BfArM

For this sector the BfArM matters twice over, and the second reason is the one readers miss. It licenses medicines and authorises trials like any national agency, but it also supervises legal traffic in narcotic drugs and publishes the register of compassionate use programmes. That register is a primary source, updated, public and checkable, and it is where German access to an unapproved psychedelic actually shows up. It records what is happening to patients rather than what a company intends. It is also easy to over-read: the register publishes one current term and not a history, so it will tell you a programme exists and will not tell you when it started.

The agency describes itself as "an independent federal higher authority within the portfolio of the Federal Ministry of Health", with responsibilities covering the licensing of medicines, medicinal product safety, medical device risk, and the monitoring of legal traffic in narcotic drugs and precursors (bfarm.de).

Is psilocybin approved in Germany? No. What exists is a compassionate use programme, which is a different thing: a route to treat patients with a medicine that has no marketing authorisation. We first sourced it properly in Issue 8: "The BfArM has approved a compassionate use programme for psilocybin in treatment-resistant depression, running at the Central Institute of Mental Health in Mannheim and a Berlin day clinic, using botanical psilocybin supplied by Filament Health. It is the first of its kind in the European Union."

Issue 10 read the whole register, all twenty-eight entries, and found the story in who is named: twenty-seven of the twenty-eight name a pharmaceutical company as the responsible party, and the psilocybin entry names a university institute and one psychiatrist. That issue is also where we set out what the register does and does not say: "The register publishes one current term, not a history." And: "It names the party who notified the BfArM, which is why Mannheim appears in that column and Berlin does not."