How you can plug in: Minnesota Department of Health releases medical cannabis timeline

Submitted by MN Norml on Tue, 07/22/2014 - 16:06

Blackberry medical cannabis

The Minnesota Department of Health has released information on the formation of the medical cannabis program. All the meetings are open to the public and soon draft proposals for medical cannabis manufacturer regulation will be released. MN NORML is paying close attention to this program's development. Will manufacturers be powerful out-of-state corporations? Will new medical conditions be added to the 'allowed list'? If we work together we can have a major impact on this rule-making process and push for responsible adult use of cannabis next year at the Minnesota Legislature.

Here is the latest information produced by the Minnesota Department of Health including an upcoming meeting to review manufacturers Friday August 8th, 10 am to 3 pm at the Skjegstad Room in the Minnesota Department of Revenue Building, 600 Robert Street North, St. Paul. There is a meeting for task force members to meet each other on Thursday, July 31, from 1:30 pm-3:30 pm, in Room B144/145 of the Orville Freeman Building, 625 Robert Street North.

The official contact info: "For more information or to ask questions not addressed here, please email requests to [email protected] or call 651-201-5598." When the public comment period starts on the medical cannabis manufacturer plan, it would be great to point out to this board that Minnesota Constitution Article 13, Section 7 clearly states: "Sec. 7. No license required to peddle. Any person may sell or peddle the products of the farm or garden occupied and cultivated by him without obtaining a license therefor." Hence, the only constitutionally congruent recommendation from this committee would be "no license required", and everyone involved ought to acknowledge this bedrock reality.

Photo Credit: Wikipedia (creative commons)

Medical Cannabis Program Key Dates

May 29, 2014

  • Medical cannabis legislation signed into law.

June 2014

July 10, 2014

  • Members of state's task force on medical cannabis therapeutic research appointed by legislature and Governor.

July 31, 2014

August 1, 2014

  • MDH releases an initial draft of manufacturer rules and the "Request for Applications" for public comment. The "Request for Applications" is the process by which potential manufacturers will apply to be selected for registration by MDH.
  • Deadline for Commissioner of Health to determine whether an adequate supply of federally sourced medical cannabis may be available, thereby removing the need for in-state manufacturing of medical cannabis for 2015.

August 8, 2014

Mid-August 2014

  • MDH may release a revised set of the manufacturer rules and the request for Application instructions for public comment.

Early September 2014

  • MDH releases request for applications to become a state-certified medical cannabis manufacturer.
  • Official notice of expedited manufacturer rules released (rules intended to govern manufacturer operations from December 1, 2014, to November 30, 2015). The effective date of the expedited rules will depend on Office of Administrative Hearing review.

Early October 2014

  • Deadline for manufacturer applications.
  • Official notice of formal rulemaking published (rules intended to cover renewal period, manufacturer operations starting December 1, 2015, patient and provider obligations)
  • Hiring of initial staff for Office of Medical Cannabis completed (Director, Research Director, Operations Supervisor, Policy Analyst and Administrative Assistant).

November 1, 2014

  • Deadline for Commissioner of Health to inform public and medical cannabis task force whether state will be able to register a manufacturer by the December 1, 2014, deadline.

December 1, 2014

  • Commissioner of Health registers two in-state manufacturers for production of medical cannabis products in Minnesota (if Commissioner has not previously determined that federal sourcing is a viable alternative). NOTE: The Commissioner may request one six-month extension of this deadline if it becomes necessary due to difficulties in finding and registering a manufacturer.
  • Deadline for Commissioner of Health to begin reporting to patients on:
    • Existing medical and scientific literature regarding the range of recommended dosages for each qualifying condition.
    • Range of chemical compositions of any plant of the genus cannabis that will likely be medically beneficial for each of the qualifying medical condition.

January 1, 2015

  • Deadline for Commissioner of Health to publish notice of proposed rules in State Register.

January 15, 2015

  • Deadline for the commissioners of state departments impacted by the medical cannabis therapeutic research study to report on the costs incurred by each department.

February 1, 2015

  • Deadline for Commissioner of Health to complete a report on the design and implementation of the registry program.

Late Winter/Early Spring 2015

  • Outreach and education efforts to potential patients and providers initiated (if you want a speaker to address your group about the Medical Cannabis program, please submit your request to [insert link to speaker request form]

March 2015

  • All personnel hired for Office of Medical Cannabis.

Late May/Early June 2015

  • Applications accepted by individuals seeking to be registered patients or designated caregiver.

July 1, 2015

  • Medical cannabis products become available to patients on the state registry. NOTE: There is a provision in the law for one six-month extension of the deadline if a manufacturer indicates it will not be able to provide medical cannabis products by this deadline.

July 1, 2016

  • Deadline for Commissioner of Health to report findings regarding the need for adding intractable pain to the list of qualifying medical conditions.

News Release. SOURCE: http://www.health.state.mn.us/news/pressrel/2014/cannabis071614.html

News Release July 16, 2014

Medical cannabis program organizing two events for coming weeks

The Minnesota Department of Health (MDH) today announced two upcoming meetings related to the state’s new medical cannabis program. The state’s new Task Force on Medical Cannabis Therapeutic Research, whose public members were announced by Governor Dayton on July 10, will have its first meeting on Thursday, July 31, from 1:30 p.m. to 3:30 p.m. The meeting will be in Room B144/145 of the Orville Freeman Building, at 625 Robert Street North, St. Paul. This initial meeting will focus on familiarizing the task force members with each other as well as their duties as outlined in the legislation.
In addition, the MDH Office of Medical Cannabis will host a meeting on Friday, August 8, for parties interested in learning more about the roles and responsibilities of the state’s certified medical cannabis manufacturers. This meeting will run from 10 a.m. to 3 p.m. at the Skjegstad Room in the Minnesota Department of Revenue Building, located at 600 Robert Street North, St. Paul. This meeting will provide prospective manufacturers and support organizations with more information about the expectations for manufacturers. The topics addressed in the meeting will include a review of the legislation, a discussion of potential supporting rules, some early information about the manufacturer selection process the state will establish, as well as an overall program timeline.
Both meetings are open to the public. For planning purposes, MDH asks that those interested in attending the August 8 meeting RSVP by Friday, August 1, to [email protected] . For more information about the medical cannabis program, please visit the MDH medical cannabis website at http://www.health.state.mn.us/topics/cannabis/index.html . -MDH- Media inquiries: Michael Schommer MDH Communications 651-201-4998

 FAQ SOURCE: http://www.health.state.mn.us/topics/cannabis/index.html

Medical Cannabis

Recognizing the potential value of medical cannabis for treating some serious conditions, the Dayton Administration, lawmakers and advocates worked together to develop a compromise that allows suffering Minnesotans to use medical cannabis in a safe manner. A copy of the final legislation can be found online at Minnesota Session Laws CHAPTER 311--S.F.No. 2470.

As the program is implemented over the coming months, the following materials may help address common questions.

For more information or to ask questions not addressed here, please email requests to [email protected] or call 651-201-5598.

Medical Cannabis Program Key Dates

FAQ on Medical Cannabis in Minnesota

What is Minnesota’s new policy regarding medical cannabis?

Legislation passed during the 2014 Minnesota legislative session creates a new process allowing seriously ill Minnesotans to acquire and use medical cannabis to treat certain conditions. A full copy of the legislation can be found online at Minnesota Session Laws CHAPTER 311--S.F.No. 2470. Governor Mark Dayton signed the bill into law in May 2014, and the medical cannabis program will be implemented by the Minnesota Department of Health (MDH) between May 2014 and July 2015. The law requires Minnesota residents with one or more of the qualifying conditions to join a patient registry that will be established by the state.

When can Minnesotans start applying to join the medical cannabis patient registry?

Minnesota residents will be able to apply for placement in a patient registry following conclusion of a rule-writing process and the submission of a report on the design and implementation of the registry program. The deadline for submitting the implementation report is February 1, 2015, meaning the patient application process would start at some point after that date in 2015.

When will medical cannabis become available?

The Commissioner will require selected manufacturers to supply medical cannabis products to patients by July 1, 2015. The legislation provides for a six-month extension of this deadline if the state encounters delays in selecting a manufacturer, or if the manufacturer encounters delays in production of medical cannabis products.

Who will be able to use medical cannabis?

Medical cannabis will be available to Minnesota residents whose health care provider certifies them to be suffering from conditions including:

  • Cancer associated with severe/chronic pain, nausea or severe vomiting, or cachexia or severe wasting;
  • Glaucoma;
  • HIV/AIDS;
  • Tourette’s Syndrome;
  • Amyotrophic Lateral Sclerosis (ALS);
  • Seizures, including those characteristic of epilepsy;
  • Severe and persistent muscle spasms, including those characteristic of multiple sclerosis;
  • Crohn’s Disease; and
  • Terminal illness, with a life expectancy of less than one year, if the illness or treatment produces severe/chronic pain, nausea or severe vomiting, cachexia or severe wasting.

The bill directs the Commissioner of Health to consider the addition of other conditions, particularly intractable pain (as defined in statute) by July 1, 2016.

Will people in bordering states be eligible to participate in the program?

Consistent with federal oversight of interstate commerce, Minnesota’s legislation restricts program eligibility to Minnesota residents and Minnesota-licensed health care practitioners.

How will the process work?

STEP 1: Minnesotans seeking to use medical cannabis to treat one of the qualified medical conditions receive certification of their condition from a Minnesota-licensed health care practitioner (a doctor, physician assistant or advanced practice nurse who is providing care to the patient) and submit an application to the Minnesota Department of Health.
STEP 2: After receipt of the application, the Commissioner of Health enrolls the patient in the registry program and issues a registry verification.
STEP 3: Starting in July 2015, Minnesotans issued a registry verification will be eligible to receive medical cannabis for their condition at one of the eight distribution facilities set up around the state by the state-approved medical cannabis manufacturers. Registered patients will pay a fee to help cover program costs.

How much will patients pay to participate in the program?

Most registered patients will pay an annual fee of $200 to participate in the program. There is a reduced annual fee of $50 for Minnesotans receiving Social Security disability, Supplemental Security Insurance payments or enrolled in medical assistance or MinnesotaCare. Patients will also pay a yet-to-be-determined price for medical cannabis products provided by the manufacturer.

How can children or incapacitated patients get on the patient registry?

The Commissioner of Health can approve and register a designated caregiver for a patient if the patient’s health care provider certifies that the patient is unable to self-administer medication.

On what grounds might a registry application be denied?

Applications will be denied only under specific circumstances, such as an applicant providing false information or an applicant lacking certification that he or she has one of the qualifying medical conditions.

Where will the state get the medical cannabis?

The medical cannabis provided to patients in the registry will come from two in-state manufacturers licensed by the state, unless the state determines by August 2014, that it can obtain an adequate supply of federally sourced medical cannabis products.

How will the state select medical cannabis manufacturers?

To become registered manufacturers of medical cannabis, entities must apply to the Commissioner of Health for consideration. The Commissioner will assess applications using several factors, including: technical expertise in growing cannabis and in making medicine in acceptable forms, qualifications of employees, financial condition, security precautions, and projected fees to patients.

When will the state begin soliciting bids from entities seeking to become an approved medical cannabis manufacturer?

The state will begin soliciting bids for medical cannabis manufacturers in late summer or fall of 2014.

Where will the medical cannabis distribution centers be located?

Each of the two registered manufacturers will establish and operate four distribution facilities around the state, for a total of eight. These facilities will be located based on geographical need and to improve patient access. No specific locations have been identified yet, and the process of selecting the locations will require input from the selected manufacturers.

How will the medical cannabis be distributed?

Each registered manufacturer will establish and operate no more than four distribution facilities around the state. Facilities will be located based on geographic need and to improve patient access.

In what forms will the medical cannabis be made available to patients on the registry?

Medical cannabis will be provided to patients as a liquid, pill or vaporized delivery method that does not require the use of dried leaves or plant form. The legislation gives the Commissioner of Health the ability to add other approved forms to the program in the future.

How will the state track the effectiveness and safety of medical cannabis?

With regard to safety and security, there are a number of precautions built into the program. For example, registered manufacturers must contract with a laboratory for testing the quality and consistency of the medical cannabis products. Manufacturers’ facilities are also subject to state inspection. With regard to effectiveness, one of the most important features of the program is a process for monitoring and evaluating the health impacts experienced by patients taking medical cannabis. This information will help patients and health professionals broaden their understanding of the benefits, risks and side effects of medical cannabis.

What are the obligations of patients and health care providers participating in the state’s medical cannabis program?

As part of their certification and participation in the program, patients must agree to continue receiving treatment for their condition. Participating health care providers must agree to provide ongoing reports about the patient’s health status/condition to the Minnesota Department of Health.