Cannabis and Cancer Care Continued with Jonathan V. Gallo

Dr. Vaughn:

Welcome to Cancer Shop Talk: Behind the Diagnosis. Today, we are speaking with a cannabis business lawyer as the third and final part of our Cannabis in Cancer Care series and we’re privileged today to have Jonathan Gallo, who’s an attorney at Vandeventer Black in Norfolk, Virginia, whose firm helps manage some of the cannabis law group, I guess, advises businesses in the industry, as this is, I’m sure, not only in medical industry, but evolving in other disciplines as well. Jonathan, we’re so happy to have you on board here and want to just give you the opportunity to introduce yourself and your background and how your practice got into some of this cannabis law in Virginia.

Jonathan V. Gallo:

Sure. Thank you for the introduction, Dr. Vaughn, thank you for having me. As you said, I’m an attorney with the law firm of Vandeventer Black in Norfolk. We have offices in Richmond, as well as North Carolina. Beginning July 1st, we are actually going to be officially merging with another law firm called Woods Rogers, so we will be Woods Rogers Vandeventer Black by July 1st, that’s a mouthful, and we’ll have additional offices out in Roanoke, and we’ll be expanding our presence in Richmond, Virginia as well.

Jonathan V. Gallo:

Vandeventer has been in the cannabis space for a number of years. We first started a few years ago in the industrial hemp space after passage of the 2018 farm bill, which legalized industrial hemp. We’re a business law firm. Cannabis businesses have the same type of issues as other businesses, commercial real estate issues, employment issues, contracting issues, environmental, IP, regulatory issues, so we decided that since we’re able to help businesses in those areas, we can certainly help cannabis businesses in those same areas, so that’s when we started a few years ago.

Jonathan V. Gallo:

My background, I not only am on the cannabis law group for the firm, I’m also a cybersecurity and data privacy law expert practitioner for the firm as well, and I help head up that group at the firm, but I got into the cannabis law space really because of my background as a regulator. I used to work for the New Hampshire Department of Health and Human Services, and in 2013, the state of New Hampshire passed legislation establishing its therapeutic cannabis program, what we would call “medical cannabis” in Virginia, and I was part of the team that after the legislation was passed, we had to write the regulations. We had to come up with the application process for what we were calling “the alternate,” and they are still called “the alternate treatment centers” there, which we call here in Virginia “pharmaceutical processors.”

Jonathan V. Gallo:

That took about a three-year effort to develop the regulations, develop the application process, have the applicants evaluated and really start the program. That’s where I came at it from, and again, as I said, I work in a business law firm, and we thought, “Well, since I’m pretty familiar with that process, it’s certainly something we can help our clients with.”

Dr. Vaughn:

I guess the big question and can maybe help with your expertise and direct where it’s going as far as medical cannabis, can you help just walk us, legally what happens after I see the patient and provide this, really, kind of a paper saying I am their oncologist and would recommend they get a medical license?

Jonathan V. Gallo:

Sure, sure. The way it works is the first thing that has to happen is the patient has to see what is called a “registered practitioner.” Only a physician that’s registered with the Board of Pharmacy can issue a written certification for the use of cannabis products for treatment and the good thing is the Board of Pharmacy on their website has a listing of all of the registered practitioners and where they’re located, so a patient seeking that can look at that information and find a practitioner in their area and go see that practitioner, obviously, if they’re accepting patients.

Jonathan V. Gallo:

Once they see the practitioner and the practitioner determines in their professional judgment, as you know, that the use of cannabis products are beneficial for the treatment or to alleviate the symptoms of any diagnosed condition or disease determined by the practitioner, and they would have to register at the Board of Pharmacy, then they would have to go to a dispensary that’s been established. There’s four licensed dispensaries in Virginia, and there’s 11, I believe, at this point with two new ones opening, 11 actual dispensaries, so there’s four licensed pharmaceutical processors. These are the entities that have the actual license to dispense the medical cannabis product. Of those four, they have 11 separate dispensary locations. Each pharmaceutical processor is allowed to have five dispensary locations in its health area. Patient goes to you, or other registered practitioner, gets a written certification, they register, and then they can go to the dispensary to get the cannabis product as listed on the certification.

Jonathan V. Gallo:

Beginning July 1st 2022, a patient, a parent, or a legal guardian does not have to be registered anymore. All that’s going to be required is a written certification for the use of medical cannabis from a registered practitioner and their government-issued ID to obtain medical cannabis products, so that’s a recent change in the law. Now, the law also allows for what are called “registered agents.” Registered agents are individuals that can be designated by a patient to basically pick up or receive the medical cannabis on their behalf. An individual can serve as a registered agent for no more than two registered patients. Registered agents will still have to be registered with the Board of Pharmacy, even though a parent, patient, or a legal guardian no longer has to be registered.

Jonathan V. Gallo:

That’s the basic process on how to approach that. Patients have a limitation of how much they’re allowed to receive. The limitation is in the law. They can receive cannabis oils as well as now, botanical cannabis, the flower, and the possession limit for botanical cannabis, it allows patients to receive up to four ounces per 30 days to be dispensed to them as far. As cannabis products in general, which include the cannabis oils, basically, the way the law reads is patient is allowed to be dispensed a 90-day supply based on the certification, and that four ounces per 30 days for botanical cannabis is included in that 90 days, so there are limits to the amount of medical cannabis product that a patient is allowed to receive.

Dr. Vaughn:

It sounds like, Jon, in basically a couple of weeks coming up, July 1st, the kind of certificate that I’ve been signing for patients, that’s really all they need now, then they could just take that to the dispensary?

Jonathan V. Gallo:

Yeah, along with their license, correct, yes.

Dr. Vaughn:

With their license, okay, so that is a big change, I think.

Jonathan V. Gallo:

Yeah, that is a change.

Dr. Vaughn:

Okay. Wonderful. Question about the four, you said there’re four main dispensaries in the state of Virginia. Are they regional? For instance, I know just being in Fredericksburg, either patients go down south, most of them go to Richmond, and I think there’s one in maybe Northern Virginia, I’m not sure if it’s Fairfax, but are these dispensaries regionalized?

Jonathan V. Gallo:

Yeah, there’s the health service area. There’s a health service area 2 and the base for that is in Manassas and there’s a health service area 3 out of Abingdon, Virginia health service area 4 in Richmond, and health service area 5 in Portsmouth. However, they have what I’ll call “branch dispensaries,” so they have multiple dispensaries in those service areas, which basically if you go onto the map, if you go onto the Board of Pharmacy map, they will list the location of each of the dispensaries, and I believe there’s one opening soon in Alexandria as well, so they’re kind of regionalized and spread out.

Dr. Vaughn:

That’s what I was wondering, just to save our patients just to travel. I mean, I feel like Fredericksburg’s always a catch market test market for Richmond, or even Northern Virginia. Would that be potentially like a branch site? Could we become a branch site of the Richmond dispensary? Is that how it would work?

Jonathan V. Gallo:

Right. Again, this health service area is by region. It’s a geographic region, and the Board of Pharmacy lists the cities and towns that are in that geographic region, except health region 1 does not have anybody in it yet because that license was withdrawn and it’s under litigation. But say, for example, the Richmond area, if you go on the Virginia NORML website, V-A-N-O-R-M-L, NORML, it will give you the locations of all of the dispensaries that are in the Commonwealth.

Dr. Vaughn:

Okay, that’s good to know. That’s great information for our patients to know where to go ’cause I think before, we’ve been relying to saying, “I didn’t really have the exact locations of these,” so the more help we can direct them, that is that’s great.

Jonathan V. Gallo:

I think two of the best sources of information are the VA NORML website, like I said, it’s V-A-N-O-R-M-L dot org, and the Board of Pharmacy website, they have a really fairly comprehensive list of frequently asked questions, walks you through the process of the certification process, has the list of all practitioners that are registered, and it also has the addresses, and the towns that are located in each health area.

Dr. Vaughn:

Gosh, that’s great. We should even have that somehow, I’m just thinking, on our website, have a link to that directly because patients ask about it much more common and family members do so just to be able to have that linked from our website to just get them access to its information would be extremely helpful.

Jonathan V. Gallo:

Sure.

Dr. Vaughn:

I guess, maybe some foresight in your mind, what do you think is the trend going to happen in Virginia? If stuff becomes more recreational, I mean, does that just changes everything we’re doing now from a legal standpoint? What do you think is going to happen?

Jonathan V. Gallo:

That’s a very interesting question because as I’m sure you’re aware last year, Virginia legalized simple possession of marijuana, so right now, in Virginia, you can possess on your person up to an ounce of marijuana provided that you’re 21 years of age or older on your person, so it’s simple possession without the intent to distribute. If you possess more than that, then that’s not legal, and there’s varying penalties for that.

Jonathan V. Gallo:

Interestingly, in this past legislative session because the laws, recreational provisions, the whole licensing process for retail sales was supposed to begin January 1st, 2024, however, the laws, it was passed last year, required most of the licensing provisions to be reenacted by the general assembly in this past legislative session. That did not happen, so really, it’s in a holding pattern as far as recreational sales are right now. The legislature did try to pass a bill that would allow pharmaceutical processors, current medical processors to dispense recreational cannabis to people other than patients. That did not get through the legislature, so really, for the recreational scene, it’s on standby now until the next legislative session to determine what’s going to happen, so right now, medical is the only legal way to obtain marijuana in Virginia under state law.

Dr. Vaughn:

At least for the next few years, it’s going to be a holding pattern, I guess. The medical cannabis is the only real access to it, I guess. Well, one question, I guess, now that in the registration or the cards were from the Board of Pharmacy, correct?

Jonathan V. Gallo:

Yes, that’s correct.

Dr. Vaughn:

Now, if patients, I guess, may as of July 1st just be able to have kind of my waiver form that I give them, or their statement form, but how do they get a card now? I guess it’s not mandatory? Or what changes as far as having the documentation?

Jonathan V. Gallo:

They still can get a card if they want to do so. They’re still allowed to get a card. It won’t be mandatory as of July 1st, but they are still able to obtain what’s called “the optional card,” and they can do that on the Board of Pharmacy by submitting the online application. I believe it’s a $50 application fee. They upload a copy of the written certification for the use of medical cannabis, their proof of age, identity, and residency, and they can get a card. My understanding is about 60 days for them to get a card, which is probably one of the reasons why the legislature changed it and said you don’t have to have a card, but example, if somebody’s considering traveling out of state and they want some official notice from the Board of Pharmacy that they are a registered medical cannabis user, a patient may opt to do that, and get the optional card.

Dr. Vaughn:

Yeah, it sounds like just a prudent thing to have on hand to have some documentation, like you’re saying.

Jonathan V. Gallo:

Yeah, it’s probably better to have that than just a certification letter.

Dr. Vaughn:

What are some of the things, I guess, you would help counsel and suggest that providers like oncologists, how to make it easier for us to, I don’t know, is it more just awareness, or just access to getting this information about medical cannabis to our patients, is there anything you foresee or maybe you see even changing where you are that some of the practices are doing? Is it more education? I’ve been trying just to understand some of the pathways from a standpoint, I’ve started to integrate it into our pattern of care programs, these kind of things, but business law standpoint, are there things that you see change, or can recommend?

Jonathan V. Gallo:

I think putting out the information on your practice website is probably a good idea, and certainly, these podcasts are helpful for your patients. As far as providing them with information, like I said, the two websites I mentioned, they have some excellent information, and also, for you as a practitioner, I mean, I think following the legislation, although the legislative session has now ended, it’s going to be starting up again in January of next year, keeping abreast of what’s going on and following the news in Virginia, and what’s going on to prepare yourself and have your finger on the pulse of what’s going on, Virginia, that way you can relay that to your patients, I think that’s good.

Dr. Vaughn:

That’s a great point. What’s the easiest way to follow the active legislation happening in Richmond Congress? is there daily newsletters or website because we get kind of bogged down all kind of stuff, but you’re right, I would love to be more tied into active legislative happening in Virginia. I don’t know, just seems like it could be difficult to access it, know what’s happening.

Jonathan V. Gallo:

It is confusing. What you can do is access the Virginia general assembly website. They have something on there called “lobbyist in a box” that supposedly tracks legislation. I have tried to do it and I was unable to successfully do it, but you would have to call them if you were having issues with it working. But the lobbyist in a box is supposed to follow the legislation that you, House bill-whatever, Senate bill-whatever, that you input into the system, and it will notify you of what’s going on with that legislation. Another way to follow specifically cannabis legislation is Virginia NORML posts a synopsis of all of the pending legislation during the session that’s related to cannabis and they list what the bill is and they give a summary of it and then they tell you what happens with it. That’s another way you can track it.

Dr. Vaughn:

That’s great. This website seems like this is the one we need to get linked to is Virginia NORML.

Jonathan V. Gallo:

Yeah, it is, it is. I’m not plugging for them or anything like that, but I’m just saying it is a good website. They do provide a good amount of information.

Dr. Vaughn:

Yeah, and like you’re saying, just get snapshots of where we are in time. What do you foresee? I mean, this next assembly, what’s the next big movement, of course, the recreational aspect, but what are you looking towards, I guess, in 2022 and ’23?

Jonathan V. Gallo:

Waiting for the general assembly to move forward on recreational sales. That’s the bottom line. That’s what everybody’s waiting for.

Dr. Vaughn:

Yeah, like you said, we’ve followed all the steps almost to get to the point of recreational use, it sounds like. How much further can you go with these little small steps, I guess? Do you think there would be any changes to medical cannabis at all? I guess we’re never going to walk it back, right? It’s out there. Is the assembly, are they monitoring the dispensaries, or how do they show, I guess, how it’s regulated, how productive it is, and how they’re doing a good, efficient job? Is that being monitored?

Jonathan V. Gallo:

Yeah, the processors have to file, I believe, reports with the Board of Pharmacy with regard to medical. I don’t foresee them repealing that because there are many states out there who have both medical and recreational cannabis. Like I said, the provisional measure that they try to pass allowing pharmaceutical processors to dispense recreationally, I could see that coming up again as a stop-gap measure because the pharmaceutical processors are already producing, they’re in the pipeline, and they know how to run their business. A lot of people, a lot of legislatures thought it made sense to allow them to be able to do that until the full retail sales came on board in 2024, and I wouldn’t be surprised if that bill came up again.

Dr. Vaughn:

It’s just been amazing to see how just from a provider of the last four years, how it’s changed, and from my standpoint, really, the idea is trying to figure out how to integrate it into our practice. I mean, it has a lot of good attributes. I’ve been a proponent of it the last couple years as far as some of the supportive measures to help with cancer patients. It’s amazing to see how this is really, really changing.

Jonathan V. Gallo:

The past several years, things have changed in Congress as well. I mean, Congress just again passed in the House just in April, the MORE Act, which is the Marijuana Opportunity Reinvestment and Expungement Act, which is a piece of federal legislation that proposes to remove cannabis as a scheduled drug under the controlled substance act. There’s been more movement as well on other potential legislative proposals. They haven’t gotten through the Senate yet, though, but there is a growing desire to act on this federally and have it regulated strictly by the states. We’ll see where that goes, because until then, you’ve got this dichotomy, illegal federally, but legal in certain states, whether it’s recreational, medicinal, or both, but patients who feel that this is something they want to talk to their doctor about their registered practitioner, and it’s legal to do so in Virginia, then they can certainly do that with the guidance of their practitioner.

Dr. Vaughn:

Is there any talk about …? I think one of the hold-ups sometimes is where some providers may not really adopt the use of cannabis, and this is a true concern, is how does it interact with maybe what we’re prescribing for therapeutic benefit, like chemotherapy, or immunotherapy? I wonder if there’s any, and it probably has to be state-run, I guess, since it is obviously federal law that bans cannabis use, but just where’s the research as far as potential trials, integrating trials with cannabis? I would love to see maybe some money that state government makes, I like to see them advocate for some research and funding from a scientific standpoint some larger trials just to see ’cause I think those are the unanswered questions I think people get uncomfortable about is how to utilize it in conjunction with standard approaches, just not knowing how it may negatively, interact with therapeutic medications.

Jonathan V. Gallo:

That’s an excellent point. I do know, though, in the past year there has been a movement towards getting more research, and I think the DEA last year was in the process of registering several additional American companies to produce cannabis for medical and scientific purposes. This is more your area, doctor, but I do know there are a number of, and I wrote an article about this maybe last year about a couple of research projects that published their results, not in the United States, but outside of the United States on their research with regard to cannabis. I’ll have to find that article and send that to you.

Dr. Vaughn:

I would love that. I know one of the big articles, I know Israel’s done a lot of research with cannabis, but you’re right, a lot of these studies, you’re extrapolating from, they’re outside the US. I think if we could get some more scientific data, I think it would, again, really just propel utilization of it in oncology and I’m sure another disciplines of medicine.

Jonathan V. Gallo:

Right, right.

Dr. Vaughn:

Well, gosh, Jonathan, I just want to thank you so much. That was so informative for me, and I’m sure for our listeners. That was just a wonderful background of cannabis and some of the legal aspects of it and really where it’s changing now. Very helpful to know now that really the certificates I assign patients can now go in, or have their family members go in to get access to medical cannabis, so it seems like it’s easier for them to get these important treatments. I thank you so much. That was just a wonderful discussion.

Jonathan V. Gallo:

Oh, I’m glad you found it so. I’m more than happy to do it. Thank you so much for having me on. It’s a great discretion and I look forward to seeing where it goes in the next year.