Proposed rules for medical use of marijuana in Massachusetts, issued Friday by the state Department of Public Health, largely sidestep the thorny matter of who will qualify for treatment with the drug and instead leave it up to doctors to decide.
The regulations say patients must have a debilitating condition — defined as causing weakness, wasting syndrome, intractable pain or nausea, or impairing strength or ability and limiting major life activities — to receive written certification from their doctor to buy the drug.
The rules also list qualifying conditions, including cancer, glaucoma, HIV/AIDS, hepatitis C, and amyotrophic lateral sclerosis, or ALS, but ultimately allow doctors and their patients to decide what other conditions would qualify for treatment.
Dr. Lauren Smith, interim public health commissioner, said her agency heeded the many requests from patients who testified during public hearings in February that the decision is best left to doctors and their patients.
“We shifted the focus away from the disease and more appropriately to how that disease affects the patient,” Smith said during a teleconference with reporters.
Voters in November approved a ballot referendum that legalized marijuana for medical use, but the measure left it to the health department to issue regulations that would implement the law.
The referendum allowed patients to possess up to a 60-day supply of marijuana for personal use, but did not define the specific amount. The draft regulations define that supply as up to 10 ounces in a 60-day period. The department said it took into account the “best practices” from 17 other states that have legalized marijuana for medical use in crafting Massachusetts’ proposed regulations.
But some advocates said 10 ounces may not be enough to address the pain and other symptoms of some patients.
Whitney Taylor, field director of the American Civil Liberties Union of Massachusetts, noted that Washington state, which adopted a medical marijuana law more than a decade ago, allows patients to possess up to 24 ounces of marijuana in a 60-day period.
“Washington state has had all these years of experience, and they have a policy statement on why they chose 24 ounces, so why do something else?” she said.
Another patient advocacy group, Americans for Safe Access, said it found the rules “generally acceptable,” but is concerned about several of the new provisions, including one that would require physicians to undergo mandatory training before being authorized to recommend marijuana to their patients.
The group said in a statement that this might “chill physician participation in the program and make it more difficult for patients to obtain a recommendation.”
The 45 pages of rules also would require applicants wishing to open a medical marijuana treatment center, known as a dispensary, to be organized as a nonprofit and to operate both a cultivation and dispensing facility. No wholesale distribution of marijuana products would be allowed.
Scott Hawkins, who heads a Boston consulting firm that has advised industry and elected officials on medical marijuana issues in several states, said Massachusetts’ draft rules are unlike those in many other states because they allow dispensary owners to cultivate their crop at an alternate in-state site.
“It allows for Western Massachusetts to participate by having a greenhouse operation,” Hawkins said. “This allows for greater economics in production, making it less expensive to produce, which would allow patients, in theory, to receive less expensive medicine.”
The regulations require dispensary applicants to document that they have at least $500,000 in an escrow account, a high hurdle particularly for nonprofit organizations that typically rely on federal funding, said Wayne Dennison, an attorney at the Boston firm Brown Rudnick.
Despite the existence of marijuana dispensaries in 17 other states, federal authorities do not recognize the them as legal operations, making them potentially subject to criminal prosecution.
“Any nonprofit that is pretty heavily federally regulated would likely run away from trying this because of their funding source,” Dennison said.
Massachusetts regulators said they intend to “minimize home cultivation” through a variety of approaches, including requiring the industry to provide and finance discounted rates for low-income residents at all dispensaries, allowing “secure home delivery where necessary,” and encouraging patients’ personal caregivers to pick up products in lieu of growing marijuana at home.
“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,” said Smith, the interim commissioner.
Addressing concerns raised by many substance abuse prevention advocates, the rules severely restrict marijuana access to patients under age 18, requiring guardian approval and certification by two physicians, one of them a pediatrician or pediatric specialist. These younger patients would only be certified to receive marijuana if they had a “life-limiting illness, likely to result in death within six months,” according to the rules.
Smith’s department also recommends strict rules for dispensary advertising, allowing no illuminated signs or signs larger than 16 by 18 inches outside the buildings. The rules prohibit the dispensaries from advertising their prices outside their facilities, and will not allow the sale of any “promotional gifts, such as T-shirts or novelty items,” bearing any symbols or references to marijuana or marijuana products.
The department said it will accept written comments immediately from patients, interested parties, and the public at large. On April 10, the department will present the draft regulations to the Public Health Council, an appointed body of physicians, academics, and policy makers that is responsible for reviewing the department’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, the department said.
State Representative Jeffrey Sánchez of Boston, House chairman of the Joint Committee on Public Health, said in a statement that the public should realize the rules issued Friday are only a “midpoint” of a long regulatory process.
“There is still time for citizens to weigh in on this proposal, and I encourage them to do so through the department’s public hearings or through written comment,” Sanchez said.
The Public Health Council is scheduled to vote on final rules May 8, and if approved, those rules would go into effect May 24, the department said.