Emese Florian, Marius Floare: Current Regulations Pertaining to Assisted Reproduction Technologies (ART)

13 December 2024 – Budapest

On 13 December 2024, at 16:00 C.E.T., we have organised a webinar-type dissemination event for the “Assisted Reproduction Technologies” project of the Central European Academy’s Central European Professors’ Network in Budapest. The attendees were law students from Babes-Bolyai University in Cluj-Napoca, Romania, and practicing lawyers from the Cluj County Bar Association in Romania.

There was one presentation given in PowerPoint format, drafted jointly by Professor Emese Florian, Ph.D., and Assistant Professor Marius Floare, Ph.D., read by Assistant Professor Marius Floare. Attorney Patricia Floare from the Cluj County Bar Association also intervened during the follow up discussions.

After the GDPR notice and the initial greetings from Professor Emese Florian and introductory remarks about the scope of the project, the presentation started, jointly drawn up by Professor Emese Florian and Assistant Professor Marius Floare, was titled “Current Regulations Pertaining to Assisted Reproduction Technologies”. Assistant Professor Floare gave the presentation.

The first part of the presentation concerned the extant regulations in Romanian law that are relevant to assisted reproduction. The Civil Code, which came into force in 2011, has a section concerning the respect owed to the human being and their inherent rights, comprising articles 58 to 69, but also a dedicated section to medically assisted reproduction (MAR) with a third-party donor, comprising articles 441 to 447. There is also a special Law on Patients’ Rights, number 46 of 2003, and a general Law on Healthcare Reform, number 95 of 2006, which includes Title VI on transplants, articles 141 to 161, and Title XVI on civil liability of medical personnel and healthcare providers, articles 653 to 692. Lower-level regulations pertinent to ART include the joint Work and Social Solidarity Minister’s and Family, Youth, and Equal Opportunities Minister’s Order number 2155/20917/2022 on the Regulations concerning the implementation of the social national interest programme of supporting couples and single people for increasing childbirths, Annex number 30 of the Health Minister’s Order number 1241/2019, regarding the approval of official guides for gynaecology and obstetrics, and Health Minister’s Order number 1527/2014 on transplants.

The presentation then tried to identify the manifest deficiencies of the legal framework on ART, which are the lack of a detailed regulation on medically assisted reproduction (MAR) with third-party donors, the complete absence of regulations on surrogacy, the lack of a specific and comprehensive statute on ART in general, and the very generic prohibitions included in the Civil Code, which only mentions eugenics and human cloning in general terms.

After identifying the deficiencies of the current Romanian ART legal framework, the presentation looked at the brighter side and brought forward the positive regulations that are in force: the existence of a detailed right to be informed and to receive a second medical opinion, as part of general patients’ rights; the requirement of prior informed consent for all medical procedures; the regulation of reproductive rights as fundamental patient’s rights; the explicit Civil Code ban on human cloning, genetic alterations, eugenics, and sex selection; the general right to confidentiality for all patients; and the ban on financial gains for products of the human body.

The presenter then delved into the Civil Code regulation on medically assisted reproduction with a third-party donor. These include the absence of filiation with the third-party donor, the fact that the third-party donor can be either male or female, and that motherhood continues to be determined solely by birth, as for natural filiation. Unlike natural reproduction, fatherhood is determined by the prior consent of a man to medically assisted reproduction with a third-party donor. The parents in medically assisted reproduction with a third-party donor can be either a single woman or a man and a woman, irrespective of marital or relationship status. The future parents must express their prior informed consent to the procedure by in notarised form. The parents can revoke consent until conception, but it also becomes ineffective in case of the death of one of the parents, either of them filing for divorce, or their intervening separation before conception. 

Afterwards, the presenter talked about the legal deficiencies in Romanian law regarding medically assisted reproduction with a third-party donor. First, legal doctrine claimed that the law does not define the relationship status of the intended parents, which leaves open the possibility of parenting outside marriage, having related parents, and parents not in a relationship. Second, if the intended father who consented to the procedure is not a biological father, he cannot challenge the paternity of the mother’s husband or former husband. Third, the confidentiality of the procedure clashes with the child’s right to know their origin.

Another topic related to ART is about its public funding, more specifically the legal requirements for receiving public funds for any ART procedures. couples with a medical recommendation form IVF with embryo transfer. In Romania, you can receive public funds for in vitro fertilisation with embryo transfer if the following conditions are met: both members of the reproductive couple must have public health insurance; only biological material from the couple must be used, explicitly excluding both third-party donations and surrogacy; the woman must be between 24 and 40 years old; the woman must have a body mass index (BMI) between 20 and 25,

the ovarian reserve must be within normal limits, with the anti-Müllerian hormone value higher than 1.1 ng/ml.

The most controversial topic regarding ART in Romania concerns surrogacy. Although the law does not explicitly ban it, other regulations make it impossible in its standard form. Motherhood in Romania is determined solely by the fact of birth. Any type of surrogacy agreement concluded prior to birth is unenforceable due to its object. In Romania, there is a legal impossibility of voluntarily transferring parental rights to a chosen person, outside the simplified adoptions by the biological parent’s spouse. Any interested party can always challenge maternal filiation if the registered mother has not given birth to the child, even if she treats the child as her own. There are several criminal and civil bans on financial gains from the products of the human body.

In the last fifteen years, there have been three attempts to regulate ART, especially medically assisted reproduction with a third-party donor. The 2009 law project PL-x number 690/2009 was restricting medically assisted reproduction to married couples or consensual partners who could prove at least a two-year cohabitation. It allowed artificial insemination, in vitro fertilisation, embryo transfer, endogenous fertilisation, and reproduction with a third-party donor. It also banned post-mortem artificial insemination, post-mortem embryo transfer, interventions when infertility is due to old age, and fertility interventions for couples who cannot prove stable cohabitation. Parliament rejected this project in 2010 for serious technical drafting deficiencies, reported gaps in its rules about a sensitive topic that could further lead to constitutionality issues.

After the Civil Code came into force in 2011, there were two attempts at regulating ART. The first was the 2012 government law project number 63/2012. This project provided that the medical criteria for both physical and mental health for ART were supposed to be adopted later by a Health Minister’s Order. It also controversially subjected a woman’s access to medically assisted reproduction with a third-party donor to the written consent from both her and her husband. Parliament rejected this project in 2016 as being too vague, confusing, and not really offering practical solutions to a delicate and important societal issue.

The last failed law project about ART was the 2013 cross-party private members’ bill number 462/2013. It allowed the reproductive techniques of artificial insemination, in vitro fertilisation, and embryo transfer. It also banned the simultaneous transfer of embryos from different donors and using reproductive material from donors closely related to the beneficiary. There was an age restriction for oocyte harvesting, between 18 and 45 years, and it allowed embryo transfers and artificial insemination only for women between 18 and 50 years of age. It stipulated a ten-year time limit for embryo and gamete storage. This project was finally rejected in 2022 for being too vague, for lacking enforcement sanctions, and for being elliptically written, while also not offering enough practical solutions to the issues of ART.  

The presenter concluded with de lege ferenda suggestions for ART. Romania should enact a general statute for all types of ART and a detailed statute for MAR with a third-party donor, as stipulated by the Civil Code. It should consider allowing for gestational altruistic surrogacy in well-defined cases while also explicitly banning paid surrogacy. The future ART statute should clearly define which couples can require ART besides married couples, better define civil liability for ART situations, and precisely define the parent’s rights over unused embryos. Participants also discussed ECHR case law, especially the rights to decide about the fate of embryos as a derivative of the mother’s right to private life.

            Following the presentation, one of the participants asked about a practical case in which Romanian parents paid for surrogacy in Ukraine, using their own gametes, and how can they get their parenthood recognised in Romania, besides simplified adoption by the intended mother and paternity acknowledgement from the biological and intended father. The answer was that the child, at birth, is subject to Ukrainian law due to their birth mother, and if Ukrainian law allows for the transfer of parenthood to the intended parents, their Ukrainian birth certificate recognises them as parents, and it needs only to be registered by the parents in Romania. Assistant Professor Marius Floare also referenced the famous ECHR case against France, where the Court found France to have violated the children’s rights under Article 8 by not recognising the American birth certificate. Similarly, Romanian authorities would either ignore the fact that the child was born because of surrogacy, if the foreign birth certificate does not mention it, or the ECHR case law would compel them to recognise factual parenthood because of the child’s right to family life under Article 8 of the ECHR.

            Another topic of discussion was whether Romanian parents could benefit from the legislation of other countries in matters of ART. This topic is relevant even for MAR with a third-party donor, which the Civil Code explicitly allows but Romanian law does not fully regulate. Parents might want to avoid the uncertainties of Romanian law and perform this procedure abroad.

           The discussions also led to the probability of extant surrogacies in Romania, probably registering the child by fraud using the procedure of late birth registration, which involves DNA testing that could certify the child’s genetic link to the intended mother, without proving that she was the one who gave birth.

            The participants also discussed Romanian case law about the recognition of surrogacy, where some courts fully recognised the effects of surrogacy, while others refused to recognise the motherhood of the woman who did not give birth, even treating her as some kind of third-party donor in an isolated case. The Supreme Court has not intervened in the matter.

            Concluding the online seminar, the participants expressed hope that the newly elected Parliament will adopt a future ART statute, solving the pending legal issues of fertility treatments. Romanian society does not have enough children, not even the number people genuinely want, and better legislation and more financing can also partially solve the demographic crisis.

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