"Enxugando Gelo?": o trabalho dos profissionais na fiscalização sanitária de medicamentos na internet / "Rolling a stone uphill?": the work of professionals in health inspection of medicines on the internet

Resumo A sociedade contemporânea convive com incertezas e vulnerabilidades que exigem a atuação dos sistemas regulatórios na fiscalização do comércio eletrônico de medicamentos não registrados e/ou falsificados. Investiga-se o trabalho dos profissionais da vigilância sanitária federal na fiscalização de medicamentos na internet e os elementos que orientam sua decisão técnica. A metodologia utilizada foi a pesquisa qualitativa, do tipo estudo de caso único, ancorada na abordagem ergológica, entre dezembro de 2020 e setembro de 2021, por meio de entrevistas e observação participante. Os mapas ergodialógicos, elaborados no Atlas.ti, subsidiaram a análise das práticas discursivas classificadas conforme esquema tripolar saber-agir-valor, resultando em três categorias. O profissional é sempre convocado a fazer escolhas e gerir situações imprevisíveis, havendo inquietações sobre a capacidade institucional para compreender e agir sobre o problema. O trabalho adquire, assim, o sentido de "enxugar gelo", em função do volume de demandas e dos poucos efeitos da fiscalização no mercado eletrônico de medicamentos. As normas, o conhecimento técnico, a experiência e a responsabilidade social, dentre outros elementos, estão presentes na tomada de decisão dos profissionais, conscientes de que, ao agir, protegem a saúde da população. Constata-se que diferentes saberes, científicos ou empíricos, podem qualificar melhor o sistema decisório na fiscalização, tornando-o mais efetivo, assertivo e transparente.

Abstract Contemporary society is plagued with uncertainties and vulnerabilities, demanding from regulatory systems the surveillance of unregistered and/or falsified medicines sold online. This study investigates the work of federal health surveillance professionals in the inspection of medicines sold online and the elements that guide their technical decision. A qualitative, single case study based on the ergological approach was conducted between December 2020 and September 2021, with data collected by interviews and participant observation. Ergodialogical maps, developed using Atlas.ti, underlined the analysis of discursive practices classified according to the tri-polar knowledge-action-value schema, resulting in three categories. Professionals are always called upon to decide on and manage unpredictable situations, questioning the institutional capacity to understand and act on the problem. The work thus takes on the sense of "rolling a stone uphill" due to the volume of demands and the limited effects of surveillance on the e-commerce of medicines. Norms, technical knowledge, experience, and social responsibility, among other elements, inform the decision-making process of professionals, who are aware that, by acting, they protect public health. Different forms of knowledge, scientific or experiential, can better qualify decision-making in surveillance, making it more effective, assertive, and transparent.

CHINA PH ARMACY Volume 33，Number 16，August 30，2022 Semimonthly Table of Contents Analysis of trans-provincia l distribution supervisio n of TCM decoction pieces in accordance with provincial standards from the perspective of benefit and risk / 中国药房

OBJECTIVE To provide ideas for solving the dispute of trans-provincial distribution of traditional Chinese medicine （TCM） decoction pieces in accordance with provincial standards （hereinafter referred to as “local TCM decoction pieces”）. METHODS Through simulation scenarios and collecting actual cases ，the conditions of trans-provincial distribution of local TCM decoction pieces were listed ；the official websites were searched or relevant personnel of drug supervision were interviewed；the current situation of trans-provincial distribution supervision of local TCM decoction pieces in China were sorted out. Based on the stakeholder theory ，the benefits and risks of main stakeholders were discussed to put forward relevant suggestions from the perspective of benefit /risk balance. RESULTS & CONCLUSIONS The conditions of trans-provincial distribution of local TCM decoction pieces in China included enterprises in B province produced TCM decoction pieces according to the A provincial standards，sold and used them in A province ；enterprises in B province produced TCM decoction pieces according to the B provincial standards ，sold and used them in A province ；enterprises in B province produced TCM decoction pieces according to the C provincial standards ，sold and used them in A province. At present ，there are no clear relevant provisions of national laws about trans-provincial distribution supervision of local TCM decoction pieces. Local regulatory opinions mainly come from the reply of the official website of drug regulatory department to online consultation ，and only Shandong ，Shanghai，Liaoning and Jiangxi have issued replies or normative documents. Totally 41.9％，38.7％ and 32.3％ of the provinces respectively allow the trans-provincial distrbution of local TCM decoction pieces in the above 3 conditions；in addition ，32.3％，16.1％ and 22.6％ provinces have unclear regulatory attitudes towards the 3 conditions. The benefits and risks analysis of relevant stakeholders shows that it is more in line with the scientific regulatory concept of benefit/risk balance to conditionally allow trans-provincial distribution of local TCM decoction pieces ，but the regulatory effect depends on the scientificity of the regulatory strategy. It is suggested that the drug regulatory departments clarify the relationship between the national and local standards for TCM decoction pieces and dingrl375@163.com differentiate the varieties of collection ；clear the regulatory requirements for trans-provincial distribution of local TCM decoction pieces by issuing high-level legal d ocuments；enrich regulatory measures and means ，and gradually adjust the requirements of trans-provincial distribution of local TCM decoction pieces .

Intellectual Property Provisions Relating to Drug Regulation in the TPP Agreement / 中国药学杂志

OBJECTIVE: To study the intellectual property provisions relating to drug regulation in the TPP agreement, analysize the interaction mechanism between drug regulation and intellectual property rights on the basis of information sharing, study the possible impact, and then discusses the references to China. METHODS: This article analysizes the TPP final text and relevant research literatures, study the interaction mechanism between drug regulation and intellectual property rights and the possible impact of, and then discuss the relevantlaw of China. RESULTS: The TPP agreement provides several intellectual property provisions relating to drug regulation, demanding the concordant relation between the registration of pharmaceutical and patent protection period, drug data protection and patent protection, which will establish the interaction mechanism based on information sharing. The intellectual property provisions relating to drug regulation are a summary of the experience of the TPP parties forming a coordinated and interactive mechanism between encouraging innovation and ensuring drug safety and an attempt to a wide range practice, which will have abroad impact on the biopharmaceutical industry. CONCLUSION: Refer to the relevant experience in TPP agreement, China can amend the Pharmaceutical Administration Law and the Patent Law in the process of revision by improving the information sharing mechanism to achieve a higher level of institutional interaction.

Supervision System and Legal Applicability of Food and Drug Regulation / 中国药学杂志

OBJECTIVE: To standardize the concept and nature of food and drug regulatory filing behavior. METHODS: According to the provisions of laws, regulations, rules and regulatory documents in the regulation of food and Drug Administration, analyze the existing problems and application defects in the regulation of food and drug regulatory record. RESULTS: To suggest how to design and perfect the food and drug regulatory filing system. CONCLUSION: As a widely applicable administrative act, administrative record is closely related to the administrative organ and the administrative relative person. Administrative filing as an extensive application, and administrative organs and administrative counterparts are closely related to the administrative behavior, more and more play an important role. Therefore, it is necessary to clean up those filing provisions, which are not standardized in the existing laws, regulations, regulations; to regulate the establishment of food and drug regulatory administrative record; to build a sound food and drug regulatory administrative filing procedures.

Analysis on Evolutionary Game and Countermeasures for Drug Safety Regulation / 中国药房

OBJECTIVE:To put forward game strategy of drug safety regulation,and to provide reference for decision-making by drug regulation department. METHODS:Based on evolutionary game theory,evolutionary game model of drug safety regula-tion was established,and the stability of evolution during drug safety regulation was analyzed. RESULTS & CONCLUSIONS:There were four possible evolutionary game results of drug safety regulation,including to provide qualified drugs,regulation;to provide unqualified drugs,regulation;to provide qualified drugs,no regulation;to provide unqualified drugs,no regulation. The evolution direction mainly depends on the parameter values involved in the payoff matrix of drug safety regulation. The stable state of drug safety regulation is related to regulation strength,regulation cost,enterprise safety input,probability of accident,acci-dent-related treatment cost,et al. Key strategies to improve drug safety regulation include increasing punishment,improving moni-toring technology,strengthening coordination mechanism,promoting social cohabitation and improving industry self-control.

Common Herbal-pairs Summary in Treating Lung Cancer by Professor Shu Qijin / 浙江中医药大学学报

Objective] To summarize the experiences of Professor Shu Qijin and to introduce his frequently used traditional Chinese medicine(TCM) herbal-pairs for treating lung cancer. [Methods] Professor Shu's experience and the treatment principles on herbal-pairs were summarized by attending the process of his diagnosis and treatment for lung cancer patients and his medical records. [Results] Shu treated that lung cancer by traditional Chinese medicine belongs to the multi-target therapy, drug although short, lung disease is also complex. However, the drug for lung cancer a target in strong, if properly combined, can hold simplification, observant insight. For advanced lung cancer patients with Qi deficiency symptoms, Shu used common heterophylla-Astragalus, Codonopsis-white atractylodes rhizome, Radix Glehniae, Ophiopogon japonicus, medicine of Fuzheng anticancer; sputum is a poison stasis, Shu divided common diffusa-sheliugu, Lobelia chinensis, Scutellaria barbata, Taxus chinensis var. mairei, Polygonum cuspidatum root medicine for detoxification Sanjie; blood stasis, Shu used common trigonous, rhizome, notoginseng, radix paeoniae rubra, etc. drug for promoting blood circulation and removing blood stasis. Anyway, Shu permited the treatment of lung cancer, on the basis of dialectical argumentation, discerning the pathogeny, disease location, disease, illness and mastering five flavors of the four properties of traditional Chinese medicine(TCM), rising and sinking, using the following drugs, clinical addition and subtraction, herbal prescription has better clinical efficacy, and attached with the case of a post-mortem. [Conclusions]Medicine of precise curative effect is determined by Shu and the mechanism of medication has higher clinical value,it is worth in-depth study and application.

South-South Cooperation: Brazilian experiences in South America and Africa / Cooperação Sul-Sul: experiências brasileiras na América do Sul e na África

Over recent years Brazil has played an increasingly active role internationally, the result of its model of integration and its foreign policy directives. The health sector is a valuable and strategic area for Brazilian technical cooperation to achieve various objectives, including its development goals. This article describes the main directives of Brazilian foreign policy, conceptually defining and characterizing South-South Cooperation, illustrated through an analysis of two Brazilian technical cooperation initiatives in healthcare: one in South America, the other in Africa. The study concludes that, irrespective of the interests and power asymmetries existing in South-South Cooperation, the objectives of this cooperation were achieved through the technical work.

Nos últimos anos, o Brasil foi ativo no âmbito internacional, tanto por seu modelo de inserção como pelas diretrizes de política externa. O setor saúde é uma ferramenta valiosa e estratégica utilizada pela cooperação técnica brasileira para lograr seus objetivos de desenvolvimento. Este artigo descreve as principais diretrizes de política externa brasileira, conceitua e caracteriza a Cooperação Sul-Sul, ilustrada mediante análise de duas iniciativas de cooperação técnica em saúde do Brasil: na América do Sul e na África. O estudo conclui que, independentemente dos interesses e das assimetrias de poder que existem na Cooperação Sul-Sul, os objetivos dessa cooperação foram alcançados por meio do trabalho técnico.

Proyecto Grannacional ALBASALUD para Centro Regulador de Medicamentos Esenciales de los países del ALBA-TCP / Grand-national Project ALBASALUD for Regulatory Center of Essential Drugs for the ALBA-TCP countries

La Autoridad Reguladora de Medicamentos de Cuba, coordina un Proyecto de la Alianza Bolivariana para los pueblos de América-Tratado de Libre Comercio (ALBA-TCP), dirigido al desarrollo de un Centro Regulador para los países del ALBA como nuevo organismo regional de integración farmacéutica, en aras de contar con un Registro Grannacional válido en todos los países partes, como herramienta para facilitar el acceso a medicamentos esenciales de calidad. Esta investigación tuvo como objetivo diseñar y conducir desde el punto de vista técnico un proyecto para crear las bases legales y metodológicas del futuro centro y sus funciones básicas. Se emplearon técnicas de grupo nominal, puntos de referencia, consultas a expertos y se crearon metodologías específicas para planear y confeccionar los documentos necesarios. Se utilizaron lineamientos de organismos reguladores internacionales, cuadros básicos de medicamentos y reglamentación farmacéutica de los países participantes. Se desarrollaron y aplicaron documentos y estrategias para el trabajo del proyecto durante la etapa de preinversión, se definió el primer listado de medicamentos esenciales del ALBA y se aprobaron las fundamentales disposiciones legales y la reglamentación para las funciones de registro, vigilancia, inspecciones, laboratorios y liberación de lotes. El Proyecto Grannacional ALBASALUD Centro Regulador de Medicamentos del ALBA-TCP aplicado ha demostrado su eficiencia y capacidad para alcanzar los objetivos trazados mediante un trabajo científico-técnico con participación colectiva, que ha garantizado las disposiciones y lineamientos requeridos para sus funciones básicas y respaldo legal

The Drug Regulatory Authority of Cuba is coordinating a Project of the Bolivarian Alliance for the Peoples of America- Free Trade Agreement (ALBA-TCP) aimed at developing a Regulatory Center that will operate as a new regional body of pharmaceutical integration for the ALBA countries. It will provide a Grand-national Register that will be valid for all the member states to facilitate the access to quality essential drugs. The objective of this research work was to design and to conduct a project from the technical viewpoint in order to lay down the legal and methodological basis of the future center and its main functions. Some techniques like nominal group, points of reference and expert consultation were used, and the specific methodologies to plan and to prepare the required documents were devised. The guidelines of international regulatory bodies, the basic groups of drugs and the pharmaceutical regulations of the participating countries were reviewed. Several documents and strategies for the project work in the pre-investment stage were developed, the first listing of essential drugs for the ALBA countries was defined and the main legal provisions and the regulation that states the functions of registering, surveillance, supervision, lab work and release of batches of the new entity were approved. The Grand-national Project ALBASALUD Regulatory Center of Drugs for the ALBA-TCP has proved its efficiency and capacities to achieve the set objectives through collective involvement-supported scientific and technical work that has guaranteed the required provisions and guidelines for the basic functions and the legal endorsement of the center