Use the patent system to regulate gene editing

Parthasarathy, Shobita

doi:10.1038/d41586-018-07108-3

Cited by 9 publications

(11 citation statements)

References 7 publications

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“…This is not unique to the Oviedo Convention. As Parthasarathy (2018) notes "when it comes to editing genes in humans and other organisms, the United States and the United Kingdom-along with many other countries-rely on laws and policies that cover existing genetic engineering technologies". Nordberg et al (2020) highlight how the current legislative and regulatory framework in Europe incorporates some general principles advanced by the United Nations Educational, Scientific and Cultural Organization (UNESCO).…”

Section: Background-technological Progress and Regulatory Inertia?mentioning

confidence: 99%

“…Some of these concerns seem potentially to be addressed by another emerging patent-based approach. Parthasarathy (2018) proposes government-driven regulation using the patent system, which, she argues, has more transparency and legitimacy than the ethical licensing approach. Rather than ethical licensing by private actors, Parthasarathy is seeking a more formal, comprehensive and government-administered regulation using the patent system.…”

Section: Potential Motivational Effects/problemsmentioning

confidence: 99%

“…Some of these concerns seem potentially to be addressed by another emerging patent-based approach. Parthasarathy (2018) proposes government-driven regulation using the patent system, which, she argues, has more transparency and legitimacy than the ethical licensing approach. Her 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.…”

Section: Introductionmentioning

confidence: 99%

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Ethics, Patents and Genome Editing: A Critical Assessment of Three Options of Technology Governance

2021

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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.

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Section: Background-technological Progress and Regulatory Inertia?mentioning

confidence: 99%

Section: Potential Motivational Effects/problemsmentioning

confidence: 99%

“…Some of these concerns seem potentially to be addressed by another emerging patent-based approach. Parthasarathy (2018) proposes government-driven regulation using the patent system, which, she argues, has more transparency and legitimacy than the ethical licensing approach. Her 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.…”

Section: Introductionmentioning

confidence: 99%

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Ethics, Patents and Genome Editing: A Critical Assessment of Three Options of Technology Governance

2021

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“…Suggested approaches for these cases focus on informal governance measures that strengthen the international culture of responsible research (National Academies 2018b) and rely on moral persuasion methods, such as codes of conduct, educational outreach, transparency, and whistle-blowing support (Tucker 2012). One clever suggestion has been to use the patent system as a tool for regulating gene editing while in its early stages (Parthasarathy 2018), but this works best for large organizations; the DIY culture is less amenable to formal methods of oversight. Harnessing the power of social norms may be one of the few means of guiding the DIY-bio community (Nyborg et al 2016).…”

Section: The Changing Face Of Technological Riskmentioning

confidence: 99%

Assessing the Benefits of Research

2020

Dangerous Science Science: Policy and Risk Analysis for Scientists and Engineers

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Writing a book requires a substantial time commitment, and I would like to thank my family for their patience. It also requires resources, and I would like to thank Stony Brook University and the Department of Technology and Society in particular for its support. Thanks also goes out to David Tonjes for his helpful advice and Scott Ferson for his gracious support and instructive discussions regarding the nature of risk and the measurement of uncertainty. I must also express my deep gratitude to the late David Ferguson, instrumental in my academic career, who imparted kindness and wisdom in equal measure. Finally, I would like to thank Sheldon Reaven for our numerous conversations on the philosophy of science, science policy, and opera. The value of his insightful comments has been exceeded only by the value of his friendship. This book has also benefitted from the insightful peer review comments provided by Professor Frederic Emmanuel Bouder. Case Study: H5N1 Influenza Research Debate Media coverage of the latest scientific discoveries and technological innovations is usually enthusiastic. Long-standing questions are answered, productivity is increased, health is improved, and our standard of living is raised-all due to modern science and human ingenuity. However, sometimes the results of research can also inspire public fear and outrage. Let us consider a recent example. In September 2011, Dutch virologist Ron Fouchier announced at a conference in Malta that his research team had recently engineered a version of the H5N1 1 avian influenza virus that was highly transmissible between mammals. Shortly thereafter, virologist Yoshihiro Kawaoka of the University of Wisconsin presented results from a similar study. The subsequent media coverage scared the general public and set off demands for a review of how science research is assessed, funded, and managed. Why would these studies be so scary? The reason centers on the lethal potential of influenza and the H5N1 virus in particular. An influenza pandemic typically occurs when a flu virus substantially different from circulating viruses mutates to become easily transmissible between humans. The combination of 1 The formal naming convention for influenza viruses includes the antigenic type (A, B, or C); the originating host (e.g., swine); the geographical origin; year of identification; strain number; or for type A viruses, the specific subtypes of two surface proteins, hemagglutinin (H) and neuraminidase (N) (e.g., H5N1) (Assaad et al. 1980). Given the complexity of formal names, popular shorthand names, such as Spanish flu, Swine flu, and H1N1 can potentially be referring to the same influenza virus. The World Health Organization has been working to improve shorthand names to make them less stigmatizing and more informative.

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“…Esta legislación restrictiva está siendo revisada por diversos países, para adaptarse a la realidad. Por otra parte, hay opiniones que consideran que la normativa que debería regir en la generación de organismos editados genéticamente, sean para la alimentación o para usos biotecnológicos o biomédicos, debería ser más liberal y similar a la ley de patentes 9 .…”

Section: ¿Qué Usos Tiene La Edición Génica?unclassified

Interrogantes y retos actuales de la edición genética

Marfany

2019

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La tecnología de la edición génica por CRISPR ha revolucionado tanto la investigación en biotecnología como en biomedicina. Esta técnica tan poderosa y versátil permite editar los genes de cualquier especie a la carta. A pesar de su potencia y efectividad, quedan muchas cuestiones para resolver y controlar su resultado final, particularmente en las aplicaciones sobre el genoma de los seres humanos. En este artículo se plantean tanto los puntos fuertes y puntos débiles de la técnica, como otras cuestiones abiertas sobre la edición génica, sobre si debe dirigirse a la terapia o a la mejora, si la modificación debe constreñirse a células somáticas o también a editar a embriones, modificando el genoma de los seres humanos del futuro.

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Use the patent system to regulate gene editing

Cited by 9 publications

References 7 publications

Ethics, Patents and Genome Editing: A Critical Assessment of Three Options of Technology Governance

Ethics, Patents and Genome Editing: A Critical Assessment of Three Options of Technology Governance

Assessing the Benefits of Research

Interrogantes y retos actuales de la edición genética

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