Health Canada Meets Federal Court Deadline!

HC-signature v2On August 11 Health Canada (HC) announced that they will meet the court imposed August 24 2016 deadline for revising the Marihuana for Medical Purposes Regulations (MMPR) . The regulations are now called the Access to Cannabis for Medical Purposes Regulations (ACMPR). These new regulations will replace the MMPR as of August 24, 2016, and are being implemented as a result of the Federal Court ruling in the case of Allard v. Canada. Health Canada has issued a fact sheet – http://news.gc.ca/web/article-en.do?nid=1110409 – with the complete set of regulations to be published on the HC website August 24, 2016.

Once we have obtained a copy of the ACMPR we will provide a detailed update to you as to what to expect under the new regulations. However, from what we have been told by HC, 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.

*IMPORTANT NOTE: Under the ACMPR, Health Canada will continue to accept and process applications to become a licensed producer (LP) that were submitted under the former MMPR. Furthermore, 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.

Highlights of Health Canada’s ACMPR announcement are as follows:

  • patients who wish to grow their own must be registered and still only “have the option of producing a limited amount of cannabis for their own medical purposes, or designating someone to produce it for them.”

  • those patients can only “produce a limited number of plants based on a formula that takes into account the individual’s daily dose”

  • here is the big win for LP’s:

    • the existing 34 Licensed Producers across Canada, which are currently supplying close to 70,000 Canadians, and future LP’s are to be the “main source of safe, quality-controlled cannabis for medical purposes”;

    • licensed producers will be the “only legal source of starting materials (seeds or plants)” and interim supply to individuals who are registered with Health Canada to produce or who have designated someone to produce for them, a limited amount of cannabis for their own medical purposes;

    • Storefront operations selling marijuana, commonly known as “dispensaries” and “compassion clubs” are not authorized to sell cannabis for medical or any other purposes.

  • 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

BenchmarkSYSTEM software is easily configured to adapt to these regulatory changes and for any future changes to the subsequent May regulatory framework. On-site laboratories that are planed, designed, implemented and supported by Benchmark Labs had already provided for on-site validation of methods use in anticipation for on-site ISO 17025(2005) accreditation that requires method validity.

Public reaction to the ACMPR announcement has been mixed. Tweed states that, “While we support a patient’s right to grow at home, the MMAR and the grow-at-home system it represents is not good policy. All of the flaws that existed in 2013 when the government concluded after extensive consultation that the MMAR presented elevated diversion risks, abuse of plant limits, and an inability for law enforcement to know legal from illegal cannabis – still exist today.” Aurora notes that, “Aurora has supported patient choice and personal production from day one.  We are thrilled with Health Canada’s response to the Allard ruling. The ability to choose to grow at home is a great step forward to improving patient access.” Both Tweed and Aurora intend to offer solutions to those who wish to grow their own product or designate a grower. Neither company is of the opinion that existing LP’s will be negatively impacted by the new ACMPR regulations.

Of interest is the metric HC used to calculate how many plants an indoor home grower can possess. For every gram a currently registered patient is prescribed per day, they are allowed to possess 5 plants. Plant size, square footage and number of watts used to illuminate the grow are not figured in. We offer up the possibility that some home growers will choose to grow “Christmas trees”, very large plants with the potential to yield several pounds each, provided the plants are well cared for and receive sufficient light.

Storefront operations selling marijuana, commonly known as “dispensaries” and “compassion clubs”, are not authorized to sell cannabis for medical or any other purposes. Although HC states that the ACMPR is a placeholder regulation until new legislation can be tabled next April, the prohibition of existing storefront operations sends a clear signal that businesses with an illegal and untested source of supply will not be allowed going forward. HC will instead look at distribution through conventional supply chains, such as pharmacies, and will no doubt insist that LP’s will be the only legal cannabis providers.

What appears to be missing from the regulations is a way to accommodate those growers and dispensary operators that purport to serve the “grey” medical cannabis market. Most of these people are not criminals in the sense that they are bad people or are doing something that is clearly harmful to society. We hope that these people, many of whom have performed key roles in changing hearts and minds regarding the utility and safety of cannabis, will have a role to play in the future Canadian medical and recreational cannabis marketplace.

What we may expect from Health Canada for “home grow” producers by next May, is something similar to what we witnessed with Provincial deregulation of alcohol production and sale in the early 1980’s. At that time some Provinces permitted individuals consumers to purchase all that they needed to make wine, beer and spirits at home or more recently to participate in comercial “U- Brew” locations for personal consumption but not for resale. However, as most you may remember, this industry was very popular during the late 80’d and into the 90’s but slowly disappeared from being common in most every neighborhoods to just a few locations per city or per province. This was largely due to a rapid increase in consumer choice with respect to high quality alcoholic beverages being produced through the introduction of “micro-brew” distilleries who themselves became highly regulated to confirm to quality and consistency while selling at relatively lower cost than existing established and imported products.

Stay tuned for our comments on the upcoming ACMPR regulations, and please contact us if you have any questions or comments.

We look forward to seeing you at our trade booth at the LiftExpo in Vancouver September 17 and 18th to meet our Vendors as well as to see our new branding for Benchmark’s complete turn-key solution approach to this fast paced and every growing sector!