Propaganda de medicamentos. É possível regular ?

A regulação da propaganda de medicamentos no Brasil incorpora quatro fragilidades: 1. A monitoração, fiscalização e punição de irregularidades são realizadas a posteriori do acometimento da infração (quando a população já foi submetida a risco sanitário); 2. As multas cobradas pela Anvisa têm valor irrisório frente aos investimentos do marketing farmacêutico; 3. Não há mecanismo que impeça que mesmo os valores irrisórios das multas sejam repassados aos preços dos produtos, onerando o consumidor; 4. A frase tida como de alerta - A PERSISTIREM OS SINTOMAS O MÉDICO DEVERÁ SER CONSULTADO - ao invés de conscientizar a população a respeito dos riscos da automedicação, estimula o uso de medicamentos sem receita, aconselhando a busca de um médico apenas no caso da persistência dos sintomas. Segundo dados da Anvisa e de estudos acadêmicos, 90% da publicidade exibida contém irregularidades. Assim, a RDC 102/2000 da Anvisa, que regulamenta o setor, se constitui em um aparente sistema de regulação, que beneficia o infrator e mantém a população sob risco. Este trabalho analisa o conceito e o uso dos mecanismos de marketing na busca de se elevar a comercialização de produtos farmacêuticos (no que se denomina produção de doenças), examina os conceitos de propaganda, medicamento, regulação e manipulação; percorre alguns estatutos internacionais referentes ao setor da publicidade de medicamentos (com foco nas diretivas da União Européia) e expõe a avaliação de organismos europeus de defesa do consumidor sobre o desempenho destas normas. Ao final, este estudo expõe as posições do setor regulado brasileiro (indústria, agências de publicidade e meios de comunicação) frente às posições de órgãos de defesa dos consumidores, da academia e da sociedade organizada no âmbito do SUS, para propor como alternativa um modelo regulador que supere as fragilidades do atual.

Sistema de informação: uma proposição para o Hospital Universitário da Universidade Federal de Juiz de Fora-MG

Esse trabalho aborda a elaboração de requisitos dos usuários como parte da adequação do sistema de informação-SISTEMA DE INFORMAÇÃO DE GESTÃO ACADÊMICA-Administrativo- SIGA-Adm, proposto para o Hospital Universitário da Universidade Federal de Juiz de Fora. SIGA-Adm está em utilização, desde 2007, na Universidade Federal de Juiz de Fora. No entanto, para a efetiva aplicabilidade no âmbito do Hospital Universitário, torna-se necessário uma investigação acerca dos processos de trabalho, dentro do HU e uma ação de melhoria desses processos, a fim de evitar a incorporação de um sistema de informação que não corresponda a realidade apresentada. A elaboração dos requisitos dos usuários para a adequação visa a ser um instrumento de intermediação para discuss��o acerca da elaboração do SIGA-Adm para o HU/UFJF. Os requisitos apresentados originaram-se no processo de gerenciamento de materiais, como resultado da utilização da Metodologia de Análise e Melhoria de Processos-MAMP, aplicada na cadeia de suprimentos do Hospital Universitário, no período de 2004 a 2005. O acompanhamento do gerenciamento de materiais é uma estratégia utilizada pela Rede Sentinela para o desenvolvimento de ações de pós-comercialização de produtos para a saúde tais como: investigação de uso, registro de produtos, retirada de produto do mercado e etc... O Hospital Universitário da UFJF é integrante da Rede Brasileira de Hospitais Sentinela, implementada pela Agência Nacional de Vigilância Sanitária, desde 2001. As ações Pós-Comercialização de Produtos para a Saúde, em Tecnovigilância, são compartilhadas pela ANVISA e pelos integrantes da Rede Sentinela, através de informações relativas a queixas técnicas e/ou eventos adversos que possam causar algum dano à população. A pesquisa indica a possibilidade do SIGA-Adm armazenar informações sobre os produtos que permitam o rastreamento em condições normais e/ou anormais de uso pela instituição, contribuindo para o exercício em Tecnovigilância. Além disso, espera-se que construção do SIGA-Adm/HU-UFJF permita integrar os sistemas existentes no HU.

A regulação das patentes farmacêuticas no Brasil: entre saúde pública, política e direito

O objetivo geral da tese é aprofundar a reflexão sobre a regulação e o exame de qualidade de patentes farmacêuticas no Brasil, em um contexto de implantação de dispositivos legais conhecidos como TRIPS-Plus ao redor do mundo. Para isso, são discutidos os mecanismos jurídicos e políticos de proteção à saúde relacionados à propriedade intelectual. Analisam-se especificamente do ponto de vista sociológico as experiências de anuência prévia para pedidos de patentes envolvendo produtos e processos farmacêuticos da Agência Nacional de Vigilância Sanitária (Anvisa) e o uso do subs��dio ao exame técnico. Em termos metodológicos, consideram-se as ações do Governo brasileiro entre 1996 a 2012, propostas de mudança da Lei de Propriedade Industrial brasileira e controvérsias ligadas a algumas modalidades de reivindicação, como polimorfos, patentes de seleção e segundo uso médico. As técnicas de pesquisa utilizadas também incluem o levantamento de material de imprensa, textos de leis, documentos e decretos relativos a medicamentos e propriedade intelectual, assim como de pedidos de patentes e de decisões judiciais concernindo à temática. Optou-se ainda por realizar entrevistas com gestores, examinadores de patentes, juristas e membros de ONGs. As conclusões indicam que as práticas regulatórias ligadas ao setor saúde não podem ser reduzidas ao simples corpo de regras formais presentes neste domínio, mas sim entendidas como agenciamentos entre atores, tipos distintos de saberes e de ferramentas de intervenção. A regulação dos direitos de propriedade intelectual relativos a produtos e processos farmacêuticos no Brasil está ligada a um processo, onde se verifica a disputa em torno de diferentes projetos e visões de mundo de grupos com maior ou menor poder para direcionar este processo. Os dispositivos da anuência prévia e do subs��dio ao exame técnico apresentam-se como elementos reguladores da propriedade intelectual de medicamentos e de impacto sobre exame de qualidade de patentes farmacêuticas, contribuindo para a consideração de questões de saúde pública ao longo da concessão destas patentes.

Sensitivity of angler benefit estimates from a model of recreational demand to the definition of the substitute sites considered by the angler

Fishery managers are mandated to understand the effects that environmental damage, fishery regulations, and habitat improvement projects have on the net benefits that recreational anglers derive from their sport. Since 1994, the National Marine Fisheries Service (NMFS) has worked to develop a consistent method for estimating net benefits through site choice models of recreational trip demand. In estimating net benefits with these models, there is a tradeoff between computational efficiency and angler behavior in reality. This article examines this tradeoff by considering the sensitivity of angler-welfare estimates for an increase in striped bass (Morone saxatalis) angling quality across choice sets with five travel distance cutoffs and compares those estimates to a model with an unrestricted choice set. This article shows that 95% confidence intervals for welfare estimates of an increase in the striped bass catch and keep rate overlap for all distance-based choice sets specified here.

NMFS / Interagency Working Group Evaluation of CITES Criteria and Guidelines.

EXECUTIVE SUMMARY: At present, the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) criteria used to assess whether a population qualifies for inclusion in the CITES Appendices relate to (A) size of the population, (B) area of distribution of the population, and (C) declines in the size of the population. Numeric guidelines are provided as indicators of a small population (less than 5,000 individuals), a small subpopulation (less than 500 individuals), a restricted area of distribution for a population (less than 10,000 km2), a restricted area of distribution for a subpopula-tion (less than 500 km2), a high rate of decline (a decrease of 50% or more in total within 5 years or two generations whichever is longer or, for a small wild population, a decline of 20% or more in total within ten years or three generations whichever is longer), large fluctuations (population size or area of distribution varies widely, rapidly and frequently, with a variation greater than one order of magnitude), and a short-term fluctuation (one of two years or less). The Working Group discussed several broad issues of relevance to the CITES criteria and guidelines. These included the importance of the historical extent of decline versus the recent rate of decline; the utility and validity of incorporating relative population productivity into decline criteria; the utility of absolute numbers for defining small populations or small areas; the appropriateness of generation times as time frames for examining declines; the importance of the magnitude and frequency of fluctuations as factors affecting risk of extinction; and the overall utility of numeric thresh-olds or guidelines.

Age composition and distribution of red drum (Sciaenops ocellatus) in offshore waters of the north central Gulf of Mexico: an evaluation of a stock under a federal harvest moratorium

Because of a lack of fishery-dependent data, assessment of the recovery of fish stocks that undergo the most aggressive form of management, namely harvest moratoriums, remains a challenge. Large schools of red drum (Sciaenops ocellatus) were common along the northern Gulf of Mexico until the late 1980s when increased fishing effort quickly depleted the stock. After 24 years of harvest moratorium on red drum in federal waters, the stock is in need of reassessment; however, fisherydependent data are not available in federal waters and fishery-independent data are limited. We document the distribution, age composition, growth, and condition of red drum in coastal waters of the north central Gulf of Mexico, using data collected from a nearshore, randomized, bottom longline survey. Age composition of the fishery-independent catch indicates low mortality of fish age 6 and above and confirms the effectiveness of the federal fishing moratorium. Bottom longline surveys may be a cost-effective method for developing fishery-independent indices for red drum provided additional effort can be added to nearshore waters (<20 m depth). As with most stocks under harvest bans, effective monitoring of the recovery of red drum will require the development of fishery-independent indices. With limited economic incentive to evaluate non-exploited stocks, the most cost-effective approach to developing such monitoring is expansion of existing fishery independent surveys. We examine this possibility for red drum in the Gulf of Mexico and recommend the bottom longline survey conducted by the National Marine Fisheries Service expand effort in nearshore areas to allow for the development of long-term abundance indices for red drum.

A comparison of two fishery-independent survey programs used to define the population structure of American lobster (Homarus americanus) in the Gulf of Maine

The population structure and abundance of the American lobster (Homarus americanus) stock in the Gulf of Maine are defined by data derived from a fishery-independent trawl survey program conducted by the National Marine Fisheries Service (NMFS). Few sampling stations in the survey area are located inshore, in particular along coastal Maine. According to statistics, however, more than two thirds of the lobster landings come from inshore waters within three miles off the coast of Maine. In order to include an inshore survey program, complementary to the NMFS survey, the Maine Department of Marine Resources (DMR) initialized an inshore survey program in 2000. The survey was modeled on the NMFS survey program, making these two survey programs comparable. Using data from both survey programs, we evaluated the population structure of the American lobster in the Gulf of Maine. Our findings indicate that lobsters in the Gulf of Maine tend to have a size-dependent inshore-off-shore distribution; smaller lobsters are more likely to stay inshore and larger lobsters are more likely to stay offshore. The DMR inshore and NMFS survey programs focused on different areas in the Gulf of Maine and likely targeted different segments of the stock. We suggest that data from both survey programs be used to assess the lobster stock and to describe the dynamics of the stock in the Gulf of Maine.

Blast fishing in southwest Sulawesi, Indonesia

Blast fishing has been a widespread and accepted fishing technique in Indonesia for over 50 years. The largest coral reef fishery in Indonesia is around the Spermonde archipelago in southwest Sulawesi. With the expanding population and the increasing demand for fish for export, fishing has intensified and fish catches per unit effort are stable or declining. The use of bombs made with a mixture of kerosene and fertilizer is widely prevalent. In the market of the city of Ujung Pendang, an estimated 10-40% of the fish from capture fisheries are caught through blast fishing. This is destroying the hard corals. Blast fishing is seen by the fishers as being much easier and results in higher catches than with other traditional methods. They believe that the only way to limit this practice is with stricter policing and higher fines. An effective management option could be to establish national marine reserves within the archipelago, supported by other income-generating activities.

Ecosystem-based Management for Protected Species in the North Pacific Fisheries

In the North Pacific Ocean, an ecosystem-based fishery management approach has been adopted. A significant objective of this approach is to reduce interactions between fishery-related activities and protected species. We review management measures developed by the North Pacific Fishery Management Council and the National Marine Fisheries Service to reduce effects of the groundfish fisheries off Alaska on marine mammals and seabirds, while continuing to provide economic opportunities for fishery participants. Direct measures have been taken to mitigate known fishery impacts, and precautionary measures have been taken for species with potential (but no documented) interactions with the groundfish fisheries. Area closures limit disturbance to marine mammals at rookeries and haulouts, protect sensitive benthic habitat, and reduce potential competition for prey resources. Temporal and spatial dispersion of catches reduce the localized impact of fishery removals. Seabird avoidance measures have been implemented through collaboration with fishery participants and have been highly successful in reducing seabird bycatch. Finally, a comprehensive observer monitoring program provides data on the location and extent of bycatch of marine mammals and seabirds. These measures provide managers with the flexibility to adapt to changes in the status of protected species and evolving conditions in the fisheries. This review should be useful to fishery managers as an example of an ecosystem-based approach to protected species management that is adaptive and accounts for multiple objectives.

Evaluation of a Pound Net Leader Designed to Reduce Sea Turtle Bycatch

Offshore pound net leaders in the southern portion of Chesapeake Bay in Virginia waters were documented to incidentally take protected loggerhead, Caretta caretta, and Kemp’s ridley, Lepidochelys kempii, sea turtles. Because of these losses, NOAA’s National Marine Fisheries Service (NMFS) in 2004 closed the area to offshore pound net leaders annually from 6 May to 15 July and initiated a study of an experimental leader design that replaced the top two-thirds of the traditional mesh panel leader with vertical ropes (0.95 cm) spaced 61 cm apart. This experimental leader was tested on four pound net sites on the eastern shore of Chesapeake Bay in 2004 and 2005. During the 2 trial periods, 21 loggerhead and Kemp’s ridley sea turtles were found interacting with the control leader and 1 leatherback turtle, Dermochelys coriacea, was found interacting with the experimental leader. Results of a negative binomial regression analysis comparing the two leader designs found the experimental leader significantly reduced sea turtle interactions (p=0.03). Finfish were sampled from the pound nets in the study to assess finfish catch performance differences between the two leader designs. Although the conclusions from this element of the experiment are not robust, paired t-test and Wilcoxon signed rank test results determined no significant harvest weight difference between the two leaders. Kolmogorov-Smirnov tests did not reveal any substantive size selectivity differences between the two leaders.

Soft Flesh in Sablefish, Anoplopoma fimbria, of Southeastern Alaska: Relationships with Depth, Season, and Biochemistry

The condition of soft-textured flesh in commercially harvested sablefish, Anoplopoma fimbria, from southeastern Alaska was investigated by National Marine Fisheries Service (NMFS) scientists from the Alaska Fisheries Science Center’s Auke Bay Laboratories (ABL) in Alaska and the Northwest Fisheries Science Center in Seattle, Wash. Sablefish were sampled by longline, pot, and trawl at five sites around Chichagof Island at depths of 259–988 m in the summer of 1985 and at depths of 259–913 m in the winter of 1986. At the time of capture and data collection, sablefish were categorized as being “firm” or “soft” by visual and tactile examination, individually weighed, measured for length, and sexed. Subsamples of the fish were analyzed and linear regressions and analyses of variance were performed on both the summer (n = 242) and winter (n = 439) data for combinations of chemical and physical analyses, depth of capture, weight vs. length, flesh condition, gonad condition, and sex. We successfully identified and selected sablefish with firm- and soft-textured flesh by tactile and visual methods. Abundance of firm fish in catches varied by season: 67% in winter and 40% in summer. Winter catches may give a higher yield than summer catches. Abundance of firm fish catches also varied with depth. Firm fish were routinely found shallower than soft fish. The highest percentage of firm fish were found at depths less than 365 m in summer and at 365–730 m in winter, whereas soft fish were usually more abundant at depths greater than 731 m. Catches of firm fish declined with increasing depth. More than 80% of the fish caught during winter at depths between 365 and 730 m had firm flesh, but this declined to 48% at these depths in summer. Longlines and pots caught similar proportions of firm and soft fish with both gears catching more firm than soft fish. Trawls caught a higher proportion of soft fish compared to longlines and pots in winter. Chemical composition of “firm” and “soft” fish differed. On average “soft” fish had 14% less protein, 12% more lipid, and 3% less ash than firm fish. Cooked yields from sablefish with soft-textured flesh were 31% less than cooked yields from firm fish. Sablefish flesh quality (firmness) related significantly to the biochemistry of white muscle with respect to 11 variables. Summer fish of all flesh conditions averaged 6% heavier than winter fish. Regulating depth of fishing could increase the yield from catches, but the feasibility and benefits from this action will require further evaluation and study. Results of this study provide a basis for reducing the harvest of sablefish with soft flesh and may stimulate further research into the cause and effect relationship of the sablefish soft-flesh phenomenon.

Toward a Model for Fisheries Social Impact Assessment

This paper presents a model for Fisheries Social Impact Assessment (SIA) that lays the groundwork for development of fisheries-focused, quantitative social assessments with a clear conceptual model. The usefulness of current fisheries SIA’s has been called into question by some as incompatible with approaches taken by fisheries biologists and economists when assessing potential effects of management actions. Our model’s approach is closer to the economists’ and biologists’ assessments and is therefore more useful for Fishery Management Council members. The paper was developed by anthropologists initially brought together in 2004 for an SIA Modeling Workshop by the National Marine Fisheries Service, NOAA. Opinions and conclusions expressed or implied are solely those of the authors and do not necessarily reflect the views or policy of the National Marine Fisheries Service, NOAA.

The Ragfish, Icosteus aenigmaticus Lockington, 1880: A Synthesis of Historical and Recent Records From the North Pacific Ocean and the Bering Sea

Knowledge of the distribution and biology of the ragfish, Icosteus aenigmaticus, an aberrant deepwater perciform of the North Pacific Ocean, has increased slowly since the first description of the species in the 1880’s which was based on specimens retrieved from a fish monger’s table in San Francisco, Calif. As a historically rare, and subjectively unattractive appearing noncommercial species, ichthyologists have only studied ragfish from specimens caught and donated by fishermen or by the general public. Since 1958, I have accumulated catch records of >825 ragfish. Specimens were primarily from commercial fishermen and research personnel trawling for bottom and demersal species on the continental shelves of the eastern North Pacific Ocean, Gulf of Alaska, Bering Sea, and the western Pacific Ocean, as well as from gillnet fisheries for Pacific salmon, Oncorhynchus spp., in the north central Pacific Ocean. Available records came from four separate sources: 1) historical data based primarily on published and unpublished literature (1876–1990), 2) ragfish delivered fresh to Humboldt State University or records available from the California Department of Fish and Game of ragfish caught in northern California and southern Oregon bottom trawl fisheries (1950–99), 3) incidental catches of ragfish observed and recorded by scientific observers of the commercial fisheries of the eastern Pacific Ocean and catches in National Marine Fisheries Service trawl surveys studying these fisheries from 1976 to 1999, and 4) Japanese government research on nearshore fisheries of the northwestern Pacific Ocean (1950–99). Limited data on individual ragfish allowed mainly qualitative analysis, although some quantitative analysis could be made with ragfish data from northern California and southern Oregon. This paper includes a history of taxonomic and common names of the ragfish, types of fishing gear and other techniques recovering ragfish, a chronology of range extensions into the North Pacific and Bering Sea, reproductive biology of ragfish caught by trawl fisheries off northern California and southern Oregon, and topics dealing with early, juvenile, and adult life history, including age and growth, food habits, and ecology. Recommendations for future study are proposed, especially on the life history of juvenile ragfish (5–30 cm FL) which remains enigmatic.

Análise do processo de formulação de uma proposta de regulamentação de propagandas de alimentos: um estudo de caso

O consumo de alimentos processados tem crescido mundialmente e esse aumento tem sido relacionado em parte, pelas estratégias de marketing utilizadas pelas indústrias alimentícias que tem como objetivo aumentar as vendas e expandir o mercado consumidor. Segundo documento Recomendações da Consulta de Especialistas da Organização Pan-Americana da Saúde sobre a Promoção e a Publicidade de Alimentos e Bebidas Não Alcoólicas para Crianças nas Américas, a publicidade televisiva é a forma mais utilizada de marketing de alimentos para crianças e está associada a maior preferência e aumentos nos pedidos de compra de alimentos e bebidas com elevado teor de gordura, açúcar e sal. No âmbito da discuss��o mais recente sobre a possível influência da propaganda de alimentos na epidemia mundial de obesidade e doenças crônicas, o governo brasileiro, por meio da Agência Nacional de Vigilância Sanitária (ANVISA), formulou uma proposta de Regulamento Técnico que normatiza os termos das atividades publicitárias e que se concretizou na Resolução da Diretoria Colegiada n 24 de 2010 (RDC24/2010). Logo após sua publicação, grupos de interesse empresarial entraram na justiça e obtiveram diversas liminares que suspenderam a aplicação da RDC 24/2010 com base em parecer contrário da Advocacia Geral da União (AGU). O debate sobre ações regulatórias no campo da alimentação e nutrição como estratégia de controle e prevenção da obesidade envolve diversos atores sociais e opiniões bastante distintas e antagônicas, principalmente quando se trata dos argumentos do grupo de indivíduos que acredita na regulamentação da publicidade como uma forma de promover a saúde versus os argumentos contrários dos setores econômicos ligados ao tema a ser regulado. Neste sentido, este trabalho teve a intenção de descrever como e por que, neste processo, algumas práticas se estabeleceram no cotidiano das instituições e identificar os embates, argumentos e conflitos de interesses que apareceram nas discuss��es a respeito da formulação da resolução. Para isso, foi feita, primeiramente, análise documental de todo o processo de formulação, através de arquivos institucionais, documentos, pareceres, relatórios, entre outros. Posteriormente, foram identificados e caracterizados os sujeitos que participaram do processo e em seguida, realizadas entrevistas semi-estruturadas com atores chaves. Foram encontradas duas teses centrais no debate em torno da formulação da resolução: a primeira, se o Estado deve estabelecer uma regulamentação sobre publicidade de alimentos e a segunda diz respeito à competência legal da ANVISA em exercer o papel regulador sobre a propaganda de alimentos. As disputas em torno destas duas teses e os argumentos que se apresentaram para defendê-las são evidentemente incomensuráveis entre si, não havendo esperança de acordo entre as partes. O caso descrito elegeu a ANVISA como o território da disputa e a aparente maioria no jogo democrático desta arena mostrou-se ineficaz diante da captura pelo questionamento da pertinência desta Agência para função de regular a publicidade de alimentos.

Government-Industry Cooperative Fisheries Research in the North Pacific under the MSFCMA

The National Marine Fisheries Service’s Alaska Fisheries Science Center (AFSC) has a long and successful history of conducting research in cooperation with the fishing industry. Many of the AFSC’s annual resource assessment surveys are carried out aboard chartered commercial vessels and the skill and experience of captains and crew are integral to the success of this work. Fishing companies have been contracted to provide vessels and expertise for many different types of research, including testing and evaluation of survey and commercial fishing gear and development of improved methods for estimating commercial catch quantity and composition. AFSC scientists have also participated in a number of industry-initiated research projects including development of selective fishing gears for bycatch reduction and evaluating and improving observer catch composition sampling. In this paper, we describe the legal and regulatory provisions for these types of cooperative work and present examples to illustrate the process and identify the requirements for successful cooperative research.