A policy view: gaps and weaknesses of substitution between biological products in law and economics dimension: the example of insulin

The purpose of the study is to analyze the act of substitution between biological products. Diabetes mellitus notes the greatest increase in the projected causes of deaths globally till 2030. The proper drug substitution process may help to increase the control over the disease management. In this paper authors try to identify and explain the challenges for the health policies and legislations in emerging markets and low- and middle-income countries. Analysis of retrospective data covering prescribed-dispensed insulin products was performed. The study is based on the law and economics approach with the application of the planning theory and modeling. The study shows the scope of substitution process of insulin and highlights the necessity of univocal legal approach profiled for this therapy area. Prognosis of created base model indicates at constant presence of substitution process of insulin. Substitution is to bring financial savings for patients, it is yet however unknown whether savings arising from the act of purchase will still have positive impact on undertaken therapy process in long-term period. These findings may inform about important factors and how emerging markets and low- and middle-income countries can increase progress of the substitution process.