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Guidance on medically assisted reproduction to be announced in Italy?

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What services are available to Italian couples seeking information and advice regarding infertility? When faced with infertility treatment, which specialist and which medical facility should they refer to in order to properly diagnose and begin treatment? Should we? There are currently significant differences in how these issues are approached in Italy. There are no nationally recognized clinical guidelines for the prevention and clinical management of infertility, and standards for funding reproductive procedures by local governments are generally inconsistent. But the new year should bring changes in this area.

Application of the law

In Italy, access to medically assisted reproduction is regulated by Law 40 of 2004. Over the years, dozens of courts have issued opinions on this law. Many have dismantled the law through rulings, for example circumventing bans on same-sex couples from undergoing such treatments and preimplantation tests.

On December 18, 2023, the Italian Scientific Advisory Board published the document “Guidelines on the adaptation of procedures and techniques related to medically assisted reproduction”, which sets out how to apply Law No. 40, taking into account the changes resulting from recent judgments. Approved the update. The version of this document currently in force dates back to 2015, and the country’s Ministry of Health is expected to publish an approved updated version soon.

Despite its title, this document is not a set of clinical guidelines for the diagnosis and treatment of infertility. Italian clinical practice institutions and public health guidelines – Sistema Nazionale Line Guida — Consolidates all recommendations to be followed by medical professionals under Law No. 24 of 2017, but does not qualify as a guideline for the clinical management of infertility.

In 2019, Italy’s National Center for Clinical Excellence, Healthcare Quality and Safety (CNEC) asked the Italian Society of Human Reproduction (SIRU) to adapt foreign guidelines on quality to the Italian environment. It was tasked with making a series of recommendations on the subject. The group established by SIRU for this work described the work done in a recently published article. Reproductive biology and endocrinology.

SIRU adaptation

“We evaluated seven to eight guidelines from different countries and because of their high quality and because Italian reproductive specialists already consider NICE guidelines as a reference for their clinical practice, we have chosen the UK National Institute for Clinical Excellence. “We chose the guidelines produced by the National Institute of Health and Welfare (NICE),” said Dr. Antonino Guglielmino, one of the authors of this article, a gynecologist and former SIRU president. “We have removed or revised recommendations from the original that are inconsistent, in whole or in part, with Italian legislation, drug selection or epidemiological data available in Italy. New recommendations are based on new scientific evidence. included on the basis of opinions expressed by professional groups and scientific societies, patient organizations and representatives of all relevant experts. ” Overall, 5 recommendations were removed, 25 were revised, and 17 were added from scratch, resulting in a total of 217 recommendations in the final version, from prevention and diagnosis to treatment of infertility. Covers all routes.

In May 2022, Italy’s CNEC issued an unfavorable opinion on this document, determining that it is not applicable to the Italian environment. Therefore no text was added. Sistema Nazionale Line Guida.

spotted health system

“It is somehow understandable why they took this decision.Currently, only some local authorities in Italy cover the costs of procedures related to assisted reproductive technology. “The recommendations in the guidelines we have developed apply. In other regions, if patients are paying out of pocket, they may not apply for economic rather than clinical reasons,” Guglielmino said. Ta.

Since 2017, medically assisted reproductive technology has been included in the basic medical package of the Italian Health Authority. Nevertheless, coverage of this basic health package has been hampered until now because health services have not published a list of covered services. Some regions, such as Lombardy, cover the costs associated with medically assisted reproduction. This is not the case in other regions such as Sicily.

The new list of eligible services was expected to be finally approved in 2023 and take effect on January 1, 2024. “However, some regions are not yet ready for changes, so this date has been postponed to April 1, 2024,” Guglielmino said. . “From then on, we hope that state-covered services will be consistently available across the country and that people in all regions will have access to a basic health package. Over the coming months, SIRU will compile the recommendations made in this document. “We will launch an initiative to establish diagnostic, treatment and care pathways for couples struggling to conceive across Italy.”

This article has been translated from italian universitypart of the Medscape Professional Network.



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