Editors: Alessandro Stasi, Tan Weng Chiang David

An Introduction to Legal, Regulatory and Intellectual Property Rights Issues in Biotechnology

eBook: US $49 Special Offer (PDF + Printed Copy): US $78
Printed Copy: US $54
Library License: US $196
ISBN: 978-981-5080-63-6 (Print)
ISBN: 978-981-5080-62-9 (Online)
Year of Publication: 2023
DOI: 10.2174/97898150806291230101

Introduction

Biotechnology, a branch of science and a fast-growing source of developing technologies, has shown immense potential for its utility across all the dimensions of our lives. Its applications range from drugs and therapeutics, industrial, household applications, biofuels, and information technology to almost all resource-based sectors, such as manufacturing, aquaculture, agriculture, and forestry. Biotechnology offers outstanding potential to meet the growing demand for food and energy production in a sustainable way. Recognizing its economic and strategic value, countries have implemented several measures to generate a homegrown biotechnology sector and help science-based companies develop.

This book covers some of the most important legal issues arising in relation to biotechnology. Topics covered in chapters include 1) the historical development of a legal framework sufficient to protect public safety, 2) the current biotechnology regulatory system and the rules directing the primary agencies that regulate the products of biotechnology (namely the FDA, USDA and EPA), 3) the regulation of human genome editing and its impact on health research, 4) law and emerging genome editing technologies from recombinant DNA technology to CRISPR/Cas9 editing, 5) the development of legal principles to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell-lines in medical research, and 6) legal issues arising from the use of genetic engineered plants and animals. The authors have ensured that the contents are easy to understand, making this an accessible reference for a broad range of readers.

This book, therefore, serves as a quick summary of the prominent legal and regulatory issues in the biotech industry for professionals, as well as scholars in legal study programs.

Audience

Professionals in the biotech industry; legal studies students.

Preface

Technology is a useful servant but a dangerous master.

Christian Lous Lange, Historian

Biotechnology, a branch of science and a fast-growing source of developing technologies, has shown immense potential for its utility across all the dimensions of our lives. Its applications range from drugs and therapeutics, industrial, household applications, biofuels, and information technology to almost all resource-based sectors, such as manufacturing, aquaculture, agriculture, and forestry. Biotechnology offers outstanding potential to meet the growing demand for food and energy production in a sustainable way. Recognizing its economic and strategic value, countries have implemented a number of measures to generate a homegrown biotechnology sector and help science-based companies develop.

The chapters cover a multitude of themes and some of the most important legal issues arising in relation to biotechnology, including the historical development of a legal framework sufficient to protect public safety (Chapter 1), the current biotechnology regulatory system and the rules directing the primary agencies that regulate the products of biotechnology, namely the U.S. Food and Drug Administration, the U.S. Department of Agriculture, and the U.S. Environmental Protection Agency (Chapter 2), the regulation of human genome editing and its the impact on health research (Chapter 3), law and emerging genome editing technologies from recombinant DNA to CRISPR/Cas9 (Chapter 4), the development of legal principles to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell-lines in medical research (Chapter 5), and legal issues arising from the use of genetic engineered plants and animals (Chapter 6).

CONSENT FOR PUBLICATION

Not applicable.

CONFLICT OF INTEREST

The author confirms that he has no conflict of interest to declare for this publication.

ACKOWNOLEDGEMENTS

Thanks to Dr. Alexei Blanc, Dr. Nazim Foury, Dr. Pantitcha Maluleem, Dr. Thitirat Witoonchart, Dr. Donatella De Ruggiero, Dr. Sergio De Ruggiero, and Dr. Mike Sunstein for their assistance in preparing the manuscript for publication. Also, I am grateful to Prof. Eugene Ackerman, Prof. Cass Balkin, Prof. Susan Kagan, Prof. Richard Stone and Prof Daniel Dorf for meticulously reviewing the entire text several times and offering valuable suggestions. Many thanks to the numerous academics who helped me with my research, especially John Miles, Robert Stroud, Angela Remondo, Alex Megram, and Rosalind Cook. I want to extend my thanks to Mahidol University International College, the University of Naples Federico II, the Faculty of Law, the Sapienza University of Rome, and the many students who have contributed to the work. And a very special thank you to Alhena and Davide.

Alessandro Stasi
Associate Professor in Law
Mahidol University International College
College in Salaya
Thailand

&

Tan Weng Chiang David
Visiting Professor in Law
Mahidol University International College, College in Salaya
Thailand