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When João Gama started practicing law in the cannabis space, working on regulation in the Portuguese and European markets, “to be honest, no one around knew a lot about it other than criminal lawyers that would defend drug dealers.”
“So I started and soon I became very immersed in the drug policy debates in Portugal and abroad,” Gama says on The Cannabis Enigma Podcast.
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Gama breaks down the difference — or lack thereof, depending on whether you’re talking law or botany — between hemp and marijuana, what needs to change before patients have access to standardized CBD in Europe, and looks ahead at what the future of global cannabis law looks like.
“I believe we are reaching the tipping point where cannabis will be legal in most of the Northern hemisphere at least,” he predicts. “And when that tipping point is achieved, there is no turning back.”
Produced by Elana Goldberg and Matan Weil, edited and mixed by Michael Schaeffer Omer-Man. Music by Desca.
Full Transcript
Elana Goldberg: Hi Jaoa, thanks for joining us here today.
João Gama: Hi, how are you?
Elana: I’m great. Thanks. So we’re here at the Portugal Medical Conference. We’re right at the end of the conference, and, we heard a whole lot of really interesting lectures throughout the week. I just heard your lecture, and I’d love for you to start off by telling us how did you get into the cannabis industry?
João: Well, that’s a nice question. I started, so I’m a lawyer and I started as a tax lawyer. That was my original work, and also at university, at academia, I’m also teaching at academia. Five years ago I started my own law firm and I decided that I could choose my clients for the first time. I had a long interest in cannabis and cannabis regulation. We have in Portugal a very forward-looking drug policy, laws from the 2000s. And I’ve always had that interest and even before on drug policy.
We had at the time some poppy authorizations, some opium cultivation sites in Portugal that had been just authorized when I created the firm, and I started, well, why don’t I look at the cannabis space? There must be something out there in the world happening. And it was happening of course, as you know. And we are talking about 2014, ‘15, it was starting to happen. Portugal has ideal conditions and we started looking at companies that … we’re looking at Portugal or speaking with companies that could, uh, see Portugal as a destination.
And then I started to study and, for a legal scholar, someone that really loves the law it’s an area of law which has many layers to it. So it’s very complex. So we have the UN conventions, criminal law, narcotics law, medicine law, also cultivation, et cetera. And all these areas interplay. And there was also, to be honest, no one around knew a lot about it other than criminal lawyers that would defend drug dealers. And therefore it was a space that was not taken. It was a space that was very complex, very beautiful in terms of interaction of laws. And it was also a passion that I had for a long time.
So I started suddenly and soon I became very immersed in the drug policy debates in Portugal and abroad.
Elana: One place where the complexity is particularly clear at the moment is in the CBD space, both in terms of hemp-derived products and cannabis-derived hemp products. Can you break those concepts apart for us a bit?
João: Yeah, so, to simplify it, we have a plant and that plant has two… there’s the high THC plant, which usually is called cannabis or marijuana, and hemp, which has lower THC, more fiber. But even if you go deep into these, you see that the division is not very clear in terms of taxonomy and botanicals. And the more you read, the more you see that also those areas of science are not yet clear.
But typically, what countries tend to regulate differently is plants with a THC level that’s above a certain limit, and plants that are not, that are below the certain limit. Hemp is to be very traditional in Europe, was very traditional in Portugal for many centuries. There were even laws that forced farmers and families to plant hemp for clothing, for ropes, for the ships that went around the world, etc. Then it went down when we joined the European Union. In the beginning, there was even public funding from the EU for the low- or no-THC plants.
Then this, this cannabis craze started and people look again at what could be extracted from the other plants. And there is this, uh, CBD, as you know, a part of a cannabinoid, of the plant that has non-psychoactive effects or at least doesn’t have the traditionally psychoactive effects of THC, which is getting you high.
Therefore people started to see what uses can be given to this. But the complexity here is that when the UN treaties that then stemmed to the national narcotics laws were written, people, well, Israel hadn’t yet discovered which were the cannabinoids. So the plant was, was listed as such, the plant, the flowering tops, the leaves, and no one knew that there were cannabinoids there or even the cannabinoid system in humans. And they are still written like that.
Which means that when you want to have an extract of the plant, which is a controlled substance, you, you either fall into the approved industrial uses or you are under the narcotics law. And what we’ve seen is a CBD space all over the world: This company’s trying to enter a space making claims of uses for products and some of them not wanting to abide by the rules of those areas of influence, meaning the company is trying to create CBD products to treat seizures and not wanting to abide by the medical cannabis or even medical regulations.
And then we have another use for CBD, which is food and food related stuff or food supplements. But in Europe, I don’t know in other parts of the world, but in Europe we have the, now since January, 2019, the, the novel foods catalog, which says that apart from seeds, all CBD extracts are considered a novel food. Meaning they were not eaten in Europe before or consistently eaten in Europe before 1997, when the regulation was out there. And therefore, companies need to apply for an authorization, need to prove, need to pro- produce evidence that it’s not toxic, that, uh, which would be the intended use for persons, meaning because it’s a new food, customers should be protected and thus customer should be protected for the substance to be listed, proof has to be done that it’s not harmful for people.
But here there’s a catch, which is that, normally if you ask for that authorization and you produce that evidence, you will not get any proprietary right or a patent unless you apply for article 26 of the regulation. You can have some protection for five years. But traditionally that’s difficult to obtain, which means that the CBD space in Europe is waiting for some company to produce the evidence to make the big investment to get CBD in the food catalog, knowing that once that happens, if article 26 is not applied, a wave of thousands of companies and products will enter, will the free ride this effort and enter the space.
So there’s a lot of confusion because regulators feel that sometimes they may be fooled by companies or some companies even sell hemp flowers which taste and smell like cannabis as drug, narcotic drug, which creates of course social unease, social unrest, the police, how will the police distinguish from a joint made with the low THC hemp and high THC, cannabis?
They don’t have a lab with all of them. So this creates a number of problems that make regulators and governments be weary of that. But the industry is moving and it happened just a few days ago. In the UK, the industry is moving, proposing regulations and being proactive, wanting to be regulated and proposing standards for all the products we categorize differently to have requirements differently so that they can hit the shelves and help patients and consumers.
Elana: What does this mean for, for the products that ended up on the shelves that are available for consumption from a standardization perspective?
João: Yeah. Standardization is an issue, lots of studies have been done very, very recently in Austria, in Czech Republic, in Germany, that show that all the products do not contain any CBD or they content more THC than they should, or they contain heavy metals, more than the can or they should, no one knows about if it’s the flowers about, pesticides, etc. So for consumers is, of course, companies want to hit the shelves very quickly, but for consumers, that’s not a good way to go. And consistently studies have showed that there are a lot of fast claims in the CBD space or even products that are not very safe for use.
And one thing is you get your CBD drops that will give you some kind of — wellness or your skincare, the other thing. Even worse is if we’re moving into the medicinal space and you’re using CBD to treat or prevent seizures or spasticity, MS spasticity and that’s even less admissible. So it’s, um, it’s important for everyone to, to wait sometime, but to have the products with the standard and quality that customers and patients deserve and need.
Elana: Right. So what should consumers look for if they’re buying products, let’s say specifically within the EU, if they’re buying CBD products, what can, what can people look for that can kind of give them some reassurance about what it is that they’re actually buying and using?
João: So they have to see if medical cannabis is regulated in their country. Typically a CBD medical product would be treated as a medical cannabis product. Meaning it has to have a special market authorization. Now that’s what customers have to look for if they are after something that’s on the, on the medical space.
If they are on the food supplement space, because of these novel foods regulation, it’s very difficult to have any CBD product that is already legal or that is regulated that can prove otherwise. Uh, I don’t see how that can happen, uh, until we have the, the authorization and that the, the EU novel food catalog. Uh, of course this does not apply to seeds, to hemp seeds, hemp seed oil, hemp seed flower, which were used before 1997 and can still be used. And that, that they will have to look for the authorization for food supplement or the related category in the country.
Elana: You mentioned obviously, uh, medical use as being separate to wellness. So talking about the medical cannabis program specifically here in Portugal, would you say that this is a good model that other countries in Europe should be following? Or are there issues with the model at this point?
João: Well, yes and no. I’ll tell first the good parts and then what, what should be improved. The good part is that the Portugal parliament produced very quickly but listening to all the interested parties, legislation, the legislations out there. The legislation is out there and it’s regulated and it’s very careful on the cultivation, extraction, et cetera on that part for patients. That’s the good part.
The other good part is that the legislation provides that because this is new to government, because they invest in education and resources for, for doctors to know how to prescribe what to do. This is another thing.
Then the not so good part of the Portuguese legislation is that, um, and like for instance, Germany, I don’t know how it is in Israel, but then like Germany, we don’t have an open clause for prescription. So unlike all other areas of medicine where in Portugal, any doctor can prescribe any, any medicine, for medical cannabis, any doctor can prescribe it. We don’t have special doctors, I think like in Israel, for prescribing medical cannabis, but he can only prescribe if normal treatments are not effective or are costly for the patient as in Germany, but for specific conditions. And these conditions are still a closed list and they are very strict. There’s one that’s less strict and it’s important that if we look at studies, patients are getting medical cannabis all over the world, mainly for pain and mental health space conditions like anxiety, difficulty in sleeping, et cetera. We don’t have that, but we have pain, neuropathic pain written in a way that’s not very clear, but that can help patients.
The other conditions that are listed, fortunately are not very common, like Tourette’s syndrome or, terminally ill patients for some conditions, Dravet syndrome and other syndromes from epilepsy for kids. So these conditions, it’s very good that they are there. The medical cannabis movement was made also and mainly because of these kind of patients, but for general access, our law is very restrictive.
Elana: Okay. And so what are the next steps? So what kind of changes in regulation, would you predict happening in Portugal moving forward?
João: For the medical space?
Elana: Yes.
João: Okay, two things. One thing is that the law states that an informed regulator can add conditions to the list. Or can revise the list, can add or subtract, but can add. So that’s one thing we see happening as doctors get more acquainted with it. Typical care, I have lots of patients asking for this condition or et cetera. That can change when their patient associations can propose that to informatics. That’s one thing.
And the other discussion we are going to have probably sooner than later is reimbursement. Currently, it’s not reimbursed, so it will be very expensive for patients. But also that’s the way it goes in Portugal and new medicine is typically not reimbursed in the beginning and then they have the case has to be made for reimbursement. But, so that’s the, the, the next step for, for medical cannabis.
Elana: Okay. And zooming out onto a kind of global scale, there’s been a huge boom in the industry in the last few years. Where do you see things moving from a regulatory perspective?
João: Well, I see others too happening, uh, happening broadly all over the world in the next, uh, two to three years, that’s happening. It’ll happen in New Zealand, uh, U.S. States, Luxembourg is considering, uh, Holland is revisiting its cannabis program. We hear things happening in the UK, France, even in Germany. So I see Europe moving fast. I see the U.S. moving fast. I see Canberra, ACT in Australia just did it. Uh, New Zealand probably will pass, uh, the referendum in 2020. So I, I believe we are reaching the tipping point where cannabis will be legal in most of the, of the, of the Northern hemisphere at least.
And, uh, and that tip, when that tipping point, um, is achieved, there is no, no turning back. Uh, I think there’s too much, does have too much prohibition, the harms of prohibition are now well known. Uh, and uh, the counterintuitive fact that, uh, it’s worse to forbid than to regulate it, it, it’s changing. People saw the experiment of hundred years of prohibition, how it failed and now they will want to move forward.
On a different scale or a different level on the regulatory level, I believe that what’s happening now, both on the medical end, on the adult use sides of cannabis will also, uh, will also push for international instruments that are not a hundred years old, like the UN conventions in their framework, they are very old, but we will have to regulate the, the cannabis, the cannabis trade and cannabis access globally, uh, for countries that decided to move forward.
There are many options to do this. These countries can sit down and make a treaty, but they also can use what is called an intercity agreement. That’s when parties of an existing treaty can agree different rules for themselves. So this means that the countries that have either medical or adult use cannabis could sit down and negotiate a treaty that would be, that would be coupled with the UN treaty that would be under the one treaty, but that for cannabis would exclude and regulate differently both adult use or medical cannabis. This would, would be able to create a global supply chain, which is important when there is a treaty more than a side by side notifications. This would create frameworks for diversion for security, to attain the primary goals of the treaties, but for these new reality of the 21st century cannabis.
Elana: Really interesting. Thanks so much for being here with us today, and it was great to talk with you.
João: Thank you. Likewise.
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