Error of judgment

Journal name:
Nature
Volume:
480,
Pages:
291–292
Date published:
DOI:
doi:10.1038/480291b
Published online

The European Court of Justice was wrong to weigh in on the definition of a human embryo.

The question of when a formless clump of developing cells can truly be said to become a human will never have a clear answer. It depends on whom you ask: biologists, theologians, and pro-life and pro-choice campaigners have all wrestled with the concept for years. Regulations that cover the relevant scientific fields and issues should take all these conflicting views into account. Not everybody will be happy with the outcome, but, by definition, not everybody can be.

In October, the European Court of Justice (ECJ) took on the question. And rather than tip-toeing around the sensitivities, the judges of the court — the highest in Europe — trampled right through them. The ECJ had been asked by the German Supreme Court to clarify ambiguous wording in the European Union (EU) directive on the Legal Protection of Biotechnological Inventions, which bans patents on procedures that use human embryos. The ECJ responded with a clumsy ruling that outlaws patents involving stem cells derived from such embryos and, some critics say, raises questions about future research into regenerative medicine (see page 310). In doing so, the court effectively stepped over the line that separates the interpretation of law, which is its responsibility, from the creation of law, which is the job of parliaments and governments.

“The ruling left many scientists, judges and legal experts in EU member states fuming.”

For the most part, the ECJ does a faultless job. This time, however, it exceeded its competence. In the case under consideration, Greenpeace had claimed that the existing directive should outlaw a patent relying on human embryonic stem cells that had been taken out by Oliver Brüstle, director of the Institute of Reconstructive Neurobiology in Bonn, Germany. But are human embryonic stem cells equivalent to human embryos in this context? The German Supreme Court, which was handling the Greenpeace complaint, passed the question up to the ECJ.

Unfortunately, the ECJ chose not to confine its analysis to the patent context, but took it upon itself to define the term 'human embryo' generally (and in the broadest possible way), and to assess the surrounding moral environment. A human embryo, it said, comprises an ovum activated to divide by fertilization or any artificial means. Moreover, it added, any research involving human embryonic stem-cell lines is immoral, because such cell lines are originally derived from fertilized eggs.

The ruling left many scientists, judges and legal experts in Germany and other EU member states fuming. Not only because the court had issued a de facto legal definition of a human embryo, but because it had done so with shoddy reasoning and without appropriate legal references. In the case of ambiguous law, a court should go back and ponder the intention of the law-makers. From its brief justification in Brüstle v. Greenpeace, the ECJ seems not to have done that.

The ECJ is made up of judges from each EU member state, and critics argue that it simply does not have the technical expertise to deal with issues such as patenting, or stem cells. Yet the court is not held to account by any external watchdog, and its decisions cannot be appealed.

Last week, an alliance of ten major German research organizations, including the German Research Foundation (DFG, the country's national granting agency), the University Rectors Conference and the Max Planck Society, put out a statement condemning the decision. But the damage has been done. Battle lines have already been drawn in the European Parliament, with those opposed to research with human embryonic stem cells calling for funds to be frozen.

The only obvious route out of the confusion created by the ECJ is for the real law-makers — the European Parliament and the Council of the European Union — to amend the ambiguous EU directive that caused all the trouble. They should tighten its loose language on the legal definition of a human embryo in terms of patenting, so that the law reflects what the lawmakers originally intended. This will take courage (and time — the original directive was a decade in the works) but, as the ECJ ruling shows, for all its sensitivities, this is not a subject on which it pays to be vague.

Comments

  1. Report this comment #34038

    Fernando A. Verdú Pascual said:

    Fernando Verdu, Francesc Frances, Ana Castello. University of Valencia. Spain

    ?The question of when a formless clump of developing cells can truly be said to become a human will never have a clear answer. It depends on whom you ask: biologists, theologians, and pro-life and pro-choice campaigners have all wrestled with the concept for years?, we can read in this Editorial.

    The undeniable fact is that the author or authors of the Editorial come from a formless clump of developing cells, which has not impeded its development.

    There are undeniable things: to be born a person, takes two zygotes. When two zygotes fuse, if all goes naturally, without external interference, then a person will born.

  2. Report this comment #34042

    Jed Goldstone said:

    A large percentage of fertilized ova/developing embryos/two fused zygotes do not implant into the human uterine wall, and thus do not progress towards viability outside the human womb. Until we can know all of the factors that determine the fate of a 2-cell embryo we cannot say that it will become a human being if left alone. Hence the current inability of anyone to reasonably determine when an activated, fertilized, dividing ovum should be protected.

  3. Report this comment #34047

    Ian Brooks said:

    "There are undeniable things: to be born a person, takes two zygotes. When two zygotes fuse, if all goes naturally, without external interference, then a person will born."

    There are undeniable things – you know nothing about developmental biology, nor the definition of 'zygote'.

  4. Report this comment #34108

    Jeremy Green said:

    Agreeing with Ian Brooks, it is ironic that previous comments refer to the fusion of two zygotes making a person. A zygote is a fertilised egg, so this fusion – according to most Catholics – would be the fusion of two souls. It is biologically possible (many humans are chimeras – fusions of two zygotes – unknown to themselves) but, if I'm not mistaken, theologically impossible (Doctrine of the Unity of the Soul). The same problem arises with zygote splitting – the mechanism by which identical twins are made. Go figure.

    They meant the fusion of two gametes. (The comment from Valencia is flawed in other ways: so what if the cells can give rise to a human – we're also made of atoms and molecules, but that doesn't mean we accord atoms and molecules the legal and moral status and dignity of individual people.)

  5. Report this comment #34110

    T Andrews said:

    "There are undeniable things: to be born a person, takes two [gametes]."
    FALSE:
    Identical twins arise from a single zygote (2 gametes) so the second twin did not require any gametes to come into existence. Theoretically iPS or placental stem cells could be manipulated to produce a person (no gametes involved). Theoretically a human clone could be produced using a single gamete and a somatic cell. Although I see not need nor desire to develop the technology to do so it is theoretically possible.

    "When two [gametes] fuse, if all goes naturally, without external interference, then a person will born."
    FALSE:
    if the gametes fuse in a test tube/petri plate they will certainly die without external interference, never will a person be born. Many zygotes fail to implant naturally and thus die. Many zygotes that even implant successfully spontaneously (naturally) abort and die. Even those that come to full term some are naturally stillborn (died before birth).

  6. Report this comment #34119

    Greg Becker said:

    "The ECJ is made up of judges from each EU member state, and critics argue that it simply does not have the technical expertise to deal with issues such as patenting, or stem cells."

    Frankly, if a student wrote that in a paper – he/she would be asked to reveal his/her references; otherwise it keeps hearsay based on gossip or the private opinion of the author(s)- or is it maybe an unauthorized quotation from Prof. Brüstle? I am surprised to find something like that here....

    The issue itself has – of course – lead to numerous statements on the court decision, especially here in Europe. However, it keeps difficult to understand why some call the decision ?surprising?: the respective EU regulations are pretty clear, and so is the decision!

    It is also remarkable that suddenly Science raises its voice, whereas for years it kept silent so strictly in the ethical discussions on hESC! Science shall not get in such topics AFTER debatable decisions have been made, but when it is about ?in-house? ethics and when it is about establishing rules and regulations!
    Grumbling afterwards is not just pointless in this case, but indicates once again that Science is notoriously tardy when it comes to ethics; but maybe it is even different, as the German saying goes: Instead of complaining about what one has failed to get, one shall be grateful for not receiving what one deserves to get. (Anstatt sich zu beschweren, nicht das zu bekommen was man sich wünscht, sollte man dankbar sein nicht das zu bekommen, was man verdient.)
    PS- I like very much the ?atom-statement? of Mr. Jeremy Green!

  7. Report this comment #34153

    frederick walz said:

    The scientific naivete of Error of Judgment is manifest in sentence 1 which reads: The question of when a formless clump of developing cells can truly be said to become a human will never have a clear answer. Why is the progression from zygote to blastocyst referred to as a formless clump when these cells and their aggregations shows clear structure? An organism composed and subtly guided by unique human DNA develops but what are developing cells? Ethical vacuity characterizes of the second and third sentences: It depends on who you ask: biologists, theologians, and pro-life and pro-choice campaigners have all wrestled with the concept for years. Regulations that cover the relevant scientific fields and issues should take all of these conflicting views into account. (Truth is arrived at by consensus?) This is not the stuff of sincere and trenchant inquiry unless you do not subscribe to the notion of truth. It should be obvious that science aims to describe truth as it pertains to physical reality and is able to determine pertinent aspects of early human development. At this time, it is scientifically clear that development, starting with the zygote, involves a human organism that is intrinsically self-directing even procuring an appropriate location in the womb for the provision of nutrition and a supportive physical environment. Large adult human beings who have power over small in utero members of their species may not value them but this conclusion does not diminish the biological truth that the latter are independent human beings. We should acknowledge that if we reverse our own biological clock we encounter the truth that we all first existed as a zygote.

    Frederick Walz

  8. Report this comment #34244

    Dianne Irving said:

    "A formless clump of developing cells"? There is a difference between "cells" and "organisms". Scientists should be precise and respect these facts known for over 125 years, institutionalized in 1942, and updated since then to the present: ?Embryonic life commences with fertilization, and hence the beginning of that process may be taken as the point de depart of stage 1. Despite the small size and weight of the organism at fertilization, the embryo is ?schon ein individual-spezifischer Mensch? [definitely and specifically a human person] (Blechschmidt, 1972). ... Fertilization is the procession of events that begins when a spermatozoon makes contact with an oocyte or its investments and ends with the intermingling of maternal and paternal chromosomes at metaphase of the first mitotic division of the zygote (Brackett et al, 1972). ... Fertilization, which takes place normally in the ampulla of the uterine tube i.e., fallopian tube ? not the uterus], includes (a) contact of spermatozoa with the zona pellucida of an oocyte, penetration of one or more spermatozoa through the zona pellucida and the ooplasm, swelling of the spermatozoal head and extrusion of the second polar body, (b) the formation of the male and female pronuclei, and (c) the beginning of the first mitotic division, or cleavage, of the zygote. ... The three phases (a, b, and c) referred to above will be included here under stage 1, the characteristic feature of which is unicellularity. [Carnegie Stages of Early Human Embryonic Development, Stage One, at: http://nmhm.washingtondc.museum/collections/hdac/stage1.pdf] -

  9. Report this comment #34297

    Tadeusz Wasiutynski said:

    I was very much surprised reading the Editorial text in the journal that pretends to be leading in the world science. From the very first sentence (e.g formless clump of developing cells) it makes impression of ideologically driven rather than science oriented. We teach students that the main goal of scientific activity is search for the truth. In the second sentence of Editorial it is suggested that the truth is something relative. If the unsigned author of the above text does not know what is the truth than should accept the most restrictive one. Otherwise there will be always somebody claiming that even developed cells with genetic defect is not human being.

  10. Report this comment #34763

    Jase Stewart said:

    I find it interesting that most posters here point out that the defining underlying issue is the nexus between conception and live birth. If one presupposes that the fusion of gametes is conception then IVF is immoral in the sense that some, if not most, of these entities will never be implanted. Why? Because it can be likened to indefinite imprisonment, or if these entities are destroyed homicide. But, this is as mysterious as it is illogical. In no charitable interpretation can one say that a zygote could ever develop into a full moral person unless implanted into a womb, save technological innovations. So, is it a partial moral being when this entity successfully beds in womb? This of course is the central theme in the potentiality argument that the U.S. Supreme Court referred to in Roe v. Wade and that Joel Feinberg discusses. So, perhaps there should be a clear contextual demarcation between the likelihood of a zygote actually becoming a moral person and those that are not intended for the purpose of seeking parenthood. Beyond this point, I find the argument to be nothing more than semantics when trying to suggest that in one instance the unborn is not a life, even a potential life, but analogous to some invasive "thing" in a woman's body that, at her pleasure, can terminate. Yet, no Court that has been petitioned that I'm aware of, would grant a man the same property rights over the unborn if they wanted to 1) have the baby, or 2) terminate the baby. Moreover, these Courts impose parental responsibility upon these men even when they do not want the child to be born. So, the Court in its wisdom has clearly articulated that the nexus between zygote and full moral person is unbroken. To wit, a zygote in this context deserves the full protection of law as a moral person with rights, albeit at the woman's pleasure (see McCulley "The Male Abortion: The Putative Father's Right to Terminate His Interests in and Obligations to the Unborn Child," 1998). The relevance here is, and to get to the point: it is nothing more than a legal fiction for the Court to call zygotes one thing for research and then another thing when imposing support. Decide what the thing is and stick to it, imposing the same standard for all and upholding equal rights. This issue is not linear, as purported, it is complex and requires deeper analysis that goes beyond prima facie issues. some commented that the role of science is to approach truth. Some philosophers would disagree with that representation of the role or purpose of science. Kuhn for example would charge you with paradigmatic perception that suits your axiological interpretation, others (anti-realists) would say that there is never enough evidence to say that we have attained truth and that there is as much evidence for at least one competing theory; what you claim to be truth is nothing more than entrenched belief. So, round and round we go. Realists on the other hand would say that their theory is sucessful if it refers to entities that exist and that we can manipulate said entities; this means that we must understand within the context of the theory what the entity is and how it works. Applying the Realist standard – a zygote will become a full moral person when supported by a woman's womb, save unforeseen complications.

  11. Report this comment #69685

    Matt Davidson said:

    I agree it is remarkable that suddenly science raises its voice, whereas for years it kept silent so strictly in the ethical discussions on this. Science shall not get in such topics after debatable decisions have been made, but when it is about ?in-house? ethics and when it is about establishing rules and regulations! I do support these kinds of reviews

    And yes, grumbling afterwards is not just pointless in this case, but indicates once again that Science is notoriously tardy when it comes to ethics; but maybe it is even different, as the German saying goes: Instead of complaining about what one has failed to get, one shall be grateful for not receiving what one deserves to get.

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