Biotech Innovations and Fundamental Rights

Name: Biotech Innovations and Fundamental Rights
Brand: Springer
Price: 106.99 EUR
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Roberto Bin Sara Lorenzon Nicola Lucchi(Editor)

Springer (Publisher)

1st Edition

Published on 13. May 2012

X, 354 pages

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978-88-470-2032-0 (ISBN)

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Intro
Title Page
Copyright Page
Preface
Table of Contents
Part I Biotech Patents
Introduction
The Case against the Privatization of Knowledge: Some Thoughts on the Myriad Genetics Controversy
1 Knowledge as a "Fictitious Commodity"
2 Intellectual Property: Techniques and Ideologies
3 Commodification and Its Discontents: the "Double Movement" Paradigm
4 Is the Human Genome Patentable? The Myriad Genetics Controversy
5 Nature, Artifice and the Legal Construction of Reality: the Decision Association of Molecular Pathology v. USPTO
6 Market Rationality and the Protection of Non-proprietary Interests: the Role of Law
Patentability Requirements of Biotech Inventions at the European Patent Office: Ethical Issues
1 European Patent Office and Patentability Requirements of Biotech Innovations
2 Conclusions
The Right to Access the Benefits of Science and Intellectual Property Rights
1 Introduction
2 Declarations, Covenants and Socio-Economic & Cultural Rights
2.1 The Drafting History of Article 27
2.2 Constitutional Sources
2.3 Evolution of the Original Draft
2.4 The Final Text
2.5 The Rationale for Majority and Minority Votes
3 Political and Legal Cultures, Human Rights and IP Rights
3.1 Positive rights v. Natural Rights
3.2 Intellectual Property Rights as Positive Legal Rights
4 Conclusions
"Ownership and Provenance" of Genetic Material in the Rules on Biotechnological Patents
Biotechnology Patents Norms: Emerging Difficulties
From the Patentability of Living Matter to the Ethics of Biotechnological Innovation: the Person-Body Relationship
1 Introduction
2 Thinking about the Body: an Approach to an Ethic of Biotechnological Innovation
3 Reviving the Person-Body Relationship
4 Whose Body? A Moral Rethinking of the Concepts by Which to Frame the Body's Belonging to Somebody
Issues and Rights in DNA-based Inventions
1 Introduction
2 DNA-based Inventions and Property Rights
3 Expressed sequence Tags and Access to Kwonledge
4 Property Rights and Human Genes
5 Conclusions
Part II Freedom of Scientific Research in Genetics
Bioethics and Freedom of Scientific Research in Gene Therapy and Stem Cell Biology
1 Introduction
2 Clinical Trials Based on Stem Cell Research
3 Ethical Impacts of Stem Cell Research: Cord Blood, Adult Stem Cells and Multipotent Stem Cells from Foetuses
4 Stem Cells from the Human Embryo: Technical and Ethical Issues
5 Stem Cells from a Cloned Human Embryo
6 Limitation of the Freedom of Scientific Research on Embryonic Stem Cells: an Example
7 From Bush to Obama: a New Era from Embryonic Stem Cell Research?
8 Patents on Embryonic Stem Cells: a Second Example of Limitation of Freedom to Research?
9 A Novel Frontier: the iPS Cells
10 Expected Benefits to Patients of iPS Cells
11 Impact of iPS Cells in the Field of Bioethics
12 Patents and iPS
13 Can iPS Generate an Embryo?
14 Conclusions
Freedom of Scientific Research in the Field of Genetics
1 Constitutional Protection and Its Limits
2 Research and Experimentation
3 Limits to Experimentation and Controls of Legality
4 The "Neutrality" of Public Intervention
5 Research, Funding, Neutrality
6 Does the "Right to Research" Have a Constitutional Statute?
Genetic Testing and Authentication of Paternity after Death of the Putative Father: the Bio-history and Its "Costs"
1 Preliminary Observations
2 Extrajudicial Reflections on Genetic Testing to Determine Paternity
3 Certain Preliminary Profiles: Notes on the Relationship between the Human Body and the Person
4 The Issue of Consent by the Relatives of the Alleged Father in the Event of His Death, and the Right to Biological Identity
The Legal Implications of Preimplantation Genetic Diagnosis
1 Introduction
2 Ethical Issues
2.1 Arguments in Favour of PGD
2.2 Arguments against PGD
3 International Human Rights Law and Procreative Autonomy
4 Legal Approaches
4.1 The Prohibitive Approach
4.2 The Cautious Regulatory Approach
4.3 The Liberal Approach
5 Conclusions
Preimplantation Diagnosis of the Embryo: Legislative Inflexibility in vitro and Attempts at Greater Flexibility in vivo
1 Uneven Interpretation of the Law: Initial Rulings Maintaining the Status Quo and the First Misgivings
2 The Decisive "About-turn" and Cancellation of the Ministry of Health Decree (21 July 2004)
3 Pressing ahead by the Court of Salerno, 13 January 2010 (Constitutionally Compliant Interpretation Pushed to Its Maximum Limits)
Some Ethical and Regulatory Aspects Involved in Direct-to-Consumer Genetic Testing (DCGT)
1 Introduction
2 Defining Direct-to-Consumer Genetic Testing
3 Ethical and Legal Concerns about Direct-to-Consumer Genetic Testing (DCGT)
3.1 Questionable Quality of Genetic Testing Services
3.2 Possible Lack of Pre-Test Information and Proper Genetic Counselling
3.3 Is Informed Consent Really Guaranteed?
3.4 Possibility of Non-Consensual Testing
3.5 Direct-to-Consumer Genetic Testing of Minors and Incapacitated Adults
3.6 Problems of Safeguarding Privacy and the Right to Protect Personal Data
3.7 Possible Negative Impact on the Health Care System
4 Regulation of Direct-to-Consumer Genetic Testing and Some Recommendations
4.1 Control of the Quality of DCGT Services
4.2 Information for Prospective Consumers and Pre- and Post-Test Counseling
4.3 Informed Consent
4.4 Privacy and the Right to Protect Personal Data
4.5 Informing the Public
5 Conclusions
Adjusting the Individualistic Framework of Protection in Human Genetic Research
1 Introduction
2 Human genetics' hypertrophy
3 Moulding consent in genetic research
4 Where consent is not enough
5 Threats to equality
6 Conclusions
Xenotransplantation and Human Rights
1 Introduction
2 Rules, Risks and Responsibility
3 Informed Consent
4 The Precautionary Principle
5 Public Health Security and Human Rights
Pharmacogenetics and Fundamental Rights
1 Introduction
2 Human Genetic Heritage as a Common Good
3 Pharmacogenetics, Patentability and Access to Medicines
4 Questions on Patient-Tailored Drugs
5 Pharmacogenetics and the Charter of Fundamental Rights of the European Union
Genetic Research and European Integration
1 Introduction
2 Fundamental Principles of the European Union on the Subject of Genetic Data: Do the Novelties of Lisbon Redraw the Framework of Powers?
3 Derived Law and Open Questions: Directives 46/95/EC and 44/98/EC
3.1 Privacy and Anonymity: the Sacrifices Made for the Right to Health
3.2 "What if I Change My Mind?" Freedom of Scientific Research and Withdrawal of Consent
3.3 Biotech Patenting and European Integration
4 Conclusions
Part III Genetic Research and Protection of Individual Rights
Genetic Data in Forensic Science: Use, Misuse and Abuse
1 Introduction
2 Genes and DNA
3 Human Genetic Diversity
4 Forensic Applications of Criminal Relevance: Genes and Criminal Behavior
5 Forensic Applications of Criminal Relevance: the Police's Racial Catalogs
6 Forensic Applications of Civil Relevance: Genetic Databases and Privacy
7 Conclusions
References
Genetic Research and Rights of the People Involved: from an Individual Approach to an Universal Perspective
1 Introduction
2 The Rights of the People Involved in Genetic Research
2.1 The Individual Perspective: the Consent Issue
2.2 The Familiar Perspective: the Biological Group
2.3 The Population and Universal Perspectives: Genetic Research and Benefit Sharing
3 Conditions of the Balance between Opposite Rights
3.1 Procedural Limits: the Extent of the Consent
3.2 Substantial Limits: the Concept of Human Dignity
4 Conclusions
Towards a Genetic Registry Office?
1 A "Snapshot" of the Latest News in Genetics
2 Pharmacogenetic Cards
2.1 Universal DNA Databases
2.2 Interconnection of Databases and "Cross" Access to Repositories
3 Relevant Legal Issues
3.1 Facets of the Right to Privacy in the Context of Pharmacogenetic Cards
3.2 Genetic Surveillance, Reductionism, Determinism and Prejudice to Democratic States in Universal DNA Databases
3.3 Which Legal Implications for the Interconnections between Databases and "Cross" Access?
4 Wandering around the Future: Landing at a Genetic Registry Office?
Genetic Data Retention and the Italian Discipline of Acquittal: Database Improvement and the Fundamental Rights of the Individual
1 Introduction
2 Sampling DNA and Personal Freedom
3 Genetic Evidence under the Adversarial Trial System
4 Feeding of the DNA Database and Storage of DNA Samples Collected in Criminal Proceedings, under Italian Law and under Supranational Principles
5 The Cases of Genetic Data Deletion Different from the Expiry of the Maximum Period of Storage
6 Deletion of Data, Samples and Profiles Taken from Restricted Persons
7 The Fundamental Rights Affected by the DNA Database Excluding the Presumption of Innocence
Use of Genetic Data for Research Purposes and Consent: Love or Hate? A Proposal of Balance Taking Account of the "SpecificWeight" of the Single Research
1 Premise: the Specifics of Genetic Research
2 The Treatment of Genetic Data for Research Purposes
2.1 The consent of those who provide data as the (nearly always) necessary condition of research: what is the meaning of consent?
2.2 Beyond consent: a principle "eroded" in the name of research interests
3 Genetic Research and Health
4 . . . but (on reflection) is the right to confidentiality "adversely affected"?
5 Variable Terms for a Reasonable Balance
The habeas data in the Genetic Research: Intrinsic Limits and Threats from Outside
1 Introduction
2 The Passage from the Physical Body to the Digital Body
3 The Concept of Genetic Data
4 Is the Biological Sample a (Genetic) Personal Data?
5 Does Anonymization Really Render a Date Impersonal?
6 Conclusions
First Observations on the Right to Development Approach to Informed Consent in Medical and Genetic Research
1 Introduction: Balancing Rights and Interests in Informed Consent
2 International Legislative Framework
3 The Right to Development, from its Proclamation to Its Interpretation
4 Right to Development and Scientific Research: the Claim for Participation
5 Conclusions
Genetic Research and Protection of Individual Rights: a First Approach to the French Model
1 Introduction
2 Key Principles and Individual Rights
3 The French Model for Regulating Biolegal Issues
Access to Genetic Resources in the Practices of States
1 The Biodiversity Convention
2 Access to Genetic Resources
3 Prior Informed Consent
4 Mutually Agreed Terms
5 National Legislation
5.1 National Institutions
5.2 The Prior Informed Consent Principle
6 Case Study Andean Community
7 Conclusions

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Biotech Innovations and Fundamental Rights

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