The Italian Council of Ministers has approved a draft bill establishing a national registry to monitor the use of puberty-blocking drugs and hormones, specifically triptorelin, in treating gender dysphoria in minors. Health Minister Orazio Schillaci and Family Minister Eugenia Roccella presented the measure.
The registry, managed by the Italian Medicines Agency (AIFA), will govern the prescription and dispensing of these medications, which will be exclusively handled by hospital pharmacies. Registry data will be reported to the Health Ministry every six months. Pending formal protocol adoption, administration of the drugs requires approval from the national pediatric ethics committee.
The legislation mandates that administering puberty blockers and hormones – currently covered by the National Health Service (with triptorelin used off-label) – is contingent upon:
1. A diagnosis by a multidisciplinary team following psychological, psychotherapeutic, and potentially psychiatric evaluations.
2. Adherence to clinical protocols to be established by the Health Ministry.
3. Obtaining informed consent as required for minors’ medical treatments.
The biannual reports to the Health Ministry must include documented outcomes of prior psychological/psychotherapeutic/psychiatric evaluations, diagnosed comorbidities, clinical monitoring, and follow-up data.
Finally, the bill creates a technical committee to evaluate AIFA’s six-monthly reports and requires the government to submit a triennial assessment to Parliament.
© Copyright ANSA. All rights reserved.