Maryland Medical Cannabis Commission Brian P Lopez Chairman

Maryland Medical Cannabis Commission Brian P. Lopez Chairman Joy A. Strand, MHA Executive Director Tuerk Conference April 19, 2018

Discussion Topics • Legislative timeline • MMCC Overview • Industry Overview Registration Databases Industry Partners • Current Statistics • Legislative Update • Medical Cannabis and Opioid Use Disorder

MMCC Mission The Maryland Medical Cannabis Commission (MMCC) develops policies, procedures, and regulations to implement programs that ensure medical cannabis is available to qualifying patients in a safe and effective manner. The MMCC oversees all licensing, registration, inspection, and testing measures pertaining to Maryland’s medical cannabis program and provides relevant program information to patients, providers, caregivers, growers, processors, dispensaries and testing laboratories.

MMCC Core Competencies Licensing – ensuring that growers, processors, dispensaries, and independenttesting lab facilities are in compliance with COMAR 10. 62 Registration – oversee the process or adding patients, caregivers, and providers to participate in the program. Compliance – team of inspectors ensures that facilities are adhering to the safety and security measures before initiating sales and during the operational stage. Safety & Quality – Commission and ITLs work together to test product for potency and purity, stability, contaminants, the product’s cannabinoid profile, and other measures that provide consumer safety and confidence.

Legislative History

Legislative Timeline 2011 - GA enacts protection for Use of medical cannabis for patients and recommen ding physicians 2014 – legislation expands MMCC role to register physicians, and conduct research medicinal use cannabis. 2013 – The MD GA created the MMCC for investigati onal use of medical cannabis 2012 – 3 bills introduced for medical cannabis in MD. All 3 fail but set the precedent for 2013 legislative victories 2015 – MMCC receives high volume of applicant ions 2017 - Bill proposed MMCC changes & prohibition of cannabis use in public 2013 – law expanded to include caregiver protection 2015 - Authorizes MMCC to license growers, processors, 2016 - Dentists, podiatrists and December 1, 2017 – Product on the shelves for

December 1 st, 2017 Product Roll-out! Product becomes available for Maryland certified patients

Organizational Structure

Commission Composition Chairman – Brian Lopez Executive Director – Joy A. Strand, MHA Deputy Director – Lori M. Dodson, M. S. MT(ASCP) Commissioner’s • • Three licensed physicians Law enforcement representative Medical cannabis scientist Registered nurse - hospice Licensed pharmacist MD NCADD Sec. of Health or Designee • • • Licensed Attorney University of Maryland representative Maryland State’s Attorneys’ Association representative Horticulture expert Office of Comptroller

MMCC Staff Executive Director Deputy Director & Laboratory Compliance Director of Policy and Gov’t Relations Develop Policy, Legislation Assistant Attorney General – Legal Advice, Litigation Director of Compliance & Enforcement – Field Inspections, Licensing, Violations 4 – Regional Supervisors 8 – Investigators

MMCC Staff Director of Quality Assurance – Patient & Provider Registry, Call Center, Emails, ID Cards 7 – QA Specialists Director of Program Analytics – Seed to Sale Tracking System Director of Information Technology 2 IT Specialists Director of Finance

MMCC Staff Administrative Support – 4 Research & Education Analyst SB 1 / HB 2 - At least 2 additional Various Consultants

Qualified Patient, Certifying Provider or Caregiver

Patient Registration • Online registration – mmcc. Maryland. gov • Upload personal information and recent photo • MMCC issues unique patient identifier via email

Patient Certification • Patient visits certifying provider and presents MMCC registration number • Provider enters recommendation for patient into MMCC data base • Patient is now able to purchase cannabis from licensed MD dispensary • Patient may purchase medical cannabis card ($50) – pending changes

Provider Registration • Be a licensed provider in good standing in Maryland Physicians, NP, Cert. Nurse Mid-Wife, Podiatrist, Dentist • Online registration – mmcc. Maryland. gov • Renew registration every two (2) years • Specify conditions they will or will not certify for

Provider Responsibility • Access patient medical history and patient examination to determine if cannabis treatment is appropriate • Establish a bona fide provider-patient relationship • Issue patient a “written certification” via the MMCC Registry • Follow up with the patient at medically appropriate intervals • Terminate certification under certain circumstances • Conduct an in person evaluation every 365 days.

Qualifying Medical Conditions • • • Cachexia Anorexia Wasting syndrome Severe or chronic pain Severe nausea Seizures • Severe or persistent muscle spams • Glaucoma • Post Traumatic Stress Disorder (PTSD) • Any condition which is severe and for which other medical treatments have been ineffective

Caregiver • Caregiver – defined (a) ‘Caregiver’ means an individual 21 years old or older designated by a patient who has agreed to assist with a qualifying patient’s medical use of medical cannabis. (b) ‘Caregiver’ means for a qualifying patient younger than 18 years old, a parent or legal guardian

Caregiver • Online registration – mmcc. Maryland. gov • • • Upload personal information and recent photo Patient designate caregivers during registration process Two (2) maximum caregivers per patient Five (5) maximum patients per caregiver Caregivers must be 21 years or older

Sample MMCC ID Card

Limits on Medical Cannabis • Patients limited to a combination of 120 grams of flower or 36 grams of THC in a 30 day period • Certifications that are not used to obtain medical cannabis within 120 days of issuance become null and void. • Patient may only have 1 provider and 1 written recommendation at a time • Patient must renew certification by visiting a provider once per 365 days.

Patient/Provider Statistics

Statewide Cannabis Patient Statistics 4. 17. 2018 Registered Patients 33, 504 Certified Patients 22, 437 Pending Patients 10, 049 60% need corrections by patients Registered Caregivers Pending Caregiver 1, 865 274

Statewide Cannabis Patient Statistics 4. 17. 2018 Minor Patients Registered Certified 123 77 Hospice Registered Certified 132 76

Statewide Cannabis Provider Statistics Physicians 555 Nursing (NP & CNMW) 207 Dentists 44 Podiatrist 7

Industry Categories • Grower • Processor • Dispensary • Independent Testing Laboratory (ITL)

Grower – 14 licensed in MD Grows several varieties of cannabis Ships cannabis material to processor, dispensaries or ITL

Processor – 13 licensed in MD Transforms cannabis into another product or extract

Dispensary – 46 licensed in MD (4. 10. 18) Storefront where patient purchase medical cannabis flower or infused products

Medical Cannabis Products in MD • • • Flower/ Pre-rolls Extracts, Oils, & Tinctures Vape Cartridges Capsules & Patches Salves, Lotions, Ointments Cannabis- infused edible food products ARE NOT approved in Maryland Pre-rolls Tinctures Extracts Oils

Guidelines and Regulation for Safe and Effective Product Testing Requirements

Independent Testing Laboratories - Sampling and product testing is done at every step where the cannabis is changed. - Independent of locations that grow, process, or dispense medical cannabis. - Must register with Commission - Must be accredited by a third-party accreditation body that adheres to 17025 ISO/IEC requirements. Current Registered ITLs

Contaminant Testing Pesticide Analysis Microbiological Impurities Water Activity Residual Solvent Testing Heavy Metal Screen Moisture Content Foreign Matter Inspection

Potency Testing Cannabinoids CERTIFICATE OF ANALYSIS Concentrations of the following: THCA CBDA CBG CBN Terpenes (alpha/beta –Pinene, beta. Myrcene, Limonene, Terpinolene, cis. Ocimene, Linalool, beta. Caryophyllene, Humulene, beta. Eudesmol, Caryophyllene oxide, trans. Nerolidol) Terpenes

Guidelines and Regulation for a Safe and Effective Product Seed-to-Sale Tracking System

• • Purpose of METRC Software: Public Health and Public Safety Metrc™ is a compliance management solution used by regulatory bodies for the oversight of the cannabis industry. Metrc is a cloud hosted on-line software tracking & reporting system. MD licensed medical cannabis businesses are required to track and report supply chain activities from ‘seed to sale’. https: //www. metrc. com

METRC™ • Total tracking of cannabis; immature plant finalized product sale • Integrated with MMCC Registry to track the amount of medical cannabis per • • • patient Facility reports – transfers, transactions, testing procedures per facility Testing results recorded in Metrc Control product recall by placing administrative holds Real-time transaction oversight Industry must document activity in METRC for state regulatory purposes

Examples of RFID Tags for Cannabis Plants

Maryland General Assembly 2018 Legislation passed relating to Medical Cannabis Note: The information presented here are for informational purposes only and not for the purpose of providing legal advice. You should contact your attorney to obtain advice with respect to any particular issue or problem.

House Bill 1035/Senate Bill 1063 Certifying Providers – Referrals Effective 10. 1. 18 • Prohibit compensation for the referral of a qualifying patient to a medical cannabis certifying provider. • Referral restrictions extend to persons or businesses compensated for registering a qualifying patient, completing an application for a qualifying patient, or submitting an application for a qualifying patient.

Senate Bill 874 – Immunity Effective 10. 1. 18 • Expand legal protections from arrest, prosecution, or other penalties for a qualifying patient, caregiver, certifying provider, medical facility, grower, processor, and dispensary to include “possession” of medical cannabis (previously limited to “use”); and • Provide legal protections to independent testing laboratories, secure transportation companies, waste disposal companies, and other entities authorized by the Commission to test, transport, and dispose of medical cannabis and medical cannabis waste.

House Bill 2 – Natalie M. La. Prade Medical Cannabis Commission Reform Act Effective upon Governor’s Signature • Increase number of grower’s licenses from 15 to 22; • Increase number of processor’s licenses from 15 to 28; • Require outreach to small, minority, and women businesses, including, (1) training programs for employment, and (2) educational information on licensing process; • Make grants to educational and business development organizations to assist small, minority, and women businesses interested in the medical cannabis industry;

House Bill 2 – Natalie M. La. Prade Medical Cannabis Commission Reform Act Effective upon Governor’s Signature • Reduce the number of Commissioners from 16 to 13, beginning on October 1, 2019; • Develop regulations to establish the Compassionate Use Fund program (MDH), which will provide access to medical cannabis for individuals enrolled in the Maryland Medical Assistance program or the Veterans Administration Maryland Health Care System; • Submit emergency regulations to implement remedial measures to promote diversity in the medical cannabis industry;

House Bill 2 – Natalie M. La. Prade Medical Cannabis Commission Reform Act Effective upon Governor’s Signature • Submit a report on the: (1) fees and revenues necessary to implement the Compassionate Use Fund; (2) providers, product demand, and consumer price; (3) progress of emergency regulations; (4) advertising and marketing practices of licensees; and (5) use of medical cannabis to treat opioid use disorder; • Submit emergency regulations that permit and regulate the use of crop protection agents (MDA); and • Grant stage one pre-approval to: (1) next two numerical selections on the August 2016 RESI grower list; (2) any licensed grower with a top-30 processor ranking; and (2) any licensed processor with a top-30 grower ranking.

House Bill 2 – Natalie M. La. Prade Medical Cannabis Commission Reform Act Effective upon Governor’s Signature SECTION 13. AND BE IT FURTHER ENACTED, That, on or before January 1, 2019, the Natalie M. La. Prade Medical Cannabis Commission, in consultation with the Maryland Department of Health, shall report to the General Assembly, in accordance with § 2– 1246 of the State Government Article, on the treatment of an opioid use disorder by using medical cannabis.

Medical Cannabis and Opioid Use Disorder Note: The information presented here are for informational purposes only and not for the purpose of providing legal advice. You should contact your attorney to obtain advice with respect to any particular issue or problem.

Medical Cannabis and Opioid Use Disorder Medical cannabis states versus states without medical cannabis laws: • Have reported fewer opiate deaths and there are no deaths related to marijuana overdose on record • Had 2. 21 million fewer daily doses of opioids prescribed per year under Medicare Part D • Opioid prescriptions under Medicaid dropped by 5. 88 percent • Saw 20. 7% fewer morphine prescriptions and 17. 4% fewer hydrocodone prescriptions.

Medical Cannabis and Opioid Use Disorder Opioid Prescriptions fewer in States that offer Dispensary Sales • States that allowed dispensaries had 3. 742 million fewer opioid prescriptions filled per year under Medicare Part D • States that only allowed home cultivation of cannabis had 1. 792 million fewer opioid prescriptions per year

References and Articles High Hopes Ride on Marijuana Amid Opioid Crisis https: //www. scientificamerican. com/article/high-hopes-ride-on-marijuana-amid-opioid-crisis/ Multiple studies have shown that pro-medical marijuana states have reported fewer opiate deaths and there are no deaths related to marijuana overdose on record. (http: //reut. rs/2 r 74 Sbe) Marijuana legalization could help offset opioid epidemic, studies find https: //www. cnn. com/2018/04/02/health/medical-cannabis-law-opioid-prescription-study/index. html JAMA – Internal Medicine - Association Between US State Medical Cannabis Laws and Opioid Prescribing in the Medicare Part D Population https: //jamanetwork. com/journals/jamainternalmedicine/article-abstract/2676999? redirect=true Could Medical Cannabis Break the Painkiller Epidemic https: //www. scientificamerican. com/article/could-medical-cannabis-break-the-painkiller-epidemic/

Any Questions? E-mail: brian. lopez@Maryland. gov joy. strand@Maryland. gov Note: The information presented here are for informational purposes only and not for the purpose of providing legal advice. You should contact your attorney to obtain advice with respect to any particular issue or problem.