Lack of law opens loophole for the sale of eggs for assisted reproduction

A recent study on assisted reproduction showed that Spain, one of the main exporters of gametes, takes advantage of the lack of legislation to sell genetic material to Brazil. The scientific magazine Mobilities presented work that retraces the path of eggs from the European country to Brazil. The demand for in vitro fertilization has grown significantly in recent years, but legislation to regulate the market has not kept up with this growth. Currently, only resolutions from Anvisa and the Federal Council of Medicine (CFM) place limits on the practice, which has many ethical controversies – from the improper purchase of human material to the consequences for those born in these circumstances.

“This is a market that earns R$800 million and is not regulated by specific law”, points out the judge of the Court of Justice of Pernambuco (TJPE) Ana Claudia Brandão, president of the Biolaw and Bioethics Commission of the Family Law Association and of Successions (ADFAS). “Importation ends up meeting demand, as collecting eggs is not simple,” she continues.

“The terminology that is often used, focused on expressions such as genetic material or cells, diverts people’s attention to a fundamental fact: donors are the biological fathers and mothers of these children, even if they are not legally recognized as such. It is a very strong bond, which cannot be ignored”, says Lenise Garcia, PhD in microbiology and president of the Brazil Without Abortion Movement.

The researchers identified a network of agents that guarantees access to clinics, often taking advantage of loopholes in the legislation of the country of origin. The traceability of human biomaterial from Europe to Brazil is difficult, particularly in relation to eggs.

“In the case studied by us, it was clear that companies based in Spain were looking for legal loopholes to be able to carry out the process of exporting gametes, since local legislation does not allow the export of these oocytes, only their circulation throughout Europe or sending them to another company Spanish based outside their country”, says the research.

“So, as direct export from Spain is difficult, banks found legal loopholes to ship.” Spain is the first country in Europe and third in the world in assisted reproduction cycles. In the country, a woman can receive up to €1,200, more than the minimum wage, to donate eggs.

Eggs tend to be used by women who choose to have children at an older age.

Sociologist Rosana Machin, professor at the Department of Preventive Medicine at the Faculty of Medicine of the University of São Paulo (USP) and co-author of the study, describes in the publication that the importation of oocytes has been taking place, with authorization from Anvisa, since 2017, following a demand increasing by these cells. “Although the reduction in the number of children per woman of reproductive age is broad and general, women with more years of education and career progression have fewer children than desired due to difficulties in reconciling work and family, or because they seek a most appropriate time to have them.”

By delaying having children, they end up finding it difficult to get pregnant and need to have genetic material from other women. “Furthermore, there is also a growing demand from same-sex couples or single people for assisted reproduction, since the CFM resolution in 2013, which qualifies them for these treatments.”

In Brazil, there are no egg banks, although donation is allowed in three situations. Altruistic donation is when a woman undergoes extraction procedures and donates gametes anonymously. There is also shared donation, which happens when the egg recipient pays for her treatment and that of the donor, without the identity of both being revealed. In this case, the donor has her treatment financed by the recipient and, in return, gives her part of the genetic material collected. The donation of gametes by relatives up to the fourth degree is still permitted, as long as there is no consanguinity.

In none of them, in principle, can there be direct payment or compensation for the donor, even though the extraction procedure is much more laborious than for male donors. “This context has limited the availability of these cells for reproductive treatment in the country”, says Machin. The scenario ends up contributing to fertility clinics seeking genetic material in other countries and reselling it in the country.

“It seems clear to me that there is an illegal practice, not only in exports, but also in the material that comes from Brazilian donors”, reinforces Garcia. “It is clear that a person does not undergo hormonal treatment to ovulate more, and surgery to remove these eggs, simply willingly. Except in cases where there is a close relationship, it is clear that an illegal transaction is involved.” In fact, the treatment involves the use of hormones, and the collection is invasive – the patient needs to be sedated. When contacted, the CFM did not respond.

If the numbers of imports of semen and embryos fluctuated between increases and decreases from 2020 to 2023, those of eggs only grew. According to data from Anvisa, in 2020 Brazil imported 1,968 egg samples. The data – still partial – for 2023 points to 2,789, a considerable increase of 41%. It is worth remembering that the period included the Covid-19 pandemic, which, in addition to harming several services, left the scenario unfavorable for those planning a pregnancy through assisted reproduction.

In February 2023, Anvisa put into effect an update to the instructions on the process of importing germ cells and tissues and human embryos, which dated back to 2011. The document details the practices considered ideal for importation. The standard created the role of importing companies, which must be authorized by the Brazilian health authority. Previously, the individual import model was applied, patient by patient. The change came into force in August this year and, at the moment, only one company is authorized to import material.

In October, Criobrasil Serviços Ltda was authorized by Anvisa to import, transport and distribute human germ cells, tissues and embryos in Brazilian territory. Other companies have requested the license and their applications are under analysis, according to the agency.

“It is necessary to prove that the importing company has the competence, responsibility and technical infrastructure to guarantee that the process will be carried out with quality and safety”, informed Anvisa, via press office. “Anvisa requests that companies responsible for importing semen and eggs strictly comply with quality and safety standards. This process includes sample selection and testing, standardization of processing, and appropriate transportation and distribution.”

CFM resolution does not consider ethical issues

Anvisa’s National Embryo Production System (SisEmbrio) monitors the number of clinics operating in Brazil, as well as indicators regarding in vitro fertilization in the country. The most recent survey, from August 2022, indicates that there are currently 175 clinics in the country, 33 in São Paulo, 12 in Rio de Janeiro, 11 in Belo Horizonte, 10 in Porto Alegre and eight in Curitiba. In 2022, there were a total of 284,232 frozen embryos in the country, 67.2% of them in the Southeast Region.

Lenise Garcia considers that the CFM’s latest resolution does not consider other serious ethical issues. “In this resolution, the CFM begins to accept a completely unethical practice, which is the exchange of eggs from poorer people at the fertilization clinic instead of paying for their own fertilization treatment. In other words, a person who has resources pays for the treatment of a poorer person, with eggs in good condition, in exchange for a few of those eggs. It’s completely unethical barter,” she assesses.

Lenise Garcia argues that Brazil urgently needs specific legislation for the practice – a law that takes into account the ethical issues of assisted reproduction, according to her. However, as it is a controversial topic, the bills currently being processed in Congress do not make considerable progress.