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Medical Marijuana In The News

DEC 11, 2017
WHO (World Health Organization) Report Finds No Public Health Risks Or Abuse Potential For CBD
By: Janet Burns-Forbes USA

A World Health Organization (WHO) report has found no adverse health outcomes but rather several medical applications for cannabidiol, a.k.a. CBD, despite U.S. federal policy on this cannabinoid chemical. According to a preliminary WHO report published last month, naturally occurring CBD is safe and well tolerated in humans (and animals), and is not associated with any negative public health effects.

Experts further stated that CBD, a non-psychoactive chemical found in cannabis, does not induce physical dependence and is "not associated with abuse potential." The WHO also wrote that, unlike THC, people aren't getting high off of CBD. "To date, there is no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD," they wrote. In fact, evidence suggests that CBD mitigates the effects of THC (whether joyous or panicky), according to this and other reports.

The authors pointed out that research has officially confirmed some positive effects of the chemical, however. The WHO team determined that CBD has "been demonstrated as an effective treatment for epilepsy" in adults, children, and even animals, and that there's "preliminary evidence" that CBD could be useful in treating Alzheimer's disease, cancer, psychosis, Parkinson's disease, and other serious conditions, such as chronic pain.

In acknowledgement of these kinds of discoveries in recent years, the report continued, "Several countries have modified their national controls to accommodate CBD as a medicinal product."

But the U.S., the report noted, isn't one of them. As a cannabis component, CBD remains classified as a Schedule I controlled substance, meaning it has a "high potential for abuse" in the federal government's view. Nevertheless, the "unsanctioned medical use" of CBD is fairly common, experts found. For many CBD users in the U.S., the substance's mostly unsanctioned and illegal state creates problems, especially as a wave of online (mostly hemp) and store-bought CBD oils and extracts have allowed patients to take the treatment process--and the risks involved in buying unregulated medicine--into their own hands and homes.

While CBD itself is safe and found to be helpful for many users, industry experts have warned that not all cannabis extracts are created equally, purely, or with the same methods of extraction. And while reports of negative reactions to pure CBD are very few and far between, researchers are able to say that the cannabinoid wouldn't be to blame alone. "Reported adverse effects may be as a result of drug-drug interactions between CBD and patients’ existing medications," they noted.

As the cannabis reform non-profit NORML reported, the WHO is currently considering changing CBD's place in its own drug scheduling code. In September, NORML submitted written testimony to the U.S. Food and Drug Administration (FDA) opposing the enactment of international restrictions on access to CBD.

The FDA, which has repeatedly declined to update its position on cannabis products despite a large and ever-growing body of evidence on the subject, is one of a number of agencies that will be advising the WHO in its final review of CBD.

The report was presented by the WHO's Expert Committee on Drug Dependence, and drafted under the responsibility of the WHO Secretariat, Department of Essential Medicines and Health Products, Teams of Innovation, Access and Use and Policy, Governance and Knowledge.

Canadian Federal legislation on legalizing marijuana unveiled
By Kristy Kirkup The Canadian Press April 2017

OTTAWA – Adults 18 and older will be able to legally buy and cultivate small amounts of marijuana for personal use, while selling the drug to a minor will become a serious new criminal offence under the federal Liberal government’s proposed new legal-pot regime.

A suite of legislation introduced Thursday would, once passed, establish a “strict legal framework” for the production, sale, distribution and possession of pot, and make it against the law to sell cannabis to youth or use a young person to commit a cannabis-related crime. New penalties would range from a simple police citation to 14 years behind bars.

“If your objective is to protect public health and safety and keep cannabis out of the hands of minors, and stop the flow of profits to organized crime, then the law as it stands today has been an abject failure,” Public Safety Minister Ralph Goodale told a news conference. “Police forces spend between $2 billion and $3 billion every year trying to deal with cannabis, and yet Canadian teenagers are among the heaviest users in the western world … we simply have to do better.

The new law would allow adults 18 and over to possess up to 30 grams of dried cannabis or its equivalent in public, share up to 30 grams of dried marijuana with other adults and buy cannabis or cannabis oil from a provincially regulated retailer. They would also be permitted to grow up to four plants per residence for personal use, as well as make legal cannabis-containing products at home. The government says it intends to bring other products, including pot-infused edibles, into the legalized sphere once federal regulations for production and sale are developed and brought into force. “The current system of prohibition is failing our kids,” said Liberal MP Bill Blair, a former Toronto police chief and the government’s point man on the legalized-marijuana file.

The plan is to have a legalized-pot system in place by the end of June 2018, he added.

“We have a responsibility to act as expeditiously as we can … we can’t drag our feet; we aspire to get this done as quickly as possible.” Under the proposed Cannabis Act, it would remain illegal to import cannabis and cannabis products, and to export them without a valid permit. Permits may be issued for certain purposes, such as medical cannabis and industrial hemp.

It would also be against the law to sell cannabis in a package or with a label that could be construed as appealing to young people, to include testimonials or endorsements, or to depict a person, character or animal. The government also aims to establish “significant penalties” for those who engage young Canadians in “cannabis-related offences” and a “zero-tolerance approach” to drug-impaired driving, along with a “robust” public awareness campaign. The RCMP and the Canadian Border Services Agency plan to work together, along with local police, to uphold laws governing illegal cross-border movement of cannabis.

Goodale made a point of noting the existing laws remain in effect until the new legislation is formally proclaimed the law of the land.

“As the bill moves through the legislative process, existing laws prohibiting possession and use of cannabis remain in place, and they need to be respected,” he said. “This must be an orderly transition; it is not a free for all.” Provinces, territories and municipalities would be able to tailor rules for their own jurisdictions, enforcing them through mechanisms such as ticketing.

They will also be permitted to set their own licensing, distribution and retail sales rules, establish provincial zoning rules for cannabis businesses and change provincial traffic safety laws as they deem necessary. Philpott says criminalizing cannabis has not deterred use among young people, noting products like alcohol and tobacco are legally available with restrictions.Once passed, the Liberal bills introduced today would make Canada the first member of the G7 to legalize marijuana for recreational use across the country.

Patients who hold a prescription for medical marijuana will still be able to order from their licensed producer and have it mailed to their home. The price for patients will be lower than the price to the public. Private insurance companies are working on covering this natural medicine for patients, same a regular pharmaceutical medications.


Understanding the New Access to Cannabis for Medical Purposes Regulations
Health Canada
August 2016

Introduction

The way individuals access cannabis for medical purposes is changing. As of August 24, 2016, the Access to Cannabis for Medical Purposes Regulations (ACMPR) will replace the Marihuana for Medical Purposes Regulations (MMPR).

Legal access to dried marijuana for medical purposes was first provided in 1999 using unique section 56 exemptions under the Controlled Drugs and Substances Act (CDSA). The decision in R. v. Parker in 2000 held that individuals with a medical need had the right to possess marijuana for medical purposes. This led to the implementation of the Marihuana Medical Access Regulations (MMAR) in 2001. The MMAR enabled individuals with the authorization of their health care practitioner to access dried marijuana for medical purposes by producing their own marijuana plants, designating someone to produce for them or purchasing Health Canada supply.

Over time, court decisions resulted in a number of changes to the MMAR. In June 2013, the Government of Canada implemented the Marihuana for Medical Purposes Regulations (MMPR). The MMPR created conditions for a commercial industry responsible for the production and distribution of marijuana for medical purposes. Under the MMPR, individuals with a medical need could access quality-controlled dried marijuana produced under secure and sanitary conditions. In June 2015, the Supreme Court of Canada, in R. v. Smith, decided that restricting legal access to only dried marijuana was unconstitutional. The Court decided that individuals with a medical need have the right to use and make other cannabis products. To eliminate uncertainty around a legal source of supply of cannabis, the Minister of Health issued section 56 class exemptions under the CDSA in July 2015, to allow, among other things, licensed producers to produce and sell cannabis oil and fresh marijuana buds and leaves in addition to dried marijuana, and to allow authorized users to possess and alter different forms of cannabis.

The ACMPR is Canada's response to the Federal Court of Canada's February 2016 decision in Allard v. Canada. This decision found that requiring individuals to get their marijuana only from licensed producers violated liberty and security rights protected by section 7 of the Canadian Charter of Rights and Freedoms. The Court found that individuals who require marijuana for medical purposes did not have "reasonable access".

The ACMPR are designed to provide an immediate solution required to address the Court judgement. Moving forward, Health Canada will evaluate how a system of medical access to cannabis should function alongside the Government's commitment to legalize, strictly regulate and restrict access to marijuana. Overall, the ACMPR contain four parts.

Part 1 is similar to the framework under the MMPR. It sets out a framework for commercial production by licensed producers responsible for the production and distribution of quality-controlled fresh or dried marijuana or cannabis oil or starting materials (i.e., marijuana seeds and plants) in secure and sanitary conditions.

Part 2 is similar to the former MMAR regime. It sets out provisions for individuals to produce a limited amount of cannabis for their own medical purposes or to designate someone to produce it for them.

Parts 3 and 4 include:

  • Transitional provisions, which mainly relate to the continuation of MMPR activities by licensed producers.
  • Consequential amendments to other regulations that referenced the MMPR (i.e., Narcotic Control Regulations, New Classes of Practitioners Regulations) to update definitions and broaden the scope of products beyond dried marijuana.
  • Provisions repealing the MMPR and setting out the coming into force of the ACMPR on August 24, 2016.

As of August 24, 2016, Health Canada will accept applications from individuals who wish to register to produce a limited amount of cannabis for their own medical purposes or to designate someone to produce cannabis for them.

Under the ACMPR, Health Canada will continue to accept and process applications to become a licensed producer that were submitted under the former MMPR. Further, all licences and security clearances granted under the MMPR will continue under the ACMPR, which means that licensed producers can continue to register and supply clients with cannabis for medical purposes. New applicants can continue to apply for licences to produce under the ACMPR.

Health Canada's role?

In administering the ACMPR, Health Canada has two main roles:

  1. Licensing and overseeing the commercial industry; and,
  2. Registering individuals to produce a limited amount of cannabis for their own medical purposes (or to have another individual produce it for them).

With respect to the licensed producers, Health Canada officials will continue to conduct a thorough review of the information on applications to ensure compliance with the regulations and associated Directives (i.e., the Security Directive). Health Canada will also continue to work closely with producers once they are licensed as a means of monitoring and ensuring compliance with the regulations and the CDSA, including through inspections.

As of August 24, 2016, Health Canada will begin to review applications from individuals who have the authorization of their health care practitioner and who wish to register to produce a limited amount of cannabis for their own medical purposes. This will involve reviewing the information submitted to ensure it complies with the regulations, and responding to requests from law enforcement to confirm the validity of a registration certificate.

In administering the regulations, Health Canada officials will work closely with a range of groups, including law enforcement, municipalities, provincial and territorial medical licensing authorities, and health care professionals, as well as Canadians who are interested in using the program.

What it means for health care practitioners?

The role of health care practitioners is unchanged by the introduction of the ACMPR. As with the previous regulations, an individual who requires cannabis for medical purposes must first get a medical document from an authorized health care practitioner. Like under the MMPR, the medical document contains similar information to a prescription, including:

  • The authorized health care practitioner's licence information.
  • The patient's name and date of birth.
  • A period of use of up to one (1) year.
  • A daily quantity of dried marijuana expressed in grams.

In a hospital setting, the person in charge of the hospital can allow fresh or dried marijuana or cannabis oil to be administered to a patient or, sold or provided to a patient or an individual responsible for the patient.

Please refer to the guidance available on the Health Canada website for more information about the authorization of cannabis for medical purposes, including the Daily Amount Fact Sheet (Dosage).

What it means for licensed producers?

Part 1 of the ACMPR covers the permitted activities and general responsibilities of licensed producers, including:

  • Requirements to obtain and maintain a licence.
  • Establishment and personnel security measures.
  • Authorized activities, including good production practices, packaging, shipping, labeling, import and export requirements, and record-keeping requirements.
  • Client registration and ordering requirements.

Part 1 includes the requirements of the MMPR and the relevant section 56 CDSA exemptions that responded to the decision in R. v. Smith, enabling the production and sale of fresh marijuana and cannabis oil in addition to dried marijuana.

Newly-permitted activities under the ACMPR include the production and sale of starting materials (i.e., marijuana seeds and plants) to those individuals who have registered under Part 2 to produce a limited amount of cannabis for their own medical purposes or to have it produced by a designated person, and the ability to sell an interim supply of fresh or dried marijuana or cannabis oil to registered persons while they wait for their plants to grow.

Licences and licence applications under the ACMPR consolidate the MMPR licence requirements for the production and sale of dried marijuana, the requirements for supplemental licences under the section 56 exemption, and the new requirements for the sale of marijuana seeds and plants.

Other notable changes from the MMPR include:

  • New labelling requirements for cannabis oil to include the carrier oil used and for cannabis oil in dosage form to include the number of capsules or units in the container, the net weight, and the volume of each capsule or unit.
  • New labelling requirements for fresh and dried marijuana to include the percentage of THC and CBD that could be yielded, taking into the account the potential to convert THC-Acid and CBD-Acid into THC and CBD.
  • Provisions enabling individuals to receive their 30-day supply of cannabis within each 30-day period beginning on the date of the first sale.
  • Modifying that the accuracy of weight and volume of products in packages must now be between 95% and 105%, as opposed to between 95% and 101%.
  • Requiring all analytical testing to be done using validated methods (e.g., contaminants, disintegration, and solvent residue testing) and requiring disintegration testing for cannabis oil in capsules or similar dosage forms.
  • Requiring notification to the Minister of Health prior to commencing a recall.

What it means for individuals who require access to cannabis for medical purposes?

Individuals with a medical need, and who have the authorization of their health care practitioner, will now be able to access cannabis in three ways: they can continue to access quality-controlled cannabis by registering with licensed producers, they can register with Health Canada to produce a limited amount for their own medical purposes, or they can designate someone else to produce it for them.

Under the ACMPR, those who are currently registered to purchase from a licensed producer may continue to do so without any interruptions to their supply. Individuals who do not currently have access to cannabis for medical purposes need to discuss their options with their health care practitioner. The practitioner may complete a medical document if it is decided that cannabis is a good treatment option.

Individuals can then use their medical document to either register with a licensed producer to obtain fresh or dried marijuana or cannabis oil, or with Health Canada to be able to produce a limited amount of cannabis themselves or designate someone else to produce it for them. As of August 2016, there are 34 licensed producers.

No matter how individuals obtain cannabis (i.e., under Part 1 or 2 of the ACMPR), their possession limit is the lesser of a 30-day supply or 150 grams of dried marijuana or the equivalent amount if in another form.

If an individual wants to produce a limited amount of cannabis for his/her own medical purposes, he/she must submit an application to register with Health Canada. An original medical document from the health care practitioner must be provided and the application must include information such as the location of where cannabis will be produced and stored.

Once successfully registered, the individual will receive a registration certificate from Health Canada. The certificate will include information required for the individual to show his/her legal authority to possess and produce cannabis. It will also include the location and maximum limits of the production and storage activities, as well as the individual's possession limit.

If an individual chooses to designate another individual to produce a limited amount of cannabis for him/her, he/she must submit an application to register with Health Canada (similar to if the individual was to produce it him/herself, but with information from the designated person). An original medical document from the health care practitioner and a declaration by the designated person, including information such as the location of where cannabis will be produced and stored, must be provided. The designated person must include a document issued by a Canadian police force proving the individual has not been convicted or received a sentence for a designated drug offence within the 10 previous years. A designated person can only produce for a maximum of two individuals including him/herself.

Once successfully registered, the registered person will receive a registration certificate from Health Canada. The designated person will also receive a document from Health Canada containing information outlining what activities are permitted. The certificate and the document could be used by either the registered person or the designated person, respectively, to demonstrate the legal authority to possess and produce cannabis.

Under the former MMAR, the only option to acquire starting materials was seeds obtained from Health Canada. In addition, individuals who were authorized to possess marijuana for their own medical purposes could only purchase an interim supply of dried marijuana from Health Canada while waiting for their production to be ready. The ACMPR permit newly registered persons to register with any of the producers licensed by Health Canada using a copy of their Health Canada registration certificate to obtain starting materials (seeds or plants) for production, and/or an interim supply of fresh or dried marijuana or cannabis oil while their own production is established.

The ACMPR outline in more detail the requirements for registered and designated persons upon successful registration, such as production, storage, transportation, and shipping.

The ACMPR also have formulas that indicate how many plants can be grown and how much cannabis can be stored, based on the daily quantity of dried marijuana authorized in the registered person's medical document.

In general, every one (1) gram of dried marijuana authorized will result in the production of five (5) plants indoors or two (2) plants outdoors. Individuals must indicate in their application whether they intend to produce marijuana plants indoors, outdoors, or partial indoors/partial outdoors. Individuals seeking to produce outdoors must confirm that the production site is not adjacent to a school, public playground, daycare or other public place mainly frequented by children.

Registered and designated persons are required to maintain any measures they think are necessary to protect the security of their cannabis. This could include, for example, installing a home alarm system or securing cannabis in locked cabinets. Health Canada has prepared an information bulletin that highlights the safety and security rules that must be adhered to under the regulations. This document further outlines a number of simple precautions that individuals can take to reduce risks to their health and safety.

If an adult, a registered person who has a designated producer can also participate in all of the activities that the designated person is authorized to conduct. This is a significant change from the former MMAR, which limited the ability of the registered person to take part in production by the designated person.

Another notable change from the former MMAR is that registered persons, as well as designated persons, will have the ability to alter the dried marijuana they harvest into other products, such as oils. In doing so, individuals are prohibited from using organic solvents (e.g., butane), given the health and safety risks posed by use of these products.

The inclusion of provisions enabling the production of products reflects the June 2015 decision in R. v. Smith. It should also be noted that registered clients of licensed producers also have this same ability to alter dried or fresh marijuana or cannabis oil into other products.

It is the responsibility of individuals to ensure that, in performing any alteration, they stay within the possession limit outlined on the registration certificate. Because the possession limit is articulated in grams of dried marijuana, individuals must manage their limit by taking into account the equivalency of their product to dried marijuana as is outlined in the regulations.

Part 2 of the ACMPR also describes other general measures, such as: how to cancel a registration; cannabis destruction requirements once production has stopped; and, instances in which Health Canada can share information with police or provincial/territorial health care licensing authorities.

What it means for law enforcement?

Broadly speaking, the role for law enforcement has not changed. Law enforcement officials have a central role in enforcing the CDSA, including whether individuals who possess, produce, sell or provide and transport, deliver or ship cannabis are operating outside of the ACMPR framework.

Law enforcement officers can contact Health Canada to verify that a licensed producer is in fact licensed or that an individual is a registered person or designated person at any time and on a 24 hour basis.

Similarly, a law enforcement officer may contact a licensed producer to verify whether a person is a client of the producer or a person responsible for the client.

When requested, a police officer must be provided with proof that the possession or production of cannabis is legal. Depending on the situation, this could be a:

  • Health Canada-issued producer's licence.
  • Health Canada-issued registration certificate.
  • Health Canada-issued designated person document.
  • Licensed producer-issued client label.
  • Licensed producer-issued "separate document" with the same information as a client label.

What remains illegal?

With the introduction of additional options, the ACMPR provide for reasonable access to individuals who require cannabis for medical purposes. However, activities with cannabis conducted outside of the ACMPR, the NCR or an exemption pursuant to section 56 of the CDSA could be illegal. Access to cannabis for medical purposes is only permitted under the terms and conditions set out in the regulations. Storefronts selling marijuana, commonly known as "dispensaries" and "compassion clubs," are not authorized to sell cannabis for medical or any other purposes. These operations are illegally supplied, and provide products that are unregulated and may be unsafe. Illegal storefront distribution and sale of cannabis in Canada are subject to law enforcement action. Any individual registered to produce a limited amount of cannabis for him/herself may not sell, provide or give cannabis to another person.

A designated person may not:

  • Sell, provide or give cannabis to any person, except for the individual for whom he/she is authorized to produce in a registration; and,
  • Produce cannabis for more than two people registered with Health Canada, including him/herself, for whom he/she is authorized to produce in a registration.

Registered and designated persons may not produce in excess of the maximum limits outlined in a registration certificate.

It remains illegal for a company or an individual to advertise cannabis to the general public.


New hire is a signal Ottawa is taking a strict line on recreational marijuana

DANIEL LEBLANC AND MIKE HAGER
OTTAWA/VANCOUVER - The Globe and Mail
Published Thursday, Jun. 02, 2016 9:16PM EDT

The Liberal government is sending further signals it plans a strict regime for recreational marijuana by hiring former public safety minister Anne McLellan to develop plans to legalize the drug.

Sources confirmed that Ms. McLellan will head a federal-provincial task force that will report to Bill Blair, the Liberal MP and parliamentary secretary for justice who is in charge of the file. Mr. Blair, a former Toronto police chief, has denounced the growing number of unregulated pot dispensaries across the country. The task force, which has yet to be announced formally, will be asked to report later this year, with legislation to legalize marijuana to be tabled in the House in the spring of 2017.

Ms. McLellan has a lot of experience dealing with marijuana issues in Ottawa. Having been minister of public safety, health and justice in the Liberal governments of Jean Chrétien and Paul Martin, she was involved in both the fight against trafficking by organized crime, and in responding to court rulings that ordered the government to provide access to marijuana for medical use. In those days, Ms. McLellan was widely seen as being right of centre in the Liberal Party. The current minister of Public Safety, Ralph Goodale, said the goal is to develop a regime for selling recreational pot that does a better job than the current situation at keeping the drug away from young people. "We want a system of strict regulation and restrictions and taxation that will keep marijuana more effectively out of the hands of our kids and stop that flow of illegal cash into the hands of organized crime," Mr. Goodale said after appearing at the public safety committee of the House on Thursday. "The present arrangement, for all of the strong language about the war on drugs, has obviously failed," he added. Ms. McLellan said in 2002, as the minister of health, that she felt "a certain degree of discomfort" around the issue of medical marijuana. She said "the courts took us down a certain path," arguing it was not her government's choice to allow the use of cannabis for medical purposes.

Brent Zettl, whose Prairie Plant Systems Inc. was the first company licensed by Ottawa to grow medical marijuana after those court decisions, said that Ms. McLellan was always most concerned with the safety and security of the system. "She is very, very rules-oriented and very cognizant of the law and very cognizant of safety," said Mr. Zettl, who has grown marijuana under one federal system or another for the past 15 years. Liberal MP Nate Erskine-Smith called Ms. McLellan a "very reasonable person" whose views on cannabis have likely evolved over the past decade or so, like those of most Canadians.

"Canada's come a long way... on the topic from the medical cannabis side, but obviously Canadians across the country want to move away from prohibition towards a regulatory environment," said Mr. Erskine-Smith, whose Toronto constituency office neighbours an illegal dispensary that was among 45 raided by police last month. "Both for public safety reasons and health reasons and also to treat Canadians like the responsible adults we are." Ms. McLellan refused an interview request on Thursday to give her current views on marijuana, but she is expected to speak publicly once the government confirms her appointment. She is a lawyer in Edmonton and the chancellor of Dalhousie University.

Provincial politicians want pot to be sold through liquor stores or pharmacies - not dispensaries - once recreational use is written into law next spring. Regardless of where it is eventually distributed, the City of Vancouver and several other West Coast communities have crafted bylaws they say can guide face-to-face sales. In a speech last month, Mr. Blair made it clear he feels that unlicensed pot dispensaries are breaking the law by bypassing federal regulations to serve the medical marijuana market.

"The current licensed producers are competing with people who don't care about the law, who don't care about regulations, don't care about kids, they don't care about communities, don't care about health of Canadians. They're pretty reckless about it. And so they're selling anything to make a fast buck before we get the regulations put in place," Mr. Blair said.

THE NEW LIBERAL GOVERNMENT HAS PROMISED TO LEGALIZE MARIJUANA

The Liberal party made the full legalization of cannabis a promise in its campaign platform, and further vowed to give the matter immediate attention. This has obviously excited many people, and there has been no lack of comments or advice from a number of the high-profile Canadian cannabis activists, such as Marc Emery, Dana Larsen, and others. Hopes appear to be running high for legalization to be right around the corner. However, often overlooked in all the excitement and rhetoric is the stated motivation by the Liberals for legalization.

The LIBERAL governments website states:
"To ensure that we keep marijuana out of the hands of children, and the profits out of the hands of criminals, we will legalize, regulate, and restrict access to marijuana."

In other words, the principle goal is harm reduction via regulation. Regulation implies bureaucratic control. This will take quite some time, and require consultation with many groups, not the least being the provinces and municipalities who will obviously want a say (and a tax cut) in anything having to do with cannabis sales. Still, given the complexity of what is being attempted (a nationally regulated recreational, privately owned, cannabis marketplace) they face a daunting challenge.

This task will be somewhat simplified because the production side of the regulations has already been created, as part of the MMPR (Marijuana for Medical Purposes Regulations), the current national medical cannabis program. Currently, there are only 26 LPs. However, there is nothing to stop Health Canada from expediting the license granting process. As the number of producers increase so will supply, which will force the price downwards. So Canadians can feel confident they will not be gouged on price, and will have choices between different products and companies.

There are many issues to be resolved: Who may sell it? Where may it be sold? How much should it be taxed? Implementation will be further complicated by the rather unique dispensary situation in British Columbia which is going through its own process in trying to manage the 150+ dispensaries and compassion clubs operating within its boundaries. Local police have taken a hands-off approach to these quasi-legal retail outlets which operate in their city and appear willing to follow whatever new guidelines the Liberals create. The various physician associations in Canada have been unhappy about being the ?gatekeepers? for giving these prescriptions.

Another important decision facing the Ministers is the issue of personal home growing. Will it be allowed? Many Canadians have expressed concerns about a few "big pot" commercial organizations controlling the marketplace. While this is unlikely to happen, given the large number of producers we will see coming on board over the next few years, the Liberals have yet to articulate their position on this issue. On the surface, there doesn?t appear to be any reasonable way in which they can prevent it, so one can assume that, much like with beer, individual citizens will be allowed to produce it on their own without permission to sell it.

And let?s not forget the possible reactions by the US Federal government. The last time talk of legalization came up here in Canada, there were quite a few people who felt that the strong stance against it by the American government was so powerful that it influenced our decision, and we backed down.

Ironically, the oddest twist in the legalization process will probably be its impact on the current medical cannabis marketplace as well as the various national and provincial medical associations. There are over 40,000 Canadians who are registered to legally use cannabis. The medical cannabis market in Canada will sustain itself, as it will offer such benefits as no tax, and tax savings, lower costs, drug insurance coverage, etc. While medical cannabis is now legal in many countries, very few regulate it at a national level, and none have taken the Canadian approach.

Given that the cannabis business is a new and exciting area of interest in Canada, those who will be involved in making it a success now have the freedom to make it happen with intelligent planning and fairness in mind. Assuming this all works out Canadians will have good reason to be proud in leading the way for other nations to follow in the march to global cannabis legalization.

Shannon Lough, CMAJ
July 28, 2015

CANADIAN MEDICAL ASSOCIATION JOURNAL

There's a budding business in the medical marijuana industry lurking between pot dispensaries and doctors' offices. Cannabis clinics connect people with physicians willing to prescribe legal access to medical marijuana - for a fee, of course.

The "prescription" is actually a Health Canada form that has to be filled out by a physician, but many doctors resent being gatekeepers to what they consider to be an unproven drug.

At least 25 clinics have sprung up in British Columbia, Alberta, Quebec, Ontario and possibly elsewhere. For people who qualify for medical marijuana and want to try it, these businesses claim to be the missing link in the system. Membership fees range from $99 to $350.

National Access Cannabis CEO Gulwant Bajwa, the former manager for Health Canada's Marihuana (sic) Medical Access Regulations, left after that program became invalid in March 2014. He says his business is "educating people on the use of cannabis so that they can make safe, and informed, and most importantly a responsible decision."

Members get access to the staff "pharmacist" - actually an international medical graduate - who asks them to provide medical documents including a letter of diagnosis from a physician, and copies of prescriptions and hospital records before arranging a telemedicine conference, for an additional $150, with a physician. If the physician prescribes access to medical cannabis, the clinic staff help the member select the best strain for their condition from those offered by Canada's 19 licensed producers. They also instruct members on ways to consume the drug and use a software system to monitor the drug usage and interaction with other prescriptions.

"We don't want people to go to the street. We want them to get the medicine from a legal source supply," Bajwa says. He says his business is not commercially linked to any of the licensed producers.

There appears to be a growing demand for these businesses. As of March of this year, Health Canada reported that more than 18 500 people had legal access to medical marijuana, but that doesn't include people grandfathered in through the previous medicinal marijuana program. The number of people with access is expected to reach 500 000 in the next few years (Int J Drug Policy 2015;26:15-19).

In a needs assessment survey by mdBriefCase, an online continuing medical education provider, 321 family doctors were asked how likely they are to prescribe access to medical marijuana: 8% say they currently prescribe, 32% say they might, 60% say it is unlikely they will prescribe.

Many of the clinics have opened in the year since the MMPR came into effect and each operates differently depending on provincial college policies.

Other clinic owners say that some doctors charge a "risk compensation." Recently, the College of Physicians and Surgeons of Manitoba began investigating reports that a doctor is charging $300 a note to buy medical marijuana at a Winnipeg dispensary.

Other provincial colleges appear to be more concerned about the use of telemedicine than payment. In British Columbia, the college's new rules around when telemedicine is appropriate, stipulate that the physician must have a long-term relationship with the patient, or be in direct communication with another physician or nurse practitioner who has such a relationship.

Prince Edward Island's college also prohibits physicians from using the medical document to prescribe marijuana through telemedicine. Dr. Cyril Moyse, the registrar of the PEI College of Physicians and Surgeons, says "one of the issues is that you have to continue to monitor the patient for effectiveness." Not all the cannabis clinics use telemedicine. Pauline Garrard, the CEO of Canna Relief Consulting Canada Inc. in Mississauga, Ont. says she found it unreliable. "We want to stay on the straight and narrow and doing all the required things that keep the doctors safe and that keeps us safe. We just want to make sure we do the right thing for patients."

At her one-year-old clinic, staff educate and help clients sort their documents. If a member's physician will prescribe the drug, membership costs $150; if not, the fee is $300, which includes finding a physician who will meet the client at an off-site clinic.

"The whole obstacle is that Health Canada has put the burden on doctors to prescribe and most of them are not willing to prescribe because they don't have the information. So patients are the ones who lose because they don't have access," Garrard says.

In Vancouver, Medicinal Cannabis Resource Centre Inc., which opened in 2010, claims to be the first such clinic. It offers a hybrid of telemedicine and off-site clinics. The annual membership fee is $275, walk-in appointments at an off-site clinic are $275, and Skype consultations cost $375.

CEO Terry Roycroft says "Physicians that have entrepreneurial spirit are looking at it as a new way to create a specialty line.

July 8, 2015

Health Canada now allowing medical marijuana producers to sell cannabis oil

Medical marijuana users can legally consume other forms of the drug beyond the traditional dried version under new Health Canada rules that follow a recent ruling by the Supreme Court of Canada.

TORONTO ? Health Canada is now allowing licensed medical marijuana growers to produce and sell concentrated cannabis oil as well as fresh marijuana buds and leaves in addition to the dried form of the drug.

The new rules announced Wednesday comes on the heels of last month?s unanimous Supreme Court of Canada decision that struck down limits on what constitutes legally allowable forms of medicinal products. Under the new rules 25 licensed producers across the country will be able to produce and sell cannabis oil, fresh buds and leaves needed to make edible products to registered patients. However, producers will not be permitted to sell plant material that can be used to propagate marijuana.

Health Minister Rona Ambrose had initially said she was outraged by the Supreme Court decision, which would let patients consume the drug in the form of edible brownies or cookies.

The high court ruling also left a grey area for commercially licensed pot producers as the decision gave medical marijuana users the right to both possess and consume cannabis derivatives, such as edibles, but it was unclear if licensed growers were allowed to sell anything other than the dried form of the drug.

Ambrose said in a statement Wednesday the new guidelines are intended to eliminate any confusion and reiterated the government?s stance that marijuana is not an ?approved drug or medicine.?

?Marijuana is not an approved drug or medicine in Canada and has not gone through the necessary rigorous scientific trials for efficacy or safety,? Ambrose said. ?Canadian courts have required reasonable access to a legal source of marijuana for medical purposes when authorized by a physician. The Government of Canada?s position is that this must be done in a controlled fashion to protect public health and safety.?

Licensed producers were pleased at the Health Canada announcement as they will now be able to increase the diversity of products offered to clients across the country.

?This is a natural sign of progression in the industry and a big step forward for patients seeking access to a variety of diverse products,? said Mark Zekulin, president of Tweed Marijuana. ?Tweed has the largest growing facilities in the country, and is ready to move expeditiously to offer its customers a diverse line of oil extracts.?

Licensed producers will be allowed to ship unscented and unflavoured oil to patients in child-resistant packaging and must be labelled with a ?KEEP OUT OF REACH OF CHILDREN? warning.

The label must also include the warning ?This product has not been authorized for sale under the Food and Drugs Act. It has not been assessed for safety or efficiency to treat or prevent any disease or symptom.?


June 11, 2015

GREAT NEWS FOR ALL PATIENTS WHO HAVE A MEDICAL MARIJUANA PRESCRIPTION

Medical marijuana patients in Canada can legally use all forms of the drug, the Canadian Supreme Court has ruled.

Medical marijuana patients will now be able to consume marijuana, not only smoke it. Cannabis oil is now permitted instead of only "dried" marijuana, meaning people can bake it into food products.

The case began in 2009 when a baker from the Cannabis Buyers Club of Canada was charged with trafficking and unlawful possession of marijuana. Former head baker of the club Owen Smith was caught baking 200 pot cookies, CBC reports. A British Columbia judge acquitted Mr. Smith and gave Canada's government a year to change laws around extracting marijuana. The case then wound up in the Supreme Court. Restricting people to dried marijuana for medical purposes has been declared "null and void" by the court.

Now, Canadians who qualify to use medical marijuana can have products like cannabis-infused cookies and tea. Medical marijuana is used for medical ailments such as Crohn's disease, seizures, HIV and nausea. In Canada, physicians decide who is eligible to use it. The court ruled that prohibiting possession of non-dried forms of marijuana is "contrary to the principles of fundamental justice because they are arbitrary; the effects of the prohibition contradict the objective of protecting health and safety".


Health Canada's Medical Pot Program Racks Up Millions In Costs As Approvals Fizzle

January 28, 2015

Medical Marijuana Toronto - Leaf
Joe O'Connal

Health Canada expects to spend more than $2 million this year to review applications from companies vying for entry into the commercial medical marijuana market, some of them having burned through millions of dollars trying to navigate a process that insiders say is mired in red tape.

The federal government, which has attracted about 1,200 would-be pot producers with the allure of a potential $1.3 billion industry, has licensed only two new companies to sell the drug in nearly a year, amid growing accusations that Health Canada's selection process is sluggish, convoluted and arbitrary. One company even believes the government is deliberately trying to stop medical marijuana growers from getting licensed, according to a court affidavit.

In total, Health Canada has licensed 23 producers, far short of the 60 originally projected to be in the market at the end of its first fiscal year in March. The 32 government employees working on the new medical marijuana program had 311 applications in their backlog as of Dec. 22.

Health Canada projected in January 2014 that the cost of processing applications alone would surpass $2 million during the program's inaugural year, according to documents obtained by the Huffington Post Canada under the Access To Information Act. That pales, however, in comparison to the millions of dollars applicants are spending before they know whether they will be approved to sell products.

Eric Nash of Island Harvest, told HuffPost that he and a number of his peers have grown frustrated. He says Health Canada keeps changing the regulatory goal posts, making it difficult for applicants to understand what it takes to get approved.

Nash's company was given the greenlight to build a facility in February 2014 by Health Canada. But he says his business has stalled since the federal government suddenly refused to perform one of the final required inspections after it quietly increased the level of security required at his facility without telling him.

"I have found the application process onerous, problematic and illusory... it seems as though Health Canada is deliberately attempting to stall and obfuscate the MMPR application process creating very significant barriers to entry," he wrote in an affidavit for an upcoming court case challenging the constitutionality of the current medical marijuana rules.

A number of applicants have privately shared their frustration with the federal government's lack of communication, perceived delays, changing requirements and seemingly arbitrary refusals. But they are reluctant to talk about it publicly for fear of invoking the wrath of Health Canada, which decides whether they ever get a license under the current rules.

One company that did not want to be identified said it has invested $1.5 million and is spending about $11,000 a month as it waits for a required inspection of its facility.

Two applicants said they had hired call centre staff before April 1 when they were optimistic that the licences were imminent, but had to fire them months later when it became apparent that the approval wasn't coming anytime soon.

So far, only one applicant is challenging Health Canada's decision to refuse it a medical marijuana licence. New Age Medical Solutions Inc. asked a federal court judge to review its rejection in November after Health Canada said it had not hired a suitable quality assurance person. The company is currently in negotiations with the government to reach an out-of-court settlement. If talks fail and the case is argued in a courtroom, the intricacies of Health Canada's vetting process could soon become a lot more transparent.

Before the program's launch last March, Health Canada appeared more relaxed in its approach to interpreting the regulations as it scrambled to have enough marijuana to supply the market, said David Brown of Lift, a website devoted to Canada's medical marijuana community.

But after a federal court judge granted a last-minute reprieve allowing some 20,000 patients to temporarily keep growing their own stock, the pressure subsided - at least until the outcome of a trial that begins next month - and Health Canada clamped down on the application process.

It has allowed 15 companies to sell their products to patients and eight more to produce but not sell. The last new entrant was approved to grow the drug in September.


October 14, 2014

The College of Family Physicians of Canada has created new guidelines to help doctors determine if and when a patient should have access to marijuana to treat chronic pain or anxiety.

The college’s recommendations advise doctors to only approve access to medical marijuana for treatment of pain in patients who haven’t responded to other treatments, and say it is not appropriate for people under 25, those with a personal or family history of psychosis and those with a substance abuse disorder.

The document was created to address the predicament doctors face because of new rules that make them responsible for approving access to medical marijuana despite the fact it has not been studied in-depth by Health Canada or approved for therapeutic purposes. A court ruling requires the department to provide access to medical marijuana when authorized by a physician. The challenge for doctors is that no comprehensive, systematic scientific evidence has been conducted to determine how effective medical marijuana is, what conditions it helps with, and who can best benefit from it.

“Physicians are in a difficult situation with a product that remains illegal in Canada and yet for which they are now asked to actually be the prescriber of this substance,” said Francine Lemire, CEO of the college.

Or, as the document puts it: “We are asked to authorize our patients’ access to a product with little evidence to support its use, and in the absence of regulatory oversight and approval.”

The gaping evidence gap prompted the Arthritis Society to also announce Monday it wants more research to study the impact of medical marijuana on pain. The organization is preparing to fund clinical studies.

“I think it’s high time that we found something to help the 4.6-million Canadians living with arthritis and trying to do something to help,” said Jason McDougall, chair of the Arthritis Society’s scientific advisory committee and a pain researcher at Dalhousie University.

The Arthritis Society is planning to earmark some of its funds to an open competition where researchers can apply to study medical marijuana. Dr. McDougall says research will allow the medical community to have a clear idea of how marijuana works and what role it should play in pain management and other conditions.

“I think physicians are hesitant about it because they don’t fully understand,” Dr. McDougall said. “That’s why we require this…research.”

Chris Simpson, president of the Canadian Medical Association, said the new college guidelines will be a critical tool for doctors and can help prevent the emergence of a “Wild West” when it comes to prescribing medical marijuana. “I think it’s appropriately cautious,” he said.

Dr. Simpson added the country’s doctors have never faced a situation like this before.

It’s estimated that about 40,000 Canadians use marijuana for medicinal purposes, and many say it helps them control pain, seizures, dementia, glaucoma and a host of other conditions.

The latest developments come just weeks after the Canadian Medical Association adopted a motion that officially opposes smoking marijuana or any other plant. The CMA argues that smoking carries clear health risks and that there is no good research backing the use of medical marijuana.

But Dr. Simpson said the position is based on the current lack of evidence and that news of the Arthritis Society’s commitment is a “positive development.”

“We’re operating or being asked to operate in an information or an evidence vacuum,” he said.

Dr. Lemire said the college will continue to meet with Health Canada and will press the need for more research. “We have to accept what is currently in place,” she said.”


Here is an excerpt from the Health Canada website from June 10, 2013 regarding, Marihuana for Medical Purposes Regulations and Transitioning to the New System:

OTTAWA, Today

The Honourable Leona Aglukkaq, Minister of Health, announced new regulations that will change the way Canadians access marihuana for medical purposes. The new Marihuana for Medical Purposes Regulations (MMPR) will be published in the Canada Gazette, Part II, on June 19, 2013.

"While the courts have said that there must be reasonable access to a legal source of marihuana for medical purposes, we believe that this must be done in a controlled fashion in order to protect public safety," said Minister Aglukkaq. "These changes will strengthen the safety of Canadian communities, while making sure patients can access what they need to treat serious illnesses."

Since its introduction in 2001, Health Canada's Marihuana Medical Access Program (MMAP) has grown exponentially, from under 500 authorized persons to over 30,000 today. This rapid increase has had unintended consequences for public health, safety and security as a result of allowing individuals to produce marihuana in their homes.

Under the new regulations, production will no longer take place in homes and municipal zoning laws will need to be respected, which will further enhance public safety.

The new Marihuana for Medical Purposes Regulations aim to treat marihuana as much as possible like other narcotics used for medical purposes. The regulations will provide access to quality-controlled marihuana for medical purposes, produced under secure and sanitary conditions, to those Canadians who need it.

The regulations will also streamline the process for applicants and health care practitioners. Under the new regime, individuals will not be required to provide personal medical information to Health Canada. Health care practitioners will be able to sign a medical document enabling patients to purchase the appropriate amount related to their conditions directly from a Licensed Producer approved by Health Canada.

In order to facilitate the transition from the current program to the new regime, both will operate concurrently until March 31, 2014. Effective April 1, 2014, Health Canada will no longer produce and distribute marihuana for medical purposes.

Existing MMAR patients who hold an Authorization to Possess (ATP)

Thousands of patients are federally exempt to possess and use medical marijuana through Health Canada's Marihuana Medical Access Regulations (MMAR). If you currently hold an authorization to possess (ATP) under the MMAR, your will need to transition to the new Marihuana for Medical Purposes Regulations (MMPR). For the steps required to transition to the new MMPR visit http://www.hc-sc.gc.ca/dhp-mps/marihuana/access-acceder-eng.php

Safety Information from Health Canada

About Marijuana/Cannabis

What is does: Consuming marijuana often produces euphoria, relaxation, time-disorientation, perception of enhanced sensory experiences, and loss of inhibitions.

What the Active Ingredients Are:

  • Tetrahydrocannabinol (THC)
  • Cannabinol
  • Cannabidiol

How this Product is Supplied:

Dried marijuana plant material.

WARNING

Before using Marijuana, always talk to your physician particularly if:

  • You have heart disease.
  • You have asthma, chronic obstructive pulmonary disease or other disease of the airways.
  • You have a history of alcohol abuse or dependence.
  • You have a history of drug abuse or dependence.
  • You have a history of serious mental disorder.

When this Product should not be used:

  • If you are allergic to any cannabinoid or to smoking.
  • If you have a history of serious mental disorder such as schizophrenia or depression.
  • If you are pregnant or planning to get pregnant. In addition to the risk of smoking, the use of marijuana when you are pregnant may be a risk factor for sudden infant death syndrome. Uterine exposure to marijuana may also cause behavioural problems in the child.
  • If you are nursing.

There may be other conditions where this product should not be used but which are unknown due to limited scientific information.

Administration of marijuana by smoking is not recommended.

Marijuana may impair your ability to drive or operate heavy machinery. The effects can last up to 24 hours after consuming.

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