phone: 202.857.4272 americansforsafeaccess.org recommendations to the georgia medical cannabis...

Phone: 202.857.4272 americansforsafeaccess.org

Recommendations to the Georgia Medical Cannabis Commission

Overview• Introduction

• Who is Americans for Safe Access?

• Cannabis as medicine

• Current situation: federal and other states

• Medical Cannabis Access in the U.S.

• Model legislation and grading criteria

• Georgia HB 1 compared to other states

• AHPA Guidelines

• Cultivation and Processing

• Manufacturing, Packaging, Labeling, and Holding

• Distribution

• Laboratory Analysis

Who is Americans for Safe Access?

Our Mission:The mission of Americans for Safe Access (ASA) is to ensure safe and legal access to cannabis (marijuana) for therapeutic uses and research. ASA works with our grassroots base of over 50,000 members to effect change using public education and direct advocacy at the local, state, and federal level.

Cannabis as MedicineHerbal

The first evidence of the medicinal use of cannabis is in an herbal published during the reign of the Chinese Emperor Chen Nung 5000 years ago. It was recommended for malaria, constipation, rheumatic pains, "absentmindedness" and "female disorders." Another Chinese herbalist recommended a mixture of hemp, resin, and wine as an analgesic during surgery. In India cannabis has been recommended to quicken the mind, lower fevers, induce sleep, cure dysentery, stimulate appetite, improve digestion, relieve headaches, and cure venereal disease. In Africa it was used for dysentery, malaria, and other fevers.

Cannabis was a part of the American pharmacopoeia until 1942 and is currently available by prescription in the Netherlands, Canada, Spain, and Israel in its whole plant form.

American Herbal Pharmacopeia issued monograph on cannabis in 2013

Cannabis as MedicineModern Pharma

• 1937: U.S. passed the first federal law against cannabis, despite the objections of the American Medical Association (AMA). "The American Medical Association knows of no evidence that marijuana is a dangerous drug" and warned that a prohibition "loses sight of the fact that future investigation may show that there are substantial medical uses for Cannabis.“ -- Dr. William C. Woodward

• Discovery of endocannabinoid system is recent (mid-90s), regulates:

• Neurotransmitter Receptors

• Appetite

• Pain

• Others

• To date, more than 15,000 modern peer-reviewed scientific articles on the chemistry and pharmacology of cannabis and cannabinoids have been published, as well as more than 2,000 articles on the body's natural endocannabinoids.

• Database of studies: http://www.cannabis-med.org/studies/study.php

Current Situation - States• 39 states plus D.C. and Guam now have some form of medical marijuana

patient protections (23 full medical states, 16 CBD or otherwise limited)

• 275 million Americans live under these laws (~85% of U.S. population)

• Approximately 2.4 million patients utilize these laws

• Over 50 medical conditions have been approved among these programs

• States with medical marijuana programs have seen drops in opioid overdoses,1 highway fatalities,2 and not experienced increased teen use3

1. Medical cannabis laws are associated with significantly lower state-level opioid overdose mortality rates.” Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in the United

States, 1999-2010 . Marcus A. Bachhuber, MD, et al., JAMA Intern Med. 2014;174(11):1875. doi:10.1001/jamainternmed.2014.5823.

2. “The first full year after coming into effect, [medical] legalization is associated with an 8–11 percent decrease in traffic fatalities.” Journal of Law and Economics, Vol. 56, No. 2 (May 2013),

pp. 333-369. Also see SAMSA study.

3. “Our results are not consistent with the hypothesis that legalization leads to increased use of marijuana by teenagers.” Medical Marijuana Laws and Teen Marijuana Use, D. Mark

Anderson, et al., National Bureau of Economic Research, NBER Working Paper No. 20332, July 2014

Current SituationFederal


• Veterans Equal Access Amendment• Lost in House (210-213)• Won in Senate Appropriations (18-2)• Check on GA Rep votes

• Rohrabacher-Farr Amendment (protecting state programs)• Won in House (242-186) w/67 GOPs and 175 Dems• Won in Senate Approps (21-9) w/8 GOPs and 13 Dems

• CARERS Act Introduced in House (S. 683/H.R. 1538)• Protects all state legal MMJ conduct from federal

interference• Removes CBD extracts from Controlled Substances Act• Lifts 3 major federal barriers to research (scheduling, NIDA

monopoly, PHS review process• All forms of marijuana are considered Schedule I federally


Medical Cannabis Access in the U.S.

• What is a “medical marijuana state”?

• ASA state-by-state grading system

• Patient Rights and Civil Protections

• Access to Medicine (Cannabis and/or Cannabis Products)

• Ease of Navigation

• Functionality (Effectiveness of current program)

• Model Legislation

• Will be updated in summer 2015


Patient Rights and Civil Protections

Patient Rights & Civil Protection from DiscriminationArrest 20Affirmative Defense 15Child Custody Protections 10DUI Protections 7Employment Protections 7Explicit Privacy Standards 10Housing Protections 7Does Not Create New Criminal Penalties for Patients 7Organ Transplants 7Reciprocity 5Scheduling 5



HB1•Protection from arrest•Includes new felony crimes•No civil discrimination protection



Arizona Revised Statutes 36-2813. Discrimination prohibited

A. No school or landlord may refuse to enroll or lease to and may not otherwise penalize a person solely for his status as a cardholder, unless failing to do so would cause the school or landlord to lose a monetary or licensing related benefit under federal law or regulations.B. Unless a failure to do so would cause an employer to lose a monetary or licensing related benefit under federal law or regulations, an employer may not discriminate against a person in hiring, termination or imposing any term or condition of employment or otherwise penalize a person based upon either:1. The person's status as a cardholder.2. A registered qualifying patient's positive drug test for marijuana components or metabolites, unless the patient used, possessed or was impaired by marijuana on the premises of the place of employment or during the hours of employment.C. For the purposes of medical care, including organ transplants, a registered qualifying patient's authorized use of marijuana must be considered the equivalent of the use of any other medication under the direction of a physician and does not constitute the use of an illicit substance or otherwise disqualify a registered qualifying patient from medical care.D. No person may be denied custody of or visitation or parenting time with a minor, and there is no presumption of neglect or child endangerment for conduct allowed under this chapter, unless the person's behavior creates an unreasonable danger to the safety of the minor as established by clear and convincing evidence.

Access to Medicine

Access to MedicineDispensaries/Commercial Producers (Consumer Safety & Provider Requirements)* 25

Personal Cultivation 25

Collective Gardens 10

Explicit Right to Edibles/Concentrates/Other Forms 10

Does Not Impose Limits or Bans on THC 10

Does Not Impose Minimum CBD Requirements 10

Allows Access to Dried Flowers 10

Access to Medicine

HB1• Registration ID cards now available• No in-state production or access to products (except

limited access to GW studies)• Patients or their caregivers must travel to a state

with reciprocity• 5% cap on THC• Minimum 1:1 THC:CBD ratio

Access to Medicine

* Consumer Safety & Provider Requirements

Mandatory Testing and Labeling Requirements 5Training 3Product Safety Protocols 4

Ownership/Employment Restrictions 1

Does Not Require Vertical Integration 1

Allows for a Reasonable Number of Dispensaries 3Provisions for Labor Standards 2Environmental Impact Regulations 2

Choice of Dispensary Without Restrictions 2Municipal Bans/Zoning 1

No sales tax or reasonable sales tax 1

Ease of NavigationEase of Navigation

Comprehensive Qualifying Conditions 25Adding New Conditions 10Reasonable Access For Minors 10

Reasonable Caregiver Background Check Requirements 5Number of Caregivers 5

Patient/Practioner Focused Task Force/Advisory Board 5

Reasonable Fees (Patients & Caregivers) 15Allows Multiple-Year Registrations 5

Reasonable Physician Requirements 10

Financial Hardship Program (Fee Waivers/Discounted Medicine) 10

Ease of Navigation

HB1• Limited qualifying conditions, but more than most CBD-

focused states

• No process for adding new qualifying conditions

• Reasonable registration requirements for pediatric patients

• Advisory board focused on improving the state program

• Physician reporting requirements may be onerous

Ease of Navigation

"Qualifying medical condition" means any condition for which treatment with medical marijuana would be beneficial, as determined by the patient's physician.“

D.C. Council, B20-0766 - Medical Marijuana Expansion Amendment Act of 2014

Functionality

Functionality

Patients currently able to access medicine through patient/caregiver cultivation 30

Free of significant administrative or medicine supply problems 20

Patients can receive legal protections within reasonable timeframe of doctor's recommendation 20

Reasonable Possession Limit (ounces) 10

Reasonable Purchase Limits 10

Allows Patients to Medicate Where They Chose 10

Functionality

HB1• Patients must travel out of state or enroll

in a limited access medical study• Administrative work occurring in a timely

fashion• Possession limits workable, but lack of

in-state access could be problematic

AHPA GuidelinesRecommendations for regulators

• Cannabis Dispensing Operations

• Cannabis Laboratory Operations

• Cannabis Cultivation Operations

• Cannabis Manufacturing, Packaging, Labeling, and Holding Operations

Enabling Legislation

Section 19 (ASA model legislation). Product Safety

The Department will adopt product safety standards for the cultivation, processing, manufacturing, labeling, testing, and distribution of cannabis based on the American Herbal Products Association Cannabis Guidelines and determine a comprehensive plan for inspection, oversight, and enforcement of such guidelines.

Enabling Legislation

Section 20 (ASA Model Legislation). Implementation of Regulations and Fees.

Within 120 days of the effective date of this law, the Department with the Department of Agriculture shall issue regulations for the implementation of Sections 15 through 22 of this Law. The Department shall create a Merit Based Approval Process, to solicit the best applications for Medical Cannabis Establishments that include solutions to foreseeable environmental, product safety, public safety, and labor & employment issues. The Department shall set application fees for medical cannabis establishments so as to defray the administrative costs of the medical cannabis program and thereby make this law revenue neutral. The Department shall establish different categories of medical cannabis establishment agent registration cards, including, without limitation, criteria for mandatory training and certification for each of the different types of medical cannabis establishments at which such an agent may be employed or volunteer. Fees shall be on a sliding scale based on the projected and/or annual gross of the medical cannabis establishment.

Enabling LegislationSection 20 (ASA Model Legislation). Implementation of Regulations and Fees.

Within 120 days of the effective date of this law, the Department with the Department of Agriculture shall issue regulations for the implementation of Sections 15 through 22 of this Law. The Department shall create a Merit Based Approval Process, to solicit the best applications for Medical Cannabis Establishments that include solutions to foreseeable environmental, product safety, public safety, and labor & employment issues. The Department shall set application fees for medical cannabis establishments so as to defray the administrative costs of the medical cannabis program and thereby make this law revenue neutral. The Department shall establish different categories of medical cannabis establishment agent registration cards, including, without limitation, criteria for mandatory training and certification for each of the different types of medical cannabis establishments at which such an agent may be employed or volunteer. Fees shall be on a sliding scale based on the projected and/or annual gross of the medical cannabis establishment.


Cannabis Dispensing Operations

• Subpart A – General provisions .................................................................................. 2 Section 1.1 Subject operations .............................................................................. 2 Section 1.2 Other statutory provisions and regulations.......................................... 2 Section 1.3 Definitions ........................................................................................... 2 Subpart B – Dispensing operations ............................................................................. 4 Section 2.1 Types of dispensing operations .......................................................... 4 Section 2.2 Ancillary operations............................................................................. 4 Section 2.3 Personnel............................................................................................ 5 Section 2.4 Physical facilities................................................................................. 5 Section 2.5 Security............................................................................................... 6 Subpart C – Cannabis product .................................................................................... 7 Section 3.1 Subject cannabis products.................................................................. 7 Section 3.2 Cannabis product acquisition.............................................................. 8 Section 3.3 Cannabis product information ............................................................. 8 Section 3.4 Cannabis product recalls .................................................................... 9 Subpart D – Compliant individuals............................................................................. 10 Section 4.1 Requirements for purchase............................................................... 10 Section 4.2 Purchase limits.................................................................................. 10 Section 4.3 Personal information ......................................................................... 10 Section 4.4 Adverse event records ...................................................................... 11 Section 4.5 Rights and responsibilities of compliant individuals .......................... 11


Cannabis Laboratory Operations


Cannabis Cultivation Operations

•


Cannabis Manufacturing, Packaging, Labeling, and Holding Operations

•

FOR MORE INFORMATION

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phone: 202.857.4272 americansforsafeaccess.org recommendations to the georgia medical cannabis...

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