In a statement, the National Authority for Medicines and Healthcare Products states that the drug in question (Spravato) is now being financed, for use in a hospital environment, in adults “with treatment-resistant Major Depressive Disorder, who have not responded to at least three different treatments with antidepressants”.

According to the decision, dated 7 May, Spravato, in association with two other antidepressants, may be used “with combination or oral potentiation strategies, in the current moderate to severe depressive episode”, in adults who have previously undergone psychotherapy and have resistance or contraindication to “electroconvulsive therapy”, do not have access to or have refused this therapy.

This information comes on the same day that a working group that includes medical, pharmaceutical and psychological associations and the National Ethics Council presents a set of recommendations for the clinical use of psychedelics, arguing that they should be classified as medicines.

“The way to access them [medicines] requires that there be a prescriber and that, after the prescription is issued, the patient resorts to a medical, clinical and pharmaceutical system that allows him to access that substance”, explained to Lusa Albino Oliveira Maia, director of the Neuropsychiatry Unit at Champalimaud and member of the working group.

Stressing that “there should be no exceptions”, he recalls that, sometimes, substances, even though they are medicines, can be used inappropriately in parallel marketing circuits.

“Psychedelics are not a unique case in terms of substances that may be of interest to consumers outside the medical system and within the medical system,” the researcher said, adding: “The circumstance that is specific in this case is that we are making a movement to transform substances that exist outside the medical, pharmaceutical and clinical world into medicines.”

The document with the recommendations, which will be presented at 5:30 pm, in the Champalimaud Foundation Auditorium, had the contribution of the orders of doctors, pharmacists and psychologists, as well as the National Council of Ethics for Life Sciences and the Portuguese Society of Psychiatry and Mental Health.

Speaking to Lusa, Albino Maia stressed that this working group is not intended to replace regulators, but merely to make a contribution, particularly in cases where there is no regulation yet approved.

As an example, he cited the use of ketamine, which is approved as an anesthetic, but is also being used (‘off label’) for some cases of depression.

“From the point of view of the use of these substances as medicine, we should not have an exception regime,” said the researcher, adding: “What we are saying is what to do under precautionary principles when there is still not enough evidence for regulatory entities to pronounce themselves.”