French Medical Consent Law: Patient Rights, End of Life, and Advance Directives
French medical consent law is governed by the Code de la santé publique and has been shaped by three landmark laws: the Loi Kouchner (Law of 4 March 2002 on Patients’ Rights), the Loi Léonetti (Law of 22 April 2005 on the Rights of Patients at the End of Life), and the Loi Claeys-Léonetti (Law of 2 February 2016 on the End of Life). These laws established the principles of informed consent, the right to refuse treatment, and the legal framework for end-of-life decision-making.
The Loi Kouchner (2002)
The Law of 4 March 2002 on the Rights of Patients and the Quality of the Health System (Loi Kouchner) was a foundational reform of French medical law. The law established the principle of informed consent (consentement éclairé) as a fundamental right of patients. The law requires that the patient be informed of the risks and benefits of proposed medical treatment and that the patient’s consent be obtained before any treatment is administered.
The law also established the right of the patient to access their medical record (dossier médical). The patient may consult their medical record and obtain a copy. The law also established the right of the patient to choose their doctor and to be treated with dignity and respect. The Loi Kouchner was a significant step in the recognition of patients’ rights in French law.
Informed Consent
Informed consent is a central principle of French medical law. The doctor must provide the patient with clear and complete information about: the proposed treatment; the risks and benefits; the alternatives; and the consequences of refusal. The information must be provided in a manner that the patient can understand. The doctor must also inform the patient of the serious risks that are reasonably foreseeable.
The patient’s consent must be free and informed. The patient may refuse treatment at any time. The patient may also withdraw consent after it has been given. The doctor must respect the patient’s refusal of treatment, even if the refusal may result in the patient’s death.
The burden of proof of informed consent lies on the doctor. The doctor must be able to demonstrate that the patient was properly informed and that consent was obtained. The failure to obtain informed consent may give rise to liability for damages.
The Loi Léonetti (2005)
The Law of 22 April 2005 on the Rights of Patients at the End of Life (Loi Léonetti) established the legal framework for end-of-life decision-making. The law prohibits the unreasonable obstinacy (obstination déraisonnable) in medical treatment. The doctor may not continue treatment that is futile or that imposes disproportionate suffering on the patient.
The law also established the principle of double effet (double effect): the doctor may administer treatment to relieve pain, even if the treatment may have the secondary effect of hastening death. The law also established the role of the personne de confiance (trusted person), whom the patient may designate to represent their wishes in medical decisions.
The Loi Léonetti explicitly prohibited euthanasia (euthanasie active) and assisted suicide (suicide assisté). The prohibition is based on the principle of the inviolability of human life. However, the law left unresolved questions about the boundaries between lawful pain relief and unlawful euthanasia.
The Loi Claeys-Léonetti (2016)
The Law of 2 February 2016 creating new rights for patients at the end of life (Loi Claeys-Léonetti) revised and strengthened the legal framework for end-of-life decision-making. The law introduced the right to deep and continuous sedation (sédation profonde et continue) until death, for patients whose suffering cannot be relieved and who have decided to stop treatment.
The law also strengthened the status of advance directives (directives anticipées). Advance directives are written instructions by which a person indicates their wishes regarding medical treatment in the event that they become unable to express their consent. The advance directives are binding on the doctor, subject to certain exceptions.
The Loi Claeys-Léonetti also established the right to a collegial decision-making procedure (procédure collégiale) when the patient is unable to express their wishes. The doctor must consult with the medical team and, where appropriate, with the personne de confiance before making end-of-life decisions.
Advance Directives
Advance directives (directives anticipées) allow a person to express their wishes about medical treatment in advance, in case they become unable to make decisions later. The advance directives may address: the refusal of specific treatments; the acceptance of pain relief; the circumstances in which life-sustaining treatment should be withdrawn; and the designation of a personne de confiance.
The advance directives must be in writing, dated, and signed by the author. They may be revoked at any time. The advance directives are binding on the doctor, subject to two exceptions: the doctor may override them in an emergency to save the person’s life; and the doctor may override them if they are manifestly inappropriate or inconsistent with the patient’s situation.
Medical Confidentiality
Medical confidentiality (secret médical) is a fundamental principle of French medical law. The doctor must keep confidential all information obtained in the course of treating the patient. The confidentiality obligation continues after the patient’s death. The violation of medical confidentiality is a criminal offence punishable by imprisonment and fines.
The obligation of medical confidentiality is subject to limited exceptions. The doctor may disclose information: with the patient’s consent; to protect the patient or others from serious harm; to comply with a legal requirement (such as reporting certain infectious diseases); and to provide information to other healthcare professionals involved in the patient’s treatment.
The Personne de Confiance
The personne de confiance (trusted person) is a person designated by the patient to represent their wishes in medical decisions. The patient may designate the personne de confiance at any time, in writing. The personne de confiance is consulted when the patient is unable to express their wishes.
The role of the personne de confiance is to express the patient’s wishes, not to substitute for the patient’s own decision. The doctor must take the views of the personne de confiance into account but is not bound by them. The personne de confiance may be a family member, a friend, or any other person trusted by the patient.
End-of-Life Decision-Making
End-of-life decision-making is governed by the Code de la santé publique and by the Loi Claeys-Léonetti. The doctor must follow a collegial procedure when making decisions about the withdrawal or withholding of life-sustaining treatment. The procedure involves: consultation with the medical team; consultation with the personne de confiance and the family; and, where appropriate, consultation with other healthcare professionals.
The decision must be based on the patient’s wishes, as expressed in advance directives or through the personne de confiance, and on the medical assessment of the patient’s condition. The decision must be recorded in the patient’s medical record. The decision may be reviewed by the courts.