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Jump to Key Points Currently available medications for psychiatric disorders such as schizophrenia, anxiety disorders, and depression often take time to work, are not sufficiently effective, or cause distressing side effects. At the same time, the documented burden of disease associated with these conditions is rising.
In Germany, work-related absenteeism has also increased significantly (see box). The need for innovative therapies is therefore substantial. However, according to experts, regulatory and economic hurdles are hindering the development and market introduction of new psychiatric drugs in Europe.
“This denies our patients access to new therapies,” said Andreas Reif, MD, PhD, director of the Department of Psychiatry, Psychosomatic Medicine and Psychotherapy at the University Hospital Frankfurt in Frankfurt am Main, Germany, at a press conference during the 39th Congress of the European College of Neuropsychopharmacology (ECNP) in Munich, Germany. “Companies are hesitant to enter the European market because of regulatory issues,” Reif continued. As a result, Europe risks falling behind other markets in access to innovative psychiatric medications.
The newly founded European Coalition for Mental Health Medicines Innovation (EU-MIC) aims to counteract this trend. Coordinated by the ECNP, the coalition brings together patient organizations, medical societies, and representatives from research and industry. Together with regulatory agencies and funding bodies, the initiative aims to review existing procedures, identify improvements, and facilitate access to innovative medications.
Mental Illnesses Impose High Costs
Data on the global burden of disease illustrate the urgency of the issue. A report in The Lancet examines the prevalence and health consequences of mental disorders. In particular, anxiety disorders, major depression, and schizophrenia contribute substantially to the number of years lived with disability worldwide.
Mental illnesses often emerge at a young age and can affect individuals for many years. Limitations in mental and physical functioning — such as those that can also occur with burnout — have far-reaching consequences for family life, employment, and social participation, Reif explained.
In addition, these disorders create considerable economic burdens. According to an Organisation for Economic Co-operation and Development estimate published in 2018, the annual social and economic costs of mental illness in the then 28 EU member states already amounted to more than €600 billion in 2015. This figure includes not only direct healthcare expenditures but also social benefits and productivity losses.
38 US Approvals — But Only 11 in Europe?
The innovation gap highlighted by EU-MIC is particularly evident when comparing drug approvals. According to the initiative, between 2016 and 2025, 38 drugs for the treatment of mental disorders were approved by the US Food and Drug Administration. By contrast, the European Medicines Agency approved only 11.
Mental Health Diagnoses Are Driving Longer Periods of Absenteeism
In Germany, too, absenteeism related to mental health diagnoses has increased significantly in recent years. This is shown by the latest Absenteeism Report from the AOK Scientific Institute, the research arm of one of Germany’s largest statutory health insurance funds.
While in 2016, mental health conditions accounted for 284 days of incapacity for work per 100 AOK-insured employees, by 2025 this figure had risen to 403 days. This represents an increase of approximately 42% over a 10-year period.
In terms of the number of sick leave cases, mental health conditions remained well below respiratory illnesses: For every 100 AOK members, there were 14.1 sick leave cases due to mental health diagnoses compared with 80.3 cases due to respiratory illnesses. However, individual sick leave periods for mental health conditions lasted considerably longer. On average, they lasted 28.5 days per case compared with just 5.7 days for respiratory diseases.
The trend in burnout diagnoses was particularly striking. Absences attributable to burnout rose from 11.0 sick days per 100 members in 2016 to 19.5 days in 2025 — an increase of about 77%. However, under ICD-11, burnout is classified as a work-related phenomenon rather than a separate mental disorder, an important distinction for international readers.
Across all diagnostic groups, sick leave among AOK-insured individuals has recently shown a slight decline. This trend continued in the first half of 2026 compared with the same period of the previous year. As a result, sick leave for the full year could decline further.
However, the rising number of sick days due to mental health diagnoses does not directly indicate a corresponding increase in the prevalence of these conditions. Changes in diagnostic practices, health care utilization, and the duration of sick leave can also influence this trend.
The difference is even more pronounced when it comes to reimbursement: According to the EU-MIC analysis, of the 38 therapies approved in the US, only three are reimbursed in all five European markets examined — Germany, France, Italy, Netherlands, and Spain. These include one medication for a mood disorder and two drugs for sleep disorders.
The figures are based on an analysis by the initiative. The classification depends on which drugs and types of approval were included. Furthermore, approval, market launch, and reimbursement must be distinguished from one another: A lack of reimbursement in all five countries does not necessarily mean that a drug is fundamentally unavailable in Europe.
From EU-MIC’s perspective, however, these differences show that European patients do not benefit from new drug developments to the same extent as patients in the US.
Where EU-MIC Sees the Greatest Obstacles
The initiative identifies regulatory requirements that do not sufficiently account for the specific characteristics of psychiatric disorders as a key cause. According to Reif, the evaluation of new psychotropic drugs often applies standards originally developed for somatic diseases and not easily transferred to mental disorders.
EU-MIC specifically identifies four structural barriers:
- Study design and efficacy endpoints: The initiative criticizes the long duration of studies and what it considers, in some cases, outdated requirements for demonstrating efficacy. It argues that patient-relevant aspects such as tolerability, quality of life, and long-term recovery are not sufficiently taken into account.
- Health technology assessment: European assessment procedures often require direct comparisons with existing therapies. Given the heterogeneity of psychiatric disorders, such studies are not always well suited to capturing the added benefit of new treatment approaches.
- Evaluation of novel mechanisms of action: According to the initiative, innovative therapeutic approaches are not sufficiently recognized, even though new mechanisms of action are particularly needed for mental disorders with diverse biological underpinnings.
- Economic disincentives: Lower European drug prices and the US most-favored-nation pricing policy, which links domestic prices to lower prices in other markets, could reduce the economic incentive to launch products in Europe.
This is the initiative’s assessment. Whether and to what extent the requirements outlined above actually delay the development, approval, or availability of individual psychotropic drugs must be examined on a case-by-case basis, taking into account specific drugs and approval procedures. Business decisions, differing study results, and national price negotiations may also play a role.
According to EU-MIC’s assessment, these factors are already contributing to certain innovative therapies — including drugs with new mechanisms of action for schizophrenia and severe depression — not reaching European patients or reaching them only after delays.
New Mechanisms of Action Alone Are Not Enough
Åsa Konradsson-Geuken, PhD, assistant professor of pharmacology at Uppsala University in Uppsala, Sweden, also highlighted the scale of the remaining unmet need. She spoke both from a scientific perspective and from her personal experience as a family member of someone with mental illness.
“Effective medications are a cornerstone of schizophrenia treatment,” Konradsson-Geuken said. While available antipsychotics can effectively treat psychotic symptoms and reduce the risk for relapse, they often have only a limited effect on other aspects of the illness — particularly cognitive impairments such as concentration and memory problems, as well as negative symptoms such as lack of motivation.
“I see what medications can do, but I also see the gaps and the side effects that interfere with daily life,” she added.
Konradsson-Geuken is also president of the European Federation of Associations of Families of People with Mental Illness and the Swedish Schizophrenia Association. In her view, it is therefore not enough simply to develop new active ingredients. What is crucial, she said, is that effective and well-tolerated therapies actually reach those affected and enable them to participate more fully in society.
This is precisely where EU-MIC aims to make a difference: The initiative seeks to strengthen dialogue among researchers, industry, patient advocacy groups, and regulatory authorities and to create conditions under which innovative psychiatric medications can be developed, evaluated, and made available to patients more quickly.
This story was translated from Medscape’s German edition.
