Clouds Hill Imaging LTD / Getty Images
A fertilized egg travels down the fallopian tube on its way to the uterusClouds Hill Imaging LTD / Getty ImagesOnce a month, one of the ovaries of women of childbearing age releases a mature egg, which is gently guided by tiny cilia inside the fallopian tube towards the uterus. It is a short voyage, about ten centimeters, which takes up to 12 days. If a healthy sperm appears during the trip, the solitary egg can fuse with it and create an embryo. If this meeting doesn’t happen, the female reproductive cell is eliminated during the woman’s next menstruation. In recent years, however, a significant number of harvested eggs have faced a much longer—and, in the case of Brazil, tortuous—journey before becoming a potential embryo, as was found by sociologist Rosana Machin, from the University of São Paulo School of Medicine (FM-USP).
In an article published in June in the journal Mobilities, Machin and two collaborators from Spain reconstructed the shifting path taken by female gametes brought in from abroad to meet the growing demand of Brazil’s assisted reproduction clinics. In a study funded by the Spanish Ministry of Science and Innovation, the researchers analyzed official import documents and the rules that regulate the commercialization and transport of human biological material in different countries. They also interviewed ten specialists, including doctors and embryologists from national and international assisted reproduction clinics, lawyers who are experts in the field, technicians from the Brazilian health agency, and owners of companies that specialize in the international transport of biological material. Thus, they were able to retrace, step by step, the routes taken by these human eggs, which have been arriving in Brazil in increasing numbers (see graphic on page 64). Since 2019, from 2,000 to 3,000 units have been imported per year. This corresponds to approximately 5% to 10% of the fertilization cycles (hormonal stimulation conducted to release eggs, which is followed by collection) conducted in Brazilian clinics, according to the National Embryo Production System (SISEMBRIO).
Two years of research revealed that the transit of this biological material entails a network of intermediary agents—including transport specialists and customs brokers—to facilitate the departure of eggs from Europe and their arrival in Brazil, at times exploiting legislative loopholes in the country of origin that could compromise the traceability of the material. “In this study, we clarified something that ANVISA already suspected,” says Machin, referring to the National Health Surveillance Agency responsible for authorizing biomaterial imports.
The researcher’s interest in Brazil’s assisted reproduction market arose in the late 1990s when the number of clinics offering this type of treatment began to rise. In recent studies, with support from FAPESP and foreign institutions, Machin has mapped the increase in these services in Brazil over the last decade, creating a profile of the clients they serve, and tracking the growth in imports of male and female reproductive cells. The results of her studies were presented in a published article in 2020 in JBRA Assisted Reproduction and in 2022 in the journal Inter Disciplina. In the latter, she identified that the greater availability of assisted reproductive technologies led not only to more foreigners arriving in the country specifically to seek the service, but also to an increase in the import of eggs and semen (see Pesquisa FAPESP issue nº 269).
“Analyzing the data on the eggs’ origins, I noticed something curious,” Machin relates. Although the documents indicated that material always originated from Ovobank, the largest female gamete bank in Spain—third-ranked in countries that donate eggs worldwide—reproductive cells could be purchased from smaller clinics. Furthermore, each year they were being sent to Brazil from a different European country.
Travel with stopovers
In Brazil, there are no egg banks, although donation is permitted under three circumstances: the first, altruistic, in which a woman undergoes gamete extraction procedures and anonymously offers her eggs to another; second, shared, when the recipient pays for both her treatment and the donor’s—without the identity of either being revealed; and third, donations that are made by relatives up to the fourth degree (cousins). None of these circumstances, in principle, allow for direct payment or compensation to the donor. In Spain, a woman can receive up to €1,200 as compensation for each egg-production cycle, more than the country’s minimum wage (€1,080), and the eggs coming from Spain are cheaper than the eggs imported from the United States, which is another major producer. “Brazilian regulations create an ambiguous situation. They prohibit paying for donations made within Brazil but allow purchases by those who pay for donations abroad,” criticizes Machin.
Because the quantity of eggs available seems to be insufficient, even with the potential for donations, several years ago ANVISA authorized importations. In 2017, the year in which purchases abroad began occurring more consistently, 51 batches of female gametes entered the country, with a total of 321 eggs. Of these lots, 86% came from Ovobank. The health documentation that accompanied the biomaterial imported from the Spanish company indicated, however, that the majority came from a subsidiary in Greece.
The following year, according to the study, the total number of imported female gametes increased by nearly sixfold, hitting 1,852; however, the number reported by ANVISA to Pesquisa FAPESP is lower, 1,322. These eggs were once again purchased from the bank in Spain; but the eggs were sent from a branch in Italy, which does not export the reproductive cells of its own citizens. In 2019, the pattern was repeated. The number of units grew again, with the Spanish egg bank as the main source, though now shipped from Slovakia. Most recently they have begun to be imported from Argentina.
At least two motives explain this juggling act. The first is that Spanish legislation is quite demanding, as the researchers found, which makes sending eggs outside the European Union laborious and time-consuming. Documents are required specifying how the samples will be used (to prevent their use in surrogate pregnancies, which are prohibited in Spain and known by the pejorative term “rental wombs.” In addition, official request forms are required from the destination clinic with documents guaranteeing the availability of the biological material. “In all my professional experience (more than 20 years in assisted reproduction) I was only able to extract embryos once—following the protocol—for transfer to the USA and it took a year to obtain the authorizations,” one Spanish embryologist, whose name was withheld for the article, told the researchers. The second possible reason, offered by the same embryologist, is that the egg bank can make a higher profit when reselling the material to a subsidiary.
Despite Spanish restrictions on direct exports, these companies got around the problem. European Union regulations allow material to move easily and quickly from one country to another within member nations without the requirements that carriers have special licenses or that the biomaterial must pass through customs. “Since direct exports from Spain are difficult, the egg banks found legal loopholes through which to ship them,” says Machin.
In principle, Spain’s assisted reproduction data-management system would make it possible to track the route samples take from collection to their final destination. It assigns a code made up of letters and numbers that identifies the establishment responsible for handling the material, the date of extraction and freezing, and the type of biomaterial (egg, sperm, or embryo) being shipped, as well as other data. This identification protocol became mandatory in 2017, but doesn’t count for samples stored before October 2016, which were allowed to be distributed without this code for the following five years. Furthermore, according to the statement of one Spanish embryologist, the system still wasn’t fully operational when the study was carried out, between September 2021 and September 2022.
Ted Horowitz Photography / Getty Images
Eggs and embryos stored in a container cooled with liquid nitrogenTed Horowitz Photography / Getty ImagesThis lack of monitoring raised suspicions that the content exported to Brazil may have been altered along the way, such as being replaced with eggs from a different origin, something that could neither be proven nor refuted. “The directors of Brazilian clinics we interviewed say that this problem should not occur, because it’s possible to ascertain the biomaterial’s origin since doctors have access to the nationalities of the egg donors,” says the USP sociologist.
Another concern arising from the more complicated transit of material within Europe was the possibility of compromised quality. Unlike sperm, which are produced continuously and released by the millions with each ejaculation, eggs are rare cells. Women are born with a limited supply and, as a general rule, release one each month. Obtaining eggs for in vitro fertilization requires the administration of hormones to induce the release of a larger number of gametes (10 to 20), in addition to examinations to evaluate the maturation of egg precursor structures (follicles). Collection is invasive, carried out by aspirating mature follicles, with the patient sedated. “It’s a procedure that causes some discomfort and usually causes transitory abdominal swelling due to the temporary enlargement of the ovaries,” says physician Nathan Ceschin, a member of the Brazilian Association of Assisted Reproduction (SBRA) and deputy director of a private fertility institute in Paraná who did not participate in the study.
Once extracted, the biomaterial must be subjected to a special freezing process and kept at around -190º Celsius. It must also be transported in a way that avoids shocks or impacts. Experts interviewed for the report, however, state that the extra travel in Europe should not harm gamete performance. “This routing is curious, but if the transport is adequate, it’s unlikely that the eggs would be compromised or that there would be any negative effects for the treatment,” comments gynecologist Luis Bahamondes, professor emeritus at the University of Campinas (UNICAMP) and director of the Campinas Reproductive Health Research Center (CEMICAMP).
Inspections carried out by experts before departure and upon arrival can also help ensure the viability of the material. “The eggs undergo an evaluation by embryologists before leaving the bank of origin and after arriving at their destination,” explains Ceschin.
Given the doubts, why continue importing? The most obvious argument is that it’s profitable for assisted reproduction centers. Another, pointed to by researchers and some experts, is that there would be a lack of female gametes to supply the Brazilian market, which is growing due to the postponement of maternity, a decrease in the price of treatment (which is still expensive, ranging from R$20,000 to R$50,000), and, since 2013, the possibility for same-sex couples or single people to undergo assisted reproduction therapy. “In Brazil, it takes six months to a year to obtain eggs for a single procedure. With imports, that time is cut in half,” says Ceschin.
In December 2022, the growing demand led ANVISA to propose changes to the regulations for importing male and female reproductive cells and embryos. The primary alteration was the creation of importing companies, which must be authorized by the Brazilian health authority. With the change, which came into effect in August, negotiations that were previously carried out by clinics and analyzed case by case by ANVISA, are now the responsibility of importers, who have been made responsible for ensuring that the exporting egg bank complies with the health standards of the country of origin, as well as for registering the samples, ensuring their quality, supervising transport, and managing customs clearance and subsequent distribution within Brazil.
“With the experience of evaluating the risks and benefits of this process and the growth in demand for imports, it was necessary to implement a more efficient regulatory mechanism,” an ANVISA communications advisor informed Pesquisa FAPESP. “The process was becoming increasingly complex, and it became necessary to establish clear responsibilities between the parties (international biomaterial banks, Brazilian and international transport companies, and Brazilian clinics) to ensure that the imports are conducted with safety, quality, and efficiency.” As of October, according to the agency, some companies had applied for authorization, but none had yet been approved.
Project
Reproductive technologies and (in)fertility: Regulation, the industry, and rights (nº 15/20543-4); Grant Mechanism Regular Research Grant; Principal Investigator Rosana Machin Barbosa (USP); Investment R$40,848.43.
Scientific articles
MACHIN, R. et al. The reproductive silk route: Transnational mobility of oocytes from Europe to Brazil. Mobilities. June 11, 2023.
MACHIN, R. et al. Assisted reproductive technologies in Brazil: Characterization of centers and profiles from patients treated. JBRA Assisted Reproduction. July 14, 2020.
MACHIN, R. Reproducción transnacional con terceros: El mercado reproductivo en Brasil. Inter disciplina. Dec. 5, 2022.
