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Before the Ohio Senate Government Oversight and Reform Committee - Interested Party Testimony Regarding House Bill No

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Before the Ohio Senate Government Oversight and Reform Committee - Interested Party Testimony Regarding House Bill No Before The Ohio Senate Government Oversight and Reform Committee - Interested Party Testimony Regarding House Bill No. 523 In View Of Other State Regulatory Approaches To Medicinal Cannabis by Ted Bibart, Legislative Analyst Benesch, Friedlander, Coplan, & Aronoff LLP Introduction and Objectives • As a Legislative Analyst I am tasked with analyzing complex statutory and regulatory schemes to determine application, compliance, and public policy significance. • I am not yet licensed to practice law in the state of Ohio, and sit for the Ohio bar examination this July. • Benesch is not actively lobbying for anyone on the issue of medicinal cannabis in Ohio. • Instead, I offer “interested party” testimony regarding the House Bill No. 523 (HB 523) and comparative state statutory and regulatory approaches to the implementation of legalized medicinal cannabis. 2 Evaluation Criteria • Federal Harmony – The given state’s statutes and regulations are viewed in the light of federal prohibition and the corresponding tension presented by Department of Justice (“DOJ”) guidance, and historic trends. • Patient Access – The state’s statutory and regulatory scheme is then evaluated for its functional distribution of medicinal cannabis to patients in need. • Viability – The statutes and regulations are then appraised for their effective creation, implementation, and regulation of the long-term market infrastructure necessary to produce and sustain a workable program. 3 Federal Harmony • The relevant historical trend is evident in the trilogy of guidance issued by the DOJ, starting with the memorandum authored by Deputy Attorney General David W. Ogden on October 19, 2009 (the “Ogden Memo”). – Here, the Ogden Memo provides clarification and guidance to federal prosecutors in States that have some form of legalized cannabis use advising against enforcement of federal prohibition as an inefficient use of limited federal resources. • On June 29, 2011, Deputy Attorney General James M. Cole drafted a memorandum (the “Cole Memo I”) that effectively restricted the Ogden Memo’s scope, while not superseding its intent. – Here, the DOJ instructs federal prosecutors that while the Ogden Memo speaks primarily to protections of legitimate patients, large scale cannabis businesses in “legal” States should not be afforded blanket protections under state law, and broad discretion is granted by the DOJ for federal enforcement of the Controlled Substances Act (“CSA”). 4 Federal Harmony • The most recent DOJ federal guidance addressing the tension between state sovereignty in legalizing medicinal cannabis use and federal prohibition was issued by Deputy Attorney General Cole on August 29, 2013 (the “Cole Memo II”). – Here, the DOJ provides definitive guidance to the broader tensions illuminated by Cole Memo I relating to the proliferation of legal state markets and regulatory schemes supporting patients in need and a flourishing medicinal cannabis industry. – The DOJ professed its commitment “to using its limited investigative and prosecutorial resources to address the most significant threats in the most effective, consistent, and rational way.” – In acknowledgement of the traditional federal-state approach to drug enforcement, deference will be given to state regulatory schemes that “contain robust controls and procedures” which are “effective in practice.” 5 Federal Harmony • So, the Cole Memo II provided eight “enforcement priorities” affording notice to States in devising a proper robust regulatory scheme to ensure stability in administration of legal cannabis markets and federal harmony. 1. Preventing the distribution of marijuana to minors; 2. Preventing revenue from the sale of marijuana from going to criminal enterprises, gangs, and cartels; 3. Preventing the diversion of marijuana from States where it is legal under state law in some form to other States; 4. Preventing state-authorized marijuana activity from being used as a cover or pretext for the trafficking of other illegal drugs or other illegal activity; 5. Preventing violence and the use of firearms in the cultivation and distribution of marijuana; 6. Preventing drugged driving and the exacerbation of other adverse public health consequences associated with marijuana use; 7. Preventing the growing of marijuana on public lands and the attendant public safety and environmental dangers posed by marijuana production on public lands; and 8. Preventing marijuana possession or use on federal property. 6 Federal Harmony • Therefore, Federal Harmony analysis of state regulatory schemes focuses on compliance with the eight enforcement priorities manifesting robust controls and procedures which are effective in practice. 7 Patient Access • Effectiveness in practice must not only be measured in compliance with the eight enforcement priorities, but in fulfilling the legislative intent of ensuring qualifying patients have adequate access to approved treatments. • Factors include: (1) patient and provider protections; (2) physician autonomy and oversight; (3) qualifying conditions and approval; (4) therapeutic treatment options; (5) supply chain logistics and infrastructure; and (6) market data analytics. • Therefore, Patient Access analysis of a state regulatory scheme values proven solutions to legalized medicinal cannabis that are effective in practice, not just on paper. 8 Viability • A state’s robust regulatory scheme must not only promote Federal Harmony and Patient Access, but must also provide the clarity and security necessary to nurture industry investment in creation of a sustainable market infrastructure to meet adequate patient demand. • Factors include: (1) balance of Federal Harmony and Patient Access; (2) barriers to entry; (3) licensing structure and cost; (4) fixed limitations to supply and dispensation; (5) operating procedures; (6) laboratory testing; (7) product safety; and (8) market data analytics. • Therefore, Viability analysis of state regulatory schemes takes a holistic approach to ensuring legislative solutions to legalized medicinal cannabis create a stable environment for the growth of effective markets to serve qualifying patients in the delicate balance of federalism. 9 Some Particular Issues Presented In Substitute HB 523 • Impairment • Testing requirements and • Physician “written metabolite levels do not specify recommendation” vs. “de facto only those enzymes which prescription” produce intoxication • Department oversight • Accessibility for cardholders who • live in "opt-out" areas or in rural Commission inclusiveness and areas without participating expertise physicians • Physician reporting requirements • No regulation for safe disposal for • Physician registration vs. excess or contaminated product application • No regulation for security at • Confidentiality and privacy of cultivation, processing, or registry to protect patients and dispensary sites practitioner • Lack of administrative hearings • Specification of amount a for licensing denial or revocation cardholder may possess at one • Vaporization vs. Combustion time 10 Topics To Be Addressed • Impairment • Physician “written recommendation” vs. “de facto prescription” • Department oversight –Reporting redundancy 11 Impairment • House Bill 523 does not address impairment directly, but does address the rebuttable presumption of impairment for Workers’ Compensation cases under O.R.C. 4123.54. • The statute maintains the terminology for qualified chemical testing for “cannabinoids” in the employee’s urine. See HB 523 page 48, line 1426 and 1442. • The term “cannabinoid” does not specify the psychoactive component in marijuana, THC (delta-9-tetrahydrocannabinol), and therefore in no way measures impairment. • In fact, a urine screening also detects the non-psychoactive marijuana metabolite THC-COOH, which can linger in the body for days and weeks with no impairing effects. 12 Impairment • States have devised common sense, and scientifically based approaches to the impairment question. • Arizona provides, per A.R.S 36-2802, “Operating, navigating or being in actual physical control of any motor vehicle, aircraft or motorboat while under the influence of marijuana, except that a registered qualifying patient shall not be considered to be under the influence of marijuana solely because of the presence of metabolites or components of marijuana that appear in insufficient concentration to cause impairment.” • In State ex rel. Montgomery v. Harris, 234 Ariz. 343, 344, 322 P.3d 160, 161 (2014), the Arizona Supreme Court decided that the State’s regulatory scheme sought “to prevent and punish impaired driving, not simply driving while having a non-impairing metabolite in one's system.” 13 Impairment • The court, in keeping with the legislative intent, articulated the perverse result of holding otherwise: • “Because Carboxy–THC can remain in the body for as many as twenty-eight to thirty days after ingestion, the State's position suggests that a medical- marijuana user could face prosecution for driving any time nearly a month after they had legally ingested marijuana. Such a prohibition would apply even when the driver had no impairing substance in his or her body and notwithstanding the State's ability to test both for THC, the primary substance that causes impairment, and Hydroxy–THC, the metabolite capable of causing impairment.” • In Dobson v. McClennen, 238 Ariz. 389, 361 P.3d 374, 378 (2015), the Arizona Supreme Court decided it was the qualifying patient’s burden “to prove, by a preponderance, that the marijuana concentration
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