Research on the impact of China's reform to delegate power, streamline administration, and optimize government services on the technology innovation efficiency of the pharmaceutical manufacturing industry.

Objective: The government has recently implemented reforms aimed at delegating power, streamlining administration, and optimizing government services. This reform has eliminated barriers that impede the growth of various industries, thereby unleashing innovative potential. Additionally, there have been several medical policies, including changes to medical insurance and centralized volume-based procurement. China's pharmaceutical market has undergone significant changes, leading to increased demands for innovation technology efficiency in pharmaceutical manufacturing. Methods: The three-stage BCC theory was employed to assess the effectiveness of technology innovation in the industry under this reform. Calculate precise comprehensive technical efficiency values, pure technical efficiency values, and scale efficiency values for technological innovation in the pharmaceutical industry across 30 provinces from 2018 to 2020, after removing environmental factors. Results: In 2020, Jiangsu and Shandong and nine other provinces reached the comprehensive technical efficiency frontier surface, joining Tianjin, Zhejiang, and Guangdong provinces. However, Gansu, Qinghai, Ningxia, and Xinjiang still need to catch up due to their smaller industrial scale and lack of technology. Discussion: To ensure the effectiveness of reforms, it is crucial to fully consider provincial differences. Articulating national and provincial policies is necessary to allow efficient provinces to continue and allocate resources toward less efficient provinces to improve overall efficiency.

Has the consistency evaluation policy of generic drugs promoted the innovation quality of Chinese pharmaceutical manufacturing industry? An empirical study based on the difference-in-differences model.

Introduction: In March 2016, the Chinese government officially launched a nationwide consistency evaluation of the quality and efficacy of generic drugs. Methods: This paper conducted an empirical study using the Difference-in-Differences method to explore the effect of this policy on the innovation quality of China's pharmaceutical manufacturing industry and further analyzed the underlying mechanism of action. Results: The results of the study show that the generic consistency evaluation policy has a significant promotion effect on the innovation quality of China's pharmaceutical manufacturing industry, and the promotion effect is the largest for non-state-owned enterprises and enterprises in the central region; in addition, the intensity of R&D capital investment and R&D personnel investment which play a mediating role. Discussion: Therefore, we should fully recognize the positive effect of generic drug consistency evaluation policy on improving the innovation quality of the pharmaceutical manufacturing industry and pay attention to the necessity of regional coordination and unification in policy implementation and the formulation of supporting policy tools. This study provides empirical evidence for the implementation effect of the generic drug consistency evaluation policy, which can provide an essential reference for the further improvement of the procedure and the R&D decision-making of pharmaceutical enterprises.

Panorama da produção local de medicamentos no Brasil: Desafios e vulnerabilidades

A parceria entre a Fiocruz e a OPAS tem uma história longa e produtiva de iniciativas de cooperação na área da saúde pública. Juntos, desenvolvem programas e projetos que buscam melhorar a saúde e o bem-estar das populações das Américas. Existem parcerias estratégicas, como os Centros Colaboradores da OPAS/OMS, em que a Fiocruz/ENSP-NAF atua como “Centro Colaborador da OMS para Políticas Farmacêuticas”. Centros, dessa natureza, visam promover o desenvolvimento de capacidades locais (nacionais), interpaíses, regionais, inter- -regionais e globais. O livro aborda questões estratégicas relacionadas à garantia do acesso universal a medicamentos em nossa Região. A publicação analisa as vulnerabilidades e os desafios do setor, caracterizando a indústria farmacêutica nacional e relacionando as questões/linhas gerais da produção local com as políticas que surgiram a partir de debates internacionais, bem como com as parcerias entre a OMS e OMC que também fazem parte do cenário. Essa publicação também aborda a reorganização da assistência farmacêutica, um tema que pode orientar políticas públicas no futuro governo brasileiro e influenciar a formulação de políticas em outros países da nossa Região. É importante destacar a riqueza que surge dessa cooperação e da publicação conjunta, que estão indissociavelmente ligadas.

Health assessment of innovative ecological rainforest in pharmaceutical industry: Case study of Zhejiang, China.

Based on the perspective of ecology and innovation management, this paper selects seven elements from two aspects, innovation subject and innovation environment, to construct the evaluation index system for the health of pharmaceutical innovation ecological rainforest in Zhejiang from 2011 to 2019, together with the entropy weighted TOPSIS method and the obstacle factor diagnosis model. We find that the health of the pharmaceutical industry in Zhejiang can be measured as three stages: stagnation period, recovery period and development period. There is a relative balance between the development of innovation subject and innovation environment. The resilience of innovation subjects, followed by economic and cultural environment, is the key factor hindering the innovation of pharmaceutical industry in Zhejiang. Finally, we propose four countermeasures, including "deploying high-level service chains, broadening investment and financing channels for enterprises, building a reservoir of global talents, and creating an inclusive and open soft environment".

Global drug diffusion and innovation with the medicines patent pool.

This paper studies the impact of the first joint licensing platform for patented drugs, the Medicines Patent Pool, on global drug diffusion and innovation. The pool allows generic firms worldwide to license drug bundles cheaply and conveniently for sales in a set of developing countries. I construct a novel dataset from licensing contracts, public procurement, clinical trials, and drug approvals. Using difference-in-differences methods, I find that the pool leads to substantial increases in the generic supply of drugs purchased, particularly in countries with stronger patent protection. In addition, there are some positive increases in clinical trials and drug product approvals after a compound enters the pool, mostly by firms outside the pool.

The impact of network positions in scientific collaboration on pharmaceutical firms' technological innovation performance: Moderating roles of scientific collaboration strength and patent stock.

Scientific knowledge is an underlying basis for technological innovation in the pharmaceutical industry. Collaboration is the main way to participate in the creation of scientific knowledge for pharmaceutical firms. Will network positions in scientific collaboration affect their technological innovation performance? Moreover, what factors moderate the firms' scientific collaboration network positions and technological innovation link? Using a dataset based on 194 Chinese publicly traded pharmaceutical companies, this paper constructs the dynamic scientific collaboration networks among 1,826 organizations by analyzing 4,092 papers included in CNKI and Web of Science databases. Then we probe the impact and boundaries of positions in the scientific collaboration network of pharmaceutical firms on their technological innovation performance through the negative binomial modeling approach. Our study confirms that degree centrality has an inverted U-shaped impact on pharmaceutical firms' technological innovation performance, while structural holes benefit it. Moreover, this article identifies that the strength of scientific collaboration positively moderates the U-shaped relationship between degree centrality and technological innovation of pharmaceutical firms, the matching of high patent stock and high structural holes can promote their technological innovation performance. The results deepen the present understanding of scientific collaboration in the pharmaceutical industry and offer new insights into the formulation of pharmaceutical firms' scientific collaboration strategies.

[Recent changes and continuity of technological and economic dependency in the pharmaceutical industry in Brazil]. / Mudanças recentes e continuidade da dependência tecnológica e econômica na indústria farmacêutica no Brasil.

This article presents the results of a study on the pharmaceutical industry in Brazil in the recent period, as part of the multicenter project Health Economic-Industrial Complex, Innovation and Capitalist Dynamics: Structural Challenges for Construction of the Universal Health System in Brazil. The four components studied in the evolution of the Brazilian pharmaceutical industry were: State industrial policies; changes in the financial and shareholding composition of companies with domestic capital; trends in production; and trade balance behavior. The analyses considered the theoretical framework proposed by Luiz Filgueiras and Reinaldo Gonçalves concerning the implementation of a "liberal and peripheral model" in the Brazilian economy since the 1990s. Data were collected and analyzed on the situation with the Product Development Partnerships (PDP) for medicines from 2009 to 2020 from the Annual Industrial Survey (PIA) of the Brazilian Institute of Geography and Statistics (IBGE) from 1996 to 2018 and data on the evolution of the sector's trade balance from 1996 to 2019. The results show that the State's agenda for the sector favored the growth in production of generic drugs and over-the-counter drugs and started some technology transfer projects via PDPs for production of biological and synthetic drugs. Despite this evolution, Brazil is still dependent on the importation of chemical and pharmaceutical inputs and finished drugs. This keeps Brazil in a situation of technological and economic vulnerability in relation to global suppliers, besides a growing trade deficit in the sector.

Este artigo apresenta os resultados de pesquisa sobre a indústria farmacêutica no Brasil, no período recente, realizada no âmbito do projeto multicêntrico Complexo Econômico-Industrial da Saúde, Inovação e Dinâmica Capitalista: Desafios Estruturais para a Construção do Sistema Universal de Saúde no Brasil. Os quatro componentes estudados sobre a evolução da indústria farmacêutica no Brasil foram: as políticas industriais do Estado; as mudanças na composição financeira e patrimonial das empresas de capital nacional, a evolução da produção; e o comportamento da balança comercial. As análises levaram em consideração o marco teórico proposto por Luiz Filgueiras e Reinaldo Gonçalves a respeito da implantação de um "modelo liberal e periférico" na economia brasileira a partir dos anos 1990. Foram levantados e analisados dados sobre: a situação das Parcerias de Desenvolvimento Produtivo (PDP) para medicamentos entre 2009 e 2020; da Pesquisa Industrial Anual (PIA), do Instituto Brasileiro de Geografia e Estatística (IBGE), entre 1996 e 2018; e os dados da evolução da balança comercial do setor entre 1996 e 2019. Os resultados evidenciam que a agenda do Estado para o setor favoreceu o crescimento da produção de medicamentos genéricos, dos medicamentos isentos de prescrição (MIP) e deu início a alguns projetos de transferência de tecnologia via PDPs para a produção de medicamentos biológicos e sintéticos. Apesar dessa evolução, o Brasil se mantém dependente da importação de insumos químicos e farmacêuticos e de medicamentos acabados. Isto nos mantém em situação de vulnerabilidade tecnológica e econômica em relação aos fornecedores mundiais, além de um aprofundamento do déficit da balança comercial do setor.

Este artículo presenta los resultados de investigación sobre la industria farmacéutica en Brasil, durante el período reciente, realizada en el ámbito del proyecto multicéntrico Complejo Económico-Industrial de la Salud, Innovación y Dinámica Capitalista: Desafíos Estructurales para la Construcción del Sistema Universal de Salud en Brasil. Los cuatro componentes estudiados sobre la evolución de la industria farmacéutica en Brasil fueron: las políticas industriales del Estado; los cambios en la composición financiera y patrimonial de las empresas de capital nacional, la evolución de la producción; y el comportamiento de la balanza comercial. Los análisis tuvieron en consideración el marco teórico propuesto por Luiz Filgueiras y Reinaldo Gonçalves, respecto a la implantación de un "modelo liberal y periférico" en la economía brasileña, a partir del año 1990. Se recabaron y analizaron datos sobre: la situación de las Colaboraciones de Desarrollo Productivo (PDP por su sigla en portugués) para medicamentos entre 2009 y 2020; de la Encuesta Industrial Anual (PIA), del Instituto Brasileño de Geografía y Estadística (IBGE), entre 1996 y 2018; y los datos de la evolución de la balanza comercial del sector entre 1996 y 2019. Los resultados evidencian que la agenda del Estado para el sector favoreció el crecimiento de la producción de medicamentos genéricos, de los medicamentos exentos de prescripción (MIP) y comenzó algunos proyectos de transferencia de tecnología vía PDPs para la producción de medicamentos biológicos y sintéticos. A pesar de esa evolución, Brasil sigue siendo dependiente de la importación de insumos químicos y farmacéuticos y de medicamentos acabados. Esto nos mantiene en una situación de vulnerabilidad tecnológica y económica, en relación con los proveedores mundiales, además de una profundización del déficit de la balanza comercial del sector.

Contratos de explotación mutuamente beneficiosos? Abuso de poder, personas vulnerables y grandes laboratorios farmacéuticos / Contractes d'explotació mútuament beneficiosos? Abús de poder, persones vulnerables i grans laboratoris farmacèutics / Mutually beneficial exploitative contracts? Abuse of power, vulnerable people and large pharmaceutical companies

En un mundo extremadamente desigual donde hay países poderosos y otros débiles, nos encontramos con empresas que aumentan de forma exponencial sus ganancias y personas con grandes necesidades socioeconómicas. Mientras los laboratorios farmacéuticos de países desarrolladosnecesitan probar sus medicamentos en seres humanos, millones de personas vulnerables depaíses en vías de desarrollonecesitanmedicamentos a los que no pueden acceder dado el contexto de pobreza en el que se encuentran. Ante esta situación, pueden surgir abusos de posiciones dominantes por parte de los grandes laboratorios sobre laspersonas vulnerables en torno al testeo y acceso a los medicamentos. Este artículo propone reflexionar y discutir, desde aportes teóricos procedentes del campo ético, lo que algunos autores han denominado contratos de explotación en alusión a la relación mutuamente beneficiosa y voluntaria entre actores empresariales y personas vulnerables. Específicamente y a partir de diversos ejemplos, analizaremos si dichos contratos cumplen o no con algunos principios éticos fundamentales.(AU)

In an extremely unequal world where there are powerful countries and others weak, we find companies that increase their profits exponentially and people with great socioeconomic needs. While pharmaceutical laboratories in developed countries need to test their medicines on human beings, millions of vulnerable people in developing countries need medicines that they cannot access given the context of poverty in which they find themselves. Faced with this situation, abuses of dominant positions may arise by large laboratories over vulnerable people regarding testing and access to medicines. This article proposes to reflect and discuss, from theoretical contributions from the ethical field, what some authors have called exploitative contracts in reference to themutually beneficial and voluntary relationship between business actors and vulnerable people. Specifically, and based on various examples, we will analyze whether or not these contracts comply with some fundamental ethical principles.(AU)

En un món extremadament desigual on hi ha països poderosos i d’altres febles, trobem empreses que augmenten de manera exponencial els seus guanys i persones amb grans necessitats socioeconòmiques. Mentre els laboratoris farmacèutics de països desenvolupats necessiten provar els seus medicaments en éssers humans, milions de persones vulnerables de països en vies de desenvolupament necessiten medicaments als quals no poden accedir, donat el context de pobresa en el qual es troben. En aquesta situació, poden sorgir abusos de posicions dominants per part dels grans laboratoris sobre les persones vulnerables, sobretot pel que fa al testatge i accés als medicaments. Aquest article proposa reflexionar i discutir, des d'aportacions teòriques procedents del camp ètic, el que alguns autors han denominat “contractes d'explotació”en al·lusió a la relació mútuament beneficiosa i voluntària entre actors empresarials i persones vulnerables. Específicament, i a partir de diversos exemples, analitzarem si aquests contractes compleixen o no amb alguns principis ètics fonamentals.(AU)

Las empresas en la investigación sobre las innovaciones en medicamentos

Propósito/Contexto. El papel de la industria farmacéutica se puede examinar desde múltiples ángulos. La presencia de estas empresas durante la pandemia ha sido obligada por la necesidad de contar, en el menor tiempo posible, con vacunas capaces de prevenir los contagios y medicamentos efectivos de tratar a los afectados, es decir, el desarrollo de productos innovadores. Metodología/Enfoque. Desde una perspectiva bioética se reflexiona sobre cuatro temas conexos con el rol de estas empresas en circunstancias análogas: las responsabilidades de los patrocinadores en los procesos de investigación; la contratación con las organizaciones de investigación por contrato (CRO); la relación con los investigadores y la interacción con los comités de ética en investigación (CEI) y, finalmente, sobre una manera de contener el doble estándar en investigación. Resultados/Hallazgos. Los patrocinadores tienen responsabilidades precisas que están orientadas por documentos y pautas internacionales. También hay una necesidad de tener una mayor claridad en el trabajo de las CRO y los investigadores pueden mejorar la interacción con los CEI; además, debe evitarse el dumping ético. Discusión/Conclusiones/Contribuciones. Se concluye que la industria farmacéutica tiene un papel de corresponsabilidad en los procesos de producción de medicamentos innovadores con los demás actores, con quienes ha de mantener un diálogo transparente y fluido, y debe orientarse no solo por las guías de buenas prácticas clínicas, sino principalmente por la Declaración de Helsinki. Un medio puede ayudar en la eliminación del doble estándar en investigación: el Código Trust, así las empresas farmacéuticas pueden contribuir a mejorar la cultura ética de la investigación.

Purpose/Background. The role of the pharmaceutical industry can be examined from multiple angles. The presence of these companies during the pandemic has been forced by the need to have, in the shortest possible time, vaccines capable of preventing infections and effective drugs to treat those affected, that is, the development of innovative products. Methodology/Approach. From a bioethical perspective, it reflects on four issues related to the role of these companies in analogous circumstances: the responsibilities of the Sponsors in the research processes; contracting with Contract Research Organizations; the relationship with researchers and interaction with the Research Ethics Committees (IRB); and, finally, on a way to contain the double standard in research. Results/Findings. The Sponsors have precise responsibilities that are guided by international documents and guidelines; there is a need for greater clarity in the work of CROs; researchers can improve interaction with IRBs; ethical dumping must be avoided. Discussion/Conclusions/Contributions. It is concluded that the pharmaceutical industry has a role of co-responsibility in the production processes of innovative medicines with other actors, with whom it must maintain a transparent and fluid dialogue and must be guided not only by the Good Clinical Practice Guidelines, but mainly because of the Declaration of Helsinki. One medium can help eliminate the double standard in research: the TRUST Code; thus, pharmaceutical companies can contribute to improving the ethical culture of research.

Objetivo/Contexto. O papel da indústria farmacêutica pode ser examinado de vários ângulos. A presença dessas empresas durante a pandemia foi forçada pela necessidade de se ter, no menor tempo possível, vacinas capazes de prevenir infecções e medicamentos eficazes para tratar os afetados, ou seja, o desenvolvimento de produtos inovadores. Metodologia/Abordagem. Do ponto de vista bioético, reflete sobre quatro questões relacionadas ao papel dessas empresas em circunstâncias análogas: as responsabilidades dos Patrocinadores nos processos de pesquisa; contratação de Organizações de Pesquisa Contratadas (CRO); o relacionamento com os pesquisadores e a interação com os Comitês de Ética em Pesquisa (CEP); e, por fim, uma forma de conter o duplo padrão na pesquisa. Resultados/Descobertas. Os Patrocinadores têm responsabilidades precisas que são guiadas por documentos e diretrizes internacionais; há necessidade de maior clareza no trabalho dos CROs; os pesquisadores podem melhorar a interação com as CEP; o dumping ético deve ser evitado. Discussão/Conclusões/Contribuições. Conclui-se que a indústria farmacêutica tem um papel de corresponsabilidade nos processos de produção de medicamentos inovadores com os demais atores, com os quais deve manter um diálogo transparente e fluido e deve ser pautada não apenas pelas Diretrizes de Boas Práticas Clínicas, mas principalmente por causa da Declaração de Helsinque. Um meio pode ajudar a eliminar o duplo padrão na pesquisa: o Código TRUST; assim, as empresas farmacêuticas podem contribuir para o aprimoramento da cultura ética da pesquisa.

Descifrando el mecanismo de inhibición de una pseudoquinasa: la quinasa ligada a integrinas y el cpd22 / Deciphering the inhibition mechanism of a pseudokinase: integrin-bound kinase and cpd22

Según la Organización Mundial de la Salud (OMS), el cáncer es una de las principales causas de muerte no infecciosas en todo el mundo. En este contexto, la búsqueda de nuevos fármacos potentes y seguros contra el cáncer es un área de gran interés para la industria farmacéutica y la investigación académica. A pesar de que las proteínas quinasas han sido una de las dianas anticancerosas más exploradas, sus parientes evolutivamente degenerado, las pseudoquinasas, han atraído la atención de la comunidad científica en la última década. La quinasa ligada a integrinas (ILK) es un miembro del pseudokinoma humano y ha sido reivindicada y validada como una diana terapéutica prometedora para las enfermedades neoplásicas. El único inhibidor de ILK conocido, CPD22, ha probado su actividad en ensayos fenotípicos; sin embargo, se dispone de muy poca información acerca de su mecanismo de acción a nivel molecular. Usando técnicas quimioinformáticas y de modelado molecular se ha dilucidado si el CPD22 es capaz de unirse a ILK y cómo lo hace. Además, nuestro modelo computacional explica el SAR generado en la campaña de optimización del cabeza de serie y los experimentos de SPR han probado, por primera vez, que la molécula se une a ILK, lo que respalda la hipótesis de inhibición por unión directa y el modelo generado.(AU)

According to World Health Organization (WHO) cancer is one of top non- infectious death causes worldwide. In this context, as such the searching of new potent and safe anticancer drugs is a hot point for pharmacy industry and academic investigation. Despite protein kinases have been one of the most explored anticancer targets, its evolutionary degenerated parents, pseudokinases, have attracted the attention of scientific community during the last decade. Integrin Linked Kinase (ILK) is a member of the human pseudokinome that has been claimed and validated as a prommissing target for neoplastic diseases. The only well-known ILK inhibitor, CPD22, has probed its activity in phenotypic assays, however very few knowledge regarding its mechanism of action at molecular level is available. Using chemoinformatic and molecular modelling techniques we were able to elucidate if this molecule is able to bind to ILK and how. Additionally, our model explains the SAR raised from the optimization campaign, and SPR experiments have probed, by first time, that this molecule binds to ILK, thus supporting the hypothesis of inhibition by direct binding and the computational model as well.(AU)

La intervención administrativa sobre los precios de los medicamentos industriales en España y su relevancia en la dispensación de los mismos en las oficinas de farmacia / Administrative intervention on the prices of industrial medicines in Spain and their relevance in the dispensing of them in pharmacies

El derecho a la salud se hace efectivo, entre otros, a través de la garantía de acceso a los medicamentos, ya que estos contribuyen a prevenir, curar, o aliviar enfermedades, así como a corregir o reparar las secuelas provocadas por éstas. Así pues, en España, se reconoce el derecho de todos los ciudadanos a obtener medicamentos mediante las prestaciones farmacéuticas garantizadas por el Sistema Nacional de Salud, que es el modelo sanitario implantado para la garantía de la protección de la salud. Con el fin de garantizar la sostenibilidad del mismo, el Estado tiene la capacidad de regular las condiciones económicas de las prestaciones farmacéuticas, así como de normativizar el precio de los medicamentos. En el presente trabajo, se analiza la intervención administrativa sobre todas las cuestiones de índole económica y política que rodean al medicamento en su relación con la protección de la salud como son: la decisión de la financiación pública, es decir, inclusión del medicamento en la prestación farmacéutica de la Seguridad Social; y, la fijación del precio de financiación del medicamento con cargo a fondos estatales afectos a sanidad o de la Seguridad Social, que son realizadas en cada uno de los Estados miembros, y en España esta capacidad corresponde al Ministerio con competencias en sanidad.(AU)

The right to health is made effective, among others, through the guarantee of access to medicines, since these contribute to prevent, cure, or alleviate diseases and to correct or repair the aftermath caused by them. Thus, in Spain, the right of all citizens to obtain medicines through the pharmaceutical benefits guaranteed by the National Health System, which is the health model implemented to guarantee health protection, is recognized. To guarantee its sustainability, the State has the capacity to regulate the economic conditions of pharmaceutical services, as well as to standardize the price of medicines. In this paper, the administrative intervention on all the economic and political issues surrounding the medicine in its relationship with health protection is analyzed, such as: the decision of public financing, that is, inclusion of medicine in the pharmaceutical provision of Social Security, and the fixing of the price of financing the medicine from state funds related to health or Social Security, which are carried out in each of the Member States, and in Spain correspond to the Ministry with competences in health.(AU)

Evolutionary Path and Innovative Development of Pharmaceutical Industrial Cluster-A Case Study of Shijiazhuang, China.

The innovation and development practices of the pharmaceutical industry are of great importance for the continual enhancement of public health. Industrial clusters are one of the important means by which the pharmaceutical industry can be transformed and developed, but there is a lack of research on the evolutionary path and development innovation of pharmaceutical industrial clusters. As a country with a major pharmaceutical industry, the transformation and development path of traditional pharmaceutical industrial clusters in China has important reference value for the sustainable development of the global pharmaceutical industry. Through an analysis of the evolution of traditional pharmaceutical industrial clusters in Shijiazhuang, this study explores the law of the dynamic evolution of pharmaceutical industrial clusters and the associated mechanisms. Specifically, we conclude that the evolutionary path of traditional pharmaceutical industrial clusters can be divided into the government-led pharmaceutical industrial cluster start-up stage, the government-guided pharmaceutical industrial cluster development stage, and the government-served pharmaceutical industrial cluster transformation stage. The operating mechanisms include a self-organization mechanism, an innovation-driven mechanism, and an outward associated mechanism, each of which plays different roles in the different stages of the dynamic evolution of the cluster, and the synergistic operation of the three mechanisms forms an important basis for the evolution of pharmaceutical industrial clusters. We found that the innovation development of traditional pharmaceutical industrial clusters is influenced by the synergy of the self-organization, innovation-driven, and outward associated mechanisms. The self-organization mechanism is a necessary condition for pharmaceutical industrial clusters to realize the transition from disorder to order. The innovation-driven mechanism is the core driving force for the innovative development of pharmaceutical industrial clusters. Finally, the outward associated mechanism is the main means by which pharmaceutical industrial clusters integrate into the global value chain.

The Impact of Compensation Gap on Corporate Innovation: Evidence from China's Pharmaceutical Industry.

The pharmaceutical industry is typically driven by innovation, and is relevant to people's livelihoods. How to effectively motivate pharmaceutical enterprises to engage in innovative activities is a hot topic. On the basis of the perspective of the combined effect of tournament theory and social comparison theory, this study explored the impact of internal compensation gap on corporate innovation by using data from China's listed pharmaceutical enterprises during 2011-2018. The findings show a nonlinear (inverted-U-shaped) relationship between compensation gap and corporate innovation within the pharmaceutical industry, which illustrates that the role of the compensation gap is not endless. We also find the optimal compensation gap between executives and employees. Further analyses indicate that this association is more pronounced in regions with low marketization levels, and in large enterprises. Moreover, the practical significance of the results is explored with an expectation of providing theoretical references for the pharmaceutical industry to establish reasonable incentive mechanisms and promote innovative development, and for the government to introduce innovation incentive policies.

The Patent Eligibility of 3D Bioprinting: Towards a New Version of Living Inventions' Patentability.

A combination of 3D printing techniques and synthetic biology, 3D bioprinting is a promising field. It is expected that 3D bioprinting technologies will have applications across an array of fields, spanning biotechnology, medical surgery and the pharmaceutical industry. Nonetheless, the progress of these technologies could be hindered, unless there is adequate and effective protection for related applications. In this article, the authors examine the patent eligibility of 3D bioprinting technologies. This issue raises concern given that existing patent systems are generally averse to nature-derived inventions and many of them exclude products of nature or discoveries from patentability. This qualitative study analyses the current patent systems in key jurisdictions, particularly, the U.S. and the EU, and their applicability, as well as effectiveness, in the context of 3D bioprinting. The study argues that the main reason for the apathy of existing patent systems towards bio-inventions is that they were designed to deal with mechanical inventions. It suggests an innovation framework that encompasses both mechanical and biological inventions to cater adequately to emerging technologies.

Self-reporting data assets and their representation in the pharmaceutical industry.

Standardizing data is crucial for preserving and exchanging scientific information. In particular, recording the context in which data were created ensures that information remains findable, accessible, interoperable, and reusable. Here, we introduce the concept of self-reporting data assets (SRDAs), which preserve data and contextual information. SRDAs are an abstract concept, which requires a suitable data format for implementation. Four promising data formats or languages are popularly used to represent data in pharma: JCAMP-DX, JSON, AnIML, and, more recently, the Allotrope Data Format (ADF). Here, we evaluate these four options in common use cases within the pharmaceutical industry using multiple criteria. The evaluation shows that ADF is the most suitable format for the implementation of SRDAs.

A oferta pública de medicamentos para aids e o papel de Farmanguinhos / Public supply of AIDS drugs and the role of Farmanguinhos

Resumo Este artigo descreve e analisa a participação do Instituto de Tecnologia em Fármacos (Farmanguinhos) na produção local de medicamentos antirretrovirais no Brasil. São também apresentadas as mudanças no padrão de provimento, a situação das parcerias para o desenvolvimento produtivo e a posição dos produtores nacionais para esses medicamentos. As estratégias metodológicas foram revisão bibliográfica, análise de documentos oficiais e dados fornecidos por Farmanguinhos e pelo Departamento de Condições Crônicas e Infecções Sexualmente Transmissíveis do Ministério da Saúde, via Lei de Acesso à Informação. Este artigo mostra que o estabelecimento das parcerias abriu novas perspectivas para o desenvolvimento da política de oferta pública de antirretrovirais para as pessoas vivendo com HIV, por contribuir para a sustentabilidade das despesas financeiras do Ministério da Saúde com medicamentos. Farmanguinhos é o laboratório público que fornece mais quantidades e recebe os maiores valores provenientes do fornecimento desses produtos ao Ministério da Saúde. Embora os medicamentos importados preponderem largamente em quantidade e valores pagos pelo Ministério da Saúde, Farmanguinhos permanece sendo um provedor fundamental na produção local de antirretrovirais. Apesar dos problemas verificados nas Parcerias, os ganhos nas competências tecnológicas na produção de antirretrovirais podem ampliar o horizonte tecnológico e produtivo do laboratório.

Abstract This article describes and analyses the part played by the Instituto de Tecnologia em Fármacos (Farmanguinhos) in local production of antiretroviral medicines in Brazil, as well as changes in the pattern of supply, the status of related Production Development Partnerships and the position of Brazilian producers of these medicines. The methodological strategies used were literature review and analysis of official documents and data provided by Farmanguinhos and by the Ministry of Health's Department of Chronic Conditions and Sexually Transmitted Infections, via the Information Access Law. This article shows that, by contributing to the sustainability of Ministry of Health expenditure on medicines, these partnerships have opened new prospects for developing the policy of public supply of antiretrovirals for people living with HIV. Farmanguinhos is the public laboratory that supplies the largest quantities of these products to the Ministry of Health and receives the largest revenues from supplying them. Although the imported medicines supplied to the Ministry of Health account for much larger quantities and revenues, Farmanguinhos continues to be a fundamentally important supplier of locally produced antiretrovirals. Despite the problems found in establishing the partnerships, the gains in antiretroviral production technology competences can broaden the laboratory's technological and production horizons.

Mudanças recentes e continuidade da dependência tecnológica e econômica na indústria farmacêutica no Brasil / Recent changes and continuity of technological and economic dependency in the pharmaceutical industry in Brazil / Cambios recientes y continuidad de la dependencia tecnológica y económica en la industria farmacéutica en Brasil

Este artigo apresenta os resultados de pesquisa sobre a indústria farmacêutica no Brasil, no período recente, realizada no âmbito do projeto multicêntrico Complexo Econômico-Industrial da Saúde, Inovação e Dinâmica Capitalista: Desafios Estruturais para a Construção do Sistema Universal de Saúde no Brasil. Os quatro componentes estudados sobre a evolução da indústria farmacêutica no Brasil foram: as políticas industriais do Estado; as mudanças na composição financeira e patrimonial das empresas de capital nacional, a evolução da produção; e o comportamento da balança comercial. As análises levaram em consideração o marco teórico proposto por Luiz Filgueiras e Reinaldo Gonçalves a respeito da implantação de um "modelo liberal e periférico" na economia brasileira a partir dos anos 1990. Foram levantados e analisados dados sobre: a situação das Parcerias de Desenvolvimento Produtivo (PDP) para medicamentos entre 2009 e 2020; da Pesquisa Industrial Anual (PIA), do Instituto Brasileiro de Geografia e Estatística (IBGE), entre 1996 e 2018; e os dados da evolução da balança comercial do setor entre 1996 e 2019. Os resultados evidenciam que a agenda do Estado para o setor favoreceu o crescimento da produção de medicamentos genéricos, dos medicamentos isentos de prescrição (MIP) e deu início a alguns projetos de transferência de tecnologia via PDPs para a produção de medicamentos biológicos e sintéticos. Apesar dessa evolução, o Brasil se mantém dependente da importação de insumos químicos e farmacêuticos e de medicamentos acabados. Isto nos mantém em situação de vulnerabilidade tecnológica e econômica em relação aos fornecedores mundiais, além de um aprofundamento do déficit da balança comercial do setor.

This article presents the results of a study on the pharmaceutical industry in Brazil in the recent period, as part of the multicenter project Health Economic-Industrial Complex, Innovation and Capitalist Dynamics: Structural Challenges for Construction of the Universal Health System in Brazil. The four components studied in the evolution of the Brazilian pharmaceutical industry were: State industrial policies; changes in the financial and shareholding composition of companies with domestic capital; trends in production; and trade balance behavior. The analyses considered the theoretical framework proposed by Luiz Filgueiras and Reinaldo Gonçalves concerning the implementation of a "liberal and peripheral model" in the Brazilian economy since the 1990s. Data were collected and analyzed on the situation with the Product Development Partnerships (PDP) for medicines from 2009 to 2020 from the Annual Industrial Survey (PIA) of the Brazilian Institute of Geography and Statistics (IBGE) from 1996 to 2018 and data on the evolution of the sector's trade balance from 1996 to 2019. The results show that the State's agenda for the sector favored the growth in production of generic drugs and over-the-counter drugs and started some technology transfer projects via PDPs for production of biological and synthetic drugs. Despite this evolution, Brazil is still dependent on the importation of chemical and pharmaceutical inputs and finished drugs. This keeps Brazil in a situation of technological and economic vulnerability in relation to global suppliers, besides a growing trade deficit in the sector.

Este artículo presenta los resultados de investigación sobre la industria farmacéutica en Brasil, durante el período reciente, realizada en el ámbito del proyecto multicéntrico Complejo Económico-Industrial de la Salud, Innovación y Dinámica Capitalista: Desafíos Estructurales para la Construcción del Sistema Universal de Salud en Brasil. Los cuatro componentes estudiados sobre la evolución de la industria farmacéutica en Brasil fueron: las políticas industriales del Estado; los cambios en la composición financiera y patrimonial de las empresas de capital nacional, la evolución de la producción; y el comportamiento de la balanza comercial. Los análisis tuvieron en consideración el marco teórico propuesto por Luiz Filgueiras y Reinaldo Gonçalves, respecto a la implantación de un "modelo liberal y periférico" en la economía brasileña, a partir del año 1990. Se recabaron y analizaron datos sobre: la situación de las Colaboraciones de Desarrollo Productivo (PDP por su sigla en portugués) para medicamentos entre 2009 y 2020; de la Encuesta Industrial Anual (PIA), del Instituto Brasileño de Geografía y Estadística (IBGE), entre 1996 y 2018; y los datos de la evolución de la balanza comercial del sector entre 1996 y 2019. Los resultados evidencian que la agenda del Estado para el sector favoreció el crecimiento de la producción de medicamentos genéricos, de los medicamentos exentos de prescripción (MIP) y comenzó algunos proyectos de transferencia de tecnología vía PDPs para la producción de medicamentos biológicos y sintéticos. A pesar de esa evolución, Brasil sigue siendo dependiente de la importación de insumos químicos y farmacéuticos y de medicamentos acabados. Esto nos mantiene en una situación de vulnerabilidad tecnológica y económica, en relación con los proveedores mundiales, además de una profundización del déficit de la balanza comercial del sector.