Comments on proposed regulations

The Marijuana Policy Project, which has been working in partnership with patients and patient advocates in Delaware for several years, submits the following comments on the regulations developed by the Department of Health and Social Services relating to the Delaware Medical Marijuana Code entitled “Rules and Regulations Governing the Delaware Medical Use of Marijuana.”

We are grateful to the Division of Public Health for its diligent work to craft medical marijuana rules. While we feel that most of the rules are reasonable, there are some provisions that we believe to be unnecessary, onerous, or contrary to the language of Delaware’s medical marijuana law. In addition, we urge the division to add rules to regulate compassion centers, as is being done in other states, including neighboring New Jersey and the District of Columbia.

When appropriate, the department’s proposed regulations are initially quoted exactly as they appear in the April 1, 2012 edition of the Delaware Register of Regulations. MPP’s suggestions are found in the comment box with underscored and struck-through language being additions or redactions to the language found in the proposed regulations.  


4.0 Designated Caregiver Registry Identification Card Application Requirements

4.1.3: Section 4.1 of the proposed regulations, among other requirements, mandates certain information and documentation be given to the medical marijuana program in order for an individual to obtain a caregiver registry identification card. Regulation 4.1.3 requires a potential caregiver to submit “written approval by the qualified patient(s) and the qualified patient(s)’ Physician(s) authorizing responsibility for managing the well-being of a qualified patient(s) with respect to the use of marijuana.”

MPP comment: § 4908A of Title 16 of the Delaware Code contains no requirement that potential caregivers seek and show evidence of approval from their patient(s)’ physician(s) in order to obtain an identification card as a registered caregiver. In fact, an application to obtain a caregiver ID card may only be denied if certain conditions are met; none of these requirements is physician approval of the caregiver. Del. Code Title 16 §4910A(b).

Besides being contrary to the letter of the law, MPP believes that requiring physicians to approve of all caregivers is bad policy. This requirement moves dangerously close to involving the physician in the medical marijuana supply chain that could lead to adverse actions against them by the federal government. The Ninth Circuit Court of Appeals has held that physicians have a First Amendment right to discuss the use of medical marijuana with their patients. Conant v. Walters 309 F.3d 629 (2003), cert denied. However, physicians cannot do so with the specific intent that the patient use the recommendation to obtain medical marijuana. If the physician were required to designate a person to obtain marijuana for the patient, it is possible that intent could be implied. 

Finally, this regulation will make it much more difficult for patients to obtain their needed medicine. The severity of patients’ medical conditions can change. A patient who is mobile at one point — and whose doctor may not think needs a caregiver at that time — may be hospitalized or bedridden at another time. A patient using prescription drugs can send their significant other or spouse to the pharmacy to pick up their medications without a doctor’s approval. The requirement that a patient designate a single person to the department already is stricter than the standard for prescription medications.

We recommend amending 4.1.3 to read:

“written approval by the qualifying patient(s) and the qualified patient(s)’ Physician(s) authorizing responsibility for managing the well-being of a the qualified patient(s) with respect to the use of marijuana.”

5.0 Registry Identification Cards

5.3.6: Section 5.3 of the proposed regulations lists several life events (including but not limited to a change of name, address, or status of a debilitating illness) that would require a registered identification cardholder to contact the department to notify them of the change. Section 5.3.6 gives teeth to the notification requirement stating that “A cardholder who fails to make a notification to the Department that is required by Section 3.5 is subject to a civil infraction, punishable by a penalty of no more than $150.00 shall result in the immediate revocation of the registry identification card and all lawful privileges provided under the act.”

MPP comment: The immediate revocation of an identification card and privileges associated with being a cardholder is extreme and contrary to the intent and language of Delaware’s medical marijuana law. § 4912A of Title 16 of the Delaware Code is the statutory companion to regulations section 3.5. § 4912A(d) states that a cardholder who fails to make a notification to the department required in § 4912A is subject to a civil violation of not more than $150. There is no statutory requirement that a failure to make a notification result in a revocation of the card and its associated privileges.

If the Delaware Legislature intended to penalize a patient or caregiver with revocation of an identification card and its privileges for failure to make a clerical notification, they would have enacted such a penalty in the law, like they did when enacting § 4919A(r) (a cardholder who sells marijuana to a non-cardholder shall have his or her card revoked). In fact, the medical marijuana law specifically states that revocation of a card will only be made for “multiple or serious” violations of the chapter. Del. Code Title 16 § 4919A(t). Immediate revocation for a first time failure to notify the department of a life change does not fit this description. For example, a patient’s condition could worsen and force a move into an assisted living facility. At a time of great emotional and physical distress, denying a person the right to use his or her medicine for a single oversight would be unwarranted and cruel. If the department feels that repeated failures to adhere to the notification requirement should result in a revocation, it could do so under the letter of the law, but we urge it to do so based on the totality of the circumstances and after the cardholder has an opportunity to be heard.

We recommend amending 5.3.3 to read:

“A cardholder who fails to make a notification to the Department that is required by Section 3.5 is subject to a civil infraction, punishable by a penalty of no more than $150.00 shall result in the immediate revocation of the registry identification card and all lawful privileges provided under the act.”

6.0 Registration and Operation of Compassion Centers

The department has reserved sections for future rules and regulations governing the compassion center program. Presumably, this decision was made after Gov. Markell stated that he would not allow the compassion centers to open to avoid adverse actions taken toward the centers by the federal government.

MPP comment: We feel it is unnecessary to wait to make rules for compassion centers and urge the department to move forward with the rule-making process. Patients need a safe source of medical marijuana.

State regulated and registered medical marijuana providers are openly and actively serving patients in New Mexico, Colorado, and Maine. Additionally, the Rhode Island General Assembly has been working with Gov. Lincoln Chafee on legislation that will result in the opening of three compassion centers across their state. Arizona, Vermont, New Jersey, and Washington, D.C. are all moving forward with regulations to implement dispensary programs as well. No state worker has ever been prosecuted for implementing a dispensary program, and no court has ever found that registering and regulating compassion centers would be a federal crime. We maintain that it is not a crime, and we believe it is inconceivable that the federal government would prosecute a state employee for implementing a regulatory program, particularly without a prior explicit warning or civil action.

While MPP appreciates that the sections were reserved for compassion center rules, we respectfully request that the department move forward with compassion center regulations. The department would be best served by reviewing regulations passed by the New Mexico Department of Health, the Rhode Island Department of Health, the Maine Department of Health and Human Services, and the Colorado Department of Public Health and Environment.

7.0 Registration and Operation of Testing Facility Centers

The department has reserved sections for future rules and regulations governing the medical marijuana safety compliance facilities. Presumably, this decision was made after Gov.Markell stated that he would not allow the compassion centers to open to avoid adverse actions taken toward the centers by the federal government.

MPP comment: We feel it is unnecessary to wait and urge the department to move forward with the rule-making process.

State regulated and registered medical marijuana testing facilities are openly and actively serving the medical marijuana program in Colorado. These facilities ensure that medical marijuana does not contain molds or contaminants and clearly determine the percentage of various cannabinoids present so patients can more easily find a strain to address their particular debilitating disease or condition. 

While we appreciate the department reserving the sections for future rules and regulations for the testing facilities, MPP respectfully requests that the department move forward with testing facility center regulations.

8.0 Monitoring and Corrective Actions

8.1.1: Section 8.0 of the regulations lays out the duties and powers entrusted to the department to monitor for and subsequently correct violations of the medical marijuana law and regulations. Section 8.1.1 states, “The Department or its designee may perform on-site assessments of a qualified patient or primary caregiver to determine compliance with these rules. The Department may enter the premises of a qualified patient or primary caregiver during the business hours for the purposes of monitoring and compliance. Twenty-four (24) hours notice will be provided to the qualified patient or primary caregiver prior to an on-site assessment except when the Department has a reasonable suspicion to believe that providing notice will result in the destruction of evidence or that providing such notice will impede the Department’s ability to enforce these Regulations.”

MPP comment: MPP believes that this provision is unlawful and should be removed in its entirety. Title 16, §4903A(m) of the Delaware code states that “mere possession of, or application for, a [medical marijuana] registry identification card or registration certificate shall not constitute probable cause or reasonable suspicion, nor shall it be used to support the search of the person, property, or home of the person possessing or applying for the registry identification card” (emphasis added). Allowing the department to conduct a search of a patient, caregiver, and/or their premises simply because they hold an identification card is in direct contrast to the above law.

We recommend amending 8.0 to remove “8.1 Monitoring” in its entirety. Delaware residents’ homes are not invaded for searches to see that they are complying with the law for other medications they are prescribed. Patients and caregivers should not — and under Delaware law cannot — be treated like criminal suspects for being state-legal medical marijuana patients.

8.0 Monitoring and Corrective Actions

8.3.1.3.6: Section 8.0 of the regulations lays out the duties and powers entrusted to the department to monitor for and subsequently correct violations of the medical marijuana law and regulations. 8.3.1.3.6 retains the right of the state to prosecute a medical marijuana patient or caregiver for possessing or transferring marijuana “outside Delaware or attempt[ing] to obtain or transport marijuana from outside Delaware.

MPP comment: This is an unnecessary regulation and will only result in harming patients. The law clearly protects patients and caregivers who possess up to a certain amount of marijuana. If they are over their possession limits, they may be subject to prosecution. In addition, Delaware patients could be traveling out of state to seek medical attention and would then be subject to prosecution for taking their physician-recommended medicine with them. Similarly, Delaware patients could be returning from a state where there is legal access to medical marijuana. Some states allow patients to give marijuana away to other patients. Patients should not have to destroy their marijuana when entering their home state, only to have to obtain more marijuana from the criminal market.

We recommend removing, in its entirety, 8.3.1.3.6.

8.0 Monitoring and Corrective Action

8.3.2: Section 8.0 of the regulations lays out the duties and powers entrusted to the department to monitor for and subsequently correct violations of the medical marijuana law and regulations. Section 8.3.2 states that a “Violation of any provision of this rule may result in either the summary suspension of the qualified patient’s or primary caregiver’s registry identification card, or a notice of contemplated action to suspend or revoke the qualified patient’s or primary caregiver’s registry identification card, and all lawful privileges under the act.”

MPP comment: We oppose this rule for many of the same reasons we oppose 5.3.6 above. The medical marijuana law already contemplates when an identification card can be revoked, and it is in the event of “multiple or serious” violations of the chapter. Del. Code Title 16 § 4919A(t). Any regulation must take this language into account.

We recommend amending 8.0 to state: “Multiple or serious violations of any provision of this rule may result in either the summary suspension of the qualified patient’s or primary caregiver’s registry identification card, or a notice of contemplated action to suspend or revoke the qualified patient’s or primary caregiver’s registry identification card, and all lawful privileges under the act.”

8.0 Monitoring and Corrective Action

8.3.3: Section 8.0 of the regulations lays out the duties and powers entrusted to the department to monitor for and subsequently correct violations of the medical marijuana law and regulations. Section 8.3.3 states that a “A registry identification card may be revoked or suspended, and a renewal application may be denied for: 8.3.3.1 failure to comply with any provisions of these requirements; 8.3.3.2 failure to allow a monitoring visit by authorized representatives of the Department; 8.3.3.3 the discovery of repeated violations of these requirements during monitoring visits.”

MPP comment: We oppose this rule for many of the same reasons we oppose 8.3.2 and 8.1.1 above. First and foremost, the medical marijuana law already contemplates when an identification card can be revoked, and it is in the event of “multiple or serious” violations of the chapter. Del. Code Title 16 § 4919A(t). Any regulation must take this language into account. Secondly, as discussed above, monitoring visits on the basis of being a cardholder are unlawful, so revocation based on said visits must be removed.

We recommend amending 8.3.3 to state: “A registry identification card may be revoked or suspended, and a renewal application may be denied for: 8.3.3.1 failure to comply with any provisions of these requirements; 8.3.3.2 failure to allow a monitoring visit by authorized representatives of the Department; 8.3.3.3 the discovery of repeated or serious violations of any provision of these requirements during monitoring visits.”