Comprehensive Guide to Patient Rights and Healthcare Quality in Belgium

Legislative and Regulatory Framework of Patient Rights in Belgium

The legal landscape surrounding patient rights is governed by several key instruments including the Directive 2011/24/UE of the European Parliament and of the Council (March 9, 2011) regarding the application of patient rights in cross-border healthcare. Nationally, the foundational text is the Law of August 22, 2002, which has been supplemented and modernized by the Law of April 22, 2019, relating to the quality of healthcare practice, and the Law of February 6, 2024. The evolution of these laws has been driven by the Government Agreement of September 30, 2020, which called for a 20-year evaluation of the 2002 law, leading to recommendations from the Vlaams Patiëntenplatform, the Ligue des Usagers des Services de Santé, and hearings at the Chamber of Representatives. A resolution passed on December 15, 2022, emphasized the active role of patients, life projects, the role of relatives, information transparency, and the importance of the patient file. Modernization efforts focus on reinforcing a patient-centered approach, including preferences and life projects in care planning, and clarifying the roles of the "personne de confiance" (trusted person) and legal representatives.

Definitions of Patient and Healthcare Services

Under the modernized legal framework, the patient is defined verbatim as "the physical person who benefits from healthcare, whether at their request or not." Previously, the definition was limited to those to whom care was "dispensed." Healthcare itself is defined as "the services provided by a healthcare professional with a view to promoting, determining, maintaining, restoring, or improving a patient's state of health, modifying their bodily appearance for primarily aesthetic purposes, or accompanying them at the end of life." This broad definition covers a wide range of interventions and professional relationships.

Professionals Governed by Patient Rights Legislation

The law applies to practitioners identified in the coordinated law of May 10, 2015, which includes:

• Physicians (Doctors)
• Nurses
• Midwives
• Physiotherapists (Kinésithérapeute)
• Dentists
• Pharmacists
• Paramedics (Secouriste-ambulancier)
• Other paramedical professions

It also extends to practitioners of non-conventional practices under the law of April 29, 1999, including acupuncturists, chiropractors, homeopaths, and osteopaths. Since September 1, 2016, the scope includes clinical psychologists, clinical orthopedagogues, and practitioners of psychotherapy.

Fundamental Rights of the Patient

The Law of August 22, 2002, establishes several core rights:

1. Right to quality services respecting human dignity and autonomy (Art. 5).
2. Right to free choice of healthcare professional, except where limited by law (Art. 6).
3. Right to information regarding health status and probable evolution (Art. 7).
4. Right to free and informed consent (Art. 8).
5. Right to refuse an intervention (Art. 8/1).
6. Right to record will through an advance declaration (Art. 8/2).
7. Right to direct access to the patient file and to receive a copy (Art. 9).
8. Right to privacy and protection of private life (Art. 10).
9. Right to assessment and relief of pain, as introduced in 2005 (Art. 11bis).
10. Right to mediation (Art. 11).
11. Right to be assisted by a trusted person (Art. 11/1).
12. Right to representation (Art. 12-15).

Article 4 emphasizes that the professional and the patient contribute together to optimal care, behaving with mutual respect. Article 4/1 mandates multidisciplinary consultation and, at the patient's request, consultation with designated relatives.

The Right to Quality and Professional Standards

Article 14 of the Law of April 22, 2019 (in effect since January 1, 2022) requires healthcare professionals to ensure the necessary framework is present to perform care with a high level of quality. The King may fix precise conditions regarding medical acts. Professionals must also maintain a Portfolio (Art. 8) containing data demonstrating they possess the necessary demonstrable competence and experience. Furthermore, hospitals must offer the same quality of care regardless of the patient's choice of room (individual, two-bed, or common), as per the Hospital Law of July 10, 2008.

Information, Consent, and Refusal

The right to information (Art. 7) is independent of the right to consent. Professionals must communicate correctly and understandably, accounting for the patient's capacity and ability to receive information, particularly for "bad news." Information must include:

• Objectives, nature, urgency, duration, and frequency of the intervention.
• Relevant risks, side effects, and contraindications.
• Possible alternatives.
• Probable follow-up care.
• Financial repercussions, including the convention status of the practitioner.

Consent must be obtained prior to any intervention and can be express or implied. For aesthetic surgery/medicine, Art. 18-20 of the Law of May 23, 2013, requires a written report and a cooling-off period of at least $15\,\text{jours}$ between the signature and the act for any procedure over $1.000\,\text{euros}$. Patients have the right to refuse or withdraw consent at any time, even if it leads to a deterioration of health or death. In such cases, the professional must explain the consequences and discuss alternatives.

Therapeutic Exception and Right Not to Know

Under the Right not to know, a professional must respect a patient's express wish not to be informed, unless non-communication causes grave prejudice to the patient or third parties. In such instances, the professional must consult another colleague and the patient’s trusted person. Conversely, the Therapeutic Exception allows a professional to temporarily withhold information if disclosure would cause manifest grave prejudice to the patient's health. This requires consultation with another professional, informing the trusted person, and a written justification in the patient file. The professional must check regularly if the risk of harm persists and communicate the info as soon as it no longer causes such prejudice.

Advance Care Planning and Declarations

Advance planning is a continuous process of communication regarding values, life goals, and care preferences. Specific types of advance declarations include:

• Euthanasia declaration: Valid for adults or emancipated minors, requiring a specific model (AR April 2, 2003).
• Organ and body material donation: Can be registered via MaSanté.be, municipal administration, or a doctor.
• Body to science: Requires a specific relationship with a university faculty of medicine.
• Funeral arrangements: Registered with the municipal administration.

Patient Records and Data Protection

The patient file (Art. 33-35 of the Quality Law) must be kept up to date and stored electronically (dates to be fixed by the King). It must include identification (NISS), family history, exam results, diagnosis, and an overview of care. Records must be conserved for a minimum of $30\,\text{ans}$ and a maximum of $50\,\text{ans}$ from the last contact. Patients have a direct right to a copy, provided within $15\,\text{jours}$. The first copy is free; subsequent copies may incur reasonable administrative fees. Access to health data by other professionals requires the patient’s informed consent and is limited to those in a "therapeutic relationship" with the patient. For deceased patients, certain relatives (spouse, partner, parents up to the 2nd degree) may consult the file via a designated healthcare professional, provided the request is motivated and the patient did not expressly oppose it.

Capacity and Representation

There is a presumption of capacity for adults. If a patient is incapable (minor or protected adult), their rights are exercised by a representative. The cascade for representation is:

1. A specifically designated mandatary.
2. The spouse/legal cohabitant/de facto partner.
3. Adult children.
4. Parents.
5. Adult siblings.

Minors capable of discernment can exercise their rights autonomously. The professional evaluates this capacity in concreto based on maturity and the nature of the act. If a minor is not autonomous, parents or tutors exercise these rights jointly. In emergency situations where the patient's will is unknown and no representative is present, necessary interventions are performed immediately in the patient's interest.

Mediation and Complaint Mechanisms

Patients have the right to file complaints regarding their rights (Art. 11). Mediation functions are available in hospitals, mental health platforms, and at the federal level. Mediation is free and confidential, aimed at restoring communication, seeking solutions, and providing information on legal alternatives (INAMI, courts, Medical Accident Fund). The Federal Commission for Control of Healthcare Practice (Art. 45 Quality Law) monitors professional fitness and compliance with the law. Annual reports are submitted to the Minister of Public Health and, since the 6th State Reform in 2016, to the federated entities.