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

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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 protections or medicinal cannabis access for visitors to Ohio. • Ohio’s nationally recognized institutions such as the Cleveland Clinic, the James Cancer Hospital and Solove Research Institute, and the University of Cincinnati draw qualifying patients and cardholders from around the country. • Without recognition and acceptance of nonresident cardholders, HB 523 would require qualifying patients who travel to Ohio to specifically break state and federal law by bringing medicinal cannabis across state borders. 17 Lack of patient reciprocity • Instead, Ohio’s statute should provide for patient reciprocity to afford visiting patients protection under Ohio’s law and access to medicinal cannabis at Ohio dispensaries. • Ohio would not be innovating in this way, as the practice is statutorily provided for in states like Nevada. See Nev. Rev. Stat. Ann. § 453A.364. • A suggested provision has been attached as Exhibit B.

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THC minimum and maximum thresholds • Multiple state legislatures, and policy experts across the country, have considered the question of whether to limit the minimum and maximum THC content across different treatment modalities. • From a scientific and treatment stand point, the percentage of THC in whole plant or dried flower is entirely different than that of concentrates. Less than 30% for the concentrate has virtually no therapeutic value, and the same can be said at about 12% for the whole plant or dried flower. See https://www.colorado.gov/pacific/sites/default/files/MED%20E quivalency_Final%2008102015.pdf.

19 THC minimum and maximum thresholds • Generally, the answer has been that maximum limits unnecessarily constrain physician autonomy and patient access, while potentially impeding scientific research. • Most scientists, doctors, and legislators have agreed at this point that limiting the THC content is unwise as more research needs to be done, and there is no threat of overdose. • No state has legislated any maximum limitation for THC content in the dried flower or plant material by percentage of dry weight.

20 THC minimum and maximum thresholds • Legislation in Colorado attempting to limit both plant and marijuana-derived products recently failed. • New Mexico limits concentrates to seventy percent (70%) by weight in its regulations. See N.M. Admin. Code 7.34.4. • Recently, Washington state has introduced some statutory legislation to limit the maximum THC in concentrates to sixty percent (60%) THC by weight, but it has not yet passed. See 2015 Washington Senate Bill No. 5052, Washington Sixty-Fourth Legislature.

21 THC minimum and maximum thresholds • Should Ohio greatly desire to statutorily innovate in this way, for both plant material and dried flower, in addition to concentrates, it should do so cautiously. • A suggested provision has been attached as Exhibit C. • Furthermore, some states have effectively determined milligram dosing limitations for THC content in edible products.

22 THC minimum and maximum thresholds • A suggested provision, utilized by other states to control dosing, could be drafted in this way: – Milligram Dosing Limitations Of THC In Edible Products • Pursuant to the limitations for minimum and maximum percentages by weight for THC content of marijuana- derived products, edible delivery forms must not exceed ten (10) milligrams of active THC in a single serving, and no more than ten (10) servings, or one hundred (100) milligrams, of active THC in a single edible unit.

23 THC minimum and maximum thresholds • The minimum THC content is an easier question because anything under three-tenths of one percent (0.3%) THC by percentage of weight is scientifically classified as hemp and not cannabis. • Almost every statute that seeks to exclude hemp has this designation.

24 Combustion vs. Vaporization • An interesting policy question around the country has surfaced as part of the larger discussion related to the allowance for treatment modalities utilizing whole plant or dried flower materials. • States such as New York have seen their program languish on the verge of collapse due to limited qualifying conditions and prohibition of whole plant or dried flower materials.

25 Combustion vs. Vaporization • Recently, Pennsylvania has attempted to legislate against “smoking” medicinal cannabis. See 2015 Pennsylvania Senate Bill No. 3, Pennsylvania One Hundred Ninety-Ninth General Assembly - 2015- 2016. • The following chart demonstrates the varying treatment options scientifically demonstrated at specific heat indexes. See ArcView Market Research and New Frontier Data, The State of Legal Marijuana Markets, 4th Edition, April, 2016. 26 Combustion vs. Vaporization

27 Combustion vs. Vaporization • Should Ohio so choose, it is possible to allow for whole plant or dried flower materials, while limiting its inhalation to vaporization. • Suggested draft language could be utilized: – For purposes of inhalation, the heating of whole-plant materials, dried flowers, extracts, oils, or concentrations to the point of combustion (temperatures of over 450 degrees Fahrenheit) will be neither authorized by this statute, nor statutorily protected from criminal or civil penalties. Therefore, for purposes of inhalation, only vaporization, or its equivalent, will be authorized under this statute.

28 Thank You For Your Time And Consideration • Ohioans and their electorate have the advantage of applying the collective wisdom of the effective, robust regulatory schemes of our sister States who have carried the burden as laboratories of democracy. • We do not have to reinvent the wheel in devising our own solutions to legalized medicinal cannabis, but we would benefit from legislating that solution rather than having it thrust upon us at the ballot. • I am grateful for the opportunity to testify, and am available to answer any questions.

29 THANK YOU Ted Bibart Benesch, Friedlander, Coplan & Aronoff LLP 41 S. High Street, Suite 2600 Columbus, Ohio 43215 Telephone: (614) 223-9372 Facsimile: (614) 223-9330 http://www.beneschlaw.com/jbibart/ E-mail: [email protected]

The content of this presentation is for general information purposes only. It does not constitute legal advice or create an attorney-client relationship. ©2016 Benesch, Friedlander, Coplan & Aronoff LLP. All rights reserved. James Bibart: (614) 223-9372 – [email protected]

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