Investigación biomédica con preembriones humanos en proceso de reproducción asistida. Una propuesta de lineamientos legislativos sobre los principios y derechos mínimos involucrados

Abstract

This master's thesis aims to analyze the legal treatment that has been given to research processes with human pre-embryos left over from assisted reproduction processes in Colombia. To fulfill this purpose, we started from the premise of an absence of specific regulations in the country that indicate the legal treatment in relation to human pre-embryos left over from assisted fertilization processes. On the other hand, once the corresponding databases were reviewed, it was verified that there is no law or relevant jurisprudential pronouncement that sets the standard on the legal situation of surplus pre-embryos from assisted reproduction processes or the use that should be given to them. to embryonic stem cells (Santamaría-Rodríguez and Vásquez-Cardona, 2007). The situation raised shows the relevance of this work, which is part of the interest in making a comprehensive legal analysis that includes the identification of the main international instruments, the study of the internal regulations of other countries on the use of pre-embryos and/or embryos in assisted reproduction processes, the pronouncements of the Constitutional Court and the contribution from the academic perspective. In addition to these legal elements, the framework of notions and theories that are part of the project is taken into account, such as assisted reproduction processes, pre-embryos and human embryos left over from said processes, since it allows a broader view of how These concepts and the divergences presented for their construction have been developed. The scope of this research is exploratory qualitative, since the information collected from documentary sources was analyzed. For this, the following conceptual categories were selected: (i) pre-embryo as genetic material; (ii) treatment of pre-embryos; (iii) scientific experimentation; (iv) the internal legal system of Colombia; (v) self-determination that implies the protection of sexual and reproductive rights; (vi) the international regulatory framework on the matter (vii) consent to donation of surplus pre-embryos for research purposes and (viii) the right to access, scientific progress and the benefits that these practices entail. Based on these issues, from a technical and ethical point of view, this academic work provides relevant information regarding the need to legally regulate the use of the pre-embryo that decides not to keep it. Thus, it begins with the justification of the analysis from two aspects, namely, its practical implication, since it highlights the importance of beginning to legislate on the scientific convenience of investigating assisted reproduction processes and pre-embryos leftovers in the mentioned processes; and the theoretical value of creating scientific knowledge about embryos and their fertilization processes. Bearing this in mind, we analyze whether pre-embryos from assisted human reproduction techniques (ART) can be considered genetic material, based on the premise that they come from a clinical process that arises from the union of male and female gametes to then be cryopreserved or implanted into the uterus (Jadur et al., 2010). It is necessary to differentiate the terms pre-embryo and embryo, since in practice they are used in a unified manner. On the one hand, it is understood that the pre-embryo is the biological material that is the product of a process in a laboratory and that has not been implanted; while the embryo is the product of the "nesting" of the pre-embryo in the uterus, so it will eventually become human (Jadur et al., 2010). Subsequently, the concept of Embryonic Stem Cells (ESC) and the importance of having a regulatory legal regime are theoretically addressed. Likewise, the international and national regulations that support the scarce regulation on the subject are explained. The concepts of biomedicine and biotechnology are also worked on, supported by a normative and doctrinal framework; Finally, the figure of Soft Law and its impact on the academic discussion that arises in this research is exposed, based on the premise that the rules of Soft Law can be introduced into internal legal systems. Finally, some minimum standards that should be considered are suggested, which are related to the possibility of proposing a legislative initiative in Colombia against scientific research with human pre-embryos in assisted reproduction processes and the conclusions of the subject are presented.