Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications.

INTRODUCTION: Promptly providing new drugs to fulfill unmet medical needs requires changes in drug development and registration processes. Health Authorities (HAs) considered as reference due to their experience and acknowledgement (Food and Drug Administration [FDA] among others) already consider innovative clinical trial (CT) designs and flexible approval procedures, but Latin America (LATAM) regulations are still far. A comparison was performed to identify gaps. MATERIALS AND METHODS: CT requirements for drug Marketing Authorization Application (MAA) and CT approval regulations were compared between LATAM and reference HAs (FDA/European Medicines Agency [EMA]/Health-Canada/Swissmedic/Therapeutic Goods Administration [TGA]/Pharmaceuticals and Medical Devices Agency [PMDA]), as of August 2022. Procedure included reference HAs regulations review, item selection, identification in LATAM regulations, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (ICH-E6[R2]/ICH-E8[R1]) implementation revision. RESULTS: For MAA, specific application requirements or ICH guideline M4(R4) on common technical document (CTD) adoption are generally stated, and phase-I/III performance is mandatory (explicitly/implicitly). Faster patient access procedures are infrequent: Priority-drug programs, conditional authorizations, or expedited procedures are scarce or non-existent. Regulatory reliance procedures are adopted through different pathways. Regarding CT approval, innovative/complex CT designs are not prohibited but usually omitted. Some countries implemented adapted CT conducting during the COVID-19 pandemic. Early scientific advice meetings (HA-sponsor) are occasionally considered. Most countries are not formally ICH-joined. CONCLUSIONS: LATAM regulations must adapt to new regulatory standards (FDA/EMA/ICH) through implementation of frequent updates, reliance/expedited procedures, early HA-sponsor interactions, innovative/complex CTs, mandatory phase-III reaching elimination, and decentralized elements for CT conducting.

Estrategia regulatoria del desarrollo de Quimi-Hib®, vacuna conjugada semisintética contra Haemophilus influenzae tipo b

Introducción: Quimi-Hib®, una vacuna cubana obtenida por síntesis química y única en el mundo, requirió una estrategia regulatoria específica, porque no hay guía con las pautas requeridas para su producción y control. Objetivo: Caracterizar la estrategia regulatoria de la etapa precomercialización de Quimi-Hib® en Cuba. Material y Métodos: Estudio descriptivo-retrospectivo de requisitos para el registro sanitario de la vacuna cubana. Se establecieron siete pasos estratégicos para abarcar los estándares reguladores vigentes y futuros, con base en opiniones de expertos para la adopción de decisiones. El punto de partida fue la guía de la OMS, aplicable a vacunas anti-Hib de origen natural. Resultados: La estrategia regulatoria se desarrolló a partir de las 15 recomendaciones de esta guía, 11 de ellas se extrapolaron a la vacuna cubana y cuatro no, pero se consideraron sus fundamentos para desarrollar cuatro requerimientos aplicables a la vacuna semisintética. Se adicionaron otros seis, tres a solicitud de la Autoridad Reguladora Nacional de Cuba y tres obtenidos de la literatura relevante disponible. Estos 21 requerimientos completan el paquete regulador, resultado de la estrategia desarrollada para esta vacuna y la posterior aprobación de su registro sanitario y comercialización. Conclusiones: La estrategia regulatoria desarrollada en este trabajo permitió definir un conjunto de recomendaciones que suple la carencia de regulaciones internacionales y contribuyó a la obtención segura del registro sanitario de la vacuna Quim-Hib® que podría generalizarse a otras vacunas con características similares.

Introduction: Quimi-Hib®, a Cuban vaccine obtained by chemical synthesis and unique in the world, required its own regulatory strategy because there is no guideline on the requirements for its production and control. Objective: To characterize the regulatory strategy of the pre-launch phase of Quimi-Hib® in Cuba. Material and Methods: Descriptive-retrospective study of the requirements for the approval of the Cuban vaccine. Seven strategic steps were established to cover current and future regulatory standards based on expert advice for decision making. The starting point was the WHO´s guideline, which applies to anti-Hib vaccines of natural origin. Results: The regulatory strategy was developed based on the 15 recommendations of the aforementioned guideline, 11 of which were extrapolated to the Cuban vaccine and four of which were not, but served as the basis for the development of four requirements with similar rationale that apply to the semisynthetic vaccine. Six additional requirements were added, three of which were requested from the Cuba's National Regulatory Authority and three of which were obtained from the available relevant literature. These 21 requirements complete the regulatory package, the result of the strategy developed for this vaccine and the subsequent approval for marketing authorization and commercialization. Conclusions: The regulatory strategy compensates for the lack of specific guidelines for synthetic Haemophilus influenzae type b vaccines and thus contributed to the approval of the first vaccine of this type. The regulatory strategy is flexible because it includes update requirements throughout the vaccine life cycle, and expert consensus was considered in its development.

The Paradox of Patient-Reported Outcome Measures: Should We Prioritize "Feeling Better" or "Feeling Good" After Total Knee Arthroplasty?

BACKGROUND: The use of preoperative patient-reported outcome measure (PROM) thresholds for patient selection in arthroplasty care has been questioned recently. This study aimed to identify factors affecting achievement of the minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) after total knee arthroplasty (TKA) and determine the overlap between the two outcomes. METHODS: We identified 1,239 primary, unilateral TKAs performed at a single institution in 2015-2019. PROMs including the Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR) and 12-item Short Form Health Survey (SF-12) were collected preoperatively and 1-year postoperatively. The likelihood of attaining PASS as per attainment of MCID was assessed. A multivariable regression was used to identify predictors of MCID and PASS. RESULTS: In total, 71.3% achieved MCID and 75.5% achieved PASS for KOOS-JR. Only 7.7% achieved MCID but not PASS, whereas almost twice this number did not achieve MCID but did achieve PASS (11.9%). Poorer preoperative KOOS-JR (OR 0.925), better SF-12 physical (OR 1.025), and mental (OR 1.027) were associated with MCID attainment. In contrast, better preoperative KOOS-JR (OR 1.030) and SF-12 mental (OR 1.025) were associated with PASS attainment. Age, gender, race, ethnicity, body mass index, Charlson index, American Society of Anesthesiologists classification, and smoking status were not significant predictors. CONCLUSION: Preoperative PROMs were associated with achieving MCID and PASS after TKA, albeit some positively and some negatively. In the era of value-based care, clinicians should not only strive to help patients "feel better" but also ensure that patients "feel good" after surgery. This study does not support the use of PROMs in prioritizing access to care.

O supervisor suposto saber: perspectivas lacanianas sobre a análise de controle / The supervisor supposed to know: Lacanian perspectives on control analysis / El supervisor supuesto saber: perspectivas lacanianas sobre el análisis de control / Le superviseur supposé savoir: perspectives lacaniennes concernant l'analyse de contrôle

De forma a preservar o ímpeto evolutivo e o alcance da psicanálise, a tarefa da análise de controle é prevenir o estabelecimento da inércia que busca o menor denominador comum e a degeneração de ideias e práticas em evolução na direção de banalizações e preconceitos. A uma instituição psicanalítica é necessário manter padrões mínimos e simultaneamente preservar-se como ambiente vibrante e dinâmico para o contínuo desenvolvimento e regeneração da psicanálise enquanto estrutura viva e simbólica. Através de uma análise de controle, cada analista adquire um estilo analítico único, que não se refere a preferências e idiossincrasias egoicas, mas a uma singular e nova articulação subjetiva dos elementos preexistentes na estrutura tradicional. Sem a realização de uma análise pessoal, a análise da contratransferência e da identificação projetiva em supervisão pode operar como resistência à análise pessoal, essa última o mais importante fator para a autoautorização do analista dentro da organização psicanalítica. O analista não é autorizado pela supervisão ou pelo supervisor, mas pela experiência analítica pessoal com o inconsciente, o sintoma e seus efeitos pós-analíticos sob a forma do que Lacan nomeia de sinthoma. Lacan diz que, ao término da análise, o analisando ou futuro analista não se identifica com o analista, mas sim com seu sinthoma.

The task of control analysis is to preserve the evolutionary impetus and edge of psychoanalysis and prevent the inertia towards the lowest common denominator, and the degeneration of evolved ideas and practices into common assumptions and prejudices. A psychoanalytic organization needs to maintain standards while also preserving the organization as a vibrant and dynamic site for the continuing development and re-invention of psychoanalysis as a living symbolic structure. Through a control analysis every analyst acquires a unique analytical style that does not refer to ego preferences and idiosyncrasies, but to a singular and new subjective articulation of the pre-existing elements of a traditional structure. Without a personal analysis, the analysis of the countertransference and of projective identification in supervision can function as a resistance to the personal analysis which is the most important factor for the self-authorization of the analyst within a psychoanalytic organization. The analyst is not authorized by supervision or the supervisor, but by the personal analytical experience with the unconscious, the symptom, and its post-analytical effects in the form of what Lacan calls the sinthome. Lacan said that at the end of analysis, the analysand or the future analyst does not identify with the analyst, but rather with his/her sinthome.

Con el fin de preservar el ímpetu evolutivo y el alcance del psicoanálisis, la tarea del análisis de control es evitar el establecimiento de inercias que buscan el mínimo común denominador y la degeneración de ideas y prácticas en la evolución en la dirección de trivializaciones y prejuicios. Para una institución psicoanalítica es necesario mantener estándares mínimos y simultáneamente preservarse como un entorno vibrante y dinámico para el desarrollo continuo y la regeneración del psicoanálisis como una estructura viva y simbólica. A través de un análisis de control, cada analista adquiere un estilo analítico único que no se refiere a preferencias del ego e idiosincrasias, sino a una singular y nueva articulación subjetiva de los elementos preexistentes en la estructura tradicional. Sin realizar un análisis personal, el análisis de la contratransferencia y la identificación proyectiva en la supervisión puede operar como resistencia al análisis personal, este último el factor más importante para la auto autorización del analista dentro de la organización psicoanalítica. El analista no está autorizado por la supervisión o el supervisor, sino por la experiencia analítica personal con el inconsciente, el síntoma y sus efectos posanalíticos en forma de lo que Lacan llama sinthoma. Lacan dijo que al final del análisis, el analista o analista futuro no se identifica con el analista, sino con su sinthoma.

De façon à préserver l'élan évolutif et l'étendue de la psychanalyse, la tâche de l'analyse de contrôle est celle de prévenir l'établissement de l'inertie qui cherche le plus petit dénominateur commun et la dégénération d'idées et de pratiques en évolution dans la direction des banalisations et des préjugés. Il faut qu'une institution psychanalytique maintienne des étalons minimaux et simultanément se préserver en tant qu'une ambiance vibrante et dynamique pour le développement continu et régénération de la psychanalyse considérée comme une structure vive et symbolique. Par l'intermédiaire d'une analyse de contrôle, chaque analyste acquiert un style analytique unique qui ne se réfère pas à des préférences et des idiosyncrasies égoïques, mais à une nouvelle articulation singulière et subjective des éléments préexistant dans la structure traditionnelle. Sans mener une analyse personnelle, l'analyse du contre-transfert et de l'identification projective en supervision peuvent opérer en tant que résistance à l'analyse personnelle, cette dernière le plus important élément pour l'auto autorisation de l'analyste chez l'organisation psychanalytique. L'analyste n'est pas autorisé par la supervision ou par le superviseur, mais par l'expérience analytique personnelle du surmoi, du symptôme et de ses effets postanalytiques, sous la forme de ce qui Lacan nomme sinthome. Lacan dit que, à la fin de l'analyse, l'analysant ou le futur analyste ne s'identifie pas à l'analyste, mais à son sinthome.

Medications requiring prior authorization across health insurance plans.

OBJECTIVE: To determine the amount of variation in numbers and types of medications requiring prior authorization (PA) by insurance plan and type. METHODS: Most health insurance companies require PA for medications to ensure safe and effective use and contain costs. We generated 4 lists of medications that required PA during 2017 for commercial, marketplace, Medicaid, and Medicare plans. We aggregated medications according to the generic medication name equivalent using codes and medication names. We compared these medications to assess how many of the medications required PA by 1, 2, 3, or all 4 of the insurance plans. We counted all prescription orders written for a patient age 18 years or older with health plan insurance during 2017 for any of the medications that appeared on the health plan's PA lists by querying the electronic health record. RESULTS: PA was required for 600 unique medications in 2017 across the 4 plans. Of 691,457 prescription orders written for 114,159 members, 31,631 (5%) were written for 1 of the 600 medications that required PA by at least 1 insurance plan. There were 12,540 medication orders (written for 6,642 members) that potentially required PA. The marketplace plan required PA for the greatest number of medications (440), followed by the Medicare (272), commercial (271), and Medicaid (72) plans. The most commonly prescribed classes of medications for which PA was required by at least 1 plan were antihyperlipidemics (22% of orders potentially requiring PA), narcotic analgesics (13%), hypnotics (12%), antidiabetic medications (9%), and antidepressants (9%). For only 25% of medications (151 of 600) was PA required by at least 3 plans, and for only 5% (32 of 600) was PA required by all 4 insurance types. CONCLUSION: Medications requiring PA can differ within a single health insurance company, but this variation may be unavoidable due to external factors.

Understanding the medication prior-authorization process: A case study of patients and clinical staff from a large rural integrated health delivery system.

PURPOSE: The barriers and solutions to the current prior-authorization (PA) process at an integrated health system were evaluated. METHODS: Focus groups were conducted with patients at an integrated health system who also had insurance from an affiliated health plan and at least 1 denial for a medication in the past year. Semistructured interviews were conducted with medical staff (physicians, office staff, and PA experts). Both focus groups and interviews were audio-recorded and transcribed. Inductive analysis was used to code transcripts and develop themes. RESULTS: Three focus groups were conducted with 13 patients, and 9 medical staff (3 staff physicians, 2 office staff, and 4 PA staff) who have interactions with the PA process interviewed. Several themes were identified including the complexity of the PA process, consequences experienced, and ineffective communication between key stakeholders. A cross-cutting theme was that stakeholders expressed feelings of frustration, anxiety, and anger throughout the PA process. All stakeholders offered insights on how the process could be improved to better facilitate their preferences, such as access to the list of medications that require PA and the need for a patient advocate. CONCLUSION: Results of this study revealed that the PA process was frustrating, upsetting, and infuriating to patients and medical staff involved in the process. Three main themes identified included the complexity of the PA process, consequences experienced from the PA process, and ineffective communication between stakeholders.

[El consentimiento informado: recomendaciones para su documentación].

Informed consent is an indispensable element to obtain adequate patient participation either in research protocols or in therapeutic design. The Committee of Ethics and Transparency in the Physician-Industry Relationship (CETREMI) of the National Academy of Medicine developed several recommendations for informed consent to be documented.

El consentimiento informado es un elemento indispensable para obtener la adecuada participación del paciente, ya sea en protocolos de investigación o en diseños terapéuticos. El Comité de Ética y Transparencia en la Relación Médico-Industria (CETREMI) de la Academia Nacional de Medicina elaboró varias recomendaciones para documentar el consentimiento informado.

Lonomia caterpillar envenoming in French Guiana reversed by the Brazilian antivenom: A successful case of international cooperation for a rare but deadly tropical hazard.

In the American continent, larval forms (caterpillars) of the Lonomia genus can cause systemic reactions in human beings. In this Paper, we report the third case of Lonomia envenoming recorded in French Guiana in 25 years, and the first in which specific antivenom was administered. Severe symptoms of the envenoming were observed in our patient including pain; coagulopathy and systemic hemorrhage. They are caused by skin contact with caterpillars. Recovery, however, was quite satisfactory thanks to the international cooperation of the health authorities in both France and Brazil.

Custo do tratamento hospitalar de melanoma maligno em Pernambuco: uma análise da judicialização do ipilimumabe a partir de demandas junto aos tribunais de Pernambuco / Cost of hospital treatment of malignant melanoma in Pernambuco: an analysis of the judicialization of ipilimumab from lawsuits in the courts of Pernambuco

O melanoma maligno é uma doença com alto índice de mortalidade. No país, há alguns tratamentos disponíveis, que não são financiados pelo Sistema Único de Saúde (SUS), como o realizado com anticorpo monoclonal, no caso específico, o medicamento ipilimumabe, levando os pacientes a recorrerem ao poder judiciário para ter acesso ao medicamento. O tratamento - procedimento cirúrgico ou quimioterápico - é garantido pelo SUS, através dos hospitais habilitados, como Centros de Assistência de Alta Complexidade em Oncologia (CACON) e Unidades de Assistência de Alta Complexidade (UNACON) e não habilitados. Constatou-se que os dois hospitais que mais realizaram estes procedimentos não estão habilitados em CACON/UNACON. Assim, analisou-se, a partir dos dados em documentos públicos, o custo das ações judiciais na compra do medicamento ipilimumabe, utilizado em pacientes com melanoma maligno pelo Estado de Pernambuco, bem como os valores pagos pelo SUS através da Autorização de Internação Hospitalar (AIH) para tratar o melanoma nos pacientes internados nos hospitais deste Estado. A pesquisa se deu nos anos de 2013 a 2015. Dos dezessete processos que tiveram deferimento por via judicial, foi visto que não houve a continuidade do tratamento em 100% destes, haja vista não conseguiram terminar o que foi preconizado na prescrição médica. As causas foram: o óbito ou a substituição do tratamento pela quimioterapia tradicional. Com isso, o custo na compra do ipilimumabe foi menor do que o preconizado nas medidas tutelares, logo o medicamento comprado para um tratamento não terminado foi remanejado para outro paciente, que ganhou a liminar posteriormente. O Estado desembolsa com o ipilimumabe quase o mesmo valor gasto com as AIH, embora a comparação entre o número de pacientes que fizeram tratamento pelo SUS, com os que tiveram acesso ao ipilimumabe por via judicial fosse 142,1 maior; no entanto, é desproporcional o custo. O gasto para atender os pacientes do SUS é 1,26 vezes maior em relação aos pacientes que acessaram as vias judiciais. Ainda foi visto que em quase sua totalidade, os magistrados de Pernambuco não evocaram nenhuma assessoria técnica a fim de obter mais informações sobre o medicamento solicitado, sendo que a concessão da medida liminar fez-se por meio da prescrição médica, além de fundamentar o direito por meio de artigos constitucionais e infraconstitucionais. Observou-se também que não houve reajuste na tabela dos valores pagos por meio das AIH nos anos da pesquisa, verificando que o menor valor pago para o mesmo procedimento cirúrgico neste período foi de R$ 40,38. O estudo aponta que mais profissionais da saúde precisam ser envolvidos no processo da judicialização, esclarecendo ao magistrado se de fato o medicamento aumenta a sobrevida do paciente em relação ao tratamento estabelecido pelo SUS, já que o impacto financeiro é alto em comparação com os benefícios alcançados nos tratamentos preexistentes e ao número de pacientes atendidos.(AU)

Cancer, especially malignant melanoma, is a disease with high mortality rate, therefore, the integral health care of patients with this disease is necessary. Treatment of malignant melanoma is guaranteed by SUS, through authorized hospitals, such as Assistance Center in Highly Complex Oncology Care (CACON) and High Complexity Assistance Units (Unacon) and also by not authorized hospitals. Among the main treatments, there are surgical and chemotherapy treatments which are paid to hospitals through the hospital admission authorization (AIH). New treatments are released on the market for malignant melanoma, but they are still not available in the public system, which leads patients with this malignant neoplasm to refer to the judiciary to have access to the drug, this process is called judicialization of health. Thus, this study aims to evaluate the legalization of ipilimumab and its financial impact on the treatment of malignant melanoma in Pernambuco, from January 2013 until December 2015. It was observed that the price of procedures paid to hospitals in Pernambuco was not ajusted in this period, since the minimum price was the same R$ 40,38 for three years. Two of the hospitals that have performed more of these procedures are not authorized as CACON / Unacon. Among the seven authorized hospitals, four hospitals have performed chemotherapy. Of the seventeen cases that have granted access to drug ipilimumab by the courts, it was detected that a percentage could not complete the recommended treatment in the medical prescription, the causes are death or replacement of the treatment by traditional chemotherapy. The ratio of cost of ipilimumab compared to the cost of the traditional chemotherapy procedure paid to hospitals by hospital admission authorization(AIH) can be 75,6 times higher. It was observed that in just one case the magistrate asked for the state manifestation, on the other cases it wasn't granted defense to public administration to explain why the drug was not supplied. In two court lawsuits the precautionary measure was granted on the same day the case was assigned, although the average time between the process distribution and granting of the precautionary measure was 9.94 days, and the time between early relief and the supply of the drug was 4.11 days. The cost to purchase ipilimumab is higher with the judicialization process comparing to the cost by hospital admission authorization (AIH), both for the treatment of malignant melanoma. Most of the court lawsuits of judiciary do not request information from other health professionals, their decision is only based on medical prescription. Thus, it is necessary to estabilish a greater link between judiciary and executive so that judicialization process does not further encumber health budget.(AU)

Anti-inflammatory and antinociceptive effects of hydroalcoholic extract from Pseudobombax marginatum inner bark from caatinga potiguar.

ETHNOPHARMACOLOGICAL RELEVANCE: The Pseudobombax marginatum (St Hil) Rob., Malvaceae, is mentioned in ethnobotanical studies. It is used as anti-inflammatory, for ulcers and gastritis, and back pain. To evaluate anti-inflammatory and antinociceptive activities a hydroalcoholic extract (HE) from inner bark was prepared. MATERIALS AND METHODS: For the anti-inflammatory activity, carrageenan-induced paw edema and peritonitis models, and also myeloperoxidase assay were used. For the antinociceptiva activity acetic acid-induced writhing, hot plate and formalin tests were employed. RESULTS: The HE extract exhibited an intense inhibition in carrageenan-induced edema model and also in myeloperoxidase activity at the doses of 100 and 300 mg/kg. The leukocyte migration into the peritoneal cavity was also inhibited at the doses of 30, 100 and 300 mg/kg. A similar profile was observed against acid-induced abdominal contortions and in formalin second phase test at the doses of 30 and 100 mg/kg, but this treatment did not affect the behavior of animals in the hot plate test. CONCLUSIONS: The experimental data of the HE from Pseudobombax marginatum show anti-inflammatory and antinociceptiva activities, confirming the indication from traditional medicine; however further studies are required to define and isolate the active anti-inflammatory and antinociceptiva components from this active specie.

Perfil dos medicamentos manipulados pelas farmácias comunitárias com Autorização Especial / Profile of medicines prepared by the community pharmacies with Special Authorization

Nos últimos dez anos, a ocorrência de doenças e de agravos à saúde, e mesmo óbitos, em pacientes que fizeram uso de medicamentos manipulados reacendeu o debate sobre a qualidade desse tipo de medicamento no Brasil. O presente estudo efetuou a descrição do perfil dos medicamentos alopáticos manipulados pelas farmácias comunitárias existentes na época do estudo, com Autorização Especial concedida pela Anvisa (Portaria SVS/MS nº 344/98), e localizadas no município de Nova Friburgo (RJ). Esta investigação foi realizada por meio de pesquisa documental das características consideradas relevantes para o estudo. Foram avaliados os registros do mês de novembro de 2006 dos livros de receituário das farmácias autorizadas a manipular substâncias sujeitas a controle especial, totalizando-se 12.253 fórmulas. Foram verificadas baixa frequência de medicamentos manipulados considerados farmacopeicos (< 1,0%) e alta frequência da forma farmacêutica em cápsula (83%); e que a manipulação destas como monodroga estava concentrada em 15 fármacos, representando classes terapêuticas de grande importância clínica, tais como: antidepressivo, anorexígeno, antipsicótico e anti-hipertensivo. O perfil dos medicamentos manipulados avaliados poderia representar, em termos de saúde pública, potencial risco sanitário quanto à segurança e à eficácia.(AU)

In the last ten years, the occurrence of diseases and health injuries, including deaths, in patients who had taken medicines prepared in community pharmacies have brought back into notice the quality of medicines in Brazil. This work analyzed the profile of the allopathic medicines prepared by the community pharmacies, existing at those time and located in Nova Friburgo city, Rio de Janeiro, by the Special Authorization granted by the National Health Surveillance Agency Anvisa (Regulation SVS/MS no. 344/98). This investigation was performed by means of a documental research on the characteristics considered as relevant to the study. For this purpose, the data recorded in November of 2006 were evaluated, extracted from the Prescriptions Books of the pharmacies which had been licensed to prepare the controlled substances. A total of 12,253 formulas were assessed; a low prevalence of officinal formulas (< 1%) and a high prevalence of medicines in capsules type (83%) were found. The capsules formulations were composed by only one active component, and they were converged on 15 substances, for preparing antidepressant, anorexigenic, antipsychotic and antihypertensive drugs. From the public health aspect, the assessed medicines profile might represent a potential sanitary risk for their safety and efficacy.(AU)

Sociedade civil, instituições participativas e representação: da autorização à legitimidade da ação / Civil society, participative institutions, and representation: from authorization to action legitimacy

In democratic Brazil, political participation has been characterized by the enlargement of civil society's presence in public policies. Such presence generated a series of institutions with the participation of civil society and state actors in the areas of social welfare, health and urban policies. Within these institutions, it began to happen what we can call an institutionalized representation of civil society. This representation is characterized by the inexistence of an explicit requirement of authorization, and the absence of a structure of territorial monopoly in the representation carried out by the actors of civil society. Representation by affinity is proposed as a manner of associating parliamentary representation and representation of civil society.

Dans le Brésil démocratique, la participation politique est marquée par une plus grande présence de la société civile dans le domaine des politiques publiques. Cette présence a engendré une série d'institutions où participent la société civile et des acteurs des États agissant sur le terrain de l'assistance sociale, de la santé et des politiques urbaines. Ces institutions ont fait apparaître ce qu'on peut appeler une représentation institutionnalisée de la société civile, dont les caractères sont tout d'abord l'absence explicite d'autorisation ainsi que l'absence de structure de monopole territorial dans la représentation effectuée par des acteurs de la société civile. Dans cet article, on cherche à discuter une façon de penser la légitimité de cette représentation en proposant la représentation par affinités comme susceptible d'associer représentation parlementaire et représentation de la société civile.