A judicialização da fosfoetanolamina sintética no Brasil / The judicialization of synthetic phosphoethanolamine in Brazil

Este artigo analisou a judicialização da fosfoetanolamina sintética no Brasil, a partir de estudo exploratório das decisões judiciais da vara de fazenda pública da comarca de São Carlos, em São Paulo, após a interrupção do fornecimento da substância pela Universidade de São Paulo. O estudo catalogou os argumentos constantes da Ação Direta de Inconstitucionalidade 5.501/DF, que julgou inconstitucional a Lei n. 13.269/2016, que autorizou a produção e a prescrição da fosfoetanolamina sintética para quaisquer tipos de câncer (neoplasia maligna) enquanto os estudos clínicos não fossem concluídos. As sentenças de primeira instância concederam a fosfoetanolamina com base no testemunho dos pacientes sobre impactos positivos do uso da substância em sua saúde e pela ausência de registro de efeitos colaterais. Juízes que concederam acesso à fosfoetanolamina tinham ciência da carência de evidências científicas de segurança e eficácia, bem como do necessário registro da substância como medicamento no órgão  regulador, nos termos da legislação sanitária. No Supremo Tribunal Federal, a ausência de evidências científicas e a utilização de legislação para criar exceção casuísta levaram à declaração de inconstitucionalidade da norma pela maioria dos votos. O estudo registra, todavia, certa indisposição do Poder Judiciário em incorporar no processo decisório a avaliação das autoridades de regulação e fiscalização em saúde como fonte da correta avaliação da segurança e eficácia de medicamentos. Em conclusão, o testemunho dos pacientes sobre as perspectivas de cura ou redução do sofrimento, somado à ausência de provas nos processos judiciais sobre os riscos do consumo da fosfoetanolamina, foram cruciais para tais decisões.

This article analyzed the judicialization of phosphoethanolamine in Brazil, based on an exploratory study of court decisions in the district of São Carlos/SP after the supply of the substance was interrupted by the University of São Paulo. The study cataloged the arguments contained in the Direct Action of Unconstitutionality 5,501/DF that deemed Law 13,269/2016, which authorized the production and prescription of synthetic phosphoethanolamine for any type of câncer (malignant neoplasm) unconstitutional, while the clinical studies were not completed. The results indicated that the judges authorized the use of the substance based on the patients' testimony about the positive impacts of the use of phosphoethanolamine on their health and the absence of side effects. The judges were aware of the lack of scientific evidence of safety and efficacy, as well as the obligation to register the substance as a medicine by the regulatory agency, according to health legislation. In the Supreme Court, the mentioned lack of scientific evidence and the strategic use of legislation to create a case-by-case exception led to the declaration of unconstitutionality of the Law by a majority of Ministers votes. The study registers, however, a certain unwillingness of the Judiciary to incorporate in the decision-making process the evaluation of the health regulatory agency as a source of the correct evaluation of medicines. In conclusion, the convinced patients' testimony about the perspectives of cure or reduction of suffering added to the absence of evidence in the legal proceedings regarding the risks of the consumption of phosphoethanolamine was crucial to the judicial decisions.

Desigualdade da participação dos consumidores e operadoras na Agência Nacional de Saúde Suplementar / Unequal participation of consumers and private health plans in the Brazilian Regulatory Agency for Private Health Insurance and Plans

Participação social é um elemento fundamental para a legitimação democrática das decisões regulatórias, bem como é um importante instrumento de accountability nas agências reguladoras. O presente artigo apresenta os resultados de pesquisa quantitativa feita nos instrumentos de participação social da Agência Nacional de Saúde Suplementar, especificamente na Câmara de Saúde Suplementar, comissões e comitês da agência, audiências públicas, consultas públicas, câmaras técnicas e grupos técnicos. A pesquisa teve por objetivo mensurar a participação dos stakeholders do mercado da saúde suplementar na agência. Estes foram divididos em cinco grupos ­ "operadoras de planos de saúde", "consumidores", "prestadores de serviço da área da saúde", "estado e servidores da ANS" e "outros" ­ de acordo com o interesse defendido no mercado da saúde. A pesquisa baseou-se nos documentos que registraram a utilização dos instrumentos de participação social da agência, como listas de presença, atas das reuniões e relatórios públicos. Os resultados indicam uma participação mais consistente e organizada das "operadoras de planos de saúde" e "prestadores de serviço da área da saúde", em contraste com os "consumidores", que participam de forma mais difusa, menos organizada e estão menos propensos a participar em câmaras técnicas e grupos técnicos, que são instrumentos que propiciam uma abordagem mais técnica ao debate regulatório.

Social participation is an essential element for the democratic legitimization of regulatory decisions, as well as an important instrument of accountability in regulatory agencies. This article presents the results of a quantitative research carried out with the instruments of social participation of the Brazilian Regulatory Agency for Private Health Insurance and Plans, specifically the Private Health Insurance and Plans Advisory Committee, its commissions and committees, public hearings, public consultations, technical councils, and technical groups. The study sought to measure the participation of Brazilian health insurance market stakeholders within the agency. These were divided in five categories­"private health insurance companies," "consumers," "health care providers," "state and ANS' employees" and "others"­according to the interests defended in the health care market. Data was collected from documents on the use of the agency's social participation instruments of, such as attendance lists, meeting minutes, and public reports. Results indicate a more organized and consistent participation of "private health insurance companies" and "health care providers" on the regulatory debates held by the agency, while "consumers" show a more diffuse, less organized participation and are less likely to take part in technical councils and technical groups, instruments that provide technical approach to regulatory debates.

Captura ou não captura? Perspectivas analíticas no estudo de políticas regulatórias / ¿Captura o no captura? Perspectivas analíticas en el estudio de políticas regulatorias / Analytical perspectives in the study of regulatory policies

Resumo A discussão de captura regulatória não é uma agenda recente em estudos do Estado, mas o estabelecimento de critérios para identificação de captura, bem como a definição de protocolos para demonstração e mensuração do fenômeno estão longe de um consenso. O presente artigo tem por objetivo, por meio de uma revisão sistematizada não exaustiva da literatura, identificar as principais estratégias de captura e suas respectivas formas de mensuração. Propõe-se a organização dos estudos de regulação em quatro eixos de estratégias de captura: por incentivos materiais, por incentivos imateriais, por ameaça e por assimetria de informação. Ademais, busca-se examinar a produção sobre o caso brasileiro e discutir os resultados contraditórios de pesquisas recentes sobre o caso da Agência Nacional de Saúde Suplementar (ANS). Identificou-se que, em geral, a literatura brasileira parte de uma abordagem ampla de compreensão de captura e que os trabalhos que se orientam por uma abordagem restritiva exploram, principalmente, o mecanismo de "porta giratória", seguindo uma tendência da literatura internacional, porém ignorando outros mecanismos com potencial explicativo. Esses achados têm implicações para desenhos de pesquisa em estudos sobre regulação, de forma a avançar as análises além das impressões iniciais e em direção a demonstrações empíricas robustas.

Resumen La discusión sobre la captura regulatoria no es una agenda reciente en los estudios del Estado, pero el establecimiento de criterios para la identificación de la captura, así como la definición de protocolos para demostrar y medir el fenómeno están lejos de un consenso. Este artículo tiene como objetivo, a través de una revisión bibliográfica no exhaustiva, identificar las principales estrategias de captura y sus respectivas formas de medición. Se propone organizar los estudios de regulación en cuatro ejes de estrategias de captura: por incentivos materiales, por incentivos inmateriales, por amenaza y por asimetría de información. Además, se busca examinar la producción sobre el caso brasileño y discutir los resultados contradictorios de investigaciones recientes sobre el caso de la Agencia Nacional de Salud Suplementaria (ANS). Se identificó que, en general, la literatura brasileña parte de un enfoque amplio para comprender la captura y que las obras guiadas por un enfoque restrictivo exploran principalmente el mecanismo de "puerta giratoria", siguiendo una tendencia en la literatura internacional, sin tener en cuenta otros mecanismos con potencial explicativo. Estos resultados tienen implicaciones para diseños de investigación en estudios de regulación, con el fin de avanzar en los análisis más allá de las impresiones iniciales y hacia demostraciones empíricas sólidas.

Abstract The discussion of regulatory capture is not recent in state studies. However, the criteria to identify capture and the definition of the research protocols to demonstrate and measure the phenomenon have still not reached a consensus. This article carries out a non-exhaustive literature review to identify the main regulatory capture strategies and their respective measurement methods. We organize the regulation studies in four axes of regulatory capture strategies: capture by material incentives, capture by immaterial incentives, capture by threat, and capture by information asymmetry. Furthermore, the study examines the Brazilian case and discusses the contradictory results of recent research on the case of the National Supplementary Health Agency (ANS). We identified that, in general, Brazilian literature starts from a broad approach to understanding regulatory capture. Also, the studies adopt a restrictive approach mainly to explore the "revolving door" mechanism, following a trend in international literature but ignoring other mechanisms with explanatory potential. These findings have implications for research designs in studies of regulation in order to advance analyses beyond initial impressions and toward robust empirical research.

Thoughts and suggestions on registration and classification of traditional Chinese medicines / 中国中药杂志

In this paper, we reviewed the history of the registration and classification changes of traditional Chinese medicines(TCM) since the establishment of China's drug regulatory agency, and put forward relevant suggestions. Although China's drug regulatory agency has gone through 22 years, the whole regulatory system was gradually built on the basis of the generic pharmaceutical industry at that time and through continuous exploration and summary of simply experience from foreign regulatory agencies. To a certain extent, the supervision of TCM drugs was also affected by some immature supervision ideas during this period. Based on the newly issued Drug Administration Law and Provisions for Drug Registration, the author puts forward some personal thoughts on the classifications of TCM drug registration. It is hoped that experts in the industry and regulatory agencies will work together to explore and improve the relevant system of TCM registration administration.

Interpretation of Data Integrity by Drug Regulatory Agencies / 中国药学杂志

OBJECTIVE: To understand the new development of data integrity by drug regulatory agencies. METHODS: Data integrity by drug regulatory agencies in domestic and abroad were interprated in this paper. Data integrity is critical elements of the pharmaceutical quality system, and drug regulatory agencies have issued practise /guidance on data integrity to highlight it. Practise /guidance provide a basic overview of key principles relating to data management and integrity which are regularly updated, revised and reviewed based on the feedback from review agencies, including the experience provided by various regulatory agencies and enterprises. RESULTS: and CONCLUSION: This paper summarizes the individual and common issues of the six major data integrity practise /guidance, explains and differentiates some concepts, which helps to understand and apply practise /guidance.

Proibicionismo e poder regulatório: uma pesquisa documental sobre o processo administrativo de classificação das drogas / Prohibition and regulatory authority: a documental research about drugs categorizing administrative process / Prohibicionismo y potestad reglamentaria: una investigación documental acerca del proceso administrativo de clasificación de las drogas

Esse trabalho tem como objetivo mapear o processo decisório identificando atores e fundamentos da produção normativa regulatória no âmbito das políticas públicas sobre drogas, consubstanciadas na edição e atualizações da Portaria SVS/MS nº 344/1998, que define as regras para substâncias de controle especial e substâncias proibidas no Brasil, e complementam o sentido da Lei 11.343/2006. Foi realizada uma pesquisa documental para elucidar os seguintes pontos: correspondência dos atos praticados pela ANVISA à necessidade de acompanhar as atualizações das listas das convenções internacionais sobre o tema; atores que tem iniciativa no processo de inclusão de substâncias; etapas do processo; utilização de instrumentos de participação social, transparência decisória e accountability; fontes consultadas para subsidiar a decisão e principais motivos relatados nos pareceres técnicos. Os resultados mostram que não há plena correspondência entre os parâmetros internacionais e a inclusão das substâncias nas listas de controle brasileiras e que o fundamento da proibição está mais relacionado a razões de segurança do que propriamente aos danos para a saúde, provavelmente devido à influência assimétrica de grupos de interesse no processo administrativo

This work aims to map the decision making process and identify actors and foundation of regulatory normative acts within public policy about drugs, consubstantiated with the edition and updates of Portaria SVS/MS nº 344/1998, which defines rules to substances under special control and forbidden substances in Brazil, and complement the meaning of Law 11.343/2006. A documentary research was made to elucidate the following issues: compliance of the acts of National Agency for Sanitary Vigilance - ANVISA to the actualizations of the lists of the international conventions about the theme; actors who have initiative of the inclusion process of substances; steps of the process; use of social participation, decisional transparency and accountability mechanisms; consulted sources to subsidize the decision and main reasons related in the technical reports. The results shows that there's not total compliance to the international parameters with the inclusion of substances in the Brazilian controlling lists and that the prohibition is more related to public security reasons than health damages, probably due to asymmetric influence of interest groups in the administrative process

Este trabajo tiene como objetivo describir el proceso de toma de decisiones y identificar los actores y la fundamentación de la producción normativa reguladora ubicada en las políticas públicas de drogas, consagrados en la edición y actualiza la SVS / MS Nº 344/1998 por el que se establecen normas para el control de sustancias especiales y prohibidos en Brasil, y complementan el sentido de la Ley 11.343 / 2006. La investigación documental se llevó a cabo para aclarar los siguientes puntos: correspondencia de los actos realizados por la ANVISA a la necesidad de seguir las actualizaciones de la lista de los convenios internacionales en la materia; actores que tienen la iniciativa de incluir sustancias; las fases del proceso de inclusión de substancias; los instrumentos de participación social, transparencia y responsabilidad en la toma de decisiones; fuentes consultadas para apoyar la decisión y las razones principales reportados en los informes técnicos. Los resultados muestran que no existe plena correspondencia entre las normas internacionales y la inclusión de sustancias en las listas de control de Brasil, así que el motivo de la prohibición está más cerca de razones de seguridad que en realidad tiene que ver con los daños a la salud, probablemente debido a la influencia asimétrica de grupos de interés en el proceso administrativo

<b>2．Expectations for MIHARI Project from the Perspective of Academia </b> / 薬剤疫学

Based on the history of pharmacovigilance activities in Japan, the expectations for MIHARI Project from the perspective of academia are discussed. First, drug safety and risk-benefit related activities should be enhanced from the early stage of drug development and/or in the regulatory approval stage. Second, more collaboration with regulatory authorities and academia should be promoted. Third, knowledge obtained from MIHARI Project should be published timely and continuously which contribute to related safety activities conducted by other than regulators.

Herbal Drug Development from Traditional Formulations: Refocusing Pharmaceutics and Posology for Accelerated Validation.

Background: The World Health Organization (WHO) recommended that the toxicity data of a traditional medicine (TM) product that has been in use for 20 years or more without untoward effects should be determined, as the first step in its research and development (R&D). Such data in conjunction with efficacy data would be used to develop an appropriate dosage form of the product. A key objective in researching such a product is to validate the basis of the therapy, including the formula. Such validation, and any attempt to modernize the product, should be guided by an understanding of the traditional know-how. The Nigerian National Institute for Pharmaceutical Research and Development (NIPRD) utilized this approach in developing Niprisan, an antisickling drug, based on a TM product used since antiquity in Yoruba Medicine. Aim: This article aimed to advocate the continuance and improvement of the WHO model of herbal drug research and regulation (HDRR) as the most logical approach for adoption by researchers and regulators. Methodology: NIPRD’s adoption of the WHO model since 1989 was reviewed in parallel with trends in herbal drug research worldwide; and within the contexts of regulatory practices by Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) and the European Medicines Evaluation Agency (EMEA), with a view to identifying more effective strategies within the WHO paradigm for HDRR. Conclusion: Drug regulatory agencies (DRAs) like NAFDAC require effective laws, policies and quality management systems (QMS) to execute their mandates effectively. On the other hand, NIPRD’s output depends upon proper actions by a seasoned and responsive DRA. Therefore, noting that NIPRD and NAFDAC were both created by military decrees in 1989 and 1992 respectively, rather than by parliament acts, it is recommended that in addition to instituting more effective laws and policies to regulate NAFDAC, both NIPRD and NAFDAC need to adopt and implement suitable QMS for self-regulation, eg: ISO 9001 for whole organizations; and ISO/IEC 17250 for the laboratories.

Study on present situation and countermeasures of Chongqing Traditional Chinese Medicine / 重庆医学

Objective To investigate the status of TCM development in Chongqing city,and to put forward countermeasures and suggestions of the development of Chinese medicine in view of the existing problems,so as to provide reference for the government and relevant departments.Methods The relevant questionnaires were issued and recycled in 20 districts and counties of Chongqing city.Part of the data culled from Chinese management office yearbooks of Chongqing.Finally,comprehensive analysis was per-formed.Results There′s enormous upside potential for the development of Chongqing traditional Chinese medicine (TCM),but there were some problems and deficiencies.The main problems were as follows:the TCM characteristics not brought into full play in traditional Chinese Medicine hospitals,lack of following talents,unsound organization management of traditional Chinese medi-cine,the government′s insufficient investment and attention for traditional Chinese medicine (hospitals,schools,“hand-to-hand”ap-proach),not enough national policy support for TCM,TCM hospitals and folk medicines of ethnic minorities,and insufficient exca-vation in ethnic minority medicine.Conclusion In order to adapt to the development of Chinese medicine and to meet the growing requirements of Chinese medicine,some countermeasures should be taken as follows:giving full play to the characteristics of tradi-tional Chinese medicine,strengthening personnel training in Chinese medicine,reforming the management mechanism,increasing the government investment,strengthening policy support for Chinese medicine and folk medicines of ethnic minorities,accelerating the process of TCM standardization,scientific and internationalization.It is suggested that the miscellaneous diseases &incurable dis-ease medicine research office and slow disease traditional Chinese medicine health care office should be established under the TCM management office.Specialized agencies are advised to mine and collect herbal remedies,recipes in ethnic minority area and so on.

Assessing new strategies for TB diagnosis in low- and middle-income countries

In this manuscript, we report the current situation of tuberculosis globally and in Brazil, the need for new strategies toward tuberculosis control, focusing on new diagnostic technologies. Critical comments are given on the state of the art regarding the evaluation of new health technologies, degree of scientific evidence needed, evaluation of clinical impact, cost-effectiveness of incorporation into the health system and the social impact.

Como realizar o correto descarte de resíduos de medicamentos? / How to do the correct discard of medicine residues?

A destinação final dos resíduos de origem farmacêutica é tema relevante para a saúde pública, devido às diferentes propriedades farmacológicas dos medicamentos que inevitavelmente se tornarão resíduos. Dessa forma, não poderão mais ser utilizados e deverão receber um tratamento específico. No Brasil, o correto descarte dos resíduos sólidos de origem farmacêutica é normatizado tanto pelo Ministério da Saúde quanto pelo do Meio Ambiente, que devem fornecer instrumentos para que os atores envolvidos em atividades que geram resíduos dessa natureza possam dar-lhes a disposição final adequada. No entanto, existem dificuldades que apenas poderão ser superadas com a integração de todos os envolvidos nessa questão. O objetivo deste artigo é fazer um levantamento crítico dos instrumentos legais disponibilizados pelos órgãos reguladores, situando cada ator e suas responsabilidades para o correto descarte de resíduos de medicamentos, protegendo assim a saúde pública e o meio ambiente.

The final destination of medicine residues is a relevant subject to the public health due to the pharmacological properties of each medicine, that in future will become a residue and will need to be treated. In Brazil, the correct discard of the solid medicine residues is regulated by the Ministry of Health and also by the Ministry of Environment, that aim to provide the producers of medicine residues with instruments that enable them to correctly discard those residues. However, there are some obstacles that can only be overcome through the integration of all agents involved in this process. The purpose of this article is to make a critical survey of the legal instruments offered by the regulatory institutions, locating each agent and its responsibilities concerning the protection of public health and the environment.

Gerenciamento de resíduos oriundos da fabricação e distribuição do medicamento Diazepam para o município de São Mateus, ES / Management of residues deriving from the manufacture and distribution of Diazepam in the city of São Mateus, ES

O presente trabalho se propôs a estudar o gerenciamento de resíduos de um medicamento de uso controlado. O Diazepam, por ser importante na terapêutica e amplamente utilizado, além de ter seu uso controlado pela Vigilância Sanitária, foi o medicamento de escolha para este estudo. Observou-se a geração de resíduos desde a fabricação do Diazepam até sua distribuição, bem como o tratamento e destinação final dos resíduos. O estudo teve início num município de médio porte, do estado do Espírito Santo, chamado São Mateus. No Brasil, 27,6 por cento dos municípios, de forma semelhante a São Mateus, são de médio porte e contam com a presença de um serviço municipal de vigilância sanitária acoplado a um serviço de meio ambiente. O estudo, que é de caráter qualitativo, teve como objetivos: identificar os principais tipos de resíduos do medicamento Diazepam; estudar as principais causas que levam à geração do Diazepam resíduo; estudar as dificuldades no gerenciamento dos resíduos sólidos pelos atores envolvidos neste processo; estudar a legislação ambiental/sanitária relacionada e seu emprego. As relações entre estas atividades e os órgãos responsáveis pela fiscalização e controle destes resíduos, principalmente no que diz respeito ao cumprimento das regulamentações, também fizeram parte do trabalho.

This work aimed to study the management of residues of a controlled prescription drug. Diazepam was the drug chosen for this study for its therapeutic importance and wide use, and for being a prescription drug controlled by the National Health Surveillance Agency - ANVISA. The generation of residues of Diazepam from manufacture to distribution as well as the management and final destination of these residues was observed. The study started in an average-size city in the state of Espírito Santo, called São Mateus. In Brazil, 27.6 percent of cities are medium-sized like São Mateus and count on the presence of a municipal health surveillance service linked to an environmental control service. The objectives of this qualitative study were to: identify the main types of residues of Diazepam; study the main causes for the generation of residues of Diazepam; study the main difficulties found in the management of solid residues by the different agents involved in this process; study the environmental/health legislation related to the subject as well as its application. The relationship between these activities and the organisms responsible for the inspection and control of these residues, mainly as refers to the enforcement of the existent regulations, were also subject of this study.