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Which services are available to an Italian couple seeking information or advice about fertility? Which specialist and which medical facility should they entrust to initiate an adequate diagnostic and treatment pathway if they face fertility struggles? There is currently a large disparity in the approach to these issues in Italy. There are no state-accredited clinical guidelines on the prevention and clinical management of infertility, and the criteria for subsidizing reproduction-related procedures by regional administrative bodies are inconsistent across the board. But the new year should bring changes in this area.

Applying the Law

Access to medically assisted reproduction is regulated in Italy by Law 40 created in 2004. Dozens of courts have expressed their opinion on this legislation over the years. Many have dismantled the law with their rulings, circumventing, for example, the ban on same-sex couples accessing such treatment or preimplantation testing.

On December 18, 2023, Italy's Scientific Advisory approved an "Update to the Guidelines Comprising the Indications for Procedures and Techniques Related to Medically Assisted Reproduction," a document showing how to apply Law 40 considering changes made in recent years by the rulings. The version of this text that is currently in force dates back to 2015, and the country's Department of Health is set to publish an approved update shortly.

Despite its title, this document is not a set of clinical guidelines for diagnosing and treating infertility. Italy's body for clinical practice and public health guidelines — the Sistema Nazionale Linee Guida — which integrates all recommendations to be adhered to by healthcare professionals in accordance with Law 24 of 2017, has not accredited any guidelines for the clinical management of infertility.

In 2019, the country's National Center for Clinical Excellence, Quality and Safety of Care (CNEC) tasked the Italian Society for Human Reproduction (SIRU) with creating a set of recommendations on the topic by adapting foreign guidelines on quality excellence to an Italian setting. The group established by SIRU for the job described the work undertaken in an article published recently in Reproductive Biology and Endocrinology.

The SIRU Adaptations 

"We evaluated seven to eight guidelines from different countries, and we chose those drawn up by the British National Institute for Clinical Excellence (NICE) for their quality and because reproductive specialists in Italy already deem the NICE guidelines a reference document in their clinical practice," said Antonino Guglielmino, MD, a gynecologist, former SIRU president, and one of the authors of the article. "We removed or amended any recommendations from the original text that are wholly or partially incompatible with Italian law or with the choice of drugs and the epidemiological data available in Italy. New recommendations were included on the basis of new scientific evidence or from the opinion expressed by a group of experts and representatives of scientific societies, patient associations, and all professions involved." Overall, five recommendations were removed, 25 were amended, and 17 were included from scratch, making a total of 217 recommendations in the final version, covering the entire pathway from prevention and diagnosis to treatment of infertility.

In May 2022, Italy's CNEC issued an unfavorable opinion on the document, judging it to be inapplicable to an Italian setting. Therefore, the text was not added to the Sistema Nazionale Linee Guida.

Patchy Health System

"I can sort of understand why they made this decision. Currently, only some regional authorities in Italy cover the costs of procedures relating to assisted reproduction. In those areas, the recommendations found in the guidelines we have drawn up are applicable. Elsewhere, in cases where the patient is self-funding, they may not be applicable, not for clinical reasons, but for financial ones," said Guglielmino.

Since 2017, medically assisted reproduction has been covered by the Italian Health Service's basic healthcare package. Nevertheless, the health service's failure to publish the list of services it covers has, up to now, prevented this basic healthcare package from being applied. Some regions, like Lombardy, cover the costs associated with medically assisted reproduction. Others, like Sicily, don't.

The new list of services covered was finally approved in 2023 and was due to take effect on January 1, 2024. "But since some regions are not yet prepared for the change, this date was pushed back to April 1, 2024," said Guglielmino. "We hope that, from then onward, the availability of services covered by the state will be consistent throughout the country so that the basic healthcare package is accessible to people in all regions. In the meantime, they are a point of reference for clinical practice for all professionals working in the fertility field. Over the next few months, SIRU will publish a pamphlet summarizing the recommendations made in the document and set to work establishing diagnostic, therapeutic, and care pathways for couples struggling to conceive throughout Italy."

This article was translated from Univadis Italy, which is part of the Medscape Professional Network.