Analysis of new drugs registered in Brazil in view of the Unified Health System and the disease burden.

The most important aspect of a new drug in terms of public health is its therapeutic value and benefit it provides for the patient and for the society. The aim of this study was to analyze new drugs registered in Brazil between 2003 and 2013 with respect to Pharmaceutical Assistance programs within the Brazilian health system and to the disease burden in the country. In our retrospective cohort study, new drugs registered in Brazil were identified through document analysis of databases and publicly available documents from National Health Surveillance Agency. The data on disease burden in Brazil was obtained from the Global Burden of Disease Study 2012, published by the World Health Organization. The level of therapeutic innovation was determined using the Motola algorithm. Although a total of 159 new medicines were used in the cohort, only 28 (17.6%) were classified as important therapeutic innovations. There is a disproportionate relationship between the percentage of new drugs and the burden of disease, with an under-representation of drugs for infectious respiratory diseases, heart disease, and digestive diseases. Incentive strategies for research and development of medicines should be prioritized to reduce the disparity regarding the burden of disease and to help develop innovative medicines necessary to improve health throughout the country.