes. They have to give us a chemistry manufacturing submission, which goes through how the active ingredient is manufactured; how the formulation is put together and the facility has to go under a good manufacturing practices and get an establishment licence so that the whole facility is checked out to make sure that the proper controls are put in place. And that a consistent
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product would be manufactured and released. And that is what is covered in Overview in paragraphs 12, 13 and onward? Yes. Now, at page -- the pages aren't numbered, starting at paragraph 18, you have a subtitle heading, "Initial drug development" and that carries on paragraphs 18 to 21, that's in which you are just describing the processes by which an initial drug is developed, and then the next section starting at 22 is the clinical trial section, correct? Correct. So from a structural viewpoint of the affidavit, is the initial drug development section, paragraphs 18, 19, 20 and 21, is that what is done before one gets to clinical trials? Yes. It's the data that should be collected before you even venture into giving the drug to a human. So you do a lot of chemistry manufacturing and animal studies; testing different toxicities of the drug. And then the clinical trial section, I take it, you are just describing the various steps that are required to have an acceptable clinical trial for the purposes of the Food and Drug Act regulatory approval? Right. The clinical trial is one of the methods -- there's three methods -- or three access methods that Canadians can obtain drugs and through clinical trials is one of those methods. So they have to submit to us a protocol explaining exactly what their -- what the drug is and what they are being used for; what the patients being used in the study are; how the analysis is going to be done; the clinical endpoints; safety measurements. So it's part of the -- the critical stage of drug development is how does it work in humans? Now, you mentioned there are three means by which the drug can reach the public; clinical trials is one. What are the other two? The other two -- and one has the special access or emergency release program that if a physician feels that their patient is not getting proper treatment and there could be available in another country an acceptable drug that they could apply
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to Health Canada to bring that drug from another country in and get it to their patient. So that's the one way, the other way is follow submission acts review and acceptable information and an NOC. And NOC would be the -- the document -Yeah. -- that issued for Cesamet, at tab B and at tab C, Marinol, correct? Right. And tab -It's proof -- it's proof that the sponsor has submitted the appropriate information to be on the market. And then you carry on in your affidavit under the heading, "Health Canada drug review process," and you're just describing what Health Canada requires and what the regulations under the Food and Drug regulations require for Health Canada to approve the substance, is that correct? That's correct. And at paragraph 41, you describe: . . . the regulatory approval process ensures the manufacturer develops a drug which is well characterized, and that its production results in consistent pharmacologic properties. The process involves the systematic assessment and reporting . . . Et cetera, et cetera. Is that in essence then a summary of everything that has proceeded? That's correct. And it's summarized in a what we call a product monograph, which is available upon request and it's posted on our website. And that explains all the clinical trials that were done, all the pharmacology, safety studies that were run and any contraindications or warnings or anything associated with that drug product. And with the exception of the notices of compliance and the compliance with conditions, you've included in your affidavit for Marinol, Cesamet and Sativex, are you aware of any other approval for cannabis-related product? No, there has not been. And then you have exceptions which allow access to drugs that have not received regulatory approval and these, I take it, are exceptions under the
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Food and Drug Act and the Food and Drug Regulations? Correct. And those exceptions do or do not apply to dried cannabis? They do not. And then you have a subject heading starting at paragraph 50, "The Consequences of Failing to Identify the Benefits and Harm of Drugs." And you have set out Health Canada's concerns and your concerns as part of the regulatory body that approves these substances with unapproved substances, correct? That's correct. And then your conclusions are set out at paragraph -- paragraph 57, correct? Yes. Now, you then -- you have sworn this as -- or affirmed this, I should say, on the 24th of January in Ontario. Paragraphs 1 through 57 of this document, do they reflect and set out your understanding and beliefs regarding what is required to bring a medical product or a drug to market under the Food and Drug Act and the regulations and the criteria that govern that process? Yes, it does. And they accurately set out your understanding of the regulations and the concerns driving them? Yes. You mentioned you had some assistance from the policy section in preparing the material. Was the assistant -- was there any assistance provided or were you given any direction to insert into your materials anything that you did not believe or accept as support or are valid? No. ECCLES: Thank you. Those are my questions in direct, My Lord. COURT: Mr. Tousaw. ECCLES: Oh, sorry, perhaps we could mark as Exhibit 44 in these proceedings a copy of Mr. Ormsby's CV. I have -COURT: Right, Exhibit 44. CLERK: Forty-four. EXHIBIT 44 (on voir dire): of Eric Ormsby Curriculum vitae
766 VOIR DIRE Eric Ormsby (for Crown) cross-exam on voir dire by Mr. Tousaw
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CROSS-EXAMINATION ON VOIR DIRE BY MR. TOUSAW: Q Yes, Mr. Ormsby, with reference to Exhibit 44, your curriculum vitae, have you at any time in your career with Health Canada worked in the Medical Marihuana Access Division or the Office of Cannabis Medical Access? No, I haven't. And at any time in your educational experience, have you studied cannabis or cannabinoids in any way? No, I haven't. You indicated that you did consult with persons in Medical Marihuana Access Division as part of your employment with Health Canada during the development of the regulatory scheme, does that mean the development of the Marihuana Medical Access Regulations in around 2000 and 2001? Yes. Since that time, have you consulted with persons in the Medical Marihuana Access Division? No. What in 2000 and 2001 did your consultations with persons in the Medical Marihuana Access Division related to the MMAR, Marihuana Medical Access Regulations, what did that consist of? I'm just trying to find out a -- the approach to exempt the dried marihuana from the Food and Drugs Act. So it's the exemption we worked with [indiscernible] And in fact, dried marihuana has been exempted from the application of the Food and Drugs Act, correct? From two sources, yes. And what are those two sources? From a contracted supplier and a supplier who has a licence, I believe, under the program. And you are speaking of either a personal use production licence or a designated person production licence? That's it, yes. And those exemptions were required because if those exemptions were not issued, then Health Canada's marihuana supplier and persons that are issued exemptions by Health Canada who produce marihuana and supply it to others, they'd be violating the Food and Drug Regulation?
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That's correct. And that exemption was achieved by way of a regulatory amendment promulgated under the Food and Drugs Act? I believe it had to go through parliament because it was amending the Act. You say you believe it went through parliament because it was amending the Act, but I take it, you are not entirely sure? I'm not sure, but it does -- it did go through the -- there's two processes to amend. There's the regulations, which is the governor in council versus changing the Act, I think requires parliamentary approval. But, yes, I'm not sure it had been. Has anyone from the Medical Marihuana Access Division or anyone else with Health Canada consulted with you about regular -- regulatory changes required in order to facilitate future amendments to the Medical Marihuana Access Regulations? We are -- I am part of the working group, which is looking into changes to the Medical Marihuana Access. And your understanding of the proposed changes I take it is that Health Canada is in the process of considering amending the regulatory scheme to licence additional commercial suppliers other than Prairie Plant Systems, correct? It's early stages, I'm not sure. We are looking at all the aspects of -- of the program. When did you begin consulting with persons regarding possible future changes to the MMAR? Started in January, I believe, of this year. January of this year? Yes. Have you read the Health Canada document published on its website "Detailing the proposed improvements," as it's titled, to the MMAR? Yes, I have. And your understanding at least from that particular document is that the proposal that was put out for public consultation was that Health Canada was going to amend the MMAR in what I will call two areas; one is the access area of persons seeking licence to possess marihuana lawfully and what I will call the supply area, how do you get
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the actual marihuana once you have been licensed to supply, correct? Mm-hmm. That's correct. Yeah. And in terms of the access area, I take it your understanding based on that document and perhaps your consultation since reading that document is that Health Canada is going to simplify the process for obtaining a licence to possess dried marihuana by removing the requirement the persons in Category 2 consult with a specialist and essentially that your general practitioner will be able to approve you to -- to possess marihuana for all conditions for which the position believes it's appropriate? I believe so. Yeah. And in the supply area, is it your understanding that Health Canada intends to essentially licence and as yet unspecified number of commercial suppliers to grow dried marihuana and provide it to authorized persons, that's your understanding, correct? That's correct. Yes. And in that amendment process, the proposal by Health Canada is that it will also remove from Canadians the lawful right to either produce marihuana for themselves or to designate someone to produce marihuana for them? That's correct. Yeah. And when did you first read that consultation document, was it January of this year? January, yes. And you say a part of a working group, who are the other members of that working group? It's all -- all areas in the branch and well in the department, so there's members from the Office of Control Substances, members from the Marihuana Access Plant, that there be the products directorate, our inspectorate who do the inspections of plants and -- and stores, and the natural health products, I believe, has a member. Yes. You mentioned an inspectorate of plants and stores. Is it your understanding that Health Canada is also contemplating the licensing of retail outlets for distribution of marihuana to Canadians? That hasn't been -- the whole method of getting it
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out there hasn't been -- hasn't been discussed yet. So a work in progress? It's -- yes. Is there a timeline that you are aware of for the implementation of the changes? I think they are looking at two years. Sometime then approximately early 2014? Yes. In your consultations, has that working group got a name? Is there a title of that working group that I can refer to? I -- I think it's -- I don't recall the formal name of it. So if I -- if I just refer to it as the working group, you'll know what I mean? Yes. In -- in that working group -- in your consultations with that working group, have you reviewed any of the submissions made to Health Canada in response to its public consultation document? No, I haven't. Have you participated in any of the meetings -consultation meetings held by members of Health Canada across the country that occurred last year in connection with the proposed changes? No, I haven't. Have there been discussions to your memory in the working group as to the impetus for these proposed changes? Why is it happening? No. I'm more of a working group member from the drug approval process, not on the -- the way that the medical access program works now. Is in the improvements or the amendments that are being contemplated to the Medical Marihuana Access Regulations, is there a suggestion that the companies or people that are going to be licensed to produce marihuana at a commercial scale, is there a suggestion that those companies or persons are going to be required to go through the drug approval process that you set out in your affidavit? I -- I'm not sure. I think they are trying to set up a different scheme not within the Food and Drugs Act, but again, it's all very preliminary. Very early days?
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Yeah, very early. Yes. Have there been discussions in that working group that you are aware of about a judicial decision in Ontario known as R. v. Mernoff[phonetic]? A I am aware of it, but I don't have the details of it, no. Q Do you, sitting here today, recall the substance of any discussions that you may have participated in about the Mernoff case? A No, I haven't. MR. TOUSAW: My Lord, I note the time. THE COURT: Yes. Two-fifteen. I am doing criminal chambers at 2 o'clock, but it will be brief. MR. TOUSAW: Yes, My Lord. (WITNESS STOOD DOWN) (PROCEEDINGS ADJOURNED FOR NOON RECESS) (PROCEEDINGS RECONVENED) THE CLERK: Recalling Her Majesty the Queen against Owen Edward Smith, My Lord. MR. TOUSAW: Yes, My Lord. Thank you. ERIC ORMSBY, recalled. CROSS-EXAM ON VOIR DIRE BY MR. TOUSAW, CONTINUING: Q Mr. Ormsby, did you have occasion -THE COURT: Before you start, had the examination in chief finished? MR. ECCLES: Yes, My Lord. Sorry, I thought -THE COURT: Well, maybe I missed my note, but . . . MR. TOUSAW: I -- I was asking questions when we broke for lunch. THE COURT: You were? MR. TOUSAW: I was. THE COURT: You were? MR. TOUSAW: I was. THE COURT: Okay. MR. TOUSAW: Thank you, My Lord. Q Just before we broke for lunch, Mr. Ormsby, I asked you about the process by which marihuana being produced for the government of Canada or by designated persons was allowed to be sold to authorized persons without running afoul with the Food and Drugs Act. And you mentioned it was
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either an amendment by parliament of the Act itself or -- or regulatory amendment. If I suggest to you that in 2003, the marihuana exemption prens Food and Drugs Act and prens regulations were promulgated as SOR 2003-261 and that that was the means by which marihuana either produced under contract for Her Majesty or under a designated person production licence was exempted from the application of Food and Drugs Act, does that ring a bell for you? Yes. And that would be a -- a regulatory process? Reg -- reg -Excuse me? Regulatory. Yes. A regulatory process by a governor in council and not by parliament, correct? Yeah. In my friend's questioning, you spoke to the -the drug Sativex and indicated that it was issued a notice of compliance with conditions which made it available for prescription in Canada. Is there a restriction on what Sativex can be prescribed for in Canada? It can only be prescribed for the indicated indications in the NOC. And so if somebody attended at their physician's office complaining of conditions outside of that which had been -- Sativex has been approved, a notice of compliance with conditions, the physician is not permitted to actually prescribe Sativex for -- for that patient, correct? That would be a practice of medicine issue where the doctor feels that he could prescribe that. Oh, I'm sorry. I -- I took your previous answer to mean that when a drug is approved with a notice of compliance with conditions, it is only approved for prescription for that particular condition that it has been approved for and for nothing else, am I -- am I wrong in that understanding? There is a lot of off-label use that we don't have control over because it's assumed to be the practice of medicine. I see. And so a physician could prescribe Sativex for an off-label use? Yeah. Before we broke, we were discussing a working
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group that you're a participant in since January of 2012 working on proposed amendments to the MMAR, Marihuana Medical Access Regulations, do you recall those questions? Yes, I do. In the context of that working group, have there been discussions about grandfathering in existing personal production licence holders? In other words, people that already have licence that produce marihuana for their own medical use, is there a discussion about grandfathering those people in so that they can continue to do so even when the other licences are taken away? It hasn't been discussed yet. Is there or has there been as part of that working group any discussion about the licensing of what are known as compassion clubs of compassionate dispensaries or under the new scheme, for the retail distribution of marihuana to patients? That hasn't been discussed yet. Has there been any discussion about the approval of commercial production under the new scheme of cannabis-based products other than dried marihuana? It's part of the initial discussion on how broad the products could be. And has part of that discussion included things like baked goods with cannabis extracts? It has. And oils, and creams and things of that nature with cannabis extract? It has been discussed, but I don't believe they are going to go that way. Has this particular case, the case you are testifying in now, been discussed as part of that working group? No. Is the assistant deputy minister for health for Canada part of the working group? No. Is the deputy minister part of the working group? No. Is the minister part of the working group? No. None of what I will call the political people at Health Canada is a member of the working group, correct?
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That's correct. Is Dr. Abramovici, who testified just before you, part of what working group? I'm not sure. I don't recognize the name, but I've only -- we've only had two meetings and both mine were from telecom -- or phoning in. I take it, you have exchanged some emails and things like that as well as part of the working group? Yes. And you don't recognize his name from those emails? No. Did you in your role as an employee of Health Canada have any participation in the amendments to the Marihuana Medical Access Regulations in 2003? No, I didn't. Same question with respect to the amendments in 2005? No, I did not. Same question with respect to the amendments in 2009? I did not. And finally, same question with respect to the amendments in 2010? No. Did you have any role in drafting what are called regulatory impact analysis statements accompanying any of the MMAR amendments that I have described? No, I did not. You are familiar with what a regulatory amendment statement is? Yes. Analysis statement, I am sorry? Yes. Commonly referred to as RIAS, correct? That's correct. And a RIAS essentially sets out the government's regulatory changes; a backgrounder for those changes; options that may or may not have been considered and the reasons for making the regulatory amendments that are being discussed, correct? That's correct. And as such, those RIAS, regulatory impact analysis statements, represent the rationale and reasoning of the government of Canada in the area
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under consideration? That's correct. Now, with respect to the Food and Drugs Act that you have referred to at some length in your affidavit, that Food and Drugs Act is -- is it fair to say that it's primarily designed for pharmaceutical substances and food -- setting aside foods for a moment, but in terms of drug substances, it's -- it's essentially designed for pharmaceutical substances, correct? No. In biologicals. Plants, even drug containing plants are not brought through the FDA approval process, it become drug products the plants themselves, I'm speaking of now not compounds derived from the plants? Through the? Through the FDA approval process? Yes, they are. Can you give examples of plants that have made it through the FDA approval process? Most of them have come through the Natural Health Product Regulations which chooses the same Act but a different regulations. Yes. With respect to what you focus on here in your affidavit, the process of initial drug development; clinical trials; Health Canada drug review process under the Food and Drug Regulation, that set of regulatory guidelines that's not a process by which plants are brought to market, correct? If they have medicinal use and they are being sold for that purpose, yes, they should come through that process because they are deemed to be drugs. And other than -- is that exclusive with the Natural Health Product Regulation or do you include in your answer things that have gone through the Natural Health Product Regulation? Both. The -And can you give an example of a plant that has gone through the process set out in your affidavit as a plant, not as a compound derived from a plant, but as a plant itself? Not -- not -- no. So, for example, the foxglove plant has not gone through the process you describe in your affidavit, but digitalis, a compound derived from
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the foxglove plant did go through that process? That's correct. And digitalis is a -- a similar compound prescription drug used to treat heart-related issues, correct? That's correct. The plant itself, as far as you know, is lawful to grow and produce here in Canada? Yes. And the plant itself has a history of traditional medicinal use. In fact, that was the impetus for deriving compounds from it taking the compounds through the FDA process? As many current drugs are done the similar way. It is, of course, a possibility that -- well, let me -- let me focus on digitalis for a moment. Digitalis is used as a group of medicines extracted from the foxglove plant, correct? Correct. It's used for treating heart conditions, and the foxglove has been used for that purpose for at least a couple hundred years? Yes. The pharmacologically active compounds are -- are extracted from the plant and that's what is used to make the prescription drug Digitalis? Correct. Yes. Digitalis plant, depending on its species, may in fact contain several deadly physiological and chemically-related compounds, correct? That's correct. It can be quite dangerous to -- well, the entire plant is toxic, isn't it? Yes. It can be dangerous to eat the plant; it can be dangerous to drink water that the plant has been soaking in, correct? Correct. Symptoms of ingestion include nausea; vomiting; diarrhea; abdominal pain; hallucinations; delirium and headache, correct? Correct. And digitalis poisoning, whether it from the plant foxglove or from the pharmaceutical substance, it can kill you, can't it? Yes, it can. And that plant -- that substance digitalis, that's
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available in the market in Canada? Yes, it is. Similarly, in your affidavit at paragraph 7, and that's paragraph 7 of Exhibit 43, you speak to a biologically derived drug and the brand name of which is Reminyl. And I take it in parentheticals after Reminyl, you have Galantamine, that is the compound, the pharmacologically active compound derived? That's -- that's the trade name. Galantamine is the trade name and Reminyl is the compound? I will wait until you get the paragraphs then. So Reminyl is the trade name. Yes. Galantamine is the active compound. And it's derived from a plant from the bulbs in the narcissus plant that's more commonly known as the daffodil, correct? Correct. Galantamine itself, while approved for clinical use, can produce significant negative side effects, correct? I am not sure. You aren't aware of that? I'm not aware of that. Are you aware of whether or not the U.S. Food and Drug Administration published an alert based on data from studies indicating that treatment of Galantamine could cause mild cognitive impairment and higher mortality rates in patients treated with that product? I'm not aware of that, no. Are you aware of FDA -- U.S. FDA changes to labelling for Galantamine that occurred in 2006 to advise patients that there are risks of Bradycardia, slow heart rate, and fainting? I'm not aware of that, no. It doesn't surprise you to hear that, though, as you say in your affidavit, sometimes the effects of these from pseudical substances that have gained approval, negative effects, they just don't become known until it gets out into the population, more and more people take it? That's correct. Yes. And narcissus itself, the daffodil plant, contains
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the alkaloid poison lycorine, doesn't it? Are you aware of that? I'm not aware of that. I take it then, you are not aware of the toxic effects of consuming the bulbs of the narcissus plant? No, I'm not. And again, it wouldn't surprise you to hear that, many plants have some toxic effects? That's true. And as far as you are aware, in terms of your experience under the Food and Drugs Act, or even the Natural Health Product Regulation or the Controlled Drugs and Substances Act, people are allowed to grow daffodils? It's not unlawful to do so? That's correct. The process that you describe in your affidavit, the entire process from lab, to clinical trial to bringing the drug to market and complying with the Food and Drugs Act, I take it that that is a -- an expensive process, isn't it? In terms of drug development for the manufacturer? Yeah. Yes, it is. It can cost 10s or perhaps even hundreds of millions of dollars to go through that process, correct? For a new synthetic chemical, yes, it would cost that much. You need deep pockets to do it? Yes. And is part of what Health Canada looks at when a drug company, for example, is making a submission to attempt to bring a drug to market to achieve a notice of compliance, do they look at the patents that that drug company has over the particular product? Yes, they do. And those patents are important to the drug company because without the patents, you don't really ever have the opportunity to profit from the drug that you're hoping to sell if you make it through the process, correct? That's right. And presumably from the pharmaceutical company perspective, the point of bringing a drug through this very expensive process is to gain approval to
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then be able to sell that drug and to profit from it at some point down the line? That's correct. You are aware that under the Food and Drugs Act, the governor in council can exempt persons or drugs and substances from the application of that Act? Yes, I am. And that's what happened with respect to marihuana either produced that are contract to the -- Her Majesty or under licence from Health Canada, correct? Correct. And is that part of the process that you are discussing with the working group when it comes to licensing future commercial producers? It's not clear which direction they are going to go. That's one of the regulatory options available? Yes. And you are aware that under the Food and Drugs Act, the minister -- Minister of Health for Canada, can make an interim order regarding a drug or a substance requiring compliance with the Food and Drugs Act or portions thereof if the minister believes that immediate action is required in order to deal with the significant risk direct or indirect to health, safety or the environment? That's correct. And the Food and Drugs Act itself contains an offence section that sets out offences for violating the Food and Drugs Act, correct? That's correct. And those offences are punishable on summary conviction by a 500-dollar fine or up to six months in jail or both on a first offence, correct? I'm not -- I'm not sure of the details of the offences. But you are aware that there are offences under the -Yes. -- Food and Drugs Act? I'm a little outdated, I think. And you are further aware that under the Food and Drugs Act, there is a regulatory regime that exists specific to natural health products, the Natural Product Regulation? That's correct.
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And that I'll just abbreviate it as the NHP Regulation. The NHP Regulation was promulgated under the Food and Drugs Act, correct? A That's correct. Q And NHP Regulation promulgated in 2003, correct? A Yes, I believe so. Q The Natural Health Product Act defines natural health products as substances set out in the schedule to that regulation, correct? A Yes. Q In part? A In part, yes. Q And those substances in which substances set out in the schedule to the regulation combination of substances in which the medicinal ingredients are set out in the schedule to regulation; homeopathic medicines; traditional medicines that are manufactured, sold, are represented for use and essentially diagnosed as treatment, prevention of disease or disorders; restoring or correcting organic functions in humans or modifying organic functions in humans, correct? A That's correct. Q There is an exclusion, however, that natural health products do not include substances which are set out in Schedule 2 to that Act, correct? A That's correct. Q Or a combination of the substances set out -- that include substances set out in Schedule 2 to the Act, correct? A That's correct. THE COURT: To the Act or to the regulation? MR. TOUSAW: To the regulation. Thank you, My Lord. Q To the regulation. A Correct. Q Yes. And Schedule 1 to the Natural Health Product Regulation brings within its ambit under Item 1, any plant or plant material, right? A Correct. Q And under Item 2, brings into its ambit extracts or isolates of plant materials, correct? A Correct. Q Schedule 2, which excludes certain natural health products otherwise that would be capped under the regulation specifically excludes any substances that are set out in the schedules to the Controlled Drugs and Substances Act, correct?
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That's correct. And so cannabis by virtue of being a plant or cannabis extracts by virtue of being extracts from a plant that are marketed or sold for health related reasons but for the exclusion would fall under the Natural Health Product Regulation, correct? It would depend on the indication because there is also a Schedule F limitation on natural health products. Explain that for me. If it's a substance that's on Schedule F that requires a prescription, it's excluded from the Natural Health Act or Natural Health Regs. And as far as -- as far as you know, at least at this time, cannabis is not a substance -cannabis, the plant, is not a substance that requires a prescription? No. There has been no approval of cannabis. In order to require a prescription, it would have to be approved as a drug product under the Food and Drugs Act, correct? Under the Food and Drug Regs, yes. And so except for that caveat that you have -that you have provided, cannabis and cannabis extracts would fall under the Natural Health Product Regulation but for their inclusion under the Controlled Drugs and Substances Act? Correct. But we have three examples, but received an NOC because they felt they needed a prescription. And that's Marinol, Cesamet and Sativex? Correct. Yeah. And presumably, the companies that manufacture those products -- well, presumably the companies that manufacture those products took them through this process, spent the money to do so and achieved the notice of compliance? Correct. Is there any discussion in the working group that you are a part of about amending the Natural Health Product Regulation to have that regulation be applicable to cannabis and cannabis extract? I would say no because the intent on the Natural Health Product Regulations is to be basically nonprescription drugs and I don't think they're ready to have such drug products available nonprescription.
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The Natural Health Product Regulation it's fair to describe as a -- as a comprehensive scheme that governs manufacture, marketing and sale of natural health products in Canada, correct? Yes. The intent of the Natural Health Product Regulation is to, as best as possible for natural health products, do the things that you've described the Food and Drugs Act and the Food and Drugs Act Regulation does for pharmaceutical substances; quality control; consistency standardization; claims; regulation; things of that nature, correct? Yes. Correct. And the Natural Health Product Regulation itself also contains an offence section for violations in the Natural Health Product Regulation, correct? I believe so. I'm not as familiar with the Natural Health Product Regulations. TOUSAW: My Lord, if I could have a moment? COURT: Yes. TOUSAW: Mr. Ormsby, thank you. Those are my questions for this witness, My Lord. COURT: Any re-examination? ECCLES: No, My Lord. COURT: May this witness be excused? ECCLES: Yes, My Lord. COURT: Thank you for your assistance, Mr. Ormsby. You are now excused. Thank you. (WITNESS EXCUSED)
MR. ECCLES: That's the case for the Crown in reply, My Lord. THE COURT: Any further evidence from the accused by way of rebuttal or otherwise, Mr. Tousaw? MR. TOUSAW: No further evidence from the accused, My Lord. THE COURT: All right. So that is it for the voir dire? MR. TOUSAW: Yes, My Lord. THE COURT: Now, how long do we think we will need for argument? MR. TOUSAW: My Lord, my friend and I had the opportunity to discuss this over the lunch break and we also had the opportunity to canvass with
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the case manager timing and scheduling of Your Lordship and availability of court. In the view of my friend and I, and I think we share this view, it's likely to require no more than four days of argument. I think my friend and I are of a mind that it would be most efficient for the presentation of the argument as well as for just consistency that those be consecutive days. I know that we have two days remaining this week, that's why we spoke to the case manager. There's an indication from her that Your Lordship is available the week of the 27th of February. My friend -COURT: Was -- was that one of the weeks originally scheduled for this? TOUSAW: It is not. This matter was scheduled to conclude on Friday of this week. And my friend is, however, available that week. I am available that week and I understand Your Lordship is available that week. It would be my respectful submission, and I think my friend concurs in this, that the most efficient course of action would be to adjourn the next two days and to schedule four days commencing on the 27th of February for argument in this matter. COURT: Right. I will stand down. I just want to talk briefly with the trial scheduler because these sorts of things tend to have a domino effect when the rota has to be changed -TOUSAW: Yes, My Lord. COURT: -- like that. So we will stand down briefly. (PROCEEDINGS ADJOURNED) (PROCEEDINGS RECONVENED)
THE COURT: I have spoken with trial scheduling and we can accommodate the 27th and so we will adjourn now till 10 a.m. on February 27th for argument. MR. TOUSAW: Thank you, My Lord. MR. ECCLES: Thank you, My Lord. (PROCEEDINGS ADJOURNED TO FEBRUARY 27, 2012, AT 10:00 A.M. FOR CONTINUATION) Transcriber List: L. Oliver - Testimony of Eric Ormsby L. Griffis - remainder of proceedings
783 Proceedings
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Victoria, B.C. February 27, 2012 THE CLERK: In the Supreme Court of British Columbia, this Monday, the 27th day of February 2012, calling the matter of Her Majesty The Queen against Owen Edward Smith, My Lord. MR. ECCLES: If it may please the court, Peter Eccles, E-c-c-l-e-s, I appear for the Federal Crown in this matter. Ms. Guest is in trial in Nanaimo this morning. THE COURT: All right. Thank you. MR. TOUSAW: My Lord, it's Tousaw, T-o-u-s-a-w, first initial K, I appear for Mr. Smith, he is present in the back of the courtroom. THE COURT: All right. Thank you, Mr. Tousaw. [DISCUSSIONS BETWEEN COURT AND COUNSEL] [SUBMISSIONS ON VOIR DIRE BY MR. TOUSAW] (PROCEEDINGS ADJOURNED FOR MORNING RECESS) (PROCEEDINGS RECONVENED) [SUBMISSIONS ON VOIR DIRE BY MR. TOUSAW, CONTINUING] (PROCEEDINGS ADJOURNED FOR NOON RECESS) (PROCEEDINGS RECONVENED) [SUBMISSIONS ON VOIR DIRE BY MR. TOUSAW, CONTINUING] (PROCEEDINGS ADJOURNED FOR AFTERNOON RECESS) (PROCEEDINGS RECONVENED) [SUBMISSIONS ON VOIR DIRE BY MR. TOUSAW, CONTINUING] (PROCEEDINGS ADJOURNED TO FEBRUARY 28, 2012, AT 10:00 A.M.) Transcriber: A. Paisley
784 Proceedings
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Victoria, B.C. February 28, 2012 THE CLERK: In the Supreme Court of British Columbia, this Tuesday, 28th day of February 2012. Calling the matter of Her Majesty the Queen against Owen Edward Smith, My Lord. THE COURT: Mr. Tousaw. [SUBMISSIONS ON VOIR DIRE BY MR. TOUSAW, CONTINUING] (PROCEEDINGS ADJOURNED FOR MORNING RECESS) (PROCEEDINGS RECONVENED) [SUBMISSIONS ON VOIR DIRE BY MR. TOUSAW, CONTINUING] (PROCEEDINGS ADJOURNED FOR NOON RECESS) (PROCEEDINGS RECONVENED) [SUBMISSIONS ON VOIR DIRE BY MR. TOUSAW, CONTINUING] (PROCEEDINGS ADJOURNED FOR AFTERNOON RECESS) (PROCEEDINGS RECONVENED) [SUBMISSIONS ON VOIR DIRE BY MR. TOUSAW, CONTINUING] [SUBMISSIONS ON VOIR DIRE BY MR. ECCLES] (PROCEEDINGS ADJOURNED TO FEBRUARY 29, 2012, AT 10:00 A.M.) Transcriber: A. Castle
785 Proceedings
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Victoria, B.C. February 29, 2012 THE CLERK: In the Supreme Court of British Columbia this Wednesday, the 29th day of February, 2012. Calling the matter of Her Majesty the Queen against Owen Edward Smith, My Lord. THE COURT: Mr. Eccles. [SUBMISSIONS ON VOIR DIRE BY MR. ECCLES, CONTINUING] (PROCEEDINGS ADJOURNED FOR MORNING RECESS) (PROCEEDINGS RECONVENED) [SUBMISSIONS ON VOIR DIRE BY MR. ECCLES, CONTINUING] (PROCEEDINGS ADJOURNED FOR NOON RECESS) (PROCEEDINGS RECONVENED) [SUBMISSIONS ON VOIR DIRE BY MR. ECCLES, CONTINUING] (PROCEEDINGS ADJOURNED FOR AFTERNOON RECESS) (PROCEEDINGS RECONVENED) [SUBMISSIONS ON VOIR DIRE BY MR. ECCLES, CONTINUING] (PROCEEDINGS ADJOURNED TO MARCH 1, 2012, AT 10 A.M.) Transcriber: S. McIntosh
786 Proceedings
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Victoria, B.C. March 1, 2012 THE CLERK: In the Supreme Court of British Columbia, this Thursday, the 1st day of March, 2012, calling the matter of Her Majesty the Queen against Owen Edward Smith, My Lord. THE COURT: Mr. Eccles. MR. ECCLES: Thank you, My Lord. [SUBMISSIONS ON VOIR DIRE BY MR. ECCLES, CONTINUING] (PROCEEDINGS ADJOURNED FOR MORNING RECESS) (PROCEEDINGS RECONVENED) [SUBMISSIONS ON VOIR DIRE BY MR. ECCLES, CONTINUING] [REPLY ON VOIR DIRE BY MR. TOUSAW] (PROCEEDINGS ADJOURNED TO MARCH 28, 2012, AT 2 P.M. FOR DECISION) Transcriber: L. Kemp
787 Proceedings
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Victoria, B.C. April 13, 2012 THE CLERK: In the Supreme Court of British Columbia, this 13th day of April 2012, calling the matter of Her Majesty the Queen against Owen Edward Smith, My Lord. MR. ECCLES: May it please the court, Peter Eccles, E-c-c-l-e-s, for the Federal Crown. THE COURT: Thank you, Mr. Eccles. MR. TOUSAW: My Lord, it's Tousaw, T-o-u-s-a-w, first initial K., I appear for Mr. Smith. He is present in the back of the court. THE COURT: All right. Thank you, Mr. Tousaw. Thank you. The clerk is now handing to counsel my written reasons for the ruling on this voir dire. For the reasons set out in that document, I have concluded that the restriction to dried marihuana in the Marihuana Medical Access Regulations is unconstitutional as it breaches s. 7 of the Charter and is not saved by s. 1. The remedy for that breach is to remove the word dried where it appears in the Marihuana Medical Access Regulation and I so order. Mr. Smith's application for a judicial stay of proceedings is dismissed, again for the reasons set out in my written ruling. Mr. Smith is remanded to criminal chambers, 2:00 p.m., Wednesday, April 25th to fix a date for jury selection and for trial. Before that date counsel will obtain dates for both jury selection and trial from trial scheduling. There may well be an application to suspend operation of the decision I have just handed down. I will give counsel an opportunity to read the written reasons and they may appear at two o'clock today to speak to any application to suspend the operation of my decision. We will now adjourn. (PROCEEDINGS ADJOURNED) (PROCEEDINGS RECONVENED) THE CLERK: Recalling the matter, My Lord, from this morning, the matter of Her Majesty the Queen against Owen Edward Smith. MR. ECCLES: May it please the court, Peter Eccles,
788 Proceedings
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E-c-c-l-e-s, again appearing for the Federal Crown. COURT: Yes, Mr. Eccles? TOUSAW: My Lord, it's Tousaw, T-o-u-s-a-w, first initial K., appearing with and for Mr. Owen Smith who's in the back of the courtroom. COURT: Yes. TOUSAW: Before my friend moves to his submissions on suspension of Your Lordship's order, I'd ask Your Lordship to grant me leave to speak very briefly to clarification of Your Lordship's judgment on the issue of remedy. COURT: Yes. [SUBMISSIONS FOR ACCUSED BY MR. TOUSAW] [SUBMISSIONS FOR CROWN BY MR. ECCLES]
THE COURT: All right. You're responding to the stay application or the -MR. ECCLES: I am. THE COURT: All right. Let me deal -- let me deal with the -MR. ECCLES: Yes, My Lord. THE COURT: -- amendment first. For the benefit of those who may have had an opportunity to read my reasons, I will say this. In spite of a great deal of anxious consideration in an attempt to avoid obvious gaps in the reasoning, one of those gaps is [indiscernible] and there is not much question that counsel have, with a lot shorter time than I have had to review this judgment, spotted a clear area where some further work needed to be done and needs to be done on the decision. I agree with the suggestion that the intent of my reasons is best reflected by making the amendment or correction to my decision suggested by Mr. Tousaw, and so the definition of marihuana now in the Marihuana Medical Access Regulation will now read, "marihuana means the substance referred to in Schedule 2 to the Act." Now, Mr. Tousaw, on the stay? [SUBMISSIONS FOR ACCUSED BY MR. TOUSAW] [SUBMISSIONS FOR CROWN BY MR. ECCLES]
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THE COURT: When do you want to come back? MR. ECCLES: I'm in these courts all of next week on another matter. The week after that I have a sentencing Monday and Tuesday which is set for two full days in this court, not before Your Lordship. I can't remember who's hearing the matter. But the Wednesday of that week would certainly work for the Crown. I'm not sure what day that is, but that'd be -MR. TOUSAW: Wednesday, the 25th of April. THE COURT: Yes. MR. ECCLES: Yes. MR. TOUSAW: We've already been asked to come back for the fix date hearing at 2:00 p.m. I can advise Your Lordship that I have a pre-trial conference that I must attend in person on an extradition matter in Vancouver that morning, but -THE COURT: All right. so -MR. TOUSAW: Unless Harbour Air is not flying that day, I'm likely to be able to be back by 2:00 p.m. MR. ECCLES: And I'm -THE COURT: But if we're going to have a battle over suspension, setting it into an afternoon may not be wise. MR. ECCLES: It -- I don't anticipate there will be a battle, My Lord, given my friend's -THE COURT: Yes, because you want the suspension. Mr. Tousaw may not be happy to agree with. MR. ECCLES: Well, I believe Mr. Tousaw would be content with the third option, suspend only as AGP holders and not a suspension in relation to DPL holders who create substantially more risk given they have the capacity to produce substantially more and have it available for [indiscernible/overlapping speakers]. THE COURT: Here is the problem. As of today I'm not supposed to be back in this court until mid May or later. I am going to have to come back from elsewhere in order to deal with this, so I want to make sure that when we fix a date it is a date that everybody's going to be ready either to agree to something or to complete their argument and get a decision. MR. ECCLES: If my friend and I cannot agree, I will certainly be in a position to complete any argument and receive Your Lordship's decision on the 25th.
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THE COURT: But Mr. Tousaw is not. What about the 26th? MR. TOUSAW: I can in the afternoon session, My Lord. I hear Your Lordship's -- the 26th is wide open. I'll say the 26th. THE COURT: 26th. MR. ECCLES: I believe it's open, My Lord. THE COURT: Kelly, can you check downstairs, talk to Diane? MR. ECCLES: I have a sentence appeal in the morning on the 26th in the Court of Appeal. I'm clear the 27th. And I have no idea how long the sentence -the sentence appeal is set for two hours, so I should be clear in the afternoon, but -THE COURT: Well, if we can't do it on the 27th, we can do it on the 20th. What's the 20th look like? MR. ECCLES: I'm unavailable on the 20th, My Lord. THE COURT: All right. 27th? Going once, going twice -MR. ECCLES: I can make myself available on the 27th. THE COURT: All right, 27th at 10:00 a.m. MR. ECCLES: Certainly, My Lord. The Crown would inquire as to whether we could have a stay of the suspension until the 27th or at the -- my friend's third option, a stay in relation to ATP holders until the 27th. MR. TOUSAW: Non ATP holders. MR. ECCLES: Sorry, non AT -- sorry, a stay in relation to those who are other than ATP holders. THE COURT: All right. Until the 27th? MR. ECCLES: Until the 27th. THE COURT: All right. MR. ECCLES: So ATP holders need not be concerned. Producers know that they're -THE COURT: Those in possession of authorizations to possess are exempted from the suspension of my order which affects from today until 10:00 a.m. on the 27th -MR. TOUSAW: Thank you, My Lord. THE COURT: -- of April. MR. ECCLES: Thank you, My Lord. THE COURT: All right. Thank you, both. (PROCEEDINGS ADJOURNED TO APRIL 27, 2012, AT 10 A.M.) Transcriber: N. Klos
791 Proceedings
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Nanaimo, B.C. January 10, 2013 THE CLERK: In the Supreme Court of British Columbia, on this the 10th day of January in the year 2012, calling the matter of Owen Smith, court file 149345-1, My Lord. MR. RILEY: My Lord, it's W. Paul Riley, R-i-l-e-y, appearing for the Crown. THE COURT: Thank you. MR. TOUSAW: My Lord, it's Kirk Tousaw, T-o-u-s-a-w, appearing with and for Mr. Smith who's seated in the first row of the gallery. THE COURT: All right, thank you. MR. TOUSAW: My Lord, we're before you this morning instead of in February when this trial had been scheduled to commence before a jury 'cause my understanding is the Crown's position on its desire to proceed to trial against Mr. Smith has waned in light of Your Honour's ruling on the Charter issues and Mr. Smith is re-electing today his mode of trial to be judge alone. I'm passing on the [indiscernible/background noise] required by the Criminal Code executed by Mr. Riley for the Crown and by myself on behalf of Mr. Smith. THE COURT: All right. So you waive the reading of the Indictment? MR. TOUSAW: We do. THE COURT: And the formal putting of the re-election to Mr. Smith? MR. TOUSAW: We do. THE COURT: Mr. Smith, having previously elected to be tried by a judge and jury, now elects to be tried by a judge without a jury in this court. That reelection, having been consented to in writing by the Crown, will be recorded. We will notify trial scheduling and the Sheriff's office that if the jury panel was particularly or specifically to be brought in for this trial it is no longer needed. Jury selection date will be struck from the record. What's the proposal, were you going to start with the trial in February or -MR. RILEY: No, My Lord. I think we can deal with that now on the understanding that Mr. Smith has now re-elected judge alone and we'd be asking Your Lordship to I guess commence the trial proper now.
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And I can indicate that the Crown has studied Your Lordship's previous Constitutional ruling and assessed its impact on the Crown's case, and in light of that ruling, the Crown's determined that -- well, the ruling has significantly impacted on the Crown's ability to prosecute its case and so we'll be calling no evidence and so I think we can do that today. COURT: All right. RILEY: Yes. COURT: And I got some indication for some reason through the Times Colonist that that was going to happen. My only concern is to -- and I haven't been able to go back into what I had and I've got a pile of stuff in my office in Victoria, but I just want to confirm that none of the admissions upon which the voir dire proceeded went beyond the voir dire and could be taken as admissions on this trial. Now, is that a safe assumption? Because I gather what's intended is, with the Crown leading no further evidence, if there is no evidence on the trial I'm being invited to dismiss the charge. If the admissions went beyond the voir dire, that is, if we started the trial for ten minutes and admissions were made, then we went into a voir dire, there may be evidence on the trial that would not safely lead to an acquittal. RILEY: Yes. COURT: Mr. Tousaw is looking concerned because he's not entirely sure at what stage the admissions -- and there were significant admissions made, at what stage they were tendered? RILEY: And I'm -- I'm new to this -- to this matter, so I -- I -- I could be corrected obviously, but my understanding was that what occurred up to this point were in the nature of pre-trial applications for Constitutional remedies and that the trial proper, if you will, hadn't started. And that -- I guess I'm reinforcing that view by the fact that the jury hasn't been called in and evidence hasn't been called. COURT: We didn't empanel the jury. RILEY: So at this point no evidence has been presented in the trial proper. COURT: All right. RILEY: And one of those admissions were initially intended to be made for the purposes of the
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Constitutional applications or to dispense with true -- with -- with proof of them when the trial proper began. At this point we've reached the conclusion, well, look, in light of the Constitutional ruling and its impact upon the Crown's case, we're simply in a position where we're choosing to call no evidence in the trial proper and so I think that addresses Your Lordship's concern -COURT: All right. RILEY: -- unless I -- unless I've missed something. TOUSAW: Yes, My Lord. I -- my memory of the proceedings, and it has been some time, is that -COURT: A year, I think. TOUSAW: Yes, is that we -- Mr. Eccles for the Crown and myself had intended to bring or agree to much of the evidence in the voir dire being used in the trial, but we hadn't taken that step because the trial itself had not begun. COURT: All right. I did check some notes that were available to me. I haven't been in my office much lately and it -- I have sufficient recollection that the admissions that were made were confined to the voir dire to the Charter challenge that I think it is safe now to say yes, the trial has started. No, I suppose it hasn't. Mr. Smith is going to have to enter a plea. Do we -TOUSAW: Not guilty, Your Honour. COURT: Do we have an Indictment? TOUSAW: Or Your -- My Lord. COURT: Madam Clerk, would you read the Indictment to Mr. Smith? CLERK: Yes. COURT: We've got to arraign him. CLERK: On court file 149345-2 in the Supreme Court of British Columbia in -- it says the City of Victoria, but of course it would be Nanaimo? COURT: Yes. CLERK: Her Majesty the Queen against Owen Smith -Owen Edward Smith, on count -- stands charged that on: Count 1: Owen Edward Smith, on or about the 3rd day of December, 2009, at or near the City of
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Victoria, in the Province of British Columbia, did unlawfully possess a controlled substance, to wit: Tetrahydrocannabinol . . . for the purpose of trafficking, contrary to Section 5(2) of the Controlled Drugs and Substances Act. How do you plead? THE ACCUSED: Not guilty. THE CLERK: On: Count 2: Owen Edward Smith, on or about the 3rd day of December, 2009, at or near Victoria, in the Province of British Columbia, did unlawfully possess a controlled substance, to wit: Cannabis . . . contrary to Section 4(1) of the Controlled Drugs and Substances Act. How do you plead? THE ACCUSED: Not guilty. THE CLERK: And this against Our Lady of -- the Peace of Our Lady the Queen Her Crown and Dignity, dated the 17th day of May 2009, in the City of Vancouver. THE COURT: All right, thank you. You may be seated, Mr. Smith. All right. That I think starts the trial. The Crown -MR. RILEY: Yes. So, My Lord, in light of the earlier Constitutional ruling, the Crown at this point calls no evidence on the trial proper. And just let me by way of explanation simply say this as well, My Lord, it may not be necessary, but just to make it clear, it's my understanding that if the matter were to proceed to trial before a jury, Mr. Smith would be advancing an argument along the lines of necessity. And just to explain where the Crown's coming from here, the -- the medical marihuana regime as reflected in the Medical Marihuana Access Regulations does not as it's -as it's drafted contemplate or permit production or distribution of THC products. Now, if the Medical Marihuana Access Regulations are valid and that limitation is valid, then Mr. Smith's claim of necessity would be significantly undermined by the fact that the law does allow for medical
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THE MR. THE MR. THE
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marihuana but does not allow for access to THC products, and so that would significantly impact upon the issues to be decided by the jury and so the Crown has reached the conclusion that we -it -- that impacts upon the viability of our case and so we're calling no evidence. COURT: All right. Motion for -TOUSAW: Motion for a dismissal here -COURT: All right. TOUSAW: -- My Lord. COURT: The Crown having elected to call no evidence or, to be absolutely safe given my confusion, no further evidence, and the defence having made an application for a dismissal or an argument in favour of dismissal, I have no alternative but to say that there is a reasonable doubt in any sense of the meaning of the phrase "reasonable doubt" as to the guilt of Mr. Smith on both counts and he is acquitted, that is, I find him not guilty on both. TOUSAW: Thank you, My Lord. RILEY: Thank you, My Lord. COURT: Thank you both. We'll adjourn. (PROCEEDINGS CONCLUDED)
Transcriber: N. Klos

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Court of Appeal CA040556

v. OWEN EDWARD SMITH

W. Paul Riley Counsel

Kirk I. Tousaw Counsel

J.C. WordAssist Ltd.

149345-2 Victoria Registry

In the Supreme Court of British Columbia

P. Eccles K. Guest K. Tousaw

J.C. WordAssist Ltd.

EXHIBIT 31: EXHIBIT 32:

EXHIBIT 42: EXHIBIT 43: EXHIBIT 44:

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