PRESIDENT OF THE SCIENTIFIC SOCIETY
INFORMED CONSENT
AGORA MEMBERS
SECTION EDITED BY THE AGORA LEGAL OFFICE
Law no. 219/2017 regulates, in addition to DAT, informed consent, aiming to protect the right to life, health, dignity, and self-determination of the individual. It establishes that no medical treatment can be initiated or continued without the free and informed consent of the interested party, except in cases expressly provided for by law. Prior to this law, informed consent was based solely on the Constitution, international law (the Convention on Human Rights and the Charter of Nice), and the Code of Medical Ethics.
DEFINITION OF INFORMED CONSENT
According to Law No. 219/2017, the relationship of care and trust between patient and physician, based on informed consent, must be promoted and valued. The legislation regulates the ways in which informed consent can be expressed: "Informed consent, obtained in the manner and with the tools most appropriate to the patient's condition, is documented in written form or through video recordings or, for persons with disabilities, through devices that enable communication. Informed consent, in whatever form expressed, is included in the medical record and the electronic health record."
The person can review their decisions at any time. Refusal (not starting) or withdrawal (interruption) applies to all diagnostic tests and medical treatments.
REQUIREMENTS
Informed consent, as a condition for the lawfulness of any healthcare treatment, is grounded in self-determination, in choices regarding one's health, understood as the freedom to dispose of one's body, fundamental human rights enshrined in Articles 2, 13, and 32 of the Constitution and Articles 1, 2, and 3 of the Charter of Fundamental Rights of the European Union. The term "informed consent" is composed of two words: consent and information. Information precedes the acquisition of consent and is a prerequisite for obtaining valid consent; consent, on the other hand, follows information and must be valid.
The patient's consent must be free and informed, preceded by complete, up-to-date, and comprehensible information regarding the diagnosis, prognosis, benefits and risks of the diagnostic tests and indicated medical treatments, possible alternatives, and the consequences of refusing or refusing to undergo the medical treatment and diagnostic test.
METHODS OF CONSENT ACQUISITION AND DOCUMENTATION OF THE ACQUISITION
Regarding the methods for obtaining consent, informed consent must be obtained in the manner and through the tools most appropriate to the patient's condition and must be documented in written form or through video recordings. "Each public or private healthcare facility shall ensure, through its own organizational procedures, the full and correct implementation of the principles set forth in this law, ensuring the necessary information for patients and adequate training for staff.
The initial and continuing education of doctors and other healthcare professionals includes training in patient relationships and communication, pain management, and palliative care.
HEALTHCARE LIABILITY
The foundation of medical practice lies in the therapeutic indication (Article 5 of the Civil Code – Acts of Disposition of One's Body) and the patient's informed consent (Law 219/2017). Therefore, the physician is civilly liable not only for error, but also for violations of the duty to provide information and obtain consent: failure to provide information, insufficient information, or failure to comply with the informed consent procedure. Agorà, through collaboration between the Legal and Clinical Boards, has developed and provides informed consent forms for the main medical-aesthetic procedures.
