Aloha Alliance!
The July meeting of the Act 230 Legislative Working Group tasked with improving the laws and regulations overseeing Hawai‘i’s medical cannabis industry came to a close yesterday, on July 19, 2017. In the audience were almost a dozen members of the Hawai‘i Dispensary Alliance, representing every aspect of the industry. The Committee heard from Big Island dispensary Hawaiian Ethos (Hawai‘i County) about their progress and plans. The Department of Health gave a brief update on the status of the registry system, the dispensary system and laboratory certification. Co-Chair Representative Della Au Belatti provided a brief overview of the legislation from the 2017 session. The various subcommittees self-organized to determine work directions for the summer, and the meeting closed with audience questions and answers expressing the public’s growing concern about the increasing delays in the program.
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. The notes are not verbatim, but as close as our notes will allow. This meeting was broadcast on Olelo, Channel 49, starting at 2:00 pm. Additional airings of the broadcast will be on Olelo 49 at the following times:
- 6:00 pm on July 27, 2017
- 10:00 pm on July 29, 2017
- 8:00 am on July 31, 2017
- 1:30 pm on August 8, 2017
If you have any questions about the meeting, or about how to get involved in the industry, email the Hawai‘i Dispensary Alliance at info@hawaiidispensaryalliance.org or find us on Facebook.
Panel Members Present and Review of June/July Meeting Minutes
The meeting began with a brief introduction of all of the committee members. 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
- Senator Will Espero
- 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
- Carl Bergquist, Drug Policy Forum
- Wendy Gibson, Medical Cannabis Coalition of Hawai‘i
- Michael Takano, Pono Life Sciences, Maui County Dispensary
- Richard Ha, Lau Ola, Hawai‘i County Dispensary
- Karen Kahikina, Department of Transportation, Airports Division
- Rob Lee – Department of Transportation, Airports Division
- Jari Sugano – Guardian of a Patient under 18
- John Paul Bingham – CTAHR
- Greg Yim – Physician
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, Dr. Michelle Ibanez, and Joy Agner, policy assistant. A guest moderator, Jose Barzola from the Public Policy Center, managed the July meeting in place of Dr. Chandler who is on sabbatical.
A review of the minutes from the previous meeting was postponed to the next meeting.
Representative Della Au Belatti gave a brief overview of the three medical cannabis bills signed into law by Governor Ige from the 2017 session.
- HB1501 – Joy San Buenaventura’s bill to decriminalize paraphernalia possession by replacing criminal penalties with a civil fine.
- HB1488 – The omnibus bill that included new patient plant count and condition provisions, allowed for inter-island transportation for testing purposes, expanded the plant count and retail location count for current dispensaries, and postponed the introduction of new licenses.
- SB786 – Because language matters, all government references to “marijuana” will now be replaced by the more clinically appropriate term “cannabis.” Thus the Working Group is now the Medical Cannabis Oversight Working Committee
Dispensary Presentation: Hawaiian Ethos
The meeting then shifted to a presentation from Big Island dispensary Hawaiian Ethos (Hawai‘i County), one of two Big Island dispensaries. Each of the dispensaries will be 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.
Hawaiian Ethos was represented by new CEO Bill Richardson.
Presentation and Notes:
Bill Richardson: First, I want to applaud my group, this is something we are building from scratch, and we have encountered a lot of problems along the way. We anticipated some, but not all of them, and I am glad to be part of such a great group.
We are one of two awardees on the Big Island.
Our Team
Chris Whidden – President
Vernon Oi – Co-Founder, Chief Science Officer
Diana Hahn – Dispensary Operations Manager
Noah Philips – Chief Compliance Officer
Kris Jacobson – Cultivation Facility Manager
Bob Shaffer – Master Cultivator
Zachary Taffany – Chief Operating Officer
Timeline
We just completed pouring the slab for our production facility.
- We plan on completing the preparation in August 2017.
- The construction of the building and the warehouse shell in September.
- Building out and setting up the grow rooms in October.
- Installing the production equipment in November.
- First dispensary open in December
This is optimistic.
We will put dispensaries in both major population centers – one in Hilo, one in Kona. Because of the size of the island, it would be good to get a third, maybe in Waimea or in Ka‘u.
Education and Resources
We have developed an extensive website – www.hawiianethos.com
We are working on developing educational support services for dispensary employees and we have created a tutorial for those working with patients in dispensaries. We are willing to share these with the other dispensaries.
The holy grail is research and the ability to target specific dosages for patients.
Diverse Products
Because of the extra time we have had without plant growing material – we have through other sources procured some chemical work and we’ve been developing products and packaging for our products. We plant to sell 50% derivative products and 50% flower because non-smoking products are probably safer.
Our target retail pricing – $250 oz, $15 gram
We want to keep pricing in range of the black market to better serve patients and because we realize that approximately 80% of our sales will be resold.
We will have a higher quality and it will be grown indoors so we hope patients will prefer us, but we still need to have prices close to what is currently available on the black market.
Our mission is to provide Hawai‘i island with safe and reliable access to cannabis medicine through evidence –based treatment choices.
Questions & Answers
Q. Sen. Rosalyn Baker – You teased us with research, can you talk about things you want to research?
A. Richardson – I can give you the short answer, Chris Whidden is leading the research effort. In short, we are looking at derivatives and methodologies for the application of products.
A. Chris Whidden – The lead-up time to opening the dispensary, the bureaucracy, left us lots of time to think what we want to release and how to package it. I can’t say too much about specifics. Some development will be about how different products impact the variety of different types of patients. Lots of patients will use traditional methods, but we want to address patients looking for more sophisticated delivery methods. It is quite conceptional, we don’t want to jump the gun, but we are using our time to optimize products for all patients.
A. Richardson – One of the holy grails is specific dosing requirements. And that ties into the software products we are building that creates an interactive methodology. Interacting with patients, doctors, and dispensaries.
Q. Sen. Baker – Have you been able to learn from other states and places overseas?
A. Whidden – Yes, Israel is a research center, the U.S. is a little behind right now. The U.S. is just trying to catch up, but the DEA has restricted research. We are looking to the research that is there. The time cannabis spent as schedule 1 substance has limited the research. At a recent conference, one researcher said we know more about tomatoes than cannabis. That is where we are at.
A. Richardson – It has been a rather frustrating effort for us. I came from the University – and now I’m trying to work with UH Hilo, but there is a roadblock there because of the fear of federal intervention. Same complaint as when I was working at UH, the Office of the General Counsel is a little over zealous.
Q. Greg Yim – You mentioned that there is a huge black market problem ,what are your challenges, what are you doing?
A. Richardson – It is the worst kept secret – but we will initially be selling to resellers – as much as 80%. We are not trying to disrupt that economy. We don’t want to put people out of work and cause other social problems. We want to keep our prices close to black market sales so we don’t disrupt the economy.
A. Richard Ha, Lau Ola (Big Island Dispensary) – Really large is a good description.
Q. Greg Yim – Is that lower pricing you are aiming for realistic? Is it sustainable?
A. Richardson – We can’t predict the future.
A. Whidden – Current models for all cannabis markets are looking at a slow migration to something like a commodities market. As rules loosen and descheduling occurs in the future it will lower prices – even in the black market, which will help in controlling the unsavory aspects of society. We will contribute to this. We don’t want the dispensaries just dedicated to the affluent group, but that the principles of free access and educational access must include medicine everyone can afford.
Q. Greg Yim – Without the black market, what would you price cannabis at?
A. Whidden – Our slide is our target. It is on par with the black market. If the black market can go cheaper, then people will turn to the black market. These are all things we know. But it comes down to economics. Should patients put themselves or health in danger for a $25 discount? We hope not, we are trying to optimize for that.
Q. Carl Bergquist, Drug Policy Forum – You alluded to the need for a third licensee or retail location on Big Island. The recent law (HB 1488) allows for transportation assistance for patients. Are you working with that issue? Are their transportation companies? Second question – Edibles – Lots of places on the mainland saw sales generally turn to edibles. Once they are allowed, will you be able to shift production.
A. Richardson – Given size of production facility, we will be able to shift gears as regulations come down. I am not personally a fan of edibles because they can be dangerous. People eat too much or children may get a hold of them. I leave it up to the Legislature.
Regarding your first question, we don’t have an answer. But we would love to have, in cooperation with Richard, a dispensary in Waimea to help get medicine closer to users. We had an interesting discussion yesterday with security officers at hotels – they are getting lots of tourist questions – but there is no answer right now. It will be a hot topic once reciprocity is allowed.
Q. Sen. Baker – Do we need another dispensary? HB 1488 gave the Department the ability to look at opening another location for each of the current licensees.
A. Keith Ridley, DOH – That is correct, we can look at helping you accomplish that.
A. Richardson – We will definitely look at that.
A. Sen. Baker – The Maui dispensaries should look at this too.
Q. Christopher Garth, Hawai‘i Dispensary Alliance – Regarding education programs, have you had good results in reaching out to the community?
A. Richardson – I can’t respond directly to that. Most of our education has been directed towards our internal workers. A lot of information that people get is anecdotal, so we want to make sure the workers have the tools they need to help those who walk in.
A. Zachary Taffany, Hawaiian Ethos, COO – We also have a physician outreach program. When patients are going to their physicians, we are providing pamphlets to physicians on how to got through their response and the process. Of the doctors we have contacted, 20% were open and 10% of physicians were not interested.
Q. Christopher Garth – How do we encourage professional outreach?
A. Richardson – I come from a family of doctors. A lot of my relatives are opposed to cannabis, probably from their training in medical school. That is why we are putting our effort into statistical models to provide physicians with information on how to best use cannabis to help patients. But it takes time.
Q. Christopher Garth – That goes back to what you said about there being very little research.
A. Taffany – Speaking to the local industry – A public information campaign is desperately needed, but it may not be best coming from us [the dispensaries]. But we are happy to support it.
Q. Sen. Baker – Physicians don’t prescribe; they certify. So for someone new to the use of cannabis, is there something you are going to do to help steer people to appropriate dosages, uses, frequency?
A. Richardson – That is the holy grail and primary focus of our efforts.
A. Taffany – It has to do with the nature of the industry – bringing shadows into the light. We are doing well with cannabis counselor training, but it is not a long term solution. We are working on a website to allow confidential consultations.
Q. Senator William Espero – Reciprocity is January 2018 at the earliest. Keith Ridley is that correct?
A. Ridley – That is what the law says.
A. Sen. Espero – But not until then.
A. Richardson – We need them to be legitimate patients.
Q. Representative Della Au Belatti – Can you accommodate the new 5000 plant production center limits (from HB1488)?
A. Richardson – Our facility is large enough.
Q. Rep. Belatti – Have you talked with DOH about that?
A. Richardson – We will.
A. Rep. Belatti – Please do.
Q. Rep. Belatti – Do you share the same recommendations from Manoa Botanicals’ presentation about the THC limits being too restrictive?
A. Whidden – It is a complicated idea. Lots of patients benefit from cannabis in different ways. Lots of people are well served with below 100 mg of THC, but it still leaves some people out. We know some whose need is higher – 1000 mg of THC a day for their conditions. They can take a lot of the small doses, but it is an expensive challenge to serve them that way under the current restrictions. I agree that thinking of those individuals would be a great thing for the Legislature to do.
Q. Rep. Belatti – Please clarify. You said there is an understanding that there will be a lot of reselling – shouldn’t the product being going straight from you to the patients?
A. Richardson – That is our goal. But we can’t control it once it leaves our premises.
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:
Please check the DOH website – Patient counts are updated monthly.
I have information here from the 2nd quarter report from the end of June:
- 17,500 patients
- 1,300 caregivers
- There was a 3% increase in patients from May, the month before
- Demographic data is included in the report
Current turn around time is for patient certification for a 329 card is about five business days. We are improving.
Q. Bergquist – In that report I see an increase in new patients with a new distribution – most of the growth is on Oahu. I don’t know why that is the case, can you look at the trends, are they people registering plants, changes in conditions, what is the increase from? Is it from patients anticipating dispensaries?
A. Scottina Ruis, DOH – I don’t have that data broken down. But we do know that with the largest population of people on Oahu, we knew we would see larger growth here. We do know that most if not all patients register a grow site so that they are not in violation of the law if they are caught with a plant. We will want to continue to monitor that and see how it continues to grow as we study the trends.
As far as the cross-section of conditions, the only condition that has changed proportionately to the other conditions is PTSD which has seen real growth, but otherwise the proportions remain the same across the conditions.
Q. Michael Takano, Pono Life Sciences Maui – Looking over the qualifying conditions – there are symptoms and diagnosis lumped together? Is this confusing for patients and physicians, have you gotten any feedback?
A. Ruis – With this last legislative session, they pulled out two conditions – multiple sclerosis and epilepsy. They were pulled out as an individual diagnosis, not as symptoms. We haven’t heard feedback about confusion along those lines however.
Q. Rep. Belatti – We know that reciprocity is coming down the road. Do you have any recommendations from a departmental perspective to identify those patients and facilitate that program?
A. Ruis – Off the cuff – We will begin looking at it in 2018. Reciprocity patients need verification and registration. They would have to present validation of true registration in another state, then we will need another new process to register them into our system. That sounds good but the time piece of the verification is hard. If another state calls us, that information is confidential – same for other states. So how are we really going to validate from 29 different states. There is no way to validate on the spot with our limited staff. The other issue is conditions in other states – some are more stringent, some are broader, and a handful are similar. It will be challenging to give patients with conditions we don’t recognize access to cannabis without giving our own Hawai‘i patients the same access.
Q. Rep. Belatti – Understanding that you are under staffed, can we look at dispensaries doing the verification process for DOH so we don’t overtax DOH?
A. Ruis – That five day turn around , really three to five, is what we are steady at right now. As the volume increases and the staff doesn’t, then there is the potential for delays. We are at a good place, we want to see a great boom, but we have to prepare for it at DOH to keep up with demand.
Q. Sen. Baker – Follow-up question – electronic health records. Does the software system the dispensaries are using, does it have a functionality that it could be part of the verification/tracking system for DOH?
A. Ridley – We know the BioTracTHC system could run a registry like system. We haven’t explored it, but we could.
A. Sen. Baker – It seems the only way is to plug in at some point.
Q. Greg Yim – If physicians elsewhere are certifying patients, why does DOH need to second guess that other state’s diagnosis. Physicians in other states are making the diagnosis, we shouldn’t judge when they arrive.
A. Sen. Baker – Its not a diagnosis. It is certifying that a condition exists.
Q. Yim – Why does the certification have to be reevaluated by us?
A. Ridley – That is the issue – confidentiality and whose rule applies – home or host state?
A. Yim – It doesn’t need to be that they must be the same. Nothing says we couldn’t have ours and they could have theirs.
Q. Sen. Espero – I’m hoping that for reciprocity we are trying to make it as simple as possible. It is happening on the mainland? Are you looking at a process they have that would make it easy and simple? Are you looking at this issue now?
A. Ridley – We are not aware of any similar processes right now, we have been busy and have not looked into it. We can look into it.
A. Bill Jarvis, Patient – Arizona operates that way.
Q. Yim – We don’t want to second guess the doctor.
A. Ridley – That is just a question we have.
A. Rep. Belatti – I will throw that question to the subcommittee.
Dispensary Licensing Program
Keith Ridley, Director of the Office Healthcare Assurance:
I’ve distributed what I’ll be providing and some attachments. AVAILABLE HERE IN FULL.
Or here individually:
Laboratories – Keith Ridley – We have submissions and re-submissions of validation studies on a weekly, even daily basis. We have active information exchanges with the laboratories. It has been positive, building a good relationship with each of them. We have a common interest in achieving certification. You can see in the handouts the dates, time frames, and turnaround times. We have accepted several validation studies, but we have more to go.
Progress is at the stage where there is a good chance that we will have a provisionally certified laboratory by the end of the month or even the end of next week. There is a lot to be done still, but a good chance.
Q. Greg Yim – Please define provisionally certified?
A. Ridley – We are not looking for perfection, there is always a processes to improve upon. We might provide certification for certain kinds of tests, while we look at certifying for the rest.
Q. Greg Yim – So provisional means they are certified for some of the tests?
A. Keith – That is correct. The requirement is that the product be tested. Dr. A. Christian Whelen, Laboratory Director at DOH is here with me. The products prior to being sold must go through the laboratory tests. It is possible that a product must be tested at multiple labs because no one lab can do all of the tests.
A. Dr. A. Christian Whelen – Provisional status is in the Interim Administrative Rules (§11-850-83) – We put it in there intentionally because we believed the certification process would take some time. We didn’t want to expect perfection at the beginning, but it consists of additional monitoring and conditions for which we will provide additional oversight to make sure the laboratories are successful.
Provisional certification for a test will allow a laboratory to perform regulatory testing for that test.
Q. Sen. Espero – There was an article in Hawai‘i News Now, May 11, stating that testing labs would be certified by June, what happened so that there was this eight-week delay?
A. Ridley – We can attribute the delay to a misquote in the paper. What we have been talking about is labs opening in the summer.
Q. Sen. Espero – Are you of a strong opinion that by August 1 sells could be happening?
A. Ridley – Are you talking about the certification of labs
Q. Sen. Espero – The law says DOH may certify labs, not shall. The law says DOH shall set testing standards, not, shall certify a laboratory.
A. Ridley – We’ve seen products not tested on the mainland with serious negative consequences – we want to avoid that. We’ve seen the news reports. Hopefully they are reported accurately. We want to make sure that products are safe so patients are safe.
Q. Sen Espero – Are we over-regulating? Going above and beyond what we have to do. More and beyond what is expected on the mainland. Literally, so much money is being lost because of our bureaucratic slowness.
A. Ridley – We appreciate your comment.
A. Dr. Whelen – Just a few days ago we reviewed information on standards available in other states. Of those standards or proposed standards, almost all of them had standards substantially similar to what Hawai‘i is trying to do.
Q. Sen. Espero – So the standards are not over and beyond? We can check that.
A. Dr. Whelen – That is correct. We are doing the best we can do. Please check us.
Q. Bergquist – After a quick look at different labs in different categories on this progress sheet. Can you give some context on the verification tests that are missing. There also seems to be a staffing issue at the laboratories. How big of an issue?
A. Dr. Whelen – Just because they haven’t submitted doesn’t mean they are not making progress. Maybe there is a lag in communications but we are checking. We have reason to believe they are making significant progress, but the questions they are asking indicate they are very close to submission.
Q. Bergquist – Once they submit, how long is the evaluation process?
A. Dr. Whelen – I have nine people, including myself, reviewing these, it is our top priority.
A. Dr. Whelen – On the staffing issue, the laboratories have indicated they have staff identified, but they want to be closer to providing services before incurring salary obligations.
Q. Sen. Baker – Clarifying question. In some of these examples it says the tests only spike before or after extraction. What does that mean and what is the importance of that information?
A. Dr. Whelen – Great question. I wrote down something based on Hawaiian Ethos presentation – an example is dosing. Accurate dosing is safer. Hawaiian Ethos is on target with that. If you don’t know the extraction efficiency, it is low or undefined, then you run the risk of overdosing the product. If your test is poor you can’t do the calculations.
Q. Sen. Baker – What is the issue with pesticides with a spike before extraction?
A. Dr. Whelen – For contaminants, if you have a hundred units of a pesticide in there, it will underestimate the contamination.
Q. Christopher Garth – Provisional licensing – Is the intention to get safe product to the shelf as quickly as possible?
A. Dr. Whelen – The intent was we know it would take time for labs to get their full certifications, so the provisional certifications is when there is enough evidence to demonstrate that the laboratories can reliably produce accurate data. The minimum standard to safely test the product. With the expectation that they will get better with time.
Q. Garth – Can make the provisional standards apply across the board?
A. Dr. Whelen – Laboratories are not light bulbs. They are very complicated. There are differences depending on the Quality Assurance processing. Certification comes with a demonstration of the stability of the testing processes. All our processes are designed to protect the integrity of testing process. Provisional licenses says you are OK, but the processes are still subject to risk that DOH wants to closely monitor. As the laboratories generate data, actual data, not just validation, that we can review, we can get a better body of evidence and that is the evidence that will move the laboratories to full certification.
Q. Michael Takano – So if a laboratory has provisional status, but is missing other types of testing, would the dispensary have to go to another lab for that extra testing prior to selling the product?
A. Dr. Whelen – Provisional certification is based on all of the analytes. If it is certified for just some analytes, then they would have to receive testing from other labs, too.
Q. Michael Takano – Are we allowed to transport between labs?
A. Dr. Whelen – Yes, the omnibus bill, HB 1488 allowed for that.
Q. Michael Takano – As a licensed dispensary, we have protocols from DOH for transportation within but not between counties. What are we supposed to do?
A. Ridley – We are looking at protocols with the AG based on the new legislation to cover all of that.
Q. John Paul Bingham, University of Hawai‘i – From your observations what are some of the bottlenecks or times for the dispensaries to get analysis from the laboratories?
A. Dr. Whelen – Speaking in general. Typically, once you optimize your testing process, then you define new bottlenecks. They then usually occur at the processing of the specimens stage. The other area for bottlenecks is the post analytic stage, but BioTrackTHC should take care of that for the most part. The different laboratories have different methodologies and strategies, we can’t yet see how the operational throughput might differ.
Q. Jari Sugano, Guardian of a Patient under 18 – The testing standards have been established and they are not excessive, so are you asking the labs to shoot for certain target percentages to get their submissions accepted?
A. Dr. Whelen – Excellent question, just this week we reissued guidance on the limitations in the testing process. On the chemistry side haveing enough CBD to spike into a product to determine your recovery. Same problem for a different reason on the microbiological contamination side. Most of our guidance for testing of the bacterial load are based on USP standards for non-sterile food products. The problem with that is that there is typically multiple 25 gram samples composted together, so it is a large quantity of product used to get down to the one colony forming unit per gram for salmonella or e coli. That was recognized, so we have issued guidance on different ways to adapt – to spike at a different level and show linearity – or if you do spike at a small concentration, then you need a statistical analysis that if you hit contamination at a low level that you have a high probability of detecting a particular contamination at that level.
It’s not simple. Typically, in a validation study the lab defines performance metrics ahead of time. In the case of our submissions some of our expectations were not expected by the laboratories. So we are clarifying and working through it with them.
Q. Sugano – Are all of the labs following the same microbial type of process, or are they each working separately with DOH?
A. Dr. Whelen – It is up to the labs separately to work out their own process and then meet our targets. In some cases it is molecular methods. In some cases traditional cultivation methods. If you consume an entire gram, that is presence/absence. In other cases it is an enumeration.
Q. Rep. Belatti – I appreciate that you are looking at firm dates for provisional certification. I appreciate you having nine lab staff. And I appreciate hearing about lab staff. But I do want to highlight the real urgency we feel. In HB1488 we gave you flexibility to take standards from elsewhere as guidance. I had the opportunity to visit a production center here and on the mainland as a government employee. DOH has already done the surprise inspections. These are high quality facilities. They are producing. We need to start seeing numbers.
In HB1488 we put in standards for patients to access the labs. Patients now want to gain access. Is there someone in DOH now who can get access to the labs up and running quickly for patients?
A. Ridley – Our understanding is that they will simply take their product directly to the labs. No specific requirements are mandatory. No real rules are required. As soon as the laboratory is certified, patients can just roll up.
Q. Re. San Buenaventura – The product only needs to be lab tested for transport. Is it possible to have DOH inspections like for a restaurant. You checked out the facility – they are not using pesticides, heavy metals. You can do a visual inspection to get them open while we wait for the labs? Is that a possibility? Laboratory certifications take time.
A. Ridley – Can the dispensaries sell products without testing? No. The statute requires testing prior to sell.
Q. Takano – On the bottleneck issue. I’m under the impression that a sequence of events still has to occur before the laboratories can open. That includes the laboratories being connected to BioTrackTHC, and those rules and protocols are not done. Any reason why you can’t start on them now, or why the laboratories can’t start now? We already know who the potential laboratories are. Since they are likely to be provisionally certified, can we get them started on BioTrackTHC sooner?
A. Ridley – They are already started on that process.
Dispensary Status – Keith Ridley. Handouts are in the packet. Since the last meeting, we provided a notice to proceed to cultivate for the dispensary on Kauai and the third dispensary on Oahu is close to a notice to proceed to cultivate. Then six of the eight licensees would have begun cultivation.
On Big Island, the two licensees are building their production centers. We have been a part of the permitting process going through the county and the dispensaries are working with our environmental folks.
Q. Bergquist – I see on retail locations that there is a distinction between no plans for second retail locations, and no site yet?
A. Ridley – Some licensees have identified second retail locations, but they have not acted on them yet. So where there is a specific location, we’ve done a first level of inspection to ensure compliance with zoning requirements. Others have said here is where we intend to build, but they have no specific plans to act. Green Aloha is looking at a second place right now, but they do not have a site identified for where that might be. So the “no-plans” are further along than “no sites yet.”
Seed-to-Sale Tracking – Keith Ridley – We’ve been doing registry integration testing. We are doing well with the tracking – no bottlenecks so far. Everything has been done in a test environment. We will do live testing in the next couple of days/weeks in anticipation of going live. Then dispensaries will look at the registry with live implementation. We are working with laboratories. We are looking at a simultaneous go live for the dispensaries and retail into the registry system in the next several days.
Laboratory Transportation – Keith Ridley – We touched earlier on the protocol for inter-island transportation for lab testing purposes. We will deploy current packing and transportation requirements. We will allow transportation by dispensary or laboratory personnel. The dispensary could take samples directly to the lab or vice a versa, as long as the samples are labeled, packed, and shipped correctly.
The statue and rules said the samples could only be handled by dispensary employee. We have softened a little. Now dispensary or laboratory employees may transport the samples.
Regarding laboratory-to-laboratory transportation, we are discussing with the Attorney General about how that will happen. We don’t anticipate a problem if satellite labs receive product and send it to the main lab. The chain of custody issues we are adequately addressing as well with the AG. (Editor’s Note: Laboratory-to-laboratory transportation would occur when a single laboratory is not allowed to perform all of the required testing; or when a satellite laboratory/pick-up station needs to ship samples to the main laboratory for testing).
Other Notes of Interest – Keith Ridley – DOH is receiving increasing numbers of media requests for access to production centers and retail locations. At this point we are not granting access. Access is limited by statute. There are two issues with access: who is getting access and photography. We don’t want pictures taken of the placement of products or cameras that could jeopardize security. So right now we are just saying no to the media or outside access to the dispensaries.
Regarding HEMIC – Keith Ridley – Regarding HEMIC, where the worker’s compensation policies were canceled. All of the dispensaries have picked up worker’s compensation insurance from other carriers. It is a non-issue at this point.
Finally – Keith Ridley – From Washington state, here is a recent publication regarding their advertising laws and their recent tightening of them. Similarly here is an article on Facebook nixing pages for retailers.
Q. John Paul Bingham – If there is a product recall as we’ve seen in other states, what oversight are we looking at from DOH?
A. Ridley – That is why labeling requirements are so stringent, including where testing was conducted, which lab, etc. So if there are any problems, we’ve talked about lot numbers and other identifiers. We can identify where a product came from, where it was tested at, so we can go back to the source.
Q. John Paul Bingham – Given the limited number of laboratories, who is doing the additional testing for DOH product/quality checks?
A. Ridley – Limited resources are an issue. We will be managing that issue.
Q. Wendy Gibson, Medical Cannabis Coalition of Hawai‘i – Does anything in the law says dispensaries have to use the laboratory on their island?
A. Ridley – The law allows for off island testing only if there is none of the required testing on the dispensary’s home island.
Subcommittee Breakout and Reports
Next the Committee split into several subcommittees for about 30 minutes to begin work on the relevant topics. Members of the public were welcome to attend and participate in the subcommittee discussions. Brief reports were made about each committees process.
Education – Chairs, Stacy Kracher, APRN/Wendy Gibson, MCCHI
We had a productive meeting. After the last Working Group session, we sent out a survey to many of our stakeholders, but we did not receive many responses. This subcommittee meeting, we produced a critique of the survey, including suggestions to make it a better survey. We will make it clearer what we are trying to learn about.
We also had good conversations about working with law enforcement, their educational needs, and the best way to deliver them. We talked about how we can collaborate in the future to put together useful presentations. They have not been trained about what the medical cannabis laws are, and the legislature keeps changing them, so how do we keep law enforcement updated. Tours of the dispensaries for law enforcement and the media could help with the education component. The dispensaries are more like a highly recommended pharmacy than a pot shop.
Product – Chair, Sen. Rosalyn Baker
We have a great group looking at products and identifying areas that need to be changed in the statute. We are also looking to DOH for new rules.
- Labeling – How do dispensaries put so much stuff that is required onto such a little item. Can we have pictures on the insert or packaging to help with use.
- New manufactured products – Trans-dermal devices, sublingual products, and we started talking about edibles and noted that we could do some research to see how other states are doing their product development, the barriers they encountered and the ways they’ve moved forward.
- We know manufacturing could be problematic, there may need to be changes. Oregon’s law has some salient features regarding manufacturing. Each person is doing research on a state.
Reciprocity – Chair, Rep. Della Au Belatti
We had a very robust discussion about the purpose of reciprocity, to recognize patient needs or if there is an economic purpose as well. It is a bit of both was the consensus with a strong emphasis on allowing patient access. We are going to be exploring opportunities for education with hotels, security, etc. – there is opportunity there. We had joining our subcommittee Jonathon White from the Department of Taxation, he had good insight into funding mechanisms and whether to impose a fee or a tax. We will meet again with more solid recommendations in August/September.
Q. Sen. Espero – Are you looking at January 1, 2018?
Q. Michael Takano – The best way is registration in the state. Is there a way to streamline this process ahead of time?
Q. Sen. Baker – Are you also talking about where visitors can use the products?
New Licenses – Chair, Rep. Joy San Buenaventura
We also had a productive meeting.
- One challenge will be to determine from the DOH Attorney General as to the status of the lawsuits of the original applicants. Will the standards that DOH used the first time be able to withstand court scrutiny.
- Horizontal vs. Vertical – We want to allow for additional production licenses. Reasons include allowing dispensaries to have varieties other than their own; allowing smaller farmers to have a share of the pie, answering my big problem of anti-trust that California/Nevada say is a problem with vertical integration; and allowing current dispensaries to farm out the expense of production if there is a need.
- The challenges include DOH staffing, they are doing the best they can, but we haven’t thrown in the wrench of reviewing new licenses.They need more staffing, there is already a bottleneck.
- The dispensary’s are concerned that new dispensaries will cause a glut in the market and bring down the cost which could affect the bottom line of the current dispensaries and their high costs.
I think there will be need for more discussion, our primary challenge is the bottleneck at DOH because of inadequate staffing. There are no objections from either dispensaries and or advocates for additional production licences as long as the new licensees are required to follow the same security, quality, and testing standards.
We need a report from DOH on the status of the lawsuits and contested case hearings that have been filed.
Patients – Chair, Carl Bergquist, Drug Policy Forum
We met before the meeting because members are part of multiple groups. We looked at delivery, discrimination, and the function of the registry. We are going to look at different states to find best practices to see if there are other areas we can address and how.
Public Input
The floor was then opened for public comments.
Q. Paul Klink – Honolulu Wellness Center – This comes from 157 patients regarding caretakers accompanying cardholders into dispensaries or non-ambulatory assistance for those who cannot get into the dispensaries – how will that work? Second question. I get numerous inquiries about house calls. These people need help. They don’t have an ID. They are old, stuck at home. I can’t do a power of attorney. I can’t get them a state ID. How do we help these patients who are in urgent need of pain mitigation without opiates.
A. Sen. Baker – The latest legislation provided for accompaniment by a registered caregiver into the facility if someone is in a wheelchair or paralyzed. They won’t need four people to get them in. It says “a” person may assist them.
A. Rep. Belatti – On the issue of the homebound. There is currently no solution. We will have to consider that.
A. Sen. Baker – If an individual could qualify for a 329 card and they are in a licensed care facility, could another licensed person in the facility purchase it for them? Is there a way to draft a rule for them?
A. Ridley – The statute does not allow use in public places. Licensed care facilities are public places.
A. Rep. Belatti – This situation needs to be addressed, these people are in hospice.
Q. Michael Rollins – PharmLabs Hawai‘i – (One of the three applying laboratories). Regarding provisional licensing, I heard two different versions today, one being that laboratories could apply to just test part of the battery and farm out the rest. I’m not concerned with that. But what if you give a lab a provisional certification even though it doesn’t meet the ISO standards? DOH is new to this, they have never certified a lab before to ISO standards for any purpose in the state. If the law says dispensaries can’t ship lab samples island to island unless there is no lab on that island, if I am on Maui and setup kiosks to ship to Maui, but another lab gets a provisional license, then it pushes me out, even though they are not certified to the full ISO standard. I would like to figure out a mechanism to rewrite the law to allow more labs to function on each island. Otherwise there is no encouragement for the laboratories.
I also encourage the laboratory subcommittee to start up again. We had two meetings and then it disappeared. But it was one of the only places we could get face-to-face conversations with all of the stakeholders at once.
Q. Patient – I have chronic pain – EDS specifically – its like a dislocation. Loose bones. All of my joints shift. A couple of years ago doctors took me off of pain medicines because my stomach and esophagus were precancerous. Three doctors said to look at medical cannabis. I never thought I would, but I was in a state where I could get it, I tried it, and I had the first good sleep in 20 years. Pain in the daytime was going down. I came back to Hawai‘i and was like wow. The dispensaries were getting approved, I thought they would get approved, but its been two years. I’m now growing myself. Its super complicated to do, and I have a teenage son which is its own complication. I’m also disappointed there are not edibles, dosing is super easy with edibles. I don’t know what it takes. This is Hawai‘i, we don’t test everything. Just push it through. Do the work after. Get the dispensaries open. The stuff right now is not tested at all. Dispensaries have high motivation to be successful. To bog it down because of remote possibilities is crazy. If there is anyway to get this so that patients can get help I would appreciate it. Now that I can sleep at night, I don’t want to go back.
Q. Terry – Patient Advocate – Patients have had enough. We’ve worked long enough. We need it now. Are the legislators in other states so much smarter than you guys? The Nevada Governor called up and said he ran out of product. He’s working for his patients. Half of the patients on my list are dead.
Q. Tai Cheng – Aloha Green – I want to clarify provisional licensing. So if we see a provisional approval, will that only be given to a lab that can do all of the tests.
A. Kerry Komatsubara, HEALTH – Provisional certification means you can do all of the testing, but under additional monitoring. Here is a proper example, a drivers permit, driving but with additional monitoring. Dr. Whelen told me that provisional licensing means the lab can start and do everything, but under additional monitoring. So provisional testing means the lab can do all the tests.
A. Ridley – I’ll talk with Dr. Whelen. We are so anxious to get them open. We didn’t want to say that if you want to apply you have to do everything. My concern is that the choice at this point is to limit them to doing everything. Provisional certification can apply to sub tests, but we will have to wait till all tests somewhere in the state receive provisional testing before the dispensaries can use them.
Q. Tai Cheng – I need to know if I’m opening up or asking my employees to take more vacation?
Q. Sen. Espero – When you said possibly by the end of next week. Is that Lab B? Does that mean lab B will be able to test? Testing is only three to four days. So the first week in August a dispensary could open, if this is the only hang-up. Is that possible, the first week in August, or is there going to be another hiccup?
A. Ridley – I wouldn’t have said what I said if we didn’t really think that it could happen. But it is contingent on looking at those validation studies that are or will be submitted and reviewing them and doing the onsite certification of that lab.
Next Steps and Announcements
Announcement: To get on the email list, go to Act230wg@gmail.com. All updates are also posted to the Act 230 website.
Next Meeting:
The next meeting will likely occur on August 23, 2-4 pm, Rm 329. Details to come (pending the rail special session). Stay tuned!
Adjournment
Conclusion
Now it is your turn! The Alliance has a role on the Committee and access to each of the subcommittees – Products, Education, Patients, Reciprocity, Licenses, and Laboratories. We need 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? 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.
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 Winter 2017 edition of the HDA Industry Update absolutely free to say thank you for your interest!