Cabinet approves registry for medications for minors' gender dysphoria

The Council of Ministers has approved a draft bill establishing a registry on the use of hormones and puberty-blocking drugs in the treatment of gender dysphoria in minors , specifically triptorelin. The measure was presented by Ministers of Health and Family Affairs Orazio Schillaci and Eugenia Roccella .

The registry, maintained by AIFA, will be used for prescribing and dispensing medications, which will take place exclusively in hospital pharmacies. The data contained in the registry will be transmitted to the Ministry of Health every six months.

Pending the adoption of protocols, drug administration will only be possible with the approval of the national pediatric ethics committee.

The bill introduces provisions for effective data monitoring and the protection of minors' health. Specifically, it establishes that the administration of puberty-blocking drugs and hormones—currently mandated by AIFA to be paid for by the National Health Service (in the case of triptorelin, off-label)—must be subject to a diagnosis by a multidisciplinary team, following psychological, psychotherapeutic, and possibly psychiatric assessments. The procedure is subject to clinical protocols to be adopted by the Ministry of Health, as well as the obtaining of informed consent, expressed in accordance with the procedures established for medical treatments on minors.

The data contained in the registry will be transmitted to the Ministry of Health every six months. The report must contain: information and details regarding the decision-making process for prescribing medications, including documented outcomes of previous psychological, psychotherapeutic, and, where applicable, psychiatric treatment; any diagnosed comorbidities; and clinical monitoring and follow-up.

Finally, the bill provides for the establishment of a technical committee to evaluate AIFA's half-yearly report and the submission of a report to Parliament every three years.