Monthly Archives: May 2014

House Version of Competing Minnesota Medical Marijuana Bills Faces Legal Hurdles That Senate Version Does Not

Last week the Minnesota House and the Minnesota Senate each passed different versions of a medical marijuana law to provide relief to some of the sick and dying.  (Current SF 2470 is the House Delete-All Bill; while current SF 1641 is the Senate Bill.)  The previous post points out some of the differences in the two Bills, which will go to a Senate-House Conference Committee.  Once the Conference Committee negotiates a single Bill from the two versions, the Bill will go back to the House and Senate for an up or down vote; and if passed, it will then go to the Governor for consideration for approval into law.

One key difference between the two versions is that the the House Bill follows a medical, clinical study format with distribution through pharmacists.  This fundamental difference will trigger presumably unintended consequences that will likely may the proposed law unworkable under other, existing Minnesota laws relating to pharmacists.

These other laws relating to pharmacies are not an issue for the Senate Bill because it follows a dispensary model, as other the other twenty-one medical marijuana states do; and does not include pharmacists  in distribution of medicine.

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House bill affirmatively requires a pharmacist to dispense cannabis. Senate bill does not.

Here are some pharmacist-related Minnesota laws and rules that will create trouble for the House bill:

Minnesota Statutes §151.15 COMPOUNDING DRUGS UNLAWFUL UNDER CERTAIN CONDITIONS.  “It shall be unlawful for any person to compound, dispense, vend, or sell drugs, medicines, chemicals, or poisons in any place other than a pharmacy, except as provided in this chapter.”

Minnesota Statutes §151.06 POWERS AND DUTIES. Subdivision 1. “Generally; rules. a) Powers and duties. The Board of Pharmacy shall have the power and it shall be its duty:
(7) to deny, suspend, revoke, or refuse to renew any registration or license required under this chapter, to any applicant or registrant or licensee upon any of the following grounds: …
(ii) in the case of a pharmacist, conviction in any court of a felony; …
(vii) employing, assisting, or enabling in any manner an unlicensed person to practice pharmacy; …
(ix) violation of any of the provisions of this chapter or any of the rules of the State Board of Pharmacy;”

Minnesota Administrative Rules § 6800.2250 UNPROFESSIONAL CONDUCT.  “Subpart 1. Prohibited conduct. Unprofessional conduct shall include, but is not limited to, the following acts of a pharmacist or pharmacy:

H. The violation of any law, rule, regulation, or ordinance of the state or any of its political subdivisions, including the Board of Pharmacy, or the United States government, or any agency thereof relating to the practice of pharmacy.

Subp. 3. Accessories to illegal drug traffic. The selling, giving away, or otherwise disposing of accessories (i.e., glassine papers, empty capsules, quinine, lactose, or similar products), chemicals, or drugs found in illegal drug traffic is unprofessional conduct by a pharmacist when the pharmacist knows or should have known of their intended use in illegal activities.

It is unclear how the House version (SF 2470 the House Delete-All Bill) can be fixed to avoid these problems which would appear to make it completely unworkable and illusory.  It is based on distribution through pharmacists — a new, first-time experiment in the United States.  No other medical marijuana state has ever tried this approach before.  On the other hand the Senate version (SF 1641 the Senate Bill) relies upon the tried and true method of dispensaries, which has been used for years in the other states with legal medical marijuana programs.  If Minnesota truly wants to provide needed compassionate relief to the sick, ill and dying in Minnesota, let’s hope the legislature’s Conference Committee agrees to send the Senate version for final approval to the House, Senate and Governor.

Conflicting Medical Marijuana Bills in Minnesota: Senate version is Good, House version is Bad

This week, the MN Senate passed a medical marijuana Bill that is better than nothing. Friday May 9, 2014,The MN House passed a Bill that is worse than nothing. The two Bills will now go to a Sentate-House Conference Committee to negotiate one Bill that will then face an up or down vote in the House and Senate, and if passed in both, then go to the Governor.

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We need to advocate, now, for the Senate version in MN. We need to urge our respective MN Senators and MN House members, as well the MN Governor, to support the current Senate version, not the current House version

A side-by-side comparison of the two bills for your reference, created by Minnesotans for Compassionate Care is reproduced below.  Please contact your legislators (and the Governor) and make sure they know what you need. Share!

SF 2470 and SF 1641

A Side-By-Side Comparison of Medical Cannabis Bills (as of May 10, 2014):

  SF 2470 The House Delete-All Bill SF 1641 The Senate Bill
Net Cost to Minnesota $4.9 million during the first three fiscal years; in the third year (FY 2017), the net cost is projected at $962,000 Cost neutral; during the first two years, the net cost is projected at $4.5 million, mostly from the Special Revenue fund; beginning in FY17, net savings are projected, with the savings in FY17 being $390,000; Note: even states with lower patients registry fees — such as Michigan — have seen multi-millions annual surpluses, as has Arizona
Sources of Cannabis A single state-approved manufacturer (3.27-3.29) 55 regulated and licensed alternative treatment centers (ATCs) (7.22-7.31)
Access Points A single manufacturer with 2 satellite locations; patients must pick up cannabis from an on-site pharmacist; pharmacists must deliver it to the patients’ homes if they are disabled, and may charge for delivery (9.21-9.23; 10.14-10.20, 13.12) 55 regulated ATCs with one in each county with over 20,000 residents, none in less populous counties, two to three in the most populous two counties, and two in St. Louis County; each patient must designate a single ATC (7.22-7.31)
Permissible Modes of Administration of Cannabis Only liquids, pills, and oils are initially allowed, patients could only vaporize liquids and oils (though extracts are more intoxicating and make dosage control difficult) (1.19-2.4) Smoking is prohibited; other means of administration are allowed (See: 4.16)
Laboratories One laboratory, selected by the manufacturer, is allowed (4.18-4.22) The commissioner will regulate and license safety compliance facilities to perform lab testing and training (3.21-3.27, 6.20-7.21)
Qualifying Conditions Cancer, glaucoma HIV/AIDS, Tourette’s, ALS, seizures, severe and persistent muscle spasms, Crohn’s disease, and other conditions added by the commissioner (2.30-3.4) Cancer, glaucoma, HIV/AIDS, Tourette’s; ALS, seizures, severe and persistent muscle spasms, Crohn’s disease; severe, intractable pain; severe nausea; cachexia or wasting; PTSD, hepatitis C, and conditions added by the commissioner (2.12-2.23)
Caregivers Only patients who are so disabled that their practitioner specifies they cannot administer their own medicine may have a caregiver; caregivers cannot pick up their medicine and can only help with the administration of cannabis at the patient’s home; caregivers must be at least 21 and can assist a single patient   (2.20-2.24, 10.19-10.20) Each patients may designate a caregiver to pick up their medicine and help administer cannabis; caregivers must be at least 21 and can’t have certain convictions; caregivers can assist no more than five patients (2.24-2.26)
Cost to Patients for Registry Identification Card and Cannabis Patients would pay $200 per year (or $50 in some cases) for registration and the single manufacturer will determine the cost of cannabis (13.3-13.16) Patients would pay $140 per year (or $26 in some cases) for a state ID card; patients could compare the costs of medical cannabis and decide which ATC to designate (8.15-8.17)
Patient Registry Identification Each patient and caregiver must have a registry identification number; no photo is mentioned (See: 2.17-2.18) Each patient and caregiver must have a registry ID card with a photograph of the cardholder (9.31); the department must set up a phone or web-based verification system for law enforcement and ATC staff (13.6-13.14)
Additional Requirement for Minors None specified, except that the manufacturer will dispense the cannabis to a minor patient’s parent or legal guardian (9.24-9.32) Minors must have two certifications and their parent/guardian must consent and control the acquisition of cannabis, the dosage, and the frequency of is use (9.5-9.18)
Selection of Provider(s) Requirements include that the manufacturer must have experience growing medical cannabis (meaning it must be from out-of-state), have long-term financial stability, and must have “demonstrated an ability to meet the medical cannabis production needs” of the program (4.1-4.17) ATCs are selected using a merit-based numerically scored selection process considering the location, character and experience of applicants, the business plan, the security plan, and the ability to maintain an adequate supply; ATCs must comply with local zoning and be 1,000 feet from schools (5.5-5.13; 7.1, 7.10-7.13)
Anti-Discrimination Provisions Includes limited anti-discrimination protections in housing, employment, child custody, and medical care (such as organ transplants) (12.12-13.2) Includes limited anti-discrimination protections in housing, employment, child custody, and medical care (such as organ transplants) (17.20-18.9)
Limitations Patients could not drive while impaired or undertake anything while impaired that would be negligence or malpractice, they could not possess cannabis at schools or correctional facilities; they could not vaporize cannabis in a public place or where minors would inhale it; patients needing caregivers could only use cannabis at their own home (3.5-3.19, 11.28-11.31) Patients could not drive while impaired or undertake anything while impaired that would be negligence or malpractice, they could not possess cannabis at schools or correctional facilities; they could not vaporize cannabis in a public place or where minors would inhale it (4.8-4.25)
Security Provisions for Manufacturer/ATCs The manufacturer’s application must show it can provide appropriate security measures (4.12) The commissioner will set security requirements, including an alarm system, facility access controls, perimeter intrusion detection systems, personnel identification system, and a 24-hour surveillance system that is accessible to law enforcement and the commissioner (5.16-5.26)
Medical Practitioners’ Role Practitioners certify that the patient has a qualifying condition; throughout the treatment, practitioners must submit the patient’s health records to the commissioner; it is not clear how often and how much data must be sent (8.12-8.14, 8.30-8.35) After a full examination of the patient, in the course of a bona fide patient-practitioner relationship, practitioners would be able to sign a written certification that a patient has a qualifying condition and that the patient is likely to receive therapeutic or palliative benefit from cannabis, allowing the patient to enroll in the program (3.34-4.6)
Available Medical Cannabis Strains The commissioner must decide the chemical composition of the cannabis (1.21, 4.23-4.27) The ATCs can decide what strains to produce based on patients need and may innovate
Medical Cannabis Business Fees The single manufacturer will pay a $20,000 annual fee; $19,000 will be refunded to unsuccessful applicants; labs appear to pay no fee (3.31-3.32) Each of the 55 ATCs will pay a $15,000 annual fee; each lab will pay $5,000 per year; $14,000 and $4,000 are refunded to unsuccessful applicants (6.27-6.30)
Packing Requirements None appear to be specified Must be compliance with the U.S. Poison Prevention Packing Act regarding child resistant packaging and exemptions for packaging for elderly patients (5.27-5.30)
Labeling Requirements Cannabis must be labeled with the patient’s name, registry number, and date of birth; the dosage; and the chemical composition (10.3-10.11) The commissioner will develop labeling rules, including the ratio of THC and CBD in products for oral consumption (5.32-5.34)
Signage and Advertising There is no mention of restrictions of advertising, marketing, or signage The commissioner will develop rules to restrict signage, marketing, and advertising (6.3-6.4)
Penalties There is no mention of the ability to suspend or revoke a manufacturer’s registration or of additional penalties for violating department rules or the medical cannabis law The department will accept complaints and may revoke the registration of ATCs, patients, and caregivers that violate the law (18.16-19.7); in addition to existing penalties, a new felony is created for any diversion of medical cannabis; a petty misdemeanor is created for a patient’s failure to provide certain notifications; new penalties are also created for letting someone else fraudulently use one’s ID card, for fraudulent records or statements, and for violations by ATCs (19.9-20.23)
Advisory Council or Task Force A task force would be established with four legislators, four patients, four health care practitioners, four members of law enforcement, four substance abuse treatment providers, and the commissioners of public safety, health, and human services; the task force would issue an impact assessment of eight things, including program design and implementation, patients’ experiences, access to and quality of cannabis, impact on law enforcement, and the impact on incidence of substance abuse; the task force would issue a biennial report (15.6-16.21) An advisory council of four health care practitioners; one patient; public safety, human services, and health designees; and one chemist or scientist will make recommendations on implementation and on adding qualifying conditions, and will assess whether ATCs are meeting patients’ needs (21.12-22.9); in addition, the health commissioner, consulting with the advisory council, will make a biennial assessment on the same factors as are in SF 2470’s task force, along with information on others states’ experience, medical literature, and a method to track practitioners who certify patients and their conditions (22.11-23.2)
Permissible Amount of Cannabis The commissioner must set ranges of doses and the manufacturer must determine the patient’s dosage; patents may have no more than a 30-day supply (9.34-10.2, 10.12-10.13) 2.5 ounces at a time (1.17)
Timeline for Access The single manufacturer must begin distributing cannabis by July 1, 2015 (4.3), but the commissioner is allowed up to three six-month delays in all deadlines, meaning cannabis may not be available until 2017 (5.1-5.3) The commission must begin issuing registry identification cards to patients and registrations to ATCs by July 1, 2015 (20.28-20.29)