Bioethical ambition, political opportunity and the European governance of patenting: the case of human embryonic stem cell science.

Scientific progress in the life sciences is dependent on the governance of tensions between the economic potential of the innovation and the cultural response from society. Ownership of the scientific innovation through patenting is a necessary part of the realization of its economic value yet, in the case of human embryonic stem cell (hESC) science, ownership of the human body and human life may offend fundamental cultural values. In the case of transnational patenting governance by the European Patent Office (EPO) and the European Union (EU), cross-national cultural conflict in the field of hESC science has produced a political demand for a form of governance that can incorporate ethical as well as economic judgements in its decision making. This paper explores how bioethics has responded to this opportunity to establish itself as a form of expert authority for the negotiation and resolution of the cultural conflict. In so doing, it shows how the political struggle that has accompanied this bid for new governance territory has been influenced both by the political tensions between the EPO and EU systems of patenting governance and the resistance of competing experts in law and science to a bioethical presence.

[The Brüstle v. Greenpeace case and the end of pre-implantation embryos discrimination]. / El Caso Brüstle V. Greenpeace y el Final de la Discriminación de los Embriones Preimplantatorios.

In October 2011 the Court of Justice of the European Union pronounced the sentence in the case Brüstle v. Greenpeace. This sentence resolves the preliminary ruling interposed by the Bundesgerichtshof. The object of the preliminary ruling was the interpretation of the expression "human embryos", on 44/98/CE Guideline, in order to resolve the litigation between Brüstle, a German neurobiologist, and Greenpeace. Brüstle have patented a process for obtaining stem cells using cells originally extracted from human embryos, Greenpeace have filed a lawsuit against this patent. The article analyzes the meaning of this sentence in the light of the discrimination of the pre-implantation embryos in Spanish law. The content of the Biopatent Guideline, the Opinions of the European Group on Ethics of Science and New Technologies related to it, the EUJC verdict and the Conclusions of the General Advocate are analyzed. We will pay special attention to the final verdict given on November 27, 2012, by the German Federal Court of Justice. The paper also considers the repercussion of Brüstle case at the European level, examining the activity of the European Parliament, in the frame of the discussion of the program Horizon 2020, and the citizen's initiative "One of us". At the Spanish level, the paper underlines the need to reform the laws of Human Assisted Reproduction and of Biomedical Investigation.

An obscure rider obstructing science: the conflation of parthenotes with embryos in the Dickey-Wicker amendment.

In 1996 Congress passed the Dickey-Wicker Amendment (DWA) as part of an appropriations bill; it has been renewed every year since. The DWA bans federal funding for research using embryos and parthenotes. In this paper, we call for a public discussion on parthenote research and a questioning of its inclusion in the DWA. We begin by explaining what parthenotes are and why they are useful for research on reproduction, cancer, and stem cells. We then argue that the scientific difference between embryos and parthenotes translates into ethical differences, and claim that research on parthenotes is much less ethically problematic. Finally, we contextualize the original passage of the DWA to provide an explanation for why the two were possibly conflated in this law. We conclude by calling for a public discussion on reconsidering the DWA in its entirety, starting with the removal of parthenogenesis from this prohibition of National Institutes of Health (NIH) funding.

Biotechnology and human dignity: a European perspective.

The precise meaning of "human dignity" is increasingly being questioned in ethics and law Is human dignity an adequate guide to policymaking in today's biotechnological era? This article is an attempt to answer this thorny issue. The emergence of the concept of human dignity as a key point of reference for the regulation of modern science and technology in the European Union is evaluated. The main contribution of this article is to prove that in EU Directives and Recommendations, human dignity is not an elusive concept but rather a regulatory restraint in European public policies on biotechnology, particularly through the influence of the European Group on Ethics in Science and New Technologies (EGE). Two examples will be elaborated to prove this claim: first, the issue of intellectual property in biotechnological inventions, and secondly the funding of research proposals involving the use of human embryonic stem cells. These examples prove that the principle of human dignity is not an empty concept as some philosophers and bioethicists claim but rather a normative guideline that is shaping European policies on biotechnology.

Embryo research in Italy: the bioethical and biojuridical debate.

This article deals with the discussion on the status of the human embryo in Italy on a philosophical, socio-ethical and juridical level before, during and after the law (n. 40/2004). Different lines of thought are outlined and critically discussed. The focus is the debate over the so-called embryonic stem cells, pointing out the ethical premises and the juridical implications. The regulations in Italy are analysed in detail, referring to legislation and jurisprudence (showing analogies and differences). In particular the author includes evidence for the debate after the law came in, with specific attention on the question of the use of imported embryonic stem cells and public financing for research and the problem of the use of frozen and non-implantable embryos.

Teetering on the brink.

The US Congress must authorize federal funding of human embryonic stem cell research.