Critical Observations from Collaborators

The integration of psychedelic therapies into European healthcare systems represents a complex challenge that extends beyond the scope of traditional pharmaceutical market access. While previous chapters have examined specific aspects of regulatory pathways, reimbursement mechanisms, and implementation approaches, this chapter offers broader perspectives from key stakeholders in the field.

Our contributors bring diverse expertise spanning commercial strategy, healthcare systems, policy development, and market analysis. Martin Gisby of Magnetar Access, offers insights on commercial strategy and reimbursement pathways; Floris Wolswijk, founder of Blossom, examines the future of psychedelic reimbursement in The Netherlands; Josh Hardman of Psychedelic Alpha, provides analysis of market access challenges and opportunities; Tadeusz Hawrot from PAREA, explores lessons from HIV/AIDS activism for mental health advocacy; and Viktor Chvátal and Sumudu Gouri Boyina from PsychedelicsEUROPE, review country-specific perspectives with a focus on the Czech Republic.

These essays deliberately look beyond immediate regulatory and reimbursement hurdles to examine longer-term questions of sustainability, scalability, and systemic impact. They highlight both opportunities and potential pitfalls, offering insights that may help stakeholders avoid common misconceptions and better prepare for the complexities ahead. While the contributors' views may appear cautionary, they reflect a shared commitment to ensuring that psychedelic therapies can be implemented in ways that are both practically feasible and genuinely beneficial to European healthcare systems and their patients.

Through these diverse perspectives, we aim to contribute to a more nuanced understanding of what successful integration of psychedelic therapies might look like and what it will take to achieve it.

Reducing the Risks for Commercialisation of Psychedelics

Martin Gisby

One of the key drivers of psychedelics research and clinical development is the for-profit commercialisation model of medicine, which is similar to most other areas of medicine. There are, however, many other entities in the psychedelics research landscape, including non-profits, charities and philanthropic funds, and academic researchers. While there is plenty of passionate debate on the merits of commercialising psychedelics and what economic & clinical model is morally appropriate, the commercial medicines route is the most likely route to secure broad and legal access to psychedelics for patients suffering from certain conditions.

A key question is which groups are going to have the resources and capability to prepare requests for marketing authorisations, maintain those licenses across Europe, and provide the support to clinicians and health systems to use these therapies safely. The resources required to do so are significant, meaning that even non-profit driven approaches require a clear commercial model, which will need to be underpinned by securing pricing, reimbursement and market access across countries. With this in mind, the following sections seek to highlight key considerations and opportunity/risk trade-offs that developers will need to make to balance the therapeutic potential of psychedelic treatments against hard economic truths.

Which Patient Population?

The population of interest for treatment with a therapy—the target patient population—is a central pillar of both the clinical and commercial strategy. With potential benefits across different conditions and potentially broad applicability, the desire to choose a broad patient group and address the needs of a greater number of patients is obvious. Developers and researchers must be cognisant that—in Europe at least—medicines with indications covering broad mental health conditions have struggled to commercialise successfully over the last decade.

When established treatments consist primarily of inexpensive generic medicines, new therapies face downward pricing pressure, either directly through payer price referencing and negotiations, or indirectly through the way this influences health economic outcomes like cost-effectiveness. Larger populations also predictably cause greater concern to payers over the additional budget impact. Therefore, therapy indications encompassing broad patient groups, such as Major Depressive Disorder (MDD) and Generalised Anxiety Disorder (GAD), will be very difficult to commercialise in Europe through national health systems.

A more risk-managed approach for developers in Europe is to focus on smaller populations with the greatest clinical need and demonstrate a significant clinical benefit. This increases the likelihood of positive HTAs and more favourable pricing and reimbursement decisions. It may seem unethical not to pursue broader patient populations if the therapeutic potential is there, but a poor commercialisation strategy in Europe may lead to insufficient revenue to cover ongoing commercialisation costs, or potentially to no market access at all.

It is also worth considering that even if pricing and reimbursement hurdles were not present, for many years after psychedelics receive a marketing approval, there is unlikely to be enough infrastructure to support use across large populations, and clinician advocacy for using these therapies widely will not be immediate.

In summary, careful selection of the target population is key for Europe, and making these decisions early and in the context of a future commercial framework is likely to be in the best interests of future patient access to these therapies.

Beware the Common Pitfalls of Drug Commercialisation in Europe

Although discussed in the report, it is important to call out some key considerations for developers. It is important not to assume that where good clinical outcomes are achievable, reimbursement and market access are assured. There is a long list of drugs and innovative therapies with excellent efficacy that have failed to achieve market access in Europe, including those with far less complex evidence packages and administration requirements than psychedelics have.

It is common not to be able to meet the value criteria of all country payers, through, for example, variations in expectations around study comparators, study endpoints, and what value is accepted. Early clinical development decisions tend to set the path to success or failure. Focusing initially on a smaller set of countries where the product is aiming to be commercialised helps prioritise the study, evidence and health economic needs. Developers frequently focus on PRMA processes in Germany, France, Italy, Spain and the UK to feed this into development decisions from Phase II clinical study design and onwards.

A critical approach in today’s drug market is to be flexible in considering how to enter into European markets, with tailoring of target patient groups, careful positioning in the local clinical pathway, and adaptive pricing helping navigate country-specific hurdles. Maintaining a rigid view and demanding absolute consistency across countries—even if coming from an ethical perspective on patient equity—risks leading to no access situations as payers do not need to or wish to consider alignment with other country systems or value frameworks.

Unique Psychedelics Commercialisation Issues - Entering Into New Territory

There are some ‘new-to-everyone’ aspects of psychedelics that present as uncertainties and potential risks that have not all been covered in this report and that developers should keep in mind:

• Multiple groups are completing clinical studies with the same active ingredient, e.g. psilocybin, LSD, MDMA. It is normal for only one developer to have the full intellectual property rights to commercialise a drug, but not so for psychedelics. This raises questions on what impacts this might have on critical commercial processes such as; intellectual property rights, regulatory exclusivity, pricing pathways and price referencing, and the potential for drug substitution.

• There has been a pivot to optimise psychedelic clinical studies to improve acceptability by regulatory bodies, including improving blinding, reducing psychotherapeutic components of care, and focussing on endpoints favoured by regulators. In this pivot, there is a risk that the already significant gap between what regulators wish to see and what payers expect to see will be even more pronounced for psychedelics. Developers must make any such decisions with both the regulator and payer in mind, and find the appropriate balance of opportunity and risk for the specific therapy and the specific indication - regulatory approval without reimbursement is a scenario all stakeholders wish to avoid.

• Scheduling of drugs is country-specific, as are re-scheduling processes. There is a need to understand how these processes will work, the time involved, and the potential scenarios that may play out. These need to be accommodated in market access planning and timelines, as well as working through any specific hurdles to implementation that remain after re-scheduling.

In addition to the above, the potential complexity of psychedelics therapy, i.e. an acutely psychoactive drug, plus therapeutic components, plus in-clinic treatment over hours—as well discussed within the report—are also new territory for developers, clinicians and health systems. This differentiated approach from traditional drug treatment, along with uncertainties such as those listed above, is a key reason why large pharma have shown limited interest in taking first-generation psychedelics assets into their drug pipelines and leading this commercialisation.

When More than One Market Access Pathway May Be the Optimal Approach

Commercialisation of therapies through the national HTA and reimbursement pathways is the most common route to market, and this should remain a goal across psychedelics stakeholders as it holds the potential for the greatest access and greatest equity for patients. This route is, however, likely to require some modification to adequately evaluate psychedelics and support optimal implementation. It would seem prudent for more than one reason for developers to look at additional market access pathways, such as those outlined in the "Potential Reimbursement and Access Pathways" chapter, including private insurer pathways, patient out-of-pocket, and charity or philanthropy-based care services.

If the national reimbursement route fails to deliver market access, these more restricted pathways may be the primary access route for patients. However, it is worth acknowledging that even in a situation where the national reimbursement pathway endorses reimbursement and access, the local implementation may be slow and restricted to certain sites of care. These additional routes of access, driven by private and charitable providers, are often more agile and quick to embrace new treatment approaches, and could play a key role in the early adoption of therapies, generating early insights into real-world practice, and thereby accelerating wider use in the clinical community. In particular, charity or philanthropic-based services often reach segments of society that are less likely to engage or be within the core health service provision. Developers should embrace partnerships that allow for these additional routes to be planned and implemented as a complementary approach to the national reimbursement system.

How Can All This Possibly Be Considered and Planned For?

With the number and variation in healthcare systems and reimbursement processes across Europe being so great, and with so many novel aspects of psychedelic therapy to consider, it is a potentially overwhelming situations for developers, especially if teams are small groups that lack prior experience of commercialising therapies, or the focus is on North America, with Europe further down the priorities list.

The key is to prioritise the patient group, the countries of primary interest, and the most relevant potential market access pathways, then map out when certain decisions need to be made. These decisions can be evaluated in turn to ensure the market access strategy and the commercial model are valid and steadily refined as the therapy moves through clinical development and closer to the market. A plethora of experienced consultants and advisors can be tapped into along the way, but a priority should be to identify the key stakeholders in the health system and engage with them as early as possible.

Many of the challenges to psychedelics market access do not have clear solutions and joint-working will be key, which means engagement at the earliest opportunity, a level of transparency on gaps in knowledge from all sides, and a flexible and agile approach to progressing common solutions. The alternative is to wait and have these gaps exposed very publicly at the point of market entry, but without the time or level of common stakeholder alignment in place to implement proper solutions. The latter scenario will leave many stakeholders unsatisfied and ultimately the patients with unmet needs who these promising treatment options may benefit will be penalised.

The Future of Psychedelic Reimbursement in The Netherlands

Floris Wolswijk

Even in a Best-Case Scenario, Capacity is a Major Bottleneck

Reimbursing psychedelic therapy is an important step, but it will not be enough. Even if approval, pricing, and integration go smoothly, there is a bigger issue: A lack of therapists to meet demand.

Unlike antidepressants, which a healthcare provider can prescribe in minutes, psychedelic therapy is resource-intensive. Based on discussions with trial therapists and psychedelic facilitators, most can manage one session per week. This limitation is due to the intensive nature of the therapy–sessions demand significant emotional processing and recovery time, precluding the possibility of multiple sessions per week. That is, at most, 50 patients per year per therapist, or 25 if two sessions are needed.

The Netherlands has 15,000 psychologists and 3,500 psychiatrists, treating around 1.5 million patients annually—an average of 80 per professional. Even if 1,000 therapists were trained in psychedelic therapy, they could only treat 50,000 people annually. While that may sound like a lot, it falls far short of demand. In the Netherlands, approximately 350,000 people suffer from treatment-resistant mental health conditions, including depression, PTSD, anxiety disorders, and alcohol addiction, who do not respond to standard care.

While psychedelic therapy will join the existing treatment landscape, its resource-intensive nature presents unique implementation challenges. Drug developers are actively exploring less therapist-dependent models, where nurses or other healthcare professionals could supervise sessions with reduced psychological support. While this might help address the capacity bottleneck, it represents a significant departure from the intensive therapeutic approach used in clinical trials. Understanding these evolving treatment models and their implications will be crucial as these therapies enter clinical practice.

The One-and-Done Myth vs. The Reality of Re-Treatment Needs

Advocates often frame psychedelic therapy as a one-off treatment—take a dose, process the experience, and move on. Such framing makes it sound simple, more like surgery than long-term psychiatric care.

However, mental health rarely works in such a binary manner. While psychedelic therapy for PTSD may approach a one-off model—where effective trauma processing might obviate further treatment—depression, anxiety, and addiction are different. They are not necessarily tied to discrete past events but to ongoing struggles shaped by stress and life circumstances.

A single psychedelic session may trigger significant change, yet for many, the benefits diminish over time, necessitating re-treatment. If, for example, half of the treated patients require another session within a year or two, the demand for treatment resources will double over time. This pattern of retreatment only exacerbates an already limited supply of trained professionals.

Health insurers and policymakers tend to focus on the cost per treatment. However, if psychedelic therapy necessitates repeat sessions without demonstrable improvements in long-term outcomes, in that case, the health system will incur higher cumulative costs without a corresponding reduction in the burden of other treatments. In other words, without a clear plan that shows improved outcomes, psychedelic therapy may simply shift costs without alleviating the overall strain on mental health services.

The Growing Pressure on an Already Overloaded System

Psychedelic therapy is entering a mental healthcare system already at its limit. The Netherlands has long faced waiting lists, staff shortages, and rising costs—problems that have only worsened.

Demand for mental health services has surged, partly due to the lasting effects of COVID-19. More people than ever need treatment for depression, anxiety, and trauma. Simultaneously, burnout drives many professionals out of the field, further restricting access to care.

Psychiatric treatments, including interventions such as rTMS and esketamine, are becoming more expensive. They require specialist staff and dedicated facilities. Although effective, these treatments are challenging to scale. Psychedelic therapy faces the same hurdle—it is not a pill but a time-intensive treatment requiring highly trained professionals.

The strain on healthcare providers' time raises a key question: Where does the time come from? No extra therapists are waiting to deliver psychedelic therapy. Every session takes hours a healthcare provider could have spent on another patient. Without more resources, other treatments will suffer.

Then, there is the issue of funding. Will psychedelic therapy fit within existing mental health budgets, or will it require additional funds? If these treatments do not yield better outcomes than existing ones, we risk incurring extra costs without reducing the overall care burden. Reimbursement models must account for this possibility.

Treatment Innovation vs. Systemic Constraints

Psychedelic therapy is not the first mental health treatment to show promise—yet promise doesn’t always translate to access. Regulators approved esketamine for depression, yet many patients still cannot obtain it due to its high cost, need for supervision, and clinical delivery requirements. Similarly, neuromodulation techniques such as rTMS offer strong results for treatment-resistant depression, but the expensive equipment and shortage of trained professionals limit its scalability.

Even traditional psychotherapy struggles with access. Therapy works, but the supply of therapists is grossly inadequate, with long waiting lists and a growing gap between demand and availability. Psychedelic therapy is no exception. It is not solely a matter of treatment efficacy—the fundamental question is whether the healthcare system can deliver it at scale.

If psychedelic therapy remains a niche treatment available only in specialist clinics, it will benefit some patients without easing the broader systemic burden. Moreover, expanding too quickly without a concurrent workforce expansion will strain resources and create new bottlenecks. A key consideration is whether psychedelics can reduce long-term care requirements for patients with chronic conditions, thereby positively impacting overall system capacity over time. However, achieving such outcomes will demand not only significant therapeutic breakthroughs but also large-scale treatment programmes and robust outcome data.

Are 2nd- and 3rd-Generation Psychedelics Part of the Answer?

If psychedelic therapy is going to reach more people, a fundamental change is necessary. The current model is slow, expensive, and overly dependent on a limited number of trained therapists. Even with full reimbursement, demand will far exceed supply.

This challenge has spurred discussion about next-generation psychedelic treatments. Instead of integrating MDMA and psilocybin into an already overburdened system, researchers are exploring ways to render treatment faster, more scalable, and easier to access. One approach involves modifying existing psychedelics. Several companies are developing shorter-acting versions of MDMA and psilocybin; if a session were reduced from eight hours to three, therapists could potentially treat more patients. These second-generation psychedelics do not alter the core treatment model but could make it more practical and affordable.

A more radical alternative is the development of ‘psychoplastogens’ that do not require therapist supervision. These third-generation psychedelics aim to retain therapeutic benefits without the accompanying hallucinogenic effects, allowing for at-home administration much like conventional antidepressants. Even if this class is not as efficacious as first- or second-generation psychedelics, the model of introducing drugs with incremental benefits over existing treatments—ones that healthcare providers can easily prescribe to thousands of patients—is a tried and tested approach that healthcare systems can successfully implement. While not intended to replace therapist-led treatment entirely, these innovations offer an alternative that might relieve some of the strain on an already stretched system.

Psychedelic therapy has the potential to help those who have exhausted other treatment options. However, securing reimbursement is only the first step. Without a strategic plan to address capacity constraints, workforce shortages, and long-term treatment needs, we risk creating a system that simply shifts costs rather than reducing the overall burden on mental health services.

Beyond Guinea Pigs: Ensuring Access to Psychedelic Therapies for Europeans

Josh Hardman

With several pivotal programs currently underway in the United States, we could see the first psychedelic therapies approved by a regulator within the next few years. But, the timeline for approval and market access in Europe remains uncertain, with the U.S. being the primary focus for psychedelic drug developers.

While any approval, anywhere in the world, will rightly be viewed as a momentous milestone for the field, it will only be the starting line for making these therapies available to those who might benefit most; especially in Europe, where this report focuses.

That is why psychedelic drug developers, policymakers, payors, regulators, healthcare practitioners and systems, patient advocacy groups, and other stakeholders must begin the work of scoping out these unique medicines’ integration into the complex systems of Europe today.

Perhaps most foundationally, psychedelic drug development programs must produce data that allows health technology assessment (HTA) bodies to compare these relatively expensive and complex interventions to the standard of care. Such programs should give HTAs confidence in modelling costs and benefits over the medium term by providing reliable inputs to such models, including elements such as data on durability. While European HTAs have similarities to one another, drug developers might be wise to design programs and data packets with specific markets and assessors in mind.

They needn’t go it alone, however, with evidence suggesting that early engagement with HTAs can lead to faster review and market access timelines. Both Maignen and Kusel (2020) and Wang et al. (2024) show that sponsors that used the UK’s NICE scientific advice pathway shaved months off their eventual appraisal processes.

Some issues are outside of the control of drug developers, however. Those include a general lack of funding for behavioural and mental healthcare interventions versus other fields of medicine like oncology in many of the EU Member States and the UK; HTA models that often valorise costs and benefits narrowly at the healthcare level, as opposed to recognising those realised at the societal level; and, in many cases, underfunded healthcare systems that have stretched budgets and resourcing shortfalls. Take the UK, for example, where I live: There is not exactly a surplus of specialised treatment environments or trained professionals. That raises all sorts of questions around service readiness or the likelihood of equitable access to psychedelic therapies, if approved—the high upfront costs and logistical burdens of psychedelic therapies would need to be rationalised against the operational realities of our National Health Service.

While drug developers must be attentive to developing interventions that can ultimately plug into existing healthcare systems and produce relevant data to support their reimbursement, there is room for innovation and implementation-readiness activity to be carried out by other stakeholders. For example, government-funded studies could support the exploration of alternative delivery paradigms for psychedelic therapies to increase scalability and reduce resource intensity. Those might include things like group or simultaneous dosing and/or preparation/integration sessions.

Governments and other non-industry research priorities might be carried out in the post-approval context, too. Those could include pharmacoeconomic or head-to-head studies that seek to ascertain the value of one therapy over another. In the U.S., for example, the Patient-Centered Outcomes Research Institute (PCORI) is funding a comparative effectiveness study of esketamine (Spravato) vs. IV racemic ketamine in treatment-resistant depression. Such studies might be of particular relevance to European countries that have taxpayer-funded healthcare systems, as it is in the interest of the public purse to determine the relative value of interventions. While it might be some time before we see generic psychedelics come to market in Europe, owing to patents and other exclusivity periods, these studies could at least put any approved therapies head-to-head with existing treatment options.

While “multi-stakeholder approach” often strikes me as an empty term, here is a case where it is surely appropriate! As such, I am pleased to have made a small contribution to this report, which aims to provide various stakeholders with insights into the state of play of psychedelics and reimbursement pathways in Europe, but also what we hope is actionable advice, especially that contained in the "Solutions and Recommendations" chapter.

To be sure, none of this is straightforward. Perhaps that is why many psychedelic drug developers are looking to side-step the complicating factors of long-duration dosing sessions and accompanying psychotherapy by moving toward shorter-duration psychedelic-based medicines that are administered in increasingly hands-off protocols. In other cases, drug developers are aiming to engineer out the trip entirely, though this report does not look substantially at this development.

But, even shorter-acting psychedelics delivered within a very slim psychological support protocol might face challenges in Europe. Look at Spravato, for example. Despite the backing of a company worth $375+ billion, the product’s availability and reimbursement across the bloc and in the UK remains uneven, as is explored in Section 2.2.2. And yet, Spravato is still a blockbuster drug thanks to strong sales in the U.S., which remains the key market of focus for most developers of new drugs.

The challenge is real, then, but nowhere near that which Europe and its citizens face when it comes to mental and behavioural health. And as I said in Brussels in late 2023, I fear that if we do not focus on ensuring access to innovative mental health treatments in Europe during their development, we risk Europeans becoming guinea pigs (Greenacre, 2023). What I meant is that we could see a scenario where Europeans serve as test subjects in the early- and mid-stage clinical trials of such interventions—as they have done in the psychedelics realm—but do not realise the benefits of such research through access to innovative therapies after they are approved in jurisdictions like the U.S.

But through a proactive approach, the genuine engagement of appropriate stakeholders, and perhaps the leveraging of innovative risk-sharing programs and Member States, psychedelic therapies just might ‘work’ for Europeans.

From Crisis to Change: What Mental Health Advocacy Can Learn From the HIV Movement

Tadeusz Hawrot

Mental health is critically important to everyone, everywhere. Yet, it stands out as an area with some of the most glaring unmet needs. Psychedelic therapies have the potential to address critical gaps in treatment for various mental health conditions in Europe. However, before reaching patients, they must first gain approval from the European Medicines Agency (EMA), followed by integration into national healthcare systems for accessibility and reimbursement.

Europe has been a fertile ground for psychedelic research, with numerous early and mid-stage clinical trials underway. The contributions of European scientists, research institutions, and study participants have driven this progress. Despite these advancements, the continent faces a significant bottleneck: a lack of late-stage clinical programmes necessary to secure regulatory approval. Based on current timelines, it appears unlikely that any psychedelic therapy will receive EMA approval before the end of the decade. Even after approval, national reimbursement systems will likely require additional years to make these treatments accessible to patients.

One key factor identified in this report that could accelerate this process is clinical advocacy. The presence of researchers, clinical groups, and patient organisations actively advocating can positively influence access timelines.

The history of the HIV treatment movement offers valuable lessons in this regard.

Activists built the success of HIV/AIDS advocacy on strategies that can inform psychedelic therapy and mental health advocacy. A key element was activists’ deep engagement with science. Activist groups didn’t just advocate—they educated themselves to challenge regulators, pharmaceutical companies, and research institutions. Their expertise in clinical trial design, drug approval, and policy allowed them to influence decision-making.

Another defining strategy was combining public pressure with institutional engagement. Protests and civil disobedience brought attention to the crisis, while trained representatives worked inside regulatory and funding agencies to shape policy. This “inside-outside” approach ensured that those most affected had a voice in decision-making.

HIV/AIDS activists also mobilised affected communities, turning fear and grief into an organised movement. Those directly impacted took action, refusing to wait for change. Psychedelic and mental health advocacy must do the same, catering for patients, families, and professionals who understand the urgency of better treatment options. Their voices highlight the consequences of regulatory delays and the need for access.

Transparency was another cornerstone of HIV/AIDS activism. Activists pushed for openness in drug pricing, clinical trial data, and regulatory processes, ensuring treatments were not just developed but also made accessible. Psychedelic and mental health advocates must demand similar accountability to prevent therapies from being limited to expensive private clinics, ensuring broader public access.

Perhaps one of the most significant achievements of HIV/AIDS activism was its success in shifting public perception. In the early years of the epidemic, the public heavily stigmatised HIV, associating it with marginalised communities and moral judgment rather than treating it as a public health crisis. Activists worked relentlessly to change this narrative, framing HIV treatment as a human rights issue and pushing for broad-based political and financial commitments. Psychedelic therapies face a different but related challenge—decades of prohibition, underfunding, and misinformation have shaped public attitudes, making regulatory progress slower and more fraught with controversy. Advocacy efforts must work to change this narrative, establishing them as legitimate medical interventions for urgent mental health needs.

Finally, securing sustained political and financial support was crucial to the HIV/AIDS response, leading to major funding initiatives and policy shifts. Psychedelic and mental health advocates must do the same, ensuring research, clinical trials, and reimbursement pathways receive necessary investment. Engaging with regulators and integrating these treatments into broader health strategies at the national and EU levels will be essential for long-term impact.

For those interested in the impact of activism on healthcare, How to Survive a Plague chronicles how ACT UP and TAG activists, many with no prior expertise, became key players in HIV/AIDS policy, forcing action from governments and pharma. The film captures their protests, negotiations, and lasting impact—offering lessons still relevant for psychedelic and mental health advocacy (surviveaplague.com).

Recognising the impact that coordinated advocacy can have, organisations like PAREA strive to mobilise a broad coalition of stakeholders—including people with lived experience, scientists, clinicians, and civil society groups—to advance policy discussions and regulatory progress. By fostering dialogue between those developing psychedelic therapies and those in charge of approving and funding them, we aim to ensure that promising treatments do not remain locked behind bureaucratic or financial barriers.

The lessons from HIV/AIDS activism demonstrate that meaningful change requires a combination of expertise, organisation, public pressure, and persistence. By adopting these strategies, psychedelic and mental health advocates can accelerate the process of making these treatments widely available, ensuring that scientific progress translates into real-world impact for people living with mental health conditions.

Advancing Psychedelic Therapy Reimbursement in the Czech Republic

Viktor Chvátal and Sumudu Gouri Boyina

To successfully advance the reimbursement of psychedelic therapies, advocacy must operate at both the EU and national levels. Based on the Treaty on the Functioning of the European Union (TFEU), public health falls within the responsibility of the EU Member States. The divergence of the national healthcare systems further strengthens this reality. Nevertheless, in the last few years, we have seen a growing interest in the EU institutions in health and mental health. Additionally, the current pressure of the new EU establishment on “competitiveness” and “resilience” creates a general discursive framework towards which the emerging sector of psychedelic therapies should be able to articulate its positions and advocacy narratives.

In multi-level, mutually interconnected governance, the EU needs active Member States and their best practices to catalyse discussion in Brussels. For example, a domestic cost-effectiveness study would advance psychedelic therapies at the Member State level while providing partial answers to current major European challenges.

The Czech Republic, during its Presidency of the Council of the EU in 2022, put mental health back on the top of Europe’s agenda through the organisation of an international governmental conference titled “Resilient Mental Health in the European Union”. With the participation of PsychedelicsEUROPE, part of the conference focused on psychedelic therapies. Overall, the advanced psychedelic ecosystem in the Czech Republic allows the country to aspire to a position as a regional role model when it comes to psychedelic therapies.

Moreover, the Czech Republic offers an example of the long-term tradition of evidence-informed policymaking regarding illicit substances. For example, the progressive Act on Psychomodulatory Substances came into force on January 1, 2025. Regarding emerging novel mental health treatments, the Czech Republic was among the first EU countries to provide ketamine therapy (PSYON clinic), which is now partially reimbursed by major public health insurance funds.

To this date, neither the EU nor Member State level discussion has sufficiently grasped the topic of advancing the regulatory framework, reimbursement schemes, or budgets. While Brussels waits to see if the new Commission will devote the same attention to mental health as the last one (a situation mainly triggered by the impact of COVID-19 and the war in Ukraine), political lobbying at the national level is often fragmented and lacks both well-defined objectives and project management.

Currently, the emerging sector of psychedelic therapies in the Czech Republic (as in other EU Member States) lacks a cost-effectiveness study that would foster structured dialogue with regulators and payers. Indeed, engaging key stakeholders in budgetary discussions would showcase the sector's maturity vis a vis state authorities that are used to this kind of exchange with representatives of traditional therapies.

Simultaneously, the growing pool of treatment providers in the Czech Republic is neither collectively organised in advocacy terms nor clearly defined in terms of their vested regulatory interests. The state is rather ubiquitous in the primarily public Czech healthcare system, further increasing the need for a comprehensive public affairs strategy that would potentially speed up the integration of psychedelic therapies into a national healthcare system.

From the broader perspective of Central and Eastern Europe (CEE), the Russia-induced war in Ukraine represents another part of a contextual mosaic of psychedelic therapies. Thanks to migration and geographical proximity, post-traumatic stress disorder (PTSD) has become an important topic not only for Ukraine but also in particular for all EU countries. In this regard, PsychedelicsEUROPE co-organised a governmental event in May 2024 to provide a platform for both Czech and Ukrainian stakeholders to discuss the potential of psychedelic therapies in PTSD treatment. The follow-up event planned for mid-June 2025 aims to introduce fresh data to decision-makers, regulators and payers to further elaborate on both cost-effectivity and the PTSD angle of psychedelic therapy.

A joint memorandum of experts will be adopted at this event and will be formally handed over to the new Czech government following the general parliamentary elections in Autumn 2025. This aims to secure continuity in a constructive regulatory exchange between experts and advocates for psychedelic therapies and state authorities on topics of critical importance, including reimbursement schemes. Amongst other things, it should be a joint interest of engaged stakeholders in the Czech Republic to motivate the state apparatus to emulate the Dutch model and establish a State Committee that would investigate the use of specific substances within the framework of psychedelic therapies.

Chapters 12, 13, 14

MOVED TO SEPARATE FILES IN THE DRIVE

6 Report Drafting