The thesis studies the legal nature, content and particularities of the State Service of Ukraine on Medicines and Drugs Control (SMDC) by focusing on the institutional and functional components of the latter's activities.
The author proves that the SMDC, by its legal nature, being a representative of the state executive power, is a part of the system of numerous other central executive authorities, implementing public policy directions assigned to it by the Ministry of Health of Ukraine. The author clarifies the special place and role of the SMDC in the system of public authorities, which is due to several aspects: it is a representative of other central executive authorities; it implements several related areas of public policy formed by the Ministry of Health of Ukraine; being established as a service, in addition to administrative services, it carries out control and supervisory and law enforcement activities; it is part of the law enforcement system; it is vested with the competence and authority to conduct proceedings in cases of administrative offences; it is an authorised entity of the blood system structure; being a component of the system of public authorities, it is simultaneously an actor of several of its subsystems.
The author emphasises that regulatory framework for the activities of the SMDC is a multifaceted process, which includes: a set of legal regulations, on the basis of the provisions thereof, allowing for their legal force, a regulatory impact on such activities is exercised; actors authorised to adopt such legal regulations, legal status thereof determines such legal force; the purpose of regulatory framework – ensuring the implementation of public policy on quality control and safety of medicines, including medical immunobiological products, medical equipment and medical devices, and the circulation of narcotic drugs, psychotropic substances and precursors, combating their illicit trafficking, blood and blood components donation, and the functioning of the blood system.
The author proves that the principles of activities of the SMDC are a set of guiding principles enshrined in the regulatory and legal provisions, according to which the bodies and subdivisions of the SMDC directly implement public policy determined by the purpose of their functioning. The author classifies the principles of the SMDC depending on the scope of their application, which indicates both their connection with other such principles and defines the specifics of the SMDC’s activities in certain areas. The first group includes the general legal principles of the SMDC, such as the rule of law; legality; equality and non-discrimination. The second group of principles of activities being studied is made up of cross-sectoral principles: objectivity and impartiality; openness and transparency; control and accountability; inadmissibility of duplication of powers; responsibility; etc.
The author argues that the essence of the administrative and legal status of the SMDC is a measure ensuring legal liability and a set of powers enshrined in the administrative law, exercised by this public authority within the framework of relevant social relations in clearly defined areas of activity for the implementation of public policy on quality control and safety of medicines and medical equipment, circulation of narcotic drugs, psychotropic substances and precursors, and functioning of the blood system.
The author proves that the forms of activities of the SMDC indicate several aspects: its subjective perception, i.e., its external expression; the area of social relations within which the respective form is applied; the direction and method of implementation of such activities; the range of participants of public relations that arise and develop within the framework of the relevant form; the scope of powers that can be exercised by the SMDC within the relevant form of its activities. The forms of activities of the SMDC depending on the consequences of their implementation are grouped into: those with legally significant consequences or legal forms of activities of the SMDC (adoption of organisational and administrative regulations (regulations on general issues of activities and individual regulations); conclusion of administrative contracts; performance of other legally significant actions); organisational, i.e. those that do not result in legally significant results, are auxiliary in nature and usually precede the use of legal forms.
The author proves that the methods of activities of the SMDC should be understood as a set of techniques and methods enshrined in the regulatory and legal provisions which are used to exert a regulatory influence on public relations within the scope of public policy on quality control and safety of medicinal products, medical devices, as well as circulation of narcotic drugs, psychotropic substances and precursors, and functioning of the blood system.
