Legislative Oversight Committee – Second Meeting Update

Aloha Alliance!

The second meeting of the Legislative Working Group tasked with improving the laws and regulations overseeing Hawai‘i’s medical marijuana industry came to a close today. In the audience were over a dozen members of the Hawai‘i Dispensary Alliance, representing every aspect of the industry. The Committee heard from Maui dispensary, Maui Wellness Group, about their progress, plans, and obstacles to development. The Department of Health gave a brief update on the status of the registry system and the dispensary system. And the meeting closed with audience questions and answers as the Committee begins to identify the topics it will focus its subcommittees on in the coming months.

The University of Hawai‘i Public Policy Center administers the operations of the working group and posts all documents generated by and for the committee to their website. If you would like to sign up for the working group’s email list, email your request to Act230wg@gmail.com.

This article will cover everything that happened in the meeting today in a detailed narrative, much like a Q&A, organized according to the meeting agenda. If you would like to watch the meeting yourself, it aired on Olelo Channel 55 at 1 pm, November 9, 2016, entitled Act 230 Working Group. If you have any questions about the meeting, or about how to get involved, email us at info@hawaiidispensaryalliance.orgo or find us on Facebook.

Introduction of New Members & Review of 10/12/2016 Minutes

The meeting began with a brief introduction of all of the committee members, including a few new names. The list of participants at today’s meeting and their affiliation include:

Present Panel Members

• Representative Della Au Belatti, Co-Chair
• Senator Rosalyn Baker, Co-Chair
• Representative Joy San Buenaventura
• Peggy Leong, Medical Marijuana Dispensary Licensing Program Supervisor
• Scottina Ruis, Medical Marijuana Registry Program Coordinator
• Keith Ridley, Hawai‘i Department of Health, Office of Healthcare Assurance
• Christopher Garth, Executive Director, Hawai‘i Dispensary Alliance
• Thayne Taylor, Neighboring County Member of the Hawai‘i Dispensary Alliance
• Carl Bergquist, Drug Policy Forum
• Wendy Gibson, Medical Cannabis Coalition of Hawai‘i
• Michael Takano, Pono Life Sciences, Maui CountyDispensary
• Richard Ha, Lau Ola, Hawai‘i County Dispensary
• Greg Yim, Doctor
• Stacy Kracher, APRN/RX
• Thomas Wills, University of Hawai‘i Cancer Center
• Calvin Tong, Honolulu Police Department
• Michael Contrades, Kauai Police Department
• Rob Lee, Department of Transportation, Airports Division

New Panel Members

• Jari Sugano – Guardian of a patient under 18
• Bill Jarvis – Patient
• Ally Park – Clinical Laboratories Hawaii (Pending Certified Laboratory Representative)

The working group is administered by Dr. Susan Chandler and the University of Hawai‘i Public Policy Center, with assistance from Center Director Collin Moore and Dr. Michelle Ibanez.

Dispensary Presentation: Maui Wellness Group, dba Maui Grown Therapies

The meeting began with a presentation from Maui Wellness Group, dba Maui Grown Therapies. Each of the dispensaries will presenting over the next few months to update the Committee about their progress, their contact with current patients, and any obstacles of general application that they are facing.

Maui Wellness Group was represented by Teri Freitas Gorman – Director of Community Affairs & Patient Affairs; Kalani Ho-Nikaido – Director of Administration; and Christopher Cole – Director of Product Management.

dba Maui Grown Therapies is a physician led, patient centered team of doctors, scientists, and agriculture specialists. Their motto, “By Maui, Of Maui, For Maui”.

They are led by:

• Co-Founder , Gregory Park, MD
• Co-Founder, David Cole
• Chief Medical Officer, Gregory Yim, MD
• Chief Science Officer, Andrew Weil, MD

With Executive Team:

• Kalani Ho-Nikaido Director of Administration
• Christopher Cole – Director of Product Management
• Teri Freitas Gorman – Director of Community Affairs & Patient Affairs
• Stephen Nikaido – Director of Production

And Science and Medical Advisory Board:

• Brian Becker, MD – Institutional Review Officer
• Julie Holland, MD – Psychopharmacologist and Psychiatrist
• Jeff McElroy, PhD – Chief Cultivation Advisor
• Michael Backes – Adviser on Curriculum and Training, Researcher, and Author of “The Cannabis Pharmacy”

Teri Gorman: Maui Grown Therapies is heavily focused on community education and engagement. Maui is a small community with deep ties to agriculture and within itself. There was immediate interest in the dispensary, and Maui Grown Therapies quickly began participating at job fairs, local events like the Annual Senior’s Fair, and answering questions. They also began meeting with local government and law enforcement officials. Through this process, Maui Grown Therapies learned that lots of seniors would like to use medical cannabis, but their living situation prevents them from growing it themselves. Maui Grown Therapies also started meeting with local doctors interested and/or concerned about the industry and spoke at IMUA Family Services for Children with Developmental Disorders. Maui Grown Therapies will be holding an physicians education session on Maui on January 25, with Dr. Weil entitled “An Introduction to Cannabis Therapy for Medical Professionals.” This event is for medical professionals and is invite only. The flyer will be posted to the Act 230 website.

Kalani Ho-Nikaido: Thank you Dept of Health and other state agencies for your efforts and cooperation over the last year.

• Maui Grown Therapies Milestones
• July 2015 – Assembled team, partnered with industry experts to create application
• May 2016 – Won the license, very proud 510 out of 520 points
• May 2016 – talked with DOH, let them know status
• June 2016 – DOH visited
• July 2016 – DOH visited for compliance inspection of building. The Narcotics Enforcement Division visited as well, they were the first to recieve NED certification
• August 2016 – Completed compliance inspection report
• August 2016 – Received Dept. of Ag to import production substrate
• December 2016 – Anticipated compliance inspection for dispensary and second production center

Challenges for the Industry

1. Implementation of Real Time Inventory Tracking System

DOH does not currently have a tracking system in place. Maui Grown Therapies has talked to 8 different states and learned that starting with a fully implemented tracking system prior to cultivation in infeasible. No other state succesfully did it, instead they have always a phased approach with intermediary steps to keep the industry moving and too allow dispensaries to start cultivation before the rest of the system was in place.

Illinois in particular is a similar scenario with a vertically integrated dispensary system using BioTrackTHC tracking software. During implementation they realized the stumbling block of full implementation before cultivation, but they were able to set-up remote access to cultivation sites to allow DOH access to dispensaries grow operations while DOH fully implemented the tracking system prior to sales.

After Maui Grown Therapies talked to BioTrackTHC – it is possible to implement a phased system in Hawaii – with the cultivation phase first to allowing growing. There is no transport, registry interface, or sales during the first four months of growing, which is time to implement the rest of the system.

This issue is pressing because it is the last clear hurdle to dispensaries being able to start growing and developing products for patients.

Dispensaries are looking at at least 4 months from the grow start date befor they will have a marketable product – best case scenarios – 112 days:

So if they start in Dec, they can open in March. If they start in January, they will open in April. If they can’t start until February, they will open in May, just in time to go through the annual licensing renewal process with DOH upon the anniversary of the license awards.

2. Banking System

This will only be an issue for the industry once the dispensaries start growing. So we have to solve the tracking issue first.

Questions from the Group:

Q. Bill Jarvis – What is the main barrier to implementation of tracking system?

A. Keith Ridley – We needed to renegotiate the contract. Now we are waiting for the original signed contract in the mail. Then the rest of the DOH contract process. But the contract for phasing as Maui wanted has been signed. After that, implementation.

Q. Carl Berquist – How are you working with the existing medical cannabis community? What about the prohibition on edibles and on interisland transport on your business and patients?

A. Teri Gorman – No database or patients yet, though we’ve heard their voice at local events. They want cannabis in non-smokable form.

A. Christopher Cole – Transport only hurts lab samples. There are three labs, one on Maui, so no issue for us

A. Ally Park – Clinical Labs will be certified by the end of the month, but chicken and egg with NED certification. Lab can transport between islands, don’t need to be denatured, can be packed on site and fedexed.

Q. Carl Berquist – What about travel between islands for patients?

A. Christopher Cole – Patients will have to buy on different islands when they travel

Q. Della Au Belatti – Slide with Maui Wellness Timeline. Please elaborate on August pre-compliance check from DOH

A. Kalani Ho-Nikado – The pre-compliance check looked at facility, Standard Operating Procedures, security for growing. Next check we will show them sales tracking and other requirements at the dispensary facility

Q. Della Au Belatti – Has the Fire Department been inspecting and involved?

A. Teri Gorman – We’ve talked to all levels of Fire Department. Police Department has visited to create action plans and inspect facility for safety concerns.

A. Kalani Ho-Nikaido – Fire Department has visited and inspected for safety and fire access. Currently re-permitting new systems or official fire approval at first center, should be done imminently. Still looking at longer term building permit for second production center.

Q. Stacy Kracher – Can we see the flyer for January Event for doctors and nurses?

A. Teri – Yes, it will be provided to the group.

Q. Buenaventura – Can you grow after the contract is signed?

A. Keith Ridley – After the contract is signed BioTrackTHC has to install first phase of tracking to allow for production. After we receive BioTrackTHC’s phasing and plan we will share it with the Working Group.

A. Kalani Ho-Nikaido – Implementation of grow side of BioTrackTHC will allow cultivation, but DOH will then have to implement the rest which may take time as well. We have research from other states – some don’t have integrated statewide system, some rely on dispensaries to submit to the state. Rhode Island changed their rules because it is a difficult task. We want to have traceability, control, visibility, and more. That research will be made available to the working group and public.

Q. Wendy Gibson – What kind of educational materials will you provide to patients. What training for staff in dispensaries?

A. Teri Gorman – Material is from our Science and Medical Advisory Board – it will be electronic and printed, distributed through the dispensary to qualified patients, and other interested parties. Training through our Board will be via compliance and medical expertise.

Q. Richard Ha – Can you describe what first phase production area is?

A. Kalani Ho-Nikaido – One production center ready for cultivation, approved by County of Maui, building permit pending for manufacturing activities.

Q. Jari Sugano – Community outreach program, any concerns from the community?

A. Teri Gorman – No concern yet, a little from a former judge, but when them walked through the program it alleviated their concerns. They mostly didn’t know that medical marijuana was a real thing for medical use. Only real concern is lack of knowledge in the population, on the other hand, we just received an invitation to speak at a youth drug and alcohol abuse conference on Maui later this month. The safeguards in place from DOH help alleviate fears.

DOH Monthly Update

After the Dispensary Presentation, DOH gave a monthly update on the progress of its Registry and Dispensary departments.

Patient Registry Program

Scottina Ruis: As of August 31, 2016,

• ~14,834 Patients – turnaround 15 days
• Data is limited on renewals, but about 60% are renewals, 30% are new each month
• Department is up 3,400 patients since January 1, 2015
• 16% of registered patients have no grow sites

Q. Stacy Kracher – Letters come back bearing Dr. address rather than APRN?

A. Scottina Ruis – We just added /APRN to anything that said physician. But we can address specific issues. So that is maybe why, I don’t know the difference between certified doctors and APRNs. Reports are run quarterly, so we won’t have data until January on how many APRN’s are providing certifications.

Patient Registry Program

Keith Ridley:
BioTrackTHC – We did receive indication that it is signed. Waiting on the original contract and signature. Going to run through the last of the DOH contract signing process before it is executed. Will walk it through the process because it is a priority. We have asked BioTrackTHC to provide us with a timeline for phases so dispensaries can cultivate as quickly as possible.

Testing Labs – We have received an application from PharmLab Hawaii, they are also going through their onsite ISO certification. They are prepared to work statewide, but are located on Maui. They will require an NED certification because of possessing and storing medical marijuana. In order to acquire testing products for calibration, that is being worked out between DOH and NED. Onsite visits from DOH Licensing and NED will happen as soon as their ISO certification is finalized. Should only take a week of inspections.

Q. Della Au Belatti – What is the status of DOH environmental health checklist?
A. Keith Ridley – We have the list of environmental requirements. We are asking the Deputy Attorney General to learn how far the 203 Exemption reaches, just the building or farther? We have the questions from the environmental health area ready to send out. The licensees have indicated they are in the middle of the building permit process and that process has engaged DOH in the environmental area to obtain similar information. The environmental parts of DOH are working directly with the Licensees. On the country permit level, DOH does not oversee that.

Q. Rosalyn Baker – So that being the case, you don’t need the opinion from the Attorney General?

A. Keith Ridley – No, we do not.

Q. Greg Yim – What about training time regarding the use of the tracking system?

A. Keith Ridley – BioTrackTHC will be conducting training for DOH, timeline will come from BioTrackTHC

Q. Joy San Buenaventura – Patients want to be able to use the labs?

A. Keith Ridley – Great question, we’ve been asked, but we don’t have an answer right now

Q. Carl Bergquist– Still true that one dispensary has no grow site visitation from DOH?

A. Keith Ridley– True, still not sure if we have visited

Q. Jari Sugano – Physicians are not knowledgeable and unwilling to certify, so patients are going through alternate physicians – paying the state fee and other fees. How difficult is it to navigate the online process?

A. Scottina Ruis – I’d like to believe it is very easy. We do walk physicians and staff through the process. It’s usually not an issue after learning the system. The system can verify active NED and Physician licenses to keep the system secure.

Q. Greg Yim – When the BioTrackTHC Contract is signed, when will the portal go live?

A. Keith Ridley – We won’t know until we receive the contract from BioTrackTHC

Q. Greg Yim – It is not that easy to wade through the DOH site?
Q. Della Au Belatti – Do you have Doctor designees to help work doctors through the system?
A. Scottina Ruis – We are still limited to just four bodies. We do have one person who usually walks physicians and staff through. The HIC agreement also allows them to provide technical support for lost passwords, etc… We have an online video and pdf to walk doctors and APRN’s through the process. We could maybe have group training for physicians?

Prioritization of Subcommittee Topics

After the Update from the Department of Health, the Committee reviewed its attempts to solidify topics for the creation of Subcommittees. A survey was sent out to obtain repsonses about prioritizing the 12 priorities identified at the last meeting.  18 of 28 members responded. They ranked the issues topped three issues 1 to 3. The results were reverse scored.

Three priorities were identified as most important, but because of the low response rate, the deadline will be extended for another week to gather Committee feedback on the priorities and Committee volunteers to staff and lead the subcommittees. The current priority categories favored by the group include: Education, Products, and Patient issues. The full list under consideration:

Patient Issues

• Speeding up/improving the patient application and certification process
• Prioritizing the most needy
• Reviewing and/or updating qualifying conditions
• Patient comfort & safety in the dispensaries (physical design)

Caregiver Issues

• Need to revisit/amend 2018 caregiver cultivation prohibition
• Understanding and developing recommendations around “card stacking”

Education

• Physician/APRN education
• Patient education
• Industry training for staff employed by dispensaries
• Education for law enforcement officers (i.e. drug-impaired driving, drug impairment training for educational professionals, training on current medical marijuana laws)
• Education clarifying what is or is not allowed (i.e. transport of marijuana in cars, airplanes, etc.)
• General public education
• Identify partnerships (i.e. the Cancer Consorium and medical associations) to encourage greater public education

Marketing and Advertising Issues

• Examine current law for standards and prohibitions against advertising
• Consider how statute may be changed to allow for advertising
• Review how advertising and mail through US Postal service is allowed for hemp products

Product

• Expanding products to include edibles
• Consider advertising and packaging concerns related to edibles
• Expanding sales to include seeds and clones
• Expanding products to include medical devices & other consumer products

Department of Health Organizational Issues

• Capacity
• Organizational structure
• Staffing, resources, and budget

Research Needs

• Medical and agricultural research
• Growing and processing
• Product research
• Gathering data from other states
• Social science research (understanding attitudes, beliefs, perceptions)
• Integrating/encouraging UH to engage in research

Labs

• Identifying best practices and testing standards adopted in other states
• Ensuring safety testing and certification consistency

Reciprocity

• Identifying issues for implementing reciprocity
• Recommendations for implementing reciprocity
• Education for tourists on law and regulations, what is and isn’t allowed (i.e. transport of medical marijuana in cars, airplanes, cruise ships, etc.)

Transportation/Accessibility Issues

• Delivery options for patients
• Interisland transportation of medical marijuana beyond limited lab exception
• Transporting medical marijuana via aircraft (DOT/Airports) or watercraft (DOT/Harbors) through areas under federal jurisdiction
• Address public safety and security concerns with increased usage of medical marijuana
• Identify safety initiatives for highways ie. increasing awareness of impaired driving — operating a vehicle under the influence of an intoxicant (OVUII) — or public education efforts to address safety concerns

Banking Options and Solutions

Dispensary License Issues

• Revisit horizontal vs. vertical production-distribution model
• As data is collected identify whether there is need to add licenses

Funding

• Tracking general fund and tax revenues from dispensaries
• Identifying funding for general public education
• Identifying funding for law enforcement training
• Funding to establish and run a state forensic toxicology lab and local lab

Q. Mike Takano – Education is top priority, can we add education to the HAR to allow dispensaries to provide education?

A. Susan Chandler – That is an issue for the SubCommittee

Identify Members & Set-up Process and Timelines for Subcommittees

The Chairs charged the Committee members with figuring out what Committees each wanted to be on, and to take a leadership role, offering volunteers to do so by email to the Chairs. Stacy Kracher did volunteer to head-up the Education subcommittee.

Public Input

Then the floor was opened for public questions:

Q. Paul Klink – Honolulu Wellness Center – for DOH, for the Doctor’s Hotline, it says DOH will get back to you as soon as humanely possible, but we’ve left messages, some as long as a month ago. Is there a better way to participate with you, email, volunteer?

A. Scottina Ruis –  The physicians hotline is to help physicians through the registration process. Public keeps calling, not physicians. Can’t give out the physician’s hotline number. If the physician identifies themselves as a physician and we can verify it, then we will call them back. We can talk on the side to figure it out.

Q. Paul Klink – Will the public be on subcommittees?

A. Della Au Belatti – Just the members of the Working Group

Q. From the Public – Need a fourth priority – testing facility, when more than one testing lab and I get one result and submit to another lab for another result – could be bad. All part of testing requirements, there has to be such that it covers all versions of THC. What are you really testing for – pesticides/heavy metals – are we doing percentages or absolute values. Who is establishing protocols for determining content of products because from different dispensaries.

A. Della Au Belatti: Please send questions and comments to Act230wg@gmail.com. One category we are looking at is labs, and it will address all of those issues

Q. Patients Without Time (Maui) – Clarification on the program – Some licensees are physicians working with the dispensaries. Under Federal Statute, Doctor’s can’t prescribe, 9^th Circuit Court said cannot be prosecuted for recommending medical marijuana provided not involved in distribution and sale. Recently upheld as well. Can Doctor’s now prescribe Schedule I substances? Patients Without of Time, we are filing Federal Complaint with Medical Board.

A. Della Au Belatti – This will be discussed by the Committee in the future. Physicians certify patients, they do not prescribe.

Q. Mae – Malie Cannabis Clinic – Timeline on the BioTrackTHC contract itself? Patients are anxious, counting on dispensaries.

A. Keith Ridley – BioTrackTHC has indicated they have signed the contract, we expect the original contract soon. Then some back-end processes to finalize the execution, hopefully by the end of next week.

Q. Patient – Patient registry software is not intuitive and not efficient. Have to submit materials more than once, Doctor’s tack on fees. Doctor’s say that patients have to walk through the application process because it is difficult. PharmLab is a testing facility?

A. Keith Ridley – Only one application has been submitted for a testing lab

Q. Alan – Drug Free Hawaii – Important to have protections for youth and pregnant women and drugged driving. Should be done through education and administrative rules. Could cap THC levels?

A. Della Au Belatti – Thank you

Q. Andy – Lab testing, Richard Ha mentioned the importance of testing, content is important, but safety side is most important.

A. Della Au Belatti – Thank you

Next Steps and Announcements

Announcement: To get on the email list, go to Act230wg@gmail.com to get all updates also on the website.

Rosalyn Baker – The Executive Officer staffing the Board of Medicine is here. There are Federal Model Guidelines for the Recommendation of Medical Cannabis. This policy will be taken up at a December meeting of Hawaii Medical Board which is a member of the Federal Board. Doctor’s involved in dispensaries cannot certify patients, even just submitting the application, they gave up that privilege.

Next meeting: December 14 @ 1:00 pm, Conference Room 325.

Wendy Gibson – First CEU course for Nurses is being offered. Sign up!

The strength of this working group is bringing and sharing our resources. Funnel the information through the Chairs.

Conclusion

Now it is your turn! The Legislative Oversight Committee will generate the successful legislative and administrative progress the industry needs in the coming years, and this is your opportunity to guide our hand. The Alliance leadership wants to solicit your thoughts, comments, and detailed considerations for any and all of these committee priorities that you would like to see action or deliberation on. What did we miss? What do you think we should emphasize? Your suggestions will be incorporated into the Alliance’s approach to the issues before the Legislative Oversight Committee.

We want to know what you think! Email us at info@hawaiidispensaryalliance.org if you have any suggestions or comments, find us on Facebook, Contact Us through this website, or give us a call anytime. You are invited to be as broad or specific with your submissions as possible.

Mahalo nui for your continued support as we build a better future for Hawai‘i’s legitimate cannabis industry!

It is the Alliance’s mission to provide up-to-date and relevant industry information to the patients, dispensary applicants, and related businesses of Hawai‘i’s growing medicinal cannabis industry. If you are not yet an Alliance member, join today to receive the HDA Industry Update every month and to take an active role in the future of Hawai‘i’s medical marijuana industry. Contact us today and we will send you the September/October 2016 edition of the HDA Industry Update absolutely free to say thank you for your interest!