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Propósito/Contexto. En este artículo se exponen las tendencias y las características de un modelo de negocio que la industria farmacéutica ha venido imponiendo con la ayuda del desarrollo de nuevos medicamentos a los que se les cuestiona su "altura inventiva" y que, a pesar de ello, les son otorgadas las patentes de segunda generación, considerándose esta una práctica abusiva y que favorece el incremento de los precios de estas innovaciones en el mercado. Metodología/Enfoque. Mediante la presentación de un caso: "la declaración de interés público del medicamento imatinib en Colombia" se identifican las estrategias y las maniobras anticompetitivas que dejan pocas oportunidades a los Estados para distribuir de manera equitativa los beneficios de las invenciones de medicamentos. En el análisis bioético del caso se caracteriza el dilema como tipo práctico, esto es, aquel en el que persisten requerimientos morales en tensión con un interés privado, en esta ocasión, entre la salud pública, por un lado, y la propiedad intelectual como política internacional, por el otro. Resultados/Hallazgos. La tesis es que este es un problema transfronterizo sintomático de la falta de justicia global en razón a la suplantación del sentido de "bien común" que ha acallado los vínculos sociales, solidarios y colaborativos. Discusión/Conclusiones/Contribuciones. Se insta a un consenso sobre las bases sociales y el respeto de la dignidad de las personas, un mandato de solidaridad superior en beneficio del bien común y el "florecimiento de la humanidad".
Objetivo/Contexto. Este artigo expõe as tendências e características de um modelo de negócio que a indústria farmacêutica tem vindo a impor com a ajuda do desenvolvimento de novos medicamentos cujo nível de inventividade é questionado. Como resultado, é-lhes concedidas patentes de segunda geração, o que é considerado uma prática abusiva e favorece o aumento dos preços destes inovações no mercado. Metodologia/Abordagem. Através da apresentação de um caso "A Declaração de Interesse Público da droga Imatinib na Colômbia", são identificadas estratégias e manobras anticompetitivas, que deixam poucas oportunidades para os Estados distribuírem os benefícios das invenções de drogas de forma equitativa. Na análise bioética do caso, o dilema é especificado como sendo prático, ou seja, um dilema em que os requisitos morais persistem em tensão com um interesse privado, neste caso, entre a saúde pública, por um lado, e a propriedade intelectual como uma política internacional, por outro. Resultados/Descobertas. A tese é que se trata de um problema transfronteiriço sintomático de falta de justiça global devido à suplência de um senso o bem comum que silenciou os laços sociais de solidariedade e colaboração. Discussão/Conclusões/Contribuições. Apela a um consenso sobre os fundamentos sociais e o respeito pela dignidade das pessoas, um mandato de maior solidariedade em benefício do bem comum, o florescimento da humanidade.
Purpose/Background. This article exposes the tendencies and characteristics of a business model that the pharmaceutical industry has been imposing with the help of the development of new drugs whose degree of inventiveness is questioned. As a result, they are granted second generation patents, which is considered an abusive practice that favors the increase of the prices of these innovations in the market. Methodology/Approach. Through the presentation of a case "The Declaration of Public Interest of the Drug Imatinib in Colombia", anti-competitive stra-tegies and maneuvers are identified, which leave few opportunities for the States to distribute the benefits of drug inventions in an equitable manner. In the bioethical analysis of the case, the dilemma is specified as a practical one, that is, one in which moral requirements persist in tension with a private interest, in this case, between public health on the one hand, and intellectual property as an international policy, on the other. Results/Findings. The thesis is that this is a cross-border problem symptomatic of a lack of global justice due to the supplanting of the sense of the common good that has silenced social bonds of solidarity and collaboration. Discussion/Conclusions/Contributions. It calls for a consensus on social foundations and respect for the dignity of persons, a higher mandate of solidarity for the benefit of the common good, and the flourishing of humanity.
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The traditional Chinese medicine(TCM) contains very complex constituents. Besides the major constituents, there are a large number of unclear trace constituents with novel skeletons and potent bioactivities, which have been regarded as one of the important therapeutic substances and the great resources of innovative drugs derived from TCM. The present review highlighted that the development of the trace therapeutic substances of TCM is closely depends on the advanced technologies for their identification, isolation, structure elucidation, and bioactivity evaluation. Additionally, this paper reviewed the novel trace compounds derived from Chinese herbal medicines which have been published in Organic Letters during 2001-2021, and summarized the important licensed drugs originated from the trace therapeutic substances and the discovery and development of trace therapeutic substances of 8 kinds of Chinese herbal medicines. This review provides references for the research and development of TCM therapeutic substances and innovative drugs.
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Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese TraditionalABSTRACT
China has entered the task stage of comprehensive medical insurance payment reform, but there are problems restricting the development of innovative medical technology in the reform of diagnosis-related groups(DRG) payment system. The author introduced the international definition and scope of innovative medical technology, and summarized the preconditions and payment policy of short-term payment of innovative medical technology under the DRG payment system; And put forward suggestions in line with China′s actual situation, including clarifying the definition of innovative medical technology, setting access conditions for additional payment or actual payment, setting up special transition funds for high-value innovative drugs, clarifying the payment amount of innovative medical technology, and formulating payment strategies for innovative medical technology.
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OBJECTIVE：To identify and evaluate the risk factors of innovative drug clinical trials ，and to provide references for the development of risk management and control strategies. METHODS ：Using the method of literature research ，the risk factors of innovative drug clinical trials were obtained ，classified and sorted out ，and the risk evaluation indicators were initially formed. On this basis ，the questionnaire was designed. By means of interview and questionnaire survey ，54 experts were invited from 4 tertiary hospitals and 1 contract research organization to score. SPSS 24.0 software was used to perform principal component analysis on risk event status data. RESULTS & CONCLUSIONS ：The risk evaluation system included 9 first-class indicators such as policy and legal risk ，clinical trial institution risk and trial scheme design risk ，and 31 second-class indicators such as industrial policy，law and regulation changes ，intellectual property risk . According to the analysis ，the risk factors of innovative drug clinical trials mainly included drug and biological sample management risk ，trial scheme design risk ，clinical trial institution risk ，safety report management risk ，ethical review risk ，policy and legal risk ，and subject management risk. Relevant parties in clinical trials need to focus on monitoring various risk factors ，establish dynamic monitoring and control mechanism and implementation guarantee mechanism ，and effectively prevent and control risk ，to promote the smooth implementation of clinical trials.
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RESUMEN En la población en general existe gran controversia alrededor del uso de medicamentos innovadores y de sus copias llamadas medicamentos genéricos. El objetivo de este estudio es cuantificar la aceptación de los pacientes, del Sistema General de Seguridad Social en Salud de Colombia (SGSSS) a la prescripción de medicamentos genéricos. Se realizó un estudio de tipo descriptivo con un diseño transversal en 63 hombres y 57 mujeres, todos adultos pacientes que asistieron a consulta externa de los sitios de práctica de una Facultad de Medicina de Cali-Colombia. Se concluye que si se usan medicamentos genéricos, se requiere que los médicos y los usuarios tengan confianza en él. Los resultados del presente estudio muestran que, aunque no en forma mayoritaria, todavía un porcentaje importante de los consumidores entrevistados dudan de la calidad y de los resultados terapéuticos de los genéricos. De manera preocupante, casi una cuarta parte de los participantes en el estudio piensa que los medicamentos genéricos son productos fraudulentos.
SUMMARY In the general population, there is a great controversy surrounding the use of innovative drugs and their copies called generic drugs. The objective of this study is to quantify the acceptance of patients from the General System of Social Security in Health of Colombia (SGSSS) to the prescription of generic drugs. A descriptive study was carried out with a transversal design. The universe was 63 men and 57 women, all adult patients who attended external consultation of the practice sites of the Faculty of Medicine of Cali-Colombia. It is concluded that if generic drugs are used, it is necessary that doctors and users have confidence in it, the results of the present study show that, although not in the majority, still a significant percentage of the consumers interviewed doubt the quality and the therapeutic results of generics. Worryingly, nearly a quarter of study participants think that generic drugs are fraudulent products.
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Bromophenols are a class of natural products featuring novel chemical structures and diverse biological activities. These compounds possess anti-tumor,antibacterial and anti-oxidation activities,which has attracted much attention from synthetic chemists. Bromophenol derivatives are synthesized using bromination,methylation,reduction and alkylation,while the total synthesis of complex bromophenol-type natural products make use of aldol reaction,Wittig reaction,reduction amination as well as Curtius rear- rangement. This review summarizes the synthesis of bromophenol derivatives and complex bromophenol-type natural products,to pro- vide reference for their efficient research.
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Based on the stakeholder theory,externalities theory and marginal utility theory,this paper analyzes the behavioral needs of stakeholders in the process of market access of innovative drugs.It also draws out the core of the government and the pharmaceutical enterprises in the policy of access to innovative drug market and supply to the community,the patients,and the medical institutions enter the mechanism of the interaction of the various stakeholders in the innovative drug market for the demand community and construct the above-mentioned stakeholder perspective Innovative Drug Market Access Policy Environment Model.Based on the status quo of China's innovative drug market access,the present study puts forward to encourage innovative drug market access to the interests of the main body,to optimize the existing innovative drug market access policy environment to make reference recommendations.
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Based on the stakeholder theory,externalities theory and marginal utility theory,this paper analyzes the behavioral needs of stakeholders in the process of market access of innovative drugs.It also draws out the core of the government and the pharmaceutical enterprises in the policy of access to innovative drug market and supply to the community,the patients,and the medical institutions enter the mechanism of the interaction of the various stakeholders in the innovative drug market for the demand community and construct the above-mentioned stakeholder perspective Innovative Drug Market Access Policy Environment Model.Based on the status quo of China's innovative drug market access,the present study puts forward to encourage innovative drug market access to the interests of the main body,to optimize the existing innovative drug market access policy environment to make reference recommendations.
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This paper summarizes the current situation and existing problems of China's innovative drug market access policy from the basic aspects of innovative drug market access,such as intellectual property rights,drug pricing,medical insurance and bidding procurement.Based on the comprehensive analysis of Japan's innovative drug market access policy,through the comprehensive comparison of the two countries innovative drug market access policy differences,the paper put forward the practical measures to encourage the listing of innovative drugs in China,from the intellectual property rights,drug pricing,medical security and tender procurement in four areas.
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As an important clue and reference for modern compound medicine,Chinese medicine compatibility has become an innovative research and development mode of fixed dose combination with Chinese characteristics and traditional Chinese medicine (TCM) characteristics.However,it is difficult to find and determine the effective substances because of the complex composition,the huge amount and the structure diversity.In order to solve these problems,innovative ideas,methods and techniques are needed.
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Quality assurance is the key to the clinical efficacy,industrial development and international development of Chinese medicine.This article,themed “developing key technologies in R&D and quality research of Chinese medicine”,introduced the advances in constructing state key laboratory of Chinese medicine,the location of overseas innovative platform,systemic research of Chinese medicine (effectiveness,safety,stability,controllability,systematicness) and R&D of innovative Chinese medicine.We also discussed how to apply advanced technologies in drug evaluation,and how to utilize the basis of scientific research and academic advances in the development of innovative drugs,thereby ensuring the safety,efficiency and controllability of drugs.
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The characteristics of self-renewal and multilineage differentiation potential of neural stem cells(NSC)provide a new strategy for the treatment of ischemic brain sequelae.It is of great significance to find out new drugs that regulate the proliferation of endogenous NSC for the damage of nerve cells and the change of microenvironment in the brain.This review summarizes the prog?ress of Wnt signaling pathway in regulating NSC proliferation,related drug targets and the current research status of Chinese herbal medicines in regulating NSC proliferation,in order to provide a reference for future studies on new drugs for the prevention and treat?ment of ischemic brain sequelae.
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OBJECTIVE:To provide a reference for innovative drugs to enter the health insurance directory smoothly and pro-mote the rapid development of pharmaceutical industry in China. METHODS:Based on related policy study of foreign and domes-tic innovative drugs entering the health insurance directory,the policy barriers of innovative drugs entering the health insurance di-rectory were analyzed and the countermeasures were put forward. RESULTS & CONCLUSIONS:In China,the foundation of drug selection was not objective enough;the review results were so vulnerable to subjective views because of the experts selection mech-anism;the health insurance directory deletion mechanism was deficient;the waiting time for innovative drugs entering the health in-surance directory was too long;innovative drugs negotiation mechanism was imperfect,etc. It is recommended that forcibly requir-ing pharmaceutical companies should provid the related data about pharmacoeconomic evaluation;the independence and pluralism of the expert group should be enhanced;drugs in the health insurance directory should be secondarily evaluated regularly;the inno-vative drugs should be given the green channel;innovative drug price negotiation rules should be unified to promote drug informa-tion sharing.
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OBJECTIVE: To discuss phase-dependent CMC requirements for innovative drugs were discussed in view of the R&D approaches of innovative drugs.
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In this paper, based on the scientific research of TCM for many years and from the front-line point of view, the author explored the mainly common problems which had been existed in the TCM research, such as the establishment of the quality standard, the research of innovative drugs, the research ideas differentia between TCM and the natural drugs, the improvement of the research management model and other issues.