Health Canada Stakeholders Consultation. Feb. 18/04

Report to the CCC

Feb 22 /04

Part #1

It was truly a such a pleasure to work with all the members of our team, even with the large number of participants and observers in the room, we had a strong presence in the formal and informal discussions. By the time I reached a computer Friday, members were responding to details of the new plan. In general , I would characterize the first responses of our members as mixed. My apologies for the delay in posting this report, I have taken some time to reflect and gather my thoughts.

Overall I felt that our input was heard and respected.

I know that most of you have familiarized yourselves with the of the new rules and the plan and I will comment on topics and suggest a possible role for CCC and other advocacy groups.


Disclosure to the RCMP:

The RCMP are taking a strong stand on disclosure and it seems to be supported by HC. The real issue is in fact trust. The RCMP are still officially not supportive of the MM program and they are not acknowledging any medical benefit of cannabis.

I would bet that most officers have never seen a card and are only exposed to the official RCMP marijuana position. LEAP and other groups will have a better idea of the police culture and could be helpful in planning strategy. We need to educate the RCMP and change the official position. We need to replace the DARE program. The DARE program is now being challenged by parents across Canada and will be another opportunity to educate and change the general mind set of the whole force.

Daunting as this may seem, we could start by examining solutions to some of our shared concerns and acknowledging the dilemma the RCMP find themselves in.

They sat and talked to us and we should continue the dialogue.

Discontinuation of grow licenses.

Picture not the current few hundred grow licenses ,but thousands and thousands of patients and production licenses. The police and the stakeholders and frankly I think the general public agree, it could dangerous to having thousands of home growing licenses.

In my opinion we already have too many patients who are growing under duress.


In from the cold:

Although HC balked at a direct discussion of the clubs, we were invited to sit at those tables because there is some will within HC to resolve the dilemma of clubs, or as some refer, the gray area. Placing the GP back in charge of the classic illnesses and taking the liability away from the doctors will open the door to licensing many club members and thousands of others.

I did not hear a clear response to the question of how category one will be reviewed and updated. Many more conditions should and will be included in this section. We can challenge for the obvious exclusions from Cat1 and secure more and more inclusiveness with every challenge. They HC know how subjective they have made the new rules, we can use the subjectivity to benefit many suffering Canadians.

Summary

The experience reaffirmed for me the need for education, of police forces, teachers, and the general public.

At our table, whenever an issue was addressed, the first concern was whether this would increase or decrease accessibility. As ridicules as this program can seem at times, the staff I met were working to make the best decisions possible within the tight lines of the job. We have been given some subtle and some not so subtle advice. We need to listen to HCs suggestions as to where roadblocks really exist and to whom we should direct or arguments.

In a game of small steps, these proposed changes are bold. They are the slippery slope to a more inclusive licensing system. We can push the wedge here by making the changes work for as many patients as possible. Numbers alone will raise the level of our voice and it will increase the demand for quality affordability and variety.

Brian Taylor

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The good news is that with the collapse of category 2 into category 1 we're slowly getting to the point where a simple doctor's recommendation will be enough to access cannabis, although it is hard for me to understand how this change is to have any real impact as long as the CMA and CMPA stay opposed to the MMAR in theory and principle.  Furthermore, for those isolated small communities that don't have medical specialists in the first place, these policy changes don't mean a thing.

More (sort of) good news is that HC will be looking to contract more than 1 cultivator when they put in an RFP at the end of this year.  Further details revealed during the meeting suggest that HC will be hiring 2 cultivators (PPS and another, in my opinion), as they have suggested that they would like to make 2 strains available through drugstores by year's end.

The most frightening developments stemming from this meeting are: 1) HC's plans to make disclosure to police a mandatory requirement for joining the program; and 2) the threat that HC plans to eliminate all DPL and PPL in the near future, forcing all legal users to use federally-supplied cannabis.

In regards to the first, the concerns are many, but begin with the logical assertion that those who use this medicine should not be descriminated against through onerous policies that betray their rights to privacy.  This proposal stems from pressure from the national police orgs. who would like to continue to bust grow-ops without having to worry about shooting a cancer patient.  It ignores our rights and our concerns over privacy, and continues to place policing concerns over those of Canada's legal exemptees.  Professionals (teachers, lawyers, doctors...) may have job-related concerns over the involuntary sharing of this information, as might anyone who travels to the U.S. (where any such info. wouls surely raise alarms at border crossings).  Furthermore, insurance companies are refusing to ensure homes where cannabis is being stored or cultivated, even legally - this is an unsolved dilemma for participants in this program.

In regards to the second, there is little logic in limiting the supply options for Canada's legitimate users of therapeutic cannabis.  If exemptees can get the strains that help them grown safely and locally, what is gained by disallowing this form of self-supply and forcing exemptees to use a poor quality, potentially dangerous federally-grown product?  Cannabis is different than other pharmaceuticals or over the counter-drugs in that it can be safely produced by the user; so why impose the cost of the federal supply on those who would rather use a known strain grown in a way that they are comfortable with (ie organics vs. HC's non-organic cultivation)?  There is no justification for allowing this kind of federal monopoly; exemptees will lose much choice and freedom - and gain nothing - from this policy shift.

Lastly, it is clear that although compassion clubs and societies have been invited to this round of consultation, Health Canada has no plans to ever license, regulate, or legalize these orgs.  When I asked Beth Pieterson and Valerie Lasher whether they could foresee a role for the clubs within the HC program, they stated that they couldn't, although we may wish to put in a proposal to cultivate cannabis for the feds when the RFP comes out later this year.  Considering that Canada's compassion clubs are currently involved in far more legitimate research than Health Canada, that clubs have a membership that is roughly 10 times that of the federal government, and that far more exemptees seek out their supply of cannabis from clubs than from the government, their reluctance to work with us is inexcusable, and is surely adding to the unnecessary suffering that this program should address in the first place.  When I inquired why HC was not interested in developing a more cooperative relationship with the clubs, I was told that it is because we are illegal.  After pointing out that according to the CDSA we could be legally licensed in a moments time at the discretion of the Minister of Health (and that we were therefore no more illegal than pharmacies, which will need the same to begin to distribute cannabis), Beth changed the subject and stated that licensing the clubs would violate our "international obligations".  This is, of course, rediculous since the production and distribution of controlled substance is clearly exempt from the UN Single Convention as long as it is for medical purposes - a document which we supplied to HC called "A Roadmap to Compassion" clearly outlines this fact.  In other words, HC's intransigence regarding compassion clubs amounts to nothing more than an unjustified monopoly, and shows no regard to actually helping sick Canadians.  Considering our incredible contributions to medicinal cannabis cultivation, distribution, and safe use, it is an incredible and inexplicable shame that Health Canada has neither the creativity nor the compassion to work more closely with the clubs.

What I would like to point out is that this is Health Canada's vision for this program; this is not our vision. This doesn't anticipate or account for future court battles, continued exemptee concerns, or constitutional challenges.  Ever since the start of this program, activists and exemptees have worked hard to ensure that the needs and concerns of Canada's critically and chronically ill are addressed by our federal govt.  When they have failed to listen or pay heed to our well-meaning advice, we have been forced to go to the press and public, or to the courts.  We continue to make a huge difference.  Until Health Canada finally shows the common sense to decentralize this program and to allow for non-profit, community-based cultivation and distribution (saving themselves money, resources, and legal difficulties), we will continue to supplement their anemic, ineffective program, and to work towards and fight for a better system.

Philippe Lucas CSA/VICS

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Basically, some of the ugly being considered for implementation is:

1.) Mandatory disclosure to police (soon probably)

2.) Plan to phase out all personal production licences and designated growing licences (2005)

Their reasoning is "concerns of diversion" and personal growing being in contravention to the international convention; HC and the feds are apparently taking a lot of heat from DEA and international community within the international convention for giving out personal growing licences. Apparently, according to the international convention, all cannabis supply has to be regulated and distributed directly by all the countries' governments within the convention.

Whether that's true or not, I have no idea. Either way, to eliminate the ability to grow one's own cannabis - or have a designated person do it for you - is wrong. It's an important right to be in full control of the input of what goes into your medicinal plants, and the low cost associated with growing your own.

Top brass at Health Canada told me that if people want to see real change in Canadian cannabis law, a.) put pressure to make changes and amendments to the international convention OR: b.) initiate Canada's withdrawal as a member country in the convention.

That would do the trick. Then things can open up big-time.

I pre-emptively struck at disclosure, diversion and personal production licence issues by presenting Health Canada with a huge written list of concerns, of which I addressed their concern of diversion by making HC take responsibility and enact a section of the MMAR: [Ref. MMAR sec.57. (1)] (it was easy to predict they'd be taking this stance)

"For diversion concerns - inspections. Implement and utilize Health Canada inspectors. The use and production of medical cannabis is legal; law enforcement for inspection is inappropriate. [Ref. MMAR sec.57. (1)] Patients and growers feel intimidated by guns and police drug squads for legal possession, use and production."

Health Canada wants to dump all responsibility onto law enforcement. Law enforcement made a "fear-based" presentation at the meeting, basically stating "Either consent now, or consent later. Either way, we'll get you."

Also, here's a final segment of my written presentation which I handed out to about 65 people in the meeting:

"Another serious concern is fear of law enforcement action taken towards legal medical cannabis users and their legally designated producers. This seems to be based on a lack of communication in regards to the fact that medical cannabis use is legal in Canada.

Initiating educational and public awareness programs for law enforcement groups and secondary stakeholders on the legal medical use of cannabis will rectify this problem.

Patients also expressed frustration that their needs and concerns as the primary stakeholders in the MMAR program are being ignored. Patients want to be heard; appropriate action should be taken to address their needs and concerns in a respectful and timely manner by all concerned.

Patients want to be treated as responsible intelligent health conscious consumers - not criminals.

Medical cannabis growers and distributors want to be recognized as providing an important and vital service to the community, not perceived as "drug dealers".

All secondary stakeholders must resolve these issues if the Health Canada medical cannabis access program is to work effectively and efficiently to meet the primary stakeholders' needs."


3.) RFP soon to come for when PPS contract runs out. (2005) It will be announced in the Federal Gazette. It will be probably 2 contracts, and criteria will be as per original PPS contract except 2 strains - Sativa and Indica.

This contract (or contracts) will also be their justification for HC phasing out all PPLs and DPLs; (personal production licences and designated growing licences) the supply will then be available to patients in a multi-strain format.

I heard the comment: "centralized 'Wal-Mart of pot".

It will be the BIG corporate sector that most likely gets this (these) contracts, definitely not the small fry.

AND NOW.... Here's all the text from the Health Canada meeting powerpoint presentation that was projected on the screens and handed out in written form at the meeting on the MMAR changes:

There is a continuous need to strike a balance between:

The fact that marihuana is a controlled substance and an unapproved drug product

Providing compassionate access to patients suffering from serious illness when conventional treatments have failed

"Givens"

Marihuana will remain illegal. Marihuana will be accessible on compassionate grounds - use will be regulated. International Drug Control Conventions will be respected. Marihuana is a drug (FDA) and not a natural health product (NHPR). Requests for authorization will require the support of a physician. There will be access to a legal standardized, quality-controlled source of marihuana.


Eric Nash

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Consultation on Proposed Changes to the Marihuana Medical Access Regulations (MMAR)

February 18, 2004

Proposed Changes: Authorization to Possess

Objectives: Facilitate patient access to marihuana for medical purposes Simplify MMAR processes Maintain a balance between responding to the different concerns of various stakeholders and the need to provide adequate regulation of a controlled substance

Proposed Changes: Authorization to Possess: Three categories reduced to two Amend required patient and medical practitioner declarations Eliminate requirement to identify conventional treatments tried and reason inappropriate or ineffective

Medical Practitioner: support of an application For category 1: schedule to the MMAR by the medical practitioner of the applicant

For category 2: other than category 1 by a specialist as defined in MMAR

Revised Schedule: Category 1 Definition Symptoms and Associated Medical Conditions

Any symptom   Compassionate end-of-life care

Severe nausea Cancer AIDS/HIV infection Cachexia, anorexia, weight loss Cancer, AIDS/HIV infection Persistent muscle spasms Multiple sclerosis, Spinal cord injury or disease Seizures Epilepsy Severe pain neuropathy, severe form of arthritis


Applicant Declaration: same for both categories

I am aware that marihuana is not an approved drug product and that no notice of compliance has been issued under the Food and Drugs Act concerning the safety and effectiveness of marihuana as a drug.

I am aware that the nature of the benefits and risks associated with the use of marihuana is not fully understood and that the use of marihuana may involve risks that may as yet be unidentified

I have discussed the potential benefits and risks of using marihuana with the medical practitioner named in this application and consent to using it only for the medical purposes stated in the application

Medical Declaration: "Medical Purpose"

Specify the medical condition(s) or symptom(s) being treated, and for which the application is being submitted

Stipulate that the applicant's medical condition(s) or symptom(s) that are the basis for this application fall under [check one] Category 1, or Category 2

Stipulate that conventional treatments have been tried or considered


Medical Declaration: "Statements"

I am aware that marihuana is not an approved drug product and that no notice of compliance has been issued under the Food and Drugs Act concerning the safety and effectiveness of marihuana as a drug

I am aware that the nature of the benefits and risks associated with the use of marihuana is not fully understood and that the use of marihuana may involve risks that may as yet be unidentified

In my medical opinion: the use of marihuana may mitigate the symptom the potential benefits from the applicant's use of marihuana may outweigh the risks associated with that use

Medical Declaration: "Statements"

The applicant will be using A daily dosage of dried marihuana of [specify] grams The following route and form of administration [specify]

If you recommend that an Authorization be issued for a  period shorter than 12 months, please specify the number of months: [specify]

Medical Declaration: Dosage in Excess of 5 Grams:

If the applicant will use a daily dosage greater than five grams: The potential risks associated with an elevated daily dosage have been considered and discussed with the applicant, including: risks with respect to the possible effects on the applicant's cardio-vascular and pulmonary systems, and psychomotor performance; risks associated with the long-term use of marihuana; as well as,  potential drug dependency

The potential benefits from the applicant's use of marihuana according to the daily dosage stated may outweigh the risks associated with that dosage


Renewals of Authorizations Possess:

Authorization valid for one year (unless shorter period specified by supporting physician) Patient and medical practitioner must both sign but requirements reduced: If no change to information, declaration that no change; Extend period of validity of photo from 2 years to 5


Disclosure to Police:

Propose to include in MMAR that applicant automatically gives consent to disclosure/exchange when submitting a signed application That consent is automatic will be noted on the application form

Information will only be communicated in response to request from police force or police officer engaged in an investigation under the Act or the MMAR.


Disclosure to Police:

Request can be made in respect of: A named individual or A specified address

Disclosure is subject to the information being used only for the purposes of that investigation


Disclosure to Police:

Only the following information can be disclosed: whether a named individual is the holder of an authorization to possess or a licence to produce whether a specified address is A place of residence of a person who is authorized to possess, and the authorization number; The site where production of marihuana is authorized under a licence to produce, and the licence number; or The site where dried marihuana may be kept under a licence to produce, and the licence number


Disclosure to Police

Only the following information can be disclosed in respect of an authorization to possess (as per ID card): the name, date of birth and gender of the holder of the authorization, the full address of the place where the holder ordinarily resides the authorization number, the maximum quantity of dried marihuana the holder is authorized to possess, the dates of issue and expiry, and if the authorization has expired, whether the holder of the authorization has applied to renew the authorization and the status of the application


Disclosure to Police

Only the following information can be disclosed in respect of a licence to produce (as per ID card): the name, date of birth and gender of the holder of the licence, the full address of the place where the holder ordinarily resides, the licence number, the full address of the site where the production of marihuana is authorized, the authorized production area, the maximum number of marihuana plants that may be under production, the full address of the site where dried marihuana may be kept, the maximum quantity of dried marihuana that may be kept at the site, the dates of issue and expiry, and if the licence has expired, whether an application to renew has been submitted to Health Canada and the status of the application.


Exchange between Health Canada and Medical Practitioner who signed the application

Authority for Health Canada to communicate with the medical practitioner to clarify the information provided on the application form Authority for the medical practitioner to clarify information that is required to process the application


Exchange between Health Canada and Applicant's Representative

If applicant designates a representative on the application form: Authority for Health Canada to communicate with the designated representative to clarify the information provided on the application form

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MARIHUANA FOR MEDICAL PURPOSES IN CANADA

Multi-Stakeholder Consultation February 18, 2004

CONTENTS:

Health Canada's Medical Marihuana Program Introduction Medical Marihuana Research Program Marihuana Medical Access Regulations Statistics

Towards a Health Care Model Vision Regulatory Review (Phase 2) Beyond Phase 2


HEALTH CANADA'S MEDICAL MARIHUANA PROGRAM

A)  Introduction

The program: Fosters research into the safety and efficacy of marihuana when used for medical purposes Defines the regulatory framework for permitting persons to possess and/or produce marihuana for  medical purposes Undertakes to create a safe, reliable, licit source and supply of marihuana for medical purposes in Canada


B)  Medical Marihuana Research Program

Goal is to assess risks and benefits of marihuana for medical purposes to increase knowledge and aid in decision making Done in partnership with the CIHR Budget of $7.5M over 5 years, ending 2006 Includes two components: Randomized Controlled Trials Safety Trials (Marihuana Open Label Safety Initiative) Two clinical protocols have  been approved to-date


C) Marihuana Medical Access Regulations - Main Features

Define the requirements for receiving authorization to possess marihuana for medical purposes and the options to obtain a legal supply Authorization to Possess - Eligibility Resident of Canada Must have a serious medical condition where the benefits of using marihuana would likely outweigh the risks, and where conventional treatments have been tried or considered Category 1 - terminal illness; requires support of one medical practitioner Category 2 - specific symptoms/conditions listed (e.g., seizures, severe nausea due to cancer) requires support of one specialist Category 3 - symptoms of a serious condition not in 1 or 2; now requires support of one specialist Onus is on the physician to assess the patient's  needs and to make a declaration on the application


Supply - Three supply options available for an authorized person: Can apply for a license to produce marihuana for his/her own personal use Can apply to have a designated person licensed to produce marihuana on his/her behalf Can apply to have access to dried marihuana, grown for Health Canada by Prairie Plant Systems


D) Statistics (as of February 6, 2004)

Possession - 717 persons authorized 612 authorized under the MMAR; 105 exempted under section 56 Cultivation / Production  - 537 persons authorized 382 hold a Personal-Use Production License; 65 a Designated-Person Production License; 87 are exempted under section 56; 3 are designated persons under section 56 Applications Under the MMAR

On average, 50 MMAR applications are received by Health Canada per month. Accessing Government of Canada (PPS) supply

51 authorized persons receive our product


TOWARDS A HEALTH CARE MODEL

A) Vision

We are now at Phase 2

B) Regulatory Review - Phase 2

Issues under consideration:

Categories of symptoms and conditions Medical practitioner declarations Patient declarations Application and renewal processes Disclosure and exchange of information Pharmacy-based distribution - pilot project

Timelines

January - April 2004 Complete formal stakeholder consultations Draft and submit regulatory proposal for approval by Minister and Treasury Board

May 2004 Pre-publish regulations in Canada Gazette, Part I Allow 30 day comment period

June - July 2004 Analyze comments received and revise proposal as necessary

August - September 2004 Publish final regulatory amendments in Canada Gazette, Part II

September 2004 Regulatory amendments into force

C) Beyond Phase 2

For Consideration

Health Canada product development Cost and affordability of Health Canada product, and compassionate coverage under Health Care Plans Registry of physicians Findings of ongoing research, and possible emergence of new marihuana products on the Canadian market Pharmacy-based distribution, and Phase out of personal production Expansion of education and awareness initiatives, and post-market surveillance programs.


LIST OF PARTICIPANTS:

Beth Pieterson - Health Canada
Cynthia Sunstrum - Health Canada
Carole Bouchard - Health Canada
Valerie Lasher - Health Canada
Linda Dabros - Health Canada
Richard Viau - Health Canada
Margaret Fuller - Health Canada
Tara Phillips - Health Canada
Lyndon Murdock - Public Safety and Emergency Preparedness Canada
Bill Campbell - Canadian Society of Addiction Medicine Stakeholder Advisory Committee Member
Henry Haddad - Canadian Medical Association Stakeholder Advisory Committee Member
Fleur-Ange - Lefebre Federation of Medical Regulatory Authorities of Canada
Isra Levy - Canadian Medical Association
Gary Rubin  - oronto HIV Primary Care Physicians Group
Tom Todd - Canadian Medical Protective Association
Mark Ware  - Montreal General Hospital Pain Centre Stakeholder Advisory Committee Member
Robert Yves - Collège des médecins du Québec
Robert Goyer  - Chair - Stakeholder Advisory Committee
Ray Joubert  - Saskatchewan  Pharmaceutical Association
Robin O'Brien -  Stakeholder Advisory Committee Member
Susan Pierce -  Canadian Pharmacists Association
Myrella Roy -  Societe canadienne des pharmaciens d'hopitaux
Greg Ujiye -  Ontario College of Pharmacists
Barbara Wells - National Association of Pharmacy Regulatory Authorities
Lynne Belle-Isle - Canadian AIDS Society Stakeholder Advisory Committee Member
Julie Dagenais - Blackburn Canadian Cancer Society
Jari Dvorak - Canadian AIDS Society
Deanna Groetzinger - Multiple Sclerosis Society of Canada
Donald W. Gross - Epilepsy Canada
Philippe Lucas - Canadians for Safe Access
Philip Lundrigan - Stakeholder Advisory Committee Member
Andrew MacQuarrie - Stakeholder Advisory Committee Member
Enrico Mandarino - Canadian AIDS Society
Christina Mills - Canadian Cancer Society
Denis Morrice - Canadian Arthritis Society Stakeholder Advisory Committee Member
Eric Nash - MedUsers
Greg Robinson - Stakeholder Advisory Committee Member
Hilary Black - Canadian Cannabis Coalition
Marc-Boris St. Maurice - Canadian Cannabis Coalition
Brian Taylor - Canadian Cannabis Coalition
David Griffins - Canadian Professional Police Association
Chris McNeil - Halifax Regional Police
Derek Ogden - RCMP - Royal Canadian Mounted Police
Michel Pelletier - RCMP - Royal Canadian Mounted Police Stakeholder Advisory Committee Member
Marc Pinnault - Ottawa City Police
Raf Souccar - RCMP - Royal Canadian Mounted Police
Muriel Montbriand - College of Nursing - University of Saskatchewan Stakeholder Advisory Committee Member


Meeting Facilitators:

Julie Westeinde  - Health Canada
Marc Valois - Health Canada


Meeting Observers:

Marilena Bassi - Health Canada
Pierre Belanger - Privy Council Office
Anthony Chapman - Privy Council Office
Jacques Cloutier - Health Canada
Luc Goudreault - Health Canada
Eric Lafleur - Health Canada
Glenda MacDonald - Pharmacist
Nicole Metevier - Health Canada
Michelle Richard - Health Canada
Sandra Toscano - Health Canada

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