Abstract
This chapter is aimed at providing the reader with an overview of the phenomenological complexity created by Gene Therapy and Germline Cell Research that has revolutionized bioethical and biojuridical debate. To achieve this goal, this chapter opens with a brief introduction to the technical highlights of Gene Therapy and Germline Cell Research and the different applications that are possible today, especially considering the innovations arising from CRISPR/Cas9 tool. The chapter continues with some reflections on the very concept of therapy, questioning the classic dichotomy between therapeutic and non-therapeutic purposes, and with an analysis of the most common bioethical and biojuridical arguments. Having established certain technical-scientific and epistemological bases, this work is intended to illustrate the complexity of ethical and social implications of Gene Therapy and Germline Cell Research and the many values involved, leading the reader to meditate on how not only diseases imply risks for humankind, but also new health’s devices.
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Notes
- 1.
Although in this work our field of reflection is limited to the applications of genetic engineering in humans, it must be emphasized that these techniques are also used in non-human organisms. Moreover, the main field of application of these is agriculture, specifically in the production of genetically modified organisms (GMOs) using recombinant DNA techniques (Fukuyama, 2002: 72).
- 2.
More specifically, CRISPR individualizes the area of DNA to be cut, interposes between the two helixes and separates them: this is when Cas9 comes into action by cutting both layers in the exact position indicated by the RNA molecule. This DNA rupture triggers the activation of cellular repair mechanisms that scientists can use to modify the desired DNA zone by deactivating the defective gene that is achieved by aggregation or subtraction of genetic material (Baylis, 2019: 51, 52).
- 3.
The use of the adjective “significant” is not casual: as highlighted by the Royal Swedish Academy of Sciences in its historical reconstruction (2020: 1), the first studies (although merely descriptive) on CRISPR in the genome of bacteria are due to a group of Japanese scientists (Ishino et al., 1987: 5429–5433).
- 4.
Until the operation carried out in November 2018 by the Chinese geneticist He Jiankui, which will be discussed below, all the experiments had been performed without implanting in utero the embryos whose genetic heritage had been modified. The two most relevant studies of germ genomic editing in embryos are that of the working group led by the Chinese geneticist Zhang, whose results have been only discrete (Zhang et al., 2014: 40–46; Liang et al., 2015: 363–372) and the most recent, and with better results, carried out by the Oregon Health and Science University working group that has attempted to correct a genetic predisposition to contracting an inherited heart disease (Ma et al., 2017: 413–419).
- 5.
Off-target modification means an unwanted and unpredictable mutation of the genome of the individual or the embryo to which the technique is addressed (Baylis, 2019: 22).
- 6.
It is worth qualifying a circumstance that, although it may seem obvious, is often lost in the reconstructions of specialized literature. In order for a genomic modification carried out in the germline of an embryo to be effectively transmitted to future generations, it is necessary for the embryo to be implanted in utero (De Miguel Beriain et al., 2019: 109).
- 7.
As the members of the German Bioethics Committee stated in their recent report on genomic editing, the current state of the art does not allow the reversibility of the germ modification directly in its recipient, but, theoretically, if in its future generations: For this, it would be “enough” to modify the embryo again in its early stages of development to “undo” the modification made in its progenitor during its embryonic development (Deutsche Ethikrat, 2019: 10).
- 8.
In addition to the ability to cure monogenic diseases, referring in terms of prevention and not strictly therapeutic, it is essential to stress that germline editing also provides the possibility of modifying the human genome so that it is presented as less predisposed to contracting certain polygenic pathologies, including some form of cancer and diabetes (Ranisch, 2020: 64). As important doctrine emphasizes, this goal is unattainable for PGD techniques for several reasons: in addition to being limited to the number of embryos produced and the genetic characteristics of the parents, embryo selection does not exclude the possibility that genetic weakness in the face of some pathologies will be transmitted to future generations (Savulescu et al., 2015: 476).
- 9.
It should be noted that, as highlighted more than 10 years ago by the renowned Italian immunologist Lucia Lopalco, not all HIV variants penetrate the body through the protein encoded by CCR5 (Lopalco, 2010: 547–600).
- 10.
In fact, the spread of the news of the genomic edition made by He Jiankui has provoked a new shift in the scientific community that, if with the dossier of the Nuffield Council of Bioethics (2018) seemed ever closer to liberal positions, He returns with force to much more cautious positions. One example is the recent publication of a series of calls to strengthen, including legally, an international moratorium on the use of these techniques. Among the most relevant, those published in Nature in 2019 (Lander et al., 2019: 165–168; Wolinetz & Collins, 2019: 175) and the Geneva Declaration, a document prepared following an important scientific congress on the subject (Andorno et al., 2020: 351–354).
- 11.
However, it is necessary to emphasize how there are illustrious examples that have clearly differentiated genetic engineering and eugenics. Among them, Jürgen Habermas who, while expressing all his concerns towards the developments of these techniques, fruit of a liberal genetics, the differences of Nazi eugenics which, however, was the product of an authoritarian model (Habermas, 2002). Along the same lines, we also find the International Bioethics Committee, which, in its 2015 report on the tension between genetics and human rights, while taking a stance against any kind of genetic intervention for non-therapeutic purposes, stresses that the objective of empowering human beings cannot be confused with Nazi eugenic projects which, however, were aimed at eliminating certain groups of individuals (International Bioethics Committee, 2015: 27).
- 12.
Colombian Constitutional Court, Judgment C-066/2013 on “conditional exequibility” of Art. 3 of Law 361/1997, point 9.1.
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Insanguine Mingarro, F.A. (2023). Gene Therapy and Germline Cells Research. In: Valdés, E., Lecaros, J.A. (eds) Handbook of Bioethical Decisions. Volume I. Collaborative Bioethics, vol 2. Springer, Cham. https://doi.org/10.1007/978-3-031-29451-8_6
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