Italy has joined the countries advocating for restricting the use of puberty blockers in individuals with gender dysphoria. The National Bioemic Committee (CNB) has recently updated its recommendations, stating that these medications should only be utilized after psychotherapy has been ineffective and exclusively within the parameters of clinical trials. The manual released in November 2024 highlights the following key points:
- The administration of puberty blockers is permissible following a comprehensive documented evaluation by a multidisciplinary team of specialists.
- All clinical trials should adhere to the Double-blind randomized controlled study model.
- The use of these drugs outside of research is only acceptable if similar stringent criteria are met, with obligatory data transfer to the National Register.
These guidelines were formulated in response to a request from the Ministry of Health in December 2023 regarding the ethical administration of puberty blockers in minors due to insufficient data on their safety and effectiveness. The CNB stated that while the potential benefits of these medications should be acknowledged, they must be balanced against doubts stemming from limited research and insufficient long-term data.
The issue remains contentious on the global stage. In nations such as the UK, Sweden, Finland, and Norway, there are restrictions on the use of blockers, whereas in Canada, the Netherlands, and Belgium, their use continues under the “Dutch protocol,” albeit with varying approaches.
The CNB conducted a series of hearings involving prominent Italian scientific societies, including the Italian Society of Pediatric Endocrinology and Diabetology, and the Italian Society of Behavioral and Cognitive Therapy. Following these discussions, the Committee concluded that there is an absence of scientific data and recommended funding high-quality research, encompassing a systematic review of existing evidence and an analysis of observational data.
The Committee stressed the importance of considering a broad spectrum of consequences – both psychological and physical – and advised that research should only proceed after the inefficacy of psychotherapy has been confirmed.