Tighten up

Italy's ministers endorse a plan for strict regulation of puberty blockers and cross-sex hormones

Photo by Sterling Lanier on Unsplash

Exiting the dead end of affirmation

Italy’s cabinet has approved a draft law for strict control over the hormonal treatment of gender-distressed minors, with the intent to rein in the excesses of the “affirmative” model and align the country with the North European shift to caution.

The bill—presented earlier this week by Health Minister Orazio Schillaci and Minister for Family, Birth and Equal Opportunities Eugenia Maria Roccella—would establish the first national registry to monitor and track the prescribing of puberty blockers and cross-sex hormones to children, as well as any mental health problems or other co-morbidities.

“In Italy, to date, no official data has ever been published on the use of [the puberty blocker] triptorelin in minors with gender dysphoria, despite the fact that the drug has been used in this area since 2019,” said the Italian parents’ group GenerAzioneD, which welcomed the bill as “a solid regulatory framework”.

“This [bill] outlines a model that protects minors with appropriate clinical tools, gradual choices and a focus on the psychological dimension, in line with what has already been initiated by the most advanced and thoughtful countries in [Northern Europe] terms of bioethics and healthcare,” GenerAzioneD said.

“This is a real rethinking of the ‘affirmative-only’ model, which in the past had led to excessive medicalisation and is now being replaced by a more cautious approach based on up-to-date scientific data and the precautionary principle.”

Pending new clinical guidelines from Italy’s Ministry of Health, the bill stipulates that hormonal treatment of gender-distressed minors will require approval from a national paediatric ethics committee.

“This introduces a safeguard to prevent abuse, family pressure or rash decisions. It is a model already in place in other sensitive clinical contexts, such as experimental therapies or irreversible surgical procedures in children,” GenerAzioneD said.

The bill states that any gender treatment with puberty blockers or cross-sex hormones must follow “a diagnosis by a multidisciplinary team and the documented results of previous psychological, psychotherapeutic, and, where applicable, psychiatric treatment”.

From Rome, the news agency Reuters reported the objections of transgender activists but said there was “a high chance” the draft bill would be enacted by Italy’s parliament because its policy aims enjoyed the support of the governing coalition of Prime Minister Giorgia Meloni.

The government emphasised the need “to protect the health of minors” and introduce “effective data monitoring”.

Laying down the law

In its commentary, GenerAzioneD said some key safeguards in the bill were already supposed to be standard practice with gender dysphoria.

In 2019, for example, puberty blockers were made available in the public health system by the Italian Medicines Agency, which insisted on the role of multidisciplinary assessment and psychological or psychiatric therapy. However, those requirements were reportedly ignored at the Careggi hospital gender clinic in Florence, which was audited by Ministry of Health inspectors last year.

The new bill would reinforce those safeguards nationally.

“The process [for hormonal treatment] does not allow for shortcuts or simplifications: each intervention will be authorised only after a thorough evaluation, documented by clinical reports attesting to the psychological or psychiatric care of the minor,” GenerAzioneD said.

The group said the focus on psychological treatment as the first-line intervention was a strength of the bill and reflected “clinical evidence that many cases of adolescent dysphoria resolve spontaneously or evolve in different ways once puberty is over.”

The bill would also give effect to findings of Italy’s National Bioethics Committee, which last year said data reporting on puberty blockers in the regions was poor, and all clinical decision-making should be “thoroughly documented” with a new national registry to track treatment.

In its report, the committee noted the insufficient scientific evidence and uncertain risk-benefit ratio for puberty blockers as a response to gender dysphoria, recommending these drugs be confined to independent clinical trials. The committee expressed doubt about the capacity of minors to give informed consent to this gender medicalisation and emphasised the role of psychological methods as first-line treatment.

The new bill—titled “Provisions for the appropriate prescription and correct use of drugs for gender dysphoria”—would require the Italian Medicines Agency to set up the national registry within 90 days.

The registry would collect information on treatment decision-making, the results of previous psychological or psychiatric therapy, any diagnosed co-morbidities, clinical monitoring of patients and their follow-up.

This supervision of treatment would take account of the clinical guidelines yet to be issued by the Ministry of Health.

Every six months, the medicines agency would report to the ministry, where a new technical committee would analyse the data, and the minister in turn would report to the parliament every three years.