Portugal approves first psychedelic drug for hospital use
The announcement coincided with the presentation of a comprehensive set of recommendations for the clinical use of psychedelics at the Champalimaud Foundation in Lisbon.
Portugal’s national medicines authority, Infarmed, has approved public funding for Spravato, the first psychedelic-based drug to be used in hospitals for adults suffering from treatment-resistant major depressive disorder.
The announcement coincides with the release of a comprehensive set of recommendations for the clinical use of psychedelics, developed by a multidisciplinary working group including medical, pharmaceutical, and psychological associations, as well as Portugal’s National Ethics Council.
The document is available in Portuguese here:
Spravato, which is esketamine, will be administered in hospital settings for patients who have failed to respond to at least three previous treatments.
It may also be used in cases where patients have not responded to or cannot access electroconvulsive therapy, provided they have undergone psychotherapy.
At the launch event held at the Champalimaud Foundation in Lisbon, experts emphasized that psychedelic substances must be regulated as medicines, requiring medical prescriptions, supervision, and proper training of healthcare professionals.
They warned against informal or non-medical use and stressed the need for clear legislation, safety protocols, and public literacy around these treatments.
Leaders from Portugal’s professional health bodies called for rigorous scientific evidence, ethical standards, and equal access in future psychedelic therapies.
“These substances cannot be anything other than medicines,” said Helder Mota Filipe, president of the Order of Pharmacists, referencing EU law.
Echoing this, the president of the Portuguese Society of Psychiatry stressed the need for robust clinical data before widespread adoption.
The guidance released reflects nearly two years of collaboration and seeks to support regulatory efforts as psychedelic-based treatments move closer to medical legitimacy in Portugal.