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Papers by Alessandro Stasi
Food and Drug Law Journal Volume 75, Number 3, 2021
This Article attempts to clarify the regulatory rationale behind FDA’s guidance for industry #187... more This Article attempts to clarify the regulatory rationale behind FDA’s guidance for industry #187 on genome-edited animals. It also addresses a critical gap in the literature: few scholars have evaluated the risks associated with genome editing in animals from a legal perspective, and none have assessed the question of whether the regulation of intentional genomic alterations in animals is in line with current scientific and technological standards. The Article comes to the conclusion that FDA should continue to use the reasonable set of criteria it has laid down in the guidance for industry #187 and evaluate intentional genomic alterations in animals as a new animal drug. Some policy recommendations are also suggested in this study for further development.
Journal of Law and Medicine 26(4):866-873, 2019
The discovery of CRISPR systems has been one of the most exciting developments in the field of ge... more The discovery of CRISPR systems has been one of the most exciting developments in the field of genetics in the past decade. The recent proliferation of intellectual property rights for CRISPR genome editing technology carries the risk of potential bottlenecks for further basic biological research and development of commercial products. To make CRISPR-based technology widely available, the reliance by the industry on efficient methods of collective management of intellectual property rights through patent pools seems inevitable. A packager of patent pools could be used as a mechanism to facilitate transactions in the market for technology and allow interested parties to deal with a single entity. This article argues that, while a global licensing platform could be effectively achieved in non-therapeutic applications of genome editing, it is questionable whether patent pooling would provide the ideal balance of incentive and reward for CRISPR genome editing technologies for human gene therapy.
Clinical Medicine Insights Reproductive Health, 2017
The National Legislative Assembly of Thailand has enacted on February 19, 2015 the Protection for... more The National Legislative Assembly of Thailand has enacted on February 19, 2015 the Protection for Children Born through Assisted Reproductive Technologies Act (ART Act). Its primary objective aims at protecting children born through assisted reproductive technologies and providing the legal procedures that the intended parents must follow. The focus of this article is to discuss the ongoing issues involving assisted reproduction in Thailand. After reviewing the past legal framework surrounding surrogate motherhood and the downsides of the assisted reproductive technology market in Thailand, the article will discuss the new ART Act and its regulatory framework. It will conclude that although the new law contains some flaws and limitations, it has so far been successful in tackling surrogacy trafficking and preventing reproductive scandals from occurring again.
Legal constraints and high costs on access to technologies have led an increasing number of patie... more Legal constraints and high costs on access to technologies have led an increasing number of patients to cross international borders to have children. This phenomenon has rapidly increased in the past few years and Thailand has become one of the major international commercial surrogacy destinations providing assisted reproductive services to individuals from all over the world at affordable costs. Most of the time, reproductive agreements have lead to a positive outcome satisfying all parties involved: intended parents, gestational carriers, private clinics and agencies. In some cases, however, reproductive arrangements have given rise to legal issues and generated controversies in terms of protection of intended children, legal parenthood and enforceability. In order to minimize some of these undesired outcomes, Thai authorities should enforce new legislations to cope with this issue, potentially using United Kingdom or Israel as model. The new legal framework should balance all parties' interests and guarantee a regulated way of engaging in surrogacy in the child's interest.
The reasonable person is a legal fiction of normative appeal that plays an important role in many... more The reasonable person is a legal fiction of normative appeal that plays an important role in many different areas of private law, public law and criminal law. Such standard is present in both contract and tort law. In the area of contract law, it can be used to determine contractual intent, breach of the standard of care or fairness of terms and conditions. In tort law, the reasonable person standard is applied to assess possible negligence. The reasonable person standard is based on the broader concept of reasonableness, which is used to derive various open ended legal expressions. Even though terms such as reasonable doubt, reasonable decision-making and reasonable care have different meanings, the concept of reasonableness acts as a common thread linking these instances of use. This paper attempts to convey an understanding of the reasonable person standard as it is applied in the civil law systems of Asian countries: who is the reasonable person and how can the reasonableness or " prudence " of his/her conduct be analyzed? After addressing these issues, the paper will analyze the application of the reasonable person standard in contract law and tort law of Asian civil law jurisdictions with a special focus on the legislation of Thailand, Japan, and the Philippines.
Books by Alessandro Stasi
Springer, 2021
This book is centered around the major issues relating to criminal law in Thailand and aims to of... more This book is centered around the major issues relating to criminal law in Thailand and aims to offer a detailed and systematic overview of the Thai criminal justice system. It is designed as a traditional textbook of criminal law which provides a succinct focused coverage of all the relevant aspects of laws, judgments, and legal reforms in a concise and readable form. Although all topics have been previously treated in the Thai language, this is the first and most comprehensive work in the English language about Thai criminal law. The book covers not only the legal system, starting from the Penal Code of 1908 and emphasizing the substantial changes that have been introduced in the past decades, but also the deep influence of doctrine and case law. It is built up in several layers, starting from the general rule, to gradually examine the more specific ones. The book begins with the elementary legal concepts to be learned by the reader, by defining the fundamental principles underlying the Thai criminal system and outlining its objectives. It then extensively describes the main offences under the Thai Penal Code and classifies those breaches of law which are crimes from those which are merely illegal without being criminal.
This book offers a general framework for understanding the main concepts, rules, and institutions... more This book offers a general framework for understanding the main concepts, rules, and institutions of the Thai legal system. It details the history of the codification of the Civil and Commercial Code and provides the reader with valuable information about the main principles which regulate relations between private individuals. The material in the book is presented in a clear and easily understandable manner, proceeding from the general principles of law and gradually moving on to the more specific ones. The text is presented in such a way as to highlight not only what private law is, but also how private law works, and why it works the way it does. Topics covered include general rules of law, the law of obligations and contracts, the management of affairs without mandate and unjustified benefits, the law of property, family law and the law of inheritance.
Elements of Thai Civil Law is meant to serve as an introduction to the study of legal concepts an... more Elements of Thai Civil Law is meant to serve as an introduction to the study of legal concepts and legal principles that apply to Thai civil law. It is designed to provide a concise and systematic overview of the norms regulating legal relationships between private persons in a clear and straightforward style that is understandable to readers unused to legal phraseology. Each chapter gives a detailed analysis of a particular area of Thai civil law as well as numerous examples of the main issues encountered in a legal practice. Subject coverage includes: the law of obligations, property law, family law and succession.
Principles of Thai Business Law is aimed at students, researchers, and practitioners who wish to ... more Principles of Thai Business Law is aimed at students, researchers, and practitioners who wish to familiarize themselves with the legal environment for their academic or professional activities. It offers both a comprehensive overview and selected details of contemporary business law in Thailand in a clear and straightforward manner. The main goal is to provide an understanding of the initial techniques of legal reasoning and legal analysis, legal institutions, concepts, and processes of the Thai legal system.
The book is built up in several layers, starting from the general rule to the gradually more specific ones. Chapters encompass not only the legal system, starting from the Civil and Commercial Code and emphasizing the substantial changes that have been introduced in the past decades, but also the deep influence of doctrine and case law. The areas of business law covered include legal persons, things, property and real rights, intellectual property, contract, tort, businesses and companies, and employment law—a knowledge of which is essential in doing business in Thailand.
Food and Drug Law Journal Volume 75, Number 3, 2021
This Article attempts to clarify the regulatory rationale behind FDA’s guidance for industry #187... more This Article attempts to clarify the regulatory rationale behind FDA’s guidance for industry #187 on genome-edited animals. It also addresses a critical gap in the literature: few scholars have evaluated the risks associated with genome editing in animals from a legal perspective, and none have assessed the question of whether the regulation of intentional genomic alterations in animals is in line with current scientific and technological standards. The Article comes to the conclusion that FDA should continue to use the reasonable set of criteria it has laid down in the guidance for industry #187 and evaluate intentional genomic alterations in animals as a new animal drug. Some policy recommendations are also suggested in this study for further development.
Journal of Law and Medicine 26(4):866-873, 2019
The discovery of CRISPR systems has been one of the most exciting developments in the field of ge... more The discovery of CRISPR systems has been one of the most exciting developments in the field of genetics in the past decade. The recent proliferation of intellectual property rights for CRISPR genome editing technology carries the risk of potential bottlenecks for further basic biological research and development of commercial products. To make CRISPR-based technology widely available, the reliance by the industry on efficient methods of collective management of intellectual property rights through patent pools seems inevitable. A packager of patent pools could be used as a mechanism to facilitate transactions in the market for technology and allow interested parties to deal with a single entity. This article argues that, while a global licensing platform could be effectively achieved in non-therapeutic applications of genome editing, it is questionable whether patent pooling would provide the ideal balance of incentive and reward for CRISPR genome editing technologies for human gene therapy.
Clinical Medicine Insights Reproductive Health, 2017
The National Legislative Assembly of Thailand has enacted on February 19, 2015 the Protection for... more The National Legislative Assembly of Thailand has enacted on February 19, 2015 the Protection for Children Born through Assisted Reproductive Technologies Act (ART Act). Its primary objective aims at protecting children born through assisted reproductive technologies and providing the legal procedures that the intended parents must follow. The focus of this article is to discuss the ongoing issues involving assisted reproduction in Thailand. After reviewing the past legal framework surrounding surrogate motherhood and the downsides of the assisted reproductive technology market in Thailand, the article will discuss the new ART Act and its regulatory framework. It will conclude that although the new law contains some flaws and limitations, it has so far been successful in tackling surrogacy trafficking and preventing reproductive scandals from occurring again.
Legal constraints and high costs on access to technologies have led an increasing number of patie... more Legal constraints and high costs on access to technologies have led an increasing number of patients to cross international borders to have children. This phenomenon has rapidly increased in the past few years and Thailand has become one of the major international commercial surrogacy destinations providing assisted reproductive services to individuals from all over the world at affordable costs. Most of the time, reproductive agreements have lead to a positive outcome satisfying all parties involved: intended parents, gestational carriers, private clinics and agencies. In some cases, however, reproductive arrangements have given rise to legal issues and generated controversies in terms of protection of intended children, legal parenthood and enforceability. In order to minimize some of these undesired outcomes, Thai authorities should enforce new legislations to cope with this issue, potentially using United Kingdom or Israel as model. The new legal framework should balance all parties' interests and guarantee a regulated way of engaging in surrogacy in the child's interest.
The reasonable person is a legal fiction of normative appeal that plays an important role in many... more The reasonable person is a legal fiction of normative appeal that plays an important role in many different areas of private law, public law and criminal law. Such standard is present in both contract and tort law. In the area of contract law, it can be used to determine contractual intent, breach of the standard of care or fairness of terms and conditions. In tort law, the reasonable person standard is applied to assess possible negligence. The reasonable person standard is based on the broader concept of reasonableness, which is used to derive various open ended legal expressions. Even though terms such as reasonable doubt, reasonable decision-making and reasonable care have different meanings, the concept of reasonableness acts as a common thread linking these instances of use. This paper attempts to convey an understanding of the reasonable person standard as it is applied in the civil law systems of Asian countries: who is the reasonable person and how can the reasonableness or " prudence " of his/her conduct be analyzed? After addressing these issues, the paper will analyze the application of the reasonable person standard in contract law and tort law of Asian civil law jurisdictions with a special focus on the legislation of Thailand, Japan, and the Philippines.
Springer, 2021
This book is centered around the major issues relating to criminal law in Thailand and aims to of... more This book is centered around the major issues relating to criminal law in Thailand and aims to offer a detailed and systematic overview of the Thai criminal justice system. It is designed as a traditional textbook of criminal law which provides a succinct focused coverage of all the relevant aspects of laws, judgments, and legal reforms in a concise and readable form. Although all topics have been previously treated in the Thai language, this is the first and most comprehensive work in the English language about Thai criminal law. The book covers not only the legal system, starting from the Penal Code of 1908 and emphasizing the substantial changes that have been introduced in the past decades, but also the deep influence of doctrine and case law. It is built up in several layers, starting from the general rule, to gradually examine the more specific ones. The book begins with the elementary legal concepts to be learned by the reader, by defining the fundamental principles underlying the Thai criminal system and outlining its objectives. It then extensively describes the main offences under the Thai Penal Code and classifies those breaches of law which are crimes from those which are merely illegal without being criminal.
This book offers a general framework for understanding the main concepts, rules, and institutions... more This book offers a general framework for understanding the main concepts, rules, and institutions of the Thai legal system. It details the history of the codification of the Civil and Commercial Code and provides the reader with valuable information about the main principles which regulate relations between private individuals. The material in the book is presented in a clear and easily understandable manner, proceeding from the general principles of law and gradually moving on to the more specific ones. The text is presented in such a way as to highlight not only what private law is, but also how private law works, and why it works the way it does. Topics covered include general rules of law, the law of obligations and contracts, the management of affairs without mandate and unjustified benefits, the law of property, family law and the law of inheritance.
Elements of Thai Civil Law is meant to serve as an introduction to the study of legal concepts an... more Elements of Thai Civil Law is meant to serve as an introduction to the study of legal concepts and legal principles that apply to Thai civil law. It is designed to provide a concise and systematic overview of the norms regulating legal relationships between private persons in a clear and straightforward style that is understandable to readers unused to legal phraseology. Each chapter gives a detailed analysis of a particular area of Thai civil law as well as numerous examples of the main issues encountered in a legal practice. Subject coverage includes: the law of obligations, property law, family law and succession.
Principles of Thai Business Law is aimed at students, researchers, and practitioners who wish to ... more Principles of Thai Business Law is aimed at students, researchers, and practitioners who wish to familiarize themselves with the legal environment for their academic or professional activities. It offers both a comprehensive overview and selected details of contemporary business law in Thailand in a clear and straightforward manner. The main goal is to provide an understanding of the initial techniques of legal reasoning and legal analysis, legal institutions, concepts, and processes of the Thai legal system.
The book is built up in several layers, starting from the general rule to the gradually more specific ones. Chapters encompass not only the legal system, starting from the Civil and Commercial Code and emphasizing the substantial changes that have been introduced in the past decades, but also the deep influence of doctrine and case law. The areas of business law covered include legal persons, things, property and real rights, intellectual property, contract, tort, businesses and companies, and employment law—a knowledge of which is essential in doing business in Thailand.