On Wednesday, 13 September, a proposal from the European Parliament on the regulation of “substances of human origin” (SoHO) was approved.

The initiative aims to establish a legal framework for action with all those substances derived from human beings that are used in therapeutic or research procedures, such as regenerative therapies, assisted reproduction, and others. These substances include those containing cells or not, living or not, excluding from this consideration organs used in transplantation, as defined in Article 3(h) of Directive 2010/53/EU.

In principle, regulation on the procurement, processing, storage and use of these substances seems to be a necessary measure to establish sufficient guarantees on their use: first, by regulating the procedures related to their selection and procurement; second, by ensuring respect for dignity in the treatment of the donors of these substances; third, by specifying the suitability of the uses of these substances and their fair distribution; and, fourth, by establishing protocols for monitoring their safety and efficacy after use to optimize the processes implemented.

Bioethical dilemmas

The difficulties in this process arise when human embryos themselves or the cells derived from their destruction are tacitly included among these substances.

Confusing an SoHO with an embryo can only be the result of profound scientific ignorance or bad faith, which pursues their unrestricted use.

That the human embryo is an individual of the human species from the moment of conception, that it possesses the information and potential to evolve in a “continuum” until birth if nourished and protected is undisputed scientific evidence today. The outdated pretensions of defining a pre-embryonic state in the first 14 days of their life, seeking to grant them a status different from that of a human being — established in the mid-1980s after the emergence of in vitro fertilization — have been abandoned even by their proponents in the face of the accumulation of evidence about the true nature of the embryo.

Despite this, a de facto exclusion of early embryos from their consideration as human beings has been established, depriving them of dignity and rights, opening the door to their creation, manipulation, editing, destruction or cryopreservation without limits in their first few days of life (generally the first 2 weeks), a term as arbitrary as it is unjust. The extension of free abortion until week 14 of gestation, as occurs in Spain, further extends this period without guarantees for the embryo, until the moment when no one doubts its human nature, perfectly evident in its physiognomy.

This inertia, which is widespread throughout the world and, unfortunately, in many scientists and health professionals, seems to have eliminated all scruples in the manipulation and destruction of immature human embryos, which can now be treated as mere “SoHO” and not real human beings.

There are three fundamental bioethical problems in obtaining and manipulating so-called SoHOs, which we shall now evaluate.

The first is the embryonic origin of human biological material whose procurement implies destruction of the embryo, regardless of its origin. Producing embryos to use them as experimental material, using the “surplus” embryos from in vitro fertilization that remain cryopreserved, designing new embryonic models from pluripotent cells and not from the fertilization process, as well as experimenting with human-animal chimeras to obtain organs and tissues by mixing cells from humans with those of other species, are procedures that involve the destruction of embryos or their manipulation, with the high risk that this poses in their future development.

The second is the use of biological material from induced abortions, whose promotion may justify an increase in the practice of abortions.

And the third is the need to ensure the possibility of identifying donors of gametes — SoHO — if those born by assisted reproduction techniques with gametes from donors were to demand the identification of the biological parents. The current regulation represents an opportunity to unify the criteria that allow resolution of the conflicts between the right to anonymity of donors, and that of those conceived to know their genetic origin.


The protection of human embryos, whatever their origin, and their non-use as a source of biological material involving their destruction is based, among other reasons, on the Judgment: ‘ECJ – Judgment of 18.10.2011 (Grand Chamber), in case Oliver Brustle v. Greenpeace e.V, C-34/10 – ‘Directive 94/44/EC on the legal protection of biotechnological inventions – Extraction of precursor cells from human embryonic stem cells’, which defines the human embryo as the product of the fertilization of gametes, or even as the product of cloning (transfer of the nucleus of a mature cell to a previously enucleated oocyte), from the first moment of its biological course, with no time limits or pauses.

Demanding respect for the dignity of every human being, the treatment to be accorded them and the limits of what can or cannot be done with their body or the substances derived from them is the duty of every scientist, politician and honorable person. The current regulatory process represents an excellent opportunity to do so with all human beings and all guarantees, but specifically, with the most defenseless, weak and innocent: the early and immature embryo.

Julio Tudela

Bioethics Observatory – Institute of Life Sciences

Catholic University of Valencia


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