Contradictions in legislation on medical waste management in the manufacturing of medicinal products

Introduction. The rapid development of the pharmaceutical industry makes the impact on the environmeте to be very important. The solution of the problem is related to waste management and, accordingly, the legislative regulation of waste management at medicinal products enterprises.

Materials and methods. The methods of the scientific hypothetical-deductive cognition, general logical methods,  and methods of research: analysis, synthesis, abstraction, generalization, induction were applied. The objects of research were laws and regulations governing relations in the field of waste management in the production of medicines, as well as departmental letters.

Results. This article analyzes the contradictions occurring in federal laws and departmental regulations related to the management of medical waste in medicinal products manufacturing, which, on the one hand, may cause the violation of citizens' rights to a healthy environment and sanitary and epidemiological well-being, on the other hand to become the reason of restrictions in development of business. The legislative definition of medical waste was shown to include, besides other things, wastes from medicinal products manufacturing, which leads to the withdrawal of pharmaceutical enterprises waste from the general field of waste legislation. At the same time, there is a transfer of regulation of medicinal products manufacturing waste management to the sanitary legislation field. However, in practice, there is a situation of double regulation by the departmental acts of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare and Federal Service for Supervision over Natural Resource Management. 

Discussion. The analysis of the experience in the field of the organization of pharmaceutical waste management in the foreign practice (WHO, EPA) has been introduced, where the concept of pharmaceutical waste was introduced, within which hazardous chemical waste, controlled substances (narcotic, psychotropic, hormones) and biomedical wastes are selected.

Conclusion. The analysis of federal regulations, sanitary norms, and rules, norms of Federal Service for Supervision over Natural Resource Management  affecting the management of waste (medical waste) in the production of medicines, shows their limited applicability to modern high-tech industries, which requires bringing the regulatory and legal acts in line and improving the standardization.