Introduction
Technological innovation makes it possible to harvest and cryopreserve unfertilized eggs (oocytes), store them, and use them later in life through assisted reproductive technologies (ART). The procedure of egg freezing generally includes two main stages: In the first stage, oocytes are retrieved and cryopreserved. In the second stage, when wishing to use the eggs for conception, the frozen eggs are thawed, fertilized (using IVF techniques), and finally transferred back into the uterus.
When first developed as an experimental procedure in the late 1980s (Waldby
2015), egg freezing was mainly used for “medical” reasons—what has been referred to as medical egg freezing (i.e., as a protective measure against adverse medical treatment outcomes, e.g., diminished fertility caused by oncology treatment). However, the development of vitrification (“fast freezing”) and intracytoplasmic sperm injection (ICSI) techniques led to a renewal of interest in egg freezing in the early to mid-2000s (Shkedi-Rafid and Hashiloni-Dolev
2011). In 2012, both the American Society of Reproductive Medicine (ASRM & SART
2013; ASRM
2018) and the European Society of Human Reproduction and Embryology (ESHRE
2012) lifted the experimental label of the procedure. Therefore, egg freezing has been endorsed as a mean for preserving fertility due to so called “social” reasons—what has been recognized as non-medical or “social” egg freezing.
Empirical research from Israel, Turkey, the United Kingdom, and the United States shows that “social” reasons include primarily relationship factors (e.g., singlehood), economic factors (e.g., lacking financial resources), career plans, and other reasons (Kılıç and Göçmen
2018; Inhorn et al.
2018; Baldwin et al.
2018).
Egg freezing in general and for “social” reasons in particular has led to heated debates in healthcare policy and practice and related social and bioethical debates. The discussion is shaped by arguments related to genetic linkage, motherhood and family, reproductive control and autonomy, (bio) medicalization, success rates limitations, the health risks involved, empowerment, alienation, and the biological boundaries which may (or may not) be crossed (ESHRE
2012; Pennings
2013; Bernstein and Wiesemann
2014; Robertson
2014; Dondorp and De Wert
2009; Kostenzer et al.
2021a; Kostenzer et al.
2021b).
As much as the technology is controversial and the discussion is diverse, so is its terminology. It ranges from non-medical or social egg freezing (Baldwin et al.
2015), freezing oocytes by healthy women (Pennings
2013), elective egg freezing (Inhorn et al.
2018), to oocyte cryopreservation for age-related fertility loss (ESHRE
2012), or planned oocyte cryopreservation (ASRM
2018). The different terminologies also reflect the controversy around whether there is a type of medical need even when it comes to non-medical egg freezing. In this paper we use the terms “medical egg freezing” (MEF) and “social egg freezing” (SEF) as those are the most commonly used terms.
Aside from issues related to SEF as such, another crucial issue to be considered concerns the distinction between MEF and SEF. Do reasons behind egg freezing qualify for a categorization into “medical” and “social”? If so, how can a distinction between the two be made in practice?
What can be considered a medical reason or need is difficult to determine and is differently negotiated among healthcare professionals, ethicists, policymakers, and patients. The debate revolves around whether or not age-related fertility decline should be regarded as a medical condition justifying the use of medical means—as a form of preventive medicine (Borovecki et al.
2018). Critics oppose this justification by considering SEF as (bio)medicalization of social problems (Dondorp and De Wert
2009), claiming SEF in fact uses medical technology for “solving” a nonmedical “problem” (Petropanagos et al.
2015, 668). Faced with socio-economic pressures and gendered labour-market barriers, women nowadays tend to postpone childbearing and are thus faced with loss of fecundity. Under such circumstances, SEF can be perceived as an individual medical solution to a wider social problem, which should thus be dealt with through social solutions; i.e., cultural accommodations, policy measures, and public health approaches (Lemoine and Ravitsky
2015).
Van de Wiel (
2015) notes in this context that the differentiation into medical and non-medical oversimplifies the complexity of the issue. She challenges this categorization and its usage for regulatory decisions. Pennings (
2013) argues that the term “social” creates a notion of desire rather than need. He further claims this differentiation is blurred and should hence not be made.
Yet in practice, the categorization into “medical” and “social” is still being made and remains a main criterion for regulating access to and cost coverage of egg freezing.
The European IVF-monitoring Consortium (EIM) for the ESHRE, as well as its Working Group on Oocyte Cryopreservation, investigated the regulation of oocyte cryopreservation in forty-three countries, showing a differentiation between the indications for egg freezing (Calhaz-Jorge et al.
2020; Shenfield et al.
2017). It was found that legislation is diverse and funding systems are highly variable. While such studies provide an important overview regarding the regulatory conditions for egg freezing, we aim at taking a step further by providing an in-depth critical analysis of regulatory frameworks of selected countries.
The aim of this paper is hence to explore how the differentiation between what is considered “medical” and “social” finds expression in regulatory frameworks and the way those may vary across countries. Based on empirical study, we illustrate the normative and constructed nature of the categorization into “medical” and “social” (see, e.g., Kingma
2013). Relying on the assumption that rules and regulations are being set as mechanisms of boundaries demarcation in actual practice (Zarhin et al.
2018), we therefore draw in this context on what was termed by Zarhin et al. (
2018) as “regulatory boundary-work”; in our case: if and how the regulatory frameworks define and differentiate between MEF and SEF. Within this context, potential practical boundaries may be set in relation to age limitation, familial/marital status, health insurance type, and medical indications. Such regulatory boundaries defining legal limitations and access can in practice play an important role in people’s reproductive and life choices. Indeed, ART and egg freezing often raise equity concerns, as they may not be equally accessible to all women (Lemoine and Ravitsky
2015). While within the scope of this study we cannot focus on the boundary-work itself (i.e., the actual considerations and processes involved in setting the regulation), we aim at analysing the work these boundaries create (i.e., in the form of meanings and possible implications).
In order to better examine this boundary-work we chose to focus on four countries: Austria, Germany, Israel, and the Netherlands. While all four are at the cutting edge of medical technologies and care standards, they represent a diverse spectrum of regulatory frameworks in the context of ART as well as generally differentiated professional cultures in biomedicine. Therefore, our choice of countries resulted in a diverse, yet balanced, comparison highlighting a wide spectrum of regulatory frameworks that is of value for understanding the boundary-work in other countries as well. By conducting a cross-national comparison of regulatory frameworks, we explore the diverse regulatory and funding schemes reflecting different negotiation and interpretations of egg freezing as medically necessary or elective treatment.
Methodology
Our research draws inspiration from the “decentred comparative research approach” (Wrede et al.
2006), which acknowledges the need for a context sensitive analysis, while emphasizing the importance of cross-national comparison in healthcare research. Drawing on collaboration across research nationals and cultures, the decentred comparative approach facilitates the uncovering of the social situatedness of healthcare as a study object—allowing researchers to understand the ways healthcare systems and practices are situated in time and place. It is further a highly (self) reflexive approach taking into account the hazard of ethnocentrism and the ways our own knowledge and perceptions as researchers are socially situated (ibid).
Our research team was formed during 2018-2019 and consists of four members—internationally dispersed with in-depth familiarity of the countries concerned: Austria, Germany, Israel, and the Netherlands. Our heterogeneous team employed both socially situated and socially distributed inter-disciplinary expertise, including diversity in nationality, ethnicity, religious background and scientific background, enabling a decentred analysis. The team’s (inter)disciplinary background includes expertise in sociology, bioethics, health policy, and medicine. The cooperation allowed for both a close reading and informed analysis of the regulation, as well as normative insights from a sociocultural and moral perspective. While collaborating towards the common aim, we constantly challenged each other’s understandings and interpretations by discussing different perspectives. This process aimed at understanding the ways both MEF and SEF are regulated and therefore understood and practiced in the different sociocultural contexts. For this purpose, we defined regulations as official documents including legislation, ministerial decisions and memorandums, medical guidelines, medical and (bio)ethical recommendations, relevant position papers, and related professional committees’ reports. Documents concerning funding regulations vary between countries and include ministerial memorandums (in the form of secondary legislations), coverage policy documents, and insurance regulations.
We used broad inclusion criteria, collecting not only documents which specifically deal with egg freezing but also documents dealing with related procedures (e.g., IVF) which are of relevance for the specific regulatory framework. In addition, we collected and analysed not only legally binding regulatory documents but also recommendations, position papers, and guidelines published by professional (medical or (bio)ethical) associations. In countries in which the official legal framework is missing or fragmented, these documents hold a significant role in the regulatory boundary work. Their role, however, should not be neglected also in countries with clear legislation (i.e., in inducing and shaping formal legislation). While we are aware of the distinct differences in nature and implications of these documents, they together form the regulatory framework and shape the handling of egg freezing.
Our empirical work followed a systematic approach, divided into three phases. (1) We collected the relevant documents and conducted a thorough analysis. Documents were collected following an extensive archive (including online) research and literature analysis. When needed, translations into English were made to allow for better understanding and comparison. All translations (from German, Dutch, and Hebrew into English) were conducted by the research team. (2) We prepared summary reports for each country, containing a detailed overview of the up-to-date regulations and its preliminary analysis. These reports also contained the relevant academic and public debates as presented in scientific literature and media accounts. The reports were circulated among the research team and extensively discussed in several digital and in-person meetings for critical feedback and preliminary comparison. The first two phases were accompanied by consultations with relevant experts in the fields of law, social sciences, ethics, and medicine in all four countries to ensure full coverage of the relevant regulatory framework. (3) In the final phase, we conducted our comparative analysis in a systematic manner, which generally corresponds with the qualitative content analysis method (Weber
1990). Summary reports were analysed thematically and compared cross-nationally to uncover discursive themes and emerging codes (Denzin and Lincoln
1994). This enabled us to detect different constructions of MEF and SEF which could be further interpreted as reflecting different forms of boundary-work.
Discussion and Conclusion
Rapid developments in assisted reproductive medicine are challenging decision-makers across countries. Their approaches—and hence boundaries—have far-reaching implications.
As our findings reveal, attempts at regulating egg freezing and the different regulatory boundary-work between the “medical” and “social” result in rather blurred demarcation lines. These blurred lines can be detected in two levels: The first is within each country—most prominently in Austria and in Germany, where the definition of MEF and its distinction from SEF is less clearly defined. The second level emerges from our comparative framework, which highlights cross-national differences in the regulatory frameworks. The different definitions of “medical” egg freezing and the diagnosed conditions under which egg freezing will be classified as MEF or SEF highlights the subjectivity of these definitions. At the same time, however, the way in which these terms are conceptualized has clear-cut consequences: crucial decisions, such as general access to the technology and its reimbursement, depend on these notions.
As our comparative findings show, while the four countries share a form of differentiation and prioritization when it comes to MEF and SEF, their respective regulatory frameworks also dramatically differentiate. The Austrian regulation of egg freezing is rather restrictive as it prohibits the usage of SEF and does not provide funding for MEF. While this regulation sets a crucial distinction between MEF and SEF, it does not establish any clear criterion for defining MEF. This lack of clarity reflects on the one hand a difficulty in setting the boundaries between the “medical” and the “social,” which is to some extent also reflected in the German framework. On the other hand, it also enables a legal grey zone for gatekeepers and flexibility in terms of making case-by-case decisions. The regulation in Germany has been missing to a large extent, with recent changes in the funding scheme, now also covering MEF for a relatively limited number of indications. In contrast, the Dutch framework sets much clearer definitions of the indications that account for MEF, which could, however, also be limiting considering indications that are not included in this categorization. The regulation further grants public funding for MEF, while creating a prioritization of MEF over SEF. The Israeli framework is even more detailed as it presents a clear and wide spectrum of clinical and diagnostic criteria for MEF, as well as a relatively generous funding scheme. Yet also here, funding is offered only for MEF, thus prioritizing the practice over SEF.
While we do not aim at determining which of the regulatory framework is most appropriate, our findings, hinting at a rather paradoxical dynamics involved in this “regulatory boundary-work,” should inform policymakers and their considerations. As our research reveals, a clear distinction between the “medical” and the “social” provides on the one hand transparency and distinct guidelines in daily practice, yet on the other hand may in certain cases also limit access to pre-defined indications, leading to lack of flexibility. “Blurred lines,” which in certain cases characterize rather restrictive regulatory frameworks, may in practice allow for loopholes (while creating involuntary gatekeepers). Each of the regulatory frameworks can thus be analysed as both enabling and disabling. What may seem as a restrictive and distinctive regulatory framework may paradoxically give “shelter” to SEF—be it implicitly. This in turn offers new insights into the working of the moral normativity of this distinction.
It is important to note, however, that in an ever more globalized landscape, these diverse regulatory frameworks may nevertheless contribute towards cross-border reproductive travel. Official data and even estimations of the scope are unavailable. It can be assumed, however, that reproductive travel for the purpose of egg freezing is a seriously considered option, particularly for women living in countries where access is restricted.
Furthermore, the differentiation between “medical” and “social,” even though used as starting point for regulatory decisions, is not self-evident and reflects very different and diverse boundary-work. Our findings therefore, present an important added value to previous bioethical research and literature discussing the problematization around the artificiality of this distinction (see e.g., Martin
2010; Pennings
2013; Van de Wiel
2015).
The difficulty in defining MEF, and the diverse regulation when it comes to including different genetic and chromosomal indications and other infertility related conditions, evolved as a specific regulatory difference in our findings. Such a practical challenge is of particular relevance to the bioethical debate focusing on the connection between SEF and (bio)medicalization—raising the question of whether age-related fertility decline should be regarded as a medical condition/problem justifying the usage of medical means. Within this context, SEF was controversially regarded as a form of preventive medicine (Shkedi-Rafid and Hashiloni-Dolev
2011 and
2012; Martin
2010).
In general, the regulatory frameworks we explored clearly indicate a prioritization of “medical” over “social” motivations. In this context, age related fertility decline per se is not classified as a medical reason for fertility preservation. Furthermore, the partly stringent description of medical indications also prioritizes some medical reasons over others. For example, while in all four countries oncological treatments were identified as qualifying for MEF, other conditions leading to infertility (e.g., chromosomal and genetic disorders) are officially acknowledged only by the Dutch and Israeli regulations.
Another important point to be noted are the cross-national differences in terms of access and funding and the potential future use of the frozen eggs via IVF. While Israel provides women with more possibilities to use the frozen eggs (regardless of whether they were frozen for “social” or “medical” reasons) due to its rather generous funding policy, the Austrian and German funding schemes are much more limiting. The selective funding scheme in Germany and Austria of the usage of IVF by single women set yet another boundary which is of relevance specifically for SEF (Kostenzer
2020). In Israel and in the Netherlands, single women are allowed to freeze their eggs for “social” reasons, knowing that they will receive funding when wishing to use those eggs via IVF regardless of their marital status. In contrast, in Germany, single women can use SEF but will not receive funding for IVF, and in Austria SEF is forbidden altogether. These differences may also hint towards different biopolitical approaches and perceptions of the “appropriate” family model across the countries, which, however, require further investigation.
Another implication identified, are existing age restrictions. Such boundaries should be understood in light of the related medical risks and pregnancy complications at older maternal ages for both the mother as well as the future offspring (for relevant discussion, including counter arguments see Bernstein and Wiesemann
2014; Baldwin et al.
2014). Furthermore, by setting boundaries for assisted reproduction, scarce resources in healthcare are rationed, also based on health technology assessment and efficacy. At the same time, however, these limitations might unintentionally contribute towards normative indications of what constitutes the “appropriate” maternal age. SEF may challenge normative ideas regarding the appropriate life course and reproductive age norms (Rimon-Zarfaty and Schweda
2019; Baldwin et al.
2014). Regulatory frameworks might therefore seemingly and implicitly also reinforce social normative ideals of women’s biographies and reproductive timing. Indeed, in all four countries, we observed some form of age limitation regarding IVF funding regulation and in Israel, Germany and the Netherlands also regarding egg freezing usage (in the context of SEF) and/or funding (in the context of MEF).
The variation and blurring we detected in our research may further reflect certain underlying norms, one of which may include ageism. Observed age restrictions may reflect certain controversial ethical concerns regarding women’s physical and mental capability of becoming mothers at older ages as well as the potential social and emotional difficulties for children of older parents (for critical discussion see Bernstein and Wiesemann
2014; Baldwin et al.
2014). Ideas regarding old parenthood are also highly gendered and thus may be critically interpreted as form of sexism while highlighting the “double standard of aging” (Sontag
2018) in the context of sexuality (Pickard
2016) as well as the moral assessment of late parenthood (Bernstein and Wiesemann
2014; Rimon-Zarfaty and Schweda
2019). With regard to egg freezing regulation, those may be reflected in the different age limitations which differentiate between men and women. Cross-national differences in boundaries apparent in funding and accessibility policies may also be understood in the context of pronatalism. In relation to Israel for example, the overall favourable regulatory framework of fertility medicine and preservation can be understood in the context of pronatalist culture (Shkedi-Rafid and Hashiloni-Dolev
2011). The cross-national differences in the regulatory frameworks may also be analysed in the context of geneticism and the importance of genetic motherhood. Indeed, in the ethical debate on egg freezing, the possibility of genetic/biological motherhood at advanced maternal age was discussed as one of the technology’s main advantages (Petropanagos et al.
2015; Dondorp and de Wert
2009).
Our study, however, also has limitations. By comparing regulatory frameworks, we could gain valuable insights as to how ideas of “medical” and “social” find practical expression. However, we did so by primarily researching documents. While we did consult experts in the field, a more in-depth approach of the respective stakeholders' perceptions is considered useful in getting a better understanding of the underlying intentions. Furthermore, we need to be aware that our analysis focused merely on the written practice, which might differ from the actual practice, on which we are not able to draw in-depth conclusions.
In conclusion, egg freezing remains to be a controversial topic for bioethical academic debate, policy, and practice, leading to convergences and divergences in the states’ understanding regarding if and how to regulate it. Within the scope of the current paper and the nature of our research we were not able to investigate possible explanations for the cross-national differences we detected in the regulatory frameworks (e.g., possible relevant sociocultural scripts). Yet, by outlining these differences, this paper problematizes the oversimplification of both concepts (MEF and SEF) and their differentiation. By that, the abstract perspective around this differentiation is expended while unveiling cross-national differences and implicit normative perceptions. Those may be further discussed in the context of bio/cryo-political mechanisms (Radin and Kowal
2017). As life is extendedly regulated by technoscientific means, the practice of cryopreservation can be analysed as facilitating the effort to choreograph ontological state (e.g., “mother” or “parent”) (ibid,13). Following our research, we wish to highlight the way such efforts, with their sociocultural underpinnings, can be reflected in and uncovered by the different regulatory frameworks. Exploring ethical and biopolitical aspects further could help to better understand regulatory differences and decision-making processes, while supporting the identification of the relevant normative implications.
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