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Between Ethical Oversight and State Neutrality / Chapter 3: Non-Invasive Prenatal Testing
Between Ethical Oversight and State Neutrality / Chapter 3: Non-Invasive Prenatal Testing
Contents
Chapter
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1–26
Titelei/Inhaltsverzeichnis
1–26
Details
27–48
Introduction
27–48
Details
1. Problem Statement
2. State of Research
3. Research Objectives and Methodology
4. Overview of the Structure
49–174
Chapter 1: Theoretical and Constitutional Foundations
49–174
Details
A. Theoretical Foundations
I. Ethically Controversial Health Technologies
1. Health Technologies and Ethical Pluralism
2. The Bioethical Approach
3. Ethical Concerns in the Field of Reproductive Technologies
a What is Special about Reproductive Technologies: The Question of Moral Status and Personhood
b Preimplantation Genetic Diagnosis and Non-invasive Prenatal Testing
i. Admissibility
ii. Public Funding
II. Between Ethical and Legal Concerns: Ethics and Law as Two Separate Systems
1. Descriptive Separation of Ethics and Law
a A Positivist Approach
b Ethical Concerns Turned Legal
2. Normative Separation of Ethics and Law
a Preservation of Ethical Autonomy and Pluralism
b Ethical Neutrality of the State
c The Separation of Ethics and Law from an Intra-Legal Perspective
B. Constitutional Foundations of the Separation of Ethics and Law
I. Ethical Neutrality of the State in Germany
1. Constitutional Foundations
2. Ethical Neutrality of the State in the Field of Health Technologies
a Neutrality of the State and the Fundamental Right to Personal Freedom and Physical Integrity
b Neutrality of the State and the Statutory Health Insurance
II. Italian Laicity
1. The Principle of Laicity in the Constitution
2. Laicity in the Field of Health Technologies
a Laicity and the Fundamental Right to Health
b The Principle of Laicity in the National Health Service
III. Procedural Principles and Accountability for Reasonableness in England
1. Constitutional Framework
a Procedural Principles and Political Constitutionalism
b A Secular and Neutral State
2. Procedural Legitimacy and Accountability for Reasonableness in the Field of Healthcare Technologies
a Building Consensus
i. Ethics and Law in Courts’ Decisions
ii. Acceptability of Legislation through Procedural Legitimacy
b Judicial Review and Accountability for Reasonableness
i. Procedural Duties and Rights in the NHS
ii. Reasonableness and Relevancy in Judicial Review
iii. Accountability for Reasonableness in the NHS
IV. Comparative Findings
1. Constitutional Framework
2. Coverage and Reimbursement of Ethically Controversial Health Technologies
175–302
Chapter 2: Preimplantation Genetic Diagnosis
175–302
Details
A. Preimplantation Genetic Diagnosis in Germany
I. PGD in the Embryo Protection Act
1. Ethical Approach
2. Initial Uncertainty
a Legislative Proposal and Public Debate
b Case Law
3. Legislative Intervention
a Reform Preparation
i. The Introduction of Three Draft Bills
ii. Opinion of the German Ethics Council
iii. Parliamentary Debates
b Introduction of §3a Embryo Protection Act
c Ethics and Law in PGD Regulation
d PGD Ethics Commissions
i. Procedure before the Ethics Commissions
ii. PGD Commissions before the Administrative Courts
iii. Influence on Patients’ Uptake of PGD
II. PGD in the Statutory Health Insurance
1. Lack of Public Coverage
2. Reform Proposals
B. Preimplantation Genetic Diagnosis in Italy
I. PGD in Law no. 40/2004
1. Ethical Approach
2. Initial Uncertainty
a Ministerial Guidelines and First Case Law
b PGD for Infertile Couples: Tacit Approval of the Constitutional Court
c PGD for Fertile Couples
3. Constitutional Court Intervention
II. PGD in the National Health Service
1. Lack of National Public Coverage
2. Direct Application of Constitutional Principles in the Case Law
C. Preimplantation Genetic Diagnosis in England
I. PGD in the Human Fertilisation and Embryology Act 1990
1. Ethical Approach
2. Initial Uncertainty
a HFEA’s Licensing of PGD
b Case law on PGD
c Emergence of ‘Regulatory Disconnections’
3. Legislative Intervention
a Reform preparation
b The Human Fertilisation and Embryology Act (2008)
II. PGD in the NHS
1. Initial Lack of National Public Coverage
2. Central Commissioning of PGD as Specialised Service
D. Comparative Analysis
I. Development and Instruments of PGD Regulation
1. PGD within the Regulation of Fertility Treatments
2. Role of Case Law and Legislation in the Adoption of PGD Regulation
3. Substantial and Procedural Tools of PGD Regulation
II. Ethical Concerns in PGD Regulation
1. Public Debates and Legislative Process
2. Statutory Texts and Implementation
3. Acceptance of PGD Regulation
III. PGD in the Public Healthcare System
1. Public Funding
2. Influence of Ethical Concerns on Public Funding and Patient Uptake
IV. Coherence with the Normative Framework
1. PGD Regulation and Implementation
2. Access to PGD: The Case of the Ethics Commissions in Germany
3. Public Funding
303–394
Chapter 3: Non-Invasive Prenatal Testing
303–394
Details
A. Non-Invasive Prenatal Testing in Germany
I. NIPT in the Private Sector
II. NIPT in the Statutory Health Insurance
1. Access to Prenatal Testing
a Prenatal Diagnoses in the Statutory Health Insurance
b Right to Know and Right Not to Know
2. The G-BA’s Assessment of NIPT
a Reactions to the Initiation of the Procedure
b Health Technology Assessment
c Consultation and Parliamentary Debate
d Inclusion of NIPT in the Maternity Guidelines
3. Room for Ethical Considerations in the G-BA’s Assessment
B. Non-Invasive Prenatal Testing in Italy
I. NIPT in the Private Sector
II. NIPT in the National Health Service
1. Access to Prenatal Screening and Diagnoses
a Prenatal Screening and Diagnoses in the Essential Levels of Care
b Informed Consent
2. Coverage of NIPT in Different Regional Healthcare Systems
3. Prospective Coverage of NIPT at the National Level
a Guidelines of the Italian National Health Council
b NIPT before the National Commission for the Updating of the Essential Levels of Care
c Criteria for Updating the Essential Levels of Care and Room for Ethical Concerns
C. Non-Invasive Prenatal Testing in England
I. NIPT in the Private Sector
II. NIPT in the NHS
1. Access to Prenatal Screening and Diagnoses
a Prenatal Screening and Diagnoses in the NHS
b Autonomy and Informed Consent
2. Evaluation Procedure before the UK National Screening Committee
a The UK National Screening Committee’s Recommendation
b Reactions to the UK NSC’s Assessment
c Evaluative Implementation of NIPT in the NHS
3. Ethical Considerations in the Assessment Procedure of NIPT
a The Nuffield Council of Bioethics’ Report on NIPT
b Considerations of Ethical Aspects by the UK National Screening Committee
c Room for Ethical Considerations in the Evaluation of Screening Programmes
D. Comparative Analysis
I. NIPT in the Private Sector
II. Public Coverage of Traditional Prenatal Testing
III. Autonomy and Informed Consent
IV. NIPT in the Public Healthcare System
1. Criteria for Access to NIPT
2. Ethical Concerns to Public Funding of NIPT
a Public Debates
b Consideration of Ethical Concerns in the Evaluation Procedure
i. Procedural Aspects
ii. Substantive Elements
c Assessment
i. Compliance with the Normative Framework
ii. Calls for More Consideration of Ethics in the Decision-Making
395–430
Conclusions
395–430
Details
I. Summary of Argumentation
1. Theoretical and Constitutional Foundations
2. Case Studies
II. Legitimately Dealing with Ethical Concerns
1. Operationalisation and Neutrality
2. Between Ethical Concerns and Legitimate Legal Interests
3. Relevance of the Institutional Interplay
4. Ethical Considerations in the Public Funding of Health Technologies
a Neutrality in Coverage Decisions
b Legal and Institutional Settings
5. Towards a Procedural Approach to Neutrality
III. Closing Remarks
431–477
Bibliography
431–477
Details
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Between Ethical Oversight and State Neutrality , page 303 - 394
Chapter 3: Non-Invasive Prenatal Testing
Autoren
Irene Domenici
DOI
doi.org/10.5771/9783748918912-303
ISBN print: 978-3-7560-1363-0
ISBN online: 978-3-7489-1891-2
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