Reforming Psychedelic Policy for 450 Million Europeans

Floris Wolswijk, the founder of Blossom, breaks apart recent developments in psychedelic research in his column on Lucid News. Blossom is your go-to place to find insights on the latest psychedelic research and the companies bringing this into practice.

To date, most of the psychedelic conversation has taken place in the U.S. But now change is underway in Europe. Though it attracts less attention – and by many measures it is far less developed – activity in Europe should not be overlooked. Boasting a population of nearly 450 million, policy reform enacted by the European Union has influence far beyond its borders.

I recently spoke with Viktor Chvatal, the Secretary General of PsychedelicsEUROPE. We discussed the founding of the initiative, policy changes in Europe, and how to get things moving inside a Byzantine organization.

What is the story behind the founding of PsychedelicsEUROPE? 

Chvatal: We established PsychedelicsEUROPE (PE) in the spring of 2021. We are a team of public affairs professionals, and we had registered a gap in Brussels regarding evidence-based advocacy for the medical use of psychedelics. At the same time, we have been also personally engaged with the topic, each of us in our own way and for different reasons.

From a larger perspective, PE was established just in time when the ‘mental health momentum’ hit the EU. In short, healthcare as such used to be a regulatory realm of the EU Member States. This changed recently with ambitious initiatives such as Europe’s Beating Cancer Plan, the revision of the EU Pharma Legislation or the revision of the regulatory framework for Blood, Tissues and Cells.

Then, prompted by the impacts of COVID-19 and, more recently, the war in Ukraine, mental health entered the room and, as a topic, is growing in significance amongst EU audiences. Among other things, we can mention the communication on the EU comprehensive action on mental health proposed by the European Commission in June this year.

As PE, we are trying to ensure that psychedelic-assisted therapy (PAT) or novel mental health treatments are an implicit part of this trend.

You recently co-established the MEP action group, a cross-party platform on psychedelic medicines in the European Parliament. What is the objective of this group?

We co-established the MEP Action Group on the Medical Use of Psychedelics with PAREA in May 2023. The establishment has been a tangible result of approximately two years of work. It is an agenda-setting and awareness-raising platform chaired by Members of the European Parliament from various political groups.

The group’s key objective is to accelerate the preparation of the regulatory landscape for psychedelic medicines in the EU Single Market. The group should also provide insights and recommendations for the regulators and policymakers for dossiers relevant to PAT, such as the above-mentioned revision of the EU Pharma Legislation or the emerging EU mental health strategy.

In my opinion, the group should also spotlight emerging practical topics such as cost-effectiveness or reimbursement schemes. There is a crucial need to address these issues properly to engage payers and regulators more effectively. Nevertheless, the pool of answers is still relatively scarce.

How does PsychedelicsEUROPE operate? Is it different from the lobbying being done in the US and UK?

Our work is very similar to the work of a public affairs agency. First, we monitor legislation and gather intelligence. Subsequently, we want to have a legitimate impact through participation in public consultations, outreach programs or organization of policy events. In general, EU policy-making (and with that also EU lobbying) is pretty technical. Therefore, we often cooperate with experts and scientists when formulating our positions, goals and tactics. In a nutshell, we strive for evidence-based advocacy.

I cannot say much about the lobbying in the UK; however, compared to the US, EU advocacy is probably more top-down, meaning that, for example, the grassroots campaign is not very prominent here.

Apart from what has been already stated, we have been lately focused on raising awareness about existing best practices from the EU Member States. In particular, the Netherlands and the Czech Republic are promising cases. Last but not least, we want to set an agenda for new emerging topics. One of them is the potential of PAT to mitigate war trauma in Ukraine.

Fighting for Access to Psychedelics on the European Continent

Part of your work focuses on healing trauma for those in Ukraine. What is the prospect of psychedelic-assisted therapy (PAT) being available through the healthcare system?

It’s a case suis generis. We haven’t dived that deeply yet to deal with regulatory practicalities. Put simply, after COVID, the European Commission focused on mental health. Recently, the EU regulator rightly registered the specter of a silent mental health pandemic resulting from the war in Ukraine. We advocate for the idea that mental health should become an implicit part of the reconstruction of Ukraine.

On the occasion of the annual World Mental Health Day in October, the European Commission hosted a high-level conference in Brussels chaired by Stella Kyrikiades, the European Commissioner for Health and Food Safety. At this event, Olena Zelenska, the first lady of Ukraine, stated that Ukrainian experts are operating under extreme conditions and are pioneering novel and unique approaches to mental health treatment.

We fully agree with this statement and believe it can be extrapolated to PAT. That’s why we organized an event in the European Parliament on November 28 titled “The Potential of PAT in Mitigating War-Induced Trauma: the Case of Ukraine.” Specifically, we would like to elaborate on MDMA and ketamine-assisted therapy. The expert speakers are Prof. Dr. Eric Vermetten, MD, Ph.D. (Leiden University, the Netherlands), Dr. Olga Chernoloz (Phoenix Ukraine, Canada), and Prof. MUDr. Jiri Horacek, Ph.D., FCMA (National Institute for Mental Health and Charles University in Prague, the Czech Republic).

I’m more than convinced it will be a very interesting event!

How are you interacting with drug developers, both nonprofit and for-profit, that have psychedelic medicines in clinical trials? Recently MAPS delayed their European Phase III trial indefinitely. Does this mean the work of PsychedelicsEUROPE is also delayed?

It’s no secret that the private sector is now predominantly focused on the US and other non-EU markets. However, that doesn’t mean that the EU has become irrelevant. Europe’s regulation is very much being cooked in Brussels, and healthcare, as well as mental health, is in the spotlight. We are in touch with numerous experts, researchers, and developers with both profit / non-profit and EU / non-EU backgrounds.

We live in a world of multi-level global governance, and the legalization of medical use of psychedelics is being catalyzed from numerous places, Brussels included. I’m personally and professionally convinced that the pendulum of interest will gradually swing towards Brussels, not only because of the ongoing revision of the EU Pharma Legislation.

Can you say more about the pharma package?

The revision of the EU general pharmaceutical legislation is a key deliverable of the Pharmaceutical Strategy for Europe and yet another step in creating the European Health Union. On April 27, 2023, the European Commission adopted the so-called Pharmaceutical Package, which, for the first time in twenty years, looks into how to revise the EU’s rules governing medicines for human use and to ensure a future-proof and crisis-resistant regulatory landscape for pharmaceuticals.

The proposed package is a response to long-lasting challenges in the EU’s pharmaceutical sector, which were further exacerbated by the COVID-19 pandemic. Some of these persistent problems observed by the Commission include unequal access to medicines, shortages of medicines, the lack of innovation to address unmet medical needs, and gaps in developing antimicrobials to tackle antimicrobial resistance.

To address these challenges and remain competitive and attractive for the pharmaceutical sector, the Commission proposed two legislative acts, including a proposal for a regulation for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency (EMA), as well as a proposal for a directive relating to medicinal products for human use. 

There are critical openings for the medical use of psychedelics, be it from the perspective of unmet need, funding, or the support of innovative treatments.

Finally, I want to ask you about the cooperation with the EU member states. You said earlier that you’re working with The Netherlands and the Czech Republic. How is this partnership going, and what outcomes would you like to see?

Again, we need to understand the context. To a certain extent, in the last two years, we and our partners (such as PAREA) invested in awareness-raising activities in Brussels that eventually yielded some significant results. The EMA is well aware of PAT, and they are organizing an important stakeholder event next year; there is a group in the European Parliament raising awareness and launching inter-institutional dialogue. What we need to add to the palette is Member States.

With our contribution, the Czech Presidency of the Council of the EU (Q3/Q4 2022) brought mental health to the table. Spain, Belgium, and, after them, Hungary is following suit. This is significant since it creates further space for discussing PAT.

What is needed in the mid-term horizon is active Member States that could become a flagbearer of the topic in the Council. When you look at best practices, you can single out the state-established commission on MDMA in the Netherlands. In the Central and Eastern Europe region, you have the Czech Republic, a country with, in regional comparison, very advanced ecosystem for psychedelics, existing attempts for progressive regulation (e.g. the ongoing draft of the Act on Psycho-modulation Substances), and an emerging system of reimbursement schemes for ketamine-assisted therapy.

Our job for Q1 2024 is to make these things well-known in Brussels.

Image by Floris Wolswijk.