Sunday 26. September 2021
#194 - June 2016

Crossing a Rubicon?

Gene editing under the scrutiny of the European Union.

Brexit is not the only concern recently reaching Europe from the other side of the English Channel: in the beginning of the current year, in the field of bioethics, the Human Fertilization and Embryology Authority of the United Kingdom has granted an authorization to the genetic modification of human embryos created through in vitro fertilization.


The controversy of this matter reaches beyond the UK. In the European Union, a dedicated Statement on the issue was released by the EGE – the European Group on Ethics in Science and the New Technologies, an independent advisory body of the President of the European Commission on ethical aspects related to these fields in connection with EU legislation or policies.


Genetic modifications may be effected either on somatic cells or germ (reproductive) cells, in this latter case being transmitted to any potential offspring. Distinction can also be made between modifications for research purposes and for reproductive purposes. Moreover, these interventions may also be differentiated according to the aim pursued, which can ultimately be either therapeutic or for human enhancement. The Secretariat of COMECE has already published an Opinion on human enhancement, an aim commonly linked to movements such as the so-called transhumanism or post humanism.


Irrespectively of the type of genetic modification of human embryos, these kind of interventions, for a start, raise two important concerns: first, these procedures are applied on embryos created through in vitro fertilization, with all the ethical issues linked to such techniques and thoroughly explained in magisterial documents such as Donum Vitae (1987) and Dignitas Personae (2008) for example; second, for their development and improvement, they imply a kind of research with embryos that entails their destruction.


The purpose of the research in the current British case is to best understand the process of development of a healthy human embryo in order to ameliorate the efficacy of the techniques of in vitro fertilization themselves. By best knowing the genes which interfere with or which hinder the development of the embryo, provoking miscarriages for example, one could in principle ‘correct’ or ‘turn off’ the defective genes, which would consist indeed of a true therapy. In practice, however – and this is how PGD (preimplantation genetic diagnosis) works – this knowledge allows the selection for implantation of the healthy embryos and the discard of the embryos with the defective genes, which raises further ethical concerns.


In any case, genetic interventions may provoke unexpected mutations in other parts of the genome, including mutations that can be transmitted to any potential offspring. With this regard, Dignitas Personae is clear in stating that “because the risks connected to any genetic manipulation are considerable and as yet not fully controllable, in the present state of research, it is not morally permissible to act in a way that may cause possible harm to the resulting progeny”. This precaution is also shared by the Convention on Human Rights and Biomedicine (Convention of Oviedo) and reflected in its Article 13.


The concerns of the EGE

In its Statement, the EGE cautions against reducing the debate to safety issues and the potential health risks or health benefits of gene editing technologies. Other ethical principles such as human dignity, justice, equity, proportionality and autonomy are clearly at stake and should be part of this necessary reflection towards the international governance of gene editing”.


The advisory Group is interested not only on human but also in non-human applications of gene editing techniques. In this regard, it is worth underline how strong, in the European society, have been the reactions to genetically modified non-human organisms.


In any case, the members of the Group did not reach a consensus regarding the ethical assessment of human germline gene modification for reproductive purposes: some of them considered that it cannot be ethically justified, calling for upholding the prohibition laid down in Article 3 of the European Charter of Fundamental Rights. Moreover, some members, owing to the “blurring lines between basic and applied research”, call also “for a moratorium on any basic research involving human germline gene modification until the regulatory framework is adjusted to the new possibilities”, whereas for other members of the EGE “there may be positions worth considering which would justify continued research”.


The Statement concludes urging the European Commission to take it as a priority to request a broader opinion on the “inextricably linked ethical, scientific and regulatory issues pertaining to germline and somatic cell gene modification”.


 José Ramos-Ascensão


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Note: The views expressed in europeinfos are those of the authors and do not necessarily represent the position of the Jesuit European Office and COMECE.