
Medical Law in Belgium
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Inhalt
- Front Cover
- Half Title
- Title
- Copyright
- The Author
- Table of Contents
- List of Abbreviations
- General Introduction
- Chapter 1. The General Background of the Country
- §1. GEOGRAPHY AND CLIMATE
- §2. POPULATION
- §3. POLITICAL AND JUDICIAL SYSTEM
- §4. POPULATION AND VITAL STATISTICS
- §5. SOCIAL AND CULTURAL VALUES REGARDING HEALTH
- Chapter 2. General Description of the Healthcare System
- §1. GENERAL OVERVIEW OF THE BELGIAN HEALTHCARE SYSTEM
- §2. REGULATION OF THE HEALTHCARE SYSTEM
- §3. FINANCING OF HEALTHCARE
- §4. HEALTH INSURANCE
- Chapter 3. Medical Law
- §1. HISTORICAL NOTE ON THE DEFINITION AND FUNCTIONS OF MEDICAL LAW
- §2. SOURCES OF MEDICAL LAW
- I. International Sources
- II. National Sources
- Part I. The Medical Profession
- Chapter 1. Access to the Medical Profession
- §1. MEDICAL EDUCATION
- I. Historical Note
- II. Constitutional Competence
- III. Undergraduate Medical Education
- IV. Graduate Medical Education
- §2. LICENSING OF GPS AND MEDICAL SPECIALISTS POSTGRADUATE MEDICAL EDUCATION
- §3. MANPOWER PLANNING: FREEDOM OF ESTABLISHMENT
- Chapter 2. Practice of Medicine
- §1. LEGAL CONDITIONS FOR THE PRACTICE OF MEDICINE
- I. Introduction
- II. Healing Arts and Medicine
- III. Legal Monopoly of Physicians
- IV. Legal Conditions for the Practice of Medicine
- A. Legal Diploma
- 1. Exemption from the Legal Diploma
- 2. Assimilation Based on Mutual Recognition
- B. Visa
- 1. Exemption from the Visa
- 2. Withdrawal of the Visa
- 3. Suspension of the Visa
- 4. Restricted Visa
- C. Inscription on the List of the Order of Physicians
- §2. ILLEGAL PRACTICE OF MEDICINE
- I. Legal Definition of the Offence
- II. Medical Activities
- A. General Remarks
- B. Specific Medical Activities
- 1. Preventive Medicine
- 2. Self-Care
- 3. Taking of Blood: Venepunctures
- 4. Radiographies
- 5. Blood Pressure Measuring and the Use of Other Simple Measuring Appliances
- 6. Eye-Examination and the Measuring of Eye Deviations
- 7. Psychoanalysis and Psychotherapy
- 8. Group Therapy
- 9. Acupuncture
- 10. Written and Oral Advice and Recommendations
- 11. Hypnotism
- III. An Unauthorized Person
- IV. In a Habitual Way
- A. The Meaning of Habitual
- B. Exceptions
- 1. Repetition
- 2. Publicity
- 3. Abuse of Titles
- V. Sanctions
- §3. USE OF AUTOMATIC 'EXTERNAL' DEFIBRILLATORS
- §4. NON-CONVENTIONAL PRACTICES IN MEDICINE
- §5. NON-SURGICAL AESTHETIC MEDICINE AND AESTHETIC SURGERY
- I. Conditions to Practise Non-surgical Aesthetic Medicine and Aesthetic Surgery
- II. Publicity and Practice Information
- Chapter 3. Control over the Practice of Medicine
- §1. THE ORDER OF PHYSICIANS
- I. Historical Note
- II. Registration on the List of the Order
- A. Obligation to Register on the List
- B. Exceptions
- 1. Nationals of EU Member States and Non-EU Member States
- 2. Military Doctors
- C. The Obligation to Register and the Freedom of Association
- D. Competent Provincial Council
- E. Refusal or Delay of Registration
- F. Registration after Being Struck Off the Register
- G. Removal from the List
- H. Maintenance of the Registration Subject to Restrictions
- III. Disciplinary Competence of the Order of Physicians
- A. Control over the Observance of the Rules of Professional Conduct
- 1. General Description of the Disciplinary Competence
- 2. Rules of Professional Conduct and Standards of Discretion, Probity, and Dignity
- a. The Code of Medical Professional Ethics
- b. Legally Determined Rules of Professional Conduct
- c. Normative Authority of the Provincial Councils
- d. The Precedent Authority of Disciplinary Decisions
- e. Advice of the Provincial Councils
- f. Advice of the National Council
- 3. Limitations to the Disciplinary Power of the Provincial Councils
- a. Non-interference in Fundamental Freedoms
- b. Duty to Motivate Decisions
- 4. Disciplinary Sanctions
- a. Possible Disciplinary Sanctions
- b. Consequences of a Disciplinary Sanction
- i. Regarding the Right to Vote and to Be Elected
- ii. Regarding the Right to Practise Medicine
- 5. The Disciplinary Procedure and Article 6 of the European Convention
- a. The Applicability of Article 6 of the European Convention in Disciplinary Proceedings
- b. Public Character of Disciplinary Proceedings
- c. Hearing Within a Reasonable Time
- d. Right to Challenge Members of Councils
- 6. Disciplinary Procedure Before the Provincial Councils and the Appeals Councils
- B. Preventive Control
- IV. Organs of the Order of Physicians and Their Function
- A. Provincial Councils
- 1. Composition
- 2. Functions
- B. Appeals Councils
- 1. Composition
- 2. Functions
- C. The National Council
- 1. Composition
- 2. Functions
- §2. PROFESSIONAL LIABILITY
- I. Introduction
- II. Civil Liability
- A. Classification of Physician's Liability
- B. Contents of the Physician's Duty
- C. The Basis of Liability and Burden of Proof
- 1. Fault
- 2. Damages
- 3. Causation
- D. Aspects of Vicarious Liability
- 1. Liability of Hospitals for the Acts of Their Medical Staff
- 2. Physician's Liability for Medical Activity of Other Persons
- III. Criminal Liability
- §3. QUALITY ASSURANCE
- §4. MEDICAL ETHICS COMMITTEES
- I. General Remarks
- II. Ethics Committees in Hospitals
- III. The Belgian Advisory Committee on Bioethics
- A. Composition of the Committee
- B. The Competences of the Committee
- C. Dissemination of the Work of the Committee
- §5. COMPENSATION OF DAMAGE CAUSED BY HEALTHCARE
- I. Introduction
- II. Damage Caused by Healthcare
- III. Conditions for Compensation by the Fund
- A. Damage Emerging from a Medical Accident Without Fault
- B. Damage Caused by a Fact That Gives Rise to Liability (Fault)
- Part II. The Physician: Patient Relationship
- Chapter 1. General Description
- §1. RIGHTS AND DUTIES OF PATIENTS AND PHYSICIANS
- I. The Law on the Rights of Patients
- A. The Duty of the Patient to Cooperate86
- B. The Right to Quality Care
- C. The Right to Free Choice
- D. Rights Related to Information about the State of Health
- 1. The Right to Information about One's State of Health
- 2. The Right Not to Know about One's State of Health
- 3. Relinquishing the Right to Information
- 4. Not Informing about a Patient's State of Health at the Physician's Initiative (The Therapeutic Exception)
- E. The Right to Give Consent
- 1. The Right to Well-Informed, Free, and Prior Consent
- 2. The Way of Giving Consent
- 3. Content of the Information
- 4. Presumed Consent in Cases of Emergency
- F. The Right to Refuse or Withdraw Consent
- G. Rights Related to the Patient's Medical Record
- 1. The Right to a Medical Record
- 2. The Right to Addition of Documents
- 3. The Right to Access
- 4. The Right to a Copy
- 5. Access by Next of Kin after the Death of the Patient
- H. The Right to Protection of Privacy and Intimacy
- I. The Right to Representation in the Event of Incompetence
- 1. The Patient Is a Legally Protected Adult
- 2. The Patient Is Not a Legally Protected Adult
- J. The Right to Lodge a Complaint
- K. The Right to Palliative Care and Pain Relief
- II. The Legal Duty to Help
- A. The Healthcare Quality Law
- B. The Law on the Healthcare Professions
- C. Article 422bis and 422ter Criminal Code
- 1. Article 422bis
- a. Applicability to Physicians
- b. Constitutive Factors of Article 422bis
- i. Great Danger
- ii. Knowledge of the Great Danger
- iii. Refusal to Help
- iv. No Serious Danger for Oneself or Others
- 2. Article 422ter
- 3. Law on Emergency Medical Care
- III. Respect for the Privacy of the Patient and Protection of the Health Data of the Patient
- A. General Rule for Processing of Personal Health Data and Genetic Data
- B. Derogation from the Prohibition on Processing of Data Regarding Health and Genetic Data
- 1. Compliance with the Principles Relating to Processing of Personal Data
- 2. One of the Following Justifications Applies
- a. The Data Subject Has Given Explicit Consent
- b. Necessity to Protect the Vital Interests of the Data Subject or of Another Natural Person
- c. Necessary for Reasons of Substantial Public Interest
- d. Necessary for Health-Related Purposes
- e. Necessary for Reasons of Public Interest in the Area of Public Health
- 3. Comply with Member States Further Conditions
- C. Rights of the Data Subject
- 1. The Right to the Protection of Personal Data
- 2. Information to Be Provided Where Personal Data Are Collected from the Data Subject
- 3. The Right of Access by the Data Subject
- 4. Right to Rectification
- 5. Restricted Right to Erasure of Personal Health Data or Genetic Data ('Right to Be Forgotten')
- 6. Right to Restriction of Processing
- 7. Restricted Right to Portability of Health Data or Genetic Data
- 8. Right Not to Be Subject to Automated Individual Decision-Making, Including Profiling
- 9. Right to Transparent Information and Communication Concerning Rights of the Data Subject
- 10. Right to Lodge a Complaint and to an Effective Judicial Remedy
- 11. Right to Be Represented
- 12. Right to Compensation and Liability
- D. Modalities for the Exercise of the Rights of the Data Subject
- E. Data Protection by Design and by Default
- F. Communication of a Personal Data Breach to the Data Subject
- G. Data Protection Impact Assessment
- H. Designation of a Data Protection Officer When Health Data or Genetic Data Are Processed on a Large Scale
- IV. Duty of Medical Secrecy
- A. General Principle
- B. Exceptions
- 1. Testimony in a Court or Before a Parliamentary Committee
- 2. Statutory Obligations to Disclose Confidential Information
- a. In the Interest of the Patient
- b. To Protect Public Health
- C. Notification of Criminal Acts
- D. Consent of the Patient or Waiver
- E. Delivering Medical Certificates to Third Parties
- V. Medical Fees
- A. Right to Fees or Remuneration for Services
- B. Amount of the Fee
- C. Fee-Splitting
- D. Unlawful Enrichment
- Chapter 2. The Physician: Patient Relationship in Specific Terms
- §1. THE MINOR PATIENT
- §2. THE PSYCHIATRIC PATIENT AND INVOLUNTARY PLACEMENT
- I. Legal Framework
- II. Involuntary Placement in a Psychiatric Hospital131
- A. Admission for Observation
- 1. Simple Procedure (Non-emergency Cases)
- 2. Emergency Procedure
- 3. Practical Modalities of the Admission for Observation
- B. Prolonged Stay
- III. Care Within a Family
- IV. The Rights of an Involuntary Placed Psychiatric Patient
- §3. THE DYING PATIENT
- I. Euthanasia
- A. Definition of Euthanasia
- B. Conditions and Procedure in Case of an Actual Request by a Terminally Ill Adult or Emancipated Minor Patient (Article 3, §§1-2)
- C. Conditions and Procedure in Case of an Actual Request by a Terminally Ill and Non-emancipated Minor Patient (Article 3, §§1-2)138
- D. Conditions and Procedures in Case of an Actual Request by an Adult or Emancipated Minor Patient Who Is Not Terminally Ill (Article 3, §3)
- E. The Actual Request of the Patient (Article 3, §§4-5)
- F. Conditions and Procedures in Case of an Advance Request by an Adult or Emancipated Minor Patient (Article 4)
- G. Notification and Control
- H. No Obligation to Perform Euthanasia
- No Prohibition to Practise Euthanasia
- Obligation to Refer
- II. Withholding or Withdrawing (Cessation) of Treatment
- III. Termination of Treatment (at the Request of the Patient)
- IV. Pain Relief with Life-Shortening Effects
- V. Palliative and Terminal Sedation158
- VI. Physician-Assisted Suicide160
- Chapter 3. Specific Activities
- §1. TERMINATION OF PREGNANCY (ABORTION)
- I. Legal Conditions for Termination of Pregnancy
- II. Evaluation of the Application of the Law of 3 April 1990
- §2. STERILIZATION
- I. Surgical Contraception
- II. Sterilization of Mentally Handicapped
- §3. MEDICALLY ASSISTED PROCREATION
- I. Legal Framework
- II. Medically Assisted Procreation
- A. Definition
- B. Monopoly of Fertility Centres for IVF and Cryopreservation
- C. Access to MAP
- III. MAP with Embryos or Gametes
- A. General Conditions
- 1. Evaluation of Causes of Sterility, Infertility, or Sub-fertility
- 2. Information and Counselling
- 3. Agreement Between the Infertility Centre and the Candidate(s)
- B. MAP Through Implantation of Embryos In Vitro
- C. MAP Through AI
- IV. Surrogacy
- §4. HUMAN GENETICS181
- I. Higher Council on Human Genetics
- II. Centres for Human Genetics
- III. Genetic Testing and Insurance
- IV. Pre-implantation Genetic Diagnosis
- A. Definition
- B. Prohibited Use of PGD
- C. Legal Use of PGD
- §5. REMOVAL AND TRANSPLANTATION OF ORGANS
- I. Scope of the Organ Transplantation Law
- II. Removal of Human Bodily Materials from Living Donors
- A. Under the Organ Transplantation Law
- 1. General Conditions
- 2. Adult Donors
- 3. Special Cases
- 4. Informed Consent
- 5. Duties of Physician Removing Organs
- B. Under the Law on the Procurement and Use of Human Bodily Material
- III. Removal of Human Bodily Material after Death
- A. Under the Organ Transplantation Law
- B. Under the Law on the Procurement and Use of Human Bodily Material
- C. Autopsies
- IV. Recipients
- §6. RESEARCH
- I. Research with Human Persons
- A. Research with Human Persons That Is Not a Clinical Trial on Medicinal Products for Human Use
- 1. Field of Application
- 2. General Provisions Concerning the Protection of Subjects of Experiments
- a. Respect for Ethical and Scientific Quality Requirements
- b. Scientific Acceptability
- c. Proportionality (Balance Between Benefits and Risks)
- d. Informed Consent of the Subject
- e. Primacy of the Human Being
- f. Favourable Opinion of a Fully Licensed Ethics Committee
- g. Intervention of a Qualified Healthcare Practitioner
- h. No-Fault Liability
- i. Obligation to Conclude an Insurance Contract
- 3. Specific Provisions for the Protection of Minors Participating in Experiments
- a. Informed Consent of the Parents or the Guardian
- b. Respecting the Explicit Will of the Minor
- c. Directly Linked to the Clinical Condition of the Participant or Directly Beneficial for Minors
- d. Validation of Previous Research
- e. Proportionality
- f. Minimal Pain, Discomfort, Fear, and Risk
- g. Competence of a Fully Licensed Ethics Committee in the Field of Paediatrics
- h. No Incentives or Financial Inducements
- 4. Specific Provisions for the Protection of Legally Protected Adults
- a. Informed Consent of the Administrator (Article 8, 1°)
- b. Directly Related to the Clinical Condition of the Participant
- c. Minimal Pain, Discomfort, Fear, and Risks
- d. Proportionality
- e. Competence of Ethics Committee Regarding Disease and Patient Population
- f. No Incentives or Financial Inducements
- g. As Soon as Possible, Informed Consent of Participant
- 5. Specific Provisions for the Protection of Persons Whose Consent Cannot Be Obtained Due to Emergency
- a. Direct Relation with the Life-Threatening Clinical Condition of the Subject
- b. Validation of Previously Obtained Data
- c. Minimal Pain, Discomfort, Fear, and Risk
- d. Proportionality
- e. Competence of Ethics Committee Regarding Disease and Patient Population
- f. No Incentives or Financial Inducements
- g. As Soon as Possible, Informed Consent of the Subject
- B. Clinical Trials on Medicinal Products for Human Usage
- 1. Field of Application
- 2. Protection of Subjects of a Clinical Trial
- a. Prior Authorization, Validation and Consolidation
- b. General Provisions Concerning the Protection of Subjects of Clinical Trials
- c. Clinical Trials on Incapacitated Subjects
- d. Clinical Trials on Minors
- e. Clinical Trials on Pregnant or Breastfeeding Women
- f. Clinical Trials on Other Vulnerable Subjects
- g. Clinical Trials in Emergency Situations
- II. Research with Embryos in Vitro
- A. Prohibited Procedures with Embryos in Vitro
- B. Prohibition to Create Embryos in Vitro Solely for Research Purposes
- C. Research with Embryos in Vitro
- 1. Research with Supernumerary Embryos
- 2. Conditions Related to the Research
- 3. Conditions Related to Place and Expertise
- 4. Informed Consent of the Persons Concerned
- 5. Favourable Opinion of the Local Ethics Committee
- 6. No Objection of the Federal Committee for Research on Embryos
- 7. Yearly Report on the Research
- 8. Follow-Up by the Federal Committee
- III. Secondary Use of Human Bodily Material for Research Purposes
- IV. Research with Human Bodily Material Without Medical or Other Applications to Humans
- V. Bio-Banks
- §7. PROFESSIONAL FREEDOM, PRESCRIBING DRUGS, TREATMENT WITH DRUGS-SUBSTITUTES
- I. Legal Framework of Professional Freedom
- II. Control over the Professional Freedom
- III. Prescription of Drugs
- IV. Treatment with Drugs-Substitutes
- Part III. The Physician and the Healthcare System
- Chapter 1. Relations with Other Healthcare Providers
- §1. PHARMACISTS
- I. The Practice of Pharmacy
- §2. DENTISTS
- I. The Practice of Dentistry
- II. Professional Relations Between Physicians and Dentists
- §3. CLINICAL PSYCHOLOGISTS
- I. The Practice of Clinical Psychology
- II. Professional Relations Between Physicians and Clinical Psychologists
- §4. CLINICAL ORTHOPEDAGOGY
- I. The Practice of Clinical Orthopedagogy
- II. Professional Relations Between Physicians and Clinical Orthopedagogics
- §5. PHYSIOTHERAPISTS
- I. The Practice of Physiotherapy
- II. Professional Relations Between Physicians and Physiotherapists
- §6. NURSING PROFESSION
- I. The Practice of Nursing
- II. Professional Relations Between Physicians and Nurses
- §7. PARAMEDICAL PROFESSIONS
- §8. MIDWIVES
- Chapter 2. Relations with Healthcare Provisions
- §1. HOSPITALS
- §2. RELATIONS BETWEEN PHYSICIANS AND HOSPITALS
- §3. HEALTH INSURANCE
- Selected Bibliography
- Index
- Back Cover
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