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Before the Ohio House of Representatives Select Committee on Medical Marijuana - Interested Party Testimony Regarding House Bill No

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Before the Ohio House of Representatives Select Committee on Medical Marijuana - Interested Party Testimony Regarding House Bill No Before The Ohio House Of Representatives Select Committee on Medical Marijuana - 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 proposed 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 HB 523 • Licensing Structure enzymes which produce intoxication • Excise Tax • Accessibility for low income • No statutory protection of qualifying cardholders conditions • Accessibility for cardholders who live • No statutory protection for in "opt-out" areas or in rural areas treatment modalities without participating physicians • No safe harbor for professionals (i.e. • No regulation for safe disposal for attorneys, CPA’s, etc.) excess or contaminated product • Physician registration vs. application • No regulation for security at • cultivation, processing, or dispensary Lack of caregiver protections sites • Lack of patient reciprocity • Lack of administrative hearings for • Confidentiality and privacy of licensing denial or revocation registry to protect patients and • practitioner Pharmacy Board control • • Specification of amount a cardholder Commission inclusiveness and may possess at one time expertise • Whole plant and dried flower access • Testing requirements and metabolite levels do not specify only those 10 Topics To Be Addressed • No statutory protection of qualifying medical conditions • No statutory protection for treatment modalities • Lack of patient reciprocity • THC minimum and maximum thresholds • Combustion vs. Vaporization 11 No statutory protection for qualifying medical conditions • As presently drafted in Sec. 3796.07, it is entirely up to the Commission to decide which medical conditions would qualify for patient access. • This does not provide statutory protection for certain conditions or symptomology, thereby providing no assurances to patients that the legislative process will meet their needs. 12 No statutory protection for qualifying medical conditions • Instead, a list of qualifying medical conditions should be provided, which the Commission may add to and not subtract. • The statutory language listing specific conditions, while creating broad physician autonomy, has been successfully utilized by many states including: – Maryland, see Md. Code Ann., Health-Gen. § 13-3304 – Arizona, see Ariz. Rev. Stat. Ann. § 36-2801 – Nevada, see Nev. Rev. Stat. Ann. § 453A.050 13 No statutory protection for qualifying medical conditions • Statutory language for Ohio does not need to be innovative, rather it should rely on the drafting of states with successful robust controls, like Arizona, Nevada, and the soon to be implemented Maryland statute. • A suggested provision has been attached as Exhibit A. 14 No statutory protection for treatment modalities • As presently drafted in Sec. 3796.06, it is entirely up to the Commission to decide which treatment modalities would be available to qualifying patients. • The present language states the Commission “may include edibles, patches, plant materials, and oils.” 15 No statutory protection for treatment modalities • This does not provide statutory protection for certain treatment modalities, thereby providing no assurances to patients that the legislative process will meet their needs. • Instead, the list provided should be preceded by “shall” instead of “may” to ensure the Commission does not limit the treatment options available to physicians and patients. The Commission should be permitted to add to list, and not subtract. 16 Lack of patient reciprocity • HB 523 does not provide for patient
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