University:
Boston University
Course:
LAW AM 700 | Intro to American Law
Academic year:

2020
Views:

87

Pages:

25
Author:

larbiwxcvbn

Proposed Regulations Governing the Sale and Use of Medical Marijuana: A Summary Summary of Law  Allows “qualifying patients” with certain defined medical conditions or debilitating symptoms to obtain and use marijuana for strictly medicinal purposes.  Requires DPH to promulgate regulation relative to the implementation of the law by May of 2013.  Eliminates state criminal and civil penalties for the medical use of marijuana by qualifying patients. Criteria  Qualifying Patient:  Diagnosed with a listed debilitating condition:   Obtained a written certification from a physician with whom the patient has a bona fide physician-patient relationship.   Cancer, glaucoma, AIDS or HIV, Hepatitis C, ALS, Crohn’s disease, Parkinson’s disease, Multiple Sclerosis, and other conditions as determined in writing by a qualifying patient’s physician. Certification must state the patient’s debilitating medical condition, its symptoms, and that the potential benefits of marijuana use outweigh health risks for the patient. Patient may possess up to a “60-day supply” for patient’s personal use.  DPH charged with defining 60-day supply. Criteria  Patient may designate a “personal care giver.”  Must be at least 21.  Must be registered with DPH.  Cannot consume the medical marijuana.  Qualifying patient with “verified financial hardship, a physical inability to access reasonable transportation, or the lack of a treatment center within a ‘reasonable’ distance of the patient’s residence” may obtain a “hardship cultivation registration” from DPH.  Permits cultivation of enough plants in an enclosed, locked facility to maintain a 60-day supply for personal use. DPH’s intention relative to home-cultivation:  DPH will seek to minimize the need for home- cultivation as follows:   Stringent caregiver provisions Incentivized “compassion programs” at Treatment Centers   Low or no-cost means tested programs at Centers Permitting home delivery  Medical Marijuana Treatment Centers (MMTCs)  May cultivate, process and provide medical marijuana to patients and caregivers.  Must be non-profit  Must be registered with DPH MMTC’s  Must complete several mandatory conditions: Paying a fee  Identifying a location, with up to 1 additional cultivation location  Submit operating procedures, including cultivation and storage of marijuana in enclosed, locked facilities.   “Dispensary Agents”  MMTC’s personnel.  Must register with DPH.  Must be at least 21.  Must have no prior felony drug convictions.  DPH may register up to 35 MMTCs in 2013.  At least 1, but no more than 5 in each county.  Number can be modified by DPH in future year. Fraudulent Use of Registration Cards  Registration cards and cultivation registration can be revoked for violation of the law or the regulations.  Fraudulent use is a crime punishable by up to 6 months in the House of Correction.  If fraudulent use was for the sale, distribution or trafficking of marijuana for non-medical use, it is a crime punishable for up to 5 years in state prison. What the Law Does NOT Do:  Change federal law making possession of marijuana illegal.  Controlled substance under the Controlled Substance Act.  Obstruct federal enforcement of federal law.  Preempt Massachusetts state law prohibiting marijuana use,      sale, etc. for non-medical purposes. Permit operating under the influence of marijuana. Require any health insurer or government entity to reimburse expenses of medical marijuana use. Require accommodation of medical marijuana use in any workplace, school bus or grounds, youth center or correctional facility. Require any accommodation of smoking marijuana in any public place. Require accommodation of smoking marijuana in public housing. Between 1/1/13 (effective date) and May 2013  Written certification by a physician will constitute a registration card for a qualifying patient.  Certified mail, return receipt showing that patient applied to DPH and photocopy of actual application will constitute a registration card for a personal caregiver.  Written recommendation of a qualifying patient’s physician will constitute a “limited cultivation registration.”  Qualifying patients may cultivate his/her own supply. Public Engagement and Comment  Listening sessions held on February 13, 14 and 27, 2013.    Worcester, Boston, Holyoke. 200+ attendees at each session. Legislators, patient-advocates, nationally-recognized dispensaries, prevention advocates, leading clinician and physician groups, municipal leadership, law enforcement.  68 letters, written comments from 16 organizations, DPH staff met with more than 20 organizations individually, and engaged legislative leadership.  Also solicited input from other states.  Goal of regulations: put in place a system that insures both appropriate access and safe municipalities. Key Policy Recommendations  Continuing Medical Education  Physicians must complete a minimum of 2.0 Category 1 continuing professional education credits (CMEs) on medical marijuana before issuing any certifications. Implementation of this requirement delayed for at least 6 months after promulgation of regulations.  Programs planned and implemented by an organization accredited by the Accreditation Council for Continuing Medical Education (ACCME), American Academy of Family Physicians or a state medical society recognized by ACCME.   Session should include explanation of proper use of medical marijuana, including contraindications side effects, dosage and should provide information on substance abuse recognition, diagnosis and treatment. Debilitating Medical Condition  Proposed regulation defines debilitating condition as follows:  “Cancer, glaucoma, positive status for human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), hepatitis C, amyotrophic lateral sclerosis (ALS), Crohn’s disease, Parkinson’s disease, and multiple sclerosis when such diseases are debilitating and other debilitating conditions as determined in writing by a qualifying patient’s physician.” 60-Day Supply  Up to 10 ounces of finished product in leaf form (or equivalent).  Based on a review and comparison of dispensing across states and stakeholders’ feedback.  Physicians will have discretion.  Time period for certification may not exceed 1 year. Bona-Fide Physician-Patient Relationship  “a relationship between a physician, acting in the usual course of his or her professional practice, and a patient in which the physician has conducted a clinical visit, completed and documented a full assessment of the patient’s medical history and current medical condition, has explained the potential benefits and risks of marijuana use, and has a role in the ongoing care and treatment of the patient.”  Physician must be licensed in Massachusetts.  Must utilize Massachusetts Prescription Monitoring Program unless otherwise specified by DPH. Fees  Fee framework will be developed upon finalization of      the proposed budget. Fees will be annualized. Fees will be revenue neutral. MMTC fees will provide the primary source of revenue. Final fee proposal will be announced for public comment in a parallel process to regulation comment. Comment on fees will probably be in late spring. Hardship Cultivation  Massachusetts will be the first state to require financial, physical or geographic hardship in order to cultivate at home.  In place to avoid diversion of marijuana and security complications associated with widespread homecultivation.  DPH is attempting to minimize home-cultivation:      Mandate provision of low-income subsidies at MMTCs. Allow secure home delivery where necessary. Encourage caregivers to pick up product. Regulation requires physical incapacity to access reasonable transportation, verified financial hardship and lack of treatment center within a reasonable distance of residence and MMTC has no home delivery. Must utilize “industry best practices” in cultivation. Laboratory Testing  Regulation requires a quality assurance and periodic testing plan in the application for a MMTC.  Regulation requires MMTC to test for contaminants, including pests, mold, mildew, heavy metals and pesticides.  DPH can require additional testing without amending regulations. Municipal Oversight  “Inclusive, but non-burdensome framework for engaging municipal government.”  No other state describes a role for local health.  DPH has responsibility for medical marijuana program, including registration of patients, caregivers, dispensary agents and MMTCs.  This incudes a comprehensive data base for all registrants.  DPH will not mandate local involvement.  DPH will not preempt local involvement.  Zoning, local fees, etc. My Questions on Local Involvement  Regulation provides that DPH, Emergency Responders and Law Enforcement have access to MMTCs without restriction.  Does this include local public health?  If not, it should.  If state inspector not available immediately and BOH gets complaint.  MMTC’s operational procedures are extremely strict and DPH intends to hire state inspectors do enforce the CMRs involved.  Food code, plumbing, waste, etc. Patient Designation of MMTCs  Qualifying patient must designate MMTC.  Can only designate 1 MMTC.  MMTC must plan for and cultivate only the amount of marijuana to meet their patients’ needs.   Accounting for a small amount of new patients. This will cut down on waste and waste disposal issues.  Patient can change designation once in a 120-day period with notice to DPH.  MMTC must limit their inventory of seeds, plants and useable marijuana. Personal Caregivers  “Agrees” to assist qualifying patient.  Informal relationship – not a contract  Must be 21.  No criminal record for felony drug violations.  May only serve one patient.  Employee of hospice or medical facility can serve more than one patient.  Patient may have 2 caregivers.  Only 1 can cultivate at home. Youth Access  More restrictive model for minors.  2 physicians must certify that patient’s debilitating medical condition, at least 1 of whom is a boardcertified pediatrician.  Parental/guardian consent required.  Access restricted to youth with life-limiting illness.  6 months. Advertising/Communications  Strict advertising restrictions.  No lit signs  No t-shirts or other promotional items.  No reference to medical benefits of medical marijuana without clear scientific supported evidence. Marijuana Infused Product (MIP)  Product infused with marijuana that is intended for use or consumption other than by smoking or vaporizing, including but not limited to edible products, ointments, aerosols, oils, and tinctures.  They can only be created and sold by a MMTC  Not considered a food or drug.  No local permit needed? MMTCs  Must meet strict sanitary requirements  Requirements for food handlers       105 CMR 300.00 Hand washing facilities Good sanitary practices Waste disposal Water supply Plumbing  Strict security measures must be in place.