No merchandising of the human body

“If the opinion of the Advocate General of the Court of Justice led the Court to issue a definitive and binding decision, European research would progress in the direction of ethical standards respectful of the dignity of the human person in all stages of life”. While awaiting the final decision of the Court of Justice of the European Union on the definition of human embryos, on their industrial and commercial use, and on patenting human embryonic stem cells (hESCs) Antonio G. Spagnolo, Dean of the Institute of Bioethics of the Catholic University in Rome, expressed his view in the editorial published by the international by-monthly bioethics magazine “Medicina e morale“. The Court in Luxembourg is poised to make a decision regarding the appeal filed by German researcher Oliver Brüstle to the Federal High Court of Germany (Bundesgerichtshof) after the Federal Patent Court of Germany (Bundespatentgericht), responding to a nullity claim by Greenpeace, ruled against the patent-eligibility of a procedure, developed by the German researcher, whereby “totipotent” cells are extracted by human embryonic stem cells (cf. SIR Europe n.52/2011).No patenting of embryonic stem cells. Spagnolo refers to the preliminary opinion issued past March 10 by the Advocate General of the Court Yves Bot, which confirms the “non-patenting eligibility” of embryonic stem cells. A patent is a legal title that grants to its owner temporary exclusive rights over the exploitation of a given invention, in a given period or place, in order to prevent others from manufacturing, selling or using the same invention without authorization. In Europe the subject is regulated by Directive 98/44/CE on the legal protection of biotechnological inventions, which does contains explicit reference to the recognition of patents in this area provided the respect for the fundamental principles ensuring the dignity and integrity of the human person. The Directive thus excludes from patentability inventions that are contrary to said principles. The EU Parliament refers to “the use of human embryos for industrial or commercial purposes” (Art. 6, n. 2, let. c). The present case, that has already divided the scientific community, involves this specific passage of the Directive.No to “manipulating” the human body . First of all, underlines Spagnolo, Bot claims that market competition must not take place at the cost of “sacrificing the fundamental values of the Union”. He underlines that the concept of human embryo must have a “community” understanding, which the Directive fails to make explicit mention of. To that regard the Advocate General refers to three different sources, namely: Member States’ legislation, the content of the Directive and present scientific findings. While Member States’ national legislations disagree on the definition of embryo and the Directive, whilst failing to provide a specific definition, stipulates the protection of “the human body”, “at the various stages of its formation and development”, for Bot, who refers to current scientific knowledge, “totipotent cells represent the first stage of the human body which they will become. They must therefore be legally categorized as embryos”. These claims, argues Spagnolo, “undoubtedly contribute to the unequivocal definition of the human embryo as a human body from the moment of fertilization. The protection guaranteed by the Directive (with the patentability ban) unquestionably also refers to these first phases of embryonic formation”. Totipotent embryonic cells “can be considered ‘parts’ of a human body as by definition they don’t hold the capacity of creating another embryo”, Spagnolo admits, however, that “since their sampling entails the destruction of the embryo at the blastocyst stage, it is the destruction of a human body, whose protection is stipulated in the Directive”. Bot’s ensuing explicit conclusion is: “To make an industrial application of an invention using embryonic stem cells would amount to using human embryos as a simple base material. Such an invention would exploit the human body in the initial stages of its development”.Benchmark for research. According to Spagnolo, in this issue, not only ‘European business interests’ need to be protected. In fact, there are other equally important aspects regarding the definition of the European standards providing for the regulation of scientific research, where the ethical aspect is not of secondary importance”. At anthropological level, “Bot’s argumentative rigour” and his reference to “the human body” constitute “an important premise leading to the coherent conclusion that the presence of a living human body can only but indicate the presence of a human being”.