State Health Council adopts medical marijuana rules

— Photo courtesy of DEA

After some adjustments to draft regulations, the Massachusetts Public Health Council last Wednesday wrote into the state’s regulatory code rules governing the medical use of the recreational drug, which voters had set into law by passing a ballot proposal last November.

Since January 1, the voter referendum had legalized an unregulated system, where a doctor’s note serves as license to grow and use marijuana for a medical purpose. The new regulations set in motion the licensure process for medical marijuana dispensaries, limits on how much marijuana a patient can generally use, and efforts to ensure access to low-income patients.

“Congratulations on a regulatory tour de force. Future regulators will be studying this, this process,” board member Paul Lanzikos told the Department of Public Health staff ahead of the unanimous vote on May 8.

The final rules maintain the definition of 10 ounces as a 60-day supply, rely on doctors to determine if a patient has a “debilitating condition” that marijuana could treat, and raise the income level that would allow a patient to qualify for discounted marijuana or allow that person to apply for home cultivation.

Under the regulations approved Wednesday, patients whose income is less than 300 percent of the federal poverty line would qualify. The draft rules featured a threshold of 133 percent of the poverty line.

While maintaining the requirement that medical marijuana treatment centers grow the marijuana themselves, prepare it for sale and serve as retailers as well, the final regulations allow for the transfer of up to 30 percent of its supply if there is a documented need, either patient-specific or following a blight or other disaster that might leave a dispensary lacking. The regulations go into effect on May 24.

The council also adopted council member John Cunningham’s amendment to refer to medical marijuana treatment centers as “a registered marijuana dispensary” in the code.

“On a practical basis, what does that actually mean?” asked member Harold Cox. He said, “I’m just trying to understand the practical implications of what you’re proposing.”

Cunningham said he hoped that the nonprofit businesses that distribute medical marijuana would refer to themselves as dispensaries rather than treatment centers.

Voters decriminalized possession of less than an ounce of marijuana in 2008 and legalized its use for medical purposes in 2012, however the drug is still outlawed by federal law, and it is still a class D controlled substance under state law, carrying a jail sentence of up to two years for someone convicted of distributing it.

“The substance is illegal federally,” said interim Public Health Commissioner Dr. Lauren Smith, noting that “this is quite different than any other treatment,” it is not taught in medical school, not approved by the Food and Drug Administration, and physicians who recommend marijuana usage should be required to undergo additional training. The training requirement is included in the regulations.

Noting that the ballot initiative provided for home cultivation when a patient has geographic or economic barriers to accessing a dispensary, DPH advisor Iyah Romm said, “We can promote steady and ongoing access to a more reliable, tested product” by requiring discounts for low-income patients.

“By choosing to engage in hardship cultivation, there is a need for the department to inspect,” Romm noted. The final regulations allow a personal caregiver to grow and provide marijuana for more than one family member, though it maintains the requirement that generally a caregiver may not provide marijuana to more than one patient.

Deputy Commissioner Cheryl Bartlett said that some members of the general public had asked the department to “promote the cottage industry where one caregiver could grow for a number of patients,” but the DPH has sought to make dispensaries the primary source of marijuana.

The new regulations allow people who are approved for hardship cultivation to obtain seeds from a dispensary, though additional shopping at a dispensary could result in the loss of cultivation privileges, Romm said.

Licensing of treatment centers will require applicants to lay out how soon they can open, and to choose a site before the second phase of licensure. In the first phase, applicants will only need to specify a county. A third stage would include registration and inspection. The application process would begin this summer, and Smith said she does not expect any dispensaries to be open before the end of the year. Before dispensaries open, patients can continue growing marijuana, though the process for obtaining a doctor’s recommendation will now be more regulated, Smith said. The regulations do not specify price.

The law calls for up to 35 dispensaries in Massachusetts.

Massachusetts towns may adopt bylaws regulating the location of marijuana treatment centers within municipal borders and may enact temporary moratoriums on the development of such centers but are not permitted to ban them, according to a decision announced in March by Attorney General Martha Coakley. Coakley ruled a ban adopted in Wakefield conflicted with the 2012 ballot law.

Smith told reporters Wednesday that she thought the regulations create a “very sound balance” between public safety and the need of suffering patients to obtain relief. She said DPH officials had taken into account “pitfalls” in other states, where “questionable conditions” became the basis for access to medical marijuana and qualifying patients had “unfettered” access to marijuana.Council member Alan Woodward said he has concerns about “mission creep” and legislation under consideration that he said would be “pushing the envelope” by allowing for recommendations from out-of-state doctors.

After voters took on the role of lawmakers last November, state legislators have considered amendments to the law, including a complete revision proposed by Sen. John Keenan (D-Quincy) that would outlaw home cultivation and require all medical marijuana to be supplied by home delivery.

Bartlett said DPH would work to “mesh” the registration of medical marijuana patients with the prescription monitoring program. Patients and dispensaries would pay fees, Bartlett said. Romm said the dispensary fee would be “substantial.”