Governing Intellectual Property Rights Within Publicly Funded Biobanks

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Governing Intellectual Property Rights Within Publicly Funded Biobanks

Author : Rajam Neethu
Publisher : Kluwer Law International B.V.
Page : 342 pages
File Size : 41,5 Mb
Release : 2019-06-21
Category : Law
ISBN : 9789403506227

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Governing Intellectual Property Rights Within Publicly Funded Biobanks by Rajam Neethu Pdf

Governing Intellectual Property Rights Within Publicly Funded Biobanks R. Neethu The boom in biobanks and health databases as research infrastructures have evoked various legal and ethical debates. Since then numerous new developments have emerged such as digitalization, big-data research and artificial intelligence which has important implications for biobank-based research and collaborations. This new paradigm offers new legal challenges for commercial involvement particularly within a publicly funded setting. In this innovative book, the author shows that securing maximum social benefit out of the knowledge emanating from the use of biobank resources lies in managing intellectual property inputs and outputs effectively in keeping with the values core to such research. Focusing on the challenges of involving intellectual property rights (IPRs) particularly in the precompetitive phase of biobank-based research, the book offers an extensive understanding of the role of different IPRs and identifies the gaps in the law and its implications for biobanks. The analysis covers important aspects in relation to biobanks such as: Digital integration and biomedical data storage; Ownership of biological samples; Commercialization and benefit sharing; Partnership models; Public sector research; Disposition of samples; Consent; Cross-border exchange; Trade secrecy; Privacy; Regulatory stewardship; Business strategies; Ethical considerations over biological resources; Patenting of inventions relating to personalized medicine; Ethical parameters within patent law; and Rights regarding genetic data and databases. The book includes observations, case studies and interviews conducted by the author. In conclusion, the author offers cogent recommendations for legal interoperability of IP rules and research practices designed to enhance the ability of biobanks to share, access and reuse data. This book is the first of its kind to explore the organizational and legislative choices for biobanks particularly while engaging in the protection of research results and technology transfer within a publicly funded setting. It will be of substantial interest to all stakeholders in biobanking, especially policymakers, biobankers and researchers working in the field of health law as well as for legal practitioners, academics and patient interest groups.

Comparative Issues in the Governance of Research Biobanks

Author : Giovanni Pascuzzi,Umberto Izzo,Matteo Macilotti
Publisher : Springer Science & Business Media
Page : 334 pages
File Size : 45,7 Mb
Release : 2013-01-30
Category : Law
ISBN : 9783642331169

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Comparative Issues in the Governance of Research Biobanks by Giovanni Pascuzzi,Umberto Izzo,Matteo Macilotti Pdf

In the last few years, the boom in biobanking has prompted a lively debate on a host of interrelated legal issues, such as the Gordian knot of the ownership of biological materials, as well as privacy concerns. The latter are due to the difficulty of accepting that biological samples must be completely anonymous without making it practically impossible to exploit their information potential. The issues also include the delicate role and the changing content of the donor’s “informed consent” as the main legal tool that may serve to link the privacy and property interests of donors with the research interests and the set of principles that should be at the core of the biobanking practice. Lastly, the IP issues and the patentability of biological samples as well as the protection of databases storing genetic information obtained from the samples are covered. Collecting eighteen essays written by eminent scholars from Italy, the US, the UK and Canada, this book provides new solutions to these problems. From a comparative viewpoint, it explores the extent to which digital technology may assist in tackling the numerous regulatory issues raised by the practice of biobanking for research purposes. These issues may be considered and analyzed under the traditional paradigms of Property, Privacy, Informed Consent and Intellectual Property.

GDPR and Biobanking

Author : Jane Reichel,Santa Slokenberga,Olga Tzortzatou,Springer Nature
Publisher : Springer Nature
Page : 432 pages
File Size : 42,8 Mb
Release : 2021
Category : Biobanks
ISBN : 9783030493882

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GDPR and Biobanking by Jane Reichel,Santa Slokenberga,Olga Tzortzatou,Springer Nature Pdf

Part I Setting the scene -- Introduction: Individual rights, the public interest and biobank research 4000 (8) -- Genetic data and privacy protection -- Part II GDPR and European responses -- Biobank governance and the impact of the GDPR on the regulation of biobank research -- Controller' and processor's responsibilities in biobank research under GDPR -- Individual rights in biobank research under GDPR -- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research -- A Pan-European analysis of Article 89 implementation and national biobank research regulations -- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations -- Part III National insights in biobank regulatory frameworks -- Selected 10-15 countries for reports: Germany -- Greece -- France -- Finland -- Sweden -- United Kingdom -- Part IV Conclusions -- Reflections on individual rights, the public interest and biobank research, ramifications and ways forward. .

Ethical Issues in Governing Biobanks

Author : Nikola Biller-Andorno,Alexander M. Capron
Publisher : Routledge
Page : 268 pages
File Size : 40,6 Mb
Release : 2016-05-13
Category : Science
ISBN : 9781317141495

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Ethical Issues in Governing Biobanks by Nikola Biller-Andorno,Alexander M. Capron Pdf

Population genomics research drawing on genetic databases has expanded rapidly, with some of this information being combined in 'biobanks'. Managing this information in an appropriate way is a highly complex ethical issue in the health policy arena. This book combines theoretical and empirical research to analyze the areas of conflict and consensus in the regulatory and ethical frameworks that have been developed to govern biobanks. Ethicists from the Department of Ethics, Trade, Human Rights and Health Law (ETH) of the World Health Organization, the Institute of Biomedical Ethics of Geneva University and the Institute of Biomedical Ethics of the University of Zurich, with the support of the Geneva International Academic Network (GIAN), examine the conditions under which genetic databases can be established, kept, and made use of in an ethically acceptable way. In addition to a comprehensive review of the scientific literature and a comparative analysis of existing normative frameworks, they present the results of in-depth interviews with experts around the world concerning the most unresolved and controversial issues. The results of that study, combined with their normative analysis, leads to recommendations for a better international framework.

Global Genes, Local Concerns

Author : Timo Minssen,Janne Rothmar Herrmann,Jens Schovsbo
Publisher : Edward Elgar Publishing
Page : 304 pages
File Size : 55,9 Mb
Release : 2019
Category : LAW
ISBN : 9781788116190

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Global Genes, Local Concerns by Timo Minssen,Janne Rothmar Herrmann,Jens Schovsbo Pdf

With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. Addressing pressing questions such as how do national biobanks best contribute to translational research and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.

Governance of Genetic Resources

Author : Catherine Rhodes
Publisher : Edward Elgar Publishing
Page : 273 pages
File Size : 54,5 Mb
Release : 2013-11-29
Category : Nature
ISBN : 9781781007006

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Governance of Genetic Resources by Catherine Rhodes Pdf

This timely study will be of interest to students and academics concerned with the management of genetic resources and its connection to issues such as intellectual property rights, biodiversity conservation and food security. It will appeal strongly t

Advances in Biobanking Practice Through Public and Private Collaborations

Author : Elena Salvaterra ,Julie Corfield
Publisher : Bentham Science Publishers
Page : 128 pages
File Size : 42,5 Mb
Release : 2017-07-10
Category : Medical
ISBN : 9781681085104

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Advances in Biobanking Practice Through Public and Private Collaborations by Elena Salvaterra ,Julie Corfield Pdf

Advances in Biobanking Practice Through Public and Private Collaborations presents an analysis of methods and current models of partnership between public and private organizations designed to improve biobanking practices in European countries. Chapters describe the state-of-the-art of public-private collaborations in biobanking on a global scale, innovative approaches to public-private partnership the role of a quality management system in biobanking collaborations, quality standard criteria specifically shaped for tumor biobanks, theoretical and practical access conditions to biobanks, the general legal framework governing biobanks at national, European and international levels and a concrete public-private partnership model for managing sample requests. The contributions in this book include examples of established biobanking institutions (such as Spanish National Cancer Research Centre, National Institute of Health, Italy, and 3C-R, France among others) which serve to give readers a concrete perspective on current biobanking practices and relevant legal and ethical issues that shape the field. This book is an ideal handbook for all medical researchers, healthcare professionals and biobanking stakeholders seeking information about international biobanking practices and business models.

Intellectual Property and Emerging Technologies

Author : Matthew Rimmer,Alison McLennan
Publisher : Edward Elgar Publishing
Page : 499 pages
File Size : 45,9 Mb
Release : 2012-01-01
Category : Technology & Engineering
ISBN : 9781781001189

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Intellectual Property and Emerging Technologies by Matthew Rimmer,Alison McLennan Pdf

This unique and comprehensive collection investigates the challenges posed to intellectual property by recent paradigm shifts in biology. It explores the legal ramifications of emerging technologies, such as genomics, synthetic biology, stem cell research, nanotechnology, and biodiscovery. Extensive contributions examine recent controversial court decisions in patent law such as Bilski v. Kappos, and the litigation over Myriad's patents in respect of BRCA1 and BRCA2 while other papers explore sui generis fields, such as access to genetic resources, plant breeders' rights, and traditional knowledge. The collection considers the potential and the risks of the new biology for global challenges such as access to health-care, the protection of the environment and biodiversity, climate change, and food security. It also considers Big Science projects such as biobanks, the 1000 Genomes Project, and the Doomsday Vault. The inter-disciplinary research brings together the work of scholars from Australia, Canada, Europe, the UK and the US and involves not only legal analysis of case law and policy developments, but also historical, comparative, sociological, and ethical methodologies. Intellectual Property and Emerging Technologies will appeal to policy-makers, legal practitioners, business managers, inventors, scientists and researchers.

Principles and Practice in Biobank Governance

Author : Mark Stranger
Publisher : Routledge
Page : 316 pages
File Size : 42,7 Mb
Release : 2016-04-15
Category : Social Science
ISBN : 9781317075875

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Principles and Practice in Biobank Governance by Mark Stranger Pdf

Rapid technological advances, the establishment of large-scale biobanks, and the exchange of data across international boundaries raise a variety of questions for regulators struggling with the problem of how to govern such stores of information and the processes connected with them. Engaging with the pressing issues of privacy, consent, access to data, and benefit sharing, Principles and Practice in Biobank Governance draws together the latest empirical research from the UK, Europe, America, Australia and Asia to focus on these challenges. Current models of governance are critiqued, principles and policies are debated, and new models and theoretical frameworks are presented through this intellectually stimulating, informative volume. This truly international volume offers new insights from a range of disciplinary perspectives and will be essential reading for policy makers and scholars across a range of social sciences, including sociology, bioethics, law and social policy.

Research Handbook on Intellectual Property and Cultural Heritage

Author : Stamatoudi, Irini
Publisher : Edward Elgar Publishing
Page : 640 pages
File Size : 45,8 Mb
Release : 2022-07-21
Category : Social Science
ISBN : 9781800376915

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Research Handbook on Intellectual Property and Cultural Heritage by Stamatoudi, Irini Pdf

This important Research Handbook offers a comprehensive analysis of the intersections between intellectual property (IP) and cultural heritage law. It explores and compares how both have evolved and sometimes converged over time, how they increased tremendously in significance, as well as in economic value, despite the fact that the former mainly pertains to the private sphere, whilst the latter is considered a ‘common good’.

The Limits to Governance

Author : Theo Papaioannou
Publisher : Routledge
Page : 310 pages
File Size : 40,6 Mb
Release : 2016-03-03
Category : Social Science
ISBN : 9781317025290

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The Limits to Governance by Theo Papaioannou Pdf

Does the state still frame debates about new technology? Can policy-makers ensure the benefits of health developments through genomics while still satisfying the expectations of society and the economic imperatives? In this critique of the new governance agenda for research and innovation in life sciences, the authors discuss the world-wide policy decisions needed, with particular reference to genomics. They suggest the many facets of policy and could be treated as a government-governance continuum, where different aspects of genomics may sit at different points, and co-exist. Their findings offer valuable insights for the future and will help promote a global solution to this problem.

Intellectual Property and Access to Im/material Goods

Author : Jessica C. Lai,Antoinette Maget Dominicé
Publisher : Edward Elgar Publishing
Page : 352 pages
File Size : 53,6 Mb
Release : 2016-07-27
Category : Law
ISBN : 9781784716622

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Intellectual Property and Access to Im/material Goods by Jessica C. Lai,Antoinette Maget Dominicé Pdf

Traditionally, in order to be protected intellectual property goods have almost always needed to be embodied or materialised (and – to a certain extent – to be used and enjoyed), regardless of whether they were copyrighted works, patented inventions or trademarks. This book examines the relationship between intellectual property and its physical embodiments and materialisations, with a focus on the issue of access and the challenges of new technologies. Expert contributors explore how these problems can re-shape our theoretical notion of the intangible and the tangible and how this can have serious consequences for access to intellectual property goods.

Transforming Biodiversity Governance

Author : Ingrid J. Visseren-Hamakers,Marcel T. J. Kok
Publisher : Cambridge University Press
Page : 389 pages
File Size : 49,9 Mb
Release : 2022-06-16
Category : Law
ISBN : 9781108479745

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Transforming Biodiversity Governance by Ingrid J. Visseren-Hamakers,Marcel T. J. Kok Pdf

A multidisciplinary approach to transforming biodiversity governance to combat the failure of current efforts and halt biodiversity loss.

Genetic Inventions, Intellectual Property Rights and Licensing Practices Evidence and Policies

Author : OECD
Publisher : OECD Publishing
Page : 112 pages
File Size : 51,8 Mb
Release : 2003-01-21
Category : Electronic
ISBN : 9789264034730

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Genetic Inventions, Intellectual Property Rights and Licensing Practices Evidence and Policies by OECD Pdf

Few topics in the life sciences today provoke as much debate as the availability of patent protection on "genetic inventions". Some hold that protection is essential to encourage innovation and development of new products. Others argue that patents ...

BIOTECHNOLOGY - Volume XII

Author : Horst W. Doelle,J. Stefan Rokem,Marin Berovic
Publisher : EOLSS Publications
Page : 378 pages
File Size : 48,8 Mb
Release : 2009-11-16
Category : Electronic
ISBN : 9781848262669

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BIOTECHNOLOGY - Volume XII by Horst W. Doelle,J. Stefan Rokem,Marin Berovic Pdf

This Encyclopedia of Biotechnology is a component of the global Encyclopedia of Life Support Systems (EOLSS), which is an integrated compendium of twenty one Encyclopedias. Biotechnology draws on the pure biological sciences (genetics, animal cell culture, molecular biology, microbiology, biochemistry, embryology, cell biology) and in many instances is also dependent on knowledge and methods from outside the sphere of biology (chemical engineering, bioprocess engineering, information technology, biorobotics). This 15-volume set contains several chapters, each of size 5000-30000 words, with perspectives, applications and extensive illustrations. It carries state-of-the-art knowledge in the field and is aimed, by virtue of the several applications, at the following five major target audiences: University and College Students, Educators, Professional Practitioners, Research Personnel and Policy Analysts, Managers, and Decision Makers and NGOs.