The growing innovation gap in European psychopharmacology
Dear ECNP Members,
When I outlined my plans for my presidency at last year’s General Assembly in Amsterdam, I highlighted two strategic priorities that I believe will help shape the future of our field. First, ECNP will make AI in mental health a central area of focus (more on that in our next newsletter). Second, we will address what I consider one of the most pressing challenges facing European psychiatry today: the growing innovation gap in psychopharmacology.
What do I mean by this? As many members were unable to attend the General Assembly, allow me to briefly explain.
Over the past 15 years, the US Food and Drug Administration (FDA) has approved 62 treatments across eight psychiatric conditions, including sleep disorders. The largest number of approvals were in schizophrenia, ADHD, major depression, sleep disorders, and bipolar disorder. During the same period, only 23 of these treatments received approval from the European Medicines Agency (EMA). More concerning still, only a fraction of these therapies ultimately became accessible to patients across Europe. While 20 were reimbursed in at least one European country, only 13 were reimbursed in three or more countries, and just two achieved reimbursement across the five largest EMA markets—France, Germany, Italy, the Netherlands, and Spain.¹
In other words, while patients in the United States have gained access to 62 new psychiatric treatments, fewer than 5% of these innovations are broadly available across Europe. This gap includes therapies with genuinely novel mechanisms of action, such as xanomeline/trospium, dextromethorphan/bupropion, and lumateperone. Looking ahead, the disparity may widen further as promising new treatments—including psychedelic-assisted therapies such as psilocybin and 5-MeO-DMT—approach potential regulatory approval.
The causes of this innovation gap are complex. Regulatory requirements play a role; for example, the EMA often requires longer clinical trials than the FDA. Yet regulation alone is not the fundamental challenge. An even greater obstacle lies in access after approval, through health technology assessment (HTA) processes that determine the value and reimbursement of new medicines.
HTAs are essential. In solidarity-based healthcare systems, they help ensure that healthcare resources are allocated responsibly and fairly. However, current frameworks often create particularly high barriers for psychiatric innovation. In some countries, new antidepressants must demonstrate superiority over established treatments in lengthy comparative studies against standard antidepressants, despite the well-known heterogeneity of depression and the absence of reliable predictive markers. Thus, promising treatments might simply fail as they are, on average, not better than, say, SSRI, although individual patients may benefit hugely. At the same time, outcomes that matter deeply to patients—such as improved tolerability, fewer sexual side effects, better metabolic safety or increased functionality —are frequently undervalued. The result is that progress in mental health is often assessed differently from progress in many areas of somatic medicine, leaving European patients with fewer therapeutic options and slower access to innovation.
This is precisely why ECNP has helped initiate EU-MIC, the Coalition for Mental Health Medicines Innovation in Europe. EU-MIC is bringing together scientific societies, industry partners, policymakers, and people with lived experience to advocate for a more innovation-friendly environment while maintaining rigorous scientific standards. Our goal is not simply faster access to new treatments, but airer assessment processes and a stronger recognition of outcomes that truly matter to patients.
The coalition is already supported by a growing number of organisations, and will continue to expand in the months ahead. Its official launch will take place at the 39th ECNP Congress in Munich this October—yet another excellent reason to join us there.
Europe has a proud tradition of scientific excellence in psychiatric drug development. Together, we must ensure that this excellence is translated into meaningful therapeutic advances for the people who need them most. I am convinced that, working collectively, we can help create a future in which innovation in mental health is not only discovered in Europe, but also reaches European patients.
Until then, stay tuned—and have a wonderful summer.
