Earlier this month, the New Mexico Department of Health issued its long overdue regulations for state-licensed, nonprofit medical marijuana providers, making it the first state to do so. Advocates say the new rules will allow for expanded access to medical marijuana for qualified patients. Not everyone is happy.

[inline:billrichardson.jpg align=right caption="New Mexico Gov. Bill Richardson signing a bill into law"]The process was long and involved, with numerous state agencies and law enforcement entities, as well as patients and advocates all trying to ensure that their interests and concerns were met. Originally mandated to be done by October 2007, the regulations were only finalized this month, with the Department of Health making late revisions based on public comments to earlier versions.

Under the newly promulgated regulations, nonprofit providers can grow no more than 95 plants, including both mature plants and seedlings, and can possess an amount of medical marijuana "that reflects current qualified patient needs." The nonprofits must sell medicine at constant unit prices and without volume discounts.

In order to apply for provider status, the nonprofits must provide copies of their articles of incorporation and bylaws, a list of all people involved in operating the facility, a list of all people who have a 5% or greater ownership in the facility, and have a board of directors that includes at least one health care professional and three qualified New Mexico medical marijuana patients. All of these people must also undergo a criminal background check.

But wait, there's more. As the regulations state:

All applicants must develop, implement and maintain on the premises policies and procedures relating to the medical cannabis program. At a minimum, the policies and procedures will include the following criteria:

• Distribution criteria for qualified patients or caregivers appropriate for medical cannabis services.
• Distribution criteria must include a clear identifiable photocopy of each registry identification card of a qualified patient and the patient's caregiver (if applicable) who are served by the nonprofit.
• Policies and procedures relating to an alcohol and drug free workplace program.
• A job description or employment contract developed for all employees, which includes duties, authority, responsibilities, qualifications and supervision.
• A personnel record for each employee that includes an application for employment and a record of any disciplinary action taken.
• On-site training curriculum, or enter into contractual relationships with outside resources capable of meeting employee training needs, which includes but is not limited to:
  a) Professional conduct, ethics and patient confidentiality.
  b) Informational developments in the field of medical cannabis.
• Training in security measures and specific instructions on how to respond to an emergency, including robbery or a violent accident.
• All nonprofits will prepare training documentation for each employee and have employees sign a statement indicating the date, time and place the employee received training and topics discussed, to include the name and title of presenters. The nonprofit will maintain documentation of an employee's training for at least six (6) months after termination of employment.

The new regulations also require patients who are growing their own to submit an application. Patients can grow up to four flowering plants and 12 seedlings. They can also possess up to six ounces of usable marijuana.

"We have worked hard to create a medical cannabis program that will be viable and meet the needs of patients in New Mexico," said Health Secretary Dr. Alfredo Vigil when the regulations were announced. "Now patients can get medical cannabis for their chronic health conditions in a way that is safe and legal under state law."

"I think the regulations will serve the patients of New Mexico well," said Melissa Milam, administrator of the Medical Cannabis Program in the state Department of Health. "I'm really happy that we are moving forward; I think that's better than to continue having this drawn-out debate over the regulations."

The first application by a nonprofit organization was accepted last week, said Milam. "We expect several more soon," she added. One hold-up, she said, was the requirement that all members of the nonprofit's board of directors pass a background check. "We're asking them to do that through the state Department of Public Safety, and those take about two weeks to process," Milam said.

Advocates are hoping the new regulations are a first step only. "We were able to get a lot of the changes we wanted into the regulations, so we're glad that the governor's office was receptive, but we didn't get everything we wanted," said Reena Szczepanski, head of the Drug Policy Alliance New Mexico office, which worked closely with Gov. Richardson for years to push medical marijuana through the legislature. "There will be room in the future to look at things like the regulations on nonprofits and plant limits."

That's because the regulations call for an annual evaluation report, Szczepanski said. "We were able to get that yearly evaluation in there, and that will give us a chance to look at revisions in the future in light of how well the program is meeting the needs of patients. We also wanted state-run providers and didn't get that. That's another thing we can look at in coming years," she said.

Some advocates wish the department had gotten it right the first time around. Bernie Ellis, MA, MPH, an epidemiologist with more than 20 years experience in substance abuse-related research and administration, is one of them. Ellis has worked for medical marijuana in New Mexico for years, dating back to the days of Gov. Gary Johnson. Ellis also brings with him the bitter experience of a federal medical marijuana prosecution in Tennessee where he currently resides. He submitted detailed recommendations on the regulations during the public comment period last year, which interested readers can obtain by contacting him via the link above.

"The biggest frustration that I share with other medical marijuana activists nationally is that the New Mexico legislation could have been the gold standard for administering medical cannabis programs, but instead it has turned out to be just one more 'same old-same old' program with unrealistically low limits on the amount of cannabis patients can possess and providers can grow," said Ellis. "Limiting patients to no more than six ounces of medicine means that patients who grow outdoors will face arrest for possessing any more cannabis than their first six weeks supply. Limiting providers to 95 plants, including those in vegetative growth, means the producers will be able to produce medicine for no more than six patients apiece."

According to Ellis, there are at least 46,000 New Mexicans whose medical conditions currently make them eligible for the state's program, and the state is now considering adding more qualifying conditions. "With these regulations, we are talking about the potential need to license about 7,500 producers (or more) to serve a population like that, instead of licensing a smaller number of producers who could produce at a more realistic level," he said.

Ellis had argued for much larger state-licensed medicinal grows. "I have done preliminary cost and staffing estimates for providers growing an acre of cannabis, which would serve several hundred patients," he said. "There is no state better than New Mexico to do this right. The population there has centuries of medicinal use of this substance, the cultural climate is very favorable for success, and Gov. Richardson put a considerable amount of his own political capital to work to get this passed. But now, after a fifteen month delay releasing the program regulations, we have a program with unrealistically low limits on patients and providers, which will allow patents to be 'legal' only a few months of the year."

"The federal government doesn't seem to get involved with less than 99 plants or 99 pounds; that's where that number comes from," said Milam. "It is a measure to protect providers."

More importantly, said Milam, the patients seem satisfied. "No patients have complained to me about the plant limits," she said. "If they don't have a problem with it, I don't either."

The regulations contain a safety valve for patients, Szczepanski noted. "If a need is indicated by their medical provider, patients can apply to possess amounts over the limit," she pointed out.

The limits on providers also have another negative consequence, Ellis argued. "With those sorts of limits, producers will not have the ability to reduce the price for medical cannabis below the current illicit price, which would defeat the goals of a program like New Mexico's," he said. "If you tell a nonprofit it is limited to 95 plants and it has to set up an elaborate security system and staff the effort commensurate with the security and horticultural needs, I don't see how they will be able to reduce the market price doing that. A larger, properly staffed facility could bring those prices down. Right now, the few providers I've talked to in New Mexico say they're just buying cannabis for patients from the illegal market and paying $200-$500 an ounce for it. I think if it were done right, we could get the cost down to around $50 an ounce."

"We're a very poor state, and many of the patients are on Medicaid or disability," said Milam. "California may have dispensaries everywhere, but they're charging black market prices. Our patients can't afford to pay $400 an ounce on top of their other medications. We're trying to set it up so marijuana is an affordable medication," she said, adding that she was sure licensed growers could beat black market prices.

"The state of New Mexico said it wanted to make cannabis available on demand to patients," Ellis continued, "but the way they're treating medical marijuana patients is analogous to telling a patient with a major infection that she needs penicillin immediately, and then handing her a loaf of bread and instructions on growing her own antibiotics. If a cancer patient has to undergo chemotherapy soon after diagnosis, he needs access to medical cannabis then, not five to seven months down the road when his first harvest might be ready."

Milam didn't disagree. "I've had doctors call me saying their patient needed medical marijuana on an emergency basis, and I have had to tell them to tell their patients to go find it themselves. This is a prime example of why the federal government needs to get marijuana rescheduled as Schedule II. The patients need to be able to go to the pharmacy and pick it up when they need it."

Despite his litany of criticisms of the new regulations, Ellis took pains to emphasize he supports the New Mexico medical marijuana program. "I am a proponent of the New Mexico approach as outlined in their legislation, but an opponent of the current regulations. Martin Luther King once said he would not have had the success he did in the civil rights arena without [black radical] Stokely Carmichael and others agitating for change. I'm trying to be Stokely Carmichael on this. If we don't watch out, they can incrementalize us, and too many patients, to death."

There are currently 207 patients registered with the New Mexico Department of Health. Now, they will soon have the opportunity to procure their medicine through the nonprofits -- or at least a few months after one actually gets up and running. In addition to the one application already in process, said Milam, at least two more are going through the criminal background check requirement and should be applying soon.

Whether and how well the new regulations will serve the needs of patients remains to be seen. "We will be monitoring the implementation, and we've been doing that through this whole process," said Szczepanski. "As these nonprofits are going forward, we will be watching to see if they are approved and if not, why not, and making sure the regs are being followed."