Bringing pharmaceutical innovation back to europe: challenges, opportunities and the path forward

Concha Caudevilla will give a brief impulse talk from an industry perspective on why fewer mental health medicines reach European patients. Psychiatric drug development presents unique scientific and translational challenges, and decisions on whether to progress new therapies for Europe reflect the broader innovation environment, including regulatory pathways, evidence requirements, health technology assessment processes, price expectations and the potential for patients to access new treatments in practice. Where these conditions are perceived as less supportive, some programmes may be deprioritised for Europe or never submitted, meaning that the access gap can begin before European regulatory evaluation. She will frame the issue across three domains. On approval, requirements such as the maintenance-of-effect study should be applied flexibly, including through post-approval fulfilment, to reduce development risk and patient waiting times. On access, a genericised market with little recent innovation signals unmet need rather than satisfied need, and value assessment should capture patient-relevant, functional, health-system and societal benefits, including incremental gains in safety and tolerability. On adoption, clinical inertia, service readiness and stigma determine whether approved treatments reach patients. Beyond building a strong coalition such as EU-MIC, Concha will invite regulators, HTA bodies, clinicians and patient and carer advocacy groups to discuss a new framework specific to mental health, focused on assessing benefits for patients, defining upfront which outcomes count and allowing long-term evidence to be generated post-approval, thereby giving developers earlier clarity and reducing regulatory and HTA divergence.