“Psychedelic renaissance in Europe is delayed one or two years compared to the United States”

Antón Gómez-Escolar (Madrid, 1988) has been involved with psychedelic substances for a good part of his life, first with projects such as Energy Control or Kosmicare (Boom Festival) and, more recently, as a member of the Spanish Society of Psychedelic Medicine, director of the book collection ‘Las guías del psiconauta’, in which he also signs the book ‘Guía esencial del renacimiento psicodélico’ (Essential guide to the psychedelic renaissance) and a populariser in the channel “La Drogopedia de Antón” and the INAWE observatory. It is no coincidence that Gómez-Escolar has become one of the visible faces of the so-called ‘psychedelic renaissance’ in Spain.

We chatted with Antón about the current state of psychedelic-assisted therapy in Europe, about research in Spain and about the eventual (and unlikely) integration of the shamanic model in the future regulatory framework.

Here you can listen to the full interview.

You participated in the conference on psychedelics for mental health organised by PAREA on 6 December at the European Parliament, what feelings did you bring back from Brussels?

The feeling I took away from Brussels was very good, in the sense that I realised that the MEPs who came to listen to us in those presentations we made came with their homework done, they came knowing what we were talking about very well, moreover. In other words, they had a good knowledge of the subject and were aware of the urgent need to move it forward, since mental health is one of the European Union’s main priorities at the moment.

In terms of legislation, where would you say the continent is in relation to North America or Australia?

It is true that Europe is lagging behind those countries in the ‘psychedelic renaissance’. The United States has had more financial support and probably had a clearer vision of going for commercialisation, that is, they were going for clinical development of the drug. Also, the big architect of the psychedelic renaissance is, in my opinion, MAPS, which is an American organisation whose goal is to make this substance [MDMA] available to those who need it most around the world, although the first step for them is to make it available in the United States.

Is the FDA being more receptive to psychedelics than the European Medicines Agency?

It is true that in Europe it is not as easy to move, bureaucratically, as it is in the United States. It is curious because criminal legislation in relation to drugs in Europe tends to be more open or more lax than in the United States, for example, or in Australia, which is a country with very draconian laws, very difficult to navigate at a legal level when it comes to illegal substances. However, there has been more business and political will there. In fact, the Australian movement has come from the politicians themselves. They have been the ones who have pre-empted their own drug regulatory agency: “We are not going to wait for the clinical trials to finish, we are going to approve it straight away because there is a great need, because this is being seen to work, so we are going to approve it for some authorised psychiatrists to prescribe it”.

The emergency fast track…

That’s right, in the United States the FDA has already given it an emergency status, the approval of ‘breakthrough therapy’, which is a designation given to drugs when they have very good results in terms of safety and efficacy and it is understood that the pathology they are intended to treat is very widespread and there is a real urgency for this drug to be available to patients. This does not work in the same way in Europe. Europe has been slower in processing clinical trials, so we are indeed behind schedule. I do not think it is a very serious delay. In fact, if we look at the specifics, esketamine, which is the first psychedelic that has been authorised for mental health use in history, was authorised in 2019 in the United States by the FDA, but it was also authorised in 2019 in Europe by the European Medicines Agency and in Spain, four or five months later. It is also true that in the case of esketamine we are talking about a substance with a very clear commercial interest, with a lot of resources behind it because there are big pharmaceutical companies that are willing to bet on it. This is not going to be the case with drugs like MDMA or psilocybin, which are substances that no longer have very clear patents. MDMA was patented in 1912. In short, Europe seems to be a year or two behind, probably a year or two behind in terms of what would be the legal procedures for approval of the medical use of psychedelics. Until these treatments begin to be tested for real in the United States, we cannot see how far behind Europeans are.

Can MEPs fast-track approval “Aussie-style”?

Personally, I don’t think Europe will do the same as Australia, firstly because we are not a country and the European Union does not have those competences, and secondly because the Union will always follow the guidelines of its European Medicines Agency. What I do know is that in recent months there have been several calls for attention to the European Medicines Agency from different Community actors, with letters published in Politico.eu, which is the most important political media in Europe. There is also a paper published by the European Medicines Agency talking about these therapies, so that’s where the attention is right now.

Another big difference between Europe and the US is that in the United States there is much more of a culture of popular legislative initiatives. There are cities or states that go straight to decriminalising a substance by popular vote before any regulatory agency does anything. This route serves as a different shortcut to the Western medical regulatory path. The popular vote also serves to decide that the substance should be the last law enforcement priority, which ‘de facto’ removes its illegal status and allows the substance to be used in other contexts without having been formally legalised for therapeutic use.

This is unthinkable in Europe.

Unthinkable. We have the case of cannabis, which in the United States legalised its use via popular initiative in several cities decades ago. In Europe, as far as I know, there have been no such votes, although there have been other types of social structures such as cannabis clubs that have sought to exploit the law, but there has been no clear social initiative to vote to regulate it. The result is that in the United States we see much more rapid progress in different ways and for different uses. In Europe I think the only thing we are going to see for the moment is the therapeutic issue and we will have to wait for the European Medicines Agency to authorise it in a few years and then each national medicines agency will have to transpose this directive into their national legislation and that will also take a few months. I estimate that we are talking about a delay of probably one or two years compared to the United States.

You have used the word “urgency” a couple of times. Do you think that Europe is also in this situation of urgency as far as the mental health of the population is concerned?

I think we are in a very urgent situation. We have levels of prevalence of mental disorders in the population that are frankly alarming. In fact, it is said that mental disorders are the leading cause of disability worldwide. This is outrageous, especially if we take into account that we come from a time when mankind was afraid of physical illnesses, infectious diseases, accidents at work… and now we have moved on to something totally psychological. Right now it is mental illnesses that are squandering the wellbeing of the population, their quality of life and, of course, the health systems, because it is very expensive and very difficult to treat mental illnesses. They are very resistant illnesses, which are very incapacitating for the person and make all kinds of activities difficult, not only physically but also intellectually.

Therefore, I see the urgency as very clear and, in fact, it is one of the great elements that have been behind the development of psychedelic-assisted psychotherapy at this time: now, after decades without relevant innovations in the field of mental health treatments, there really is a situation of alarming need that truly justifies jumping into a pool that years ago they didn’t dare to jump into and now they do.

What limitations do you think psychedelic therapy has?

A very important limitation that we are going to face immediately is the limitation of implementation because, although it is true that these treatments are very effective and efficient because they save a person from having to spend years going to therapy and we can solve it in a few interventions in a few days, then there is the reality of clinical practice. If we are talking about a country that relies heavily on its national health system, as is the case in Spain, it is very difficult that overnight and with the same resources that the health system has today, we can offer so many patients this treatment that requires many hours of a therapist sitting with a patient, a treatment that requires a very intensive and rapid intervention. Moreover, we cannot talk about the patient being able to do the therapy “in instalments”, as it is done now: half an hour with the psychiatrist and you don’t get another appointment for three months.

What will probably happen is that these therapies will be available to a specific part of the population, those who have more resources, because they will be able to access them through a private route. You have to bear in mind that you will need a psychiatrist (or whoever they authorise) with you for 6 hours at a time, plus some preparation sessions and four or five integration sessions after the psychedelic experience. It would be miraculous if we had the resources to apply it to the whole population.

Any other limitations to implementation?

As we have seen many times in the history of medicine and pharmacology, treatments always offer fabulous and even incredible results when they are in the experimental phase of clinical trials. Then, when it comes time to apply them in the real world, the balloon deflates quite a bit, i.e. they show less efficacy. This makes sense, because when you are in a clinical trial the conditions are ideal: the patient is the ideal patient, has all the inclusion criteria, has no exclusion criteria, the therapist is mega trained in how to intervene, monitored and also both the researcher and the patient have expectations that this is going to work and that makes the environment perfect for it to work.

In the real world, when you come across clinical practice, the most normal thing is that the efficacy of these treatments is much lower than what we have seen in clinical trials. We have to lower our expectations a little, bring our feet down to earth a little and understand that although these treatments are very promising, this does not mean that they are going to be a panacea, miraculous, nor that they are going to free us from the structural problem that we have in the West from which a large part of these mental disorders emerge. There are structural problems in our society that are behind the rise of all these mental health illnesses and psychedelics are not going to fix them, no matter how good the treatments are.

What role is left for traditional, ritual and shamanic practice in the future landscape of mental health with psychedelics?

I fear that in countries that do not specifically regulate the use of these plants within the right to freedom of religion and worship, they will remain outside the law. For example, the United States authorises the use of certain psychoactive substances as long as they are the central sacrament of a number of religions that they have included in a list of authorised religions and, therefore, this exception is allowed for the practitioners of that cult or religion, but this is not something that is universal in all countries. Consequently, I believe that those countries that do not have special protection for this right are going to see how, at a legislative level, these substances, which today are already illegal or illegal, will probably remain in the same state, while marketing is authorised only for certain companies that have some kind of patent or market exclusivity and, of course, their use by a series of health professionals, most probably psychiatrists, who will have the power to administer this medicine or use it…. I think that, given the shortcomings of the system, we are going to see a combination of different professionals and, for example, a psychiatrist will administer the substance, but the monitoring or subsequent integration sessions will be carried out by a psychotherapist, for example, or by a person who is not strictly a psychiatrist, because a psychiatrist’s time is very expensive and scarce, so it could very well be a psychologist, facilitator or even a nurse who is there to accompany the patient and take vital signs from time to time to guarantee safety.

And what will happen to facilitators working in the ‘underground’ today?

I think that at a legal level, they will remain in the same situation they are in now, I don’t think they will go backwards, but I don’t think that a legal use outside the medicalised regulatory framework of a controlled substance will be contemplated either. There is always the fear that pharmaceutical authorisation will be accompanied by a persecution of traditional uses that have been there for centuries, as a way to guarantee a certain “monopoly”, to clear the market of those uses that were already there so that only the authorised use remains, but I want to believe that this is not going to be the case. I hope that the huge contribution that the traditional uses of psychedelics have made to this new renaissance in the West will be taken into account. That is, if it were not for traditional uses, we would not know that psychedelics can cure, nor would we have virtually any of the elements of psychedelic-assisted psychotherapy that are so successful today. It would seem to me to be a striking injustice if these newly licensed treatments were to come along and the first thing they did was to put even more pressure on those who have been using them without problems for centuries. Having said that, I am afraid that these kinds of legislative decisions are on a level that is not very humanitarian or common sense. I hope that legislation on the use of psychedelics will be legislation that will be influenced in some way by the effects of psychedelics themselves, by which I mean I hope that those people who legislate on psychedelics will also have had some knowledge of how these plants work. In fact, one of the aims of the Spanish Society of Psychedelic Medicine is precisely to maintain an active dialogue with representatives of the traditional uses of psychedelics in order to also try to respect their legitimacy and that somehow these uses are not outlawed by future medical licensing legislation or in future medical use in the countries of the Global North. It doesn’t make sense that a use that has been around for many centuries and many millennia bringing benefits to communities and without causing major problems is now going to be outlawed because we have decided that we are going to use it in the West as well, and unfortunately this has happened in previous situations in history.

Do the associations of which you are a member also defend this hybrid model of mental health, biomedical and shamanic?

More than defending a hybrid model, which could be interesting but can be very complex to include in such a rigid regulatory framework as the health sector and with current scientific standards, what is being defended is that justice be done and the ancestral way of working of those peoples whose knowledge has allowed the psychedelic renaissance to take place in the West and that we now have this fantastic tool for the treatment of mental disorders such as psychedelic-assisted psychotherapy on the table. This does not necessarily mean that there is a hybrid model, but it does mean that there can be a coexistence and that no more pressure is put on those uses that have existed for centuries or millennia and that have been proven not to cause any public health problems.

How do you see the knowledge of the Spanish political class regarding psychedelic therapy?

First of all, I would like to add that in Europe there has been a big acceleration since more or less September 2022, that is to say that less than half a year ago psychedelics started to be seriously discussed at the level of the European Medicines Agency.

In the end, the whole orchestra will play to the rhythm set by the European Medicines Agency, and as far as the regulation of medical use is concerned, I don’t think anyone is going to get ahead of it.

The case of Spain is very curious, because here we had the enormous privilege of starting up the most advanced line of research in psychedelics today, which is MDMA for post-traumatic stress, thanks to José Carlos Bouso’s study in Madrid, but, as usually happens in Spain, we have great researchers but there is a lack of support and funding for research and, in general, a lack of innovative spirit in the administrations. There is a great fear of innovating, of being the first to do something, there is a fear of making mistakes and this fear is what holds back this type of research. Those who don’t take risks don’t lose, but they don’t win either, and in the end that means falling behind and losing anyway. Unfortunately, we have a tremendously ignorant political class that does not look beyond its own prejudices or those of its voters, and this was clearly seen in the way Bouso’s study on MDMA in post-traumatic stress was closed down. Now it turns out that the great mental health innovation of this century is going to be psychedelics, and having had them right under our noses for 20 years, and with world-class researchers, we have let them slip through our fingers so that other, braver countries can now take the lead.

That said, I think Spain is in a very good legislative position to do research with psychedelics. Our laws are much more lax and open, which also facilitates certain research frameworks, as well as research into unregulated therapeutic uses, such as ayahuasca ceremonies, consumption groups or clubs, which would be absolutely unthinkable in other countries.

More so in Catalonia than in the rest of Spain…

That’s the way it is. The most innovative mentality in Spain is in Catalonia; you only have to look at where these kinds of initiatives flourish. In Madrid, we’re not so bad either, but it’s true that in the psychedelic field, strong research groups have not yet crystallised. For example, in Seville we are having a very bad experience: we had everything we needed to start a psilocybin clinical trial just waiting for the ethics committee to give us the green light and, after a year of waiting and answering questions, two days ago the ethics committee told us they didn’t know what psilocybin was. This is very frustrating, because we have everything to be able to succeed at European or even world level but then you find yourself with this lack of interest, this fear, when there are already dozens of successful studies in this field.

The result is that, in the end, the research that is being done in Catalonia [MDMA at the Hospital St. Joan de Deu and others] is being done by foreign companies that are taking advantage of the good legislative climate in Spain to bring their clinical trials here.

I think we have a good legal ecosystem for research with psychedelics but we are not taking advantage of it ourselves because we have no industry, no major funding for public research, no retreat companies, etc… It is a shame that, being something that also started here, we could have been pioneers and exported professionals and expertise, and yet we are going to end up as usual: buying it from other companies outside of here.

An industry that needs a certain legal certainty before investing.

Today we already have much more protective legislation than in other European countries, but you can’t base an entire psychedelic industry on this difference: you need legal certainty. I am afraid that is going to take a long time, and the case of cannabis is very illustrative. It is a substance that was approved for medical use in 1996 in some US states and has been extended to recreational use, while in Europe we are still debating which countries can use the plant therapeutically. The same thing is happening with psychedelics: the culture and knowledge has existed here much earlier than in other countries, but we are the last ones to introduce legislative changes. I must say that in the case of psychedelics I am more optimistic than in the case of cannabis because in this case there are a series of pathologies for which it has a very clear use and research is being carried out through the “pharmaceutical” route.

As a result, the path it is taking is very straight and limited through the European Medicines Agency, which is different from that of cannabis, which is taking a more complex path legislatively, with important debates on its administration model, utilities, pathologies, safety, etc. and a lot of struggle from civil society. I think that psychedelics for medical use will be available in Spain even before cannabis.

How long do you estimate it will take to be implemented?

It is going to be a slow process because of the obstacles I mentioned earlier: the way the health system is structured and the time a psychiatrist spends with a patient, which is 15 or 20 minutes, we can’t imagine that a psychiatrist could spend 6 hours with a patient. Psychedelics will not take long to be available in private clinics, and in fact sketamine already is, but they will be accessible to large masses of the population.

Is it a requirement to remove psychedelics from the UN banned substances list for the psychedelic renaissance to become a reality?

It is not strictly necessary but it would be tremendously helpful. In fact, the scientific use of substances is always authorised, regardless of their legal status, but it is true that in terms of scaling this up to the national health service level, it would be a major problem if these substances were still in Schedule 1.

Apart from Schedule 1, there are other, less restrictive schedules. These include drugs such as amphetamine, a substance which, despite being used outside the medical context in the form of speed, is sold in pharmacies because it has recognised medical uses such as the treatment of attention deficit hyperactivity disorder. I think there will come a time when psychedelics will be moved up the list to be more accessible to health systems, but if we look at it in terms of geopolitics, there are countries that have a strong moral influence in their legislation – such as Russia or China – and are likely to reject this reclassification. However, countries like Australia or Canada have already approved the medical use of psychedelics or cannabis, and at the level of international drug policy nothing too relevant has happened yet.

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