Governing Intellectual Property Rights Within Publicly Funded Biobanks

Governing Intellectual Property Rights Within Publicly Funded Biobanks PDF

Author: Rajam Neethu

Publisher: Kluwer Law International B.V.

Published: 2019-06-21

Total Pages: 342

ISBN-13: 9403506229

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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.

Biobank-Related Research and Intellectual Property Rights

Biobank-Related Research and Intellectual Property Rights PDF

Author: RAJAM. NEETHU

Publisher:

Published: 2017

Total Pages:

ISBN-13:

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This article concerns the legal and practical challenges related to biobank research in the area of Big Genomic Data and its implications for medical research in Europe in the light of the New Recommendation CM/Rec (2016)6 on research on biological materials of human origin and the Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks, 2016.On the one hand there is the need to exploit the vast amount of resources collected thanks to huge capital investments to meet the demands of health care. This calls for better research partnerships. Health researchers involved in such research use IP rights to protect their research. On the other hand, biobanking involves ethical considerations which govern the management and use of relevant resources. Balancing these two often is a challenge.This article examines the issues related to research partnerships within publicly funded biobanks and focuses on the legal implications of Big Genomic Data research and IP rights within publicly funded biobanks.It examines two central issues in relation to biobanks: ownership and informed consent of participants under the lens of IP law. While IP law policies tend to focus on the promotion of innovation, the contextual discussion on biobanks also calls for the consideration of ethical aspects.

Comparative Issues in the Governance of Research Biobanks

Comparative Issues in the Governance of Research Biobanks PDF

Author: Giovanni Pascuzzi

Publisher: Springer Science & Business Media

Published: 2013-01-30

Total Pages: 334

ISBN-13: 3642331165

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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.

Ethical Issues in Governing Biobanks

Ethical Issues in Governing Biobanks PDF

Author: Nikola Biller-Andorno

Publisher: Routledge

Published: 2016-05-13

Total Pages: 268

ISBN-13: 1317141490

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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.

GDPR and Biobanking

GDPR and Biobanking PDF

Author: Jane Reichel

Publisher: Springer Nature

Published: 2021

Total Pages: 432

ISBN-13: 3030493881

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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. .

Global Genes, Local Concerns

Global Genes, Local Concerns PDF

Author: Timo Minssen

Publisher: Edward Elgar Publishing

Published: 2019

Total Pages: 304

ISBN-13: 1788116194

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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

Governance of Genetic Resources PDF

Author: Catherine Rhodes

Publisher: Edward Elgar Publishing

Published: 2013-11-29

Total Pages: 273

ISBN-13: 1781007004

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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

Advances in Biobanking Practice Through Public and Private Collaborations PDF

Author: Elena Salvaterra

Publisher: Bentham Science Publishers

Published: 2017-07-10

Total Pages: 128

ISBN-13: 1681085100

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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.

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