The right to health and medicines: the case of recent multilateral negotiations on public health, innovation and intellectual property.

The negotiations of the intergovernmental group known as the 'IGWG', undertaken by the Member States of the WHO, were the result of a deadlock in the World Health Assembly held in 2006 where the Member States of the WHO were unable to reach an agreement on what to do with the 60 recommendations in the report on 'Public Health, Innovation and Intellectual Property Rights submitted to the Assembly in the same year by a group of experts designated by the Director General of the WHO. The result of these negotiations was the 'Global strategy and plan of action on public health, innovation and intellectual property' which was approved by the World Health Assembly in 2008. The intention of the Global Strategy and Plan of Action (GSPOA) which was produced by the IGWG was to substantially reform the pharmaceuticals' research and development system in view of the findings that this system, whose purpose is to produce medicines for diseases which affect the greater part of the world population which lives in developing countries, had failed. The intellectual property rights imposed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the recent trade agreements could become one of the main obstacles to access to medicines. The GSPOA makes a critical analysis of this reality, and opens the door to searching for new solutions to this problem.

[Alternatives to the drug research and development model]. / Alternativas al modelo de investigación y desarrollo de medicamentos.

One-third of the global population lacks access to medications; the situation is worse in poor countries, where up to 50% of the population lacks access. The failure of current incentive systems based in intellectual property to offer the necessary pharmaceutical products, especially in the global south, is a call to action. Problems related to drug access cannot be solved solely through improvements or modifications in the existing incentive models. The intellectual property system model does not offer sufficient innovation for developing countries; new mechanisms that effectively promote innovation and drug access simultaneously are needed. A binding international agreement on research and development, negotiated under the auspices of the World Health Organization, could provide an adequate framework for guaranteeing priority-setting, coordination, and sustainable financing of drugs at reasonable prices for developing countries.

Alternativas al modelo de investigación y desarrollo de medicamentos / Alternatives to the drug research and development model

Un tercio de la población mundial carece de acceso a los medicamentos y la situación es peor en los países pobres, en los que hasta un 50% de la población carece de acceso. El fracaso de los sistemas actuales de incentivos, basados en la propiedad intelectual, para ofrecer los productos farmacéuticos necesarios, especialmente en los países del sur, llama a la acción. Los problemas relacionados con el acceso a medicamentos no pueden ser resueltos tan solo a través de mejoras o adaptaciones de los modelos de incentivos existentes. El modelo del sistema de propiedad intelectual no ofrece la innovación necesaria para los países en desarrollo, se necesitan nuevos mecanismos que de forma simultánea y eficaz promuevan la innovación y el acceso a los medicamentos. Un tratado internacional vinculante sobre investigación y desarrollo, que se negocie bajo los auspicios de la Organización Mundial de la Salud, puede proporcionar el marco adecuado para garantizar el establecimiento de prioridades, la coordinación y la financiación sostenible de los medicamentos a precios asequibles para los países en desarrollo.

One-third of the global population lacks access to medications; the situation is worse in poor countries, where up to 50% of the population lacks access. The failure of current incentive systems based in intellectual property to offer the necessary pharmaceutical products, especially in the global south, is a call to action. Problems related to drug access cannot be solved solely through improvements or modifications in the existing incentive models. The intellectual property system model does not offer sufficient innovation for developing countries; new mechanisms that effectively promote innovation and drug access simultaneously are needed. A binding international agreement on research and development, negotiated under the auspices of the World Health Organization, could provide an adequate framework for guaranteeing priority-setting, coordination, and sustainable financing of drugs at reasonable prices for developing countries.

O gerenciamento da pandemia da gripe A (H1N1): uma visão alternativa / The management of a A (H1N1) pandemic: an alternative view

Este artigo tem por objetivo analisar os interesses comerciais não relacionados à saúde pública que surgiram durante a condução da pandemia da gripe A (H1N1) no Hemisfério Norte. Também busca refletir como a preparação para esta pandemia poderia se tornar um peso para os países do Hemisfério Sul. Além disso, este trabalho examina a complexidade da divulgação científica pelos meios de comunicação em casos de surtos epidêmicos graves.

Asociación entre títulos de anticuerpos anticardiolipinas y eventos trombóticos / Association between anticardiolipin titles and thrombotic events

Introducción: la trombosis es la manifestación principal del síndrome antifosfolípido (SAF); los marcadores serológicos de esta entidad son los anticuerpos anticardiolipinas (aCL), la anti-β2 glicoproteína 1 y el anticoagulante lúpico. Aún se discute si los títulos de aCL o la presencia de un "segundo hit" son factores de riesgo para trombosis. Objetivo: evaluar la asociación entre fenómenos trombóticos vasculares con la presencia y los títulos de aCL; además del papel de otros factores protrombóticos. Material y método: estudio descriptivo transversal. Se revisaron historias clínicas de pacientes con sospecha clínica de SAF y con al menos una medición de títulos de aCL, se evaluó la presencia o no de eventos trombóticos y de comorbilidades (segundo hit). Resultados: historias clínicas de 49 pacientes, 33 con un total de 36 eventos trombóticos de los cuales 23 ocurrieron en lechos venosos y 13 en lechos arteriales. Aunque la mayoría de los pacientes con títulos de aCL > 20 GLP o MLP se encontraban en el grupo de trombosis, no se encontró asociación significativa entre la presencia de trombosis y los títulos de aCL; como tampoco entre trombosis y la existencia de otras comorbilidades. Conclusiones: los hallazgos encontrados permiten sugerir la mayor frecuencia de eventos trombóticos en pacientes con títulos de aCL < 40 en dos mediciones y aportan información sobre las características clínicas de los pacientes con aCL y sospecha de SAF en nuestro medio; sin embargo, no son suficientes para categorizarlos como un factor de riesgo definitivo de trombosis.

Background: thrombosis is the main clinical manifestation of the antiphospholipid syndrome (APS); anticardiolipin antibodies (aCL), anti-β2 glycoprotein-1 antibodies and lupus anticoagulant are the serological markers of the disease. Whether the titles of aCL or the presence of a "second hit" are risk factors for thrombosis is an unresolved issue. Objective: to evaluate the association between vascular thrombotic events with the presence of aCL. The relationship between thrombosis and the titles of aCL, as well as other prothrombotic factors was also assessed. Methodology: descriptive cross-sectional study. The clinical charts of patients with possible APS and at least one laboratory measurement of aCL were reviewed. The presence of thrombotic events and the existence of comorbid states (second hit) were also evaluated. Results: the records of 49 patients were assessed, 33 with a total of 36 thrombotic events, 23 had occurred on veins, and 13 on arteries. Though the majority of the patients that had titles of aCL above of 20 GPL or MPL were located in the group of thrombosis, there was no significant association between the titles of aCL and the presence of thrombosis. Neither significant association was found between thrombosis and the presence of other comorbid states. Conclusions: these findings allow suggesting the increased frequency of thrombotic events in patients with titers of aCL lower than 40 twice and also add information about the clinical characteristics of patients with aCL and suspected APS in our region; however, they are not enough to categorize them as a definitive risk factor of thrombosis.

Has the implementation of the TRIPS Agreement in Latin America and the Caribbean produced intellectual property legislation that favours public health?

OBJECTIVE: The World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement establishes minimum standards for intellectual property rights, including patent protection for pharmaceuticals; therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs. METHODS: Legislation in 11 Latin American and Caribbean countries was analysed. The variables considered in the analysis were: the term of patents issued, patentable subject matter, transition periods (that is, time until legislation was enacted), reversal of the burden of proof of patent infringement, exhaustion of rights, compulsory licensing and the early working exception (which allows a country to complete all procedures necessary to register a generic product before the original patent expires). FINDINGS: By 2000, all of the countries studied had reformed their legislation to conform to the agreement. Brazil and Argentina used the transition period until 2005 to grant patents in the pharmaceutical industry. All countries, except Panama, made use of the safeguards and flexibilities available through the agreement by including mechanisms for compulsory licensing in their legislation. Argentina; Bolivia, Colombia, Ecuador, Peru and Venezuela (countries that represented the Andean community); the Dominican Republic; and Panama included mechanisms to allow parallel importation. Mexico did not. Brazil only permits parallel importation after a compulsory licence has been issued. The early working exception is included in legislation in Brazil and the Dominican Republic. CONCLUSION: The countries in this study did not incorporate all of the mechanisms allowed for by the Agreement and are not adequately using the provisions that enable World Trade Organization (WTO) members to obtain better health for the public, particularly in regard to gaining access to medicines. This situation may deteriorate in future if other agreements establish more restrictive rules for intellectual property rights.

Farmacoeconomia: evaluación cientifica o estrategia comercial? / Pharmacoeconomics: Scientific assessment or commercial strategy?

The new global context, the dramatic rise in the cost of many health technologies, and the mounting pressures that constrain health sector budgets in most countries have created the need to evaluate health interventions, including pharmaceuticals, from an economic perspective. Pharmacoeconomics is "the application of economic theory to pharmacotherapeutics" and is often linked to commercial marketing. We propose standardizing the various methods of economic analysis so as to allow for comparisons and assessment of correct relationships. The author concludes pharmacoeconomics is simply an analytical fool that can be applied for scientific assessment or commercial promotion, depending on the objectives and purpose for which the use of this new discipline is intended

Muerte cerebral: incidencia, causas y manejo en Trujillo / Brain death: incidence, causes and handling in Trujillo

Con la finalidad de identificar la incidencia de casos de muerte cerebral, las causas y el manejo, se analizaron 36 casos de pacientes críticos admitidos a las UCI del Hospital Belén MINSA y Hospital Víctor Lazarte Echegaray - EsSalud de Trujillo - Perú, entre enero de 1995 y setiembre de 1999. La incidencia en el período de estudio fue de 2.08 por ciento. Las causas identificadas fueron Traumatismos Encefalocraneano Grave 44,44 por ciento. Enfermedad vascular cerebral 22.22 por ciento. Post reanimación cardiopulmonar 22,22 por ciento. Tumor cerebral 5.56 por ciento, meningoencefalitis tuberculosa 2.78 por ciento y ahogamiento 2.78 por ciento. El manejo posterior al diagnóstico fue el de continuar tratamiento en 61,11 por ciento, soporte mínimo en 38,89 por ciento. A solicitud de la familia se retiró la asistencia ventilatoria en 11,11 por ciento de los casos. Dadas las características socioculturales de la población atendida se sugiere continuar con el soporte mínimo hasta la asistolia o el retiro consentido de los familiares. Se llama la atención sobre un número significativo de donantes potenciales perdidos. Es necesario difundir los criterios de Harvard para el diagnóstico de muerte cerebral entre el personal de salud y comunidad.

Estudio, diseno e implementacion de una politica nacional de médicamentos esenciales: Colombia / Study, design and implementation of the national essential drugs policy: Colombia

El presente documento es un resumen del informe final y se compone de dos partes: 1. Una presentacion de los terminos de referencia y de la situación global del sector farmaceutico en Colombia. 2. Un resumen de las principales recomendaciones del informe de acuerdo a los terminos de referencia (puntos 1 al 7). El punto 8, "Plan de acción", elaborado con los responsables del Ministerio de Salud, traduce las diferentes recomendaciones del informe, en las lineas generales de un plan de acción nacional de médicamentos esenciales, a largo plazo