A.I. Rarog, Uve Hellmann, P. Golovnenkov. Responsibility of Physicians for Professional Carelessness under Criminal Legislation of Russia and Criminal Law of Germany Concerning Pharmaceutical Industry

Abstract: The article consists of two parts. The first part deals with the problem of responsibility of physicians in the Russian criminal law. It is indicated that unlike the German criminal legislation thoroughly regulating the circulation of medicines and medical products as well as matters of criminal responsibility for breach of statute-established rules of circulation the criminal legislation of Russia actually ignores the danger of illegal circulation of adulterated and expired medicines. That is why the first part of the article gives consideration to the general problems of responsibility of medical personnel for doing harm or for posing hazard to life or health in the course of performing of their professional activities. The second part of the article is a review of the German legislation concerning responsibility of physicians for professional carelessness. It is noted that besides apparent positive research opportunities the scientific and technological progress in the process of globalization of economic relations, especially in pharmaceutical industry, is characterized by a number of adverse events relevant in terms of criminal law. The range of possible delinquent acts in the field of pharmaceutical research, production and distribution of medicines is rather wide. It covers not only misdeeds of individual persons not engaged in entrepreneurial activities but also deeds that take place in divisions of national and international corporations. One also has to face cases of export and import of poor-quality and barred medicines with involvement of the third world countries and emerging nations, tampering with results of pharmaceutical research, holding-up of information of adverse by-actions of medicines as well as not taking or untimely taking of actions to withdraw medicines suspected of posing hazard to life of customers. Mass media publishes reports on criminal processes connected with bribery of private physicians by large pharmaceutical companies and with distribution of adulterated or barred medicines. Criminal law regulation of relations connected with adulteration and other illegal circulation of medicines (criminal law concerning pharmaceutical industry) belongs to the section of protection of consumer rights of the German economic criminal law and is characterized by three features. Firstly, criminal legal rules stipulating responsibility for illegal circulation of medicines are reflected not in the general legal codification (Strafgesetzbuch) but in special branch laws. Special Branch Law of the Federative Republic of Germany on circulation of medicines is the primary legislative act in the field of pharmaceutical law. Secondly, besides the rules that are criminal legal in the narrow sense, the Law of the Federative Republic of Germany on circulation of medicines includes essential elements of administrative offense, with the sanctions being administrative penalty for certain actions violating the rules of the German legislation on circulation of medicines. Thirdly, disposition of all the said rules is blanket, i.e., they include references to other provisions of the Law of the Federative Republic of Germany on circulation of medicines to describe certain features of the objective aspect of the essential elements. It is this blanket structure of essential elements that causes the main complications of the German criminal law concerning pharmaceutical industry. Multiple references to the provisions of the Law of the Federative Republic of Germany on circulation of medicines that in its turn are not closed in many cases but, on the contrary, refer to other rules of the German and European legislation as well as multiple specifying subordinate statutory acts make the essential elements in question very complicated for review and comprehension.