International Women’s and Gender Studies in Lower-Saxony, Germany
From Woe to Woe: Egg Donation in Israel1 Dr. Carmel Shalev
Abstract The debate in Israel around the legal regulation of oocyte (egg) donation has been going on for several years, in light of a perceived "shortage" of eggs for infertility treatment. Regulations that were put in place to permit the importing of eggs from foreign countries did not answer the growing demand, and practices of reproductive medical tourism emerged. In 2007 a governmental bill proposing to regulate egg donations for both infertility treatment and research, was set on the agenda of Israel's parliament, the Knesset. The gist of the bill was to allow donations by healthy volunteers, as opposed to current regulations which restrict donation only to women who are themselves undergoing fertility treatment. It would also permit donation of eggs for research, which is not allowed under current law. This paper describes the parliamentary debate on the bill in 2008, which echoes familiar themes of empathy for the suffering of women in need of donations and the ability of medical technology to offer relief, but also features the emergence of a female voice that expresses a critique from the perspective of the donors.
A. The Demand for Eggs for Infertility Treatment
Israel has been a pioneer in the field of medically assisted reproduction (MAR), and boasts the highest rates of MAR intervention in the world in terms of per capita consumption of cycles of treatment. (Collins, 2002; Shalev and Gooldin, 2006). Nonetheless, there is no act of parliament that regulates the field of reproductive technology in an over-all governance scheme, and different uses of repro-genetic medicine are regulated in piece meal fashion, often by secondary legislation or administrative guidelines of the Ministry of Health. Thus, artificial insemination is regulated under administrative guidelines issued by the Director-General of the Ministry of Health (MoH Artificial Insemination Directive, 2007); while in vitro fertilization [IVF] is governed by regulations issued by the Minister of Health, under the general authority to regulate matters of public health. The Public Health (Extra-Corporeal Fertilization) Regulations, 1987 [IVF Regulations] address a broad range of issues, including the accreditation of clinics, conditions of access to treatment, storage of fertilized eggs, and informed consent to treatment.
As regards egg donations, the IVF Regulations provide that only women undergoing infertility treatment for their own selves may act as donors.The rationale for this restriction is related to the health risks of undergoing the intervention, including ovarian hyper-stimulation which can be life threatening in extreme cases, and the surgical hazards of the procedure. Indeed, at the time the IVF regulations were issued, there had been instances of death from ovarian hyper-stimulation, and in one case a woman had died in a hospital from abdominal bleeding following the egg retrieval procedure. (MoH Public-Professional Commission, 2000) In view of these dangers, the regulator adopted a paternalistic approach that healthy volunteers should not be allowed to subject themselves to these risks.
However, with the rapid pace of technological development, the change in societal attitudes to the biological family, and the emergence of a private global market of medical tourism, together with a consumerist approach to the utilization of new reproductive technologies – there is evidence of an increasing demand for donated eggs. Besides the core needs of women who suffer from ovulatory disorders, egg donation is now perceived as a means by which a woman’s child-bearing years can be extended. For example, in 1998 a professional committee suggested clinical guidelines for public funding of IVF in Israel that set an age limit of 45 years for women undergoing IVF with their own eggs, whereas the age limit for those undergoing IVF with donor eggs was set at 51. (Medical Guidelines for IVF Treatment, 1998) In other words, the possibility of egg donation created a new group of potential MAR consumers consisting of women in the 45-51 age group, who previously had considered their reproductive years to be over.
But women who require medical assistance to conceive are unlikely to be willing to donate their eggs to another woman. Because of the rigorous nature of the egg procurement procedure and the relatively low rates of success per cycle of treatment, women undergoing IVF ordinarily prefer to fertilize all the eggs retrieved in a given cycle and to preserve them for their own future use. The discrepancy between the reluctance of infertility patients to donate eggs, and the increasing demand for eggs by women in need, led to what was considered to be a “shortage” of eggs for donation.
By the year 2000 the chair of the Knesset Committee for the Advancement of Women estimated that 2,000 women were waiting for donations. (Knesset Committee Protocol, 2000, per MK Y Dayan) Within a few months, she submitted a legislative bill on the matter, designed to increase the pool of eggs for donation. It proposed to recognize the egg recipient as the legal mother of the child, to establish a central registry of donations, and to allow anonymous egg donation by volunteers, who would be compensated for their “time and suffering”, in a sum equal to the average wage for each egg retrieval procedure (Egg Donation Bill, 2001). However, the legislative initiative subsequently stalled in face of the opposition of ultra-religious political parties. It raised questions about the halakhic status of the offspring, that affects marital eligibility under religious law, and whether a registry would be subject to medical or rabbinical control. (Knesset Committee Protocol, 2001) These questions illustrate a tension in the constitutional definition of Israel as a "Jewish democracy". On the one hand, marriage falls under the exclusive jurisdiction of religious courts under Israeli law. On the other hand, reproduction is protected by a right to privacy and there is a general right to non-discrimination under its constitutional law jurisprudence. The halakhic aspects are interesting, but lie beyond the scope of this paper which focuses on tensions in the female voices in the debate. For present purposes, suffice it to say that as a result of religious opposition, this legislative initiative and consequent bills have not yet ripened into the enactment of a statutory scheme to regulate the matter.
Meanwhile, private IVF clinics started to offer economic inducements to infertility patients to donate eggs. This was not an overt transaction of buying and selling eggs, nor did clinics expressly offer to pay patient donors. Although payment for sperm is an accepted norm, and Israeli law did not contain at the time any express prohibition on trading in human body parts, it was considered improper to engage in commerce in eggs. Instead, the clinics offered benefits in the form of treatment services, i.e. they waived certain costs of treatment if patients would agree to "share" their eggs with other women in need.
Public clinics did not engage in this practice so as to steer clear of blurring the lines of the ethical prohibition on trafficking in human body parts, and the economics of the scheme were not entirely transparent. But in the private clinics, according to one professional article (Rabinerson et al. 2002), the costs of treating the recipient of the donated egg were covered by national health insurance, so that the clinic recovered the deduction it had given the egg donor.
B. The “Eggs Affair”
One consequence of the lack of over-all governance of MAR in Israel is that there is no official data on the total numbers of egg donations in the country. But it is common knowledge that donations from infertility patients in Israel decreased drastically in the wake of a scandal that came to be known as the “eggs affair”. Data from a study in three hospitals showed a decrease from 113 cycles of oocyte donation in 1999 to 34 in 2000. (Rabinerson et al.)
The scandal was exposed by the press in 2000 when some women filed a civil action in torts against one of Israel’s leading fertility experts, a former chief of gynecology at one of its largest public hospitals. The women alleged that the doctor submitted them to excessive hormonal stimulation, retrieved dozens of eggs from single treatment cycles, and used these eggs in the treatment of large numbers of recipients at a private clinic – without their informed consent. The civil action was eventually settled out of court in an agreement for the award of compensatory damages. (Reznick R, 2005) But the plaintiffs had also filed police complaints, and these led to an investigation under the criminal law.
The criminal proceedings spread over years of legal battle, and ended eventually in a professional disciplinary tribunal. Because the case was never adjudicated in a court of law, and the decisions of the disciplinary court are not made public, the facts of the affair were never made clear. But according to journalist reports, the doctor was alleged to have endangered the lives of two women by excessive ovarian stimulation, and to have obtained patient consent with only partial information about the numbers of eggs and intended recipients, and the attendant risks. Apparently the state prosecutor’s office considered that there was not enough evidence to charge the doctor with criminal negligence. Instead, in 2003, it offered a plea bargain: if the doctor would admit certain facts, the case would be referred to a disciplinary venue. However, the complainant women challenged the plea bargain before the Attorney-General. As a result, it was revoked, and a criminal indictment was brought to the Tel Aviv Magistrates Court with charges of fraud. Then the doctor challenged the indictment on procedural grounds in a petition to the High Court of Justice. Finally he agreed to a plea bargain, and in 2007 he pled guilty to disciplinary offences of behavior unbefitting a doctor and violations of patient rights (Reznick R, 2007_1 ), and was sentenced to suspension of his medical license for a period of two and a half years. (Reznick R, 2007_2)
The facts to which the doctor confessed were that he took hundreds of ova from private patients undergoing infertility treatment without their permission. In one case he removed 232 ova from one woman and used 155 of them for 33 recipients. In another, he took 256 ova and used 181 for treating 34 other women. (Siegel-Itzkovich J, 2007) It is safe to assume that no reasonable woman would agree to be the potential genetic mother of over 30 children. The magnitudes are quite shocking, and both the plea bargain and the sentence seem lenient.
Be that as it may, the scandal raised two issues of principle. First, it indicated the need for restrictions on the number of eggs taken from any one donor, as well as on the number of recipients. Second, it illustrated the potential conflict of interests when infertility doctors treat both potential donors and patients in need of a donation. But most importantly, the scandal resulted in a crisis of trust, and the practice of egg donation in the country not only decreased as a result, but ceased almost entirely.
When the government finally submitted to the Knesset a proposal for legislation – the Egg Donations Bill, 2007 [the 2007 Bill] to which we shall return below – the trauma from this affair echoed in the parliamentary committee discussion, which opened with a statement of the legal advisor to the Ministry of Health, that –
“A few years ago there happened a very unpleasant affair in Israel, where eggs were taken from women by a gynecologist without the matter being properly regulated, and as a result tens of eggs were taken from one woman and given to a large number of women, without the donor being aware of the fact. … When this affair blew up, something happened in Israel. The few women who were [previously] prepared to give eggs while undergoing treatment, stopped donating. The direct result of this was that there were no egg donations in the State of Israel.” (Knesset Committee Protocol, 2008_1, per Atty. M Hibner)
C. Trans-National Donations
Meanwhile, women in need of eggs started traveling to IVF facilities in other countries, such as the Ukraine, Cyprus, and Romania, which collaborated with Israeli doctors. This practice had been legitimated in 2001, when the IVF Regulations were amended so as to allow the use of eggs from abroad. (Public Health Regulations (Extra-Corporeal Fertilisation) (Amendment), 2001) Under the amendment it was permitted “to implant an egg retrieved and fertilized outside Israel, in the body of a woman in Israel”. This meant that the sperm of the male partner could be frozen and transported to a facility abroad, where it would be used to fertilize a donated egg; the fertilized egg would then be frozen and transported back to Israel for implantation in the female partner.
The Ministry of Health authorized four clinics in Israel (two of them private) to perform these procedures after examining and approving the clinical conditions and laboratory methods of their collaborating clinics in Romania and the Ukraine. (Knesset DRI, 2006) At least in one case, doctors and laboratory specialists from the Israeli clinic trained their collaborators abroad in order to ensure that the medical treatment, the fertilization and the freezing, including accurate identification of the egg and sperm, would be performed according to Israeli standards. (IVF Website_1) The amendment to the IVF Regulations includes a general requirement that all necessary measures be taken to protect the health of the donor, and also specify the maximum daily hormonal dosage that may be used for inducing ovulation. But they do not provide for any form of insurance against the risks of ovarian hyper-stimulation or complications of the surgery. In addition, while “informed consent” would be required in the case of local donors under Israeli law, the Regulations suffice with mere “written consent” from donors abroad. And they do not say anything about payment for egg donations, although it is common knowledge that donors abroad do receive payment.
Furthermore, the nature of the actual practice of Israeli women traveling abroad for egg donations changed when local physicians started referring their patients to clinics abroad for the entire process of donation, fertilization and implantation. There seem to be two reasons for this – the one legal and the other technological. First, there might be legal restrictions on the export of fertilized eggs from other countries. Second, it appeared that success rates of treatment with frozen embryos are lower than with freshly fertilized eggs. (Knesset DRI, 2006) Much as medical tourism for kidney donations increased when it became known that transplantation success rates were higher with organs from live donors than with cadavers, so too the evidence-based benefits of egg donation technology gave rise to medical entrepreneurism in the global market. The shortage of egg donations is intrinsic to the technology which created the need in the first place. Innovative trans-national profit-making practices in egg donations emerged to meet the need by increasing the supply through private technology transfer.
Thus, physicians began to refer women for egg donations in IVF centers in foreign countries. Often these doctors were the medical entrepreneurs behind the setting up of those facilities. They might accompany their patients to the facility abroad and themselves perform the fertilization and implantation there. One such Israeli website explains that a woman who wishes to have an egg donation will need to travel abroad to the clinic where the egg is donated for implantation of the embryos; she will fly there together with other patients and be accompanied by a doctor from the treatment center who will also perform the implantation; and “all air travel arrangements, plane tickets, taxes, transfers and full pension hotel accommodation are taken care of by Center staff and included in the cost of treatment.” (IVF Website_2) The pattern of the practice, including the tourism package, is typical of medical and reproductive tourism in general and not unique to Israel.
However, Israel stands out in its designation of public funds to support these practices in the case of egg donation. In general, Israel is the most generous country in the world in terms of its public funding for infertility treatment. The National Health Insurance [NHI] Law, 1994 obligates health care funds to provide for all Israeli residents a basic basket of health services, which includes "infertility diagnosis and therapy" and "artificial fertilization … for the purpose of bearing a first and second child – for couples who do not have children from their current marriage, and also for a childless woman who wishes to establish a single-parent family", without any limit on the number of treatment cycles. (NHI Law Second Addendum, 1994) The NHI Law also includes an extraordinary provision which authorizes the Minister of Health to decide that a health service included in the basic basket can be provided in a foreign country, which means that the patient has a right to receive funding for the treatment abroad (section 12). And in 2005 the Ministry of Health issued a circular that clarified the legal obligation of the health funds to provide egg donation services outside Israel within the coverage of the NHI. (MoH Egg Donation from Abroad Directive, 2005)
It is not clear whether the administrative directive in the circular applies only to cases in which the fertilized egg is imported into Israel for implantation in accord with the IVF Regulations, or whether it also obligates the health funds to cover the costs when the woman travels for implantation abroad. In any event, health funds may provide universal services above and beyond their legal obligations under the NHI Law. According to a patient rights organization website, “because there are no egg donations in Israel” all the health funds participate in the costs of donation abroad to the sum of approximately $2,000.(Patient Rights Website) At least one of the health fund supplementary insurance programs covers most of the expenditure for up to two egg donations outside Israel, including when the implantation is performed there. (Health Fund Supplementary Insurance Policy)
D. The Suffering of Infertility
The extraordinary scope of public funding to support access to reproductive technologies in Israel is one expression of a pronatalist culture, which has been described in the social science literature. (For example, Birenbaum-Carmeli D, 2004; Remennick L, 2006; Haelyon H, 2006) The primacy of the value of reproduction can also be seen in the jurisprudence of the courts of law, which have ruled time and again that restrictions on access to infertility treatment are invalid. The courts have articulated a "right to parenthood" that derives from fundamental individual rights to liberty, privacy and dignity and ranks high in the hierarchy of constitutional human rights. The often poetic style of the judgments rendered by the justices, reflects the importance of reproduction in Israeli society:
"It seems that no-one would dispute the status and central importance of parenthood in the life of the individual and the society. These are fundamental tenets of human culture throughout the ages. Human society exists by virtue of reproduction." (Nahmani v. Nahmani, 1995, per Justice T Strasberg-Cohen)
"The right to parenthood is a natural fundamental right, a birthright that is inherent in the human being. This right stems from the right to self-realization…, and its foundation is in personal autonomy and the right to dignity and privacy.
The right to parenthood is at the base of all bases, at the foundation of all foundations, it is the subsistence of the human species, it is the aspiration of the human being… and its deprivation is a most grave injury to one's basic aspirations and to the essence of one's human existence. …
Since we are concerned with a basic human need … the right to parenthood does not apply only to natural reproduction, but also to birth as a result of fertility treatments…
The right to parenthood is not merely the right to non-interference in one's private considerations whether to be a parent, but also applies to creating the conditions that would enable one to realize one's decision." (Anonymous v. Clalit, 2008, per Justice N Arad quoting Supreme Court precedents)
The theme of the value of parenthood recurs in the opening statement of the Minister of Health to the Knesset plenary when the 2007 Bill passed its first reading. The statement also applauds the technology that affords relief for the suffering of infertility:
“In the State of Israel the value of parenthood, the right to bring children into the world and realization of the personal aspiration within the family unit are extremely central, both from the cultural and halakhic point of view. … The opening of many IVF units all over the country, the freezing of fertilized eggs for many years, bringing children into the world by means of surrogacy, posthumous sperm insemination and more – all these are the fruits of technological progress that found legal redress in legislation…. The current bill is one more step in this direction, since it addresses the issue of egg donation, a subject that touches considerable suffering of many couples and women and has been a significant barrier to realizing the right to parenthood.” (Knesset Plenary, 2007)
The suffering of infertility is particularly poignant for the women. Their plight is presented dramatically in the parliamentary committee by a spokeswoman for an egg donation web forum, who chose to remain anonymous:
“I have been barren for ten years. … The label of sterility is painful, but I know I am not alone. Thousands of women have a common fate … I am talking about those who are denied the fruit of the womb and depend on the mercy of another woman to become pregnant. We have all arrived at this stage [of seeking an egg donation – CS] after much suffering and torment. We have all had our full of inseminations, fertilizations, treatments, imaging, surgery and medical procedures, more and less painful. … We all yearn for a child of our own. Sadly, this our finishing line. This is the only way left to us to carry a child in our wombs, and to feel it is created from our flesh.” (Knesset Committee Protocol, 2008_1)
Empathy for the women in need of egg donations had been the motivation when the issue was first laid on the parliamentary agenda in 2000, and behind the legislative bill that ensued, as well as two additional and almost identical private member bills that were proposed in 2003 and 2005. (Egg Donation Bills, 2003; 2005)However, the government had not deemed it necessary to address the matter until the matter of eggs for research arose.
E. Eggs for Research
In 2000, in the wake of the first parliamentary debate and the exposure of the "eggs affair", the matter of egg donations for infertility treatment had been taken up by a Ministry of Health ad hoc committee. It discussed the medical risks that were the historic justification for the prohibition on volunteer donation in the IVF Regulations, and concluded that the risks of donation under the current state-of-the-art were no longer grave enough to prevent donation by volunteers. It therefore recommended legislation that would allow volunteer donations and produced a draft proposal similar to the private member bill, which included restrictions on the number of donations and offspring from any one volunteer. (MoH Legislative Proposal, 2001)
Nonetheless, the government did not act on the committee's recommendation until a legal problem arose in relation to research in cloned stem cells. A statute that prohibits reproductive cloning was enacted in 1999 (Prohibition of Genetic Intervention Law, 1999), but it did not prohibit nuclear cell transfer cloning of embryos for stem cell research (that is, basic research for "therapeutic" cloning). Cloning research would be subject to approval by an ethics review committee under the general regulatory rules that govern bio-medical experiments in human beings. But the IVF Regulations provide that eggs taken from a woman’s body may be used only for the purpose of her fertilization, which precludes the use of eggs for research. Therefore, cloning research could not be approved, despite the fact that the anti-cloning statute had not intended to prohibit it.
To overcome this obstacle, the ethics committee vested with advisory authority under the anti-cloning statute called for regulation that would allow donation of eggs for research.(National Committee for Medical Experiments, 2003) In view of this, the Ministry of Health put on hold the draft legislation that had been proposed by its ad hoc committee to answer the need of infertile women for egg donations, so as to prepare a comprehensive proposal that would also regulate the donation of eggs for research. Thus, the 2007 Bill covers egg donations for both infertility treatment and research.
F. The Eggs Donation Bill, 2007
Despite recognizing the need for eggs for research, the primary objective of the 2007 Bill is to regulate donations for the purpose of infertility treatment. Thus the rule is that the procurement procedure would not be undertaken except for the purpose of reproducing a child, but a donor may choose to designate eggs for research, on the condition that most of the eggs retrieved in the treatment cycle would be used for implantation in a recipient undergoing infertility treatment. The essence of the Bill is to permit donations from volunteers. The donation would be anonymous as between the donor and the recipient, while permission for a “directed” donation may be granted only in exceptional circumstances. The donor should be aged 20 to 35 years old, and there would be restrictions on the number and frequency of procurement cycles (no more than three retrieval cycles, spaced at intervals of at least 180 days), and the number of recipients from each retrieval procedure (no more than two – which means that no more than six children could be born from any one donor). Another provision states that eggs may not be retrieved from a volunteer donor without the approval of a physician, and upon certain multiple conditions. For example, informed consent is required, and there is protection for confidentiality and the privacy of personal data.
The Bill also empowers the donor to make an autonomous choice about designating some of her eggs for research. But the Bill does not require the disclosure of specific information about the nature of the research, so that blanket consent might be obtained. Similarly, the Bill would allow the export of eggs for research purposes subject to administrative approval, but the woman’s consent is not required. This is at odds with the standards of informed consent to participate in research that apply to the donation of DNA for genetic research under Israeli administrative rules, which clearly require inter alia that research participants be informed of the specific objective of the research and whether the donated biological material will be exported. (MoH Guidelines on Biobanks, 2005)
In order to encourage women to volunteer as donors, the Bill proposes a compensation scheme that is similar to that of organ donations (Organ Transplantations Law, 2008). On the one hand, it prohibits commercial transactions (i.e., giving or receiving, either directly or indirectly, any consideration for the retrieval of eggs, or their allocation to infertility treatment or research). On the other hand, the State would pay “compensation” to donors for the effort and risk entailed in undergoing the procurement procedure. Nonetheless, concerns about exploitation of vulnerable women arise in light of another provision of the Bill, to wit that special permission would be required for a married woman to donate eggs because of considerations that go to the status of the child under religious halakhic law. In other words, the rule would be that volunteer egg donors are unmarried women, comporting with a similar provision in Israel’s surrogacy law. (Embryo Carrying Agreements Law, 1996; Shalev C, 1998) But the soci-economic status of single women is relatively low in general, and the Bill does not provide redress for such disadvantage.
G. The Interests of Donors
The most notable aspect of the parliamentary debate on the government's proposed bill is the emergence of a new feminist voice. While the interests of infertile women resonated in the initial debate with the concerns of feminist parliamentarians, the new voice is concerned with protecting volunteer donors from abuse.
The estimated numbers of women in need in the current debate are a dramatic three-fold increase from those when the debate began less than ten years ago. The representative of a civic organization supporting infertile couples also raises the question of funding, and commiserates with the inability of many to afford the cost of an egg donation outside Israel:
“6,000 women are waiting for an egg donation. An egg donation abroad costs between 5,000 and 8,000 dollars. Almost 3,000 women a year cannot afford this. We need to find fast solutions. We consider ourselves as representatives of the mouths that cannot speak.” (Knesset Committee Protocol, 2008_1, per Ms. O Balaban, Chen Patient Organization)
This is how the experience is described by the spokeswoman for the egg donation web forum:
“It’s not pleasant to say so, but there is good livelihood for lots of good and respectable doctors. I’m going for an egg donation for the tenth time [emphasis added – CS]. I find myself together with friends running across the globe, in all sorts of places in Eastern Europe, with different routes, in all sorts of clinics, and with all due respect to the tests our doctors do, our rights are not observed and we are not sure what proper medical or other supervision there is there, but who will give up the dream?” (Knesset Committee Protocol, 2008_1, per Anonymous)
This statement creates consternation about the poor standard of medical treatment Israeli women receive abroad, and the need to provide an answer to their needs inside the country. But a grassroots feminist non-governmental organization (Isha L'Isha – Woman to Woman) appears in the parliamentary committee with a critical voice expressing concern for the lot of the donors, both inside and outside the country, and some parliamentarians take up the cue.
A main point of contention relates to the potential conflicts of interest of treating physicians, which are compounded when the procurement of eggs for research is allowed:
“They talked here about the lack of donations in the wake of the [eggs] affair. It was said that the affair created a very large crisis of trust between the women patients and the medical system. … In addition… we are talking about research interests, financial interests, pharmaceutical company interests, fertility clinic interests, huge interests that are about economics, prestige, professional, personal and also institutional. At this great junction of interests, the person supervising the entire process will be the head of an IVF unit.” (Knesset Committee Protocol, 2008_2, per Ms. Y Hashash, Isha L’Isha Haifa Feminist Center)