REVIEW ARTICLE |
https://doi.org/10.5005/jp-journals-10009-1953 |
The Ethical, Legal, and Social Issues Impacted by Assisted Reproductive Technologies in Croatia
Department of Obstetrics and Gynaecology, Subspecialist of Reproductive Medicine, Poliklinika Repromed, Zagreb, Croatia
Corresponding Author: Erden Radončić, Department of Obstetrics and Gynaecology, Subspecialist of Reproductive Medicine, Poliklinika Repromed, Zagreb, Croatia, Phone: +385914828101, e-mail: erden.radoncic@gmail.com
Received on: 06 January 2023; Accepted on: 28 January 2023; Published on: 14 April 2023
ABSTRACT
Background: While assisted reproductive technology (ART), including in vitro fertilization (IVF), has given hope to millions of couples suffering from infertility, it has also introduced countless ethical, legal, and social challenges. The objective of this paper is to identify the influence of legislation and discuss various ethical, legal, and social aspects of ART in Croatia through various periods after its introduction in infertility treatment.
Scope of review: This paper gives a short review and depicts the ethical, legal, and social challenges they introduce influenced by past and contemporary legislation in Croatia.
Conclusion: In the future, advancing technology is likely to exacerbate the existing and open even more new ethical, legal, and social challenges. The ethical issues surrounding ART are complex and multifaceted, and they can be difficult to navigate. ART is directly challenging society to reevaluate the way in which human life, social justice, and equality are viewed. This is especially true for legislation whom which is expected to modify existing laws to accommodate the unique contemporary challenges created by ART.
How to cite this article: Radončić E. The Ethical, Legal, and Social Issues Impacted by Assisted Reproductive Technologies in Croatia. Donald School J Ultrasound Obstet Gynecol 2023;17(1):74-78.
Source of support: Nil
Conflict of interest: Dr. Erden Radončić is associated as the Co-Editor (Human reproduction) of this journal and this manuscript was subjected to this journal’s standard review procedures, with this peer review handled independently of this Co-Editor and his research group.
Keywords: Assisted reproductive technology, Ethical issues, Legislation.
This paper was presented at the symposium Zagreb—New York ethical and perinatal dialogue (first International symposium when does human life begin? Ethics, law, and professionalism in reproductive medicine; and fetal neurology—from short to long-term follow-up—how to proceed? Multicenter results on the clinical use of Kurjak’s antenatal neurodevelopmental test), held on 8–9th October 2022 in Zagreb, Croatia.
INTRODUCTION
Worldwide, >70 million couples are afflicted with infertility.1 Since the first successful IVF procedure in 1978, the use of this and related technologies have become commonplace around the globe. In Croatia, about 17% of couples are infertile, meaning that about 80,000 couples have problems with natural reproduction. During 2019, a total of 16 authorized ART clinics started 9,069 ART cycles, of which 8,136 ART procedures were performed, resulting in 1,909 pregnancies, and the birth of 1,783 children.2 Over the past decade, the use of ART services has increased at a rate of 5–10% annually.3
This paper gives a chronological impact of legislative changes in the Republic of Croatia and its ethical–legal challenges, most visible in the field of ART, and outlines some of the prominent ethical, legal, and social challenges they introduce through various periods.
EARLY YEARS OF ASSISTED REPRODUCTIVE TECHNOLOGIES IN CROATIA (1978–2009)
In this early period, Croatia never had legislation regarding ART. As part of former Yugoslavia in 1978, the Act on Health Measures for the Exercise of the Right to Free Decision on Childbirth was passed, which, following the development of medical technology, mentioned artificial insemination as the only recognized infertility treatment. The Act had only six articles related to ART—two of which allowed artificial insemination by husband and artificial insemination by donor—and therefore, there were neither procedures nor ethical issues that needed to be regulated.
In 1983, Croatian experts managed to give birth to the seventh baby born after IVF treatment in the world, a tremendous success just 5 years after the first IVF baby was born in the United Kingdom.
Robert Veriga was born on 23rd October 1983 in Zagreb (Fig. 1), which was a great success and, at the same time, was an incentive for the development of this branch of medicine. Consequently, ethical dilemmas came later—egg donation and embryo cryopreservation were not addressed either. From time to time, the issues of legal regulation of the field of human reproduction were raised, but this initiative remained on the table.
Fig. 1: First Croatian baby was conceived by ART in 1983
At the beginning of the 2000s, such mistrust among the patients was created that in 2003 the whole business began to violently collapse, and patients fled across the border. Donations of semen became so rare that there were no longer any conditions for the reduced scope of work, but the profession remained persistently silent, knowing that it was working in a legal gray zone all the time. During the golden period of Croatian ART until 2003, 10,000 procedures or more were performed annually.
Frankly, up until 2009, ART was not regulated, and professionals worked in the field according to the best clinical practice at the time and on their own conscience.
INDEPENDENT CROATIA AND THE PERIOD OF THE FIRST LEGAL REGULATION OF ART (2009–2012)
From Pioneering and Breakthrough Practices to the Dark Age of ART
The introduction of the Croatian Act of ART in July 2009, strongly influenced and supported by conservative political forces backed by the Catholic Church, marked a step backward compared to the modern approach to ART in western countries. The Act introduced unnecessary difficulties for patients and denied them the gold standard of treatment, as well as forcing medical professionals to adopt an unprofessional, unethical, and uneconomic approach to ART.
Optimizing variables and procedures is crucial for the best possible outcomes for IVF patients. A systematic approach to establishing standardized, universally adopted best practices that incorporate technological laboratory advancements should enable a gold standard of care with high quality gametes and embryos, leading to improved take-home rates of healthy babies.4 “The gold standard of ART,” which is practiced by most European countries, involves fertilizing all egg cells obtained in one hormonal stimulation procedure and the possibility of cryopreserving all surplus embryos with the intention of later embryo transfer for any reason. Due to the impossibility of adequate treatment and the influence of radical worldviews, many couples were deprived of the possibility of becoming parents with the help of modern medicine.
Among many controversial and ethical problems brought by the new conservative legislation, the most prominent were as follows.
Restriction of Fertilization to no More than Three Oocytes
The goal of multiple oogenesis is to obtain more high quality fertilizable oocytes, which significantly increases the chances of pregnancy. Limiting the number of fertilized oocytes to three, argued as a prevention measure for the creation of surplus embryos and as absolute legal embryo protection based on religious belief, goes against scientific data. Many experts agree that an average of 15 oocytes are needed for a high probability of live birth.5
The rationale behind this statistically obtained number is supported by the probability of implantation of an advanced embryo (e.g., blastocyst stage), which is relatively low. In good laboratory practice, every five fertilized oocytes should lead to the formation of at least two embryos on the blastocyst stage, and on average, half of the formed blastocysts will implant. It is clear that the number of surplus embryos is not the same in the early (cleavage) stage and the late (blastocyst) stage and many early embryos are lost during natural selection. This is especially important to consider during the counseling of infertile couples, keeping in mind their religious beliefs and the option of late-stage embryo cryopreservation.6,7 Furthermore, many authors believe the “one and done” approach, where a single cycle of controlled ovarian hyperstimulation aims to retrieve a maximal number of oocytes, may be more suitable for a significant number of couples, depending on their individual response to stimulation.8
Strict Prohibition of Embryo Freezing
The prohibition on cryopreserving surplus embryos forced infertility specialists to transfer all of the embryos obtained, resulting in an unacceptably high level of perinatal complications, such as an increase in multiple pregnancies, a high rate of second trimester spontaneous abortions, and preterm deliveries. This also implies higher overall costs and an increased risk of procedure-linked complications due to repeated ART procedures.9
Anonymity Withdrawal for Gamete Donation
There is ongoing global debate about anonymous vs nonanonymous gamete donation, and in Croatia, the lack of anonymity and the absence of gamete banks make it difficult for potential donors to decide to donate.
Discrimination Against Specific Subgroups of the Patient Based on Sexual Orientation
The consequences of the law in terms of discrimination against same-sex communities are still in effect today. Women in same-sex unions do not (and still cannot) have the right to access ART, despite recommendations to the contrary.
Mandatory Psychological and Legal Counseling was Required before ART Infertility Treatment
This unreasonable requirement also complicates and makes the procedure more expensive in cases where a couple’s sex cells are joined only through a medical procedure and where a doctor’s consultation is sufficient. It is unclear what advice a psychologist, psychiatrist, or lawyer should offer a couple on their own decisions, and this requirement has been one of the major causes of patients seeking treatment across borders. However, counseling has been and continues to be welcomed for couples seeking infertility treatment through heterologous (donor) ART.10,11
As expected, the results of such restrictive legislation led to a drop in the overall and specific success rate for procedures performed between 2009 and 2012 (Fig. 2). Compared to other European countries, there was a significant drop in almost all standard ART parameters in good prognosis patients. In contrast, the average surveillance data for European countries showed that 79.2% of births were singletons, with a twin rate of 19.9%, and a triplet rate of 0.9%.3 These paradigms were created as a consequence of the definition of the embryo and are based on the doubtful assumption that the embryo is clearly defined.12
Fig. 2: Comparison of the results between cryopreserved embryos and oocytes before and after introducing the Act of Medically Assisted Reproduction in Croatia 2008–2009
It should be noted that the first attempt at legal regulation of ART in Croatia, despite its immaturity, has also brought some positive changes resulting in better treatment. This includes the complete rebuild and/or modernization of all public health owned ART centers, the implementation of clean room-based quality management and licensing, the reimbursement of six IVF/intracytoplasmic sperm injection stimulated cycles, modernization, up-to-date equipment and education, and an undisputable improvement in the quality of ART. However, many of the above-mentioned ethical problems remained as intrinsic weaknesses of the legislation due to the overemphasis on legal embryo protection and the simultaneous creation of a new ethical problem while disregarding others that arose. As already concluded elsewhere,12 unlike the conservative/Catholic approach, prevalent ethics precepts hold that the embryo’s interests should be balanced against the interests of the other parties involved.
THE SECOND ATTEMPT AND CURRENT STATE OF ART LEGISLATION IN CROATIA (2012–TODAY)
In July 2012, the Croatian Parliament adopted a new, improved version of the ART Act, which replaced the earlier version despite strong opposition from the Catholic Church and the opposition center-right party responsible for the then current law from 2009. The most important correction of previous shortcomings is the maximum allowable number of fertilized oocytes, which is now 12, and the possibility of cryopreserving surplus embryos. However, many other questions remain unchanged.
UNRESOLVED QUESTIONS IN CURRENT CROATIAN ART LEGISLATION
Some of the articles in the Act of Medically Assisted Reproduction are unclear, confusing, and vague due to a lack of courage to resolve certain ethical issues. There are 13 out of 64 articles with these problems, covering subjects such as the following.
ART Procedures for Single Women
According to various articles of the Act, women without a partner and lesbians still cannot undergo medically assisted reproduction. Single women are partially allowed to do so, but only once they prove a medical diagnosis of infertility first. For the majority of patients (e.g., those without a partner), this is not easy to accomplish, as there is no active attempt to achieve pregnancy, a first step in managing infertility by professionals. This is a clear example of nonethical discrimination based on partner/marital status and/or sexual orientation. In other words, the procedure is allowed only if infertility is diagnosed and all other possibilities for pregnancy have already been tried without success, which can be fulfilled only by having a partner (Table 1).
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Embryo Donation
The Act allows for the donation of oocytes and sperm or embryos if both donors agree to do so. However, in practice, there is no register or database of embryos, oocytes, or sperm, and no public healthcare clinic or service offers this possibility or even mentions it. Another problem is the requirement for nonanonymity of donors, which is why people decide not to be potential donors of embryos or gametes even if they technically could.
Conscience appeal not covered
The law allows for the appeal of conscience, raising the question of whether a person with certain beliefs can work professionally in IVF treatments. There is a trend of training young physicians in ART who do not practice evidence-based medicine but rather belief-based or retro medicine, such as fertility care and similar approaches. There are elements of obstructive conscientious objection.13
Embryo Disposition
Countries around the world have adopted different approaches to dealing with leftover frozen embryos. The debate over embryo storage and disposal, which is driven by the belief that the destruction of potential human life is unethical and immoral, has not been resolved in the Croatian ART Act. There is only one article of the Act that states that the embryos must be kept for 5 years and nothing more. After this period, there are no articles of the Act that clearly define and allow for the disposition or destruction of embryos as a final measure. This legal uncertainty prevents both medical institutions and patients from taking any action. The problem of covering the costs of cryopreservation is also an ethical and legal dilemma arising from this deficiency in the legislation. For instance, what if a couple does not want to further cryopreserve their embryos and does not want to cover the cost of forced preservation? There is no penalty for such a patient decision, but there is a potential penalty for physicians and institutions who decide to take care of “orphan” embryos in a legally nondescribed fashion. There is also a justified fear among professionals that due to the lack of clear legal regulation, a judge may make a decision based on their own religious views and conscience rather than clearly defined law. Continuing to store embryos without clear guidance and limitations creates problems for both patients and clinics, and it is a shared responsibility between the clinic and the patients to keep cryopreserved embryos.
CONCLUSION
Assisted reproductive technology (ART) is a technology that has successfully treated millions of infertile couples around the world, but it has also introduced a significant spectrum of new social, ethical, and legal challenges. The embryo has become a highly controversial entity, defying traditional boundaries as well as traditional scientific, legal, and moral paradigms.
In general, the ethical issues surrounding ART are complex and multifaceted, and they can be difficult to navigate. Individuals, professionals, and society need to consider the potential consequences and implications of these ethical problems and make informed decisions that are consistent with their values and principles. Since ART is a question of medical achievement in the treatment of infertility and should not be a religious question, adjustments to the legal framework are necessary to clarify topics that interfere with ethical issues and are left undefined. The medical profession should also remain true to medical beliefs and science.
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