Jorge Antonio Zepeda Bermudez

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 Organizations 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.

Innovation and Access to Medicines for Neglected Populations: Could a Treaty Address a Broken Pharmaceutical R&D System?

As part of a cluster of articles leading up to the 2012 World Health Report and critically reflecting on the theme of “no health without research,” Suerie Moon and colleagues argue for a global health R&D treaty to improve innovation in new medicines and strengthening affordability, sustainable financing, efficiency in innovation, and equitable health-centered governance.

A produção pública de medicamentos no Brasil: uma visão geral

Este artigo analisa o papel da producao publica de medicamentos no Brasil, a partir de analise bibliografica e documental. Examina as principais caracteristicas da industria farmaceutica e do mercado de medicamentos em suas dimensoes internacional e nacional. Enfatiza, particularmente, a producao de medicamentos do setor publico, bem como aspectos da visao governamental sobre o tema. O estudo se fundamenta na analise de documentos oficiais do Ministerio da Saude. A exposicao conclui com um diagnostico da situacao atual do parque de laboratorios publicos, que mostra a existencia de problemas de ordem politica, administrativa e de funcionamento, aliados a baixa capacitacao tecnologica e a escassez de recursos humanos qualificados em geral.This paper analyzes the role of government production of medicines in Brazil, based on a review of the literature and public documents. It begins by examining the main characteristics of the national and international pharmaceutical industry and market dimensions, mainly in the public sector. The government view was examined through Ministry of Health documents. The article concludes with a diagnosis of the state-owned pharmaceutical industry in Brazil, showing a variety of difficulties faced by the laboratories due to political and institutional constraints, management deficiencies, shortage of qualified human resources, and low technological capability.This paper analyzes the role of government production of medicines in Brazil, based on a review of the literature and public documents. It begins by examining the main characteristics of the national and international pharmaceutical industry and market dimensions, mainly in the public sector. The government view was examined through Ministry of Health documents. The article concludes with a diagnosis of the state-owned pharmaceutical industry in Brazil, showing a variety of difficulties faced by the laboratories due to political and institutional constraints, management deficiencies, shortage of qualified human resources, and low technological capability.

Avaliação da assistência farmacêutica às pessoas vivendo com HIV/AIDS no Município do Rio de Janeiro

This study evaluates access by people living with HIV/AIDS to pharmaceutical care provided by public health care facilities in the city of Rio de Janeiro, Brazil, focusing on availability, accessibility, and accommodation. The evaluation was conducted using the implementation analysis approach, assessing the process of producing intervention outcomes, considering its relationship to the organizational context. A case study was performed in 11 public health facilities selected according to: different health program areas; diverse levels of complexity; and more than 100 HIV/AIDS patients registered. The degree of implementation (89%) was considered acceptable. Problems with human resources skills and lack of a quality program were identified. Some limitations of the indicators are discussed. Finally, the study highlights the importance of this kind of evaluation as a methodology for continuous monitoring of quality in pharmaceutical care.

The UNITAID Patent Pool Initiative: Bringing Patents Together for the Common Good

Developing and delivering appropriate, affordable, well-adapted medicines for HIV/AIDS remains an urgent challenge: as first-line therapies fail, increasing numbers of people require costly second-line therapy; one-third of ARVs are not available in pediatric formulations; and certain key first- and second-line triple fixed-dose combinations do not exist or sufficient suppliers are lacking. UNITAID aims to help solve these problems through an innovative initiative for the collective management of intellectual property (IP) rights – a patent pool for HIV medicines. The idea behind a patent pool is that patent holders - companies, governments, researchers or universities - voluntarily offer, under certain conditions, the IP related to their inventions to the patent pool. Any company that wants to use the IP to produce or develop medicines can seek a license from the pool against the payment of royalties, and may then produce the medicines for use in developing countries (conditional upon meeting agreed quality standards). The patent pool will be a voluntary mechanism, meaning its success will largely depend on the willingness of pharmaceutical companies to participate and commit their IP to the pool. Generic producers must also be willing to cooperate. The pool has the potential to provide benefits to all.

Talidomida no Brasil: vigilância com responsabilidade compartilhada?

This paper discusses issues related to the regulation and rational use of thalidomide in Brazil, by means of a historical approach comprising three different stages. The first part is a historical review of the controversial drug since it was first synthesized, then marketed and subsequently banned during the 1950s and 60s, until the present, when an apparently irreversible process of rehabilitating the drug is under way. Brazilian experience with the use of thalidomide is described, emphasizing legal, political, and institutional work led by two social movements, the Brazilian Association of People with Thalidomide Syndrome (ABPST) and the Movement for Reintegration of People with Hansens Disease (Morhan). The article describes the results and analyzes an active search of new cases in what is a second generation of thalidomide syndrome in Brazil. Finally, based on clinical and scientific evidence of thalidomides therapeutic efficacy, the growth of social movements struggling both for and against authorization of the drug, and a restrictive regulation proposed by the Ministry of Health, the article discusses the implementation of policies for the regulation and rational use of thalidomide in Brazil.

Validation of a tool for assessing the quality of pharmaceutical services

This paper presents the validation process for a tool assessing basic pharmaceutical services through an analysis of the implementation of a Basic Pharmaceuticals Distribution Program by the Brazilian Federal government. The process began with the drafting of a theoretical model, based on a state-of-the-art review and allowing the selection of various conceptual dimensions and respective criteria that best represented the construct. The second step involved weighting indicators for the construction of quality scores. Three models were tested for ranking implementation levels, and seven simulations were conducted, determining the score most closely reflecting the selected indicators in two different matrices. The objective was to select the most coherent and consistent version between implementation levels and expected outcomes, while simultaneously enhancing validity of chosen criteria. Testing of the various models and the results obtained showed that augmenting the validity of the study was possible without altering data. This endeavor is justified in understanding the scope and limitations of these measurements and of the choices involved in issues concerning their weighting and interpretation.

Uso indicado e uso referido de medicamentos durante a gravidez

Few studies describe drug utilization in pregnancy focusing on prescribing practices. This study is part of a larger survey on perinatal care in the City of Rio de Janeiro, Brazil. The type of hospital (public, contracted out by the Unified National Health System, or private) determined the stratification of 10,072 hospitalized post-partum women, who were asked about medication used during pregnancy. Hospital records supplied information on drugs prescribed during labor. Drugs were classified according to the Anatomical Therapeutic Chemical (ATC) system. Another system was used for specific cases of referred use. A mean of 2.08 drugs was prescribed during labor, and a mean of 2.3 was reported during pregnancy. Anesthetics, antibiotics, oxytocin, and analgesics were the most frequently prescribed during labor, with significant differences between strata. Ferrous sulfate, vitamins, scopolamine, and acetaminophen were the main drugs reported during pregnancy. Women who had attempted abortion referred use of various kinds of tea (49.7%) and misoprostol (9.2%). The drug utilization pattern was consistent with the literature. This study offers knowledge on prescribing patterns during labor and self-reported use during pregnancy in both the public and private sectors.

Novos medicamentos registrados no Brasil: podem ser considerados como avanço terapêutico?

Technological advances in the last century led to the discovery of a variety of medicines. Their introduction, not always with significant therapeutic gains and not without risk, made the register by regulatory agency an important moment in their evaluation. The aim of this study was to analyze 49 new medicines registered by the National Health Surveillance Agency (Anvisa), between the years 2000 and 2002 and commercialized in the first half of 2003, considering their therapeutic advantage. Most medicines (42.9%) were from the American pharmaceutical industry. Most of them (63.3%) were classified as a new molecular entity, followed by the new fixed dose combinations (28.6%). Seventy-five percent were registered at the Food and Drug Administration (FDA). It was possible to obtain the classification of its New Drug Application (NDA) according to their therapeutic potential to 33 medicines and 57.6% of them were classified as standard. Most of the new registered medicines did not provide any therapeutic advantage. It is suggested that Anvisa disseminate the analysis information on innovation, efficacy, safety, brought (or not) by new drugs. This kind of information is important to consumers, health professionals and health managers.

Acesso a insumos em saúde: desafios para o Terceiro Mundo

A exclusao social no âmbito da saude e marcante. Na America Latina, com uma populacao de cerca de 560 milhoes de habitantes, a metade nao esta coberta por mecanismos de pro-tecao social e mais de 100 milhoes de pessoas nao tem acesso aos servicos de saude, por razoes economicas ou geograficas, e nem mesmo a agua potavel ou saneamento basico. Neste contexto, os desafios que se apresentam para nossos sistemas e servicos de saude, na tentativa de assegurar o acesso aos insumos essenciais, confrontam-se com o padrao de iniquidade que nos transforma numa regiao de desequilibrio, de extrema concentracao de renda e de injusticas evidentes.No marco de assegurar o acesso a insumos, temos que considerar que lidamos com produtos, com servicos e com populacoes vulneraveis. Nesse contexto, temos que bus-car equilibrar a garantia de acesso com padroes de equidade e produtos de qualidade. O acesso a insumos deve ser considerado no marco de politicas de saude, de CT proteger as realizacoes alcancadas, enfatizando a sustentabilidade das politicas sociais; enfrentar os novos desafios, entre os quais podemos incluir como assegurar acesso a novos produtos, como regular o mercado farmaceutico frente a nova Biotecnologia, Genomica e Proteomica. Tambem consideramos os novos marcos regulatorios que estao sendo impos-tos aos paises da regiao na negociacao de tratados de livre comercio (TLC) mais restritivos que os acordos globais subscritos no âmbito da Organizacao Mundial do Comercio, em especial o Acordo TRIPS.Entre as principais barreiras ao acesso a novos produtos e novas tecnologias, despon-tam os denominados TLC TRIPS-Plus, impondo restricoes alem das nossas legislacoes nacionais e impedindo a entrada de produtos competidores de menor preco no mercado que se torna monopolico pela protecao patentaria. Os termos aprovados nos TLC se sobre-poem aos marcos legislativos e alteram substancialmente as politicas de acesso a insumos em saude.Nossa regiao nao e homogenea e as solucoes nao podem ser uniformes. Onde se loca-liza a inovacao e o longo caminho entre a descoberta e o acesso devem merecer politicas integradas. As licoes aprendidas no Brasil, com sua politica de Ciencia, Tecnologia e Inova-cao em Saude, e o alinhamento das politicas com o desenvolvimento economico, social e cultural sao reflexoes para assegurar um investimento capaz de gerar conhecimento com base em necessidades sociais que influenciem a agenda de pesquisa, assegurando inova-coes em produtos, processos/metodos, politicas e estrategias. Pensemos coletivamente e ousemos dar o salto, de politicas nacionais isoladas a uma integracao sub-regional e regio-nal, que venham assegurar o investimento na melhoria das nossas condicoes de saude.