Stakeholder Details

14.3.1 Drug Developers/Sponsors

Drug developers (pharmaceutical companies, biotech firms, sponsors, or manufacturers) create and bring new medicines to market. Large established companies like Johnson & Johnson, Pfizer, and Merck have been developing treatments for conditions like cancer, heart disease, and mental health disorders for decades. These industry giants invest billions in research and development each year. Alongside them, smaller biotech companies often focus on specific medical areas or new treatment approaches, bringing fresh innovation to healthcare. These smaller firms are typically started by scientists, university researchers, healthcare professionals, or entrepreneurs who spot opportunities to develop new treatments that could help patients.

Drug developers are the companies (including non‑profits) responsible for bringing psychedelic therapies to market. They lead (but also delegate; see below) everything from early research through clinical trials and work to prove their treatments are safe and effective. Their work involves testing new compounds, running patient trials, and dealing with drug approval regulators.

These companies face unique challenges because psychedelic treatments are different from regular pills or injections. Most psychedelic treatments combine the drug with therapy sessions, which means companies need to create new ways to test and deliver these treatments. They must also work closely with various groups, including regulators, doctors, insurance companies, and patient groups.

A crucial part of their job is ensuring quality and safety while gathering solid scientific proof that their treatments work. They need to show not only that their drugs are safe but also that they're worth the cost and can work in real‑world healthcare settings. This includes creating clear instructions for administering the treatment and training programs for healthcare professionals.

Additional Drug Developer Stakeholders

• Contract Research Organisations (CROs): Help manage clinical trials by collecting and analysing data, finding suitable trial patients, and ensuring everything follows the rules. They are experts in running trials and often have connections with experienced researchers and clinics.
• Clinical trial sites: Locations where treatments are tested. These can be hospitals, clinics, university research centres, or CRO facilities that usually require special rooms for therapy sessions and trained staff to safely administer psychedelic treatments.
• Contract Manufacturing Organisations (CMOs): Responsible for making the actual drugs. Since psychedelics are controlled substances, CMOs must follow strict quality standards and special security rules while working with developers to create high‑quality, consistent products.
• Quality assurance organisations: Check that all processes and documentation meet required standards. This is especially critical for psychedelic drugs, which face extra scrutiny.
• Other specialist companies: Provide technical support, such as testing drug samples or developing new delivery methods for treatments.

Drug Development Stakeholders

The organisations described below represent a non‑exhaustive selection chosen based on their significant involvement in psychedelic therapy development and implementation. This approach highlights organisations that are likely to influence the near‑term landscape of psychedelic therapy in Europe while acknowledging that the field is rapidly evolving, with new entrants and developments regularly emerging.

• Compass Pathways (Compass): A UK‑based mental health care company pioneering the development of psilocybin treatment for treatment‑resistant depression. Their COMP360 psilocybin therapy has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and is conducting Phase III clinical trials across Europe and North America.
• Lykos Therapeutics (Lykos; formerly known as MAPS PBC): A crucial player in the psychedelic therapy landscape, closely associated with the non‑profit Multidisciplinary Association for Psychedelic Studies (MAPS). Lykos focuses on developing MDMA‑assisted therapy for post‑traumatic stress disorder (PTSD). Although their Phase III trials demonstrated significant improvements in PTSD symptoms, the FDA issued a Complete Response Letter in August 2024, and no Phase III trials for MDMA‑assisted therapy have commenced in Europe.
• Cybin Therapeutics (Cybin): A Toronto‑based biotechnology company dedicated to advancing psychedelic therapeutics for mental health disorders. Their lead candidate, CYB003 (a deuterated psilocybin analogue), received FDA Breakthrough Therapy Designation in March 2024 and is in Phase III trials for major depressive disorder (MDD), while they are also developing CYB004 (a deuterated DMT molecule) in Phase II for anxiety disorders.
• Mind Medicine (MindMed): A clinical‑stage biopharmaceutical company developing psychedelic‑inspired therapies. Their lead candidate, MM120 (LSD), received FDA Breakthrough Therapy Designation in March 2024 following positive Phase IIb results for generalised anxiety disorder (GAD), with Phase III trials initiated in late 2024. The company also investigates LSD therapy for adult ADHD but has recently pulled back its European operations.
• Usona Institute (Usona): A non‑profit medical research organisation focused on advancing psilocybin therapy for major depressive disorder (MDD). Usona has initiated Phase III clinical trials and collaborates with leading research centres in North America and Europe.
• Awakn Life Science (Awakn): A UK‑based clinical‑stage biotechnologies company developing novel treatments for severe alcohol use disorder (AUD). Their lead candidate, AWKN‑001, is an intravenous ketamine formulation in Phase III trials after promising Phase II results demonstrating significant reductions in alcohol cravings and improvements in clinical endpoints.
• Johnson & Johnson's Janssen Pharmaceuticals: Developed Spravato (esketamine), a nasal spray approved for treatment‑resistant depression (TRD) and depressive symptoms in adults with MDD with acute suicidal ideation or behaviour. Spravato, a ketamine derivative offering rapid antidepressant effects, has been approved by the European Medicines Agency (EMA) and is available in several European countries.
• Clerkenwell Health (Clerkenwell): A UK‑based Contract Research Organization (CRO) specialising in psychedelic clinical trials. It offers comprehensive services including trial design, trial execution, regulatory support, and patient recruitment. Clerkenwell Health currently operates two trial sites in London and plans to expand further.
• Atai Life Sciences (Atai): A clinical‑stage biopharmaceutical conglomerate with a diverse pipeline that includes VLS‑01 (buccal film DMT) for treatment‑resistant depression and EMP‑01 (oral R‑MDMA) in Phase II for social anxiety disorder. Atai is also a major investor in Compass Pathways.
• Beckley Psytech (Beckley): A UK‑based company dedicated to developing psychedelic medicines for neurological and psychiatric disorders. Beckley is exploring the therapeutic potential of 5‑MeO‑DMT and psilocybin, with clinical trials underway in Europe targeting conditions such as depression and cluster headaches.
• GH Research: An Irish biopharmaceutical company developing 5‑MeO‑DMT‑based therapies for treatment‑resistant depression. Its lead product, GH001, is undergoing clinical trials in Europe.
• Small Pharma: A UK‑based neuropharmaceutical company developing DMT therapy for depression. Their lead candidate, SPL026, is being evaluated in clinical trials to assess efficacy and safety, combining psychedelic compounds with supportive therapy for rapid and durable relief from depressive symptoms.

14.3.2 Regulatory Authorities

Medicines regulation in Europe is a multi-layered process involving the European Medicines Agency (EMA) and national regulators in individual countries. The EMA is the central authority for evaluating and approving medicines across the European Union (EU) through the centralised authorisation procedure. This is particularly important for novel treatments like psychedelics, which often involve innovative compounds and therapeutic approaches. However, national regulators retain authority over healthcare delivery and pricing, creating a dual-layered framework where both EU‑wide and country‑specific factors influence market access.

The EMA works closely with national regulators, ensuring consistency in safety and efficacy standards while allowing countries to address local healthcare priorities. In the Netherlands, Germany, and the Czech Republic, national agencies collaborate with the EMA during the drug approval process and often adapt EMA recommendations to fit their specific regulatory environments. In the UK, which operates outside the EMA framework, a separate system led by the Medicines and Healthcare products Regulatory Agency governs drug approvals.

Regulatory authorities in individual countries play a significant role in shaping the landscape for psychedelic medicines. The Netherlands is known for its progressive approach to drug policy, which could impact the approval and integration of psychedelic treatments. Germany is the largest market in the EU, and commercial launches of novel medications are often done here first. The Czech Republic, with its history of psychedelic research, may also provide fertile ground for clinical trials and approvals. Meanwhile, the UK's independent regulatory framework allows for potentially faster approval processes but requires developers to meet separate requirements, adding complexity to multi‑country launches.

Regulatory Stakeholders – Europe

The European Medicines Agency (EMA) is the central regulatory authority for medicinal products across the European Union. Based in Amsterdam, the EMA evaluates new medicines’ quality, safety, and efficacy through its centralised procedure, resulting in valid marketing authorisations in all EU member states.

The agency operates through specialised committees, such as the Committee for Medicinal Products for Human Use (CHMP), which leads the scientific evaluation of applications, and the Committee for Advanced Therapies (CAT), which focuses on innovative medicines – including therapies that overlap with psychedelics. The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for ongoing safety monitoring of medicines post‑approval, ensuring that psychedelic therapies maintain high safety standards throughout their lifecycle.

Regulatory Stakeholders – Country‑level

The Dutch Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen; CBG‑MEB) is the primary regulatory authority overseeing the approval of medicines in the Netherlands. It collaborates with the EMA for EU‑wide authorisations but also handles national regulatory responsibilities, such as monitoring the safety and quality of medicines on the Dutch market. The CBG‑MEB is an independent administrative body that falls under the responsibility of the Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport; VWS).

In Germany, the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte; BfArM) manages drug approvals and pharmacovigilance. BfArM collaborates with the EMA on EU‑wide procedures while maintaining oversight of clinical trials and the approval of therapies for the German market. The BfArM operates under the Federal Ministry of Health (Bundesministerium für Gesundheit; BMG).

The State Institute for Drug Control (Státní ústav pro kontrolu léčiv; SÚKL) is the Czech Republic’s primary regulatory body. It oversees drug approvals, clinical trial authorisations, and post‑market surveillance. SÚKL works in alignment with EMA procedures while managing local regulatory responsibilities. It operates as an independent body under the Ministry of Health of the Czech Republic (Ministerstvo zdravotnictví České republiky).

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s primary regulatory authority for approving and monitoring medicines. The MHRA operates independently of the EMA, with its own regulatory framework for safety, quality, and efficacy evaluations. It is an executive agency of the Department of Health and Social Care (DHSC). The MHRA also oversees clinical trials conducted in the UK, providing national guidance on regulatory compliance.

14.3.3 HTA Bodies

In Europe, Health Technology Assessment (HTA) has transitioned from a decentralised process involving national agencies and voluntary networks like EUnetHTA to a more centralised framework under Regulation (EU) 2021/2282. Effective January 2025, this regulation establishes mandatory joint clinical assessments (JCAs) for specific health technologies, starting with oncology drugs and advanced therapy medicinal products (ATMPs). The HTACG coordinates these assessments, promoting harmonisation and efficiency across the EU. Despite this centralisation, final decisions on reimbursement remain at the national level.

For innovative therapies like psychedelics, HTA evaluations must consider not only the cost‑effectiveness of the drug itself but also the broader healthcare delivery model, such as the integration of psychedelic therapy into existing mental health frameworks.

Each country maintains its own approach to HTA, reflecting differences in healthcare systems and reimbursement policies. Throughout the EU and the UK, HTA bodies assess therapies’ real‑world impact on patient outcomes and cost‑effectiveness. Defining what constitutes patient outcomes and other factors around cost‑effectiveness can vary widely between countries. These assessments inform decisions on whether treatments will be covered by public insurance or healthcare systems, making them a critical gateway for market access.

Psychedelic therapies face unique challenges in HTA evaluations because they often combine pharmacological and therapeutic components, creating a complex value proposition. HTA bodies must assess the drug’s efficacy and the therapeutic context in which it is delivered. This makes the role of HTA bodies critical in ensuring that these treatments are affordable and accessible to patients who can benefit from them.

HTA Stakeholders

Implementing Regulation (EU) 2021/2282 has formalised collaboration among national HTA bodies by establishing a Coordination Group on Health Technology Assessment (HTACG). This group oversees joint clinical assessments and joint scientific consultations, aiming to improve the efficiency and quality of HTA processes across Europe by developing shared methodologies and conducting joint assessments of health technologies, including innovative therapies like psychedelics.

The regulation mandates participation from all EU member states, creating a more structured framework for multi-country assessments, reducing duplication of effort, and providing consistent guidance. The HTACG operates under the European Commission’s Directorate‑General for Health and Food Safety (DG SANTE).

The Health Care Institute of the Netherlands (Zorginstituut Nederland; ZiN) is the Dutch HTA body responsible for evaluating new therapies’ cost‑effectiveness and societal impact. ZiN determines whether treatments, including psychedelic therapies, are eligible for reimbursement under the Dutch universal healthcare system. ZiN evaluates drugs on their clinical outcomes and broader healthcare implications, such as implementation challenges and the burden on healthcare providers. ZiN operates as an independent body under the Ministry of Health, Welfare, and Sport (Ministerie van Volksgezondheid, Welzijn en Sport; VWS).

The Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen; IQWiG) is Germany’s primary HTA body. IQWiG assesses the clinical benefit of medicines, medical devices, and procedures, producing recommendations for the Federal Joint Committee (Gemeinsamer Bundesausschuss; G‑BA), which makes final decisions on reimbursement. While IQWiG operates independently, its evaluations form the foundation for G‑BA’s policy decisions.

The State Institute for Drug Control (Státní ústav pro kontrolu léčiv; SÚKL) in the Czech Republic includes a dedicated HTA division that evaluates the cost‑effectiveness of new therapies. SÚKL’s HTA division provides critical recommendations on reimbursement to the Ministry of Health and determines whether therapies offer sufficient benefits to justify their inclusion in the public insurance system. As a relatively small market, the Czech Republic often references HTA evaluations from larger EU member states or JCAs while adapting them to local healthcare needs.

Health Technology Assessment across the UK operates through distinct regional bodies. The National Institute for Health and Care Excellence (NICE) conducts assessments for England and Wales, evaluating the clinical and economic value of new treatments for NHS England and NHS Wales. In Scotland, the Scottish Medicines Consortium (SMC) performs independent assessments for NHS Scotland, often reaching different conclusions from NICE based on Scotland‑specific health priorities and economic considerations. Northern Ireland’s Department of Health considers both NICE and SMC guidance, with the ability to selectively implement recommendations through its own review process.

These HTA bodies conduct their evaluations independently of their respective medicines regulators. Their assessments are highly detailed, often considering long‑term cost‑effectiveness and real‑world implementation challenges, making their recommendations critical for the adoption of psychedelic therapies in their regions. Whilst NICE operates under the Department of Health and Social Care (DHSC) in England, each regional body collaborates with their respective NHS organisations to integrate approved treatments into healthcare delivery. This devolved approach means that access to psychedelic therapies could vary significantly across UK regions, depending on the individual assessments and recommendations of each HTA body.

14.3.4 Insurance and Reimbursement

The reimbursement of psychedelic therapies hinges on the decisions made by payers, which include public insurance bodies, private insurers, the national Ministry of Health or a sub-division thereof, and national health systems, depending on the country. After regulatory approval establishes a treatment's safety, efficacy, and quality, and health technology assessment evaluations determine its clinical benefits and economic impact, payers decide—or are obliged to follow HTA guidelines—whether and under what conditions the therapy will be covered.

The payer landscape across Europe and the UK is highly diverse. In countries like the Netherlands and Germany, regulated competition models involving private or semi‑private insurers dominate. At the same time, the Czech Republic relies on a universal system funded by public health insurance funds. The UK's National Health Service (NHS) provides care through a tax‑funded single‑payer system. These differences influence how new therapies, including psychedelics, are assessed and integrated into healthcare systems, with private insurers often negotiating individually and national systems relying on centralised decisions.

Ultimately, payers' decision‑making processes are the final hurdle in bringing psychedelic therapies to patients at scale. These organisations play a pivotal role in determining whether the treatments are accessible only to those who can afford them out‑of‑pocket or integrated into public and private insurance systems to benefit a broader population. This makes payer engagement a crucial focus for developers and advocates of psychedelic therapies.

Insurance and Reimbursement Stakeholders

In the Netherlands, health insurance operates under a regulated competition model, with private insurers playing a central role in determining coverage. Major insurers include Achmea, VGZ, CZ, and Menzis, which collectively cover most of the population. These insurers are required by law to provide a standardised basic insurance package, with coverage decisions often influenced by recommendations from the Health Care Institute of the Netherlands (ZiN), the national HTA body. The Ministry of Health, Welfare, and Sport (VWS) oversees the system, ensuring compliance with regulations and managing risk equalisation to maintain fairness among insurers. Supplementary insurance packages, offered at the discretion of insurers, may play a role in covering additional costs related to psychedelic therapies, such as extended therapy sessions.

Germany’s dual‑payer system includes statutory health insurance (SHI) providers—also known as sickness funds—and private health insurers. Key sickness funds include AOK (Allgemeine Ortskrankenkasse), TK (Techniker Krankenkasse), and Barmer, which are some of the largest SHI providers in the country. The Federal Joint Committee (G‑BA) is the primary decision‑making body responsible for determining which treatments are reimbursed under the SHI system. The G‑BA relies on input from HTA evaluations conducted by the Institute for Quality and Efficiency in Health Care (IQWiG). The >National Association of Statutory Health Insurance Funds(GKV‑Spitzenverband) represents all statutory health insurance funds and plays a crucial role in pricing decisions and negotiations with pharmaceutical companies. For private health insurance (PHI), which covers about 10% of the population, coverage decisions are made independently but often reference G‑BA rulings. The Federal Ministry of Health (BMG) oversees the system, ensuring that SHI and PHI providers adhere to national healthcare objectives.

The Czech Republic's healthcare system is primarily financed through public health insurance funds. Všeobecná zdravotní pojišťovna (VZP) is the largest insurer, covering approximately 60% of the population. Other major funds include Česká průmyslová zdravotní pojišťovna (ČPZP) and Zdravotní pojišťovna Ministerstva vnitra (ZPMV). These funds operate under the regulatory framework of the Ministry of Health and rely on recommendations from SÚKL for coverage decisions. The Ministry of Health also plays a critical role in determining how innovative treatments like psychedelic therapies are integrated into the public healthcare system, balancing cost considerations with clinical needs.

In the UK, the National Health Service (NHS) operates as a single‑payer system, funded by general taxation and managed regionally by organisations such as NHS England, NHS Scotland, NHS Wales, and Health and Social Care Northern Ireland (HSCNI). Decisions on which treatments the NHS in England and Wales reimburses are guided by NICE recommendations, which evaluate the clinical and cost‑effectiveness of therapies. For psychedelic treatments to be included, NICE must provide a positive appraisal, after which NHS bodies determine implementation strategies. Private insurance plays a limited role in the UK, mostly for supplementary coverage, and would likely cover psychedelic therapies only for those seeking care outside the NHS framework.

14.3.5 Healthcare Professionals

Healthcare professionals are central to the delivery of psychedelic therapies, ensuring their safe and effective administration. These therapies require a multidisciplinary team, typically psychiatrists, psychologists, nurses, pharmacists, and specially trained facilitators. Their roles extend beyond administering the drug, encompassing preparation, supervision during the session, and integrating insights into the patient’s broader treatment plan. This positions healthcare professionals as crucial stakeholders in translating clinical research into real‑world patient outcomes and informing reimbursement and market access processes whenever possible.

Healthcare professionals also advocate for their patients, communicating practical challenges and patient outcomes to other stakeholders, including insurers, regulators, and treatment centres. As psychedelic therapies become more widely adopted in healthcare systems, their expertise will be critical in shaping reimbursement and caregiving policies and refining treatment protocols.

Healthcare Professionals Stakeholders

Psychiatrists are likely to play a leading role in the administration of psychedelic therapies, particularly in the preparation and supervision of sessions for patients with complex mental health conditions. As medical doctors specialising in mental health, psychiatrists can prescribe medications, assess patient eligibility, and monitor for potential contraindications.

Psychologists, particularly those specialising in clinical or counselling psychology, are expected to take a central role in the therapeutic aspects of psychedelic treatments. Their expertise in psychotherapeutic modalities makes them well‑suited for preparing patients, providing support during sessions, and conducting integration therapy.

Nurses are critical for the day‑to‑day management of psychedelic therapy sessions, particularly in clinical and hospital settings. They may assist in monitoring patients’ physical and emotional well‑being during the treatment and ensuring the environment's safety.

Pharmacists are essential for ensuring the proper handling, storage, and dispensing of psychedelic substances, given their classification as controlled drugs. They may also play a role in educating healthcare teams about dosing protocols and drug‑drug interactions. While pharmacists are already trained to manage controlled substances, the need for additional knowledge about the unique properties of psychedelics may necessitate new educational modules or certifications.

Social workers, occupational therapists, or specialised psychedelic guides could support patients through various stages of treatment. These professionals may help with non‑medical aspects of care, such as creating a supportive environment or assisting with integrating therapeutic insights into daily life. Their involvement will depend heavily on the evolving regulatory and professional landscape, as the necessity of formal certifications or licensure for these roles remains an open question.

14.3.6 Mental Health Facilities/Treatment Centres

Mental health facilities and treatment centres serve as the infrastructure stakeholders in the implementation of psychedelic therapies, encompassing hospitals, private clinics, rehabilitation centres, and specialised therapy centres. These facilities provide the controlled environments required for psychedelic therapy, which necessitates a combination of medical supervision and therapeutic support in settings specifically designed for these novel treatments.

Currently, several pioneering facilities across Europe are adapting their infrastructure to accommodate psychedelic therapies. These include dedicated private clinics like Clerkenwell Health in the UK, academic medical centres participating in clinical trials, and established mental health institutions developing protocols for future implementation. These early adopters are creating blueprints for the specialised therapy rooms, safety protocols, and operational procedures needed to deliver psychedelic treatments effectively.

Treatment Centres Stakeholders

Private clinics operate semi‑independently of public healthcare systems, allowing them to innovate and rapidly adopt cutting‑edge treatments. They cater primarily to patients who can pay out‑of‑pocket or access supplementary insurance, making them a natural entry point for experimental therapies like psychedelics. These clinics often offer tailored care, integrating psychedelic therapy into comprehensive mental health programs that combine psychotherapy, medical oversight, and wellness‑focused approaches. However, fully private clinics face significant challenges in scaling these treatments due to high costs, limited reimbursement options, and regulatory constraints.

Private clinics in countries like the Netherlands are regulated by a public insurance system. Although privately managed, they must adhere to public healthcare guidelines and rely on decisions from health technology assessment bodies and insurance companies to determine which treatments are reimbursed. This hybrid model allows for greater accessibility but limits clinics' ability to offer treatments outside public insurance coverage.

Hospitals play a dual role in psychedelic therapy, acting as both research hubs and clinical providers. Hospitals typically operate through multiple channels: inpatient facilities providing residential care, outpatient clinics for day patients, and community clinics offering specialist care in more localised settings. Dozens of hospitals across Europe participate in clinical trials to evaluate the safety and efficacy of psychedelics, often collaborating with pharmaceutical companies and academic institutions. For implementation, hospitals offer the advantage of advanced medical infrastructure, ensuring the highest levels of patient safety. However, integrating psychedelic therapies into hospital systems may be complex, requiring dedicated treatment spaces and training for multidisciplinary teams. Hospitals are particularly critical for administering treatments to patients with severe mental health conditions who require close monitoring.

Trauma centres, including those specialising in the treatment of veterans and victims of violence or war, are emerging as important stakeholders in psychedelic therapy. These facilities focus on treating post‑traumatic stress disorder (PTSD) and other trauma‑related conditions, which are some of the most promising areas for psychedelic applications. In regions affected by recent conflicts, such as Ukraine and surrounding countries, trauma centres could play a pivotal role in providing psychedelic therapy for individuals dealing with war‑related psychological wounds. These centres face unique challenges, including the need for culturally sensitive approaches and addressing stigma among populations unfamiliar with psychedelic treatments.

Community mental health centres serve as critical access points for underserved populations, making them important stakeholders in the equitable distribution of psychedelic therapies. These centres often treat individuals with limited financial resources or those facing systemic barriers to care. Integrating psychedelics into community mental health settings poses significant challenges, including funding constraints and training needs. However, these centres have the potential to democratise access to psychedelic therapies, ensuring that their benefits reach a broader demographic.

14.3.7 Medical Societies/Professional Associations

Medical societies represent healthcare professionals involved in mental healthcare, including psychiatrists, psychologists, pharmacists, and nurses. These associations develop standards, provide guidance, and support the safe integration of psychedelic therapies into clinical practice.

While no Europe‑wide medical societies focus specifically on psychedelic therapies¹, established professional associations address these treatments within their respective fields. Each group contributes unique expertise: psychiatric associations lead discussions on patient eligibility and safety, psychological associations focus on therapeutic techniques, and pharmacy associations address handling and dispensing. These societies also play key roles in developing training curricula, continuing education programs, and best practices.

Medical societies serve as intermediaries between healthcare professionals and regulators, helping shape policies and standards for implementing psychedelic therapies. Their involvement ensures treatments are implemented responsibly and with broad medical community support.

Medical Societies/Professional Associations Stakeholders

In the Netherlands, psychiatrists are represented by Dutch Psychiatric Association (Nederlandse Vereniging voor Psychiatrie; NVvP), which plays a leading role in shaping mental health guidelines and policy. Psychologists are organised under the Dutch Institute of Psychologists (Nederlands Instituut van Psychologen; NIP), the most influential body for setting professional standards across clinical and counselling practices. Pharmacists are represented by the Royal Dutch Pharmacists Association (Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie; KNMP), which provides critical guidance on handling controlled substances like psychedelics. Nurses are organised under the Dutch Nurses Association (Verpleegkundigen & Verzorgenden Nederland; V&VN), which promotes professional development and best practices in healthcare. Additionally, the Royal Dutch Medical Association (Koninklijke Nederlandsche Maatschappij tot bevordering der Geneeskunst; KNMG) serves as an umbrella organisation for medical professionals, including psychiatrists and general practitioners, and significantly influences national healthcare policy.

In Germany, the German Association for Psychiatry, Psychotherapy, and Psychosomatics (Deutsche Gesellschaft für Psychiatrie und Psychotherapie, Psychosomatik und Nervenheilkunde; DGPPN) and the German Society for Neurology (Deutsche Gesellschaft für Neurologie; DGN) work in partnership as the leading organisations for psychiatrists and neurologists, advancing standards in psychiatric and neurological care. Psychologists are represented by the Professional Association of German Psychologists (Berufsverband Deutscher Psychologinnen und Psychologen; BDP), which advocates for professional development and ethical practices. Pharmacists fall under the umbrella of the Federal Union of German Associations of Pharmacists (Bundesvereinigung Deutscher Apothekerverbände; ABDA), which encompasses regional chambers and professional associations. Nurses are supported by the German Nurses Association (Deutscher Berufsverband für Pflegeberufe; DBfK), which works to improve training and working conditions. The German Medical Association (Bundesärztekammer; BÄK) serves as the central body for all physicians, setting professional standards across medical disciplines and influencing healthcare policy.

In the Czech Republic, psychiatrists are represented by the Czech Psychiatric Association (Psychiatrická společnost České lékařské společnosti Jana Evangelisty Purkyně; ČLS JEP), which is part of the broader medical society system. Psychologists are organised under the Czech‑Moravian Psychological Society (Českomoravská psychologická společnost; ČMPS), which focuses on professional development and ethical guidelines. Pharmacists are represented by the Czech Chamber of Pharmacists (Česká lékárnická komora; ČLnK), which oversees professional ethics and training. Nurses are supported by the Czech Association of Nurses (Česká asociace sester; ČAS), which advocates for professional standards in nursing. The Czech Medical Chamber (Česká lékařská komora; ČLK) is the central body overseeing medical professionals and contributing to national healthcare policy.

In the UK, psychiatrists are organised under the Royal College of Psychiatrists (RCPsych), which leads discussions on mental health policy and education. Psychologists are represented by the British Psychological Society (BPS), which sets accreditation standards and supports a wide range of psychological specialities. Pharmacists fall under the Royal Pharmaceutical Society (RPS), which guides clinical practice and professional standards. Nurses are represented by the Royal College of Nursing (RCN), which focuses on education, advocacy, and professional development. The British Medical Association (BMA) acts as an umbrella organisation for doctors, advocating for improved working conditions, healthcare policies, and professional development across disciplines. The Medical Psychedelics Working Group, established in 2020 by Drug Science, brings together healthcare professionals to advance psychedelic research and treatment integration within the UK healthcare system, working to overcome regulatory barriers and promote evidence‑based approaches to psychedelic medicine.

14.3.8 Patient Advocacy Groups

Patient advocacy groups are instrumental in influencing healthcare policies and the adoption of new treatments. Psychedelic therapies have shown efficacy across a range of mental health conditions, challenging the traditional "siloed thinking" that often categorises treatments strictly by specific diagnoses. This broad applicability can diffuse advocacy efforts, as it requires coordination among various groups representing different patient populations.

In Europe, patient advocacy groups have been less prominent in the discourse surrounding psychedelic therapies.² However, this landscape is evolving. Initiatives like the Psychedelic Access and Research European Alliance (PAREA) have emerged, bringing together patient advocacy groups, scientific associations, and industry partners to promote the assessment and integration of psychedelic treatments within the EU. Additionally, organisations such as PsychedelicsEUROPE are working to transform psychedelic research into sound regulatory policies for Europeans.

Despite these developments, the influence of European patient advocacy groups in the realm of psychedelic therapies remains comparatively limited. As the evidence base for these treatments grows, there is potential for these groups to play a more active role in shaping policies and ensuring patient access to innovative mental health interventions.

Patient Advocacy Groups Stakeholders

The Psychedelic Participant Advocacy Network (PsyPAN) is a global non‑profit organisation founded in 2021 by participants in clinical trials using psilocybin for depression. PsyPAN focuses on amplifying the voices of participants in psychedelic clinical trials and therapy settings, aiming to improve safety and well‑being standards across the sector. By pooling lived experiences, PsyPAN develops guidelines and best practices for trials and treatment centres to ensure participant‑centred care. The organisation provides consultancy and advocacy services to stakeholders and fosters a global community that contributes to shaping the future of psychedelic therapies.

The Psychedelic Access and Research European Alliance (PAREA) is a collaborative initiative focused on promoting the integration of psychedelic therapies within European healthcare systems. PAREA works with patient advocacy groups, researchers, and industry stakeholders to support the assessment and implementation of psychedelic treatments. Its efforts are centred on creating regulatory pathways and ensuring patient access to these therapies. While still in its early stages, PAREA has emerged as a key voice advocating for the safe and ethical inclusion of psychedelics in European healthcare.

PsychedelicsEUROPE is an alliance dedicated to transforming psychedelic research into actionable policies within the European Union. This organisation focuses on bridging the gap between scientific evidence and regulatory frameworks to ensure the responsible adoption of psychedelic therapies. PsychedelicsEUROPE collaborates with policymakers, researchers, and advocacy groups to establish guidelines that facilitate the integration of psychedelics into mainstream healthcare. Their work emphasises creating frameworks prioritising safety, efficacy, and equitable access.

Mental Health Europe (MHE) is a leading pan‑European organisation dedicated to promoting mental health and advocating for the rights of individuals with psychosocial disabilities. Collaborating with its members, MHE strives to create a Europe where mental health issues are destigmatised, and individuals have equal opportunities for inclusion and care.

Global Alliance of Mental Illness Advocacy Networks‑Europe (GAMIAN‑Europe) is a patient‑driven organisation that represents the interests of those affected by mental illness. Its objectives include advocacy, education, destigmatisation, and capacity building, making it a significant stakeholder in mental health discussions across Europe.

European Patients’ Forum (EPF) is an umbrella organisation encompassing various patient groups across Europe and disease areas. With 78 members, including disease‑specific patient groups and national coalitions, the EPF provides a cross‑disease perspective in policy‑making, directly impacting patients’ lives.

In the Netherlands, mental health advocacy is robust, with numerous organisations dedicated to various aspects of mental well‑being. The Dutch Association of Mental Health and Addiction Care (De Nederlandse ggz) represents over 100 member organisations that provide a wide range of services—from mental health promotion and prevention to specialised care and assisted independent living. They engage in ongoing dialogues with client organisations, health insurers, governments, and professional associations to advocate for comprehensive mental health care. Another significant organisation is the MIND Platform, which unites around 50 client and family organisations in the mental health sector.

Germany's mental health advocacy landscape includes several key organisations. The Federal Association of Relatives of the Mentally Ill (Bundesverband der Angehörigen psychisch Kranker; BApK) supports families dealing with mental illness, offering counselling, information, and advocacy to improve mental health services. Additionally, the German Depression Foundation (Stiftung Deutsche Depressionshilfe) works to raise awareness about depression, reduce stigma, and improve care for those affected.

In the Czech Republic, mental health advocacy is represented by organisations such as the National Association of Patients' Organizations (NAPO), a coalition advocating for patients' rights and better healthcare services across various health issues, including mental well‑being. The Czech Association for Mental Health (Česká asociace pro duševní zdraví) focuses specifically on mental health, providing support, education, and advocacy for individuals with mental health conditions and their families.

The United Kingdom has a rich landscape of mental health advocacy organisations. Mind is a leading charity that offers support and campaigns for better services and a better understanding of mental health issues. The Mental Health Foundation focuses on research and policy development to prevent mental health problems and support recovery. Rethink Mental Illness provides services and support for those affected by mental illness and advocates for policy changes and greater awareness.