A global market access journey in cannabinoid pharmaceuticals

What does it take to bring a cannabinoid pharmaceutical to market?

We were delighted to welcome Michael Sassano (CEO – SOMAÍ Pharmaceuticals) as the first guest on our new Global Whispers webinar series. Michael shared with us his company’s experiences bringing new products to market, the challenges SOMAÍ Pharmaceuticals have faced and the lessons the Pharma industry can learn from their journey.

In the webinar, Clare asked Michael about:
- Drug development and clinical trial processes for medical cannabis products
 - Differences between the herbal medicines market and the Pharmaceutical market
 - Overcoming regulatory and reimbursement challenges
 - Finding the right place for cannabinoid medicines within existing pathways of care
 - Perceptions, pathways and routes to access in different markets
 - Lessons for the wider Pharma and Biotech industries

Learn more about this webinar and our guest speaker Michael Sassano at: https://mtechaccess.co.uk/global-market-access-journey-cannabinoid-pharmaceuticals/

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Transcript

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- [Narrator] Welcome to this Mtech Access webinar. At Mtech Access, we provide health economics and outcomes research and market access services from strategy through to implementation. Get in touch today to discuss your market access goals. First, though, I hope you enjoy the webinar.- [Clare] Welcome everyone to the first Global Whispers webinar. This is the first of a new series from us, so please look out for future webinars that we'll be putting out in the future. The topic today is what it takes to bring a cannabinoid pharmaceutical to market. I'm Clare Foy, I'm the Director of Global Market Access at Mtech Access. We have a great audience joining us today from industry and from healthcare systems. And I'd particularly like to welcome our global affiliate partners who play a key role in the work that we do. For anyone that doesn't know us very well, Mtech Access is a global specialist health economics, outcomes, and market access consultancy. We have a track record in expert delivery and we provide specialist support to our pharmaceutical and Medtech clients. We work as a collaborative partner to healthcare systems in the UK and worldwide. And today we're focusing on product development and specifically the challenges and opportunities of bringing a cannabinoid product to market. I'm delighted to welcome our guest, Michael Sassano who is CEO of SOMAÍ Pharmaceuticals. Welcome Michael, thank you so much for joining us today. Could you please take a moment to introduce yourself and your role at SOMAÍ?- [Michael] Thanks for having me here. I'm glad to be a part of your first of the series. And yeah, my name's Michael Sassano, I'm the CEO of SOMAÍ Pharmaceuticals. We're Lisbon based pharmaceutical manufacturer concentrated on cannabinoid formulations for the European market.- [Clare] Fantastic. So we'd love to hear a bit more about the company and also about your own career background. So let's start by hearing a bit about the company and your vision for the future and how you're helping patients today. And we'll take people on a journey through, you know, where you've come from and where you are now and what your aspirations are.- [Michael] Yeah, absolutely. So I started in the cannabis business in the United States, and I've lived and worked in Europe for the last few decades. And I decided that the time was right to build a facility in Europe that concentrated strictly on the manufacturing of formulations, and ultimately to make medicines out of cannabis for the European market. So what SOMAÍ Pharmaceuticals does is, you know, structurally, we take the product from the growers, the farmers, the cultivators, from all different countries, mainly here in Portugal, and we process that. So that's a method of we extract it, we will distil it to make it a more refined API ingredient, and then we'll make formulations thereof. Now those formulations may end up in final dosage form for drops, sprays, oral drops, sprays, soft gel caps. We also make transdermals, we're working on creams with another pharmaceutical company, but the idea is that we will make multiple delivery devices as well as multiple formulations, so that the doctors have quite a lot of choices when trying to administer cannabinoid containing medicines for their patients. And our basic premise is to offer the doctors a wide range of delivery methods, as well as formulations to treat all sorts of indications that they may be addressing for their patient base. And on top of that, our addressable market is in multiple countries. So it's not just the EU, it's all around the world actually, where cannabis is accepted as a medicine.- [Clare] That's wonderful, thank you. So what about you? Let's hear a bit more about you and your career to date and what has led you to this career that you're currently working in now?- [Michael] Yeah, I mean, in the beginning, you know, my career was based on a combination of Wall Street and then real estate development. I saw when the European, when the US markets were opening up initially in the early days, there was a need for infrastructure. So I took that building and banking background and applied it towards the cannabis industry. As time went on, you know, we realised, okay, well mostly 90% of the people out there are actually addressing some sort of ailment and could be something more serious. As we know, people are addressing more serious ailments like multiple sclerosis, or epilepsy, cancer 3, you know, but then there's less serious stress, anxiety, possible sleep disorders, which could be severe or mild in their needs. And that ultimately led us, led me to building more facilities that were more concentrated on what exactly we were trying to solve. So early on we got, I started working with pain clinics to address different variations, pain is a very general topic, but you know, various pain applications for their patient pains. And then I saw as Europe was opening up that applying the same need for infrastructure existed there. But it also segued into, you know, in a higher challenge to address indications that weren't accepted yet in Europe, and trying to not only make products for that, but also address clinical studies, informal and formal clinical studies in order to open that market up past what already currently exists in various pharmacopoeia here. So the history kind of segued from, you know, looking at it as the opportunity to build more infrastructure, which is still needed in most countries, especially Europe. Even the United States to some degree needs a much more massive infrastructure to support what's currently there, but also to segue that into building that knowledge and education for doctors in order to address things that aren't currently being addressed in the markets.- [Clare] I think you've touched on this a bit, but I'd be interested to hear a bit more about how it was discovered that medical cannabis was something that had therapeutic potential and the journey from discovering that to actually getting it licenced as a medical product. So could you tell us a bit about the drug development process please?- [Michael] Yeah, absolutely. So if you think about, you know, the development of the US market as a base to where we are here in Europe, the US market started off as medical markets, same with Canada. Both started off as as medical markets. Now, it wasn't the medical that we understand here in Europe, it was a much easier medical market. A patient could come in to a doctor, there would be a general understanding of what they were trying to solve. And you would get in the United States, a general card which would allow you to enter into a dispensary. And so what started off as a medical market, you know, changed into what I would call an OTC or an adult use market, fairly rapidly. In the 2014, 2013 era it started changing to that. Still today, roughly 10 billion dollars is generated under what I would call a quasi medical market scheme as opposed to the entire market in the US at 31 billion. And as you juxtapose that to the Canadian market, it's roughly a 4 billion total market whereas that market segued very quickly from a medical to a OTC adult use market, the medical side of that is much less somewhere in the range of 200 to 400 million. So what does Europe look like comparatively to those markets? Europe's roughly around a 500 million dollar market and that market you have to go to a doctor and each country has different rules. Germany, as an example, has made it much easier to access medical cannabis that could rely on, they can rely it basically on the doctor's guidance as to what's best for their patients. And that was a reform that happened back in 2017. Well, that market has grown to a roughly around half of the entire European market, 250 million plus. Whereas some countries, as an example, the UK, in order to receive medical cannabis, the doctor and the patient has to show that they've tried three different therapies before they move on to cannabis. Obviously that's a lot more restrictive than the doctor's choice. And that market is is clearly a much smaller market comparatively to markets that are much more open. So what does that involve? So mostly what we are addressing, you know, from SOMAÍ Pharmaceuticals perspective, the herbal medicine market of cannabis. So we are making formulations that have as initial APIs, the THC distillate or THC crude oil, or the CBD crude or distillate oil, and then combinations thereof. Now, these require a different standard of registration than if you were to go for full clinical trials like your Epidiolex or your Sativex. And for the herbal medicines and for the countries that support them, you're generally proving out a quality standard, which would be the EU GMP Pharmaceutical Quality and stability at minimum of proving out at least one year's worth of stability and should be two years worth of stability. So the journey starts with, in making those products, the journey would start with your initial inputs, which would be those two APIs, CBD or THC, the formulation of them with your reactors, the bottling of them. And you have to come to a decision what markets addressed. So for example, Germany is a magisterial market, so these would be registered as magisterial products, whereas other countries like the UK, Australia, which is not in Europe, but accepts EU GMP products, these accept finished dosage forms, and you would make those products, and the initial products were oral drops but now things are starting to develop, other products from the sprays as I said that, so my deals with soft gel caps or capsule, you know, are becoming more popular delivery methods, creams and transdermals, all which require registration. So that's the general process. And if you'd like, we could even go deeper as to the formulations or formation thereof.- [Clare] Thank you, I think that gives us a really good insight. I mean, there are obvious differences in the herbal medicine market compared with the pharmaceutical market. I think I'd be interested to hear about the challenges you face from regulators. You've talked about the manufacturing process and purification and so on, but have you, what other kind of challenges have you faced in terms of generating data? What evidence have they wanted to see about the efficacy and use of the product?- [Michael] Yeah, that's a great question. When you start with the first premise the manufacturing side, approving out your quality and stability. Well this, even though this is a tough step and there's a lot of challenges inside of those steps, it's probably the easier step when you try to zoom out and look at the regulatory aspect of each country. So each country has a different regulatory framework. They have different regulatory paperwork requirements, although, you know, much of it's very similar. You know, show us that you manufacture this under GMP, show us that you have your stability at least one year, you know, these are your basic paperworks, but then the nuances get much more complex. So let's start with the basics, right? The magisterial prep market. So countries like Germany, or Italy, or Poland right now, you know, Germany being your largest market in Europe, Italy being your second largest in Europe, and Poland an up and coming market, just as examples of magisterial prep markets. Each one of those countries, although similar, the regulators have a different look and a different understanding of the extract use. In Germany, which is one of the older markets, they're more used to the extract market. So the development of different formulations has become, you know, let's say power for the course for them. They understand the difference between an extracted oral solution or that the pharmacies may want to buy distillate and then combine the THC distillate and then combine them. Whereas the Italian market, they're just getting their arms around the concepts of extracts and have registered just three products, although the second largest market. Now Italy, previous to that, most of the control came from the army and they controlled all the distribution, they controlled all of the pathways for cannabis and it would occur in the form of a tender offer. They would offer out producers, cultivators, the option to join in a tender for the Italian market. What's changed is that now the health regulators, although flower is still regulated by the army, now extracts which products that we produce are directly registered with the Italian regulators. And they have the say so as to those products that come in the market. And as it's just starting out, there's a limited amount of products that are available, but there's nuances also as to what they want. So the German market may want 30 millilitre bottles or 25 millilitre bottles with magisterial caps, whereas the Italian market may be looking, although they will accept that form, they're also looking that there's compounding steps. So they would prefer to have more bulk magisterial APIs. So if you were going to make your 10:10, 10 THC, 10 mgs of THC and 10 mgs of CBD, and you would've normally be distributing that in 30 millilitre bottles and you would, that would be your normal finished doses or magisterial prep form for the German market. The Italians would maybe prefer a hundred millilitre or a 500 millilitre solution that can then be broken down by the pharmacist into smaller orders, more tailored to the individual patient's needs. So that could be, they may want a 5:5 or a 10:10 but the delivery that we would have to manufacture for them would be stability in a 500 millilitre casing. And you know, although each one of these countries, you know, basically conforms similarly to the next, there is differences in what they would require, or what they would prefer, or what their pharmacists prefer, or what their regulators consider a better product to be sold in that magisterial market. Now, if you reverse course and you look at finished dosage forms and you take for example an Australian market, which is very similar to the UK market also, they have similar health pass under special access programmes. Under their programmes, they prefer to have finished dosage forms. So they would prefer that the oral drops come in finish form with a screw cap plus a top that is a child resistant, that it's more commensurate to products you would see, for example, in the Canadian markets where it comes with a syringe and the dosages can be exacted from the bottle directly. It's not magisterial prep, it's delivered from the pharmacist ready to be used directly to the patient. And they would accept different formats of delivery. Australia or the UK will accept formats of, as I said, spray bottles. They will accept the formats of the gel capsules and the soft gel caps. And they want more finished form dosages forms, but they may even go farther than them. They would accept faster excipient mixes other than let's say your basic MCT oil or olive oil and they will accept excipients that may help faster absorption, more bioavailability. So these are advanced products that are more commensurate with the US and Canadian markets now, and they're willing to accept those at this point in time, or a nanoemulsion product which increases absorption and allows for more product, more of the cannabinoids to be accepted into your system. Well these products would be accepted now in those market, in those kind of markets, whereas the magisterial prep markets of Germany would not accept those markets, they're very strictest to their excipient mixes. And this lends to a lot of confusion, you know, because ultimately what's one product in one country is a completely different stability test that you have to do in another country because the cap is different, you know? The paperwork is different. If you wanted to recommend dosaging in a country like Germany, which you cannot do unless you have clinical trials on the dosaging. Well, in the market like Australia or the UK, there are dosaging guidelines based on practises from around the world that have been amalgamated or based on usages by physicians in Australia or the UK. So you can actually make guidelines based upon the common usages or informal trials, whereas most of the European countries would not accept this. And so each country brings that complexity of trying to understand not only what they'll accept, but producing the right documentations and the right stability for what they will accept. And that's the biggest challenge because at present we're dealing with nine different countries and every one of those countries is different either in a small way or a very large way. And for sure most of them are different in language, in requirements for paperwork, inserts, labelling, almost each one of those has a different, a label or paperwork required for them, as well as different paperwork necessary to register those products. So it's probably the most involved portion of the work and it's almost easier in my mind to make the formulations than to actually make formulations, and stability, and paperwork for each of those countries, and requirements for these countries. But then if you want to take it one further step, now you have up and coming countries, which are many. So Spain, you're expecting to hear their proposal sometime by June, it was expected at the end of 2022. And they will have their own requirements for access of cannabis products. So all of the up and coming markets, which is more than the existing markets, you have to keep track of, and make sure that although the paperwork is going to be similar, and to some extent some of it will be the same, you're going to have to develop a regulatory pathway and keep track of those companies and be prepared to address those countries when they come on.- [Clare] Yeah, I think that challenge is not unique. I think we can definitely draw parallels to the pharmaceutical industry there and it's very interesting to hear about the variation, but I think as I say that, that's definitely the case in other markets as well. So I know you have access to patients in several countries now, but what is the picture in terms of reimbursement? Have you had to deal with payers? Have you actually managed to get some reimbursement in those countries or is it mostly out of pocket payments by patients?- [Michael] The majority of countries are out of pocket, but in Germany the majority is insurance driven. So, but it's been changing. So let me give you, let's focus in on Germany'cause that really is the insured market of choice, let's say today. If in the past both flower and extractable products were accepted for insurance reimbursement, the insurers as well as the doctors prefer extract. It's more commensurate with the pharmaceutical application than the flower market. And so the insurers have been pushing back, and successfully, at reducing their exposure, let's say to the flower market and have pretty much put most of their weight towards extract market. So the extracted formulated products, magisterial prep products that are being sold by the pharmacist. So that's very robust on the extract. And the trend is towards that and to go away from the flowers. Now with that, and roughly in Germany, there's about a 50/50 split when it comes to the overall market of insured versus private pay scenario. But when you put that towards the extract, it becomes 90% insured to 10% uninsured. And the biggest, and that trend's going to continue, but keep in mind, extract may only occupy about 15 to 20% of that German market and increasing, the largest segment of increase. And if that becomes like most mature markets in the world, it'll probably be either 30 to 50% of the entire market. But they're in the very early stages right now. So early products that initially came, there was, you know, and you're only talking the past three years, extracts have started to emerge in the market. There was limited selection, now there's quite a lot of selection. What may have been one brand is now 15 brands, which may have been one or two formulations is now 15 to 20 different formulations. But still the product diversity is not there in order for that market to really get more robust. And what do I mean by that? So there is the addressable issue of absorption and feeling the effect. And as an example, if you are to take an extract formulation at this point in time with basic MCT oil, you would have an onset of roughly 45 minutes to approximately an hour depending on many variables. And if you are in pain or you're trying to solve an issue, well, too many patients, that's a little bit too long, quite a bit too long and they end up gravitating back to the flower because it goes right into the lung system and it's absorbed almost instantaneously. And so there's one aspect of providing that relief and the more advanced products that are more commensurate with larger markets like the US where faster absorption and bioavailability is almost commonplace. And addressing that concern and the adoption of that concern is going to be a driving factor to the insurers being able to support, only supporting or majoritively supporting, ensuring that extract market. And not all people can take an oil based solution. Not all people can accept MCT oil into their systems or other, so that's also going to decrease adoption. And it'll also be a concern for the insurers to understand that some people, that the majority of people that are seeking relief by the flower may not be able to convert to an extractable product as they are being sold, or at least produced for that market today. As we see more advanced products, more delivery devices trending away from a magisterial prep market, you'll most likely see insurers being able to take a heavier stance as to how they want to address ensuring the patient bases going forward.- [Clare] That's really interesting. I just wonder if you could tell us a bit more about the patients that could benefit from cannabinoid therapy. I know you mentioned one or two earlier, but in what areas do these products offer potential?- [Michael] Yes, so I mean there there's two trains, there's two thoughts, two trains of schools, and maybe three actually. So let's take the three areas of cannabis products. So the first one is I said earlier would be a true pharmaceutical product that has gone through clinical trials. And those products that exist on the market today would be products like Epidiolex, Sativex, Marinol, dronabinol. And so those are, and there's about 300 different trials going on right now for other medicines in that area. So what generally are they, what indications currently exist there? So multiple sclerosis, epilepsy, stage 3 cancer relief. These are your top indications, but the clinical trial, there's a lot of clinical trials, as I said, 300 to up to 1300 when you add in CBD 300 on the THC side, 1300 roughly on the CBD side. And they're addressing indications anywhere from sleep to multiple different pain disorders, is generally anxiety, stress, certain mental disorders, what they're looking at. So there's quite a few that they're addressing there. Now, the second train of thought would be the herbal medicine market. And once you kind of enter into that area, which is non-clinical, you're looking more at the data of what people are using. So as I said earlier, the Canadian market is a very interesting market because it's one of the older medical markets for cannabis. And the Canadian regulators just put out recently a really great 200 page report, which basically summarises factually what the doctors are prescribing, what the patients are using it for, and has a lot of different indications as to their preference, the patient's preferences, and what their preferences anywhere from service to product selection, to indications they are solving. And it's a very wide range. So it's the major ones that I had indicated before, multiple different areas of pain management, similar, you know, things that people are trying to address mentally, you know, anxiety, stress, sleep, all of these keep coming up one through 15 as the top indicators of what people are trying to accomplish. To less of a degree there's not much data out of the US market because it's not federally accepted. There's quite a bit of data coming out of the Australian market. They keep addressing similar indications, as I said, under the herbal remedies. Herbal medicines and how they're being used, how clinics are using them. And the same in the European markets. We're looking at similar data, which is delivered to us by the regulator, but not clinical. And then if you were to break down the third category, which is the larger swath of the cannabis market, it's the over-the-counter market or the recreational or adult use market. And there is no necessary data there except for informal papers. As I alluded to earlier, there were studies where 90% of the people using self-administering cannabis are using that to solve the similar indications that I've I've outlined. And it seems that most of the studies and most of the success is rotating around things that involve the CB1 and CB2 receptors. Things that, especially things that affect your nervous system, different pain management. These seem to be more commensurate with a successful use cases, anti-inflammatory qualities, things that, you know, there's a lot of work going into arthritis now, especially with the use of CBD, it's anti-inflammatory components that looks very promising. You know, they're mixing that with, they're also looking at the usage of different terpenes to enhance it, which is more on the herbal side of our equation as opposed to the pharmaceutical side. But it's all around the board in those areas. But as an example, one final example, you know, many studies have been done around pain and has been very inconclusive because, especially around THC, because the psychotropic effective THC to one person, it may be helpful, it may be used in its various pain management testings, on the other side, there's enough evidence to say that the psychotropic may enhance the pain effect to some people. So the results are not there from a clinical standpoint, but when you go down to the herbal or the OTC standpoint, there's a completely different look as to how people are treating themselves.- [Clare] Hmm, yeah. There's still so much we don't understand, I guess, about the brain and how that works. And it's quite interesting, leads me to the next question about the perception of using these products. So how have you found that patients react to the idea of using this kind of product and what have you had to do to change the perception and educate people that it can be safe and efficacious and help them with these complicated conditions?- [Michael] Yeah, I mean, I guess in one side, I'll take back a previous statement that the hardest part was dealing with regulators. And I would say the hardest part is educating doctors and patients. And so I could kind of, I'll take a global perspective on that. If you look at a US market as an example, the cannabis producers are getting direct feedback from the patients or customers that come into the dispensaries. There is no doctor in between and there is no pharmacy in between. So direct from the dispensary where the patients or clients would purchase the product to the producer exists. So this market has developed very rapidly and the information is very detailed because every point of sale, a place offer some kind of programme to capture information as to why the clients are using and why those patients are using it. What is the feeling of those products, what's the acceptance of those products, even down to do they like the labelling, they're gathering all this data and it's a very robust data gathering process. Larger companies like Columbia Care currently, they have advanced data collection programmes for almost everybody that walks in. Whether it's customer loyalty programmes or offering people chances to test out different products in order to gather information on those products for research and development, for making other products. Do you like the taste? You know, all of these things are being analysed in real time and very fast. You know, they can make a product and put it on the shelf with no stability, with no necessary quality standards that we have to deal with here in Europe, making a medicine. So there's a tremendous amount of information that we can learn from those markets, but it doesn't necessarily apply when we transfer over that understanding to the European market. Now we have, as a manufacturer, we have a pharmacy that we would deliver to or a distributor in between, and there is no data flow between that pharmacy and us, or that pharmacy, or that distributor and us. Maybe we would get details on, we would obviously know about volumes that are necessary but not necessarily what people are using. And then that information becomes even more blocked from us when you add the complexity of what the patient is dealing with, with their doctor, that's between the patient and the doctor. So we as manufacturers to some degree, we're blinded as we are, we're much more blinded than we are when we're dealing with a market like the US and we're getting direct information to make products better and make products for them. You know, that said, a lot of what we are bringing to the market is we understand that certain markets want, you know, certain formulations that are common to the doctors, and how they're prescribing them varies greatly. So, you know, generally people dealing with issues like cancer 3 and pain like that, they're looking at 25 milligramme to 50 milligramme and even higher up to a hundred milligramme dosages of THC in order to solve the issues that they're looking at. So we have general understandings what they are and we do understand from feedback of distributors and pharmacies that were direct to, you know, what formulations are working best. And then we get general information from the regulators of different countries as to what they want. But still educating those doctors, there is no advertising per se, and getting, you know, talking to the doctors and explaining to them the different usage of the products, especially in Europe is still very arduous process of knocking on the doors, sitting with the doctors, showing them different data that you're using and collecting in order to help them to understand how better to prescribe the medicines. And if you are dealing with, let's say the 200 to 100 and even less doctors that are prescribing in Germany as an example, you know, maybe there's 30 main ones, well that's not so, you don't really need to educate them. They have their own ideas. But now, you know, when you span that out to the thousands of GPs, or trying to get to all the various pain clinics, you know, now that task becomes almost impossible for an industry our size or the size of our industry'cause it's quite small. You know, we don't have hundreds to thousands of salespeople around that can address those markets. So you're more confined to industry conferences where the doctors may gather, or specific pharmacists may go to learn about the products. And still you're not going to get, you know, to that granular level, at least at this stage. And there's not much help from the governmental organisations to educate these doctors. You know, and especially there's not really much help to educate patients, there is no direct to patient education programme that us as manufacturers could embark on. So, you know, there's a massive gap of education that a market like the US that can propel itself to a 31 million dollar market fairly quickly because there's no curbs, there's very little curbs as to the educational tools that are available for doctors, or for patients, or for consumers. There's, you know, plenty of online and ways to research from the US perspective. But then when you put that to the European perspective and the doctor's perspective, there is no necessarily link that you could find information online, you can decide if that's credible information, you would have to segregate to information in your language, which makes it even much less than educational programmes that you might want to search out. Once you go from the English language, where you could find lots of literature, which is the same in Canada or Australia or any of those markets. And then you're looking for Italian literature, well, there's going to be a significantly lower amount of that if you want to study about that. And from the doctor's perspective, there's even less credible information that they could draw on in order to make a decision whether or not to prescribe cannabis for their patients. So that educational level is a monumental task being conquered by the cannabis producers in Europe, but also in various clinics that are developing around Europe, and those are your primary sources at this present time.- [Clare] That's great, and again, I think we can all relate to that and the importance of tailoring the value proposition to the audience so that you're getting the information across in the right way. Yeah, it's really interesting. I think just with the last five minutes or so, you described some big challenges in this journey and I was wondering what lessons you think pharma companies or other manufacturers in the space of healthcare could learn from your story and how could you inspire them perhaps with overcoming some of those challenges?- [Michael] Yeah, I mean, look, if you're a contract manufacturer in Europe trying to, and thinking, and you have the ability to manufacture narcotics, which is your starting requirements. You know, there are producers like ourselves that are happy to educate you as to what the opportunities are. And I think that's a useful tool to understand it. You also, you know, if you're, we all have the ability to read the same information. It's how we interpret that information, which becomes the challenge. So, you know, if your country is not currently one of the main countries that I've talked about, so, you know, in the Netherlands, you have the Netherlands that has a programme. Denmark has a programme, the UK has a cannabis programme, Germany has a cannabis programme, to some smaller extent, Ireland has a tender programme for a limited amount of indications. It's less that you'll be manufacturing there then that programme is accessed for all existing products that are manufactured. France has a programme more in a test phase. It's, you know, there is questions as to making the product in that country. Spain, although you can make the product in that country, they still have to announce their programme. Czech Republic, Czechia, you know, they have a programme, it's going to advance more. So, you know, Italy of course as I've mentioned. But there's some countries, although they may accept the cannabis like those, they may not allow the manufacturing of the product. So understanding your region and what the opportunity is in your region is important, and understanding who's up and coming. You know, what regulations might impact me as a contract manufacturer or pharmaceutical producer, you know, what could be coming and what kind of contacts could I make, for example, in Portugal, which has the largest European cannabis infrastructure in the EU. You know, can I reach out to those sources and try to see what the opportunity is in my country? You know, and the answers there is yes, that would be your best source to try to manage exactly what might come and prepare for that future. And what I would imagine is that after the December 2020 UN resolution to accept cannabis as a medicine, that more countries will either look at the economic impact of them allowing the production of cannabis, either in manufacturing with existing pharmaceutical manufacturers or cultivating, you know, more countries will allow that economic, let's say advantage to open up their countries, but then as to opening up the medicine to their population that may be a completely different challenge, a completely different set of understandings by the political or health ministers of those countries. And, you know, we are watching in real time those things happening. As I said, Spain is one of the larger countries that should come online this year. And that process has been long, you know? And almost to some extent painful to watch. You know, it went from just a few weeks ago, you know, a few months ago, let's say we're expecting regulations at the end of the year, 2020 to just a few weeks ago, the health minister saying,"Well, I only see evidence of the help that cannabis can provide in the range of multiple sclerosis and epilepsy." Clearly that would be the stance that GW Pharma would take as a clinical trial drug manufacturers. And then suddenly a week later they say,"Okay, we're going to have a framework in place, which may include the herbal manufacturers like ourselves to give broader access to their doctors." So, you know, each country not only may make their decision in manufacturing, but each country has a separate decision making process in order to support the possibilities of their patient bases and their doctors. And understanding those two differences are probably the key to your geographical location or your decision to enter in, or distribute, or produce, or manufacture, or even go to cultivation of a cannabinoid products.- [Clare] That's great, thank you. I think we can all relate to those challenges, the challenges of diverse market needs. And I don't think this is unique at all to this therapy area. So even if you are outside the medical cannabis world, I think it's certainly something that we've experienced in healthcare. I suppose the key is to come up with a strategy that accounts for all of those differences and mitigates for them so that you know, you've got something that works across the different needs and different archetypes. So thank you Mike, that was really fascinating. We enjoyed hearing about that. I think it's a new area for some of us and I think it's been really insightful. So thank you for your time, and thank you to the audience for listening and we hope to see you again in our future webinars. And please do get in touch if you think there's anything Mtech Access can help you with. Thank you.- [Narrator] Thank you for watching. If you'd like to find out more about our work or how we could support your market access goals, please email info@mtechaccess.co.uk or visit our website at mtechaccess.co.uk.