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 book “An Introduction to Legal, Regulatory and Intellectual Property Rights Issues in Biotechnology” covers 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).
About the editor:
Dr. Alessandro Stasi is an Associate Professor in Law and member of the research cluster ‘Technology, Public Policy and Sustainability’ at Mahidol University International College (MUIC), Thailand. He has authored several books and academic articles in leading international journals. Prior to joining Mahidol University International College, he held academic posts at Ramkhamhaeng University and King Mongkut’s Institute of Technology Ladkrabang. Alessandro Stasi also provides advice to private clients, international organizations, and non-governmental organizations. He read Law at the University of Naples Federico II, Italy, and subsequently completed an LLM with Merit and two PhD degrees at the University of Nice Sophia-Antipolis in France.
Dr. Tan Weng Chiang David is a Visiting Professor in Law and member of the research cluster ‘Technology, Public Policy and Sustainability’ at Mahidol University International College (MUIC), Thailand. He completed his Bachelor of Laws degree (honors) from the University of Buckingham in England, Master of Business Administration from the Central Queensland University in Australia and Doctor of Philosophy from the Assumption University in Thailand. His unique combination of academic knowledge and professional experience as a senior legal consultant on commercial and corporate issues, has proven to be an invaluable asset to his employers and students alike.
Keywords:
Biotechnology, USDA, Intellectual Property, Patent, FDA, Genome editing, Human genome project, CRISPR, GMO, Genetic engineering, EPA.
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