A muchos pacientes se les niega el acceso a los servicios de salud y a los medicamentos en América Latina, por lo que los jueces tienen que intervenir. Esta tendencia de judicialización se ha acelerado durante la última década. En un sentido similar, la literatura existente sobre la justiciabilidad y judicialización del derecho a la salud se ocupa de la cuestión de si los jueces deben intervenir o no en la protección del derecho a la salud. Objetivo: Evaluar los desafíos derivados del litigio del Derecho a la Salud en Colombia, Argentina, Brasil y México. Metodología: Marco analítico y metodológico cualitativo, descriptivo y comparativo. Incluye una revisión bibliográfica y 37 entrevistas semiestructuradas a jueces, académicos y funcionarios gubernamentales. Además, se realizó un análisis jurisprudencial de la jurisprudencia más reciente en los 4 países mediante análisis de contenido. Resultados: En los cuatro países estudiados persiste un enfoque moderado orientado a las repercusiones en el litigio y, preocupado por las consecuencias del proceso de judicialización. Esto supone, en primer lugar, la incorporación de algunos límites y condiciones en el reconocimiento del derecho a la salud por parte de los Tribunales y, en segundo lugar, en términos generales, que las sentencias no están teniendo en cuenta las causas estructurales que afectan a la litigiosidad. Conclusiones: Los tribunales deberían avanzar hacia un equilibrio intencional en el reconocimiento, los remedios, la supervisión y la evaluación de las sentencias. Esto implica ser más reflexivos y estratégicos que reactivos y pasivos. En otras palabras, cuanto más inmaduro sea el sistema sanitario y más causas estructurales se perciban, más reflexivos y estratégicos deberían ser los Tribunales y más se debería promover el reconocimiento, la protección, la supervisión y la evaluación. Los Estados también deben adoptar medidas contundentes contra las causas estructurales y deben hacer operativo un enfoque de la salud más práctico y basado en los derechos, de manera tangible.

Monitoring the safety of medicine use in children is of paramount importance since during the clinical development of medicines only limited data on this aspect are generated through clinical trials. Use of medicines outside the specifications described in the license (e.g. in terms of formulation indications contraindications or age) constitutes off-label and off-license use and these are a major area of concern. These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in pediatric populations. This book will be of interest to all health care professionals medicine regulatory authorities pharmacovigilance centres academia the pharmaceutical industry and policy-makers. Systems for monitoring medicine safety are described in Annex 1. Pharmacovigilance methods and some examples of recent information on adverse reactions to marketed medicines are discussed in Annex 2.

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.

Cancer is low or absent on the health agendas of low- and middle-income countries (LMCs) despite the fact that more people die from cancer in these countries than from AIDS and malaria combined. International health organizations, bilateral aid agencies, and major foundations—which are instrumental in setting health priorities—also have largely ignored cancer in these countries. This book identifies feasible, affordable steps for LMCs and their international partners to begin to reduce the cancer burden for current and future generations. Stemming the growth of cigarette smoking tops the list to prevent cancer and all the other major chronic diseases. Other priorities include infant vaccination against the hepatitis B virus to prevent liver cancers and vaccination to prevent cervical cancer. Developing and increasing capacity for cancer screening and treatment of highly curable cancers (including most childhood malignancies) can be accomplished using "resource-level appropriateness" as a guide. And there are ways to make inexpensive oral morphine available to ease the pain of the many who will still die from cancer.

The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.

Stories of transnational terror and justice illuminate the past and present of South America’s struggles for human rights. Through the voices of survivors, human rights activists, judicial actors, and experts, The Condor Trials unravels the secrets of transnational repression masterminded by South American dictators between 1969 and 1981. Under Operation Condor, the regimes of Argentina, Bolivia, Brazil, Chile, Paraguay, and Uruguay closely monitored hundreds of exiles and kidnapped, tortured, murdered, or forcibly returned them to their countries of origin. This cross-border network designed to silence opposition in exile transformed South America into a borderless zone of terror and impunity. Francesca Lessa shows how, gradually, transnational networks of activists materialized and effectively transcended national borders to achieve justice for the victims of these horrors. Based on extensive fieldwork, archival research, trial ethnography, and over 100 interviews, The Condor Trials explores South America’s past and present and sheds light on ongoing struggles for justice as its societies come to terms with the unparalleled atrocities of their not-so-distant pasts.