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Self-Spreading Biotechnology and International Law / Summary of Results
Self-Spreading Biotechnology and International Law / Summary of Results
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1–44
Titelei/Inhaltsverzeichnis
1–44
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47–128
Part One: Self-Spreading Biotechnology Challenges International Law
47–128
47–106
Chapter 1: The Emergence of Self-Spreading Biotechnology
47–106
Details
A. Principles of Genetics and Molecular Biology
I. Basics of Molecular Biology
II. Natural Genetic Change and Inheritance
1. Genetic Mutation
2. Sexual Reproduction
3. Mendel’s Laws of Inheritance
III. Anthropogenic Genetic Change
B. Genome Editing
I. Functioning of Genome Editing
II. Engineered Nuclease Techniques for Site-Specific DNA Cleavage
1. Zinc Finger Nucleases
2. Transcription Activator-Like Effector Nucleases
3. CRISPR-Cas
III. Applications of Genome Editing Techniques
1. Agriculture
2. Basic Research and Medicine
3. Human Germline Editing
4. Industrial Biotechnology
IV. Technical Challenges of CRISPR-Cas Based Genome Editing
1. Off-Target Effects
2. Genetic Mosaicism
3. In Vivo Delivery of CRISPR-Cas Components
V. Environmental Risks and Ethical Concerns Connected to the Use of Genome Editing
1. Alleged Environmental Risks of Genome Editing in Agriculture
2. Risks and Ethical Concerns Relating to Human Genome Editing
C. Engineered Gene Drives
I. Natural Gene Drive Mechanisms
1. Over-Replication Mechanisms
2. Interference Mechanisms
II. Development of Engineered Gene Drives
III. Potential Applications of Engineered Gene Drives
1. Control of Vector-Borne Diseases
a) Modification Drives
b) Suppression Drives
c) Current State of Development
2. Control of Invasive Species
3. Agriculture
IV. Limitations and Risks of Applying Engineered Gene Drives
1. Limitations of Current Gene Drive Techniques
2. Risks Related to Gene Drive Applications
a) Unintended Geographic Spread
b) Intended but Unauthorized Spread
c) Undesired Spread to Non-Target Species
d) Dual Use of Gene Drive Techniques
3. Potential Ecological Effects of Suppressing a Target Species
4. Potential Transboundary Effects of Gene Drives
D. Horizontal Environmental Genetic Alteration Agents (HEGAAs)
E. Self-Spreading Biotechnology Not Involving Genetic Alteration of the Target Organism
I. Use of Genetically Modified Viruses in Plant Pest Control
II. Self-Disseminating Vaccines
III. Mass Releases of Sterile Genetically Modified Insects
IV. Use of Wolbachia to Suppress Mosquito-Vectored Infectious Diseases
F. Summary
107–128
Chapter 2: Concepts and Terms Relevant to Transboundary Harm Caused by Biotechnology
107–128
Details
A. ‘Genetically Modified’ and ‘Living Modified’ Organisms
B. Types of Damage Potentially Caused by LMOs
C. The Distinction Between ‘Responsibility’ and ‘Liability’
D. The ‘Polluter-Pays’ Principle: State or Operator Liability?
E. Standards of Liability: Fault-Based, Objective, Strict, and Absolute Liability
F. Procedural Issues in Enforcing Civil Liability in a Transboundary Context
G. Civil Liability and ‘Administrative Liability’ for Damage to the Environment
H. Summary and Outlook
131–364
Part Two: Prevention of Transboundary Harm
131–364
131–246
Chapter 3: The Regulation of Biotechnology in International Law
131–246
Details
A. The Cartagena Protocol on Biosafety
I. Scope
1. Subject Matter: Living Modified Organisms Obtained Through Modern Biotechnology
a) Living Organism
b) Genetic Material
c) ‘Novel Combination’ of Genetic Material
d) Obtained Through the Use of Modern Biotechnology
aa) ‘Application of in vitro nucleic acid techniques…’
bb) ‘… that overcome natural physiological reproductive or recombination barriers…’
cc) ‘… and that are not techniques used in traditional breeding and selection’
e) Coverage of Certain New and Emerging Techniques
aa) Genome Editing
bb) Engineered Gene Drives
cc) Genetically Modified Viruses
dd) Techniques That Harness Natural Mechanisms of Self-Propagation (Wolbachia)
2. Restriction to Hazardous LMOs?
3. Activities Covered by the Protocol
4. Exemption for Transboundary Movement of LMOs Which Are Pharmaceuticals (Article 5)
5. Conclusions
II. Substantive Provisions
1. Advance Informed Agreement Procedure for Transboundary Movements of LMOs
a) Scope of the AIA Provisions
b) Procedure of Obtaining an Advance Informed Agreement From the Party of Import
c) Risk Assessment
d) Role of the Precautionary Principle in Decision-Making (Article 10(6))
e) Role of Socio-Economic Considerations in Decision-Making (Article 26)
f) Rules for LMOs Intended for Direct Use as Food or Feed, or for Processing (Article 11)
g) Exemption of Contained Use and LMO-FFP: The ‘Intended Use’ Problem
aa) Genuine and Disguised Changes to the Intended Use
bb) Responsibilities of Exporting Parties
cc) Responsibilities of Importing Parties
h) Conclusions
2. Risk Management and Preparedness
a) Risk Management (Article 16)
aa) Obligation to Establish Appropriate Risk Management Measures (para. 1)
bb) Imposition of Preventive Measures Based on Risk Assessment (para. 2)
cc) Prevention of Unintentional Transboundary Movements (para. 3)
(1) The Notion of ‘Unintentional Transboundary Movement’
(2) Obligation to Take ‘Appropriate Measures’
(3) Requirement of a Risk Assessment
dd) Appropriate Observation Period for Any LMO (para. 4)
ee) Obligation to Cooperate (para. 5)
b) Notification in Case of Unintentional Transboundary Movements (Article 17)
c) Illegal Transboundary Movements (Article 25)
aa) Prevention of Illegal Transboundary Movements (para. 1)
bb) Obligation to Dispose of the LMO in Case of an Illegal Transboundary Movement (para. 2)
d) Handling, Transport, Packaging, and Identification (Article 18(1))
e) Conclusions
3. Information-Sharing Through the Biosafety Clearing-House (Article 20)
4. Application in Relation to Non-Parties (Article 24)
5. Upward Derogation (Articles 2(4) and 14)
6. Liability and Redress (Article 27)
III. Conclusions
IV. Excursus: The Relationship Between the Cartagena Protocol and EU Biotechnology Law
1. The European Union’s Legal Framework for GMOs
2. Scope of the GMO Regime in the European Union
3. Compatibility of the European GMO Regime With the Cartagena Protocol
B. Convention on Biological Diversity
I. Jurisdictional Scope (Article 4)
II. Prevention of Transboundary Harm (Article 3)
III. Regulation and Control of Risks Associated With the Use and Release of Living Modified Organisms (Article 8(g))
IV. Provision of Information to Parties Receiving LMOs (Article 19(4))
V. Control of Invasive Alien Species (Article 8(h))
VI. Impact Assessment and Minimization of Adverse Impacts (Article 14(1))
1. Environmental Impact Assessments (lit. a)
2. Procedural Obligations (lit. c and d)
VII. Examination of the Issue of Liability and Redress (Article 14(2))
VIII. Are Eradication Programmes Prohibited Under the CBD?
IX. Conclusions
C. International Trade Law
I. Key Provisions of International Trade Law
II. Agreement on Sanitary and Phytosanitary Measures: Potential Source of Conflict With the Cartagena Protocol
III. Resolving Potential Conflicts Between International Trade Law and the Cartagena Protocol
D. International Plant Protection Convention
E. World Organisation for Animal Health
F. Codex Alimentarius
G. United Nations Convention on the Law of the Sea
H. International Regulations on the Transport of Hazardous Goods
I. International Health Regulations
J. Disarmament and Humanitarian International Law
I. Biological Weapons Convention
II. ENMOD Convention
III. International Humanitarian Law
IV. Conclusions
K. Summary
247–316
Chapter 4: Prevention of Transboundary Harm from Biotechnology Under Customary International Law
247–316
Details
A. The Legal Foundation of the Obligation to Prevent Transboundary Harm
B. Scope of the Obligation to Prevent Transboundary Harm
I. Harm
II. Transboundary Harm
1. ‘Extraterritorial’ Transboundary Harm
2. Harm to Areas Beyond National Jurisdiction
3. Harm to ‘Global Commons’
III. Harm Caused by ‘Physical Consequences’
IV. The Threshold of ‘Significant’ Harm
V. Risk of Harm
VI. Foreseeability of Harm and the Role of Precaution
1. Foreseeability as a Precondition of Prevention
2. The Precautionary Principle (or Approach)
3. Precaution and the Burden of Proof
4. Precaution in the Area of Biosafety
VII. Living Modified Organisms and the Risk of Transboundary Harm
1. Scholarly Opinions
2. Transboundary Effects of LMOs and the Notion of ‘Significant Harm’
3. Anticipation of Risk
VIII. Conclusions
C. Prevention of Transboundary Harm as an Obligation of ‘Due Diligence’
D. Procedural Duties in the Context of Prevention
I. Adoption and Enforcement of Effective Domestic Regulation
II. Environmental Impact (or Risk) Assessment
1. Legal Status
2. Triggers of the Obligation
3. Process and Content of EIAs
4. Standards for Risk Assessments of LMOs/GMOs
5. Conclusions
III. Use of the Best Available Technologies
IV. Cooperation
1. Notification
a) Timing
b) Addressees
c) Content
d) Procedure
2. Exchange of Information
3. Consultations and Negotiations
V. Public Participation
1. Legal Status Under General International Law
2. Public Participation Under the Cartagena Protocol
3. GMOs Under the Aarhus Convention
a) Status Quo
b) The GMO Amendment
c) The Lucca Guidelines
VI. Obligations When Damage Is Imminent or Inevitable
1. Notification in Emergency Situations
2. Obligation to Control and Mitigate Damage
VII. Conclusions
E. Establishing Breaches of the Obligation to Prevent Transboundary Harm
I. Occurrence of Harm as an Indication of a Breach
II. Occurrence of Harm as a Prerequisite of a Breach
III. Relationship Between Procedural and Substantive Obligations of Prevention
F. Summary
317–364
Chapter 5: The International Governance of Engineered Gene Drives
317–364
Details
A. The Development of COP Decision 14/19
B. Legal Status of COP Decision 14/19
I. Functions of COP Decisions
II. COP Decisions as ‘Soft Law’
III. Soft Law Status of Decision 14/19 for Parties to the CBD
IV. Effect on Non-Parties
C. Substance, Context, and Consequences of COP Decision 14/19
I. Precautionary Approach (or Principle)
1. References to Precaution in Earlier COP Decisions
2. Early Deployment of Gene Drives as a Precautionary Measure?
3. Assessment
II. Preconditions for Environmental Releases of Engineered Gene Drives
1. Scientifically Sound Case-by-Case Risk Assessment
a) Status of the Obligation Under International Law
b) The Cartagena Protocol’s AHTEG on Risk Assessment
aa) Guidance on Risk Assessment and Monitoring of LMOs
bb) Additional Guidance on Risk Assessment of Engineered Gene Drives
c) Assessment
2. Appropriate Risk Management Measures
a) Status of the Obligation Under International Law
b) Proposed Risk Management Strategies for Gene Drives as ‘Best Available Techniques’?
aa) Phased Pathway to the Deployment of Gene Drives
bb) Self-Limiting Gene Drives
c) Assessment
3. Free, Prior and Informed Consent
a) Status of the Obligation Under International Law
aa) CBD Mo’otz Kuxtal Voluntary Guidelines
bb) United Nations Declaration on the Rights of Indigenous Peoples
cc) Assessment
b) Excursus: Consent of Individuals as a Human Rights Requirement?
4. Conclusions
III. Safety of Synthetic Biology in Contained Use
1. No Binding International Rules on LMOs in Contained Use
2. The WHO Laboratory Biosafety Manual
3. Excursus: Regulation of Gene Drives in Contained Use in the European Union
4. Containment Standards for Gene Drives Formulated by Researchers
IV. Conclusions
D. Governance of (Potential) Transboundary Spreads
I. Regulation of Transboundary Movements Under the Cartagena Protocol
1. ‘Likely’ Transboundary Movements as ‘Intentional’ Transboundary Movements?
2. Proposal for a Clarification
II. Transboundary Spreads and the Obligation to Prevent Significant Transboundary Harm
E. Summary and Outlook
367–492
Part Three: Operator Liability
367–492
367–460
Chapter 6: The Nagoya – Kuala Lumpur Supplementary Protocol on Redress and Liability
367–460
Details
A. Negotiating History
B. Scope
I. Subject Matter: Living Modified Organisms
1. LMOs That Are Pharmaceuticals for Humans
2. Products Derived From LMOs
II. Damage to Biological Diversity
1. Biological Diversity
2. Adverse Effects on the Conservation and Sustainable Use of Biological Diversity
a) Adverse Effects on Conservation
b) Adverse Effects on Sustainable Use
c) Conclusions
3. Threshold of Damage: ‘Measurable’ and ‘Significant’
4. Risks to Human Health
5. Domestic Criteria to Address Damage
6. Types of Damage Not Addressed by the Supplementary Protocol
7. Conclusions
III. Damage Resulting from LMOs ‘Which Find Their Origin in a Transboundary Movement’ (Article 3(1))
1. Damage Resulting From Authorized Uses Following Intentional Transboundary Movement (Article 3(2))
2. Damage Resulting From Unintentional Movements (Article 3(3))
3. Damage Resulting From Illegal Transboundary Movements (Article 3(3))
4. Damage Resulting From Transboundary Movements From Non-Parties (Article 3(7))
5. Damage Resulting From LMOs in Transit
6. Damaged Caused by Domestic Activities With LMOs
7. Conclusions
IV. Temporal Scope (Article 3(4))
V. Spatial Scope (Article 3(5))
VI. Conclusions
C. Administrative Liability: Response Measures to Redress Damage to Biological Diversity
I. Meaning and Scope of ‘Response Measures’
II. Identification of the Liable Operator
III. Establishment of a Causal Link and Standard of Proof (Article 4)
IV. Implementation of Response Measures (Article 5)
1. Requirement of the Operator to Take Response Measures (para. 1)
2. Responsibilities of the Competent Authority (para. 2)
3. Measures When There Is a Threat of Damage (para. 3)
4. Response Measures Taken Instead of the Responsible Operator (para. 4)
5. Recovery of Expenses by the Competent Authority (para. 5)
6. Reasoning and Legal Review of Decisions (para. 6)
V. Transposition into Domestic Law
1. Provision of ‘Rules and Procedures That Address Damage’ (Article 12(1))
2. Response Measures Already Addressed by Domestic Civil Liability Law (Article 5(7))
3. Implementation of Response Measures ‘in Accordance With Domestic Law’ (Article 5(8))
VI. Conclusions
D. Civil Liability for Material and Personal Injury
I. Scope: Material or Personal Damage Associated with Biodiversity Damage
1. Material or Personal Damage
2. Damage ‘Associated’ With Biodiversity Damage
II. Provision of Adequate Rules and Procedures on Civil Liability (Article 12(2))
III. List of Elements to be Addressed When Developing Civil Liability Law (Article 12(3))
IV. The Meaning of ‘Adequate’ Rules and Procedures
V. Conclusions
VI. Excursus: Draft Guidelines on Civil Liability and Redress
E. Other Provisions
I. Exemptions From Liability, Time and Financial Limits, and Right of Recourse (Articles 6 to 9)
II. Financial Security (Article 10)
1. Right of Parties to Provide for Financial Security (para. 1)
2. Consistency of Financial Security Provisions With Existing International Law (para. 2)
3. Study on Financial Security Mechanisms (para. 3)
4. Conclusions
III. Relationship to State Responsibility (Article 11)
IV. Review of Effectiveness (Article 13)
V. Relationship to Rights and Obligations Under International Law (Article 16)
VI. Governance- and Process-Related Provisions (Articles 14 to 21)
F. Issues Not Addressed by the Supplementary Protocol
I. Transboundary Harm
II. Designation of a Competent Authority
III. Right of Affected Individuals to Request Action
IV. International Coordination of Response Measures
V. Jurisdiction, Applicable Law, and Mutual Recognition and Enforcement of Judgments
G. Excursus: CropLife International’s Implementation Guide
I. Proposed Scope of Domestic Implementing Legislation
II. Identification of the Liable Operator and Exemptions
III. Determination of Damage
IV. Identification of Suitable Response Measures
V. Civil Liability
VI. Conclusions
H. Summary and Outlook
461–476
Chapter 7: A Private Liability Scheme: The ‘Biodiversity Compact’
461–476
Details
A. Membership
B. Scope
C. Causation, Identification of the Party Liable and Standard of Liability
D. Defences
E. Response
F. Financial Caps and Time Limits
G. Claims Process, Arbitration and Enforcement
H. Conclusions
477–492
Chapter 8: A Customary Obligation to Ensure Prompt and Adequate Compensation for Transboundary Damage?
477–492
Details
A. Scope of Application and Use of Terms
B. Requirement to Ensure Prompt and Adequate Compensation
I. The Standard of ‘Prompt and Adequate’ Compensation
II. Imposition of Strict Operator Liability
III. Compensation Funding
C. Obligation to Provide for Response Measures
D. Obligation to Provide for International and Domestic Remedies
E. Relationship to the Law of State Responsibility
F. Legal Status: Emerging Customary International Law?
495–712
Part Four: Responsibility and Liability of States
495–712
495–594
Chapter 9: State Responsibility for Transboundary Harm Caused by Biotechnology
495–594
Details
A. Requirements of the International Responsibility of a State
I. Conduct Consisting of an Action or Omission
II. Attribution
1. Conduct by State Organs and Persons Exercising Governmental Authority
2. Conduct by Persons Instructed or Controlled by the State
a) The Criteria for Attribution Under Article 8 ARSIWA
aa) Instruction
bb) Direction
cc) Control
b) Attribution of Private Activities Causing Transboundary Harm
aa) Regulatory Oversight
bb) Enterprises Owned and Controlled by a State
cc) Research and Development Activities by Public and Governmental Institutions
dd) State-Funded Research and Development Activities
3. Attribution of Conduct Acknowledged and Adopted by the State as Its Own
4. Attribution by Lex Specialis Norms
5. Attribution of Transboundary Harm Through Human Rights Law?
6. Conclusions
III. Breach of an International Obligation
1. International Obligation of Any Origin or Character
2. Conduct in Breach of the Obligation
3. No Requirement of Fault
IV. Circumstances Precluding Wrongfulness
1. Consent
2. Self-Defence
3. Countermeasures
4. Force Majeure
5. Necessity
6. Reparation in the Event of a Circumstance Precluding Wrongfulness
B. Legal Consequences of International Responsibility
I. Obligations of Cessation and Non-Repetition
II. Obligation to Make Full Reparation
1. Recoverable Injury
2. Causation
a) Proof of Causality for Environmental Damage
b) Harm Within the Ambit of the Rule Breached
c) Concurrent Causes of Damage and ‘Shared Responsibility’
3. Forms of Reparation
a) Restitution
aa) Objective of Restitution
bb) Restitution Not Materially Impossible
cc) Disproportionality of Restitution
b) Compensation
aa) Loss of Life and Personal Injury
bb) Property Damage
cc) Loss of Profits or Income
dd) Damage to the Environment
ee) Punitive Damages
ff) Interest
c) Satisfaction
4. Contribution to the Injury and Failure to Mitigate Damage
III. Right to Take Countermeasures
C. Implementation of State Responsibility
I. Standing to Invoke State Responsibility
1. Invocation of Responsibility by Injured States
2. Invocation of Responsibility by Non-Injured States
a) Right of Non-Injured States to Invoke Responsibility
b) Remedies Available to Non-Injured States
II. Claims for Injured Nationals
1. The Law of Diplomatic Protection in Cases of Transboundary Harm
2. The Requirement to Exhaust Local Remedies in Cases of Transboundary Harm
III. Invocation and Enforcement of State Responsibility
1. The Claims Process Envisaged in the ARSIWA
2. Settlement of Disputes
3. Non-Compliance Procedures
a) The Compliance Mechanism Under the Cartagena Protocol
aa) Role, Functions and Procedures
bb) Recent Practice
cc) Legal Status
b) The Relationship Between Non-Compliance Procedures and State Responsibility
4. Conclusions
D. Summary and Outlook
595–616
Chapter 10: Strict State Liability for Transboundary Harm?
595–616
Details
A. International Treaties
B. State Practice
C. Human Rights Law
D. International Law Commission
E. Conclusions
617–664
Chapter 11: Compensation for Environmental Damage in International Law
617–664
Details
A. The Reparative Approach: Mitigating, Evaluating, and Restoring Environmental Damage
I. Types of Response Measures Subject to Reimbursement
1. Mitigation Measures
2. Restoration Measures
3. Evaluation Measures
II. Limitations to Compensability
1. Limitation to ‘Reasonable’ Measures
2. Limitation of Reimbursement to Incremental and Extraordinary Expenses
3. Limitation of Restoration Costs to the Monetary Value of the Impaired Environment?
III. Compensability of ‘Environmental Solidarity Costs’
B. The Compensatory Approach: Monetary Compensation for Damage to the Environment
I. Compensability of ‘Pure’ Environmental Damage
1. The Practice of International Liability Treaties
2. The Stance of the International Law Commission
3. Compensability of Environmental Damage in the United Nations Compensation Commission
4. Compensation of Environmental Damage Before the International Court of Justice (Case of Costa Riva v. Nicaragua)
5. Conclusions
II. Forms of Compensation for Damage to the Environment
1. Compensatory Restoration
2. Monetary Valuation of Environmental Damage
a) Valuation Based on Market Prices
b) Non-Market-Based Valuation Techniques
c) Benefit (Or Value) Transfer Method
d) Costs for ‘Hypothetical’ Response Measures
3. Conclusions
III. Case Study: Valuation of Environmental Damage in the ‘Certain Activities’ Case Before the ICJ
1. Costa Rica’s ‘Ecosystem Services Approach’
2. Nicaragua’s ‘Replacement Costs Approach’
3. Nicaragua’s ‘Corrected Analysis’
4. The Court’s Judgment: ‘Overall Assessment’ of Environmental Damage
5. Assessment
C. Summary
665–670
Concluding Remarks
665–670
Details
671–688
Summary of Results
671–688
Details
Chapter 1: The Emergence of Self-Spreading Biotechnology
Chapter 2: Concepts and Terms Relevant to Transboundary Harm Caused by Biotechnology
Chapter 3: The Regulation of Biotechnology in International Law
Chapter 4: Prevention of Transboundary Harm from Biotechnology Under Customary International Law
Chapter 5: The International Governance of Engineered Gene Drives
Chapter 6: The Nagoya – Kuala Lumpur Supplementary Protocol on Redress and Liability
Chapter 7: A Private Liability Scheme: The ‘Biodiversity Compact’
Chapter 8: A Customary Obligation to Ensure Prompt and Adequate Compensation for Transboundary Damage?
Chapter 9: State Responsibility for Transboundary Harm Caused by Biotechnology
Chapter 10: Strict State Liability for Transboundary Harm?
Chapter 11: Compensation for Environmental Damage in International Law
689–712
Zusammenfassung in deutscher Sprache
689–712
Details
Kapitel 1: Das Aufkommen von sich selbst ausbreitender Biotechnologie
Kapitel 2: Relevante Konzepte und Begriffe im Kontext grenzüberschreitender Schäden durch Biotechnologie
Kapitel 3: Die völkerrechtliche Regulierung der Biotechnologie
Kapitel 4: Verhütung grenzüberschreitender Schäden durch Biotechnologie im Rahmen des Völkergewohnheitsrechts
Kapitel 5: Die internationale Regulierung synthetischer Gene Drives
Kapitel 6: Das Zusatzprotokoll von Nagoya/Kuala Lumpur über Haftung und Wiedergutmachung
Kapitel 7: Ein privatrechtliches Haftungssystem: Der „Biodiversity Compact“
Kapitel 8: Eine gewohnheitsrechtliche Verpflichtung zur Sicherstellung einer unverzüglichen und angemessenen Entschädigung für grenzüberschreitende Schäden?
Kapitel 9: Staatenverantwortlichkeit für durch Biotechnologie verursachte grenzüberschreitende Schäden
Kapitel 10: Staatliche Gefährdungshaftung für grenzüberschreitende Umweltschäden?
Kapitel 11: Ersatzfähigkeit von Umweltschäden im Völkerrecht
713–720
Table of Cases
713–720
Details
721–742
Table of Treaties and Instruments
721–742
Details
743–808
Bibliography
743–808
Details
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Self-Spreading Biotechnology and International Law , page 671 - 688
Summary of Results
Autoren
Felix Beck
DOI
doi.org/10.5771/9783748913528-671
ISBN print: 978-3-8487-7377-0
ISBN online: 978-3-7489-1352-8
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