Brüstle v. Greenpeace: Implications for Commercialisation of Translational Stem Cell Research

2015 ◽  
Vol 22 (2) ◽  
pp. 141-164
Author(s):  
Juli Mansnérus

The lack of consensus on a common definition of the term ‘embryo’ has resulted in legal uncertainty affecting the permissibility of human embryonic stem cell (hESC) research and the commercialisation prospects and patenting of inventions of hESC origin in the eu. The Brüstle v. Greenpeace case, which by providing a very broad definition of a human embryo restricts the patentability of hESC-based inventions, aims at harmonising the patenting practices regarding interpretation of Article 6.2.c of Directive 98/44/ec. It fills the gaps in national laws by providing binding interpretation guidelines for national courts. As currently no marketing authorisations have been granted to hESC-based products, implications of this judgment for translational hESC research together with other barriers to commercialisation of such research need to be analysed. In addition, whether the main obstacles relate to patenting restrictions or whether something else in the innovation system is impeding the market entry of these innovative products is discussed.

2014 ◽  
Vol 54 (1) ◽  
pp. 3-22 ◽  
Author(s):  
Maya Mitre ◽  
Bruno P.W. Reis

This case study deals with the regulation of human embryonic stem-cell (hESC) research in Brazil. It aims to analyze the process that led to the authorization, in 2005, of the use of stem cells obtained from so-called supernumerary embryos for purposes of research and therapy. We argue that the pro-research lobby in Brazil had considerable success because it framed the issue by referring to Brazil’s peculiar policy background in the fields of assisted reproduction and embryo research. Moreover, this group of actors strategically avoided associating hESC research with abortion, highlighting the humanitarian aspects of this kind of research, rather than the motto of freedom of scientific research. Finally, it was able to rely on the judgment of a fairly progressive Supreme Court, which was also sensitive to public opinion at a time of ‘court activism’ or the ‘judicialization of politics’ in Brazil.


2010 ◽  
Vol 38 (2) ◽  
pp. 229-237 ◽  
Author(s):  
Dan W. Brock

The intense and extensive debate over human embryonic stem cell (hESC) research has focused primarily on the moral status of the human embryo. Some commentators assign full moral status of normal adult human beings to the embryo from the moment of its conception. At the other extreme are those who believe that a human embryo has no significant moral status at the time it is used and destroyed in stem cell research. And in between are many intermediate positions that assign an embryo some degree of moral status between none and full. This controversy and the respective positions, like the abortion controversy, is by now well understood, despite the lack of progress in resolving it. I have argued briefly elsewhere that early embryos do not have significant moral status, but I do not want to reenter that debate here. Instead, I want to focus on an issue that has had relatively little explicit and separate attention, but is likely to loom larger in light of the Obama administration’s partial lifting of the Bush administration’s restriction on the embryos that can be used in stem cell research that receives federal funding.


Hypatia ◽  
2010 ◽  
Vol 25 (3) ◽  
pp. 577-609 ◽  
Author(s):  
Shelley Tremain

Until now, philosophical debate about human embryonic stem cell (hESC) research has largely been limited to its ethical dimensions and implications. Although the importance and urgency of these ethical debates should not be underestimated, the almost undivided attention that mainstream and feminist philosophers have paid to the ethical dimensions of hESC research suggests that the only philosophically interesting questions and concerns about it are by and large ethical in nature. My argument goes some distance to challenge the assumption that ethical considerations alone must be foregrounded in philosophical discussions about hESC research by introducing a critical stance on the epistemological and ontological assumptions that underlie and condition it. A central aim of the paper is to show how Foucault's insights into knowledge-power, taken in combination with Hacking's claims about styles of reasoning, can make these assumptions evident, as well as cast light on their potentially deleterious implications for disabled people. Arguing in this way also enables me to draw out constitutive effects of research on stem cells, that is, to indicate how the discursive practices surrounding research on stem cells, as well as the technology itself, contribute to the constitution of impairment.


2009 ◽  
Vol 22 (2) ◽  
pp. 31-54
Author(s):  
Françoise Baylis ◽  
Timothy Krahn

In an effort to quell ongoing debate about the ethics of human embryonic stem cell (hESC) research, there have been concerted efforts to develop ethical standards for both embryo and hESC research and to entrench these standards in law. Surprisingly these efforts have not included efforts at standardizing the meaning of the pivotal term ‘embryo’. This paper reviews the legal framework for embryo research in the United Kingdom, the United States and Germany and highlights the absence of any agreed upon standard for what counts as a human embryo. This is an important lacuna, especially in light of the most recent advances in stem cell research involving the reprogramming of human somatic cell nuclei to generate human induced pluripotent stem (iPS) cells.


2013 ◽  
Vol 20 (2) ◽  
pp. 145-165
Author(s):  
Fionnuala Gough

Abstract Disagreement about matters of public policy concerned with moral issues is inevitable in pluralist democracies. One approach to the resolution of moral conflicts in society is the concept of deliberative democracy, which emphasises the process or procedure which ultimately allows a political decision to be reached. The Republic of Ireland effectively has no legislative framework regulating human embryonic stem cell research (hESC research). This article proposes that Irish policymakers establish a procedural framework, similar to that used in other European democracies, to allow the development of appropriate regulations pertaining to hESC research in Ireland. In particular the article will consider how a three-tier model of procedural regulation has been used to achieve certainty in the area of hESC research in the United Kingdom and Germany and how this model might be applied to Ireland.


2010 ◽  
Vol 29 (2) ◽  
pp. 73-95 ◽  
Author(s):  
Eileen Burgin

In response to former President George W. Bush's funding limitations on human embryonic stem cell (hESC) research, California voters in 2004 passed Proposition 71, the most expansive state-funded medical research initiative in United States history. This study examines California's experiment in the life sciences, a particularly fitting analysis now as President Barack Obama has freed up additional federal funding for hESC research. In addition to exploring the general pitfalls of states, rather than the federal government, serving as principal players on hESC science and the perceived flaws in California's program, the analysis considers the strengths of state activism and of California's enterprise. On balance, given the Bush administration's policy on hESC research, the U.S. benefitted from state innovation. Moreover, even with the new federal regulatory policy on hESC research, California should be able to mesh its program with the federal initiative and remain a prime mover in this arena. The essay draws on informal interviews with key actors in California and on Capitol Hill in 2008 and 2009.


Sign in / Sign up

Export Citation Format

Share Document