European Union Health Law 4th edition

Medical Law

European Union Health Law 4th edition

By Herman Nys
Kluwer Law International August 2023

Specifications

ISBN-13
9789403512570
Publisher
Kluwer Law International
Publication
August 2023
Format
Paperback
Jurisdiction
Netherlands ? Countri(es) for reference only
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Derived from the renowned multi-volume International Encyclopaedia of Laws, this convenient volume provides comprehensive analysis of the law at EU level affecting the physician-patient relationship and the interaction of physicians with other healthcare providers and the healthcare system.

Although the legal aspects of healthcare in Europe most often fall under national law, the past two decades have witnessed the emergence of a distinctive field of EU health law with its own underlying principles and structural coherence, founded in a series of directives and CJEU decisions. This book examines the areas in which EU law now must be taken into account in healthcare, including aspects of patients’ rights, recognition of professional qualifications and minimum training conditions, professional rules of conduct, clinical trials and investigations of medicinal products and medical devices, health and genetic data, and beginning and end of life issues.

Succinct and practical, this book will prove to be of great value to professional organizations of physicians, nurses, hospitals, and relevant government agencies. Lawyers representing parties with interests in the European Union will welcome this very useful guide, and academics and researchers will appreciate its comparative value as a contribution to the study of health law and medical law in the international context.

Table of Contents

List of Abbreviations
General Introduction
§1. MEDICAL LAW AND HEALTH LAW
§2. MEDICAL LAW AND HEALTH LAW IN THE EU
§3. EUROPEAN UNION HEALTH LAW OR EU HEALTH LAW
I. EU Biomedical Law
II. EU Health Law
§4. THE CONTENTS OF EU HEALTH LAW IN THIS MONOGRAPH
Part I. Definitions
Chapter 1. Definition of Healthcare, Medical Care and Health Services in EU Law
§1. ARE HEALTHCARE AND MEDICAL CARE SYNONYMOUS IN EU HEALTH LAW?
I. Healthcare
II. Medical Care
§2. HEALTH SERVICES
I. Services to Assess, Maintain or Restore the State of Health of a Patient
II. Prescription, Dispensation and Provision of Medicinal Products and Medical Devices
A. Medicinal Product
B. Medical Device
C. Health Technology
III. Freedom of Member States to Determine Health Services
A. The Selling of Contact Lenses Is Not a Health Service
B. An Optician’s Shop Is Not a Health Service
C. Pharmaceutical Activities Are Health Services
1. Health Services Include Pharmaceutical Services
2. All Pharmaceutical Services Are Health Services
D. Pharmacies Are Health Services
E. Dental Services Are Health Services
F. Day and Night Reception Centres for the Elderly
G. The Administration of Medication by a Nurse
H. Sports or Fitness Clubs Are Not Health Services
Chapter 2. The Concept of Health Professionals in EU Law
§1. NOT LIMITED TO REGULATED PROFESSIONS
§2. MEDICAL, ALLIED AND PHARMACEUTICAL PROFESSIONS
§3. LARGE MARGIN OF DISCRETION FOR MEMBER STATES TO DETERMINE A MEDICAL OR A PARAMEDICAL PROFESSION
I. Opticians
II. Physiotherapy
A. General Observation
B. Physiotherapy and Disturbance Field Diagnostics (Method of Treatment Alternative to Traditional M
C. Physiotherapy and Osteopathy (Non-conventional Therapy)
D. Psychotherapy
Part II. Access and Pursuit of the Healthcare Professions
Chapter 1. The Mutual Recognition of Professional Qualifications
§1. PURPOSE
§2. EFFECTS OF RECOGNITION
§3. THE EUROPEAN PROFESSIONAL CARD
I. Limited Implementation of EPC for the Healthcare Professions
II. Application for an EPC and Creation of an IMI File
III. Processing and Access to Data Regarding the EPC (Prohibition and Restriction of Activities)
IV. Verification of the Authenticity and Validity of an EPC by Third Parties
§4. PARTIAL ACCESS
§5. PROPORTIONALITY PRINCIPLE AND PROPORTIONALITY TEST
Chapter 2. Free Provision of Services
§1. PRINCIPLE OF FREE PROVISION OF SERVICES
I. No Restriction of Free Provision of Services
II. Subject to Professional Rules Directly Linked to Professional Qualifications
III. Exemption from Authorization by, Registration with or Membership of a Professional Organization
§2. DECLARATION TO BE MADE IN ADVANCE
§3. USE OF THE PROFESSIONAL TITLE OF THE MEMBER STATE OF ESTABLISHMENT
§4. PRIOR CHECK OF PROFESSIONAL QUALIFICATIONS
§5. ADMINISTRATIVE COOPERATION IN THE EVENT OF JUSTIFIED DOUBTS OR COMPLAINTS
§6. INFORMATION TO BE GIVEN TO THE RECIPIENTS OF THE SERVICE
Chapter 3. Freedom of Establishment Through Recognition on the Basis of Coordination of Minimum Trai
§1. DOCTORS OF MEDICINE
I. Principle of Automatic Recognition
II. (Admission to) Basic Medical Training
III. (Admission to) Specialist Medical Training
IV. Types of Specialist Medical Training
V. Specific Training in General Medical Practice
VI. Pursuit of the Professional Activities of General Practitioners
§2. NURSES RESPONSIBLE FOR GENERAL CARE
I. Principle of Automatic Recognition
II. Training of Nurses Responsible for General Care
§3. DENTAL PRACTITIONERS
I. Principle of Automatic Recognition
II. Basic Dental Training
III. Specialist Dental Training
IV. Pursuit of the Professional Activities of Dental Practitioners
§4. MIDWIVES
I. The Training of Midwives
II. Procedures for the Automatic Recognition of Evidence of Formal Qualifications as a Midwife
III. Pursuit of the Professional Activities of a Midwife
§5. PHARMACISTS
I. Principle of Automatic Recognition
II. Training as a Pharmacist
III. Pursuit of the Professional Activities of a Pharmacist
Chapter 4. Freedom of Establishment Through the General System for the Recognition of Evidence of Tr
Chapter 5. Common Provision on Establishment: Use of Professional Titles
Chapter 6. Detailed Rules for Pursuing the Profession
§1. KNOWLEDGE OF LANGUAGES
§2. USE OF ACADEMIC TITLES
§3. APPROVAL BY HEALTH INSURANCE FUNDS FOR DOCTORS AND DENTAL PRACTITIONERS
Chapter 7. Exchange of Information Regarding Disciplinary Action and Criminal Sanctions and Alert Me
§1. EXCHANGE OF INFORMATION REGARDING DISCIPLINARY ACTION AND CRIMINAL SANCTIONS
§2. ALERT MECHANISM
Part III. The Practice of the Healthcare Professions
Chapter 1. The (Illegal) Practice of Medical Acts
§1. OSTEOPATHY
§2. EYE EXAMINATIONS
Chapter 2. Professional Rules of Conduct
§1. SINGLE-PRACTICE RULE
§2. ADVERTISING FOR MEDICAL SERVICES
I. Legal Prohibition of Advertising
II. Prohibition by National Disciplinary Rules
§3. MEDICAL FEES
Part IV. Patients’ Rights in EU Law
Chapter 1. Who Is a Patient in EU Law?
Chapter 2. Patients’ Rights in EU Law in General
§1. INTRODUCTION
§2. PATIENTS’ RIGHTS IN THE CHARTER OF FUNDAMENTAL RIGHTS OF THE EU
I. Introduction
II. Free and Informed Consent (Articles 3.1. and 3.2a Charter)
III. Right to Privacy and Right to Data Protection
IV. Right of Access to Preventive Healthcare and to Benefit from Medical Treatment
§3. PATIENTS’ RIGHTS IN SECONDARY EU LAW
I. Right to Report Suspected Side Effects of Medicinal Products
II. Right to Report Suspected Adverse Reactions of Medicinal Products
III. Right to Receive Information Regarding Implantable Medical Devices on an Implant Card
§4. PATIENTS’ RIGHTS IN EU SOFT LAW DOCUMENTS
I. Documents Approved by the European Parliament
A. European Charter on the Rights of the Patient
B. European Charter for Children in Hospital
II. The European Charter of Patients’ Rights
A. Introductory Remarks
B. European Charter of Patients’ Rights: Part One – Fundamental Rights
C. European Charter of Patients’ Rights: Part Two – Fourteen Patients’ Rights
1. Article 1 Right to Preventive Measures
2. Article 2 Right of Access
3. Article 3 Right to Information
4. Article 4 Right to Consent
5. Article 5 Right to Free Choice
6. Article 6 Right to Privacy and Confidentiality
7. Article 7 Right to Respect of Patients’ Time
8. Article 8 Right to the Observance of Quality Standards
9. Article 9 Right to Safety
10. Article 10 Right to Innovation
11. Article 11 Right to Avoid Unnecessary Suffering and Pain
12. Article 12 Right to Personalized Treatment
13. Article 13 Right to Complain
14. Article 14 Right to Compensation
D. European Charter of Patients’ Rights: Part Three – Rights of Active Citizenship
E. European Charter of Patients’ Rights: Part Four – Guidelines for Implementing the Charter
III. Opinion on ‘Patients’ Rights’ of the European Economic and Social Committee
A. Introduction
B. Rights of Patients
1. Right to Information
2. Right to Free and Informed Consent
3. Right to Dignity
4. Other Individual Rights
C. Recommendations for Implementing Patients’ Rights
D. Towards an Affirmation of Collective Rights
IV. Patient’s Rights in the Interinstitutional Proclamation on the European Pillar of Social Right
Chapter 3. Patients’ Rights and the Cross-Border Healthcare Directive
§1. THE PATIENTS’ RIGHT TO HEALTHCARE
I. The Patients’ Right to Healthcare
A. The Patients’ Right to Receive Healthcare in Another Member State
B. The Special Case of Access to Organs for Transplantation
§2. PATIENTS’ RIGHTS TO INFORMATION
I. The Patients’ Right to Information with Regard to Reimbursement
II. The Patients’ Right to Information Regarding the Nature of Healthcare and the Circumstances in
A. Information on Request of the Patient by the NCP of the Member State of Treatment
1. Relevant Information on the Standards and Guidelines on Quality of Safety
2. Information on Supervision and Assessment of Healthcare Providers
3. Information on the Accessibility of Hospitals for Persons with Disabilities
4. Information on a Specific Provider’s Right to Provide Services370
5. Information on Patients’ Rights, Complaints Procedures and Mechanisms for Seeking Remedies
6. Information on the Legal and Administrative Options Available to Settle Disputes, Including in th
7. Information on NCP in Other Member States
8. Language in Which Information Is Provided by NCP
B. Information to Be Provided by Healthcare Providers
§3. THE PATIENTS’ RIGHT TO HEALTHCARE THAT IS SAFE AND OF GOOD QUALITY
I. Healthcare Corresponding with National and Union Quality and Safety Standards
II. Quality and Safety as a Justification for Prior Authorization
A. The Treatment Presents a Particular Risk for the Patient or the Population
B. Serious and Specific Concerns Relating to the Quality or Safety of the Care Provided by a Healthc
III. Quality and Safety as a Justification to Refuse a Prior Authorization
A. The Patient Will Be Exposed to a Safety Risk
B. The General Public Will Be Exposed to a Substantial Safety Hazard
C. Concerns Regarding the Quality and Safety of the Care Provided by a Healthcare Provider
IV. Healthcare Within a Time Limit Which Is Medically Justifiable and Religious Beliefs
§4. THE PATIENTS’ RIGHT TO COMPLAIN
§5. THE PATIENTS’ RIGHT TO RECEIVE COMPENSATION FOR DAMAGES
§6. THE PATIENTS’ RIGHT TO RESPECT OF PRIVATE LIFE
§7. THE PATIENTS’ RIGHT TO A MEDICAL RECORD AND ACCESS TO IT
§8. THE PATIENTS’ RIGHT TO RECOGNITION OF A PRESCRIPTION FOR A MEDICINAL PRODUCT
Part V. The Physician-Patient Relationship in Specific Terms in EU Law
Chapter 1. Clinical Trials on Medicinal Products for Human Use
§1. INTRODUCTION
§2. FIELD OF APPLICATION OF THE CLINICAL TRIALS REGULATION
§3. THE PROTECTION OF SUBJECTS IN CLINICAL TRIALS
I. Prior Authorization
II. General Provisions for the Protection of Subjects
A. General Principle
B. Proportionality Requirement (Balance Benefits-Risks)
C. Informed Consent
1. Express Informed Consent as a Rule
a. Prior Information
i. Basic Rule
ii. Contents of the Information
iii. Understandable to a Layperson
iv. Provided in a Prior Interview
v. In Writing and Available to the Subject
b. Express (Written, Documented and Well-Considered) Consent
2. Implicit Informed Consent for Cluster Trials
3. Withdrawal of Informed Consent
D. Respect for the Rights to Physical and Mental Integrity, Privacy and Data Protection
E. As Little Pain, Discomfort, Fear and Any Other Foreseeable Risk
F. Medical Care under the Responsibility of an Appropriately Qualified Medical Doctor/Dental Practit
G. No Undue Influence
H. Protection of Subjects During the Clinical Trial
1. Conduct in Accordance with the Protocol and Good Clinical Practice Principles
2. Adequate Monitoring of the Conduct of the Clinical Trial
3. Qualified Investigator
4. Suitable Facilities
5. Notification of Serious Breaches of Safety and Rights of a Subject
6. No Costs to Be Borne by the Subject
I. Damage Compensation
J. Summary of the Results of the Clinical Trial Within One Year
III. Clinical Trials on Incapacitated Subjects
A. Incapacitated Subject
B. Informed Consent of the Legally Designated Representative
1. Basic Rule
2. Legally Designated Representative
3. Participation and Signature of the Subject
C. Information to Be Provided to the Incapacitated Person
D. Respect for the Explicit Wish to Refuse or Withdraw Consent
E. No Incentives or Financial Inducements
F. Clinical Trial Is Essential and No Alternative
G. Directly Related to the Medical Condition of the Subject
H. A Direct Benefit for the Subject Or
I. Some Benefit for the Population Represented by the Subject and Directly Related to the Life-Threa
J. Ethical Assessment on the Basis of Expertise in the Relevant Disease
IV. Clinical Trials on Minors
A. Basic Rule
B. Informed Consent
1. Informed Consent of the Legally Designated Representative
2. Participation of the Minor
3. Assent of the Minor
4. Informed Consent of the Minor When He Reaches the Age of Legal Competence
C. Information to Be Provided to the Minor
D. Explicit Wish to Refuse Is Respected
E. No Incentives or Financial Inducements
F. A Medical Condition That Only Occurs in Minors Or
G. Essential to Validate Alternatives
H. Directly Related to the Medical Condition of the Minor or No Alternative but Minors
I. A Direct Benefit for the Minor Or
J. Some Benefit for the Population Represented by the Minor
K. Ethical Assessment on the Basis of Paediatric Expertise
V. Clinical Trials on Pregnant or Breastfeeding Women
VI. Clinical Trials on Other Vulnerable Subjects
VII. Clinical Trials in Emergency Situations
Chapter 2. Clinical Investigations on Medical Devices
§1. FIELD OF APPLICATION
§2. CONDITIONS TO CONDUCT A CLINICAL INVESTIGATION
I. Generally Applicable Conditions
A. Authorization
B. No Negative Opinion of an Ethics Committee
C. Sponsor Established in the EU
D. Proportionality Requirement (Balance Benefits-Risks)
E. Informed Consent of the Subject
F. Contact Details for Further Information
G. Respect for the Rights to Physical and Mental Integrity, to Privacy and to Data Protection
H. As Little Pain, Discomfort, Fear and Any Other Foreseeable Risk
I. Medical Care Under the Responsibility of an Appropriately Qualified Medical Doctor/Dental Practit
J. No Undue Influence
K. The Investigational Device Conforms to the Applicable General Safety and Performance Requirements
L. Carried Out in Accordance with Recognized Ethical Principles
M. Qualified Investigator and Other Personnel
N. Suitable Facilities
O. Damage Compensation
II. Clinical Investigations on Incapacitated Subjects
III. Clinical Investigations on Minors
IV. Clinical Investigations on Pregnant or Breastfeeding Woman
V. Clinical Investigations on Other Vulnerable Subjects
VI. Clinical Investigations in Emergency Situations
Chapter 3. Performance Studies on In Vitro Diagnostic Medical Devices
§1. FIELD OF APPLICATION
§2. CONDITIONS TO CONDUCT A PERFORMANCE STUDY
I. General Requirements Regarding Performance Studies
II. Additional Requirements for Certain (Invasive) Performance Studies
III. Performance Studies on Incapacitated Subjects
IV. Performance Studies on Minors
V. Performance Studies on Pregnant or Breastfeeding Women
VI. Performance Studies on Other Vulnerable Subjects
VII. Performance Studies in Emergency Situations
Chapter 4. Non-interventional Post-Authorization Safety Studies
Chapter 5. Use of Human Embryos for Purposes of Scientific Research
Chapter 6. Genetic Testing
Chapter 7. The Processing of Data Concerning Health and Genetic Data
§1. FIELD OF APPLICATION
§2. PROCESSING OF DATA CONCERNING HEALTH AND GENETIC DATA
I. Prohibition of Processing of Data Concerning Health and Genetic Data
II. Derogation from the Prohibition on Processing of Data Regarding Health and Genetic Data
A. Compliance with the Principles Relating to Processing of Personal Data
B. One of the Following Justifications Applies
1. The Data Subject or the Holder of Parental Responsibility Has Given Explicit Consent
2. Necessity to Protect the Vital Interests of the Data Subject or of Another Natural Person
3. Necessary for Reasons of Substantial Public Interest
4. Necessary for Health-Related Purposes
5. Necessary for Reasons of Public Interest in the Area of Public Health
C. Comply with Member States Further Conditions
III. Rights of the Data Subject
A. The Right to the Protection of Personal Data
B. Information to Be Provided Where Personal Data Are Collected from the Data Subject
C. The Right of Access by the Data Subject
D. Right to Rectification
E. Restricted Right to Erasure of Personal Data Regarding Health of Genetic Data (‘Right to be For
F. Right to Restriction of Processing
G. Restricted Right to Portability of Data Regarding Health or Genetic Data
H. Right Not to be Subject to Automated Individual Decision-Making, Including Profiling
I. Right to Transparent Information and Communication Concerning Rights of the Data Subject
J. Right to Lodge a Complaint and to an Effective Judicial Remedy
K. Right to Be Represented
L. Right to Compensation and Liability
IV. Modalities for the Exercise of the Rights of the Data Subject
V. Data Protection by Design and by Default
VI. Communication of a Personal Data Breach to the Data Subject
VII. Data Protection Impact Assessment
VIII. Designation of a Data Protection Officer When Data Regarding Health or Genetic Data Are Proces
§3. SCIENTIFIC RESEARCH WITH DATA CONCERNING HEALTH OR GENETIC DATA520
I. Introduction
II. Research after Anonymization of the Data
III. Appropriate Safeguards for the Rights and Freedoms of the Data Subject
IV. Explicit Consent
V. Processing for Research Purposes Is in the Public Interest or Has a Legitimate Interest
§4. THE EUROPEAN HEALTH DATA SPACE
A. Rights of Natural Persons and Access and Transmission of Personal Electronic Health Data for Prim
B. Access by Health Professionals
Chapter 8. Transplantation of Organs
Chapter 9. Clinical Use of Tissues and Cells of Human Origin for Human Application
Chapter 10. Rights of the Medical Examinee
§1. RIGHTS OF THE LIVING ORGAN DONOR
§2. RIGHTS OF THE LIVING DONOR OF TISSUE AND CELLS
§3. RIGHTS OF THE DONOR OF BLOOD
Part VI. Beginning and End-of-Life Issues in EU Law
Chapter 1. Beginning of Life
§1. DEFINITION OF THE LEGAL TERM ‘PERSON’ OR ‘INDIVIDUAL’
§2. PROTECTION OF THE HUMAN BODY
§3. DEFINITION AND PROTECTION OF THE HUMAN EMBRYO
§4. IN VITRO FERTILIZATION AND THE BEGINNING OF A PREGNANCY
§5. GAMETES DONATION FOR REPRODUCTION
§6. VOLUNTARY TERMINATION OF PREGNANCY
§7. FORCED STERILIZATION
Chapter 2. End of Life
§1. THE DECEASED ORGAN DONOR
§2. THE DECEASED CELLS AND TISSUE DONOR
§3. ADVANCE DIRECTIVES
§4. EUTHANASIA
Selected Bibliography
Index
Back Cover
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