Medical Cannabis in Maryland

1. Medical Cannabis in Maryland A presentation to January 20, 2016 By Eric E. Sterling, J.D. Chair, Policy Committee Maryland Medical Cannabis Commission mmcc.maryland.gov

2. Disclaimer • These slides, and my comments, cannot be relied upon as a statement of the law • The law is spelled out in the statutes and regulations and those are the sources to consult • If you have legal questions regarding your participation in Maryland’s medical cannabis program, you should consult with a lawyer

3. Program Principles • Principles of Maryland’s Medical Cannabis Program: • Ensure proper security and protection of public safety • Assure the highest quality medicine is produced and distributed • Expedite patient access • Details spelled out in the statutes and regulations

4. Background • Maryland General Assembly created Medical Cannabis Commission in 2013 to carry out program to dispense cannabis to Maryland patients based on “Academic Medical Centers” • That approach was not feasible • Approach replaced in 2014 and revised in 2015. • Delegates Dan Morhaim, M.D. and Cheryl Glenn and Senator Jamie Raskin were key advocates in General Assembly throughout process • Commission now has 16 members – DHMH Secretary plus 15 appointees of the Governor

5. Regulations • Commission started developing regulations in fall of 2013 • Commission provided interim drafts and many opportunities for public comment • Early version published in January 2015 • Second version published in June 2015 • Regulations, as published in June, took effect September 14, 2015 • Link to regulations on Commission website: mmcc.maryland.gov

6. Funding • Program costs not funded by Maryland taxpayers • Program costs entirely paid for by fees from licensees

7. Funding • Application fees: • Grower: Stage 1 - $2,000; Stage 2 - $4,000 • Processor: Stage 1 - $2,000; Stage 2 - $4,000 • Dispensary: Stage 1 - $1,000; Stage 2 - $4,000 • Annual fees: • Grower: $125,000 • Processor: $40,000 • Dispensary: $40,000 • Registration of Grower Agents, Processor Agents, Dispensary Agents -- $200

8. Funding • No fees to be paid by physicians • No fees to be paid by patients to register or to obtain a written certification • If patient wishes to obtain an identification card from the Commission, fee $50 • Independent testing laboratory registration fee $100, valid for 2 years • Independent testing laboratory agent fee $200

9. Application for license • For Growers, Dispensaries and Processors, there are two stages in applying: First stage – Pre-approval: • Complete a detailed application and submit by deadline • Application reviewed, scored and ranked by independent third party reviewer • Commission considers scored & ranked applications to issue a pre-approval of license to successful applicants

10. Application for license Second stage – Issue License: • Pre-approved applicant completes financing, construction, hiring, training, etc. and prepares to open • Commission investigates financial background • Applicant tells Commission that it is ready for inspection of premises and operation • Commission inspects premises, reviews S.O.P.s, training • If inspection passed , Commission awards license to start operating

11. Current Status of Program • Application for licenses opened September 28, 2015 (Start of first stage of application process) • Deadline to submit application was 4 p.m., November 6, 2015 • Commission received 1081 applications: • 146 grower applications • 124 processor applications • 811 dispensary applications

12. Current Status of Program • Independent third party now reviewing applications to score and rank • Next step: Commission will review the scored and ranked applications and award pre-approvals. That will end first stage of application processand commence second stage of application process • Commission now registering physicians • Not registering patients yet

13. Security - Safety • Shaping the Program: • Commission includes Chief of Police (representative of law enforcement); a State’s Attorney; a representative of the Comptroller • Limited number of growers and licensees • No more than 15 licensed growers • Growers may operate one dispensary • Additionally, other licensees may operate a single dispensary. No more than two such dispensaries in each of the 47 senatorial districts • Maximum number of dispensaries statewide – 109

14. Security - Safety • Personnel in industry • Fingerprint-based criminal history check of all investors, managers, employees • Background investigations of all applicants, including investors, managers • Detailed financial investigation of investors • No one with a felony drug conviction can be part of the program • Pre-employment urine testing for all personnel • All personnel must be trained in safety and security • Licensees need drug-free workplace policy

15. Security - Safety • No one can obtain cannabis from a licensed dispensary without a written certification from a Maryland physician who is registered with the Commission • Physician must be licensed with the Maryland Board of Physicians • Physician license must be “active, unrestricted, and in good standing”

16. Security - Safety • Premises used for production, dispensing & processing: • Constructed to prevent unauthorized entry • 24 – 7 recording surveillance cameras throughout • Security lighting • Security alarm systems • Must meet local zoning and planning codes • Procedure to control public access: • Record all visitors • Visitors must always be supervised

17. Security - Safety • Control of cannabis • Demanding inventory controls from “seed to sale” • Any diversion reported to Maryland State Police • All transactions recorded • Strict transportation security • Strict control in dispensaries • Vaults for cannabis • Exclusion of persons other than patients • Commission review of security plans

18. Security - Safety • Commission will regularly inspect all licensees • Licenses can be revoked for violations • Commission can fine violators up to $10,000 • Any possession, distribution or use of cannabis diverted from the program is penalized by up to five years in prison and a $10,000 fine in addition to other CDS penalties

19. Security - Safety • Patients and patient use of cannabis not excluded from offenses of: • Operating vehicles under the influence • Smoking cannabis in a motor vehicle • Smoking cannabis in a public place

20. Security - Safety • Cannabis products packaging: • Plain, opaque and, if requested, child-resistant (Many patients may be handicapped and need easy-to-open package) • No resemblance to trademarked or product-specialized packaging of candy, snack, baked good or beverage • No feature that might mislead anyone about the contents • No cartoon, color scheme, image, or feature that might make the package attractive to children

21. Security - Safety • Cannabis products packaging: • Finished product lot number, expiration date • Conspicuously itemized contents • Personalized label

22. Security - Safety • Package Warnings: • Keep away from children • Illegal for any person to possess or consume the contents other than the patient • Illegal to transfer (other than caregiver to transfer to patient) • Poison Control Center telephone number • Telephone number to report adverse patient event

23. Quality • Goal to produce medicine that is consistent, batch to batch, lot to lot • Growers and processors encouraged to produce cannabis in a range of means and routes of administration • Growers and processors to produce plant varieties and products containing high CBD levels, in addition to other plants & products

24. Quality • Detailed written Standard Operating Procedures for all cultivation, processing and dispensing • Licensees will be required to follow S.O.P. as a condition of the license • Every batch of cannabis and every lot of cannabis-infused product must be uniquely identified and tracked at all production stages • Records of production must be retained to enable a review of all stages of production of every batch and lot • Licensee to systematically receive complaints

25. Quality • Strict horticultural controls set forth in regulations • Incoming materials must be segregated and inspected to prevent contamination • Every batch and lot must be analyzed by a registered, accredited Independent Testing Laboratory, which provides a certificate of analysis for every batch and lot

26. Quality • Every batch and lot must be analyzed and labeled with cannabinoid ingredients: • THC • THCA • CBD • CBDA • Certain terpenes • CBG • CBN

27. Quality • Prevention of contamination • Analysis must look for: • Heavy metals, mercury, lead, arsenic, cadmium • Foreign matter (insects, hair, other adulterants) • Microbiological impurity

28. Quality • Prevention of contamination • Analysis must detect and report any microbiological impurity: • Total aerobic microbial count (TAMC) • Total yeast mold count (TYMC) • Pseudomonas aeruginosa bacterium • Aspergillus spp. molds • Staphylococcus aureau bacterium • Aflatoxin B1, B2, G1 & G2 mycotoxins • Ochratoxin A toxin (produced by molds) • Pesticide residue

29. Quality • No batch or lot may be released unless it meets the specification set for it • Producers must do stability testing • Producers must retain samples sufficient for follow-up testing

30. Quality • Complaints, adverse events and recalls • All licensees and registered physicians must be prepared to receive, organize, record and respond to complaints and reports of adverse events • All substantive complaints and reports of serious adverse events must be investigated • If re-analysis reveals that the retention sample does not meet specification, producers must order a recall

31. Physician Registration • To issue “written certifications” to qualifying patients, physician registers at Commission website • No Registration fee • Registration valid for two years • No specialized or minimum additional training required • Attest that Maryland medical license is Active, Unrestricted, and In Good Standing • Is registered to prescribe Controlled Dangerous Substances in Maryland

32. Physician Registration • On Web form physician affirms to follow practice standards: • Will complete standard patient evaluation • History • Physical examination • Symptom review • Gather other pertinent information • Will assess patient outcome, provide follow-up care, and collect/analyze data

33. Physician Registration • Check off medical conditions for which physician might issue certifications for medical cannabis • Identify other patient inclusion criteria • Specify any reasons physician may deny issuing a certification to a patient

34. Physician Registration • Physicians encouraged to register to treat: • Chronic or debilitating disease or medical condition, or treatment, that causes: • Cachexia • Anorexia • Wasting Syndrome • Severe or chronic pain • Severe nausea • Seizures • Severe or persistent muscle spasm • Glaucoma • Post Traumatic Stress Disorder (PTSD)

35. Qualifying Patients • Patient must register with Commission before physician can issue written certification • Patient must • Live in Maryland; or • Be physically present in Maryland for the purpose of receiving medical care from a medical facility in Maryland • If younger than 18 years old, parent or guardian must be caregiver • No fee for patient unless patient desires ID card

36. Qualifying Patients • Physician and patient must have a “bona fide” relationship: • Treatment or counseling relationship • Physician has • Reviewed patient’s relevant medical records • Completed an in-person assessment of the patient’s medical history and current medical condition • Created and maintained records of patient condition in accord with medically accepted standards

37. Qualifying Patients Bona fide relationship (Continued) • Reasonable expectation physician will • Monitor patient progress while using medical cannabis • Take medically indicated action • To provide follow-up care • Regarding efficacy of medical cannabis as treatment • Report any adverse event associated with use of medical cannabis

38. Written Certification • Issue by logging onto commission website • Physician’s name, license number, telephone number • Patient’s name, DoB, address, county • Condition(s) requiring medical cannabis • Date patient is qualified • (Optional) Print out certification for patient use

39. Written Certification • Basic quantity limit of 30-day supply • 30-day supply defined as: • 120 grams of usable cannabis or • 36 grams of Delta9-THC in a medical cannabis infused product • Physician may authorize greater quantity on determination that those amounts inadequate to meet patient’s medical needs

40. Written Certification • Physician shall terminate certification if • Patient meets exclusion criteria • Treatment no longer medically necessary • Adverse effects outweigh medical benefits • Evidence patient is diverting cannabis • May terminate for abuse of any substance • Notify Commission of termination in one (1) business day

41. Written Certification • Patient may seek renewal not less than 30 calendar days after issuance • Physician may renew if • Patient is still registered • Bona fide physician-patient relationship still exists • Patient meets inclusion criteria • Patient does not meet exclusion criteria • Medical benefits likely outweigh health risks • Cannot renew without full in-person patient assessment within 365 days before renewal

42. Dispensaries • Dispensaries to be located throughout the state: • Up to two per each of 47 state senatorial districts • Up to 15 associated with licensed growers (not counted in senatorial district allocation)

43. Dispensaries • Extensive training of dispensary agents in: • Pharmacology of cannabis • Potential therapeutic and adverse effects of cannabis • Dosage forms and pharmacodynamics • Potential drug interactions • Recognition of symptoms of substance use disorders and acute intoxication

44. At Dispensary • Patient or caregiver goes to the dispensary, or contacts dispensary for delivery by dispensary • Patient or caregiver presents proof of identity • Dispensary logs onto Commission database to confirm validity of written certification and amount of Cannabis that can be dispensed • Patient consults trained dispensary agent on appropriate medication

45. At Dispensary • Before cannabis is dispensed, the patient must acknowledge that the patient is not immune from liability or prosecution for: • Operating a vehicle under the influence of medical cannabis • Smoking in a public place • Smoking in a motor vehicle • Acting under the influence in a manner that would constitute negligence or professional malpractice. • Smoking cannabis on private property where not allowed

46. At Dispensary • Patient also must acknowledge: • It is illegal to transfer the cannabis to any person • Obtaining medical cannabis does not exempt patient from prosecution under federal law • Scientific research has not established the safety of the use of medical cannabis by pregnant women • Use of medical cannabis to treat a medical condition is not approved by the U.S. FDA

47. Physician Protection • Federal law forbids cultivating, manufacturing, distributing, prescribing and possessing cannabis but… • Since 1996, states have been authorizing: • Physicians to recommend the medical use of cannabis to their patients • Patients to possess and use cannabis • Cultivation of cannabis by patients, collectives, licensees • Dispensaries to distribute cannabis to patients with recommendations

48. Physician Protection • Since 1996, 23 states and D.C. have enacted medical cannabis laws • Since 2010, these include AZ*, CT, DE, DC, IL, MA*, MD, MN, NH, NJ, NY (* by initiative) • In 19 years, Federal government has never sued a state to block its medical cannabis law

49. Physician Protection • Since 2009, U.S. Department of Justice has issued three memoranda that it will not prosecute physicians, patients, dispensaries and growers who comply with their state’s medical cannabis law • 2009 Ogden Memorandum (Oct. 19, 2009) • 2011 Cole Memorandum (June 29, 2011) • 2013 Cole Memorandum (Aug. 29, 2013) • Feb. 2014 – U.S. Treasury issued memorandum that said “financial institutions can provide services to marijuana-related businesses” operating under state law

50. Physician Protection • In 2014, Congress enacted a law barring the U.S. Department of Justice from interfering in the implementation of state medical cannabis laws (Section 538 of Continuing Appropriations Act of 2016, P.L. 114-53, sec. 103, 129 Stat. 502 (2015)) • Re-enacted on Dec. 18, 2015 for 2016 (Sec. 542 of P.L. 114-113) • In October 2015, interpreting that law, a Federal Court blocked U.S. Department of Justice from trying to stop a California dispensary from operating (U.S. v. Marin Alliance for Medical Marijuana, U.S.D.C., No. Dist. Cal., Case No. C-98-00086-CRB, Oct. 19, 2015)