Current Legal Framework and Challenges of Assisted Reproductive Technologies

Current Legal Framework and Challenges of Assisted Reproductive Technologies (ART) in Romania Presented by: Dr. Emese Florian and Dr. Marius-loan Floare Date: April 14, 2025 Current State Of Romanian ART Regulations - general principles in the Civil Code - general framework for medically assisted reproduction (MAR) with third party donor - use of basic regulations for cell transplants as placeholders - detailed patient's rights rules cover informed consent, confidentiality and reproductive rights - general malpractice regulations cover both fault-based and no-fault civil liability - - no regulations on surrogacy - no detailed regulation on MAR with third-party donor - no specific and comprehensive statute on ART - very generic prohibitions in the Civil Code (eugenics, human cloning) Similarities Of Legal Status Of Children Born Out Of ART VS Naturally Conceived Children - motherhood determined by birth - paternity established by legal presumptions for married couples, acknowledgement or court decision for informal couples - equal legal status for children born/conceived to a married couple or those born to an informal couple - fatherhood determined by consent to the procedure (for MAR with third-party donor) vs determined by biological conception - veil of confidentiality limits the possibility to know details about the third-party donor vs practically unlimited right to know their origins - no possibility of a legal father if they are born from MAR with a third-party donor performed for a single woman vs always having a possible legal father Positive Extant Regulations - Detailed right to be informed and to receive a second medical opinion. - Prior consent required for all medical procedures. - Reproductive rights as fundamental patient's rights. - Ban on human cloning, genetic alterations, eugenics and sex selection. - General right to confidentiality for all patients. - Ban on financial gains for products of the human body. Challenges For Children Born Out Of ART - knowing they are the product of ART - piercing the "veil of confidentiality" - getting details about their biological ascendants in cases of MAR with third-party donors - no possibility of having a legal father (except adoption) if they are the product of MAR with a third-party donor carried out by a single woman - no limits on who the parents can be if they are a man and a woman Challenges To Surrogacy In Romania - Motherhood determined solely by the fact of birth. - Un-enforceable nature of surrogacy agreements concluded prior to birth. - Legal impossibility of voluntarily transferring parental rights to a chosen person outside simplified adoptions by the biological parent's spouse. - Maternal filiation can be challenged if the registered mother has not given birth to the child, even if the child is treated as her own. - Criminal and civil bans on financial gains from the products of the human body. Failed Attempts To Regulate MAR - 2009 project (PL-x no. 690/2009) • MAR reserved for married couples or consensual partners who could prove at least a two-year cohabitation • allowed artificial insemination, in-vitro fertilization, embryo-transfer, endogenous fertilization and reproduction with a third-party donor • banned post-mortem artificial insemination, post-mortem embryo-transfer, • interventions when infertility is due to old age, fertility interventions for couples who cannot prove a stable cohabitation • rejected in 2010 for serious technical drafting deficiencies, gaps in its rules about a sensitive topic that could lead to constitutionality issues Failed Attempts To Regulate MAR After The Civil Code Of 2011 - 2012 government project (PL-x no. 63/2012) • medical criteria for both physical and mental health were supposed to be adopted later by a Health Minister's Order • subjected a woman's access to medically assisted reproduction with a thirdparty donor to the written consent from both her and her husband • rejected in 2016 as being too vague, confusing, and as not really offering practical solutions to a delicate and important societal issue - 2013 cross-party private members' bill PL-x no. 462/2013 • allowed reproductive techniques were artificial insemination, in-vitro fertilization, and embryo-transfer • banned simultaneous transfer of embryos from different donors and using reproductive material from donors closely related to the beneficiary • age restriction for oocyte harvesting - between 18 and 45 years • embryo-transfers and artificial insemination only for women between 18 and 50 years of age • ten-year time limit for embryo and gametes storage • rejected in 2022 for being too vague, lacking enforcement sanctions, being elliptically written and for not offering practical solutions De Lege Ferenda Suggestions - enact a general statute for all types of ART - detailed statute for MAR with third-party donor - possibly allow for gestational altruistic surrogacy in well-defined cases - explicitly ban paid surrogacy - define which couples can require ART besides married couples - better define civil liability for ART situations - define the parent's rights over unused embryos