Minnesota Department Of Health Updated Medical Cannabis Manufacturer Questions and Answers
Recently, the Minnesota Department of Health provided additional questions and answers to help potential manufacturers in the application process. Most of the questions the MDH addressed were asked by attendees at the August 8, 2014 meeting. Below is an excerpt of some of MDH’s questions and answers (the full list of questions and answers can be found here.)
How Many Total Distribution Sites will There be Across the State of Minnesota?
Each manufacturer will have for distribution sites by July 1, 2016 for a total of eight locations across the state. At least one issue reason site for each manufacturer has to be up and running by July 1, 2015.
Is MDH Open to Additional or Different Distribution Method for Strategies Beyond the Traditional “Retail” Location? If So, is That Something that Should be Included in the Application?
MDH is interested in the ideas of applicants regarding creating convenient methods to get medical cannabis registered patients and encourages any ideas to be included in the application.
Well Telemedicine are Automated be Allowed with the Medical Cannabis Program?
MDH is interested in collecting ideas on an approach that would allow telemedicine system with the Minnesota statute. Keeping in mind the statute states “the manufacturer shall require that employees license as pharmacists pursuant to chapter 151 be the employees distribute the medical cannabis to a patient.”
Is MDH Planning Worker Protections and Training on Regulatory Issues?
The statute does not require specific protections are training but the Request for Applications specifies that each manufacturer to describe how they will protect workers and what training they will provide.
Does the Law Prevent Patients from Working for Manufacturers?
The law does not prevent patients from the workers nor require workers to be patients.
Why Does There Need to be Two Separate Manufacturers with Separate Facilities?
The language of the statute requires two manufacturers. Also, having two manufacturers prevents a natural disaster, pest or fungal outbreak from eliminating an entire crop of cannabis and thereby threatening supply to patients.
Explain How Having two Manufacturers is in the Best Interest of the Business and Patients? The Structure Would Seem to Provide No Competition.
The law requires that MDH register to manufacturers to produce medical cannabis. MDH is focused on identifying the two best manufacturers and any inquiries regarding the rationale of the statute should be directed to your local legislator.
Is There a Cap on Square Footage of Facilities?
Are There Any Alternative Energy Requirements?
Is the Congressional District Approach to Service Areas the Most Efficient Given the Potential Density of Patients in the Twin Cities?
The statute directs that “distribution facility shall be located based on geographical need throughout the state to improve patient access.” MDH is open to other ideas and suggestions however, the MDH believes that the district approach to service areas provides population balance between the two manufacturers and also ensures geographic dispersion.
How will MDH Determine Which Manufacturer will be Allowed to Have a Distribution Site Each Manufacturer Proposes Sites Within the 30 Mile Radius Limit?
This will require some discussion and negotiation between the two manufacturers and MDH.
How Will Zoning and Local Approvals Occur? Once a Manufacturers Registered Will they Then He to Get Approval from the Local Municipality?
MDH understands that applicants need to manage their investments for receiving a registration and therefore some official zoning may not be in place prior to application. However any approvals or recognition of support from local government obtained by an applicant considered as part of the evaluation process.
Does the Manufacturing Facility to be in the Service Area Assigned to the Manufacturer?
No, the manufacturing facility can be located anywhere in Minnesota the distribution sites do not need to reside in the service area assigned.
How Does this Business Legislation Applied to Indian Reservations?
American Indian reservations are sovereign nations. Any questions regarding Minnesota’s medical cannabis program and how or if it applies to American Indian reservation should be directed to each tribe.
Health Care Practitioner Questions
What Does the Law Mean When it Says There Should be No Financial Relationship Between a Manufacturer and a Healthcare Practitioner?
If the healthcare practitioner is not certifying patient conditions that MDH will permit the healthcare practitioner to have a financial relationship with the medical cannabis manufacturer.
What Happens if a Doctor Refuses to Certify a Patient’s Condition?
The statute does not require physicians to participate in the program.
What is the Timeline for the Lab Approval by the Commissioner?
The MDH expects the Commissioner will approve laboratories in the winter or spring of 2015, but a timeline has not been established.
MDH Stated that Labs Will Need to be Certified by 2016, But Medical Cannabis Needs to be Available in July 2015. How Will that Work for the Labs/Product Testing?
The process of a lab becoming fully certified according to international standards can take up to 18 months. The statute allows the Commissioner to provisionally approve the laboratory that has not yet had time to become certified. The laboratory approval process will be covered in the manufacturer expedited rules.
Will the Labs Own the Data they Collect?
Unknown at this time. This will be an issue that manufacturers and laboratories should address when they enter into a contract. The only requirement under the statute is that the lab test data be shared with the state.
There are Concerns that Some Pharmacists and CPAs Will Not Want to Become Involved With the Manufacturers Due to Risking Their Licenses. Is the MDH Going to be Able to Survey Providers and Pharmacists?
MDH is not going to survey pharmacists or other service providers on this issue and there is no data to validate that concern.
Why is the Word Manufacturer Used for Both Growing and Manufacturing?
The statute defines “medical cannabis manufacturer” or “manufacturer” to mean entity registered by the Commissioner to cultivate, acquire, manufacture, possess, prepare, transfer, transport, supply, or dispensed medical cannabis, delivery devices, or related supplies and educational materials.
Does the Manufacturer Have to be a Nonprofit Organization or Have a Specific Corporate Structure?
There is no specific corporate structure that is mandated.
What if the Department Cancels or Revokes the Manufacturer’s Registration?
Rules regarding this process have yet to be defined.
What Will be the Re-Registration Process?
Rules regarding this process have yet to be defined
What if One Manufacturer Goes Out of Business?
MDH does not plan to develop rules for scenario were one of the two manufacturers goes out of business detail rules in this area will be addressed rulemaking that occurs during 2015.
Manufacturer Application Fee Questions
Are any Hospitals or Pharmaceutical Companies Planning on Applying to Become a Manufacturer?
MDH is not aware of any hospitals, pharmaceutical companies or healthcare providers interested in becoming medical cannabis manufacturers.
Who Pays the $20,000 Application Fee?
All that apply pay the non-refundable application fee.
Is the $20,000 Application Fee Refunded to Those Who are Not Registered as Manufacturers?
No. The fee is nonrefundable. This is contained in the legislation.
Manufacturer Application Questions
Does the Application Request Identifying Employees? How is an Applicant Supposed to Have Employees if they Have not Been Registered Yet?
The request for application does not require employees to be identified however, if an applicant knows who their employees would be included that information would be helpful to the MDH. Expected qualifications of positions can be provided in the absence of specific people being identified.
Is the Data and Application Going to be Public? What about Financial Information That is Provided?
Information application will become public wants to manufacturers have been registered with the exception of any data that has been identified as trade secret.
Should an applicant let MDH know if they want to give a presentation with the application?
Yes. Let MDH know if you want a presentation be aware however that MDH reserves the right to request each applicant to provide a presentation.
Is MDH Willing to Travel Out of State to Conduct a Site Visit?
Who Pays for the Travel Costs to an Out-of-State Site Visit?
The state will pay for the costs of the site visit.
Will Bonus Points be Awarded for Residents of Minnesota?
No, not directly.
Will There be Any Special Considerations for Minnesota Ownership of a Manufacturer?
No, not directly.
Will the MDH Only Evaluate Experience in Legal Growing?
All information provided in in an application will be considered.
What Will Happen if No One is Capable and/or No One Applies?
In the event no suitable manufacturers registered, the statute allows the Commissioner to initiate the registration process.
After the RFA Submission Due Date Passes Will the MDH Communicate How Many Applications were Received?
MDH will provide some general information to the public regarding the process.
How will MDH Handle Having Four High Scores into Low Scores in Different Service Areas?
If one service area does not have any applicant that meet the minimum scoring requirements, MDH may solicit new applications for just that service area.
What Will be the Initial Demand for Medical Cannabis?
Exact demand is unknown until patients register with the program.
How Will Un-Used Medical Cannabis be Collected and Disposed Of?
The statute does not address this issue however MDH anticipates that manufacturers will address this in their RFA.
Is there Anything that Would Prohibit the Manufacturer from Billing a Patient?
Will the MDH Define How the Active Ingredients in Cannabis Should be Extracted?
MDH will not define what methods can or cannot be used to extract active ingredients from cannabis plants.
Will Only Certain Cannabis Chemical Compositions be Allowed?
The statute does not specify any stranger chemical compositions that are required. However the Commissioner shall review of publicly report the existing medical and scientific literature regarding the range of recommended dosages for each qualifying condition in the range of chemical compositions of any plant of the genus cannabis that will likely be medically beneficial for each of the qualifying medical conditions. This reports must be published by December 1, 2014 and updated annually.
How Will the Product be Tested Before July 1?
The MDH acknowledges that the timeline is tight. Based on MDH is conversations with those in the industry the challenging timeline is achievable. The Commissioner can request a six-month extension of the July 1, 2014 starting date but would like to avoid using the extension if at all possible.
Will Tincture or Other Medication That Can be Taken Sublingually be Allowed?
Yes, a tincture is a liquid and is allowed.
Can the Oils be Used in Edibles and Sold at the Dispensary?
No, edibles are not allowed in the statute.
Are There Restrictions on the Method of Ingesting the Oil, Liquid, or Pill?
The MDH is researching whether or not a spray is contemplated.
Will Testing the Product be Both at Growing and After Processing be Necessary?
It is standard practice for a manufacturer to test product throughout the growing and manufacturing process to ensure the end product meets quality standards and specifications.
What is the MDH’s Estimate for a Shelf Life?
The MDH expects manufacturers to establish their own shelf life claims.
Can the Manufacturers Act as a Research Facility? Can New Products be Developed? For Example, Could a Manufacturer Produce a Topical Cream as an Alternative Method for Ingestion?
The MDH currently has this question under review.
Statute and Rules Questions
Are the Expedited Rules the Law?
The expedited rules become law once the accepted by the Office of Administrative Hearings and the governor does not be told the rules.
What Protections Would There be for Investors Against any Federal Violations?
The state of Minnesota cannot grant protection for investors or employees of the manufacturer against any federal charges.
Is There an Easy Way for the Industry to Know if a Requested Change is a Legislative Change or Rule Change?
If the statute does not include a necessary topic, MDH lacks authority and must seek a legislative change. The topic is included in the statue, MDH has flexibility to dress it via the rules.