Advancing Psychedelic Access in Europe - Inside the European Forum of National Psychedelic Societies

With psychedelics, we apply a disruptive intervention with which we open a window for psychotherrapeutic change. >> It appears that these are some of the most effective treatments that we have much more effective than standard anti-depressants and just psychotherapy. And it is imperative that we offer to the people that are suffering access to evidence-based treatments that are effective [music] and we do have them now. So this is why I'm advocating for psychedelics. >> These drugs are we talking about are mainly LSD, psilocybin, MDMA, also demetrialine [music] which is the active component in Iawaska. Some of people would also classify ketamine or ibagane as as psychedelics also 5met. Our idea at the moment is to push forward mainly psilocybin for treatment resistant depression for example and also in the future MDMA for post traumatic disorder [music] because those are probably the two indications and the two substances that are more research and more developed at the moment. Our role is probably to make it h happen sooner, [music] faster and safer because we really think that if we wait a lot of time [music] for these innovations to happen, there will be life lost in the in the process. We are an organization that wants to make sure that [music] psychedelics are brought to public healthare systems and to people in a way that is responsible, ethical, driven by science and that we see in the future equitable access that people who [music] really need these treatments can have them available and we hope that uh this will be also covered by by health insurance. It feels really good to be part of the of a group in in in Europe that is trying to bring forth the psychedelic case. >> Supporting Paria made a lot of sense because we see that psychedelics are the new revolution and the new uh the new space in which we can definitely see hope uh coming in. >> This therapeutic option is possible in Switzerland thanks to like a compassionate use approach. So it's [music] uh exceptional medical use of a substance that is still an illegal illicit drug. [music] Actually Europe could do a lot because uh it's a possibility for European countries to access directly to illicit substances in a compassionate [music] use way. So there is actually uh the jeridical um framework to do exactly what's happening in Switzerland in every given European country. So I would say people should just start doing it. We are privileged at PA to have this 360 [music] overview to see what's happening in many other countries and [music] we just believe that there is such a wealth of experience and enthusiasm and knowledge there that it would really make sense to put everyone together in the same room and then you know the magic happens. So so that's what we really uh did. We brought everyone together. So we have today leaders from 25 countries and almost 30 organizations with us. So I feel like we are really making history um with this gathering today. [music] Psychedelic uh treatments, psychedelic drugs are still largely speaking a category that is called investigational drugs. they are still undergoing uh clinical trials that are supposed to show on large populations that they are they have a positive risk profile on one hand and on the other that they are efficacious and then of course cost effective more down the line. So we are still at the stage where they are just um the trials are just kind of passing through late trials which are big trials with hundreds of people. So this is kind of large enough to really give us a solid signal about their efficacy. So this is where the field is with an exception of ketamine because Bravato is already approved as the treatment but all the others are really nearing this finishing line but a lot of companies in the space are prioritizing the US and they will be kind of filing for these new therapies and um registering them in the US and in Europe. We see that some countries say we do not we do not want to wait. We believe we know enough about their therapeutic potential and we can start already at a very kind of small scale with pilots make them available for people who have tried many other therapies but you know it didn't work for them. So we have Switzerland who has been doing something that is called limited medical access for around 10 years now with more than 4,000 people who are already uh helped. We have the Czech Republic and Germany who last year introduced early access programs in Germany. It's a compassionate use for psilocybin for treatment resistant depression. And in Czecha then they rescheduled psilocybin for treatment resistant conditions. Not only depression, it could be maybe alcohol use disorder, maybe anorexia, but of course mostly this will be still depression. And we have a number of other countries and organizations who are here with us in Brussels who are exploring how to engage with their regulators and policy makers to also open up these little pockets of access in their respective countries. [music] Compassionate uh use is um actually a European program. It's a it's a European regulation of drugs that are in development that are in clinical trials but that have not yet been approved. It's for patients who cannot participate in such a clinical trial and it has to be a life-threatening disease. So if you think about our program, it's treatment resistant depression. That's of course a life-threatening disease. There is enough evidence that psilocybin is working. There are clinical trials running several um uh in the world and uh so that that that's sufficient to fulfill the criteria for a compassionate use program. It really helped that we had done our study. So we we provided all the results of our clinical trial that was a lot of paper all uh efficacy data safety data to the regulators in Germany. Uh we wrote a treatment protocol which was close to our study protocol and of course we we could show that we have experience with this treatment and uh and then it was relatively um straightforward uh to to get the this approved [music] in Switzerland. Psychedelic assisted therapy is legal since 2014 for uh exceptional medical use of substances that are still considered like illegal drugs. So we can use MDMA, LSD and psilocybin having a specific request to the federal office of public health for a specific patient which must be a person having a uh treatment resistant mental health problem. I would say there are already some data on the real world use of this therapy that uh at least are comforting us in the safety of it and also are already showing its efficacy. The demand in Switzerland is still very high. There are only I would say around 100 medical professionals that can uh do psychedelic therapy. So it's [music] still quite a niche. >> [music] >> In 2016, I opened a a clinic in New Mexico um doing ketamine for depression and then brought that to Norway. Over the last years, we've been focused on getting generic ketamine approved in the public system. And we did that through uh health technology assessment uh through the uh medicines agency, not in a compassionate use uh way that they recently passed it in uh France. We very strategically focused on ketamine. Ketamine's already approved. Um it's legal. It's used as a medicine. What we decided to do was to implement on a national level public ketamine for depression. And by all the infrastructure that you need for any psychedelic assisted therapy, whether it's MDMA or uh psilocybin or anything else, it's pretty much the same. So the the everything around the process is very similar. As soon as these other drugs come, which they will soon, you can just plug that right in into a functioning public health system where people can have access to this for free, which is, you know, what we need. A compassionate use dosier in Belgium cost €25,000 simply to submit. So in July of last year, [clears throat] we managed to secure the funds for dosier actually for two dosier from a single philanthropic donation. So what helped us first and foremost starting from a very clear why and in our case that was to expand access for patients who do not have time to wait in an equitable and affordable way. By 2025, we already had two clinical trials running. And we think this is a key element. When you're interacting with the authorities, you want to have the credibility and the knowhow already established. The third one was creating critical mass. So we mapped and identified all of the existing knowhow within Belgium. All academics, clinical psychologists trained abroad or doing retreat retreats abroad. Um and we built partnerships with them. So these are really highc caliber people who want to support our initiative people who really want to do something with psychedelics in Belgium. We hope to be able to submit by the 1st of December next this year [music] which means that by the end of March next year we could um we could end up with a decision on doier. Our main focus is um making psychedelics accessible in Ukraine [music] and uh as far as right now it's not allowed to do any research and any medical use of the substances in Ukraine. We have some same uh situations is probably in a lot of country. We have the some substances listed in a forbidden list and what we need right now is to reschedu to transfer the substances to the other list where we can have a kind of controlled use of those substances. When the war started, it started to be clear that the population of Ukraine is highly traumatized right now with the PTSD, with war related trauma and a lot of other things uh including the injuries and the loss on the battlefield. This is not the PTSD as we say, it's not post-traumatic, it's ongoing trauma. So that's something that makes Ukraine different from other countries right now. And of course we have to treat a big uh number of veterans and their families and their family members. We have one of our co-founders Tanislavi Medulan. He is a war veteran. He is amput. What he says that suffering the physical injury wasn't for him as hard as suffering mental problems and this PTSD and its effects. So he tried the therapy with salicyad and with mushrooms just you know natural ones and it proved to be very successful and only one time one session was enough to cure him which for him it's a kind of miracle and he is open to tell his story and he did it in a European parliament yesterday so we are open and we are like talking about those cases because it helps us to advocate and there some representatives of Ukrainian government were this event some our MPs and the best professors European institutions par and others and we had a very productive discussion on on this and I assume that we achieved a kind of a milestone where some kind of decision have to be made to allow at least researchers in Ukraine because they desperately need it. [music] So the state actually in Spain when it comes to psychedelic research and regulatory development is changing quite fast actually we're having a lot of uh clinical research studies being done in the last previous year and we really hope that in the next years there's going to be much more in the last year we have been working very hard to pushing forward the the access of these treatments mostly uh via the compassionate access program that is what we want to achieve and especially we want to build something similar to Germany. So having a program that all hospitals are following the same uh procedure the same protocol that way we can compare the results we can generate scientific evidence at the same time as we are treating patients that are really in need of these uh innovations. [music] the access to psychedelics in [music] Poland um for now um it's only in the clinical research in Poland we didn't have hippie revolution in the 60s so basically psychedelics are classified and also seen as dangerous narcotics of abuse and um to change the opinion of the public um we have um organized uh the conference psychedelic science and we organized this conference in collaboration with the department of law and administration at the Warso University. We have also created the first post-graduate studies in Poland about medical potential of psychedelics and we are trying basically to change the law uh to decriminalize psychedelics and also to legalize [music] the medical use. [music] Cannabis and ketamine are legal for medical use right now. [music] When it comes to other psychedelics, we are a little bit left behind, but we are very slowly catching up. We have our first clinical trial in Athens and the Saloniki uh for treatment resistant depression in three hospitals and it just started this year. So the the trial is with silosin and it uh it offers some kind of hope that we are catching up with other developments that are happening [music] in Europe and the the rest of the world. [music] There are two access pathways um for kind of early access um of psychedelic substances. there's a compassionate use as it is in Germany where you have to find a an institution that gets um the permission to do compassionate use program with sponsor company that is providing the substance and there is also a named patient use in Austria. The named patient use is is a patient by patient um decision and a patient by patient case and does not need to be connected with a specific sponsor company. Currently none of those projects are realized in Austria. So none of them is happening yet. So we're trying to talk to authorities um also to stakeholders how this could be um possible to implement. >> So in Estonia we are one of the few countries in the EU that doesn't have any clinical trials running currently. I mean we are a small country. So we're then also trying to learn from the steps that have been done elsewhere that we don't have to invent the bicycle ourselves and right now uh what is accessible in in Estonia is a kamin as a therapy but right now in private clinics we saw the first clinic opening up last year and it's it's a brave first step and which seems to have also motivated uh other or the next next psychiatrist to open up clinics in in different uh cities across the country and so kamine uh since it's uh still used off label means that it doesn't have a national health reimbursement. This this means that it's still you know quite quite not accessible. It's only for those who can afford it and right now there's only one doctor who is you know doing the therapy which means you know there's a huge line and and so we need we need more uh clinics opening up. We need to increase the access we have in Brussels all the EU institutions that are legislating that that are deciding about our everyday life in different countries to some extent it's also happening with health certainly with scientific research as well and so this is why para is really very active and engaging with the EU policy makers we have European Parliament we have the European Commission where we for instance there is a director general for health director general for research there [music] is a council which brings together all the 27 member states and they you know do a number of different policy ps and files and legislations that are relevant to [music] public health to mental health and will be relevant to psychedelics increasingly there's the European medicine agency of course so [music] that's where we want to be and that's where we want to influence these processes >> the paria network has been very very helpful in first of all empowering us [music] seeing that there are so many other countries in the same stage that we are and we are not alone in you know [music] trying to raise awareness and trying to change the [music] the legal status of the substances. On a second level we have access to [music] to information and training and resources that we wouldn't have otherwise. So [music] so the network can actually help us get where we want to go faster. >> We are doing it uh very well as a team. we are learning from each other and I think this is the way to go the way we're going at the moment like uh national developments and international exchange at the same time that we have also contacts and connections with international organizations like the European medicine agency or the European Parliament as we were doing yesterday. All that going in parallel I think is the way to go for a faster and especially for a more efficacious uh implementation of psychotic therapies in the European context.