The first medical cannabis laws in this country were focused on the criminal justice aspects of the issue such as protecting patients and cultivators from arrest and prosecution. This left very little for regulators to oversee with the exception of patient registry and ID programs. Medical cannabis laws are now more robust and comprehensive including civil protections, quality controls, distribution programs and other public health and safety issues; leaving broad discretion to regulating agencies to implement the intent of the law.
The outcomes of these regulations are not always beneficial to patients and providers. Seventeen years of experience with medical cannabis laws has taught us that authorizing the use of cannabis for medical purposes is only the first step and the nuances of the laws and regulations are extremely important. Implementation providers and opportunity to create regulatory models based on patient needs and the following document is an attempt to articulate that vision in regulatory terms.
An important part of evaluating regulatory proposals is identifying insincere models that put onerous restrictions on patients or seek to surreptitiously enact a de facto ban on safe access. The good news is that regulators no longer need to guess impacts of regulations and can look to other states for insights on working models. The following are general principles for analyzing regulatory guidelines. It is ASA's position that the true test of successful medical cannabis policy is when the patient community has achieved safe and legal access.
Comparison of State Medical Cannabis Regulations
|Fee Structures - Patients and Caregivers||$25||$150 patient; $200 caregiver; reduced patient fees for financial hardship||$35||$100||$100; $25 for patients with financial hardship||$25||Free for patients and non-cultivating caregivers; $300 for caregivers who cultivate medicine||$50 patients and caregivers (fee waiver available); $100 hardship cultivation license||$100; $25 for financial hardship||$75||$50||$200; $20 for financial hardship||$30; waiver available for financial hardship||$200, additional $50 if individual is cultivating medicine; reduced fees of $100 and $20 for certain financial hardship||$100 patients; $25 for financial hardship; $200 caregivers||$50|
|Restriction on Access to Multiple Dispensaries||No||No||Yes||Yes||Yes||Yes||Yes||No||Yes||Yes|
|Adding Conditions||Petition process||Bi-annual petition process||Petition process||Bi-annual petition process||Bi-annual petition process||Petition process||Petition process||No (physicians may recommend for any condition)||Petition process||Petition process||Petition process and biannual advisory board meeting||Petition process||Petition process||Petition process||Petition process||By legislative action only|
|Purchase Limits||Max 2.5 ounces during any 14-day period||2 ounces||"One month supply" TBD by the Commission||Maximum 2 ounces within a 30-day period||Maximum 2.5 ouces in a 15-day period||Maximum 10 ounces in a 60-day period||Maximum 2 ounces within a 30-day period||6 ounces||Maximum 2.5 ouces in a 15-day period||Maximum 2 ounces within a 30-day period|
|Caregiver Limits on Number of Patients||1 patient per caregiver||Max 5 patients per caregiver||Max 5 patients per caregiver||1 patient per caregiver||None||1 patient per caregiver||1 patient per caregiver||Max 5 patients per caregiver||Max 3 patients per "provider" including the provider if they are a patient||1 patient per caregiver||1 patient per caregiver||Max 4 patients per caregiver||None on caregivers, cultivators may grow for a max of 4 patients||Max 5 patients per caregiver||1 patient per caregiver|
|Physician Registration or Education Requirements||No||No||Physician Registration||No||No||No||No||Registraion and education required||No||No||No||No||No||No||No|
|Dispensary, Manufacturing and Cultivation Licensing||No||Yes||Yes||Yes||Yes||No||Yes||Yes||No||Yes||Yes||Yes||No||Yes||Yes|
|Fee Structures - Licensed Providers||$500 per dispensary agent; $5,000 dispensary application fee||$7,500 - $18 application fee range depending on the number of patients||$1,000 application fee; $5,000 renewal fee; $50 per employee fee||$5,000 application fee; $3,000 renewal fee||$15,000 application/renewal fee ($14,000 refunded to rejected applicants)||$31,500 application fee (total, 2 phases); $50,000 annual registration; $500 dispensary agent fee||$50 per provider||$20,000 application and renewal fee||$1,000 application fee; renewal fee ranges $5,000-$3,000 based on how long they have been licensed||$250 application fee; $5,000 biennial registration fee; $100 fee per employee||$2,500 application fee; $20,000 registration certificate fee; $30,000 registration renewal fee|
|Ownership and Employment Restrictions||Yes||Yes||Yes||Yes||No||Yes||Yes||Yes||Yes|
|Disposal Requirements for Unused Medical Cannabis||Yes|
Regulations for Patients and Caregivers
Patient privacy is of the utmost importance. Information about patients, caregivers, or healthcare providers contained in a registry should be kept confidential in perpetuity. This information should only be used to confirm the validity of an identification card to law enforcement officials when the patient or caregiver has presented the identification card. The unsanctioned release of registry information should carry administrative and criminal penalties.
Patient and Caregiver Identification
The regulatory agency charged with maintaining a patient registry should issue both patients and caregivers identification cards. These cards should include a photograph of the patient or caregiver and an identification number that can be utilized by dispensaries, manufacturers, and cultivators for recordkeeping without identifying a patient’s name. ASA prefers that the identification cards be issued for a period of two years or longer to reduce the cost and burden for patients. Identification cards and the rights and privileges afforded by registration should not be revoked until determined warranted by the completion of an administrative hearing or legal proceedings.
Fee Structures – Patients and Caregivers
Fees for patient registration should be set to meet reasonable administrative costs of the registry program. Patient fees should not cover costs of medical marijuana business oversight. Because of the financial situation of many chronically ill patients, ASA recommends a sliding scale fee tied to state or federal benefits, Colorado’s program is based on 185% of the federal poverty level, while Massachusetts has implemented a scale based on 200%. ASA recommends that sliding fees are implemented based on number of patients served.
Restriction on Access to Multiple Dispensaries
The medical marijuana field is restricted by the inability to conduct scientific studies on use and efficacy. Despite this fact, many medical marijuana businesses continue to improve and develop their medicinal offerings. As a result, ASA believes that patients should be allowed to obtain medical marijuana products from multiple dispensaries so that they can access products beneficial to their condition without restrictions or change fees.
Multiple Year Registrations
Most medical marijuana patients with chronic illness see a primary physician regularly, while visiting their medical marijuana specialist for registry application and renewals only. These medical marijuana specialists do not typically take insurance for these visits and charge patients a compensating fee. Because these chronically ill patients incur heavy medical costs already, ASA recommends that multi-year registrations be available to these patients based on the condition listed on their application.
ASA’s position regarding a process for adding conditions for which medical cannabis is allowed to be recommended be as simple and timely as possible. Decisions should be based on whether or not the condition impairs a patient’s ability to carry on the activities of daily living. The process should not be allowed to consider other treatments available or exclude any type of studies from a review of literature.
Distance from a dispensary and an individual’s condition should be considered when determining purchasing limits. If limits are not defined by legislation, ASA believes that the patient’s recommending health care provider should be able to recommend up to a three month purchasing allowance.
Background checks or restrictions due to past convictions for caregivers should not be mandated as patients should have the right to select the caregiver who best serves their needs. ASA believes that so long as caregiver is in compliance with zoning and building requirements in the jurisdiction which they cultivate for patients, no limit on the number of patients they can provide for should be implemented. Caregivers should not be required to provide any services to patients other than medical cannabis and education on its use.
Regulations for Physicians
Any physician that is in good standing with the State should be allowed to recommend the use of medical cannabis to his or her patients. Physicians who use medical cannabis themselves should not be restricted from recommending medical cannabis. Because patients with chronic illness seek health care services from a variety of sources, ASA prefers that nurse practitioners, naturopathic doctors and chiropractors be allowed to recommend medical cannabis if it is not prohibited by legislation. Health care professionals that are allowed to recommend medical cannabis should not be allowed to have direct or indirect financial interest in a dispensary, manufacturer, or cultivation operation or financially benefit from any business that might benefit from a patient’s or caregiver’s use, acquisition, or purchase of medical cannabis.
Regulations for Licensed Operators
Dispensary, Manufacturing, and Cultivation Licensing
In situations where the number of dispensaries, manufacturers, and cultivators will be limited, ASA believes that applicants should be evaluated on their ability to consistently provide safe, quality medical cannabis products to patients. Lottery style application systems do not guarantee that operators who will best serve patients are selected. The ability to provide the best patient access to medical cannabis should be heavily weighted in any scoring process.
Fee Structures – Licensed Providers
Fees for provider licenses should be set to cover the cost of oversight only, keeping in mind that patient fees should not cover costs of medical marijuana business oversight.
ASA believes that the proper training of employees is essential to deliver safe, quality cannabis products to patients and caregivers. Third-party training programs should be required to include:
- medical cannabis laws and rules
- federal and state conflicts
- employee and patient safety
- cannabis as medicine and patient care
- product safety and recall procedures
Healthy and safety regulations should protect the health of patients. Medical cannabis businesses should be required to comply with standards established to ensure safe products. ASA has worked with the American Herbal Products Association to provide recommendations to regulators for dispensaries, manufacturers, cultivators and laboratory operations. The regulatory agency should ensure compliance with good practice standards through agency or third-party inspectors. States should allow cultivators and manufacturers to certify medical cannabis products organic in accordance with State statute for organic food products.
Patients have a right to accurate labeling of cannabis products. Dispensaries, manufacturers, and cultivators should be required to provide patients and caregivers with identity statements for every cannabis product sold, manufactured or cultivated. ASA’s position is that if any potency claims are made by a business, they must have proof a valid third-party analytical test. If third-party laboratory services are available in the State, cultivators and manufacturers should be required to provide dispensaries with valid microbiological and chemical analysis results for each batch of cannabis product.
Ownership and Employment
Generally ownership and employment restrictions are laid out in legislation. ASA recommends that Regulatory Agencies with rulemaking authority on these issues allow some level of secured investment from out of state. Limiting capital to the system restricts businesses from expanding to meet patient needs. It is preferable that marijuana related convictions do not automatically exclude a person from ownership or employment and instead each individual circumstance should be reviewed.
Security requirements should not intrude on the privacy of patients. ASA’s position is that rules should not require the recording of patient names or require a camera image of their identification be tied to purchase records.
Dispensaries, Manufacturers, and Cultivators required to retain records with patient identification should only be required to record a patient identification number and should not be required to record any patient or caregiver names. ASA believes these businesses should not be required to maintain records pertaining to a patient’s health history or medical cannabis recommendation.
It is ASA’s position that medical cannabis businesses should be prohibited from making false advertising or marketing claims. Some advertising restrictions may be appropriate for certain jurisdictions, however, a complete ban on print and internet marketing limits the ability for patients and caregivers to get information on dispensaries and medical cannabis products and to find out information on recalled products.
Disposal of Medical Cannabis
Rules for the disposal of medical cannabis should not be overly onerous. ASA supports rules that simply require that un-consumed medical cannabis and medical cannabis waste be rendered unusable by mixing with normal household trash or by composting.
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