scholarly journals Governance Choices of Genome Editing Patents

2021 ◽  
Vol 3 ◽  
Author(s):  
Naomi Scheinerman ◽  
Jacob S. Sherkow

There are a variety of governance mechanisms concerning the ownership and use of patents. These include government licenses, compulsory licenses, march-in rights for inventions created with federal funding, government use rights, enforcement restrictions, subject-matter restrictions, and a host of private governance regimes. Each has been discussed in various contexts by scholars and policymakers and some, in some degree, have been employed in different cases at different times. But scholars have yet to explore how each of these choices are subject to—or removed from—democratic control. Assessing the range of democratic implications of these patent governance choices is important in understanding the social and political implications of controversial or wide-ranging technologies because their use has a significant potential to affect the polity. This paper seeks to unpack these concerns for genome editing, such as CRISPR, specifically. Patents covering genome editing make an interesting case because, to date, it appears that the polity is concerned less with certain kinds of access, and more with distribution and limits on the technology’s particular uses, such as human enhancement and certain agricultural and environmental applications. Here, we explore what it means for patents to be democratic or non-democratically governed and, in so doing, identify that patents covering many of the most controversial applications—that is, ones most likely to gain public attention—are effectively controlled by either non- or anti-democratic institutions, namely, private restrictions on licensing. This may be effective—for now—but lawmakers should be wary that such restrictions could rapidly reverse themselves. Meanwhile, other choices, like compulsory licenses, more broadly touch on democratic deliberation but, as currently structured, are aimed poorly for particular applications. Insofar as the public wants, or perhaps deserves, a say in the distribution and limits of these applications, illuminating the ways in which these governance choices intersect—or fail to intersect—with democratic institutions is critical. We offer some concluding thoughts about the nature of patents and their relationship with democratic governance as distributed claims to authority, and suggest areas for scholars and policymakers to pay close attention to as the genome editing patent landscape develops.

Author(s):  
Yuliia Yu. Bobrova ◽  
Yuriy O. Bobrov

The analysis of numerous scientific publications demonstrates the great relevance of gender studies at the current stage of Ukrainian social development, in almost all spheres of social relations. As for ensuring equal participation of men and women in the functioning of the military organisation of the state, the implementation of such a gender balance contributes to improving civilian control over it through the possibility of developing the capacity of regulatory bodies in gender issues, promoting dialogue between the community and control bodies, and drawing public attention to the problems of accountability of institutions of this organisation. The main purpose of this study is to highlight the state of gender equality in the military organisation of the state through the lens of civilian democratic control. The study determined the state of legislative regulation of the concept of military organisation of the state and civil democratic control. The study analysed the introduction of a gender perspective in Ukraine in the subject matter and the dynamics of establishing a gender balance in the military organisation of the state; the impact on existing trends of legislative initiatives. It is stated that the modern Ukrainian army is mostly “male”. Despite the fact that women are allowed to serve in the military, they do not take part in making socially important decisions, they do not hold high military positions, and career growth is challenging for them. The study identified the main problems of implementing gender equality in the Armed Forces of Ukraine and other structures of the Defence Forces of Ukraine, which are more based on social stereotypes of pre-defined roles for men and women. Civil control over the Armed Forces is described as a socio-political process in this area


2021 ◽  
Vol 27 (1) ◽  
pp. 68-102
Author(s):  
Seth Mayer ◽  

The American criminal justice system falls far short of democratic ideals. In response, democratic communitarian localism proposes a more decentralized system with a greater emphasis on local control. This approach aims to deconcentrate power and remove bureaucracy, arguing local control would reflect informal cultural life better than our current system. This view fails to adequately address localized domination, however, including in the background culture of society. As a result, it underplays the need for transformative, democratizing change. Rejecting communitarian localism, I defend a mass deliberative democratic approach to criminal justice reform that relies on institutions outside localities to democratize local institutions and background cultural patterns. Nonetheless, local institutions must be empowered to exert democratic control, as well as to influence institutions outside the locality. This process of democratic co-development offers greater hope for political equality, non-domination, and inclusive democratic deliberation about criminal law than democratic communitarian localism.


2019 ◽  
Vol 45 (8) ◽  
pp. 514-523 ◽  
Author(s):  
Christopher Gyngell ◽  
Hilary Bowman-Smart ◽  
Julian Savulescu

In July 2018, the Nuffield Council of Bioethics released its long-awaited report on heritable genome editing (HGE). The Nuffield report was notable for finding that HGE could be morally permissible, even in cases of human enhancement. In this paper, we summarise the findings of the Nuffield Council report, critically examine the guiding principles they endorse and suggest ways in which the guiding principles could be strengthened. While we support the approach taken by the Nuffield Council, we argue that detailed consideration of the moral implications of genome editing yields much stronger conclusions than they draw. Rather than being merely ‘morally permissible’, many instances of genome editing will be moral imperatives.


2021 ◽  
Vol 3 ◽  
Author(s):  
Oliver Feeney ◽  
Julian Cockbain ◽  
Sigrid Sterckx

Current methods of genome editing have been steadily realising the once remote possibilities of making effective and realistic genetic changes to humans, animals and plants. To underpin this, only 6 years passed between Charpentier and Doudna’s 2012 CRISPR-Cas9 paper and the first confirmed (more or less) case of gene-edited humans. While the traditional legislative and regulatory approach of governments and international bodies is evolving, there is still considerable divergence, unevenness and lack of clarity. However, alongside the technical progress, innovation has also been taking place in terms of ethical guidance from the field of patenting. The rise of so-called “ethical licensing” is one such innovation, where patent holders’ control over genome editing techniques, such as CRISPR, creates a form of private governance over possible uses of gene-editing through ethical constraints built into their licensing agreements. While there are some immediately apparent advantages (epistemic, speed, flexibility, global reach, court enforced), this route seems problematic for, at least, three important reasons: 1) lack of democratic legitimacy/procedural justice, 2) voluntariness, wider/global coordination, and sustainability/stability challenges and 3) potential motivational effects/problems. Unless these three concerns are addressed, it is not clear if this route is an improvement on the longer, slower traditional regulatory route (despite the aforementioned problems). Some of these concerns seem potentially addressed by another emerging patent-based approach. Parthasarathy proposes government-driven regulation using the patent system, which, she argues, has more transparency and legitimacy than the ethical licensing approach. This proposal includes the formation of an advisory committee that would guide this government-driven approach in terms of deciding when to exert control over gene editing patents. There seem to be some apparent advantages with this approach (over traditional regulation and over the ethical licensing approach mentioned above—speed and stability being central, as well as increased democratic legitimacy). However, problems also arise—such as a “half-way house” of global democratic legitimacy that may not be legitimate enough whilst still compromising speed of decision-making under the “ethical licensing” approach). This paper seeks to highlight the various advantages and disadvantages of the three main regulatory options—traditional regulation, ethical licensing and Parthasarathy’s approach—before suggesting an important, yet realistically achievable, amendment of TRIPS and an alternative proposal of a WTO ethics advisory committee.


Bionatura ◽  
2019 ◽  
Vol 4 (3) ◽  
pp. 895-896
Author(s):  
Abril Saldaña Tejeda

Recent genetic technologies have uncovered the urgent need for global governance of health that can guarantee an ethical consensus on human genome editing and stem cell research. Although the majority of gene-transfer trials have been located in the Americas and Europe, the regulation of human somatic cell genome editing is generally limited in Latin America and largely informed by ethical concerns about genetically modified plants and animals, biopiracy, biosecurity, and use of stem cells for clinical care. Few jurisdictions in the region (i.e., Chile, Panama, Ecuador, and Colombia) have explicitly addressed somatic genome editing. Jurisdictions often address concerns regarding the use of new biotechnologies (i.e., CRISPR-Cas9) for human “enhancement” purposes rather than the prevention or cure of serious medical conditions 1.


2020 ◽  
Vol 13 (1) ◽  
pp. 62-68
Author(s):  
Athanasios Alexiou ◽  
Panagiota Simou ◽  
Filia Alexiou ◽  
Stylianos Chatzichronis ◽  
Ghulam Md Ashraf

Background: While modern humans seek ways to extend life expectancy, the necessity of advanced bioengineering tools for the production of effective human enhancement applications appears as compelling as ever. Objective: The technological future of Homo sapiens has been scheduled within a quantum environment and advanced physical interventions are imperative to occur in the anatomy of modern humans, including genetic improvement and human cloning. New terminologies and latest projects such as genome editing, mind uploading and tissue engineering applications for the growth of new organs are issues of discussion in this paper. Methods: Several advanced biotechnological methods are presented in this paper, including the 14-days rule, the 2045 Initiative project and the CRISPR technique and their social and ethical implications are discussed. Results: The exponential aging of the population results in rapidly increasing demands for next-generation drugs and innovative pharmaceutical products that target individualized genetic treatment, resulting in the emergence of controversial ethical and social implications in the forthcoming post-Homo sapiens Era. Conclusion: The next-generation ethics must be clarified, an interdisciplinary debate should be initiated, and all the different perspectives must be recorded and evaluated to adopt the most efficient practices for controversial topics like the potential digital immortality.


1991 ◽  
Vol 85 (3) ◽  
pp. 801-828 ◽  
Author(s):  
B. Dan Wood ◽  
Richard W. Waterman

A new paradigm of political-bureaucratic relations emerged through the 1980s holding that U.S. democratic institutions continuously shape nonelective public bureaucracies. Several empirical studies support the paradigm with evidence suggestive of political manipulation but none reveals the scope or specific mechanisms of political control. We explore the dynamics of political control of the bureaucracy explicitly to determine the scope and mechanisms. We examine output time series from seven different public bureaucracies for responsiveness to political tools applied in the late Carter and early Reagan administrations. We find responsiveness in all seven cases. The evidence also shows that political appointments—a shared power of the president and Congress—is the most important instrument of political control; changing budgets, legislation, congressional signals, and administrative reorganizations are less important. These findings confirm intuitive assertions by institutional scholars and suggest a method of “policy monitoring” that could enhance future democratic control of the bureaucracy.


2010 ◽  
Vol 24 (1) ◽  
pp. 19-43 ◽  
Author(s):  
Kate Macdonald ◽  
Terry Macdonald

Whereas representative democratic mechanisms have generally been built around preexisting institutional structures of sovereign states, the global political domain lacks any firmly constitutionalized or sovereign structures that could constitute an analogous institutional backbone within a democratic global order. Instead, global public power can best be characterized as “pluralist” in structure. Some recent commentators have argued that if global democratization is to succeed at all, it must proceed along a trajectory beginning with the construction of global sovereign institutions and culminating in the establishment of representative institutions to control them. This paper challenges this view of the preconditions for global democratization, arguing that democratization can indeed proceed at a global level in the absence of sovereign structures of public power. In order to gain firmer traction on these questions, analysis focuses on the prospects for democratic control of corporate power, as constituted and exercised in one particular institutional context: sectoral supply chain systems of production and trade. It is argued that global democratization cannot be straightforwardly achieved simply by replicating familiar representative democratic institutions (based on constitutional separations of powers and electoral control) on a global scale. Rather, it is necessary to explore alternative institutional means for establishing representative democratic institutions at the global level within the present pluralist structure of global power.


Author(s):  
Miquel-Àngel Serra

The concepts of posthuman, transhuman, transhumanism and human enhancement, and their use of emerging technologies, are described together with their scientific and social implications. Genome editing techniques for enhancement purposes, as well as their scientific, societal, and ethical drawbacks are specifically discussed. In particular, we focus on a perspective of personal and collective responsibility and social inclusion, considering all people, with their functional diversity or different abilities. Pros and cons of proposals for radical transformation as endorsed by transhumanism (genome editing), their impact on future generations and on subjects with functional diversity, and the need of a global ethical frame, are discussed.


2019 ◽  
Vol 25 (2) ◽  
pp. 182-188
Author(s):  
Galina Pisarska

Abstract Corruption poses a serious danger to the democratic foundations of each country. The need of an effective legal mechanism for combating corruption is increasingly being interpreted as key criteria for strengthening democratic institutions and introducing modern standards of transparency and democratic control into the governance of society. There are adopted a number of national, regional and international legal anticorruption acts which are particularly important, especially in the context of Bulgaria’s integration processes in the European area. In this connection, ensuring the democratic values in European society represents a big challenge for regulatory claims and capabilities of law with a view to the dynamic development of society. The current survey examines at the main type the development of anticorruption legal framework and aims to provide guidance for optimizing and improving the existing system of effective measures for the fighting against corruption and to clarify its place in the confirmation of democracy.


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