The Association for the Study of Reproductive Biology (ASEBIR) has this Tuesday expressed its rejection of the draft order that regulates the training program of the clinical laboratory specialty, considering that it encroaches upon the proper field of assisted reproduction and reduces it to a branch of diagnosis, when in reality it constitutes a treatment.
According to ASEBIR, the program, currently in the public consultation phase until November 26, reserves four months of a four-year residency for training in assisted reproduction. During that training period, it would be sufficient to “participate or simulate” 10 techniques and assess five embryos, without requiring that teaching hospitals have an 'in vitro' fertilization laboratory (FIV).
“An embryo is not a sample. In our laboratories, nothing is analyzed to obtain a result: an embryo is fertilized, cultured, and cared for, and then transferred to a patient. That is not learned in four months of rotation or by simulating techniques,” the president of ASEBIR, Nicolás Prados, has emphasized.
The association counters these conditions with the current requirements of the Ministry of Health, set out in the “Authorization and inspection guide for centers and services of assisted human reproduction,” approved by the Interterritorial Council of the National Health System (CISNS) in June 2024 and supported by the National Commission on Assisted Human Reproduction.
This document places at the front of 'in vitro' fertilization laboratories, sperm training, and gamete and embryo banks professionals with specific training in reproductive biology and at least three years of experience. For the person responsible for the laboratory, it raises the recommendation to six years and to have certification backed by national scientific societies.
Claim for a specialty in clinical embryology
In this scenario, ASEBIR has again demanded the creation of a clinical embryology specialty, a request it submitted to the Ministry of Health a year ago and about which it is still awaiting a response, in order to provide a training and legal framework for those who already perform these functions and to strengthen patient safety.
The association insists that assisted reproduction is an activity of "enormous healthcare importance". In Spain there are more than 400 centers and nearly 2,000 professionals dedicated to this field, who carried out 168,372 IVF cycles in 2023, according to the most recent registry available.
More than 400 specialists have certification from ASEBIR and 337 have accreditation from the European Society of Human Reproduction and Embryology (ESHRE, for its acronym in English), which places Spain as the European Union country with the highest number of embryologists certified by this entity.
At the same time, the association emphasizes the recognition that the European Union grants to assisted reproduction by including it in the European framework for substances of human origin, the SoHO Regulation. This regulation, which will enter into force in the EU as of August 2027, equates the assisted reproduction laboratory with tissue banks and cellular transplant services.
ASEBIR has highlighted the contribution of specialists in clinical laboratory work to the diagnosis of fertility and andrology, and has stressed that cooperation between the two areas is essential. "Defending the identity of the assisted reproduction laboratory is not disputing that of the clinical laboratory," it has emphasized.
The association has already submitted its submissions to the draft order and has offered itself to the Ministry of Health and the scientific societies involved as an interlocutor to design a model that guarantees the safety of patients, donors, and offspring.