ICB statement on the patentability of human embryonic cells

25 February 2000

Abstract

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The ICB criticises the decision of the European Patent Office (EPO) to issue the University of Edinburgh, which collaborates with the US company Bio Transplant, the patent (number ER 695 351) on the isolation and culture of stem cells from embryos and adult tissues and their genetic modification.

The ICB emphasises how the question of the production and utilization of embryos for experimental purposes and the patentability of human life for the purpose of commercial exploitation is ethically unacceptable, and, moreover, it is in open contrast with the regulations adopted on an international level. Consequently, it refers to the Convention on Human Rights and Biomedicine of the Council of Europe (1997), in which the provisions under article 18 prohibits the creation of human embryos for research purposes, and under article 21 in which financial gain from the human body and its parts is prohibited; the Additional Protocol of the Oviedo Convention on Human Cloning (1998) prohibits the cloning of human beings; and the Universal Declaration on the Human Genome and Human Rights adopted by UNESCO (1997), which symbolically defines the human genome as the common “heritage of humanity” in the provisions under art.11 and prohibits practices that are contrary to human dignity, specifying among these, the reproductive cloning of human beings.

The rectification issued by EPO immediately after the event, specifies that, the object of the patent does not include the human species or therefore the cloning of human embryos; this, in the opinion of the ICB, is of no legal or ethical value in the absence of specific amendments to the text itself. The Committee expresses its satisfaction with the decision of the Italian government to appeal against the issuing of the aforementioned patent. In addition, the ICB hopes that the institutions and political bodies will present the instrument for ratifying the Convention of Oviedo and the Additional Protocol on Human Cloning as soon as possible; and that the text of the transposition of directive n. 98/44 on the legal protection of biotechnological inventions should exclude any ambiguity regarding the illegitimacy of patenting the human body, of any of its parts and in any of its stages of development.

Lastly, the Committee expresses its concern for the possible adverse impact on public opinion, particularly regarding the risk of creating widespread mistrust of biomedical sciences, which could produce unnecessary obstacles to the freedom of science and research. Therefore, the ICB hopes that strategies for collaboration regarding the private sector, the public institutions involved and the institutional bodies will be fostered “in order to direct specific utilization of the findings of scientific research to the promotion of significant and fairly shared benefits”.

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