Informed Voluntary Consent for Medical Intervention in the Russian Federation, the USA and Germany

Abstract

The paper aims to identify systemic problems in Russian legal regulation related to obtaining informed voluntary consent of a patient for medical intervention, and developing proposals for their solution using the experience of the United States of America and the Federal Republic of Germany. This study argues that informed voluntary consent is of a civil-law nature, constituting a unilateral personal expression of the patient’s will. While it exhibits the characteristics of a transaction as defined in Article 153 of the Civil Code of the Russian Federation, it is subject to the restriction provided for in paragraph 4 of Article 182 of the same Code, which excludes from the scope of agency actions that are closely connected with the person. The study identifies several systemic problems in the Russian regulatory framework: the excessively general character of the information disclosure standard set forth in Article 20 of the Federal Law «On the Fundamentals of Protecting the Health of Citizens in the Russian Federation»; the lack of comprehensive requirements for the content of consent in the context of fee-based medical services and services provided beyond clinical recommendations; and the insufficiency of regulation concerning the strictly personal nature of consent, particularly in legal the absence of a mechanism for advance directives in cases where the patient may subsequently be unable to express his or her will. As a proposed solution, the author advocates for the adoption of the German model of a detailed disclosure standard, which comprises a specific list of mandatory elements to be disclosed and shifts the burden of proof concerning compliance with this obligation to the benefit of the patient. The need to introduce the institution of sick leave orders into Russian law is substantiated.