In Italy, the need for a regulation of the criteria behind Hormone Replacement Therapy for trans people is putting access to health care at stake
Transgender people are all those whose gender identity doesn’t match the sex they were assigned at birth. They often choose to go through some medical and juridical procedures such as legal name change, gender-affirming surgeries and Hormone Replacement Therapy (HRT).
This therapy consists in the intake of sexual hormones (testosterone in the case of a masculinizing treatment, estrogens and antiandrogens for a feminizing therapy) to achieve the desired phenotypic characteristics needed for the mental and physical well being of trans people undergoing such a process.
Leaflets of hormonal medicaments, though, do not include gender affirmation as one of the possibilities of their usage, probably as a consequence of the lack of health literature on the topic. This absence reverberates in the possibility for National Health Systems (NHSs) to acknowledge their prescription and reimbursement for gender affirming therapies. Nonetheless, some European countries already overcome this barrier allowing their citizens to access HRT freely.
On the 30th of September 2020 the Italian Medicines Agency (AIFA) finally approved Hormone Therapies for Transgender People. While this decision could be a welcomed step forward in the acknowledgement of trans people and their needs, the resolution still doesn’t solve many of the problems they face in accessing reaffirming therapies.
Hormone Replacement Therapy before the AIFA resolution
Up until the approval of the new AIFA resolution, transgender people in Italy had two ways to access hormone placement therapy.
They could ask for an “off-label usage”, namely the prescription of a medication for a therapy not included in its leafleat. Accessing this strategy were mostly trans people who had not had their legal names and statuses rectified, as – i.e. – female documents do not justify a prescription of testosterone, formally intended for male hypogonadism only. Off-label prescriptions, though, cannot be reimbursed by the NHS, weighing completely on the funds of the persons undergoing the transition.
Alternatively, people who had had their legal status adjourned, could get a phony diagnosis of hypogonadism and access most of the hormones for free.
This overall situation resulted in huge inequalities and confusions throughout the country, increasing economic barriers and excluding many trans people from accessing a life saving therapy. Hormone therapies are, in fact, vital for both the mental well being of all trans people and the hormonal balance of those who underwent gonads removing surgeries.
What happens now with hormone replacement therapy ?
After the new AIFA resolution, the Italian NHS approves of testosterone, anti androgens and estrogens being used with government fundings in case of a diagnosis of “gender dysphoria or incongruence observed by a multidisciplinary equipe of specialized medical practitioners”.
This new decision is a clear improvement on the right of a safe and inclusive access to hormone medicaments and a step forward the institutional acknowledgment of trans bodies and identities.
Access to Hormone Replacement Therapy could guarantee specific traceability of its usage, limit – even without completely nullifying it – the need for illegal (and, most of the times, dangerous) markets or exchanges of testosterone, estrogens and antiandrogens and provide epidemiological data for some research on trans health. These researches have so far been biased by the lack of data due to the grey zones created by the previous prescription criteria.
Is all the glitters gold?
The new mechanism, though, still leaves some issues to be solved in order to finally achieve the full coverage of trangender needs.
Point 2 of the AIFA Resolution mentions the need of a Gender Dysphoria diagnosis provided “by a multidisciplinary equipe of specialized medical practitioners” before accessing Hormone Therapy through the NHS. This definition leaves room for various interpretations that may – contrary to what expected – paralyze the system and increase the difficulties of the process with inequalities based on the chances to adhere to such criteria.
The institutional website InfoTrans.it (run by the Italian National Health Institute and the National Office Against Racial Discrimination) in its Services Map pictures the imbalance of recognized centers through the country.
In the south of Italy there are overall 4 centers, a number that doubles in the north with its 8tservices. This all sums up to less than 20, the number of all the italian regions.
If we add to that the 9 Local Health Authorities (LHA) and the 6 Polyclinics that have in their workforce the needed professionals, we get a total of 27 centers that could meet the new AIFA criteria.
This leaves uncovered and uncared for all those trans people who do not live close enough – nor have the opportunity to get to – one of these centers and limits the possibilities for doctors and LHAs to autonomously provide a gender dysphoria diagnosis.
Furthermore, the recognized centers already have long waiting lists that will only worsen once they’ll become the only way to obtain the required documentations.
One more problem of the new resolution rises from the criteria needed to diagnose Gender Dysphoria.
AIFA broadly mentions DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) and ICD-11 (International Classification of Diseases).
These two manuals, though, have substantial differences in their perspectives of trans identities.
In Italy the approved protocols refer mostly to the DSM-5 criteria, with a pathologizing and standardised approach that not all trans people abide to. This obliges transgender people willing to obtain the green light to their gender affirming process to “tell the doctors what they want to hear”, forcing themselves into the expected answers.
The ICD-11, on the other hand, published by the WHO in 2018, moves the focus from a mental disorder to a sexual health condition.
This may, in a hopefully near future, broaden the possibilities for trans self determination, as it’s already happening in some international medical centers, without the need for a pathologizing and standardised perception of transgender identities.
The AIFA Resolution, though, does not completely solve the systemic barriers in the safe and free access to hormone replacement therapy, helping out only those who can easily get to the authorised medical centers and practitioners, still leaving behind anyone who for geographical, economical and social isolation has no way to do so. Let’s keep in mind that transgender people face already some of the biggest treats when it comes to social inclusion, work placements and educational careers.
Access to medicaments and health services needs to become part of a wider inclusion progress, shifting from a few specialised centers and medical doctors to a general knowledge and competence of the needs of the transgender population in all health providers.
Last but not least, it is time to get past the diagnosis-therapy view of trans identities, lighting up an inclusive space for all lives and experiences that are not a disease to be cured.
Matteo Cavagnacchi and Lorenzo Barbaro
top picture by Alessia Runfolo @ale_runf
 Hormones and Hormone Therapy under Medical Supervision – TGEU 2021
 Gazzetta Ufficiale della Repubblica Italiana, Serie Generale n.242 del 30-09-2020
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