Patents, supply of medicines and protection of public health

INTRODUCCIÓN: A fin de cumplir con las obligaciones asumidas en la Organización Mundial del Comercio, Argentina comenzó a conceder patentes sobre medicamentos en octubre de 2000. Cerca de 1.000 patentes farmacéuticas fueron concedidas entre 2000 y 2007 OBJETIVOS: caracterizar el patentamiento farmacéutico y, en particular, establecer el tipo de materias protegidas, las aplicaciones terapéuticas y el origen de los titulares de patentes otorgadas; examinar el posible impacto del nuevo régimen de patentamiento sobre las adquisiciones públicas de medicamentos; clarificar en qué situaciones y con qué procedimientos pueden otorgarse licencias obligatorias, especialmente en casos de emergencia sanitaria; y examinar qué implicaciones tiene el marco legal nacional e internacional de la propiedad intelectual sobre las políticas de salud pública. MÉTODOS: Se diseñó y analizó una base de datos con las patentes concedidas en el período indicado. Se revisaron los procedimientos de adquisición de medicamentos del Ministerio de Salud de la Nación y el marco legal aplicable, así como las negociaciones internacionales en curso. RESULTADOS: casi la totalidad de las patentes otorgadas pertenecen a empresas extranjeras; la mayoría se refiere a enfermedades del sistema nervioso e incluyen reivindicaciones del tipo "Markush". La mayoría de las patentes son de derivados o variantes de productos existentes (sales, formulaciones, polimorfos, etc.). CONCLUSIONES: El estudio concluye con recomendaciones, sobre los procedimientos de adquisición, concesión de licencias obligatorias y la transparencia del sistema de patentes en lo concerniente a medicamentos.INTRODUCTION: In order to comply with its obligations in the World Trade Organization, Argentina started to grant patents on pharmaceutical products in October 2000. In the period 2000-2007 near one thousand pharmaceutical patents were granted. OBJECTIVES: To characterize pharmaceutical patenting and, in particular, to establish the type of protected subject matter, the therapeutic uses and the origin of patent owners; to examine the possible impact of the new patenting regime on public procurement of medicines; to clarify in which situations and with which procedures compulsory licenses can be granted, particularly in cases of health emergencies; to examine the implications of the national and international legal framework of intellectual property on public health policies. METHODS: A data base with the patents granted in the above-mentioned period was designed and analyzed, the procurement procedures of the National Ministry of Health were studied, as well as the applicable legal framework and ongoing international negotiations. RESULTS: The study revealed that almost all granted patents belong to foreign companies. The majority refers to diseases of the nervous system and includes 'Markush-type'. In addition, the great majority of patents relate to derivatives or variants of existing products (salts, formulations, polymorphs, etc.). CONCLUSIONS: The study concludes with recommendations, about procurement procedures, the grant of compulsory licenses and the transparency of the patent system as regards medicines.Facultad de Ciencias Médica

Measuring the Progress and Success of Regional Health Policies: PRARI Toolkit of Indicators for the Union of South American Nations (UNASUR)

PRARI is a social development research project that looks at world-regional social governance, politics, and policy. PRARI brings together an international team of researchers studying the scope for enhancing the effectiveness of the contributions of Southern regional organisations to poverty reduction. It receives funding from the ESRC

Monitoring Pro-Poor Health-Policy Success in UNASUR

Monitoring pro-poor health policies at the regional level is essential for both countries and the regional bodies themselves, by identifying the issues related to the policy guidelines, the approach to health or information flows, as well as understanding implementation mechanisms of health policies at the local level. In order to address poverty and health problems, and strengthen ties between regional organizations and member countries, it is essential to generate mechanisms to track accountability to commitments and exchange of information to support the monitoring and evaluation of activities. Since its creation, UNASUR through the South American Health Council (CSS) has invested political and human resources in the area of health. The Five Year Plan 2010-2015 of the CSS, despite a number of pending activities, is the demonstration of this commitment. Added to this are the new activities the CSS gradually developed, which complement the work of the Council, such as their incursions in global health diplomacy. However, policy directions are still guided by the original values and principles included in the 2010-2015 health work plan. The “Poverty Reduction and Regional Integration” (PRARI) project presents an opportunity to generate a monitoring system that is based on existing needs in the region and supports the link between the countries and UNASUR, as well as UNASUR’s position at the global level. The aim of the PRARI project is to support the development of a monitoring system in collaboration with key stakeholders in the region. The focus will be the actions of the CSS in key policy areas such as primary health care, pharmaceutical policies and surveillance systems. Global processes such as those pertaining to the incoming sustainable development goals (SDGs) wil also be considered. In order for this indicator-based monitoring system to be effective and have an impact, it requires ‘regional ownership’ and the active participation of regional and national experts throughout the process of indicator development, implementation and evaluation. Furthermore, institutional support from UNASUR and its Member States, the main beneficiaries of this process, is critical for the monitoring system to be fully operational

Cost-effectiveness analysis of the 10- and 13-valent pneumococcal conjugate vaccines in Argentina.

OBJECTIVE: Since the 10-valent pneumococcal conjugate vaccine (PCV-10) and 13-valent pneumococcal conjugate vaccine (PCV-13) were recently licensed for use in Argentina, both vaccines were evaluated to estimate the costs, health benefits and cost-effectiveness of adding a PCV to the routine child immunization schedule. METHODOLOGY: The integrated TRIVAC vaccine cost-effectiveness model from Pan American Health Organization's ProVac Initiative (Version 1.0.65) was used to assess the health outcomes of 20 successive cohorts from birth to 5 years of age. PCV-10 and PCV-13 were each compared to a scenario assuming no PCV vaccination. A 3+1 (three doses+booster) schedule and a vaccination price of US$20.75 per dose was assumed in the base case for both vaccines. RESULTS: Introduction of PCV-13 rather than PCV-10 would increase the number of life years gained (LYG) by at least 10$ 8973 and US$10,948 for PCV-10 and PCV-13 respectively, and US$ 8546 and US$10,510 respectively, after incorporating costs saved by households. When PCV13 was compared to PCV10 directly, the additional benefits of PCV-13 was conferred at a cost of US$ 28,147 per DALY averted. Cost-effectiveness was influenced mainly by vaccine price, serotype replacement, pneumonia mortality and discount rate. CONCLUSION: Routine vaccination against S. pneumoniae in Argentina would be cost-effective with either PCV-10 or PCV-13. PCV-13, with higher coverage of local serotypes, would prevent more cases of pneumonia, invasive pneumococcal disease, sequelae and deaths with a higher number of LYG and DALYs averted, but PCV-10, due its higher impact in the prevention of AOM, would save more costs to the healthcare system