New drugs in Brazil: do they meet Brazilian public health needs?

Abstract

To describe the new drugs marketed in Brazil during the period 2000-2004, compare the description to the country's burden of disease, and suggest initiatives capable of addressing the situation from the perspective of a developing country. Records of new drugs were surveyed in an official drug registration database. The new drugs were categorized by Anatomical Therapeutic Chemical classification, indication, and innovation, and compared with the needs of the country's burden of disease. Data on the morbidity and mortality rates of selected diseases (diabetes, Hansen's disease, hypertension, tuberculosis) were retrieved from official documents and the literature. During the period investigated, 109 new drugs were launched. Most were general anti-infectives for systemic use (19), followed by antineoplastic and immunomodulating agents (16). The number of new drugs launched in 2004 was roughly one-third that of 2000. Of 65 new drugs, only one-third can be classified as innovative. Most new drugs were intended to treat noninfectious diseases that typically affect developed countries, diseases that constitute only a fraction of the country's challenges. A mismatch occurs between public health needs and the new drugs launched on the Brazilian market. Not only did the number of new drugs decrease in the study period, but only a few were actually new in therapeutic terms. Developing countries must acquire expertise in research and development to strengthen their capacity to innovate and produce the drugs they need.