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Minnesota Medical Cannabis
Patient Registry Program
August 8, 2014
Jamie L. Olson
Legislative Analyst/Attorney
House Research Department
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Medical Cannabis in the U.S.
Medical cannabis allowed (21 + DC)
Recreational & medical use allowed (2)
Limited products allowed (11)
August 8, 2014
House Research Department
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Design of the
MN Registry
Program
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House Research Department
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General overview
• 2 licensed manufacturers
▫ 4 distribution sites
▫ 1 manufacturing site
• No smoking
• New criminal and civil penalties created
• Limited qualifying conditions
August 8, 2014
House Research Department
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Patients
• Qualifying medical conditions
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Cancer*
Glaucoma
HIV/AIDS
Tourette’s
ALS
Seizures
Severe and persistent muscle spasms
Crohn’s disease
Terminal illness with life expectancy of under one
year*
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House Research Department
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Patients
• Participation in the registry program
• Responsibilities during participation
• Civil and criminal protections
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House Research Department
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Health Care Practitioners
• Participation in the registry program
• Responsibilities during participation
• Civil and criminal protections
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House Research Department
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Manufacturers - Registration
• $20,000 non-refundable application fee
• December 1 – Registration/Re-registration
• Conditions of registration
▫ Supply medical cannabis by July 1, 2015
▫ Comply with requirements under law
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House Research Department
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Manufacturers - Registration
• Factors to be considered by MDH
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Technical expertise in cultivation and conversion
Qualifications of employees
Long-term financial stability
Ability to provide appropriate security
Demonstration of ability to meet production needs
Projection and ongoing assessment of fees on
patients
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House Research Department
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Manufacturers - Regulation
• Fees
▫ Annual fee for cost of regulation/inspection
▫ Charges to patients
• Operating documents
▫ Procedures to ensure accurate record keeping
▫ Procedures to implement appropriate security
measures to deter theft
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House Research Department
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Manufacturers - Regulation
• Location of facilities
▫ Distribution facilities – geographic based on need
▫ Not within 1,000 feet of a school
• Employees
▫ No one under 21 years old
▫ Background check for disqualifying felony
conviction
▫ Pharmacist(s)
▫ Required identification during transport
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House Research Department
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Manufacturers - Regulation
• Security
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Alarm system
Facility access controls
Perimeter intrusion detection system
Personnel identification system
• Contract with independent laboratory
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House Research Department
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Manufacturers - Regulation
• Inspection
▫ Reasonable inspection by MDH
▫ Certified annual audit
▫ Examination of business affairs
• Monthly report to MDH
▫ Amount and dosages distributed
▫ Chemical composition of MC
▫ Tracking number assigned to distributed MC
August 8, 2014
House Research Department
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Manufacturers - Production
• Requirements
▫ Reliable and ongoing supply
▫ One enclosed, locked facility
▫ Processed into allowable form prior to distribution
• Allowable forms
▫ Pill
▫ Liquid (including oil)
• Deadlines
▫ July 1, 2015 – distribution from at least one site
▫ July 1, 2016 – distribution from all four sites
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House Research Department
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Manufacturers - Distribution
• What may be distributed
▫ Allowable forms & products
▫ Packaging
▫ Labeling
• To whom
▫ Patients, caregivers, parents
▫ Registry verification
• By whom
▫ Pharmacist(s) employed by manufacturer
• How much
▫ 30-day supply
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Manufacturers - Other
• Relationship with health care practitioners
• Marketing restrictions
• Criminal and civil liability
• Criminal protections
August 8, 2014
House Research Department