Capricious Actions by Health Canada Causing Detrimental Reliance to MMPR Applicants
- Health Canada plays favorites with MMPR Applicants and LPs.
- Arbitrary behavior towards applicants by Health Canada.
- Health Canada lacks placement of, or effective adherence to internal SOP’s.
- Health Canada’s internal system broken. Corrective actions required.
Health Canada has demonstrated a clear lack of diligence through capricious actions towards applicants throughout the MMPR application process, costing millions in undue expenses and irreparable damage to many legitimate business enterprises.
Without disclosing why Canadian’s largest Marijuana for Medical Purposes Regulations (MMPR) applicant CEN Biotech Inc. was being targeted, the company was recently given a letter seeking additional information with intent to reject the company’s license application within 20 days if sufficient information cannot be presented within that time frame to justify a contrary decision. The reason for the letter is unknown at this time, though CEN Biotech has responded with a federal application for judicial review through the Ontario courts, which outlines a grave misrepresentation of the intent of Health Canada, misleading communications towards the company, and arbitrary actions towards applicants in general.
Under the compelling of mandamus, Health Canada has 10 days to respond by either issuing a license to CEN Biotech, or opposing the application in federal court. This deadline is upon us.
Incidentally, these arbitrary actions by Health Canada bear a striking resemblance to the general behavior of Health Canada towards at least one other applicant Island Harvest Inc. who has been distributing and selling Cannabis for medical purposes as a designated licensed producer under Health Canada’s Marijuana Medical Access Regulations (MMAR) since 2002.
Eric Nash, CEO of Island Harvest Inc. has been cultivating, distributing and selling cannabis for medical purposes as a designated licensed producer since 2002 under the MMAR, and has been actively involved over the course of the years in working with governmental and regulatory authorities in providing valuable recommendations, research data, and guidance. To showcase a couple notable highlights, Mr. Nash has been invited to provide input to Health Canada by the Office of Policy and Strategic Planning in regards to the future of the Canadian federal medical cannabis access program, and has also attended the United Nations General Assembly Special Session on international drug policy to provide input on regulatory framework models for medical cannabis distribution protocol.
Mr. Nash has a history of continued political support from every level of local government, including federal, city, and regional authorities. In 2013, he prepared the operational infrastructure, facility, and government application for commercial cannabis production under the new MMPR. He hired top quality control personnel, identified an acceptable facility, and provided all documentation to Health Canada to obtain licensed producer status at level 5 security requirements on August 27th, 2013.
After a “ready to build” letter was requested, several requests for additional information were sent to Island Harvest from the Licenses and Permits Division at the Office of Controlled Substances. Each time the information was provided to Health Canada, an additional 4 page request for information would arrive. On February 24th, 2014 a long anticipated “ready to build” letter was finally in hand. For those who don’t understand the significance of a “ready to build” letter, this letter acknowledges that the applicant is fully prepared and authorized to build a medical marijuana cultivation facility. It is Health Canada’s way of saying; “Your application is approved, and you can have your facility. As long as you follow all the requirements set forth in the MMPR regulations, we will give you your license”. It is in essence, Health Canada’s promise to the applicant.
5 steps to licensing were laid out by Health Canada to Island Harvest Inc., the same 5 steps that were laid out to CEN Biotech Inc., and other applicants. These are: Screening, Reviewing, Ready to Build, Pre-License Inspection, and Issuance of License. The ready to build letter from Health Canada to Island Harvest stated: “Your proposal meets the requirements of the quality assurance pre-licensing report and record keeping requirements of the MMPR.”
And also: “Please inform us when you have completed your security installation and the electronic security is functional. We will arrange for the pre-license inspection. The inspection will confirm compliance with all requirements of the MMPR, including the security of the cultivation area and the security of the storage area.”
And finally: “Once a pre-license inspection has been conducted to verify compliance with the requirements under the MMPR and the key personnel identified in your application have received the security clearance required under the MMPR, a producers license will be issued.”
Both of these applicants, Island Harvest and CEN Biotech, performed all the required steps that were laid out by Health Canada, including top on the line security protocols at their facilities, and passing the required security clearances. Both of these applicants received the same promises of moving forward with final review and inspection and also received additional requests for verification, as well as notices on increased security level requirements being implemented. Both applicants received requests to provide additional information over the course of multiple correspondences back and forth.
On July 4th the company island Harvest received an email from Health Canada requesting additional information and stated: “Please provide us the information requested in this letter by close of business on July 23rd, 2014. If you do not respond by this date the Minister must refuse to issue a producers license pursuant to section 26 of the MMPR and your file will be closed.”
For those of you following the CEN Biotech story, this appears to be the exact same form of communication that is accompanied by a 20 day standard warning which was given to CEN Biotech after being leaked in part and out of context to the media before the company had any knowledge of its existence. If this format wording is the same used in recent correspondence to CEN Biotech, which it appears very much to be, then the company’s recent press release stating additional information was requested, is accurate in entirety.
Note that the letter to Island Harvest also stated: “We would also like to note that if inspection is successful and you are granted an MMPR license, this will be contingent on an upgrade to a minimum security level 7 vault within the next 12 months.” Note that CEN Biotech already met the increased security requirements at the time they built their facility. However, CEN Biotech’s letter for additional information was received even after pre-licensing inspection was completed at the very end of the process and license was being awaited. In light of similar experiences and event timelines, this is extremely suspect behavior by Health Canada.
On July 14th, after providing all requested information to Health Canada, Mr. Nash phones Health Canada at the Office of Controlled Substances and speaks to one Jacinthe David, who is the manager of the Licenses and Permits division. Perhaps the name sounds familiar. This is the same person who appears to have interfered with CEN Biotech’s licensing process and seriously delayed and or hindered the company from receiving a license to this date. When Mr. Nash calls, he is told by Ms. David: “We’ve been avoiding your inspection because were upgrading everyone to a level 7 security.” She also told Mr. Nash that Health Canada will not inspect a level 5 facility. Therefore… it took a full year of application processing time for the company to be advised for the first time, that the Licenses and Permits Division will not inspect a level 5 facility, which Health Canada had previously approved in a signed “Ready to Build” letter to Island Harvest Inc.
Mr. Nash attempted to seek further information from other Health Canada officials in regards to these new requirements, and was then scorned in a written communication from Health Canada and advised for the first time ever of this official level 7 minimum security requirement which had apparently been changed without any notice to applicants. After much wasted time and expense, Mr. Nash was asked to resubmit his plan for a facility with level 7 securities, and was unable to locate any stated requirement of a level 7 security requirement in any part of the application, guidance document, or written Health Canada directives.
After eventually being able to provide the level 7 security plan to Health Canada, Mr. Nash was also asked to provide a business plan with projected crop yields etc. The story continues, and does so with other applicants alike, including CEN Biotech.
Yet it seemed the goal posts set by the office of controlled substances are constantly moving, to the extent that it appears to be intentional stalling of the MMPR application process, creating very significant entry barriers and causing extreme financial burden to applicants. Correspondence from Health Canada regarding questions pertaining to the MMPR are also answered anonymously for the most part, making it impossible at times for applicants to cite specific individuals they have communicated with.
In a November 7th, 2014 correspondence with Deputy Health Minister George Da Pont, Mr. Nash describes his experience as follows:
“Health Canada is clearly moving the regulatory goalposts of the MMPR to obfuscate the application process to limit businesses entering the market, which has nothing to do with their supposed mandate of ensuring public health, safety or security… I am astounded and appalled at the disingenuous behavior of Health Canada with the unimaginably slow file processing times of over one year, with Island Harvest’s application now approaching 18 months with no foreseeable end in sight.”
In sworn affidavit, Mr. Nash also states: “I have discovered that Health Canada has stalled our application, delayed communications, changed regulations without notice to industry applicants, failed to respond in a timely manner and generally ensured that the MMPR application process is as laborious, misleading and as difficult as possible for our company as a Licensed Producer applicant. I see no indication that these actions by Health Canada will change in the future based on my past experience and background as a MMPR applicant.”
In a recent application for judicial review filed by CEN Biotech with the federal courts, we see an extremely similar situation. “MMPR program continued to move the goal post for compliance and readiness of the facility and had multiple facilities and license types for other MMPR applicants such as “conditional licensure” and failed to provide any communication of such opportunity.”
Health Canada does appear to be playing favorites with applicants. Readers and MMPR applicants would like to know why. I encourage you, when your done reading, to review the timeline laid out in the CEN Biotech application for judicial review which can be found in this recent article on our site.
Health Canada demands Standard Operating Procedures (SOP’s) from applicants and LP’s, yet they fail to adhere to an SOP themselves in regards to licensure selection criteria.
They apply differing standards towards different applicants at different points in time.
It is also clear that if currently licensed LPs had to meet the same criteria requested of CEN Biotech Inc. Little or none would currently be licensed. If one were to ascertain information in regards to Tweed, one would allegedly find a shared building, no perimeter security, and no gate. This means that anyone who so desires, could walk up to the front door and knock. In stark contrast with CEN biotech’s prison style double layered fencing, with razor wire and high security 24hour a day manned security gate who is having a very hard time being licensed. Or Aphria, with no fence, no security, and reported marijuana odors in the vicinity. Or Aurora who was allegedly granted license with a non-operational HVAC, while CEN Biotech with millions spent is held up for the type of fastening used on an interior vent. Some applicants are also still advertising on social media, which is against MMPR regulations. Yet they continue unhindered, while others follow to a tee and are ignored. Readers and MMPR applicants want to know why.
I point this out not to point fingers at these LP’s, but to demonstrate that in addition to serious demonstrated forms of arbitrary actions by Health Canada, distinct and purposeful prejudice may very well also exist in the licensing program. Some applicants are also permitted to grow between inspection and license, while some are not. Some applicants receive and maintain license with clear deficiencies in place, with little to no wait time between call for inspection and licensing, while some are given the task of chasing goal posts, as if they were an unreachable mirage in the desert, or a pot of gold at the non-existent end of a Canadian rainbow.
Canada, it would seem your applicant’s and patients implore you… to act.
Note: If you are an applicant or a patient in the MMPR program and you wish to share your story, provide feedback, or connect with other applicants, please contact us at firstname.lastname@example.org.
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Disclaimer: Author has no affiliation with any companies mentioned in this article and was not compensated in any way shape or form. Any opinionated content is the expression of the author.