BOSTON, MA — The Massachusetts Public Health Council voted Wednesday to approve the final regulations issued by the Department of Public Health (DPH) for the implementation of the state’s first medical marijuana program.
Wednesday’s approved regulations are the work of weeks of deliberation, during which DPH sought input from medical marijuana patients and other stakeholders, which allowed the patient community to successfully voice its concerns.
Patient advocacy group Americans for Safe Access (ASA) in coalition with Massachusetts Patient Advocacy Alliance (MPAA) and the ACLU have been working with DPH to offer guidance and recommendations regarding the proposed regulations.
“We applaud the Massachusetts Department of Public Health for continuing to work expeditiously to implement the state medical marijuana law,” said ASA Executive Director Steph Sherer. “We are pleased that many of the issues patients expressed concern about were improved from the draft regulations.”
The approved final regulations establish the framework for the Massachusetts medical marijuana program, or Question 3, which was ushered in last November by 63 percent of the state’s voters.
The law allows qualifying patients with serious illnesses to get a recommendation from their licensed physician for the use of marijuana, and further enables patients to obtain their medicine from a registered Medical Marijuana Treatment Center (MMTC).
Overseen by DPH, the MMTCs will be licensed to cultivate, process, and sell medical marijuana to qualifying patients who are allowed to obtain up to 10 ounces in a 60 day period. Patients who qualify under a hardship provision will be able to cultivate for themselves if unable to access a MMTC due to distance, disability, or low income.
Many of the concerns from the draft regulations that could have limited patients’ access to medical marijuana have been addressed. For example, where the draft regulations would have prohibited patients from obtaining their medication from more than one MMTC, and placed unique and onerous restrictions on minors who might benefit from medical marijuana, the final regulations have sufficiently revised these restrictions to better meet patient needs.
Dr. Karen Munkacy, an anesthesiologist and delegate to the Massachusetts Medical Society, as well as a board member of ASA, agreed that the regulations adopted today are an improvement for patients over the draft regulations. Dr. Munkacy said that “The final regulations ease some of the obstacles that would have been created by the draft regulations for physicians who want to incorporate this medicine into their practice.”
Below is a summary of the final regulations that will go into effect on May 24, 2013:
Registered Marijuana Dispensaries: DPH requires each non-profit organization, now known as a Registered Marijuana Dispensary (RMD), previously known as medical marijuana treatment centers, to operate their own cultivation and dispensing facilities. This allows for uniform seed-to-sale control and maximized security. Limited wholesale distribution of marijuana is allowed between dispensaries to maximize appropriate access to patients with legitimate needs. The change in nomenclature, proposed and adopted by the Public Health Council, stems from a recognition that the activity of these entities is limited to cultivation, preparation, and dispensing of products, and that they do not provide treatment to patients.
Promoting Patient Access: Recognizing the challenges presented by having access to only one RMD, DPH has responded to public comment by adopting a regulation in which patients may choose which RMD to purchase products from, similar to a pharmacy, instead of being required to designate only one RMD. This inclusive framework will promote appropriate access for patients in need, while strict requirements on RMDs will ensure security.
Hardship Cultivation: DPH minimizes home cultivation by optimizing access through a variety of approaches, including: 1) Mandating the industry provides and finances discounted rates for low-income residents at all RMDs. 2) allowing secure home delivery where necessary, and 3) encouraging personal caregivers to pick up product in lieu of cultivation.
Personal Caregivers: A family member or friend who is at least twenty-one (21) years old may care for a patient using marijuana for medical purposes. DPH’s final regulation requires that except in the case of certain health care workers providing care to a qualifying patient, or immediate family members, a caregiver may only serve one patient. A qualifying patient may have up to two caregivers.
Debilitating Medical Condition: DPH does not further define which medical conditions qualify patients for medicinal use of marijuana, instead leaving that important decision to physicians and their patients. DPH does, however, define the word ‘debilitating,’ clarifying that medical marijuana is intended for use in patients with serious conditions.
Defining a 60-Day Supply: Balancing the potential for diversion with legitimate patient needs, the final regulation allows up to 10 ounces for a personal 60-day supply. Physicians retain the autonomy and authority to increase the amount of a 60-day supply in limited circumstances as they see fit in their professional judgment.
Defining a Bona-Fide Physician-Patient Relationship: Means 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.
Limiting Pediatric Access: The regulation restricts access to those less than 18 years of age, requiring parent or guardian approval and certification by two physicians, one of whom must be a pediatrician or pediatric specialist. The regulation allows youth access for a life-limiting illness, likely to result in death within two years. Recognizing the need of a small population of youth with debilitating conditions that may not lead rapidly to death, two physicians may override the life-limiting restriction if they determine the benefits of medical use of marijuana outweigh the risks.
Laboratory Testing: The regulations require a quality assurance and periodic testing plan for contaminants, such as pests, mold, mildew, heavy metals and pesticides. The testing is to be done by an accredited, independent laboratory and paid for by the RMD.
Municipal Oversight: DPH has responsibility for the medical marijuana program throughout the state, including registration of individuals and RMDs, inspection of RMDs, and enforcement. DPH has developed an inclusive framework for engaging municipal government. DPH does not preclude municipalities from assessing fees or passing certain local regulations, including zoning or siting. The regulation takes local support into account in the consideration of applications. The regulation also requires that applicants notify communities early in the application process, and grants certain rights to local authorities in the inspection of RMDs.
Advertising: Recognizing the concerns of the substance abuse prevention community and municipalities, while also taking into account the need for qualifying patients to have access to information about RMDs, DPH has limited certain advertising materials, including, for example, prohibiting ads that depict or encourage the recreational use of marijuana, or portray youth, or show smoking or smokable products.
Deceptive Packaging: The regulations prohibit marijuana-infused, edible products from resembling any form of commercially available candy.