(Apr. 23, 2013) On February 25, 2013, Germany promulgated an Act Improving the Rights of Patients [hereinafter Patients’ Rights Act]. (Gesetz zur Verbesserung der Rechte von Patientinnen und Patienten,Bundesgesetzblatt [BGBl] I at 277.) The Act creates the “treatment contract,” a special contract that by law now governs every relationship between a person administering medical treatment and the patient. Although the law is aimed primarily at physicians, its scope encompasses also other health care professionals (C. Katzenmeier, Der Behandlungsvertrag – Neuer Vertragsatypus im BGB (The Treatment Contract – New Type of Contract in the Civil Code),Neue Juristische Wochenschrift 817 (2013)).
The detailed new provisions are inserted into the Civil Code (Bürgerliches Gesetzbuch, repromulgated Jan. 2, 2002,BGBl I at 42) as sections 630a through 630h, and they regulate the rights and duties of the “treating person” (hereinafter physician) and the patient on issues such as medical consent, disclosure, record-keeping, and the burden of proof when liability for treatment errors is claimed. Many of the rights granted to patients by the new legislation had already been developed by case law and non-binding guidelines (Dieter Hart, Patientenrecht nach dem Patientenrechtegesetz,Medizinrecht 159 (2013)), yet it is expected that their codification will make it easier for patients to know their rights (Press Release, Bundesministerium der Jutstiz (Federal Ministry of Justice),Patientenrechtsgesetz passiert den Bundesrat (Patients’ Rights Act Passed in Federal Council),(Feb. 1, 2013)).
A formerly disputed issue that is now resolved in the new Act is the extent to which a physician must inform the patient of his mistakes made in treating the patient (Dirk Olzen & Angela Metzmacher, Erste Überlegungen zum Referentenentwurf für ein Patientenrechtegesetz (Reflections on the Ministerial Draft of a Patneints Rights Act),Juristische Rundschau 271 (2012)). Section 630a (2) now provides that the physician must inform the patient of his treatment error if it is recognizable to the physician, and this information must be provided either upon request of the patient or when it is necessary to avert injurious consequences. The information can be used in a criminal proceeding only with the consent of the physician; it appears, however, to be freely available for civil law suits (Katzenmeier, supra). The restriction as to criminal proceedings corresponds to the privilege against self-incrimination that is expressed in the German Code of Criminal Procedure (Strafprozessordnung, repromulgated Apr. 7, 1987,BGBl I at 1074, English translation available from the Federal Ministry of Justice website) in sections 55 and 136. While not a constitutional principle, the privilege is nevertheless an overarching tenet of German law, as rooted in the Roman law maxim “nemo tenetur se ipsum accusare (no one is bound to accuse himself)” (Lutz Meyer-Gossner & Jürgen Cierniak, Strafprozessordnung 6 (2010)).
Treatment errors are not defined in the law; according to some experts, they are likely to be deemed to have been committed when the physician deviates from the prescribed medical standards (Katzenmeier, supra). Section 630a (2) of the Civil Code now requires that treatment must follow the generally recognized standards of the profession, unless patient and physician had agreed on a different course of action.
An important issue that was already resolved by case law and has now been codified in section 630h of the Civil Code is the distribution of the burden of proof in medical malpractice cases. The provision is interpreted as continuing to adhere to the basic principle of compensation in breach of contract situations, according to which the claimant must prove the injury, the violation of a contractual duty, and the causal connection between the two (Civil Code, § 280). However, in egregious cases in a medical treatment context, this burden of proof is reversed through various presumptions. Thus a treatment error is presumed when an injury occurs that corresponds to a known risk inherent in the treatment that the physician should have been able to control. Also, the physician is presumed to be at fault for an error if he has not recorded the course of the treatment or not kept records. Causation is presumed if the physician carried out a procedure for which he had not been certified and also if the physician committed a serious treatment error that is capable of causing the injury at issue (Civil Code § 630h).
In addition to creating this framework of civil law rules for physicians and patents, the rights of patients in the overall health care system are strengthened by the Patients’ Rights Act. Thus, patients’ rights organizations are given various rights to be heard in decisions relating to health care policy issues, and the Act expands the rights of patients vis-à vis the statutory health insurers in which 90% of the German population is enrolled. In particular, the Act now requires the health insurance carriers to decide on the approval of requested treatments within certain periods which, depending on the requested treatment, range from three to six weeks. If a reasoned decision is not given to the insured within the required period, he may have the treatment carried out and bill the health insurer (Patients’ Rights Act, art. 2 (1)).