Search

This article discusses the characteristics and trends of the global and Brazilian pharmaceutical industry in the 21st century, its transformations and industry trends, and its actors. Qualitative research and the technique of document analysis allowed us to check that in early 20th century, the global pharmaceutical industry was characterized by homogeneous structure and reduced supply of products. After the Second World War, there was strengthening of the production of medicines based on chemical synthesis and diversification of supply and demand for drugs. The pharmaceutical market has shifted from broader competition for one of oligopolistic character. In the 1990s, these industries' portfolio expanded to areas of animal health, hygiene / personal care and nutrition / dietetics. In the 2000s, the global pharmaceutical industry intensified this process, and due to the expiration of patents on medicines, focused on the generic segment, acquiring companies in emerging markets. The Brazilian pharmaceutical industry followed the lines of the global pharmaceutical industry and started to invest in the production of generic medicines, herbal and advancement of biotechnology, with public financial support of the BNDES. This context continues to demand advances in health innovation, and demands of the health regulation to face the challenges arising from this great transformation. It is worth mentioning the challenges relating to costs of drugs and their strong impact on health systems, particularly those of more inclusive character. [ABSTRACT FROM AUTHOR]

This paper discusses the Brazilian experience of health regulation from 1999 to 2008. It aims to understand the interfaces of the regulatory process in health in Brazil, particularly the pharmaceutical industry, seeking to identify, historically, the actors and contexts relating to the proceedings. The research was based on literature review and survey of the resolutions of the Board of the National Health Surveillance Agency. This survey identified the concentration of these resolutions in the following areas: drugs, human resources and food. Regarding drugs, emphasis was placed in three key words: drug registration, practices and substances subject to special control. In addition to a brief history of the evolution of Brazilian health surveillance, this paper focused on the regulatory aspects of the National Health Surveillance Agency and its relationship with the pharmaceutical industry. Therefore, the text was guided by the desire to answer the following question: is the experience of regulation of the National Health Surveillance Agency able to cope with the adverse scenario created by the world crisis, especially with regard to the pharmaceutical industry? The main conclusion of this study is that despite the many challenges to be overcome by the National Sanitary Surveillance Agency in Brazil today, the experience of regulation has made good progress in this decade. A further finding is that these developments were, for the pharmaceutical industry, a protection against the adverse situation created by the global crisis. [ABSTRACT FROM AUTHOR]