Potential Reimbursement and Access Pathways

As psychedelic therapies move closer to approval in Europe, healthcare systems face a crucial question: How will patients access these treatments? The path from regulatory approval to patient access is complex, particularly for treatments that combine drugs with a psychotherapeutic component. This chapter examines nine different pathways that could make psychedelic therapies available to patients.

The standard route for new medicines—through national health systems and insurance companies—may struggle to handle psychedelic therapies. These treatments do not fit neatly into existing systems designed for either drugs or therapy, but not usually both together. Esketamine (Spravato), which gained regulatory approval in Europe, has faced challenges getting covered by health systems. For future psychedelic treatments, which may have more complex evidence and delivery requirements, these challenges could be even more significant.

Alternative pathways may offer solutions. Private insurance and out-of-pocket payment already provide limited access to ketamine therapy in several European countries. Pilot programs and research initiatives are testing new ways to deliver and pay for these treatments. Some countries are exploring innovative frameworks for complex therapies that do not fit standard assessment methods.

This chapter analyses each potential pathway, drawing on real examples from across Europe. We examine how different approaches work, what barriers they face, and which combinations of pathways best support patient access. The goal is not to identify a single perfect solution but to understand how different routes to access could work together as these therapies enter healthcare systems.

Understanding these pathways is crucial for everyone involved in bringing psychedelic therapies to patients—from drug developers and healthcare providers to insurance companies and evaluators. While some routes may work better in certain countries than others, healthcare systems will likely need a mix of approaches to make these treatments widely available to patients who could benefit from them.

Standard National Reimbursement Pathways

Most new medicines in Europe follow a standard pricing, reimbursement, and market access (PRMA) path to get paid for by health systems. After regulatory approval, national bodies assess if the treatment works well enough and offers good value for money. These assessments, called health technology assessments (HTAs), help decide if public healthcare systems or insurance companies should pay for the treatment. While this pathway works well for many medicines, the likelihood of clinically effective psychedelics achieving reimbursement and access in most countries through this pathway may be low due to unique aspects of the evidence and limitations in existing HTA methodologies. The likely result is high variability from country to country in their reimbursement decisions.

Learning from Spravato

The experience with esketamine (Spravato) shows how complex this pathway could be for future psychedelic treatments. Different countries reached very different conclusions about Spravato's value, with Germany, for example, awarding it a considerable clinical benefit with favourable pricing (albeit after a second review). Still, NICE in the UK did not recommend it for use in England & Wales.

The learning here is that developers must approach each national HTA process with a tailored approach with regard to the evidence submitted, the positioning of the therapy in the country's clinical pathway, and a price in line with the payer’s value framework. Additionally, relatively limited numbers of patients with TRD have received Spravato treatment even in countries that have approved it for reimbursement, highlighting the challenges around integrating a therapy with novel aspects of administration, a unique patient-specific experience, and a requirement for in-clinic observation.[27]1

Key Challenges

The current assessment methods weren't designed specifically for treatments like psychedelics. They face several significant hurdles:

Clinical evidence requirements often do not fit psychedelic therapy trials. Standard trials should ideally compare new treatments directly against current treatments, but this is harder with psychedelics, where keeping studies 'blind' is challenging. Also, these treatments may lack the long-term data at launch that assessment bodies want to see.

Some reimbursement evaluation groups will consider trying to assess the efficacy and costs of the drug separately from the therapy sessions that might be part of the care protocol to deliver it. Where this is relevant, this split may be methodologically impossible to do, but if completed, it makes it harder to show the full value of the combined treatment. Such an approach in trying to split out the therapeutic components may also create additional challenges in reimbursement, as only the drug might be reimbursed, with no straightforward reimbursement for any therapist or other HCP time to support the use of the therapy with patients.

Setting up clinics to deliver psychedelic therapy will require some investment in facilities and staff training. Current assessment methods may include these setup costs when deciding if treatments offer good value, which can penalise therapies with novel administration and patient management requirements. These costs are also likely to be difficult to determine accurately before use in real-world practice, creating additional challenges for the standard national reimbursement and HTA evaluation processes.

Lessons from Other Complex Treatments

Health systems have historically struggled to assess innovative treatments that do not fit standard models. Cell and gene therapies have faced similar challenges, leading to delayed access and eventual changes to assessment methods. Even combination drug treatments in cancer care—which may be more methodologically straightforward than psychedelic therapy for an HTA evaluation—have proved difficult to evaluate and agree on fair pricing and reimbursement conditions for each component of care, often limiting access for patients.

Opportunities in Some Markets

Among the countries studied, the Netherlands shows more promise for psychedelic treatments using standard reimbursement pathways. The Netherlands’ national HTA evaluation may consider broader societal benefits, not just direct medical costs. Dutch insurers already pay for therapist sessions for many mental health conditions as part of the basic insurance coverage package, and they reimburse these sessions alongside Spravato and ketamine treatments. These characteristics of accepting a broader range of value and having drug and therapist reimbursement channels in place may provide the flexibility needed for different psychedelics treatments to gain access.

Limited Prospects

Given these challenges, psychedelic treatments will likely struggle to gain broad access across Europe through the standard assessment pathways as they stand. Even if psychedelic therapies prove clinically effective in clinical trials, the current HTA and reimbursement processes are not particularly well-suited to evaluate their unique features. Although most stakeholders prefer that psychedelics be assessed fairly and effectively through the standard national reimbursement pathway for drug therapies, healthcare systems may need to use alternative pathways to make these treatments available to patients if assessment methods remain unadapted.

Modified National Reimbursement Pathways

Instead of following the standard national PRMA evaluation approach, health systems could proactively adapt and optimise the evaluation methodology or overall reimbursement process to account for notable differences in the way evidence can be generated for psychedelics and the infrastructure required to implement these therapies. The adaptation process could involve modifying current clinical assessment frameworks to capture better the unique therapeutic contexts and outcomes of psychedelic treatments while leveraging established reimbursement mechanisms to support their integration.

If health authorities and policymakers optimised current pathways to address the unique aspects of these treatments, clinically effective psychedelics would have a much better chance of gaining widespread access. Of all the pathways described in this chapter, the modified national reimbursement pathway is the one that is most likely to lead to broad and equitable access to psychedelics.

Changes to Treatment Assessment

Several key changes to HTA processes could help evaluate psychedelic therapies more fairly:

First, evaluators should assess treatments as complete packages—drug plus any psychotherapeutic component together—rather than any attempts to try to evaluate the drug component alone. The evaluation should reflect how these treatments will work in practice.

Second, the requirement for head-to-head clinical trials against current treatments in order to achieve favourable reimbursement or pricing conditions could be relaxed where developers provide clinical justification. These head-to-head trials are particularly challenging for psychedelic therapies due to difficulties with blinding and where there is a more complex treatment protocol.

Third, assessment bodies need new guidelines for analysing psychedelic therapy studies. These should address specific challenges like blinding issues and potential reporting bias in ways that maintain scientific rigour while acknowledging practical limitations.

Broader Value Consideration

Healthcare assessment bodies could improve their evaluation of psychedelic therapies by taking a broader view of treatment benefits beyond immediate clinical results. This approach could look at longer-term impacts, such as patients' ability to return to work or live independently, alongside broader benefits, including reduced hospital visits and less need for other treatments.

A complete assessment would also consider the broader societal benefits that HTAs often miss in standard evaluations. These include economic factors such as lower disability payments, increased tax revenue when patients return to work, and the positive effects on families and communities when people recover from conditions that previously resisted treatment. By looking at these broader benefits, assessment bodies would better capture the full impact of psychedelic therapies in their evaluations.

Utilisation of Conditional Reimbursement

One approach that could help address the issue of gaps in longer-term clinical and economic outcomes, and also how psychedelic therapies may perform in a real-world health system, is the greater use of conditional reimbursement. Psychedelic therapies that show promise but do not neatly meet, for example, the existing standardised HTA criteria or set value thresholds or have a higher degree of uncertainty, would greatly benefit from an initial controlled period of access.

Health authorities and manufacturers can establish conditional reimbursement with clear criteria for where they might grant it, with clear commitments made by the manufacturer and health service to generate and analyse the specific data required to address the uncertainty. Such conditional reimbursement schemes could also include tailored pricing arrangements for individual therapies to ensure appropriate risk sharing between the manufacturer and the payer, or manufacturers could receive payment only when patients achieve outcomes (i.e a pay-for-performance arrangement).

Learning from Other Complex Treatments

Similar changes have already occurred for other innovative treatments. The Innovative Medicines Fund (IMF) in England and Wales has been critical for providing temporary funding for some cell and gene therapies while gathering evidence about their long-term effects. Similarly, multiple European countries have successfully developed specialised assessment methods for Advanced Therapy Medicinal Products (ATMPs), proving that evaluation systems can evolve to meet new therapeutic challenges.

New Payment Models

Beyond changing how healthcare systems assess treatments, they need new ways to manage the costs of psychedelic therapy. The current systems, designed for traditional pharmaceuticals, may struggle with treatments that combine drugs, therapy, and specialised facilities. However, several promising approaches have emerged from different healthcare systems.

• Fixed-Cost Allocations The Netherlands offers a particularly useful model, where some care providers receive a set fee to manage a patient for 6-12 months. This approach allows providers to use innovative treatments when appropriate without getting caught up in separate payment streams for drugs, therapy, and facilities. Traditional payment models like diagnostic-related groups (DRGs) or drug-only reimbursement often discourage using treatments with high upfront costs, even if they might save money in the long run. A more flexible, outcomes-focused approach could better support the adoption of psychedelic therapies.

• Pay-for-Outcomes Arrangements More sophisticated payment models could link reimbursement directly to patient outcomes rather than just paying for services delivered. Some Dutch insurers offer providers bonus payments when treated patients do not require readmission within six months. This arrangement encourages innovation and investment in effective treatments, even with higher initial costs. Similar models could work for psychedelic therapies, with payments tied to achieving remission, maintaining health at specific time points, or reducing overall healthcare usage.

Implementation Challenges

Making these changes work requires careful planning and investment in infrastructure. Clinics need appropriate facilities and trained staff to deliver psychedelic therapy safely. Support for infrastructure development might require direct investment from national healthcare bodies or predictable reimbursement models that help clinics plan investments. Even approved treatments might remain unavailable without proper infrastructure support due to practical barriers.

Coordinated Funding

One of the biggest challenges is that drug costs, therapy sessions, and facility costs often come from separate budgets. This fragmentation makes it harder to implement treatments that do not fit neatly into existing categories. New approaches could include combined funding packages covering all treatment components, clear guidance on acceptable resource use for insurers, and special budgets for multidisciplinary care. Determining a core service specification with health system authorities could provide a reference point to inform new funding arrangements. Healthcare administrators and policymakers would need to implement these changes to ensure that all necessary components of psychedelic therapy can be funded together.

Stakeholder Involvement

Changes to HTA, reimbursement approaches and payment systems need support from multiple groups, including national commissioning bodies, insurance companies, professional medical organisations, healthcare providers, and patient advocacy groups. While these modifications would still operate within existing national reimbursement pathways and healthcare frameworks, they represent significant changes requiring careful implementation. Success likely depends on starting with pilot programmes that follow new therapies from modified HTA evaluations into real-world practice to monitor clinical effectiveness and financial sustainability before broader adoption.

Private Insurance Care Provision

Private insurance represents a potentially significant pathway for accessing psychedelic therapies, particularly in the early stages of their introduction to healthcare systems. While national health services and basic insurance plans may be slow to adopt these novel treatments, enhanced private insurance policies could offer earlier and broader coverage options for suitable patients.

This pathway is especially relevant because private insurers often have more flexibility in their coverage decisions and may be more receptive to innovative treatments that can demonstrate value beyond traditional medical outcomes. Additionally, payments for clinical staff may be higher, which supports the financial viability of therapies requiring more in-clinic time. Although this route will only serve a portion of the population, it could play a crucial role in establishing the real-world use of psychedelic therapies.

The Scale of Private Insurance

The proportion of people with enhanced private healthcare insurance varies significantly between European countries. In the UK, private insurance typically provides access to selected services unavailable through the NHS, particularly in areas like mental health and oncology. In countries with insurer-based systems, enhanced policies often come through workplace employer schemes or individual decisions to take out premium policies.

For some countries, like the Netherlands, supplementary insurance presents a popular add-on to mandated insurance coverage. Eighty percent of the Dutch population chooses this alternative private-like insurance. Across most European countries, enhanced private coverage typically reaches 10-20% of the population, predominantly among higher-earning individuals.

Opportunities for Access

Private insurers may be better positioned than national systems to approve and cover psychedelic treatments. Their decision-making processes tend to be more agile and often take a broader view of treatment value.

Private insurers are particularly attuned to workplace-related benefits, such as helping people return to work and improving productivity. This focus aligns well with the potential benefits of psychedelic therapies in treating conditions that often affect workplace performance, such as depression and PTSD. Over recent years, enhanced mental health therapy provision has become a growing trend in private health insurance plans, reflecting increased demand from employed individuals seeking support for their mental health.

Limited But Important Role

While private insurance will only provide access to a small portion of the population, its role in establishing psychedelic therapies should not be underestimated. In many countries, private insurance coverage may be one of the first pathways through which patients can access these treatments.

Private clinics operating under insurance contracts can build valuable experience and develop clinical expertise. Furthermore, healthcare professionals often work across both private and public systems, allowing for the cross-fertilisation of knowledge and insights. This overlap could prove particularly valuable as public healthcare systems consider adopting psychedelic therapies.

The influence of private insurance coverage extends beyond its immediate beneficiaries. Healthcare systems may significantly limit access to psychedelics without changes to how they evaluate and fund these therapies. In such scenarios, the experience gained through private insurance coverage, alongside fully out-of-pocket payments, will be crucial in supporting the establishment of private clinics. These clinics can serve as centres of excellence, generating real-world evidence and building the case for broader patient access through public healthcare systems.

Private Out-of-Pocket Payment For Patients

Private out-of-pocket payment represents one of the most straightforward pathways for accessing psychedelic therapy. However, it inherently limits access to those who can afford to pay for treatment themselves. This pathway already exists across Europe for various mental health treatments and may serve as an important early route for psychedelic therapy access, even as broader reimbursement options develop.

Current Private Treatment Landscape

In every European country, private clinics offer services funded directly by patients or their families. Patients seeking psychedelic treatments may find this arrangement particularly relevant, as existing healthcare systems often fall short of providing adequate treatment for PTSD, depression, anxiety, eating disorders, and addictions. Many patients already seek private care for these conditions, accessing treatments that may be difficult to obtain through public healthcare systems. These include repetitive transcranial magnetic stimulation (rTMS) for depression, intensive behavioural therapies for addiction, and specialised trauma treatments like trauma-focused cognitive behavioural therapy (TF-CBT) and eye movement desensitisation and reprocessing (EMDR) for PTSD.

Ketamine as a Case Study

The role of private payment is particularly evident in the current landscape of ketamine therapy. For off-label ketamine treatments, private payment is often the only route to access. Even for approved treatments like esketamine (Spravato), in countries where national health systems have not approved reimbursement, such as England, private clinics provide access to those willing to pay, typically charging between €2,000 and €5,000 for a course of treatment.

Limitations and Barriers

However, this pathway faces significant limitations. Private clinics offering psychedelic therapy are likely to concentrate in larger urban centres, creating geographical barriers for many potential patients. Combined with the substantial costs of treatment and the limited number of clinics, these factors mean that only a small proportion of patients who might benefit from psychedelic therapy will be able to access it through private payment alone.

Hybrid Models and Insurance Integration

Some countries, particularly the Netherlands, have developed an interesting hybrid model where insurers combine coverage for psychotherapy with private payment for the drug component of treatment. In these cases, patients pay out-of-pocket for the psychedelic drug and certain treatment elements, while the psychotherapeutic care is covered or partially covered by insurance. This model currently operates in Dutch clinics offering ketamine and esketamine treatments, providing a potential template for future psychedelic therapy provision.

Lessons from the United States

The experience in the U.S., where out-of-pocket payment for ketamine treatment is common, offers some insights into the limitations of this approach. While private payment has allowed for the establishment of hundreds of ketamine clinics, treatment centres often struggle to attract enough patients who can afford their services. The high cost of out-of-pocket payment suggests that even when treatment facilities are available, the requirement for substantial out-of-pocket payment significantly constrains access to those who might benefit from these therapies.

Innovative Alternative Access Pathways

The innovative alternative access pathway represents the most theoretical of all potential routes to market for psychedelic therapies. Yet, it could prove crucial for addressing these treatments' unique challenges. This pathway would likely emerge as a government or health system-led initiative specifically designed to accommodate therapies that address key unmet needs while falling outside conventional assessment frameworks.

The Need for Alternative Pathways

For psychedelic therapies, standard assessment processes like Germany's AMNOG or England's NICE evaluations may prove particularly challenging. The need for alternative pathways stems not from seeking special dispensation for psychedelics but rather from recognising that conventional HTA expectations might be impractical or inappropriate.

The unique nature of psychedelic therapy trials, which often can not follow standard double-blind protocols, and the need for specialised treatment settings create evidence packages that differ significantly from typical pharmaceutical submissions. Psychedelic therapies might require three or four studies to meet existing evidence standards, while manufacturers typically address standard regulatory and HTA evidence needs with one or two Phase III trials.

Current Country-Specific Initiatives

The UK has made some progress in this direction through its Innovative Licensing and Access Pathway (ILAP), which aims to accelerate the time to market for innovative medicines. The pathway, relaunched in early 2025, provides enhanced regulatory guidance and connects stakeholders across the system to support study design, development, approval processes, and implementation within the national health service.

However, even this pathway ultimately requires a standard NICE (England and Wales) or SMC (Scotland) HTA review, potentially limiting its usefulness for psychedelic therapies. While a separate, standalone process designed explicitly for psychedelics might provide an alternative access route in some countries, developing such frameworks could take a decade or more, as evidenced by the slow adaptation of systems to accommodate Advanced Therapy Medicinal Products (ATMPs).

Moreover, psychedelic therapies face unique challenges compared to other innovative treatments like ATMPs. Psychedelic therapies operate in the mental health space, which traditionally receives less attention and funding than physical health conditions, faces ongoing stigma, and presents more complex challenges in demonstrating and capturing value within existing assessment frameworks.

Learning from Other Innovative Therapies

The introduction of ATMPs, such as cell and gene therapies, has provided valuable lessons. Several manufacturers in Germany and the UK have successfully negotiated innovative payment models with insurers, including pay-for-performance arrangements.

Developers and payers have successfully used this approach for treatments like Luxturna, Kymriah, and Yescarta, demonstrating how novel therapies can achieve reimbursement through creative solutions that address payer and provider needs. Healthcare systems could adopt similar models for psychedelic therapies, allowing them to measure treatment outcomes and link them to payment structures. However, payers may view these agreements differently for psychedelic therapies since these treatments cost less than recent cell and gene therapy launches and target much larger patient populations.

European Collaborative Initiatives

Across Europe, several collaborative initiatives could support alternative access pathways. The WHO/Europe Access to Novel Medicines Platform, launched following the Oslo Medicines Initiative (2020-2022), represents a significant development in this space. This platform brings together public and private sectors to address challenges around access to innovative treatments, particularly focusing on affordability and health system sustainability. Given the expected high costs of psychedelic therapies, this type of collaborative framework could prove valuable in developing viable access solutions.

The National Competent Authorities on Pricing and Reimbursement (NCAPR) explores dynamic pricing frameworks that could suit psychedelic therapies, particularly by tying payments to long-term performance data. With funding from EU4Health and backing from the European Commission (EC), NCAPR focuses on efficiency, affordability, transparency, and innovative payment methods. These priorities align well with the challenges presented by psychedelic therapies.

Regional collaborations are also delivering some outcomes. The Beneluxa Initiative, while primarily focused on ATMPs, demonstrates how countries can work together to agree on access for innovative treatments. Belgium and the Netherlands have been particularly active in this space. Similarly, the Joint Nordic HTA Bodies and Nordic Pharmaceutical Forum show how regional cooperation can facilitate access to innovative therapies. The Valletta Declaration Group, while maintaining a lower profile, serves as a platform for information exchange and is expected to increase its activity in the coming years. These collaboratives may benefit from the introduction of EU HTA between 2025 and 2030, as the Joint Clinical Assessment (JCA) will provide a common clinical evaluation available at the same time as an EMA approval, which they can use to prioritise therapies or engagement with manufacturers.

Future Prospects and Challenges

While the development of alternative access pathways, specifically for psychedelics, remains theoretical, several factors could accelerate their emergence. The SUSTAIN-HTA initiative, supporting the HTA Coordination Group and its Subgroup on Methodology, aims to align HTA methodologies across Europe. It has also stated an interest in exploring broader concepts of value and new pricing models to make evaluations more accurate and relevant. Initiatives such as this could create opportunities for more flexible approaches to evaluating psychedelic therapies. However, it may take the failure of one or more psychedelic therapies to achieve positive HTA outcomes before countries seriously consider developing alternative pathways.

The emergence of early examples, such as the Netherlands' hybrid model, where insurance covers psychotherapy while patients pay for the drug component, suggests that innovative solutions are possible. As psychedelics move closer to market, there is hope that individual countries or the EC will proactively discuss innovative alternative access pathways rather than waiting for conventional approaches to fail.

Implementation Considerations

Any alternative pathway must balance several key elements: rigorous evidence requirements, practical feasibility for providers, and financial sustainability for healthcare systems. Healthcare systems could adopt a more balanced approach by supporting the use of psychedelic products in real-world practice while simultaneously gathering additional evidence rather than demanding comprehensive study data packages before granting any access.

The implementation needs to consider various factors such as treatment setting requirements, therapist training and certification, outcome monitoring, and payment mechanisms. Dynamic pricing frameworks, as explored by NCAPR, could be particularly relevant, allowing for initial uncertainty about long-term outcomes while ensuring value for healthcare systems. Such frameworks could incorporate real-world evidence collection, allowing pricing and access decisions to evolve as more data about treatment effectiveness in clinical practice becomes available.

Charity or Philanthropy-Based Care Services

The charitable and philanthropic pathway represents a unique aspect of psychedelic medicine, characterised by significant involvement from non-commercial stakeholders in development and potential service provision. This pathway could play a crucial role in establishing initial treatment services and funding access for specific patient groups, particularly in underserved areas of mental health and addiction services.

Non-Commercial Development Landscape

The psychedelic sector stands out for its unusually high proportion of non-commercial stakeholders involved in therapy development. Notable not-for-profit organisations such as MAPS and the Usona Institute have initiated clinical trials with psychedelics. Beckley Foundation and Heffter Research Institute have been instrumental in funding early clinical trials during the "psychedelic renaissance". More recent additions like Norrsken Mind continue this tradition of philanthropic involvement in psychedelic research and development.

Public and Philanthropic Research Funding

Public and philanthropic funding has supported psychedelic research globally, with significant commitments from both national and international bodies. The scale of this funding has been substantial, particularly in recent years. In the United States, the National Institute on Drug Abuse (NIDA) has made major investments, including nearly $4 million to Johns Hopkins University for psilocybin research in tobacco addiction, up to $14 million to Gilgamesh, and $15 million to New York University (NYU) researchers through the Defense Advanced Research Projects Agency (DARPA). Additional U.S. funding has come through the Department of Veterans Affairs (VA) and the National Institutes of Health (NIH) for various psychedelic studies.

In Europe, several major government-backed initiatives are underway. The German government has funded the EPIsoDE study investigating psilocybin for major depressive disorder. At the same time, the European Union has allocated over €6.5 million to the PsyPal project—coordinated by the University Medical Centre Groningen—which explores psilocybin therapy for psychological distress in palliative care patients. The Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership, along with developer Awakn, has funded a £2.4 million ketamine research trial in alcohol dependency, alongside funding for psilocybin research in opioid addiction and gambling. Additional European support has come from bodies such as Poland's Medical Research Agency.

While these funding amounts are significant and demonstrate growing institutional support for psychedelic research, they represent only a fraction of the total investment needed to bring psychedelic therapies through clinical trials and to market. The complete development pathway, including multiple Phase III trials and the necessary infrastructure for delivery, requires investment levels that typically exceed the resources available through public and philanthropic sources alone.

Role in Service Provision

While non-commercial entities may face challenges in managing full regulatory review and commercialisation processes, they could be vital in supporting access post-approval. Charities and not-for-profit organisations become particularly important when they already support patient care in areas such as addiction services and mental healthcare.

Addiction Services Model

Addiction services provide an instructive example of potential charitable involvement. In the UK, while national smoking cessation programmes are centrally funded, drug and alcohol addiction services often operate through localised funding. They may also involve third-party providers with limited resources. The decentralised funding structure and resource limitations create opportunities for non-commercial entities to support service provision in multiple ways.

Organisations can potentially directly fund treatment services, enabling immediate access for patients who might otherwise face lengthy waiting times or financial barriers. They might also support the development of necessary infrastructure, including dedicated treatment rooms and monitoring equipment. Additionally, these entities could fund comprehensive staff training programmes to ensure the proper delivery of psychedelic therapies.

Innovative Partnership Models

Novel collaborations between commercial and non-commercial entities are emerging. An instructive example is the evolution of Awakn Life Sciences' ketamine-based alcohol dependency treatment programme, which combines public research funding (through NIHR) with innovative service delivery partnerships. Their collaboration with a mental healthcare charity and private investment company demonstrates how different stakeholders might work together to provide treatment access while sharing risks and potential returns.

Future Potential

While Europe lacks an equivalent to the powerful advocacy and funding role of the U.S. Veterans Affairs, mental health charities at national and European levels could significantly influence service provision. Even temporary charitable support during initial post-approval periods could generate valuable evidence and momentum for broader service provision across healthcare systems.

This pathway could prove particularly valuable in reaching traditionally underserved populations who might not engage with conventional healthcare services but who potentially have the most to gain from psychedelic therapies. By supporting initial access and generating real-world evidence, charitable pathways could help build the case for broader healthcare system adoption of psychedelic therapies.

However, while these funding amounts are substantial, they fall significantly short of the total investment needed to bring psychedelic therapies through clinical trials and to market. The complete development pathway, including multiple Phase III trials and the necessary infrastructure for delivery, requires investment levels that typically exceed the resources available through charitable and philanthropic sources alone.

Pre-Marketing Authorisation Access

Recent developments in Switzerland and Australia demonstrate emerging governmental approaches to psychedelic therapy access through special provisions. Switzerland has established a framework where psychiatrists can apply for authorisation to administer specific psychedelics, evaluating applications on a case-by-case basis. Australia made headlines when its Therapeutic Goods Administration (TGA) authorised specially licensed psychiatrists to prescribe MDMA for treatment-resistant PTSD and psilocybin for TRD, marking a significant shift in the regulatory approach. End-of-life care presents another compelling case for compassionate use access, alongside treatment-resistant conditions, given the urgent nature of patient needs and potential therapeutic benefits.

Named-Patient Access Routes

Several European countries maintain provisions for named-patient access to unapproved treatments, particularly for severe conditions or mental health emergencies. This mechanism operates outside standard health technology assessment channels, allowing clinicians to source treatments for individual patients through controlled importation pathways. These provisions are particularly relevant for patients who have exhausted conventional treatment options or face life-threatening conditions. Two key challenges in pre-authorisation access are securing funding for treatment and overcoming barriers related to Schedule 1 controlled drug status, which can significantly restrict handling and administration.

Canadian Model: Progress and Challenges

Canada's Special Access Program (SAP) represents the potential and limitations of compassionate use frameworks. The programme's implementation has drawn criticism, even though it theoretically enables eligible patients to access psilocybin and MDMA. Stakeholders note that approval processes often move slowly and inconsistently, highlighting the challenges of balancing urgent patient needs with regulatory oversight.

Dutch Initiative and Future Prospects

The Netherlands is exploring an innovative approach through its proposed MDMA research initiative. A state commission has recommended conducting a large-scale naturalistic study of MDMA therapy for PTSD. While this approach could theoretically offer a blueprint for other European countries, combining practical access with structured data collection, its implementation faces significant political hurdles. Despite the commission's evidence-based recommendations, the current political climate and ongoing debates around drug policy make swift adoption unlikely.

Operational Challenges and Considerations

While compassionate use pathways circumvent some traditional licensing requirements, they present their own challenges. Regulators must maintain robust safety monitoring while facilitating timely access. Resource requirements for outcome monitoring and data collection can be substantial, particularly in real-world settings outside controlled trials. Healthcare providers need specific training and infrastructure to deliver these treatments safely.

Strategic Importance

These pathways serve multiple strategic functions in advancing psychedelic therapy access. They provide immediate options for patients who cannot wait for full approval processes, generate real-world evidence to support broader adoption, and offer alternative treatments not yet integrated into standard reimbursement systems. While these programs may not match the scale of formal approval pathways, they represent a crucial option for urgent cases. They could catalyse broader acceptance of psychedelic therapies within healthcare systems.

Future Implications

Compassionate use and early access programs could evolve into springboards for broader medicinal legalisation under defined conditions. They create a precedent for controlled medical use while generating valuable safety and efficacy data. Although these pathways alone cannot meet the entire demand for psychedelic therapies, healthcare systems can incorporate them as an important component of a comprehensive access strategy, particularly during the transition period before establishing formal approval and reimbursement systems.

Continuation of Unregulated and Underground Therapeutic Use

The underground use of psychedelics for therapeutic purposes has existed for decades, operating outside formal healthcare systems and legal frameworks. While strictly illegal in most countries, enforcement varies significantly across Europe. Some regions, like the Netherlands, maintain unique positions with unregulated substances, such as psilocybin-containing truffles, being used in unregulated therapy.[28]2 Similar patterns of limited enforcement exist in Portugal, Spain, and the UK, where underground therapeutic networks continue to operate.

Drivers of Continued Underground Use

Several factors contribute to the persistence of underground therapeutic use. Limited access to approved treatments, long waiting lists, and lack of reimbursement for legal psychedelic therapies create barriers that drive people toward unofficial alternatives.

A growing concern is the increasing public awareness of psychedelics' therapeutic potential through media coverage and research publications. The combination of widespread publicity and limited legal access creates a particularly dangerous situation where vulnerable individuals, desperate for mental health treatment and aware of these potential benefits, may feel compelled to seek help through whatever means available. Without accessible, regulated options and insurance coverage, more people will likely turn to underground networks or unregulated above-ground providers, potentially exposing themselves to significant risks.

Even when legal options become available, approved indications often restrict access to specific patient groups, leaving others to seek alternative routes. Additionally, some communities maintain a deep-seated distrust of mainstream healthcare systems or prefer traditional healing approaches, making underground networks their preferred choice regardless of legal status.

This situation presents a critical challenge for policymakers, healthcare payers, and governments. The gap between the growing awareness of therapeutic potential and limited legitimate access creates a public health risk that cannot be addressed through prohibition alone. A comprehensive approach to regulation and access is needed to protect vulnerable individuals seeking treatment.

Safety and Quality Concerns

The unregulated nature of underground therapy presents significant risks. Practitioners' qualifications and experience vary widely without oversight, ranging from well-trained professionals operating outside the law to inexperienced practitioners. The absence of medical screening, proper containment, and emergency support systems creates serious safety concerns.

When adverse events occur, they often go unreported, limiting our understanding of risks while potentially damaging public perception of all psychedelic therapy, including legal programmes.

Data and Evidence Implications

Underground use creates a significant blind spot in our understanding of psychedelic therapy's real-world impacts. Without systematic data collection or adverse event reporting, valuable information about benefits and risks remains hidden. This gap affects research, policy development, and safety monitoring, making developing evidence-based standards for legal therapeutic use harder.

Economic and Access Considerations

Even if future legal psychedelic therapies become available, two key factors will likely sustain underground markets. First, without comprehensive insurance coverage, the high costs of approved treatments will drive many people toward more affordable underground alternatives. Second, regulatory restrictions limiting approved uses to specific conditions will leave many potential patients without legitimate access options, particularly those with conditions that fall outside approved indications.

While underground services may offer broader accessibility and lower costs, this comes with significant risks due to a lack of quality control, standardisation, and safety protocols. This parallel system could also complicate efforts to establish legitimate markets and develop sustainable reimbursement pathways, as it may undermine pricing structures and create conflicting treatment standards.

Future Outlook

Even as legal access to psychedelic therapy expands, underground use is likely to continue and potentially increase. Some patient populations may remain excluded from approved programmes, while others may prefer alternative approaches outside mainstream healthcare. This reality suggests a need for comprehensive policy approaches that address both legal access and harm reduction strategies for those who continue to seek underground treatment.

The challenge for policymakers and healthcare systems lies in acknowledging this parallel system while working to expand safe, legal access. The experiences of countries like the Netherlands, with its quasi-legal psychedelic markets, may offer insights into managing the interface between underground and regulated therapeutic use. However, the primary goal should remain to establish robust, accessible, and regulated therapeutic pathways that reduce the need for underground alternatives.

Ironically, when regulators and payers restrict access to psychedelic therapies due to evidence gaps or uncertainties, patients may ultimately seek treatment through underground channels where risks are higher and oversight is minimal – effectively undermining the very protections these restrictions aim to provide.

Cross-Border Healthcare and Medical Tourism

Even before the formal approval of psychedelic therapies, patients have been travelling within Europe to access treatments in countries with more permissive frameworks. The Netherlands, Spain, and Portugal have become informal hubs for those seeking psychedelic treatment, though these services often operate in legal grey areas. Some clinics openly advertise to international patients, while others maintain more discrete operations.

Future Framework Under EU Directives

The EU Cross-Border Healthcare Directive could provide a formal pathway for accessing psychedelic therapies once they receive approval in some Member States. This directive allows EU citizens to seek medical treatment in other EU countries and claim reimbursement up to the cost level of equivalent treatment in their home country. As different EU countries adopt varying approaches to psychedelic therapy approval and reimbursement, this mechanism could become increasingly relevant.

Practical Considerations

While cross-border healthcare offers a potential solution for patients in countries with restricted access, several practical challenges exist. Treatment protocols for psychedelic therapy often require multiple sessions and extended stays, making international travel logistically complex and expensive. Distance complicates integration sessions and follow-up care, and language barriers could affect the therapeutic process. Additionally, home country healthcare systems might resist reimbursing treatments not yet approved in their jurisdiction.

Strategic Implications

Cross-border access could create pressure for the harmonisation of psychedelic therapy regulations across Europe. Countries that become early adopters might influence broader acceptance by demonstrating safe and effective delivery models. However, this pathway will likely remain a niche option, primarily serving patients with sufficient resources and mobility to access care abroad. Developing cross-border treatment networks could nonetheless contribute valuable data on different regulatory and delivery approaches.