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This paper aims to analyze the interfaces between Brazilian Competition Law and the issue of access to medicines, with a special focus on abuse of industrial property rights and related exclusionary and exploitative effects. The paper analyzes the case law of Brazilian Administrative Council for Economic Defense (CADE) in the pharmaceutical sector and discusses abusive practices such as illegitimately imposing non-existent or invalid intellectual property rights with anticompetitive purposes. It then addresses abusive strategies in the exercise of industrial property rights which are, in essence, valid: i.e., exclusionary practices, aimed at artificially raising barriers to entry; and exploitative practices, directly translated as the exercise of market power to the detriment of the consumer. The latter ultimately result in exploitative excessive prices; contractual, quality or privacy degradation; and restrictions on supply, such as by hoarding/preventing the exploitation of industrial property rights. The paper concludes that the prohibition of exploitative pricing under the current competition law is legally valid and effective, with certain methodological concerns towards reducing the risk of wrongful convictions (for instance, by applying screening tests to determine the markets that are candidates for intervention). In view of such guidelines, the pharmaceutical industry appears to be an important candidate for antitrust attention, given the magnitude of the harm potentially derived from non-intervention against the practice. Remedies in this area, importantly, should focus on identifying and solving the sector's structural competitive problems. In the case of medicines subject to price regulation by the Drug Market Regulation Chamber (CMED), the technical expertise of the competition authority may be of great value in terms of competition advocacy, a fact that is demonstrated in light of recent discussions on extraordinary price adjustments because of competitive problems in certain markets.
Competition law may play an important role in drug pricing control by containing high prices derived from economic violations. Since the use of competition tools is not limited by the TRIPS Agreement or other international binding disciplines, there is ample policy room to explore how countries, especially in the Global South, can benefit from strengthening their jurisdiction on that matter. This article briefly explains the Brazilian Competition System by describing the structure of the Brazilian competition authority (CADE - Administrative Council for Economic Defense) and the main economic violations set forth by Brazilian law. It describes the convergence of competition with the consumer protection system. It also discusses three relevant pharmaceutical market cases examined by the competition authority (sham litigation, overpricing and economic abuse, buy-and-raise and exclusionary practices). Finally, it presents some lessons from the Brazilian case on the challenges of using competition law to confront abuse or misuse of intellectual property rights in the pharmaceutical market, with lessons to other developing countries.
Although ideally a patent system for pharmaceuticals should serve to incentivize research into the development of new medicines, the COVID-19 pandemic has exposed the equal importance of drug access and affordability. This book, by focusing on the Brazilian rule which makes the grant of pharmaceutical patents dependent on the prior consent of the National Health Surveillance Agency (ANVISA), shows how the Brazilian model affords an example for other countries to follow in dealing with tensions between patent protection and the right to healthcare. Based on an empirical study in which the author examined 147 reports issued by ANVISA as a basis for its decisions, the book deals with such central questions concerning the interface of regulation and innovation in the patent system as the following: compatibility between ANVISA’s prior consent mechanism and the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; how “evergreening” and “trivial patents” undermine public health and access to medicines; ways of correcting abuses of patent rights and controlling quality of patents; and the discourse on health as a human right. Along with her examination of ANVISA reports, the author analyzes how Article 229-C LPI, which introduced the need of ANVISA’s prior consent to the patent grant of pharmaceuticals in Brazil, has been interpreted in Brazilian case law. Interviews with Brazilian experts are also included. In its commitment to harmonizing patent rights and the right to access of affordable medicines, Brazil’s patent system for pharmaceuticals stands out as a workable response to the basic problem of access to medicines in the developing world. By describing the successes and failures in the Brazilian policy of promoting drug access, this book helps policymakers in developing and emerging countries to better explore TRIPS flexibilities when dealing with similar problems, and provides practitioners in the law of the World Trade Organization, patent law, competition law, and health law with a guide to how a more equitable pharmaceutical patenting system could work in practice.
It has been more than 20 years since Brazil's 1988 Constitution formally established the Unified Health System (Sistema Unico de Saude, SUS). Building on reforms that started in the 1980s, the SUS represented a significant break with the past, establishing health care as a fundamental right and duty of the state and initiating a process of fundamentally transforming Brazil's health system to achieve this goal. This report aims to answer two main questions. First is have the SUS reforms transformed the health system as envisaged 20 years ago? Second, have the reforms led to improvements with regard to access to services, financial protection, and health outcomes? In addressing these questions, the report revisits ground covered in previous assessments, but also brings to bear additional or more recent data and places Brazil's health system in an international context. The report shows that the health system reforms can be credited with significant achievements. The report points to some promising directions for health system reforms that will allow Brazil to continue building on the achievements made to date. Although it is possible to reach some broad conclusions, there are many gaps and caveats in the story. A secondary aim of the report is to consider how some of these gaps can be filled through improved monitoring of health system performance and future research. The introduction presents a short review of the history of the SUS, describes the core principles that underpinned the reform, and offers a brief description of the evaluation framework used in the report. Chapter two presents findings on the extent to which the SUS reforms have transformed the health system, focusing on delivery, financing, and governance. Chapter three asks whether the reforms have resulted in improved outcomes with regard to access to services, financial protection, quality, health outcomes, and efficiency. The con
This is a comprehensive reference text that examines the current state of Legal Medicine, which encompasses Forensic Medicine, in the 21st century. It examines the scope of both legal and forensic medicine, its application and study and has adopted a wide ranging approach including multinational authorship. It reviews the differences between and similarities of forensic and legal medicine, the need for academic qualification, the applications to many and varied fields including international aid, military medicine, health law and the application of medical knowledge to both criminal law and tort/civil law, sports medicine and law, gender and age related factors from obstetrics through to geriatrics and palliative care as well as cultural differences exploring the Christian/Judeo approach compared with that within Islamic cultures, Buddhism and Hinduism. The book looks at practical applications of legal medicine within various international and intercultural frameworks. This is a seminal authoritative text in legal and forensic medicine. It has a multi-author and multinational approach which crosses national boundaries. There is a great interest in the development of health law and legal medicine institutes around the world and this text comes in on the ground floor of this burgeoning discipline and provides the foundation text for many courses, both undergraduate and postgraduate. It defines the place of legal medicine as a specialized discipline.​
Reshaping Health Care in Latin America: A Comparative Analysis of Health Care Reform in Argentina, Brazil, and Mexico
This work provides a comprehensive and detailed examination of all relevant legislation and practice in Brazil that affects business and investment. Doing Business in Brazil offers a wide-ranging analysis and commentary on Brazilian business laws as well as a detailed description of the Brazilian government, legislature and judiciary. Appendices provide all important legislation, regulations, and decrees (most translated into English) that impact on business and investment in Brazil. Topical Coverage Includes: Business OrganizationsForeign Investment RegulationImport-Export ControlContractsBankruptcy and InsolvencyPropertyAdministrative LawTaxationSocial and Labor LawIntellectual and Industrial PropertyFinancial InstitutionsInsuranceLicensing AgreementsTrade Regulations and AntitrustInformatics Law Value Package
This book examines the construction of an innovation system in Brazil’s health industries over the past twenty years. The authors argue that the system has remained active despite the crisis that began in 2014. However, while this crisis has led to cuts in public spending on research and health, it has simultaneously tended to stimulate local production and invention aimed at reducing deficits in the trade in medicines and medical technologies. The contributors highlight a model combining the acquisition of new technologies with social justice and the right to health, and introduce new concepts of the “nationalization” of technologies, innovation through copying and civil society regulation of industrial property and of the medicinal drug market.
This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Across the world, developing countries are attempting to balance the international standards of intellectual property concerning pharmaceutical patents against the urgent need for accessible and affordable medicines. In this timely and necessary book, Monirul Azam examines the attempts of several developing countries to walk this fine line. He evaluates the experiences of Brazil, China, India, and South Africa for lessons to guide Bangladesh and developing nations everywhere. Azam's legal expertise, concern for public welfare, and compelling grasp of principal case studies make Intellectual Property and Public Health in the Developing World a definitive work. The developing world is striving to meet the requirements of the World Trade Organization's TRIPS Agreement on intellectual property. This book sets out with lucidity and insight the background of the TRIPS Agreement and its implications for pharmaceutical patents, the consequences for developing countries, and the efforts of certain representative nations to comply with international stipulations while still maintaining local industry and public health. Azam then brings the weight of this research to bear on the particular case of Bangladesh, offering a number of specific policy recommendations for the Bangladeshi government—and for governments the world over. Intellectual Property and Public Health in the Developing World is a must-read for public policy-makers, academics and students, non-governmental organizations, and readers everywhere who are interested in making sure that developing nations meet the health care needs of their people.