The hyper‐regulation of abortion care in Italy

This paper argues that the current abortion regulation by Law 194/1978 is an inadequate basis for the provision of good quality abortion care and must be reformed. First, the paper explains why Law 194/1978 creates a hyper‐regulatory regime that is inconsistent with the best clinical evidence and practices in the field as well as relevant international human rights law, as outlined in the World Health Organization's (WHO) 2022 Abortion Care Guideline. Second, it highlights gaps between what the law says and what happens in practice, pointing out how the everyday life of Law 194/1978, especially in the practices of gynecologists, is far removed from international standards of quality abortion care and has yet to comply with international human rights law. Third, it sets out some alternative routes to abortion access “outside” Law 194/1978. Finally, it concludes with some suggestions for a change in the practice of gynecology and a call for the reform of Law 194/1978, in favor of a bodily autonomy model of regulation grounded on decriminalization, demedicalization, dehospitalization, and self‐management to ensure compliance with the WHO standards and international human rights law.


| INTRODUC TI ON
The death from septic shock of 32-year-old Valentina Milluzzo in the "Cannizzaro" public hospital in Catania in the 19th week of her twin pregnancy in 2016. 1 The uncovered scandal of the cemeteries of aborted fetuses with the names of pregnant women on the graves in 2020. 2 The widespread refusal of abortion care by gynecologists 3 (p.Table 28).These are just a few of the reasons for believing Italy to be a country that is particularly unfriendly toward pregnant people seeking abortion care.
Law 194 was approved in 1978 on the wave of feminist campaigns for "free and safe on-demand abortion" 4 and has regulated abortion access in the country ever since. 5This legal reform marked a shift from the prohibitive model of the almost total ban of abortion under Fascist-era laws toward a model of hyperregulation based on partial decriminalization, medicalization, hospitalization, and a quasi-monopoly over abortion procedures in public health care. 5spite the limits of this hyper-regulatory regime, over the course of its 45-year existence, the conditions to reform Law 194/1978 have been lacking, contributing to its retention in its original form with no significant updates.The pro-choice movement has mainly advocated for the implementation and the defense of Law 194/1978   against the attempts by anti-choice groups to restrict abortion access.More recently, even the new right-wing Prime Minister Giorgia Meloni reassured the public that she will not "repeal" or "change" Law 194/1978. 6Against this backdrop in which Law 194/1978 seems to represent an untouchable compromise for many people regardless of political affiliations and beliefs, the present article argues that this legislation is an inadequate basis for the provision of goodquality abortion care and must be reformed.The argument proceeds as follows: it explains why Law 194/1978 creates a hyper-regulatory regime that is inconsistent with best clinical evidence and international human rights law, as recently outlined in the World Health Organization's (WHO) Abortion Care Guideline; [7][8][9] it highlights how the everyday life of Law 194/1978, especially in the practice of gynecology, is far removed from international standards of quality abortion care and relevant international human rights law; and then it sets out some alternative routes to abortion access "outside" Law 194/1978.
It concludes with some suggestions for a change in the practice of gynecologists and a call for reform of Law 194/1978.

| THE HYPER-REG UL ATION OF ABORTION
The official title of Law 194/1978 ("Norms on the social protection of motherhood and the voluntary interruption of the pregnancy") and the principles of the law set out in Article 1 ("The State guarantees the right to conscious and responsible procreation, acknowledges the social value of motherhood and protects human life from its beginning.The voluntary interruption of the pregnancy, [regulated] by this law, is not a means of birth control […].") clarify a rule/exception relationship between the continuation of every pregnancy and abortion.This model of hyper-regulation aims at discouraging pregnant people from getting abortions, and exerting control over those who choose to undergo the procedure.Abortion thus becomes a legally available health treatment only in specific circumstances relating to the reasons why the pregnant person wants to access an abortion, who the abortion provider is, and where and when the abortion takes place.
Abortion is legal when it is performed in the event of a serious risk to the pregnant person's health or life, whose assessment varies depending on the stage of pregnancy.This approach conflicts with the WHO recommendation "that abortion [should] be available on the request of the woman, girl or other pregnant person" 7 (p.26).According to Article 4 of Law 194/1978 during the first 90 days of pregnancy, abortion access is admitted "when the continuation of the pregnancy, the birth or the motherhood could put at serious risk the [psychophysical] health, in relation to [their]   health, economic, social or family conditions or to those in which the conception has taken place, or the presence of fetal abnormalities".According to Article 6, after 90 days of pregnancy, abortion can be performed when "the pregnancy or the birth put at serious threat the life of the woman" or in the presence of significant fetal abnormalities that jeopardize the psychophysical health of the pregnant person.When there is "the possibility of autonomous life of the fetus", Article 7 §3 says that the pregnancy can be interrupted only in the presence of a threat to the life of the pregnant person and the "medical doctor that performs the procedure must adopt every suitable measure to save the life of the fetus".
In terms of the abortion provider, Article 8 of Law 194/1978 identifies the medical doctor working within an obstetric/gynecologic department as the only health worker legally entitled to provide abortion services.This provider restriction is inconsistent with the wide range of health workers (e.g.general medical practitioners, midwives, nurses) who are competent to provide abortion care according to WHO guidance 7 (p.59).
Regarding settings, Article 8 also establishes that abortion can be lawfully performed only in a public hospital or, in the first 90 days of pregnancy, in private hospitals with a specific abortion license and public family planning centers.These provisions contribute to the abnormal status of abortion as a treatment that is rarely available in private health care 3 (p.Table 23).In fact, Law 194/1978 has created a model of abortion care where legal and publicly funded abortions are closely intertwined, to the extent that privately funded abortions are likely to be illegal.This restriction of the settings in which abortion can be legally performed is also inconsistent with the diverse range of settings identified in WHO guidance 7 (pp.64-77; 94-99).The WHO's "best practice statement" regarding service delivery says that "[t]here is no single recommended approach to providing abortion services.The choice of […] the location of service provision (from among the recommended options) will depend on the values and preferences of the woman, girl or other pregnant person, available resources, and the national and local context.A plurality of service-delivery approaches can co-exist within any given context" 7 (p.96).
In terms of time limits, as noted above, Law 194/1978 imposes different conditions on access to abortion on the basis of gestational age (i.e. up to 90 days; after 90 days of pregnancy) and when there is "the possibility of autonomous life of the fetus" 5 (Articles 4, 6, 7).
Moreover, according to Article 5, at the discretion of the medical doctor, a mandatory waiting time of 7 days can be imposed on those seeking access to abortion in the first 90 days.These provisions also conflict with WHO guidance, which both recommends against any prohibition of abortion based on gestational age limits and against mandatory waiting periods to access it 7 (pp.28, 41).
Where the conditions dictated by Law 194/1978 are not met, abortion remains subject to severe sanctions.According to Article 19, a pregnant person (with the exception of under 18-year-olds and people with learning disabilities) may face a pecuniary sanction of between 5000 and 10 000 Euros if an illegal abortion is performed within the first 90 days of pregnancy, and imprisonment for up to 6 months after 90 days of pregnancy.These sanctions also apply in the case of self-managed abortion with pills, which is recommended by the WHO up to 12 weeks of pregnancy 7 (p.98).Moreover, when abortion is performed after 24 weeks, there is case law that classifies it as murder under Article 575 of the Italian penal code. 10Grounded on a very broad understanding of "person," this case law is inconsistent with WHO's recommendation on full decriminalization of abortion as well as the European norm that tends not to criminalize the conduct of women with regard to their own pregnancies 7 (p.24). 11ummary, the hyper-regulation arising out of Law 194/1978   results in a clinically unjustifiable and disproportionate web of rules that limit abortion access, maintaining exceptionalism and reproducing stigma around this treatment.

| LIVED RE ALIT Y OF ABORTI ON S ERV I CE S
Law 194/1978 creates significant tensions when it comes to delivering quality abortion care, particularly considering the actual experience of accessing abortion services in the country, based on the last available report of the Italian Minister of Health of June 2022 relating to the abortion statistics of 2020. 3 Despite being the only category of health professional legally allowed to provide abortions, 64.6% of gynecologists refuse to offer abortion care 3 (p.Table 28).They do so based on a conscientious objection clause outlined in Article 9 of Law 194/1978 that recognizes a legitimate exemption from the obligation to provide care only in relation to activities "specifically and necessarily directed to provoke the interruption of the pregnancy, and not from the care before and after the treatment".However, the same Article 9 does not exempt the conscientious objector from performing an abortion when it "is essential in order to save the life of a woman in imminent danger".Article 9 §4 does prohibit the so-called "facility objection," which refers to the institutional refusal to provide abortion care.Outside of these exceptional circumstances, the refusal to provide care can result in criminal proceedings, such as under Article 328 of the Italian penal code. 12,13For example, two decisions by the Court of Cassation (the highest court of appeal in Italy) upheld charges against conscientious objecting gynecologists for denying postabortion care following the swallowing of pills. 12,13stly, Article 9 §6 establishes that the conscientious objection is "withdrawn with immediate effect" if the conscientious objector takes part in activities covered by the conscientious clause.This is an important norm to consider.Indeed, on the one hand, if a conscientious objector refuses to perform an act that is not covered by the right of conscientious objection, that behavior becomes relevant under the criminal law.On the other hand, if the conscientious objector performs an act which is covered by the conscientious objection, the conscientious objector loses their right as conscientious objector.
Article 9 of Law 194/1978 does not provide a clear framework to establish when the refusal of care lawfully operates, for example in the case of medical abortion in which the pregnant person is the one materially performing the abortion.This lack of clarity is only one of the points of tensions that the law and practice of conscientious objection has with the WHO's recommendation that "access and continuity of comprehensive abortion care [must] be protected against barriers created by conscientious objection" 7 (p.60).Another shortcoming of the formulation of Article 9 is the lack of a duty of referral to a nonobjecting provider, which is inconsistent with the WHO's recommendation 7 (p.60), 14 and FIGO's Guideline on Conscientious Objection 15 (p.45).
The barriers that conscientious objection poses to abortion care in Italy have raised concerns within human rights treaty bodies of the United Nations (UN) [16][17][18][19] and nongovernmental organizations such as Human Rights Watch. 20Following its own recent conclusions from 2015, 16 along with those in 2017 by the UN Human Rights Committee (HRC) 17 and the Convention on the Elimination of All Forms of Discrimination against Women (CEDAW), 18 the Committee on Economic, Social and Cultural Rights (CESCR) expressed ongoing worry in 2022 19 (paras.57, 58).It highlighted that access to abortion services continues to be restricted, especially due to healthcare workers conscientiously objecting to performing such procedures 19 (para.57).
Furthermore, even within the context of regional human rights protection, the European Committee of Social Rights (ECSR) has identified a violation of the European Social Charter's framework (referred to hereafter as "the Charter" or ESC).This violation pertains to abortion services in Italy, as highlighted in two unresolved complaints that remain unaddressed over a decade after their registration. 21,22In both decisions, International Planned Parent-  22 These two abortion decisions under the ESCR complaints on abortion in Italy within the ESC's framework revolve around the continuing refusals of abortion care by gynecologists and the ineffectiveness of Article 9 §A that obliges the facilities to provide abortion services "in all cases". 21,22In both cases, the complainant organizations have succeeded in proving that the ineffective implementation of Article 9 §4 amounts to a breach of the right to health and of nondiscrimination of pregnant women across the country "through a differentiated intersectional analysis, with gender, geographical location, health status, and socioeconomic disadvantage" 23 (p.232). 21,22gardless, the two decisions of the ECSR in 2013 and 2015, 21,22 the two Resolutions of the Committee of Ministers of 2014 and 2016, 24,25 and three assessments of the ECSR on the follow-up in 2018, 2021, and 2022, [26][27][28] Italy continues to fail to comply with the ESC's framework.Out of all the facilities obligated to provide abortion services "in all cases," only 63.8% comply with this legal requirement of Article 9 §4 3 (p.Table 23bis).The official data show that the public hospital remains the primary setting for abortion services in Italy (95.2%), with the remaining abortions taking place in the very few private hospitals with a specific abortion license (4.8%), and clinics (0%, corresponding to a total of 24 abortions in Tuscany) 3 (Table 23).Only recently, new regional protocols for Tuscany (2020), 29 Lazio (2021), 30 and Emilia-Romagna (2021) 31 allow for medical abortions to take place as an outpatient treatment in public family planning centers and clinics.
In terms of abortion techniques, the text of the law on this point was shaped by the requests made during the 1970s abortion campaigns. 4Article 15 explicitly refers to the "use of the most up to date, most respectful of the psychophysical integrity, and least risky abortion techniques".Despite this provision, 8.6% of abortions take place with the use of dilatation and curettage (D&C) only (with a striking 30.4% of terminations in Sardinia performed this way), a practice that was rejected by feminist and radical selfmanaged abortion groups as early as the 1970s 3 (p.Table 25). 4wever, the actual figure of D&C usage might be higher than these numbers suggest, as they do not consider the combined use of D&C with another technique-a situation that can potentially apply to most abortions.Vacuum aspiration as the sole technique or followed by sharp curette checks accounts for 55.8%, while the use of mifepristone and a prostaglandin as the primary (or sole) method applies to 31.9% of all abortions 3 (p.Table 25).These data should be considered alongside the reported figures on the use of general anesthesia (37.7%) and deep sedation (24%) 3 (p.Table 24), which are in tension with the WHO guidance that, for surgical abortion at any gestational age, "recommends against the routine use of general anaesthesia" 7 (p.49).The available data do not mention an eventual usage of the WHO's recommended technique of dilatation and evacuation (D&E) and are silent on the use of feticide or embryo reduction 7

(p. 65).
It is also important to consider that medical abortion was introduced only in 2009, with the anomalous and clinically unjustified limitation that it should have been made available only up to 49 days of pregnancy and as an inpatient treatment with the recommendation of at least 3 days in hospital. 32Following a policy update in 2020, medical abortion is now available up to 63 days of pregnancy and can be provided as an outpatient treatment. 30,31,33wever, in most cases pregnant people are still required to access a health facility at least three times for a medical abortion: once for a health check (medical certification, scan); once to swallow the mifepristone; once to swallow the prostaglandin (misoprostol); and a fourth time for a follow-up check following the abortion. 29,31ile this hyper-medicalization of the use of abortion pills aligns with the logic of Law 194/1978, it is important to note that the law's wording refers to "necessary health checks" without further specifications such as requirements for blood tests and scans 5 (Article 5).Yet, the same WHO guidance recommends "against anti-D immunoglobulin administration for both medical and surgical abortion up to 12 weeks" and "against the use of ultrasound scanning as a prerequisite for providing abortion services" 7 (pp.44 and 47).
In terms of waiting time, in 75% of cases medical doctors issue a document that requires a mandatory waiting time, thereby delaying the pregnant person's access to abortion by 7 days 3 (p.Table 18).Only 25% of medical doctors provide a certificate that enables immediate access 3 (p.Table 18), aligning with the WHO recommendation against mandatory waiting time 7 (p.41).Moreover, while the legal provision of waiting time applies to abortions in the first 90 days of pregnancy, official data show that there is a clinical practice-also for abortions after 90 days of pregnancy-to distinguish between "urgent" (71.3%) and "nonurgent" (28.7%) abortions 3 (p.45), 5 (Articles 5 and 7).For under 18-year-olds, in the first 90 days of pregnancy the law mandates the agreement of the parents or, alternatively, a judicial approval, further delaying their access to the procedure 5 (Article 12).This additional requirement does not comply with the WHO recommendation that abortion should be available on request without a third-party authorization 7 (p.43).In cases involving under 18-year-olds, the urgency of the medical certificate could bypass this additional bureaucratic step, but in only 1.3% of all abortions performed for under 18-year-olds (corresponding to 19 abortions) did the medical doctor grant an urgent certificate without mandatory waiting time 3 (p.Table 22).
Official data show that the majority of abortions take place up to 12 weeks of pregnancy (93.4%), with a very small portion taking place between 13 and 20 weeks (5.1%), and only 1.4% of abortions performed at 21 weeks and beyond 3 (p.Table 19).The very small percentage of abortions performed at and after 21 weeks is indicative of the very restrictive interpretation of the legal limit adopted by Article 7 §3 Law 194/1978, limiting abortion where there is the "possibility of autonomous life of the fetus". 34

| ABORTI ON S "OUTS IDE" L AW 194/1978
The abortions discussed above are the legal ones, which are closely monitored by the Italian National Institute of Statistics and the Italian National Health Institute 3 (pp. 11-13).The data on abortions form the basis of the Minister of Health's annual report on the implementation of Law 194/1978 5 (Article 16) that, regardless of any political affiliation, routinely emphasizes the reduction of abortions "according to the auspices of the Law [194/1978]" and positively portrays this result as a "success in terms of public health" 3 (p.18).
The annual reports of the Italian Minister of Health simplistically present the decline in abortions as further evidence of the effectiveness and positive impact of Law 194/1978 in "preventing" the occurrence of abortions 3 (p. 18).Notably, the same official reports unproblematically refer to an estimate from 2016, which suggests that between 10 000 and 13 000 illegal abortions still occur annually in the country 3 (p. 19).As a phenomenon inherently difficult to investigate, there is limited information available on abortions taking place "outside" the scope of Law 194/1978, in particular in private health facilities (i.e.hospitals, clinics, medical practices) that are not legally entitled to provide abortion services; self-managed abortion through pills; and travel abroad.

| Abortions in private health facilities not authorized to provide these services
Over the years, media reports and court decisions have shed light on cases of illegally practiced abortions taking place privately, with significant amounts of money sometimes changing hands. 35,36It may come as a surprise that some pregnant people may prefer an illegal abortion, despite the significant costs and the potential legal risks (i.e.administrative or criminal sanctions) versus the possibility of completely free legal access.However, the very limited information deduced from relevant court decisions suggests that reasons underlying privately funded abortions include a straightforward process (especially for under 18-year-olds), timely access to the procedure, surpassing gestational age limits, and ensuring privacy. 35,36This last point is often overlooked, but it can be very difficult (including for example in cases of high profile and public figures requiring time-sensitive treatment) to fully protect privacy when the primary legal avenue for obtaining an abortion is a public hospital 7 (p.9).However, we cannot exclude the possibility that some illegal abortions in private facilities may take place less transparently.Due to the absence of an official national map indicating where abortion services are available throughout the country, it remains challenging to identify those very few private hospitals that are legally authorized to provide abortions.Given the abnormal restriction of abortion in private health care, it is reasonable to believe that some women may unknowingly undergo an illegal abortion in a private hospital without being fully aware that the hospital is not licensed to provide it. 37

| Self-managed abortion
Another way to access abortion "outside" the legal boundaries of Law 194/1978 is through self-management using pills, the safety of which is underlined by robust scientific literature and which is now recommended by the WHO 7,38 (Abortion Care Guideline, p. 98). 11In Italy, prior to the pandemic, there was significant stigma surrounding self-management using pills (i.e.Cytotec, the commercial name of purchasable misoprostol for the treatment of gastroduodenal ulcers, behind medical prescription) even among feminists and political groups advocating for reproductive rights. 39The COVID-19 pandemic brought about a change, but the struggle for abortion still revolves around Law 194/1978, with demands focusing on the need for more gynecologists without conscientious objection to abortion, as well as more public hospitals and health facilities where abortion can be accessed. 40Despite a significant delay in the Italian feminist and pro-choice movement debating and addressing the topic of self-managed abortion, the practice likely exists in Italy.In 2018, in response to increased requests from Italy, the telemedical abortion provider Women on Web translated its webpages into Italian. 41The first study on the requests from Italian residents to Women on Web between 2019 and 2020 indicates a further growth in requests for pills during the COVID-19 pandemic. 42

| Abortion travel
A portion of abortions take place abroad likely because of the strict gestational age limits set by Law 194/1978. 43

| THE WAY FORWARD: A BOD ILY AUTONOMY MODEL
This article highlights how the obstacles to quality abortion care in Italy are connected to two issues: the hyper-regulatory regime of Law 194/1978 and the organization and clinical practice of services that do not adequately adhere to international standards of quality abortion care and human rights protection, [7][8][9] including the right to sexual and reproductive health. 44,45The CEDAW Inquiry Report on Northern Ireland more recently reiterates the recommendation that the state party "provide women with access to high-quality abortion and post-abortion care" 46 (para. 86).This recommendation on Northern Ireland applies to Italy because Italy is a party to CEDAW. 18To ensure that Italy complies with the WHO Abortion Care Guideline 7 and regional and international human rights standards, this article proposes a two-step strategy: the first step aimed at improving clinical practice and the second step focused on reforming Law 194/1978.The first step requires implementing the findings of the ECS-R, 21,22,[26][27][28] the CESCR, 16,19 the HRC, 17 the CEDAW Committee, 18 and the WHO Abortion Care Guideline, 7 through a more gendersensitive interpretation of the existing framework of Law 194/1978.The creation of national guidelines to ensure equitable abortion care across the country to overcome regional differences 21,22,[24][25][26][27][28] is proposed.Elements of such national guidelines might include: • Removing the mandatory waiting time of 7 days by issuing urgent certificates as a matter of course 5 (Article 5).
• Prohibiting practices that conflict with quality abortion care (e.g. the use of D&C alone or in combination with other methods) 5 (Article 15).
• Eliminating unnecessary screening of the pregnant person such as mandatory scans and blood tests.
• Reducing the number of visits necessary to access a medical abortion. 304,45 As Petros Stangos, a member of the ECSR, Today, the conditions that classify an abortion as a crime seem arbitrary and difficult to justify, particularly in light of the increasing protection of sexual and reproductive health within international human rights law, 8,44,45 including its normative developments 46 and a substantial body of literature supporting the full decriminalization of abortion. 47To comply with the WHO Guideline calling for decriminalization and international human rights law that considers criminalization of medical procedures that only women need as a violation of women's equal rights to health care 44 (para.14), abortion services need to be regulated like any other health treatment 7 (p.24). 11,46,47 conclusion, Law 194/1978

CO N FLI C T O F I NTE R E S T S TATE M E NT
The author has no conflicts of interest.

hood
Federation European Network (IPPF EN) v. Italy (Complaint No. 87/2012) and Confederazione Generale Italiana del Lavoro (CGIL) v. Italy (Complaint No. 91/2013), the ECSR found a violation of Article 11 §1 (the right to health) and Article E (nondiscrimination clause) read in conjunction with Article 11 of the Charter. 21,22In the second complaint, CGIL v. Italy, which also concerned the working conditions of the nonconscientious objecting medical personnel involved in abortion procedures, the ECSR additionally found a violation of Article 1 §2 of Charter (i) first ground (right to work) on the basis of the difference of treatment between conscientious objecting and nonconscientious objecting practitioners (paras.235-246); and the violation of Article 26 §2 of the Charter (right to dignity at work) for the failure of Italy to take preventative action to ensure the protection of nonobjecting medical practitioners from moral harassment (paras.289-298).
his concurring opinion in the IPPF-EN v. Italy decision, the violations of the Charter are: the result not only of Act No. 194/78 being implemented ineffectively […] but also in principle because of the fundamental structure of the 1978 act and, more particularly, [Articles] 4 and 5, which regulate women's right to abortion in a manner incompatible with the requirements of Article 11 of the Charter [emphasis added]. 21While one might think that Law 194/1978 has the predictable constraints of outdated legislation, the definition of the boundaries between what is legal and illegal in this area was already inconsistent with the extensive knowledge and experience of safe abortion among feminist and radical groups prior to the approval of Law 194/1978. 4 presents significant obstacles to the provision of quality abortion care in Italy.Awareness of these limitations should prompt a broad reflection regarding the type of legal regulation that can best serve the fulfillment of the health and sexual and reproductive rights of pregnant people seeking abortion in Italy.This debate should be open to civil society and informed by the best available scientific evidence and knowledge in the field.Changes in the legal regulation of abortion should aim to overcome the hyperregulatory model of Law 194/1978 and instead be grounded in the principles of bodily autonomy, decriminalization, demedicalization, dehospitalization, and self-management.To create an agenda for such changes, the role of Italian gynecologists, through their professional scientific societies such as the Società Italiana di Ginecologia e Ostetricia (SIGO), can be crucial.Medical doctors, and gynecologists more specifically, could contribute to an evidence-based approach consistently with the WHO Abortion Care Guideline. 7ACK N OWLED G M ENTS I am extremely grateful to Dr Anna Pompili and Professor Sally Sheldon for their generous and attentive comments and suggestions on the draft of this article.I also express my sincere gratitude to Professor Rebecca Cook for her editorial support throughout its development.The final version of the article was edited using suggestions from Professor Sheldon and ChatGPT.