According to the Minister of Health, the central purpose of this measure is to decentralize access to medical abortion so that women can undergo this procedure at their local health centers. To implement this healthcare restructuring, the government will establish a regulatory plan based on three main pillars:

• Amendment of the Royal Decree on the authorization of health centers with the aim of adapting the technical requirements and facilities of health centers to the practice of pharmacological abortions.
• Modification of the technical data sheet of mifepristone before the Spanish Agency for Medicines and Health Products (AEMPS), eliminating the requirement for its dispensing and administration exclusively in hospital settings.
• Update of the common portfolio of services of the National Health System (NHS) to expressly include the provision of chemical abortion at the first level of care.

The Ministry justifies this regulatory shift by citing the need to “save patients travel” and offer “close support.” Furthermore, the Ministry asserts that in 2024, nearly eight out of ten voluntary terminations of pregnancy in Spain (approximately 80%) continued to be performed in private, publicly funded medical centers, a pattern the new regulation aims to alter by shifting the widespread use of medical abortions to the public primary care network.

Clinical complications and serious risks of mifepristone use

Mifepristone (RU-486) ​​is a synthetic steroid that works by competitively blocking uterine progesterone receptors. Progesterone is the hormone essential for maintaining the maternal decidua and providing vascular support to the embryo. By inhibiting progestational action, it triggers the collapse of endometrial blood vessels, decidual necrosis, and the detachment of gestational tissue. In medical abortion protocols, mifepristone is administered in combination with a prostaglandin analogue (misoprostol) to induce uterine contractions and expulsion of the fetus.

Far from being a harmless procedure or one that does not require intensive medical supervision, the scientific literature accumulates solid evidence about the severe physical complications associated with mifepristone.

Underreporting of serious adverse effects in drug information sheets

A comprehensive report developed by the Ethics and Public Policy Center (EPPC) in the United States, prepared by researchers Jamie Bryan Hall and Ryan T. Anderson on a massive sample of 865,727 chemical abortions performed between 2017 and 2023, has revealed that 10.93% of women suffered serious adverse events within 45 days after taking mifepristone.

Among the serious complications identified were episodes of sepsis, severe pelvic infections, massive uterine bleeding, the need for blood transfusions, emergency room visits, and unexpected hospital admissions. This empirical finding demonstrates that the actual rate of adverse events is at least 22 times higher than the 0.5% figure reported in the official information approved by the Food and Drug Administration (FDA) and in the manufacturer’s (Mifeprex) package insert, which was based on small clinical trials with only 30,966 participants.

Increase in chemical abortion and concealment of complications in emergency rooms

In Spain, according to data reflected in analyses by the National Institute of Statistics (INE) and studies by the Association of Accredited Clinics for the Interruption of Pregnancy (ACAI), pharmacological abortion has experienced a very notable growth, going from representing 5.4% of all abortions in 2010 to 25.1% in 2021, reaching 22,603 ​​chemical abortions in a single year (an average of 62 pharmacological interventions per day).

Similarly, the use of chemical abortions increased from 5.4% in 2010 to 25.1% in 2021 (reaching 22,603 ​​pharmacological procedures annually). In the official registry published by the Ministry of Health for 2024 (submitted at the end of 2025), a total of 106,172 voluntary terminations of pregnancy (VTPs) were reported in Spain. Of these, 22,563 (21.25%) were performed in public hospitals and 83,609 (78.75%) in private or publicly funded clinics.

The use of the chemical abortion procedure (mifepristone combined with misoprostol) has been on the rise, supported by the Ministry of Health’s initiative to bring medical abortion to primary care centers. In autonomous communities such as Cantabria, Galicia, Navarre, and Catalonia, public or medical abortion coverage far exceeds 40-50% of all procedures.

Summary of empirical evidence on mifepristone complications

Consequences of abortion in women

Bioethical and medical research indicates that the negative consequences of voluntary abortion should not be categorized under the rigid label of ‘syndrome,’ since the clinical manifestations do not occur identically in all patients. However, extensive international epidemiological literature confirms the existence of objective, serious, and lasting sequelae that affect both the psychiatric and physical health of women, as well as their mortality rates.

Psychiatric disorders and their consequences on mental health

Longitudinal studies with large follow-up cohorts establish a clear cause-and-effect relationship between voluntary termination of pregnancy and the subsequent appearance of psychiatric pathologies and other sequelae.

Thus, a quantitative meta-analysis by Coleman (2011), published in The British Journal of Psychiatry, on a sample of 877,181 women (including 163,831 who had had abortions), concluded that women who have abortions are 81% more likely to suffer from mental health problems. Specifically, they had a 34% higher risk of anxiety, a 37% higher risk of depression, a 110% higher risk of alcoholism, and a 220% higher risk of marijuana use. The study determined that 10% of all mental disorders in women are attributable to a history of abortion.

Also, the longitudinal study by Fergusson et al. (2008) conducted in Christchurch (New Zealand) on a cohort followed from birth to age 30, showed that induced abortions are associated with an increase in mental problems between 1.86 and 7.08 times higher than that of women who did not have abortions, increasing the overall psychiatric risk by 30%.

The qualitative and clinical survey by Coleman et al. (2017) assessed the emotional aftereffects in women after an abortion, highlighting that 23.7% openly acknowledged that they had ended a human life, 14.4% suffered from clinical depression, 14% guilt and remorse, 12.4% self-hatred or anger, 10.9% feelings of shame, 9% drug or alcohol addiction, 7.7% self-destructive behaviors, and 6.2% suicidal ideation or direct suicide attempts.

Finally, a cohort study by Auger et al. (2025), published in the Journal of Psychiatric Research, involving 28,721 induced abortions and 1,228,807 births in Quebec, Canada, with up to 17 years of follow-up, found that the hospitalization rate for severe psychiatric disorders was 104.0 per 10,000 person-years in women who had abortions, compared to 42.0 in other pregnancies. Induced abortion was strongly associated with hospitalizations for psychiatric disorders (HR 1.81), substance abuse disorders (HR 2.57), and suicide attempts (HR 2.16).

Risk of premature mortality and the ‘dose-dependent’ effect

In terms of physical health and overall survival, the systematic review and meta-analysis by Reardon & Thorp (2017), based on 68 linkage studies of health records, provided extremely serious evidence on the post-abortion mortality rate:

• Massive increase in the risk of death: The risk of death from any cause during the year following an induced abortion is 170% higher than that of women who carried their pregnancy to term and gave birth to a live child. Induced loss doubles the risk of mortality compared to a natural miscarriage.
• Dose-dependent effect of repeated abortions: The mortality rate increases exponentially with the number of abortions. The mortality rate for women with one induced abortion is 1.45; for two abortions it rises to 2.14; and for three or more induced abortions it jumps to 2.92 compared to women with no history of abortion.
• Causes of death and self-destructive behaviors: Among the main causes of excess mortality are suicide, overdose accidents, and self-harm. Medical literature confirms that pregnancy termination triggers neurophysiological and immune imbalances that exacerbate self-destructive behaviors.
• Protective effect of full-term motherhood: Studies by Jalanko et al. (2017) in the European Journal of Public Health showed that, in adolescents, continuing pregnancy to delivery acts as a protective factor for health, reducing the risk of suicide by 50% and death from injury or poisoning by 40% compared to women who had abortions.

Bioethical assessment

The Ministry of Health’s proposal to include medical abortion in the primary care services portfolio raises profound bioethical objections concerning the status of the human embryo, the principle of medical non-maleficence, and a woman’s right to free and genuine informed consent. These objections are compounded by the omission of the information necessary to properly assess the potential consequences of its use.

The administration of mifepristone deliberately seeks the destruction and expulsion of the embryo. Promoting the removal of the procedure from hospitals to expand its widespread use under the pretext of ‘convenience’ does not change the ethical substance of the act: it constitutes a direct attack on the primary and inalienable right to life of the unborn child.

Transferring the prescription and administration of mifepristone to healthcare centers represents a de facto demedicalization of a medical intervention with high complication rates. As demonstrated by empirical data from Hall & Anderson (2025), nearly 11% of women experience serious adverse events such as sepsis, uncontrollable bleeding, and retained fetal tissue requiring immediate surgical dilation and curettage.

Extending chemical abortion to primary care centers, which lack the hemodynamic support resources, blood banks, and emergency operating rooms needed to respond to related emergencies, will increase the risk to affected patients, who will have to go to hospital emergency services.

The principle of autonomy requires that any patient receive complete, objective, rigorous, transparent, and intelligible information about the risks, physical complications, and psychiatric sequelae of treatment before making a decision. Concealing the true rate of complications associated with mifepristone (referred to as a simple ‘easy method’ or ‘routine pill’) and silencing the overwhelming body of evidence regarding the increased risk of mental disorders, depression, addiction, and premature death constitutes a serious violation of women’s rights. Without comprehensive information about the proven sequelae, consent is invalidated, and the woman’s autonomy is profoundly undermined.

It is deeply concerning that decisions regarding public health and drug regulation appear to be driven by ideological and political imperatives rather than rigorous medical evidence. The insistence of regulatory agencies on downplaying the side effects of mifepristone—and even on obstructing research documenting its harmful effects on women’s health—constitutes an unacceptable bias.

It is therefore urgent not only to manage rigorous scientific information, but also to provide it to the people involved, as well as to guarantee the conscientious objection of Primary Care professionals.

Protecting the health and life of both the mother and the unborn child in a comprehensive manner is an unavoidable priority.

Julio Tudela. Cristina Castillo. Bioethics Observatory. Catholic University of Valencia