Department of Public Health Issues Draft Medical Marijuana Regulations
Draft regulations balance patient access with community safety; part of ongoing process to create system that is right for Massachusetts
BOSTON — The Massachusetts Department of Public Health (DPH) today filed draft regulations with the Secretary of the Commonwealth, advancing implementation of An Act Regarding Humanitarian Medical Use of Marijuana.
In November 2012, 63 percent of Massachusetts voters approved Ballot Question 3, with majority support from 349 out of 351 communities across the Commonwealth. The Act became law on January 1, 2013, allowing qualifying patients with certain defined debilitating medical conditions to obtain and use marijuana for medicinal purposes as approved by their physicians. Under the law, DPH was charged with drafting regulations for medical marijuana in Massachusetts.
The draft regulations filed today reflect unprecedented public input from hundreds of stakeholders across the Commonwealth including legislators, patient advocates, nationally recognized dispensaries, prevention advocates, leading clinician and physician groups, municipal leadership and law enforcement. DPH also took into account best practices from 17 other states as well as public input from several listening sessions the Department held. Release of these draft regulations is an important step in the ongoing public process which will include further review and public comment opportunities.
“DPH solicited an unprecedented level of input in drafting these regulations to create a medical marijuana system that is right for Massachusetts,” said DPH Interim Commissioner Dr. Lauren Smith. “In this proposal, we have sought to achieve a balanced approach that will provide appropriate access for patients, while maintaining a secure system that keeps our communities safe.”
Through the ballot initiative, DPH was charged with creating regulations for cultivation and dispensing of medical marijuana and guidelines for personal caregivers, among other issues. DPH’s draft regulations define the following:
- Medical Marijuana Treatment Centers (MMTCs): DPH requires each non-profit MMTC organization to operate their own cultivation and dispensing facilities. This allows for uniform seed-to-sale control and maximized security. No wholesale distribution of marijuana products would be allowed.
- Hardship Cultivation: DPH intends to minimize 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 MMTCs. 2) allowing secure home delivery where necessary, and 3) encouraging personal caregivers to pick up product in lieu of cultivation.
- Personal Caregivers: Must be at least twenty-one (21) years old. DPH recommends that except in the case of an employee of a hospice, nursing facility, or medical facility providing care to a qualifying patient, 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: DPH recommends allowing up to 10 ounces for a personal 60-day supply, after taking into account the amount permitted in other states that have legalized medical marijuana. Physicians would have the authority to increase the amount of a 60-day supply in limited circumstances.
- 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 Youth Access: DPH proposes a highly restrictive model for access to those less than 18 years of age, requiring guardian approval and certification by two physicians, one of whom must be a pediatrician or pediatric specialist. Only those with a life-limiting illness, likely to result in death within six months, would be certified.
- Laboratory Testing: DPH recommends requiring a quality assurance and periodic testing plan that tests for contaminants, such as pests, mold, mildew, heavy metals and pesticides.
- Municipal Oversight: DPH has responsibility for the medical marijuana program throughout the state, including registration of individuals and MMTCs, inspection of MMTCs, 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.
- 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 MMTCs, DHP 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.
Beginning today, DPH will accept written comments from patients, interested parties, and the public at large. On April 10, 2013, DPH will present the draft regulations to the Public Health Council, which has the ultimate responsibility for reviewing DPH’s recommendations and approving final regulations. On April 19, public hearings will be held in Northampton, Boston, and Plymouth, and on April 20 the public comment period will close.
For qualifying patients who have already received a written recommendation from a physician, no further action is needed at this time. The law allows such a qualifying patient to cultivate a supply of marijuana for personal medicinal use. Until DPH finalizes regulations and implements this program, this provision remains in effect.
This spring, DPH will also be engaging in a process to determine fees for medical marijuana registrants. By law, this program must be self-sustaining through the fees on medical marijuana treatment centers and on patients using these products. No taxpayer dollars will be used to subsidize medical marijuana.
After finalization of these regulations, DPH anticipates engaging in a competitive application process for medical marijuana treatment centers in the summer and fall of 2013.
For further information, frequently asked questions (FAQs) are available on the DPH medical marijuana website, www.mass.gov/medicalmarijuana, along with a memo to the Public Health Council summarizing key issues, as well as the full draft regulations.
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