Assisted procreation: what really changes with the new guidelines?

The Ministry of Health has published in the Official Journal the guidelines containing the new indications of medically assisted procreation procedures and techniques, as required by law number 40 of 2004 («Regulations regarding medically assisted procreation»). We asked him to explain them to us Edgardo Somigliana, director of the Emergency Department and Obstetrical-Gynecological Acceptance and Medically Assisted Procreation of the Milan Polyclinic.

Can Professor Somigliana comment on the PMA guidelines just published?
«It should first of all be specified that the guidelines just published on the PMA (medically assisted procreation, ed) are part of law 40 which provides for periodic updates, and are completely different from the “clinical” guidelines which are instead drawn up following a rigorous, codified and transparent process of evaluation of scientific evidence”.

What changes for citizens?
«Actually nothing, these are not the clinical applicability guidelines. To see concrete changes we must wait for the real approval on a national scale of the new LEAs (the essential levels of assistance, i.e. the benefits and services that the National Health Service provides free of charge or upon payment of a “ticket”, ed.) which would effectively change the approach and availability of access to MAP services for all citizens at a national level. In short, from North to South, infertile couples could benefit from the same treatments, at the same price. The implementation of LEAs will be the real innovation because it will finally allow PMA to be part of “Medicine” and to be guaranteed to everyone.”

What points do you consider most interesting in the updated version of the guidelines of law 40?
«This is a much more detailed document than previous versions although, as mentioned, it does not have the strength of clinical guidelines as the document is influenced by the law in force and does not follow a rigorous process of analysis of scientific evidence».

And what about the possibility that a woman can ask for the implantation of the embryo in the event of separation or death of her partner?
«There is nothing new in the document on these two points, it has always been like this. Law 40 says so and the latest ruling in this regard, relating to May 2023 (Constitutional Court Ruling 161/2023), confirmed it. When PMA is carried out, both members of the couple sign a shared consent which clearly states that the embryos can be transferred even if the male partner objects at a later time. The rationale behind this aspect of Law 40 is to protect the embryo, maximizing the possibility that it can be implanted. Of course, many of us technicians (and patients) do not share this aspect, but that is how it is, until it is decided to rewrite the law”.

How does it work abroad?
«In the event of separation, in all countries, there must be double consent on the transfer of the embryo for implantation. However, in cases of death of the partner there are differences between countries.”

Can the PMA be a solution to combat the birth rate in our country?
«In my opinion it cannot be the solution, certainly not the only one, but a new sensitivity is needed towards those who need to resort to this type of treatment. A sterile couple who wants a child has a medical problem that must be able to be resolved as such within the hospital process that hopefully leads to childbirth, not as “something” to be experienced separately.”

Should law 40 be changed?
“Absolutely yes. We need to draft a new law that is above all shared. The tensions that followed the advent of Law 40 were destructive and unhealthy. PMA is a topic on which perhaps each of us would have our own vision. We need to find a meeting point that satisfies the many souls of our society, and that is respectful of people who suffer.”