Generic drugs in Brazil: historical overview and legislation

The Brazilian generic drugs policy was implemented in 1999 with the aim of stimulating competition in the market, improve the quality of drugs and improve the access of the population to drug treatment. The process of implementing this policy allowed the introduction and discussion of concepts that had never before been used in the context of drug registration in Brazil: bioavailability, bioequivalence, pharmaceutical equivalence, generic drugs, biopharmaceutical classification system, biowaiver. The present article provides definitions for these concepts in the context of Brazilian legislation as well as a historical and chronological description of the implementation of the generic drugs policy in Brazil, including a list of current generic drug legislation. This article contributes to the understanding of the Brazilian generic drugs policy and facilitates the search for information concerning the legal requirements for registration of drugs in Brazil.

Forest Policy Reform in Brazil

Rapid deforestation in the Brazilian Amazon, caused by economic, social, and policy factors, has focused global and national attention on protecting this valuable forest resource. In response, Brazil reformed its federal forest laws in 2006, creating new regulatory, development, and incentive policy instruments and institutions. Federal forestry responsibilities are maintained within the ministry of the environment; its regulatory agency responsibilities are divided among three different branches of the agency; many powers are delegated to states and municipalities; and a new private concession system is being developed. These reforms offer promise to improve forest protection and management in Brazil but must overcome significant institutional and social resistance for success.

Emerging Issues Concerning the Education of Speech and Language Pathologists and Audiologists in Brazil and South America

Diversity is one of the major characteristics of Brazil and all South America. This paper presents an overview of the current situation of the education of speech and language pathologists (SLP) and audiologists in Brazil and in several other countries of South America. This paper also discusses the main challenges shared by these countries. The discussion is focused on the mutual interferences between education and the areas of professional practice, cultural diversity and continued education. There are many emerging issues about the education of SLP and audiologists in South America. The suggested conclusion is that, despite the many differences, the South American SLP and audiologists` education would benefit from joint efforts and collaborative experiences. Copyright (C) 2010 S. Karger AG, Basel

Health in Brazil 6 Health conditions and health-policy innovations in Brazil: the way forward

Brazil is a large complex country that is undergoing rapid economic, social, and environmental change In this Series of six articles, we have reported important improvements in health status and life expectancy, which can be ascribed largely to progress in social determinants of health and to implementation of a comprehensive national health system with strong social participation. Many challenges remain, however. Socioeconomic and regional disparities are still unacceptably large, reflecting the fact that much progress is still needed to improve basic living conditions for a large proportion of the population. New health problems arise as a result of urbanisation and social and environmental change, and some old health issues remain unabated. Administration of a complex, decentralised public-health system, in which a large share of services is contracted out to the private sector, together with many private insurance providers, inevitably causes conflict and contradiction. The challenge is ultimately political, and we conclude with a call for action that requires continuous engagement by Brazilian society as a whole in securing the right to health for all Brazilian people.

Oral health in Brazil - Part II: Dental Specialty Centers (CEOs)

The concepts of health promotion, self-care and community participation emerged during the 1970s and, since then, their application has grown rapidly in the developed world, showing evidence of effectiveness. In spite of this, a major part of the population in the developing countries still has no access to specialized dental care such as endodontic treatment, dental care for patients with special needs, minor oral surgery, periodontal treatment and oral diagnosis. This review focuses on a program of the Brazilian Federal Government named CEOs (Dental Specialty Centers), which is an attempt to solve the dental care deficit of a population that is suffering from oral diseases and whose oral health care needs have not been addressed by the regular programs offered by the SUS (Unified National Health System). Literature published from 2000 to the present day, using electronic searches by Medline, Scielo, Google and hand-searching was considered. The descriptors used were Brazil, Oral health, Health policy, Health programs, and Dental Specialty Centers. There are currently 640 CEOs in Brazil, distributed in 545 municipal districts, carrying out dental procedures with major complexity. Based on this data, it was possible to conclude that public actions on oral health must involve both preventive and curative procedures aiming to minimize the oral health distortions still prevailing in developing countries like Brazil.

Oral Health in Brazil - Part I: public oral health policies

This paper reviews the historical development of public health policies in Brazil and the insertion of oral health in this context. Since 1988, Brazil established a Unified National Health System ("Sistema Único de Saúde" - SUS), which was conceived to assure access to health actions and services, including oral health. However, a history of lack of access to health services and the health problems faced by the Brazilian population make the process of building and consolidating the SUS extremely challenging. Since 2004, the Oral Health National Policy has proposed a reorientation of the health care model, supported by an adaptation of the working system of Oral Health teams so that they include actions of health promotion, protection and recovery. Human resources should be prepared to act in this system. The qualifying process must take in consideration knowledge evolution, changes in the work process and changes in demographical and epidemiological aspects, according to a perspective of maintaining a balance between technique and social relevance.

Contaminated sites and brownfield management State of art in Brazil and in Germany

Purpose - The aim of this paper is to briefly present aspects of public brownfield management policies from Brazilian and German points of view. Design methodology approach - The data collection method combined literature and documental research. The bibliography included Brazilian and German literature about brownfield management. The documental research includes Brazilian and German legislation and official documents published by CETESB, the Environmental Company of the State of São Paulo, Brazil. Furthermore, publications of German governmental research institutions have been integrated in the paper. Findings - In Brazil, despite the lack of a federal public policy, the State of São Paulo has approved specific rules to deal with contaminated sites. Topics that could be targets of scientific studies have been identified. Experiences in Germany show that it is essential to have political will and cooperation between the different political levels and technical disciplines. Partnerships between German and Brazilian universities would be welcome as there is a wide range of opportunities for academic post-graduation studies and research focusing on human resources capacitation in environmental management. Originality value - The paper makes an original contribution of exploring an area (brownfield management) that is at the forefront of discussion in academe and industry

Democracy on the edge: limits and possibilities for the implementation of an urban reform agenda in Brazil

In Brazil the 1990s constituted years of institutional achievements in the fields of housing and urban rights, given the incorporation of the principles of the social function of cities and property, the recognition of tenure rights for slum dwellers and the direct participation of citizens in the decision making process of urban policies, within the 1988 Constitution. These proposals have become the pillars of the Urban Reform agenda which has penetrated the federal government apparatus since the creation of the Ministry of Cities under Lula's administration. The article evaluates the limits and possibilities for the implementation of this agenda through the analysis of two policies proposed by the Ministry: the National Council of Cities and the campaign for Participatory Master Plans. The approach is based on the organization of the Brazilian State in terms of urban development, the relationship with the political system and the characteristics of Brazilian democracy.

Democracy on the Edge: Limits and Possibilities in the Implementation of an Urban Reform Agenda in Brazil

The 1990s in Brazil were a time of institutional advances in the areas of housing and urban rights following the signing of the new constitution in 1988 that incorporated the principles of the social function of cities and property, recognition of the right to ownership of informal urban squatters and the direct participation of citizens in urban policy decision processes. These propositions are the pillars of the urban reform agenda which, since the creation of the Ministry of Cities by the Lula government, has come under the federal executive branch. This article evaluates the limitations and opportunities involved in implementing this agenda on the basis of two policies proposed by the ministry - the National Cities Council and the campaign for Participatory Master Plans - focusing the analysis on government organization in the area of urban development in its relationship with the political system and the characteristics of Brazilian democracy. Resume Au Bresil, les annees 1990 ont ete marquees par des progres institutionnels en matiere de logement et de droits urbains, dans le sillage de la Constitution de 1988 qui integre les principes d`une fonction sociale de la ville et de la propriete urbaine, ainsi que la reconnaissance du droit a la propriete pour les squatters urbains et la participation directe des citoyens aux processus d`elaboration des politiques urbaines. Ce sont egalement les piliers du programme de reforme urbaine qui releve de l`executif federal depuis la creation d`un ministere des Villes par le gouvernement Lula. Pour evaluer les limites et potentiels lies a la mise en place de ce programme, cet article s`appuie sur deux politiques publiques proposees par le ministere, le Conseil national des villes et la campagne en faveur des Plans directeurs participatifs, en analysant plus particulierement l`organisation gouvernementale en matiere d`urbanisme par rapport au systeme politique et aux caracteristiques de la democratie bresilienne.

Petroleum royalties and regional development in Brazil: The economic growth of recipient towns

In 1997, Brazil approved law n(cr) 9478, establishing new rules for sharing petroleum royalties with Brazilian municipalities. The goal of this paper is to evaluate whether royalties distributed under the new law have contributed for the development of benefited municipalities. For that the difference-indifferences estimator (diff-in-diff) is used, which compares the evolution of the economic product into the municipality affected by the new law with the unaffected ones, by exploring the new legislation as an exogenous change. The data refer to the municipal gross domestic product (GDP) growth rate before and after the event. Results are surprising, showing that royalty receivers grew less than municipalities that did not receive such resources. The difference is small but statistically significant. In general, an increase of one real in royalties per capita reduces the growth rate of the municipal product in 0.002 percentile points. (C) 2009 Elsevier Ltd. All rights reserved.

Opportunistic and partisan election cycles in Brazil: new evidence at the municipal level

This article tests the hypothesis of opportunistic and partisan cycle models using a new large data set of Brazilian municipalities over the 1989-2005 period. The results show an increase in total and current expenditures and a decrease in municipal investments, local tax revenues, and budget surplus in election years. They also show that partisan ideology exerts a relative influence on the performance of the local public accounts. These results confirm that both opportunistic and partisan cycles have occurred in the management of the budgets of Brazilian municipalities after the end of the military government.

Assessing the ex ante economic impacts of transportation infrastructure policies in Brazil

This paper uses a fully operational inter-regional computable general equilibrium (CGE) model implemented for the Brazilian economy, based on previous work by Haddad and Hewings, in order to assess the likely economic effects of road transportation policy changes in Brazil. Among the features embedded in this framework, modelling of external scale economies and transportation costs provides an innovative way of dealing explicitly with theoretical issues related to integrated regional systems. The model is calibrated for 109 regions. The explicit modelling of transportation costs built into the inter-regional CGE model, based on origin-destination flows, which takes into account the spatial structure of the Brazilian economy, creates the capability of integrating the inter-regional CGE model with a geo-coded transportation network model enhancing the potential of the framework in understanding the role of infrastructure on regional development. The transportation model used is the so-called Highway Development and Management, developed by the World Bank, implemented using the software TransCAD. Further extensions of the current model specification for integrating other features of transport planning in a continental industrialising country like Brazil are discussed, with the goal of building a bridge between conventional transport planning practices and the innovative use of CGE models. In order to illustrate the analytical power of the integrated system, the authors present a set of simulations, which evaluate the ex ante economic impacts of physical/qualitative changes in the Brazilian road network (for example, a highway improvement), in accordance with recent policy developments in Brazil. Rather than providing a critical evaluation of this debate, they intend to emphasise the likely structural impacts of such policies. They expect that the results will reinforce the need to better specifying spatial interactions in inter-regional CGE models.

Political Parties and Governors as Determinants of Legislative Behavior in Brazil`s Chamber of Deputies, 1988-2006

This article examines the relative importance of regional and national forces in shaping the behavior of Brazilian legislators at the national level. A widely held view is that national legislators respond to state pressures in making decisions, rather than pressures from the national government. Governors not only can influence national debates but also can determine outcomes by exerting control over their states` legislative delegations. This article examines a dataset of all roll-call votes in the Chamber of Deputies between 1989 and 2006 to isolate and evaluate the impact of local pressures on legislative voting. Spanning the terms of five presidents and five different congresses, the data show that the local influence is weaker than the national on the voting decisions of individual legislators and the voting cohesion of state delegations. Alternative institutional resources allow the central government to counteract the centrifugal pressures of federalism and other institutional influences.

Assessing deaf and hearing children`s communication in Brazil

In Brazil there are no specific tests for either signed or spoken language for deaf children. A protocol evaluating communicative abilities independent of modality of communication (sign language or spoken language), and comprising assessments of (a) pragmatic profile; (b) modality of communication and linguistic level; (c) complexity of communication; and (d) style and efficacy of communication between parent and child was administered to 127 deaf and hearing children. The children, aged 3-6 years old, were distributed in three groups: 20 with severe hearing loss, 40 with profound hearing loss and 67 normally hearing. Deaf children were found to be delayed, independent of their linguistic level and preferred modality of communication. The protocol in this study proved to be an useful instrument for gathering relevant information about the three groups of preschool children`s communicative abilities, and particularly suitable for use in countries where standardized assessments are not available. Learning outcomes: The reader will be introduced to the use of an assessment protocol comprising its development, application and data analysis. The reader will be informed about assessment of deaf children`s preferred modality of communication, by the participation of a bilingual (sign language user) professional. Communication abilities can be assessed independently of the linguistic modality. In developing countries in general, where simple and easy to administer assessments tools are scarce, such a protocol is of specific value. (c) 2010 Elsevier Inc. All rights reserved.

Health technology diffusion in developing countries: a case study of CT scanners in Brazil

Background The development of products and services for health care systems is one of the most important phenomena to have occurred in the field of health care over the last 50 years. It generates significant commercial, medical and social results. Although much has been done to understand how health technologies are adopted and regulated in developed countries, little attention has been paid to the situation in low- and middle-income countries (LMICs). Here we examine the institutional environment in which decisions are made regarding the adoption of expensive medical devices into the Brazilian health care system. Methods We used a case study strategy to address our research question. The empirical work relied on in-depth interviews (N = 16) with representatives of a wide range of actors and stakeholders that participate in the process of diffusion of CT (computerized tomography) scanners in Brazil, including manufacturers, health care organizations, medical specialty societies, health insurance companies, regulatory agencies and the Ministry of Health. Results The adoption of CT scanners is not determined by health policy makers or third-party payers of public and private sectors. Instead, decisions are primarily made by administrators of individual hospitals and clinics, strongly influenced by both physicians and sales representatives of the medical industry who act as change agents. Because this process is not properly regulated by public authorities, health care organizations are free to decide whether, when and how they will adopt a particular technology. Conclusions Our study identifies problems in how health care systems in LMICs adopt new, expensive medical technologies, and suggests that a set of innovative approaches and policy instruments are needed in order to balance the institutional and professional desire to practise a modern and expensive medicine in a context of health inequalities and basic health needs.