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National Medical Cannabis Unity Conference
April 30, 2021, Online, USA
National Medical Cannabis Unity Conference
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Global Update: International Rescheduling and Standards
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In December of 2020, a historic decision by the United Nations Commission on Narcotic Drugs (CND) was made when it adopted the World Health Organization’s (WHO) recommendations to remove cannabis and its resin from Schedule IV under the UN Single Convention on Narcotic Drugs of 1961. What does this mean for the United States and the other over 40+ countries that have legalized medical cannabis? What successes and pitfalls are we seeing in other countries who have legalized medical cannabis?

This panel was recorded live at ASA's 9th Annual National Medical Cannabis Unity Conference on April 29, 2021 and features: Pavel Pachta, Max Monahan-Ellison, and moderator Steph Sherer.

About speakers

Pavel Pachta
International Regulatory Affairs Director at ICCI - International Cannabis and Cannabinoids Institute
Max Monahan-Ellison
Co-Founder & Partner at eCB Consulting Inc.
Steph Sherer
Executive Director at Americans For Safe Access

Drug Regulatory Control Consultant, former Deputy Secretary of the International Narcotics Control Board (INCB), former Chief of the Narcotics Control and Estimates Section of the Secretariat of INCB at the United Nations Office on Drugs and Crime (UNODC), contributor to several UN and WHO publications.

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Max is a seasoned healthcare strategist at the intersection of emerging therapeutics and traditional healthcare & pharma with expertise in policy, communications, marketing and public affairs. He has spent his career taking complex problems and making them digestible and actionable for clients, patients, policy makers, and healthcare professionals, and has a strong understanding of health systems. Max has also led survey research on broad patient populations and advised provincial and federal governments and regulators on medical cannabis issues. He co-founded boutique cannabis and emerging therapeutics consulting firm, eCB Consulting Inc. and in addition to his role as Board Chair of Medical Cannabis Canada, Max is a member of the Best Medicines Coalition, and a medical cannabis columnist for The GrowthOp.

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Steph Sherer is founder and President of Americans for Safe Access (ASA), the largest national member-based organization of patients, medical professionals, scientists, and concerned citizens promoting safe and legal access to cannabis for therapeutic use and research. Her direct experience with the medical benefits of cannabis and her political organizing background led Steph to form ASA in 2002 with the purpose of building a strong grassroots movement to protect patients and their rights. As a powerful advocate, a skilled spokesperson, and an energetic initiator of campaigns, Steph has trained over 100,000 individuals across the country on civic engagement. Steph has become the foremost international leader and expert on medical cannabis patient advocacy and, alongside American Herbal Products Association (AHPA), has created the first industry standards in the areas of distribution, cultivation, analytics, and manufacturing, packaging and labeling.

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Hello everyone. Thank you for joining us. We are going to have a bitter creative panel. So we shouldn't. It's been doing a great job, but I don't think I saw Biden's, Global Summit. There were a lot of texts problems. And so I think that if I didn't, can I have some issues? So, can we do things, everybody for being patient and part of our Tech issue today? Is that Val, pach defines himself in an airport and can I join a buy buy laptop and so he's on the phone. So I have him on my cell phone and where should I actually start the panel fixing up a little bit

of an update from Chevelle about what's been happening with the scheduling, an impact, in a little bit of information about some of those policies and they're going to let him catch a flight. And then Max, and I are going to have more of a dialogue about how this impacts of work. We're doing in Canada, and the US, and just how we're seeing an impact other work. And in other countries that sound all right to bail. Welcome by WhatsApp and you are now live at the AC Unity conference. So good to hear your voice. And hopefully next year. I will see you in person, but it seems like

over the years. When we've had you speak at the ASA conference. It's always been sort of this long off, dream that we would ever affect you in policy. And so it is very exciting for me to introduce you to our conference after something very positive has happened. So why you tell our attendees? What happened last year with w? Joe and and the UN. Through WhatsApp Suri I can so I can show you that you're doing great. No need to shout to International control

under the 1961, Honda Accord e, Drive of the existence of the under control instead of a drive to General. Invited to enforce the most control measures for the substances and even to consider there a Prohibition. 96, California and Canada. And they were trying to persuade. Government. ASA was driving and I remember that very well. I remember I remember. 2019. Decided. They decided to go for it means it's not it's not anymore considered as a very dangerous substance

with no money to use. So, you asked me to ask me. What does it mean? When it says, every kind of do toilets every type of tooth pulling. Sigma electric, which is very dangerous. And many governments are boring during the scheduling framework of international drug control 3D. So, Any other drug Bull and pure as the old pitbull? So for example, your Contraband down step-by-step information regarding the United States regarding regarding medicine on the way

that the research Scientific research. Exciting change in the international drug control, which is spectacular, but that was very comprehensive. Thank you so much for both. Before we let you go. I catch your flight. You, I just want to ask you one more question and that is just recently the international narcotics control board, which is which is basically the global DEA. But without guns, they made a recommendation to the UN about about how to move forward, medical cannabis, and I'm just wondering, if you can tell me one, what should have weights? Do they hold with the UN as far

as the member states is Popping these policies. And and what do you what do you think of of their of their comments? Implemented by government. Which is very dangerous and which is considered to have medical. old still a narcotic Are government building now and we are encouraging availability. For medical purposes. And is now trying to improve government government. I think they already open and they already included in the mainstream. Well, thank you so much as I could and just in case our our members haven't seen pavel's before you can go back to that several of our conferences and

on webinar is so you can search his name on our website in and find lots of other videos. And I also just want to say about his been, a mentor of mine, helping us and our members are navigate Who and the UN at Camino, narcotic drugs, and this is a huge win after patients globally, and we could not have done it without you fell. So I just want to say thank you so much, and I can't wait to see you in person. Thank you. Thank you. Thank you. So exciting. So I just wanted to say, you know, a lot of people to ask me of in the past.

Why Americans for safe access was working on this issue at the UN, and you're there are actually two reasons that we put this on our strategic plan in 2003. And that was one. We had mini pelican Federal politicians in the US were telling us that we couldn't, they couldn't change federal law to, to accept the medical use of cannabis because the US was signed on to these treaties. Are they use it as an excuse? So we couldn't do that. So, you know, we went ahead and change the treaty got rid of the excuse, but I think what is

most important and exciting for our work in United States, but also globally is. Now you every country that has signed on to these treaties. They have made a commitment. It's not just About what drugs are illegal drug treaties were also about ensuring that the citizens of these kind of every country that they are insured access to these medications. And now that cannabis is listed with medical value. It means that country use are obligated to find a way to get medical cannabis to their citizens. So, yo, this is definitely something that I'm hoping will help the United

States, but where will definitely, how are in countries where medical even mentioning medical cannabis has been taboo? So you at all, so lots of countries in the Middle East, more conservative areas, and in Africa, in southern Europe, in Asia, I mean, this is part of South America. Countries were really, you know, cannabis has held in some places in the Philippines. Were you held a death penalty? It is a big deal, the big deal, Max in yourself and then tell us how how this is impacted. Are you seeing impacting the work for patients and in Canada? Yeah, so

my name is Max. I've been working in this sector for quite some time. But my background is in healthcare dealing with, you know, highly stigmatized and complicated as he stayed. So when that's rare disease, diabetes, obesity myself for a long. Of time. So I've been, I just took over as the chair of the board of medical cannabis Canada, which is your National nonprofit in the Canadian Market advocacy work. And I also found it at consulting firm with a few endocannabinoids, experts providing guidance on post public policy as well. As you know, the nitty-gritty of product

development. So, you know, I think it's it's a really exciting time going back to it as a Focaccia salad. It is really a symbolic when I would say and like you said it is one step toward broader access to patient, but I think the lesson that we know from any piece of federal legislation is that it is going to be your partner National legislation. This is going to be up to the member states to discretion. Execute on medical cannabis, and I think we've seen already even in the Canadian Market in international market. Quality of access to medical cannabis, doesn't

necessarily mean equity and access, and I think we're going to see disparities across different regions and how they roll out, you know, medical cannabis legalization. And there's going to be a need to to address really situational and Country specific. Needs indigenous issues or you know, representing larger display disability, you know, I think there isn't going to be a one-size-fits-all approach to Medical legalization and even just looking between our two countries, you know, it's going to be a very different-looking piece of Federal Regulation, then Market, but the nice

thing is that your kind of cadence you want in terms of equality development. You want to reduce barriers for each country, to be able to move forward in their own legislation. But at the same time, there's going to be battles. Bi-State contacts and has received an international place that it's it's, it's hard to get a sense of how you said you eat. Countries are so different, the way they approach medicine. And so, finding cookie-cutter approach is going to be challenging but where I think countries are forced to have discussions about harmonization is when it comes to international trade

and I'm wondering, I know I've seen some trade come from, I know there's Canadian products that are being imported to Germany to that to that program. And I'm wondering if there are other other products being imported into Canada, if they're in the medical cannabis program. And if so has that has that changed anything about the the actual access for patients or or the approach to the medical approach for doctors and patients. Yeah, so I'm not at an international trade expert, especially in terms of importation into the KD Market. What I will say is that it's not

the best place to be an importer purely because it's incredibly competitive and there's quite a large amount of product offerings. Especially looking at the w h o n. I n c, b decisions. I don't think we're going to see as much of an access impact in the Canadian Market, you know, we have a statutory review of the Cannabis at coming up next year as well as a formal review. The medical framework years following and you know, I think our own internal efforts around that piece of those reviews are going to be the most impactful for an access perspective. You know, I think there is a lot of product

in Market. Hear the challenge is, there are still serious access perrier's to patients in in the Canadian Market. Whether that be the fact that, you know, cost is a huge burden or going back to the issues and things. Like even packaging, accessibility. I just wrote Buc-ee's on this recently. Where you know, when you're regulating medical cannabis under the same framework as a recreational stream, there's a lot of important efficiencies that help producers save money and terms of production and compliance. But at the same time, you know, we're lacking the substantial

exemptions needed in the Cannabis act to allow producers to develop things like, you know, accessible packaging, so impatient. And I'm on Hydromorphone. I can go into my Pharmacy pharmacy and ask for, you know, packaging the hill going to go and not super child-resistant because let's say, I'm dealing with arthritis, developing. Are you guys have a review coming up this year? What are going to be some more important things that you are going to take complications with our patient advisory committees, as well as

other nonprofit stakeholders to make sure that we're representing the actual in of the needs and desires of patience, but, you know, a few things were going to be looking at our So this is looking at, like I said, packaging, accessibility expanding the medical, exemptions to allow, for license, sellers to develop packaging, that actually works for for a lot of patient dealing with mobility issues at the same time. That's looking at TC limits, which I know is an issue. We have in state by state legalization of medical with some lemon and caps, right? Now. You're a pro product

key. See when it's a challenge for a patient using specific those options because, you know, if they require a lot higher dose include exemptions to do as well, as, you know, any other tax bring work applied to cannabis. That includes in the producer side too, because actually interesting if you are, I believe it. If you're producing both Rack in medical, You participate in the medical market and you get tax an additional percentage of revenues. So it's just, you know, we received this incentivisation. So, you know, what's interesting is

markets like in Europe as well as some state, state Markets, pharmacy dispensing. But in Canada, the medical Access program doesn't have any dedicated brick-and-mortar access points, you can only access federally directly from my license medical sellers. There's been some amazing. And so we're looking at things like Pharmacy to spend saying and, you know, just trying to expand access to to also care for me because I think of our population uses cannabis for medical purposes. Sell 5

million people, but we only have four hundred thousand active medical documents. So that means Whatever we do. We're trying to just, you know, find ways to not prevent access to a medical Market but ensure safe access and also Equitable access because they're especially living with disability and others who are dealing with other intersectionality second treatment that they're the ones from Luke Lucas was was in the conference yesterday. You have good for an long-term friend. He

actually created Canadians for safe access. I was just a patient group, was it was there before I before yours. And obviously, think of all the overtime, but he was talking about insurance coverage. And I'm wondering how you guys have a different experience program in Canada than we do here in the United States. But how are you going to approach insurance coverage? And I'm wondering if the un Change in? Scheduling could help that process. So insurance coverage is interesting cuz you know, we were specifically and

there's not really a mechanism necessarily get for Medicare or private benefits coverage within the Cannabis. So that's an issue. We are working on. Just not specifically in that with you. So, you know, it's much more of a one-on-one. It's a kind of the behind-the-scenes Grassroots lobbying effort because, you know, the challenge is pharmacare, is probably a Faraway. It also is something that is executed by the province's, so it's, which is the equivalent of states in the Canadian market. So, it's complicated to get National pharmacare for cannabis, and it listens as a formality. But life

beliefs, that I did watch that. The last candidate thinks that around 6% of patients and full benefits coverage, where, you know, Germany, you're looking at the majority. So, you know, we are behind in that regard but what it comes down to, is Expanding. I'm almost to health economics, argument of cannabis in terms of reducing its about the medication and that's it. I keep messaging generally is we find that Regulators as well as Leo don't resonate as much with the argument of, oh, it's such an efficacious treatment.

Everyone should get access. But what does resonated you know, we're in the middle of an opioid crisis, are seeing positive benefits dependency and being able to get patients off of Highly addictive medication. So, you know, what he's doing is fantastic because the huge need and that's something we're doing as well as we're trying to expand patient, Focus research, even if we're not doing full clinicals, but looking at the impact on other drug use and trying to make that claim, whether it's to a regulator or do a private insurance coverage provider of why there's value in providing products.

Also, I'm sorry to keep rambling on the coverage. We do have in Austin cases its second line. Third line. It's for a very limited amount of indication. So, you know, we know about 50% of patients, depending on the recent you look at it's always a bit variable or treating for things like chronic pain, but you know, you're looking at indications and benefits providers that don't always cover what the majority of patients treated with your seeing, you know, my current location, but you know that access to a broader

patient pool. Yo in Holland, which was the one of the first next to Israel, a country based or federally legal medical, cannabis program, in Europe. This is what a state-based insurance and what we had heard and I still, I would still love to use a platform. Like I am CBC to try to get more cooperation between countries that have medical cannabis laws, whose information. But what the Dutch insurers were finding was less, unless emergency room visits for cannabis patients, as well as a

deduction and other medications. As far as a cost-saving on this was before the opioid pandemics. It was really interesting to think about you and ensure seeing this in their business plan and it gets really been our approach or Americans for safe. Access is looking at all these different stakeholders and make sure you speak their language. So you don't go into an industry Association and talk about patient needs to go in talk about new Industries and money. And the same thing with with talking to ensure that this is not about policy. It's about about saving money and I think

one of the the the potential positive components looking forward to that is that pharmaceutical companies and farm and enters Donuts. Charlie always get along and not mine. I'm wondering as far as the Canadian Regulators go and infusion Advocate. How much are your are you looking at other countries? As we now have 44 countries that have medical cannabis laws. Are you, are you learning more as Aziz? Different models are coming forward and do you see bringing any of

that into that the Canadian Pro? If you if you had your your spirit your wish list your success list and I mean a hundred percent sure. I think you know, there's not a one-size-fits-all model but a lot of different countries are doing really interesting things that you know, could be adopted by some of the earlier earlier stage players. Like I mean, looking at Mexico who's really investing in in fostering, not only local production, but supporting indigenous communities that you know, I need to be a benefit of this policy, you know, you're looking at like I mentioned earlier, a

lot of different countries or are looking for ways to expand insurance coverage that we are not even close to reaching in terms of the numbers. And then, you're also seeing things like, you know, dispensing routes and better access on in some occasions to hdb support. So, you know, I think it's the same thing. I hope in the US as well. As you know, I think we have always been a federal system and it's easier as an advocate actually, because it starts the federal level and they're still bad. Delete mentioned at 20% tax in PC. You know, I work to try to get a bill through the legislature

still Prudential arguments. But where I've been really impressed with a sign that you think your battles going to continue. Even after federal agent is going to be that, you know, you started at the state level and those markets. Are you going to maintain? There's going to be an equities both within States and across the country regardless of fundamental federal policy. So, you know, I think state-by-state International markets, the Canadian Market, we're always going to need to learn from each other because like I said, it is just not

one-size-fits-all in it. It needs to come from the patient from the situational contacts, but learning from everyone that we can We've been seeing from like the German market and also, some of the other European markets is standardization of product. And I think that, you know, what's interesting. There's always been this dialogue about the US program being so amazing because there's such a diversity of products. And that, and that's true and exciting, but I wonder if that diversity of products is there because we don't have standardized products. Meaning

that if there were products, you could depend on the dosage that diversity is often because you're, you can't find what works cuz you don't know what's, right. And so I one of the things that we have constantly been doing it Americans. Get back to me if they have at least two strategy, meetings a year sometimes for a time because the political landscape changes so much and it's really important to always be looking at at that goal that you want at the federal level. And so I think really looking We're always talking about is that the the state by state program we

created was really supposed to be a pit stop. And so we you really move cannabis into an acceptable medicine. But in order to do that, you know, it wasn't just looking at the law enforcement side of things. We're actually talking about changing how we view medicine. And, you know, it turns out that that side of things are complicated and navigating law enforcement and navigating the legal side of things. Now, we have to get him to really entrenched industry of how we how we talked about medicine and how we get to people and you

make a good point because it's an issue that you're going to see in every legalize cannabis Market, you know, we're never going to atleast, this is true. But you know, I don't expect a scene cannabis in its current form at getting things like a drug identification number, but I think what we need to see is that we need cannabinoid products. Better distributed in a medical setting and given better access patient. At the same time. I do see, you know, the federal legalization. The US is an amazing opportunity for clinical research leadership because Ariana is the biggest barrier to Clinical

Research in Canada's money. And the US has always had a much higher level of capital in terms of pharmaceutical investment. So, you know, I think long-term this Market will always be there to all used to be incredibly important, but I also see an expansion of pharmacological cannabinoid treatments in the future hundred percent. That'll probably be regulated by the FDA that said I would love to see an alternative dose control formats in the existing Market, find something similar. I'm just not sure especially in the US contacted and I think a previous playlist mention this if the

FDA would even get into that discussion, but you know what, I think Saturday is sterilization is very important. Product diversity is no problem. As long as you know, you got some strong manufacturing standards there, any labor Is has pretty good in the Canadian Market. We have quite strong oversight, spell Canada. And so, you know, it's I think that is the benefit of federal legalization, it going to see the US and extension Clinic research on hundred percent. But also, like you said, kind of a rules of the game that allow hopefully also multi-state operators to be able to

get big in a way that is effective and efficient, whereas, you know, rather than in a way that could be challenging at Frosty's. Fractured Emperor, for our members, may not do this American Safe access help. Start an organization called IMC, PC does the international medical cannabis, patients Coalition. What is a group of medical cannabis organizations from all over the world and we get together on a regular basis and do things like change the UN scheduling of cannabis

as well. Look at model legislation. So max. Thank you so much for being on the panel. And thank you so much. Your contributions imctc. Will thank you so much for all the work you're doing. I am American as well and I'm just so happy to see all this progress being made both in the US and internationally self thinks that he says, welfare fraud in June, for having me.

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Pavel Pachta
Max Monahan-Ellison
Steph Sherer