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Technological Capability Building in the Brazilian Pharmaceutical Industry Ricardo L. Torres and Lia Hasenclever QUERY SHEET This page lists questions we have about your paper. The numbers displayed at left can be found in the text of the paper for reference. In addition, please review your paper as a whole for correctness.
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LATIN AMERICAN BUSINESS REVIEW 2016, VOL. 17, NO. 3, 1–22 http://dx.doi.org/10.1080/10978526.2016.1209038
Technological Capability Building in the Brazilian Pharmaceutical Industry Ricardo L. Torresa and Lia Hasencleverb a
UTFPR—Federal Technological University of Paraná, Curitiba, Brazil; bUFRJ—Federal University of Rio de Janeiro and UCAM—Cândido Mendes University, Rio de Janeiro, Brazil ABSTRACT
ARTICLE HISTORY
This article presents a study of the level of technological capability of national pharmaceutical companies in order to assess their absorptive capacity of foreign technology for producing biological drugs. The research collected primary data through surveys of 24 Brazilian pharmaceutical companies (classified into three categories: state-owned laboratories, private pharmaceutical companies, and start-ups), who answered a closed questionnaire about technological capabilities and learning strategies. The data were analyzed using descriptive statistics regarding the type of organization, level of technological competence (basic, intermediate, and advanced), and the nature of technological competence (operational and innovative). The results show that private pharmaceutical companies have a greater capacity to absorb foreign technology due to their previous experience with incremental innovation. In contrast, the state-owned pharmaceutical laboratories lack technological competencies in production and research and development (R&D) and therefore must make veritable “technological leaps” to comply with the demands of Brazil’s Ministry of Health. The start-ups, however, although standing out in terms of the degree of novelty of their technological innovations, lack the complementary assets to exploit economically the results of their R&D and are dependent on local industry to bring new products to market. Regarding technological learning, which requires a more active strategic positioning by the firms, most organizations proved to be dependent on public policies to invest in technological capability building, focusing strictly on incorporating technology for drug production (except for some private pharmaceutical companies), without seeking to advance in technological innovations.
Received 25 November 2015 Revised 8 March 2016 Accepted 5 April 2016 KEYWORDS
Catching up; pharmaceutical industry; technological capability building
RESUMEN
Este artículo presenta un estudio sobre el nivel de competencias tecnológicas de empresas farmacéuticas nacionales, con el objeto de evaluar su capacidad de absorber la tecnología externa de producción de medicamentos biológicos. La encuesta recopiló datos primarios obtenidos a través de entrevistas con 24 empresas farmacéuticas brasileñas, clasificadas en tres categorías: laboratorios farmacéuticos oficiales, laboratorios farmacéuticos privados y empresas start-ups, que respondieron un cuestionario cerrado sobre capacidades
CONTACT Ricardo L. Torres
[email protected] Universidade Tecnológica Federal do Paraná, Av. Sete de Setembro, 3165, Rebouças, Curitiba, PR, Brazil CEP 80230-901. © 2016 Taylor & Francis
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tecnológicas y estrategias de aprendizaje. A continuación se analizaron los datos mediante estadísticas descriptivas, de acuerdo con el tipo de organización, el nivel de competencia tecnológica (básico, intermedio y avanzado), así como la naturaleza de la competencia tecnológica (operacional e innovadora). Los resultados muestran que los laboratorios farmacéuticos privados tienen más capacidad para absorber tecnología externa, debido a su experiencia previa con innovación incremental, mientras que los laboratorios farmacéuticos oficiales carecen de competencias tecnológicas en el ámbito de la producción e I&D, lo que implica la necesidad de verdaderos “saltos tecnológicos” para que logren atender las demandas del Ministerio de la Salud. Las start-ups, sin embargo, se destacan por el grado de novedad de sus innovaciones tecnológicas, pero carecen de activos complementarios para explotar económicamente los resultados de su I&D, permaneciendo dependientes de la industria local para lanzar nuevos productos en el mercado. Con respecto al aprendizaje tecnológico, que depende de un posicionamiento estratégico más activo de las empresas, la mayoría de las organizaciones mostró depender de las políticas públicas para invertir en capacitación tecnológica, orientando su atención estrictamente a la incorporación de la tecnología para producir medicamentos, sin tratar de avanzar en innovaciones tecnológicas, con excepción de algunos laboratorios farmacéuticos privados. RESUMO
Este artigo apresenta um estudo do nível de competências tecnológicas de empresas farmacêuticas nacionais com o objetivo de avaliar a sua capacitação para absorver a tecnologia externa de produção de medicamentos biológicos. A pesquisa coletou dados primários através de entrevistas com 24 empresas farmacêuticas brasileiras, classificados em três categorias: laboratórios farmacêuticos oficiais, laboratórios farmacêuticos privados e empresas start-ups, que responderam a um questionário fechado sobre capacidades tecnológicas e estratégias de aprendizado. Os dados foram analisados por estatística descritiva de acordo com o tipo de organização, o nível de competência tecnológica (básico, intermediário e avançado) e a natureza da competência tecnológica (operacional e inovativa). Os resultados mostram que os laboratórios farmacêuticos privados possuem maior capacidade de absorção da tecnologia externa, devido a sua experiência prévia com inovação incremental, enquanto os laboratórios farmacêuticos oficiais carecem de competências tecnológicas no âmbito da produção e da P&D, o que implica a necessidade de verdadeiros “saltos tecnológicos” para que consigam atender às demandas do Ministério da Saúde. Já as start-ups se destacam pelo grau de novidade de suas inovações tecnológicas, mas carecem de ativos complementares para explorar economicamente os resultados da sua P&D, sendo dependentes da indústria local para lançamento de novos produtos no mercado. Com relação ao aprendizado tecnológico, que depende de um posicionamento estratégico mais ativo das empresas, a maioria das organizações se mostrou dependente das políticas públicas para investir em capacitação tecnológica, focando estritamente na incorporação da tecnologia de produção dos medicamentos, sem procurar avançar em inovações tecnológicas, com a exceção de alguns laboratórios farmacêuticos privados.
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Introduction This article presents a study of the level of technological capability of Brazilian pharmaceutical companies. The main objective was to evaluate the capability of these companies to generate innovations and absorb foreign technology. The interest in the subject stems from the policy for industry and technology instituted by Ministry of Health in 2008. With the creation of the Executive Group Industrial Health Complex, by 2014, 104 public-private partnerships (Productive Development Partnerships, PDP) were signed between the public laboratories and the domestic and foreign private laboratories. The objective was to nationalize production and reduce the cost of drugs considered strategic in Brazil’s Unified Health System (SUS). These partnerships consist of transferring the production technology of drugs whose patents are about to expire and whose selling prices are extremely high in Brazil to local production. Such products require technology that is more advanced compared to the majority of pharmaceutical products manufactured in Brazil. The approved partnerships last for up to 10 years, during which the production technology of the critical technological component (active pharmaceutical ingredient and/or drug) should be incorporated by the Brazilian partners. The policy gives rise to a division of tasks between the public and private laboratories in certain product categories, whereby the final formulation of the drug is handled by the public laboratory and pharmaceutical chemicals are produced by the national private laboratory. To convince the mostly foreign, technology-owning companies to enter into such partnerships, the federal government guarantees purchase, through public procurement, during the PDP’s contracts. This means that until the complete incorporation of the production technology, the drugs continue to be provided by the company that owns the technology and the national laboratories act just as sales intermediaries. In the meantime, the public labs can initiate the project serving only as distributors of the imported product; the private labs, when involved, can manufacture the semi-finished products. The PDPs thus anticipate a progressive approach to incorporating technology. As the national laboratories advance in the vertical integration of drug production, the advantages of the corporation owning the technology are reduced. Regardless, because the products’ patents are about to expire, the strategy of collaborating seems interesting to multinational companies, given the direct access to the public market provided in the PDP, which would avoid them facing possible competition at the end of the patent term of protection from generics producers. Among the product categories targeted by the PDP, biological products were chosen as the object of study, since such medicines represent the most complex technology and are most expensive for the SUS. Against the backdrop of the previously mentioned policy, this study sought to evaluate the
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capacity of national labs to absorb foreign technology, with an emphasis on biopharmaceuticals based on recombinant DNA technology. Incorporating the production technology of these drugs is not trivial, especially for an industry such as the Brazilian pharmaceutical industry, which is characterized by formulation of generic drugs and imports of active pharmaceutical ingredients (API). The low innovation profile and experience focused on less technologically complex production activities (formulation of generics) represent great challenges to the national laboratories to incorporate the technology for producing biologics. The article is structured, after this introduction, as follows: Section 2 presents a brief theoretical review of absorptive capacity and technological learning; Section 3 presents the methodology used for data collection and assessment of the technological capability of national pharmaceutical companies; Section 4 displays and discusses the results; and Section 5 lists the conclusions.
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Absorptive capacity and technology transfer
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This section presents an overview of the literature on the topics of this article (absorptive capacity and technological learning) in order to guide the research evaluating technological capabilities in Brazilian pharmaceutical companies. In this sense, the difference between the concepts of operational technological capabilities associated with the production and marketing of products, and that of innovative technological capabilities, associated with technological change is highlighted. The distinction between these concepts corresponds, respectively, to the same distinctions between productive capacity and technological capability proposed by Bell and Pavitt (1993), or the routines related to operating activities and search processes proposed by Nelson and Winter (2005). We also highlight the importance of research and development (R&D) activities to create a knowledge base for organizations to provide them an absorptive capacity, that is, an ability to recognize the value of new information, assimilate it, and apply it to commercial ends, as theorized by Cohen and Levinthal (1990). Thus, conducting R&D has a dual purpose: on the one hand, it seeks to foster internal and immediate development of new technologies, translating into product or process innovation; on the other, it represents an internal learning effort to enable the organization to absorb external knowledge or technology. The literature on technological capability in developing countries shows that latecomer firms tend to follow a process of learning that is the reverse of innovative companies, as in the innovation cycle of Utterback and Abernathy (1975). This trajectory “from imitation to innovation,” as proposed by Kim (2005), suggests a sequential technological learning, starting with technological activities of
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less complexity. However, this linearity is not always necessary. According to Lee and Lim (2001), firms can create pathways for technological capability building through development of new technologies, such as the case of the Korean mobile phone industry with CDMA technology, or even leap-frogging technological capability steps, as in the Korean computer memory industry, entering at more advanced stages of production without repeating the trajectory of the incumbent firms. However, these cases tend to be less common in the literature than the process of reverse and gradual learning. The intensity of learning and the trajectory of technological capability, in turn, are determined by the combined action of incentives from the environment and the behavior of companies. As suggested by Amendola and Bruno (1990), companies can adopt relatively passive or active strategies related to technological change. The technological learning trajectories are largely the result of deliberate actions of investment in technological capability building, through multiple learning strategies, such as technology transfer, hiring personnel with expertise, reverse engineering, collaborative R&D, and so on. As suggested by Figueiredo (2003b), organizational learning tends to be more effective the greater the number of learning mechanisms adopted by the organization. And the multiple learning mechanisms are implemented only by organizations making a conscious decision and fostering a strategic and discretionary positioning in relation to technology. The key to making decisions concerning technological capability building lies in the way companies perceive the environment. The competitive environment is given not only by the perception of external factors: this perception is conditioned by the level of competencies of the organizations themselves, as suggested by Amendola and Bruno (1990). The perception of each company is affected by their degree of search competencies. Thus, according to Cohen and Levinthal (1989), the companies that invest the most in R&D have the best understanding of opportunities arising from the environment and are the most able to respond actively to these incentives. Thus, the findings in the literature served as a reference for analyzing the phase of development of the Brazilian pharmaceutical industry. If, on the one hand, they point to R&D as a basic condition for technological innovation in science-based industries, as suggested by Pavitt (1984), on the other, and perhaps more important, they point to the central role of the national industry’s absorption capacity, particularly in pharmaceutical biotechnology. This new knowledge field can be considered a new technological paradigm for drug research, development, and production, according to Dosi’s (1982) definition, since it harnesses molecular biology, genetic engineering, and living cell culture (mainly micro-organisms or animal cells) as technology to search for and produce such drugs—the latter technologies very different from the competencies required for the manufacture of products or processes in the area of chemical synthesis.
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Methodology Sample and selection
The study collected primary data from Brazilian pharmaceutical companies that were classified into three categories: stated-owned laboratories (SOL), private pharmaceutical companies (PPC), and small technology-based firms (Start-ups), which answered a closed questionnaire about technological capabilities and learning strategies. This division represents a peculiar characteristic of the Brazilian pharmaceutical industry. While the private national labs have grown exponentially in recent years, a result of the Generics Act of 1999, the public labs belong to an official network that complies with SUS standards. Such labs operate under the auspices of various legal structures (foundations, corporations, local authorities), and are of different levels of government—state and federal. In addition to these enterprises, there operates a number of small technology-based companies, some of which originated from incubators. This set of selected companies represents companies that have the potential to incorporate biotechnology in their production processes, either in the production of API, or biological products, such as vaccines, recombinant proteins, and monoclonal antibodies. The first stage of the research consisted precisely in identifying these companies. Three data sources were used, the first being Ministry of Health PDP list, published December 2013, which contained 25 public-private partnerships for technological transfer and development of biological products.1 The SOL and PPC participants were consulted based on this list. Regarding the start-ups, a search was made in the directories of three associations: Anprotec, Biominas, and Bio-Rio.2 The final list of potential companies was complemented by a query to the list of biological products registered in Brazil, provided by National Health Surveillance Agency (ANVISA) in 2012.3 Criteria for inclusion as a company of interest were: (1) nationally controlled companies and (2) effective or potential capability for the production of biopharmaceuticals. Transnational corporations (TNC) were deliberately excluded from the study for two reasons. First, because the development of a domestic industry—in light of international experience—occurs mainly through the growth and strengthening of genuinely national companies. Second, because TNC scarcely invest in R&D in Brazil, but rather, concentrate such activities in their headquarters or branches in other parts of the world. All companies participating in the biological products PDP, classified in three subgroups, were invited to participate in the study. The other companies were selected at random or by referral from the surveyed companies themselves, as long as they (1) engaged in production or R&D in biological medicines or were large generic manufacturers and (2) had market experience and the publicly stated intention of investing in biotechnology.
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Table 1.
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Number of companies of interest, invited and interviewed in the field survey.
Data
PPC
SOL
Start-ups
Total
Companies of interest Companies invited Companies interviewed Valid responses* Success rate
15 12 9 7 58%
8 8 8 8 100%
21 17 9 9 53%
44 37 26 24 65%
Source: Authors. *Note: For the two cases excluded from the analysis, only partial answers were obtained by email; thus, it was not possible to include them in the presentation of the final results.
Table 1 summarizes the total number of companies identified in each subgroup, the number of companies invited to participate, and response rate to the questionnaire. As can be seen, valid responses were received from 65% of the invited companies. Data collection was performed via a closed questionnaire administered between March and November 2014.
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Operationalization of concepts and data analysis
It is important to clarify that the interest of the research did not reside only in the acquisition of productive capability of the pharmaceutical labs but also in the acquisition of innovative technological capabilities and other organizational competencies—critical to the success of the pharmaceutical industry—such as the ability to deal with regulatory and marketing issues. Table 2 was inspired by the work of Lall (1992); Bell and Pavitt (1993); and Figueiredo (2003a; 2012) and represents the analytical framework used to infer the firms’ level of technological capability. In short, we sought to assess the depth of competencies (vertical dimension), which can be understood as (1) the level of complexity of the competencies the companies have and (2) the diversity of capabilities (horizontal dimension), which corresponds to the functions performed by firms. Under the heading of innovative technological capabilities, the organizations were asked about the R&D conduct, the nature of this activity, and the degree of novelty of the results (i.e., both the expected results and those already achieved, in terms of technological innovation). The set of competencies assessed in this item refers explicitly to the technological competencies defined by Bell and Pavitt (1993). In contrast with similar Table 2.
Evaluation matrix of organizational competencies from the field survey.
Level of capability
Innovative technological capabilities
Operational technological capabilities
Basic Intermediate Advanced
R&D, new products and processes, degree of innovation, intellectual property, etc.
Industrial production, vertical integration, complexity of manufactured products, marketing, etc.
Source: Authors.
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work applied to other sectors of economic activity (Figueiredo, 2003a, 2003b; Tacla & Figueiredo, 2003; Ariffin & Figueiredo, 2004; Castro & Figueiredo, 2005; Ferigotti & Figueiredo, 2005, 2005, 2009), it was decided to maintain the simplicity of the analytical framework, following Figueiredo (2012), since this research involved several companies, and a detailed study of each organization (in order to classify more accurately the levels of technological competencies and the trajectory of accumulation of competencies of each of them, as performed in some of these studies) would be impossible. In contrast, the operational technological capabilities, also in Table 2, refer to the industrial production and related activities, which correspond to the same distinction made in the work of Bell and Pavitt (1993). Under this heading were assessed the degree of vertical integration, diversification of the production line, and the technical mastery of the production plant. In addition, we also evaluated some complementary capabilities related to Teece’s (1986) concept of “complementary assets” and other organizational capabilities needed to bring a new product or process to the market and accrue profits from this novelty. In this sense, it is understood that organizations that already have a brand, have developed distribution channels, representation, and sales teams, and so on, have competitive advantages over start-ups, which can be extremely competent in R&D and eventually launch a new product on the world market, but do not have competence or experience in marketing, for example. In order to sort the levels of technological capabilities, industry professionals were consulted to clarify the capabilities that can be considered basic, intermediate, or advanced in the pharmaceutical industry. The classification criteria of basic, intermediate, and advanced technological levels of capability were defined according to the criteria described in Table 3 and Table 4. Table 3 lists the criteria for scoring the innovative technological capabilities. Twelve indicators were used, each with a specific rule for determining the level of capability of companies. Table 4 shows the scoring criteria for operational technological capabilities. Similarly, seven indicators were used, each with its own algorithm, to classify the capability level of each company. The selection of these indicators was a way to synthesize the evaluation of technological capabilities—a complex task because the questionnaire included many questions and variables. The data were analyzed using descriptive statistics according to (1) type of organization (SOL, PPC, and Start-ups); (2) level of technological competence (basic, intermediate, and advanced); and (3) nature of technological competence (operational/innovative). The determination of the technological capability level of each indicator was done using an algorithm, described in Table 3 and Table 4. In the case of variables such as number of innovations and number of patent applications
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Table 3.
Classification criteria for innovative technological capabilities.
Indicators 1—Innovative results: number of product innovations (median = 2, 3rd quartile = 8) 2—Innovative results: number of process innovations (median = 2, 3rd quartile = 4) 3—Innovative results: number of patent deposits (median = 2, 3rd quartile = 20) 4—R&D efficiency: Expenses/number of product innovations (median = R $1773, 3rd quartile = R $4000) 5—R&D efficiency: Expenses/number of process innovations (median = R $3000, 3rd quartile = R $5,528) 6—R&D efficiency: Expenses/number of patents (average = R $750, 3rd quartile = R$ 2,160) 7—R&D efficiency: People/number of product innovations (median = 7, 3rd quartile = 12) 8—R&D efficiency: People/number of process innovations (median = 5, 3rd quartile = 21) 9—R&D efficiency: People/number of patents (median = 4, 3rd quartile = 10) 10—R&D efficiency: People/number of projects (median = 1, 3rd quartile = 3) 11—Scope of R&D: product + degree of novelty
12—Clinical trials: product: product + degree of novelty
Source: Authors.
Basic description of the algorithm Up to mean = basic mean to 3rd quartile = intermediate greater than 3rd quartile = advanced Up to median = basic median to 3rd quartile = intermediate greater than 3rd quartile = advanced Up to median = basic median to 3rd quartile = intermediate greater than 3rd quartile = advanced Up to 1st quartile = advanced 1st quartile to median = intermediate above median = basic Up to 1st quartile = advanced 1st quartile to median = intermediate above median = basic Up to 1st quartile = advanced 1st quartile to median = intermediate above median = basic Up to 1st quartile = advanced 1st quartile to median = intermediate above median = basic Up to 1st quartile = advanced 1st quartile to median = intermediate above median = basic Up to 1st quartile = advanced 1st quartile to median = intermediate above median = basic Up to 1st quartile = advanced 1st quartile to median = intermediate above median = basic Algorithm: Pharmaceutical chemical + new to the company = basic Pharmaceutical chemical + new to the national market: intermediate Pharmaceutical chemical + new to the global market: advanced Biopharmaceutical + new to the company = basic Biopharmaceutical + new to the domestic market: intermediate biopharmaceutical + new to the domestic market: advanced formulations + new to the company = basic formulations + new the market = basic formulations + new to the global market: intermediate Algorithm: Pre-clinical trials + API + new to the national market = basic pre-clinical trials + API + new to the global market = intermediate pre-clinical trials + biopharmaceutical + new to the domestic market = intermediate pre-clinical trials + biopharmaceutical + new to the global market = advanced pre-clinical trials + formulations + new to the domestic market = basic pre-clinical trials + formulations + new to the global market = intermediate clinical trials + API + new to the domestic market = intermediate clinical trials + API + new to the global market = advanced clinical trials + biopharmaceutical + new to the domestic market = intermediate clinical trials + biopharmaceutical + new to the global market = advanced clinical trials + formulations + new to the domestic market = basic clinical trials + formulations + new to the global market = intermediate
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Table 4.
Classification criteria for operational technological capabilities.
Indicators 1—Industrial capability: technology + GMP
2—Biological products: product + degree of novelty
3—Field of plant: technology + skills
4—Regulatory affairs: competencies + certifications
5—Intellectual property: competencies + filings
6—Marketing: distribution channels + sales team
7—World class: destination of exports
Basic description of the algorithm Algorithm: API + GMP = intermediate API – GMP = basic biopharmaceuticals + GMP = advanced biopharmaceuticals – GMP = intermediate formulations + GMP = intermediate formulations – GMP = basic Algorithm: Monoclonal antibodies or biopharmaceuticals + new biological products = advanced monoclonal antibodies or biopharmaceuticals + biological products = intermediate other products + new biological products = intermediate other products + biological product = basic Algorithm: API + 3rd party technology = intermediate API + own technology = advanced biopharmaceuticals + 3rd party technology = intermediate biopharmaceuticals + own technology = advanced formulations + 3rd party technology = basic formulations + own technology = intermediate Algorithm: Internal team + ANVISA/CTNbio = basic internal team + other agencies abroad – exports = basic internal team + other agencies abroad + exports = intermediate Internal team + FDA/EMA – exports = intermediate internal team + FDA/EMA + exports = advanced Algorithm: Internal team + patent filings in BR = basic internal team + foreign patent filings = intermediate internal team + foreign patent filings + patent number >3rd quartile = advanced Algorithm: Institutional customers/Others = basic hospitals/wholesale/retail/+sales team = intermediate all distribution channels + sales team + exports = advanced Algorithm: Latin America, Africa, Middle East = Basic Asia, Oceania, Other = intermediate USA and EU = advanced
Source: Authors.
(indicators 1 to 10), the sample itself was classified, that is, using descriptive statistics (quartiles). Moreover, we chose to use combined indicators to avoid overestimating the technological capabilities of the companies. The overvaluation of capabilities was observed during the research, a problem caused by the compact and closed format of the questionnaire as well as the ambiguity of certain issues interpreted differently by the respondents. Thus, in order to control these subjective influences, several combinations of answers were adopted to obtain a classification more suited to the reality of the companies surveyed. For example, the ability to conduct preclinical and clinical trials was weighted by the effective introduction of new products in the past five years and the degree of novelty of the innovations expected by companies. In addition, clinical trials with biopharmaceuticals were considered more complex than
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Table 5.
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Maximum score in the evaluation of technological capabilities.
Level Basic Intermediate Advanced Total
Innovative technological capabilities
Operational technological capabilities
19 19 16 54
19 16 9 44
Source: Authors.
those done with chemical-based medicines, as a function of, for example, immunogenicity risk.4 Thus, it was sought to evaluate not only the capabilities that firms reported in binary questions (yes or no) but also what they actually do as evidence of their capabilities. The final results are presented as percentages achieved, on average, by the companies in each subgroup, for basic, intermediate, and advanced technological capabilities, as defined in the following formula: �P g � n P pi � 100 g pm�ax g i¼1 Ck ¼ Tk Where: g Ck : average percentage of g level technological capabilities obtained by the firms in subgroup k. g pi : score obtained by the firm i at level g. g pm áx: maximum score at level g for technological capabilities. Tk: total firms surveyed in subgroup k. g: level of technological capability (basic, intermediate, advanced and total). i: index number of the surveyed firm. n: index number of last surveyed firm in subgroup k. k: subgroups (SOL, PPC, Start-ups and Total). Table 5 presents the maximum score for each level and type of technological capability analyzed in the research. The minimum score is zero. Therefore, the results should be interpreted strictly as the percentage of adherence to the selected capabilities in Tables 3 and Table 4.5 In the case of certain innovative technological capability indicators, presented in Table 3, we used the quartiles to differentiate the firms. For example, the indicator “number of product innovations” and the capability level (basic, intermediate, or advanced) in which each company placed, was set according to the statistical position; that is, if a company was in the first or second quartile, it would be placed in the basic level; in the third quartile, intermediate; and in the fourth quartile, advanced level. Despite its methodological limitations, this method was an objective solution found by the authors to rank the firms. The comparison of the sample data with data from Brazilian Innovation Inquiry (PINTEC), the official source of industry statistics, proved to be unfeasible. Besides the difference in the base year, the survey questionnaire
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inquired about new products launched in the past five years, while PINTEC covers three years. Nor was comparison with the standards of the world’s leading pharmaceutical companies possible, due to the unavailability of systematic data for such a comparison. For the other indicators, algorithms were developed (described in Tables 3 and Table 4) to establish the levels of technological capability. This definition was based on the authors’ perceptions about the results of a series of previous interviews with experts in the pharmaceutical industry, academia, and pertinent government agencies. Ten organizations were interviewed; in one, a private laboratory, 15 people were interviewed as it appeared an ideal case in the set of selected companies. In all, 25 professionals were surveyed. For these indicators, a combination of two or more characteristics was essential to determine the level of technological capability of the organizations surveyed. It is important to note, therefore, that the results across the companies in the sample are comparative and must be interpreted as such. At this stage, it was not sought to assess the Brazilian companies vis-à-vis other successful technological catching up strategies. Thus, the organizations were assessed both as to variety of capabilities and as to the complexity of capabilities. Thus, the questionnaire assessed both the diversity of the organization and the degree of vertical integration (e.g., the line of products manufactured can range from chemical and pharmaceutical chemical intermediates to medicines and biological products) as well as the level of technological complexity mastered by the organization (e.g., whether the organization conducts R&D for new chemical-based and biologic-based medicines). Note that there is a possibility of incomplete results at the basic, intermediate, and advanced levels (i.e., in our classification it is not necessary to obtain 100% of basic competencies for the organization to have some degree of intermediate competencies, and so on). Results and discussion
Table 6 presents the general characteristics of the companies. Of the total of 24 companies, 8 were SOL, 7 were PPC, and 9 were Start-ups. The SOL are the General characteristics of companies interviewed.
Data Age of the organization (years, average) Number of persons employed (average) Annual revenue (1000 BRL, average)* Number of organizations
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Description of sample
Table 6.
410
SOL
PPC
Start-ups
Total
60 862 409,633 8
25 809 281,014 7
6 14 2065 9
29 529 219,281 24
Source: Authors. *In the questionnaire, the Net Sales figure was requested. However, not all respondents had this information or wanted to release it. In some cases, Gross Sales was informed; in others, Total Gross Revenue. Thus, the Annual Revenue refers to the revenue reported by respondents, which is based on different definitions.
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oldest organizations, with an average age of 60 years, while the PPC average 25 years, and the Start-ups, 6 years.6 The SOL also have, on average, the largest number of employees (862), followed closely by the PPC (809); the start-ups, as expected, employed, on average, 14 people. Regarding annual revenue, the SOL had average sales of almost R $410 million. It is worth noting, however, that part of this revenue derives, in many cases, from budget transfers from the federal or state government. This reflects (and will reflect in other results) the diversity of the legal classifications of the SOL, which range from federal authorities, through foundations and public companies, to university departments. The PPC have average annual revenue of just over R $280 million; the start-ups, R $2 million. It is worth mentioning that in the start-ups subgroup, many of the companies surveyed do not yet have sales revenue: their activities involve R&D or production currently funded by the partners’ own resources or economic subsidies. In summary, the sample data show that the SOL are the both oldest and highest average income companies. The number of persons employed shows that the SOL and PPC are large organizations and that the start-ups are young, technology-based companies that make no revenues and depend on the success of their technological development and collaboration with business partners to render their business viable. The start-ups are mostly incubated or recently graduated companies whose projects are financed by development agencies. Considering this profile of each subgroup (business type), we next present the main results of the technological capabilities of the companies surveyed. Table 7 shows selected R&D indicators of the companies surveyed. Interestingly, in the PPC subgroup, all respondents engage in internal R&D; the likelihood of the SOL engaging in R&D is the same as the overall average; start-ups rank below average. The observation about start-ups reflects the fact that the sample included some focused on other activities, such as production or marketing, rather than technological development. As can be seen, average annual spending on internal R&D is about R $26 million in the SOL and R $20 million in PPC—both above the overall average. Table 7.
Selected R&D indicators of companies surveyed.
Indicator Organizations with continuous internal R&D (%) Annual expenditure on internal R&D (1,000 BRL, average) Experience with internal R&D (years) Organizations with continuous internal R&D (%) Annual expenditure on outsourced R&D (1000 BRL, average) Number of R&D projects in progress (average) Staff assigned exclusively to R&D (average) PhDs assigned exclusively to R&D (average) Source: Authors.
SOL
PPC
Start-ups
Total
88 25,786 58 88 33,768 20 208 65
100 20,219 21 86 7188 53 51 10
78 2286 4 56 489 9 7 6
88 15,243 28 75 12,656 26 69 21
440
445
450
455
460
465
470
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R. L. TORRES AND L. HASENCLEVER
However, looking at spending on outsourced R&D, the SOL average rises to almost R $34 million—the double of the average spending of the entire sample —while average PPC spending is only R $7 million per year. That is, the SOL’s much higher cost of outsourcing of R&D results in a very high total spending on R&D compared to PPC. In the case of start-ups, the average annual expenditure on internal R&D is just over R $2 million (which exceeds average annual revenues), while outsourced R&D is about R $490,000.7 The SOL also stand out with respect to experience in R&D and the number of personnel (PhDs and non-PhDs). Also of note is the fact that the PPC have, on average, a relatively large number of ongoing projects—more than double those of the SOL (53 versus 20). This result may be associated with a higher efficiency of R&D activities in the private sector. As we shall see, this same difference is evident with respect to the results of R&D, measured by the number of patents and the number of innovations implemented in the past five years. Table 8 shows the products portfolio of the firms surveyed. Note that only among start-ups exist nonindustrial companies exist, that is, companies focused exclusively on R&D or purely commercial activities.8 None of the SOL produces API; all perform the final drug formulations. The PPC include some companies specializing in pharmaceutical chemicals, which justifies the fact that only 71% of them produce medicines (formulations). These organizations were included in the study because they have projects incorporating biotechnology in their production processes. Start-ups also figure more frequently in biopharmaceuticals; indeed, most of the companies that responded positively to this item work with biologics, and their industrial capability reflects, therefore, both the “vocation” and “bias” of the selection of the study. Overall, half of the companies surveyed already produce or are about to commence production of biopharmaceuticals, which are biosimilar.9 The item “other” encompasses hyper-immune serums, vaccines, and disease diagnosis kits. Some vaccines, however, produced through recombinant DNA technology, were included under “biopharmaceutical (API)” in Table 8. Table 8.
Product line of companies with industrial production (%).
Data
SOL
PPC
Start-ups
Total
Organizations with industrial production (%) Pharmaceutical chemical (API) Biopharmaceutical (API) Chemical intermediates Other inputs for pharmaceutical production Inputs for pharmaceutical research Medicines (formulations) Packaging and containers Other
100 0 63 0 13 0 100 0 63
100 43 43 0 43 29 71 14 57
33 0 44 0 11 0 22 0 56
75 13 50 0 21 8 63 4 58
Source: Authors.
475
480
485
490
495
500
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Thus, the profile of the industrial capability of the organizations surveyed are, in order of importance: medicines (formulation), other (especially vaccines and serums), and biopharmaceuticals, the latter due mainly to local production of biological products MS through the PDP.
505 Q3
Evaluation of technological capabilities
Next we present a summary assessment of the technological capabilities of the pharmaceutical companies interviewed according to level of complexity (basic, intermediate, and advanced) and nature of competencies (innovative and operational). We begin the exposition with the results of innovative technological capabilities, as shown in Table 9. As can be seen, the PPC, present, on average, the highest levels of innovative technological capability at all levels. On average, 74% have basic competencies, 63% intermediate, and 36% advanced. The last row shows the average of the total capabilities evaluated. Thus, the PPC have an average of 59% of the basic-to-advanced capabilities evaluated in the research. About the two other categories, in general, the start-ups have a higher level of innovative technological capabilities than the SOL (40% versus 38% in total); additionally, the start-ups have the highest average percentage of intermediate competencies (38% versus 34%) and advanced competencies (24% versus 12%). It is worth noting that although the PPC show better results when analyzing the advanced innovative capabilities—those needed for technological catching up—they exhibit, on average only 36% of the evaluated competencies, while start-ups exhibit 24% and the SOL, only 12%. These data reveal the still incipient levels of innovative technological capabilities of the pharmaceutical companies surveyed. Moreover, it is interesting to note the great variability in the levels of competencies (see the minimum and maximum percentages shown in brackets in Table 9). Once again the PPC stand out, and one notes that in this subgroup there appear companies that amounts to 100% of basic capabilities, 84% of intermediate capabilities, and 63% of advanced capabilities. This reveals that despite the low average level of competencies observed in the survey, some of the companies surveyed exhibit high Table 9. Levels of innovative technological capabilities of companies interviewed (%, average, minimum and maximum). Level Basic Intermediate Advanced Total
SOL 63 34 12 38
(47–84) (16–63) (0–22) (22–59)
PPC 74 63 36 59
(42–100) (32–84) (0–63) (35–78)
Start-ups 56 38 24 40
(16–89) (0–84) (0–50) (6–76)
Total 64 44 23 45
(16–100) (0–84) (0–63) (6–78)
Source: Authors. Note: The highlighted values refer to the average. The values in parentheses denote the minimum and maximum values, respectively, as a percentage of the total companies classified in each category.
510
515
520
525
530
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R. L. TORRES AND L. HASENCLEVER
innovative capability. Moreover, the minimum and maximum percentages are even more revealing of the SOL’s innovative deficiencies (note that there are labs with no advanced innovative capability and that the best lab attained a maximum of 22% of the advanced competencies evaluated). Still looking at these minimum and maximum values, a favorable framework for start-ups relative to SOL is apparent, which reflects somewhat the profile of these companies. Usually originating from universities and geared toward technological development, spinoffs10 rely on the expertise of renowned researchers and partnerships with private companies that collaborate in their technological activities. An overview is presented in the last column of Table 9 that shows the average percentage of all firms. It can be seen that, on average, the interviewed companies exhibit 64% of the basic innovative capabilities, 44% of the intermediate, and 23% of the advanced. Therefore, a number of gaps are yet to be filled by the companies surveyed with respect to the innovative activities of greater technological complexity and higher socioeconomic impact. Table 10 presents the same results for the operational technological capabilities. Again, the PPC present better results than the other subgroups with respect to all levels of operational capabilities. On average, the PPL exhibit 53% of the basic operational capabilities, 42% of the intermediate, and 30% of the advanced; while the SOL have, on average, 47% of basic capabilities, 30% of intermediate, and only 10% of the advanced. The start-ups present results well below the average of the other two groups, with only 26% of the basic operational capabilities, 13% of the intermediate, and 5% of the advanced. Comparing the total of operational technological capabilities, from basic to advanced, the PPC present, on average, 44% of the assessed competencies, the SOL, 33%, and the start-ups, 17%. Similarly, we can compare the minimum and maximum values in order to assist in assessing the levels of operational technological capabilities among the companies surveyed. Once again, it can be seen that the PPC group includes the companies that scored the highest in all levels of complexity, with companies with up to 68% of basic operational capabilities, 63% of intermediate capabilities, and 30% of the advanced Table 10. Level of operational technological capabilities of companies interviewed (%, average, minimum and maximum). Level Basic Intermediate Advanced Total
SOL 47 30 10 33
(32–68) (6–56) (0–22) (18–55)
53 42 30 44
PPC
Start-ups
(21–68) (6–63) (0–44) (11–61)
26 13 5 17
(5–58) (0–38) (0–33) (2–45)
Total 41 27 14 30
(5–68) (0–63) (0–44) (2–61)
Note: The highlighted values are averages. The values in parentheses are the minimum and maximum values, respectively, as percentage of the total companies classified in each category. Source: Authors.
535
540
545
550
555
560
565
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capabilities evaluated in the research. On the other hand, the sample contains organizations with no advanced operational capability in the three subgroups. In short, there is a wide variety of organizations regarding the level of operational technological capabilities: they have, on average, limited competencies (see the last quadrant, whose average overall achievement of evaluated operational capabilities was only 30%). The main points that justify the low operational technological capabilities are the focus on the domestic market and the exports limited to developing countries. The sample includes practically no companies exporting to European Union and United States, the most regulated and competitive markets in terms of global pharmaceutical companies. This observation is suggestive of the limitations of the operational technological capabilities of the Brazilian pharmaceutical industry to adapt their production plants to the regulatory requirements in those countries and deliver a sufficient level of efficiency to compete abroad. It must be pointed out that the presentation of the results in each of the previous tables is more of a classification than an absolute number to be analyzed: the purpose of the format is to be able to compare the subgroups. Thus, the higher percentages in innovative capabilities do not mean that the companies surveyed are more competent in innovative activities than in operational activities. This is because the evaluation criteria are quite distinct in each dimension; therefore, a direct comparison can be misleading. In order to get an overview of the technological capabilities of the companies surveyed, we must analyze the data in Table 11, which show the sum of the innovative technological and operational capabilities. As can be seen, the PPC exhibit, on average, 61% of basic operational and innovative capabilities, 51% of intermediate capabilities, and 33% of advanced capabilities; this average is 55%, 32%, and 11%, respectively, for the SOL. The general assessment is unfavorable for start-ups, which had only 38% of the basic technological capabilities, 24% of the intermediate, and 14% of the advanced, on average. Although they have innovative capabilities superior to the SOL, when the innovative and operational competencies are analyzed Table 11. Levels of innovative technological and operational capabilities of companies interviewed (%, average, minimum and maximum). Data Basic Intermediate Advanced Total
SOL 55 32 11 35
(42–76) (17–46) (0–28) (22–35)
PPC 61 51 33 50
(47–84) (34–71) (12–52) (36–70)
Start-ups 38 24 14 27
(13–58) (0–51) (0–32) (5–27)
Total 50 35 19 37
(13–84) (0–71) (0–52) (5–70)
Note: The highlighted values are averages. The values in parentheses are the minimum and maximum values, respectively, as percentage of the total companies classified in each category. Source: Authors.
570
575
580
585
590
595
600
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R. L. TORRES AND L. HASENCLEVER
together, the limitations of these companies is evident—especially with respect to production and marketing. Analyzing the minimum and maximum values, the pattern repeats, the PPC having higher capability than the SOL, and, as expected, the SOL having higher capability than the start-ups. It is interesting to note, however, that the PPC subgroup has the highest maximum values of technological capability at all levels of complexity. Indeed one company had 70% of the total capabilities evaluated, which shows there are companies with operational and innovative potential for technological catching up in the Brazilian pharmaceutical industry, despite the low frequency of firms with this profile in the sample. Table 11 summarizes the overall assessment of the operational and innovative technological capabilities. The SOL stand out in terms of basic capabilities, 55% compared to the total, 50%; the PPC excel in basic, intermediate, and advanced; and the start-ups with low operational technological capability, but with an important innovative potential, which can complement the national pharmaceutical industry, especially the private sector, as shown in Table 9.
605
610
615
Conclusions Despite the survey results suggesting a potential for the development of a Brazilian “biopharmaceutical” industry, they raise—at the same time—a series of questions about advancing technological capabilities. The SOL have an important gap in production capability: some even still lack their Certificate of Good Manufacturing Practices from ANVISA, which is basic and necessary condition for drug registration. Moreover, although some have a good R&D structure, the innovation results are below those observed in the private sector. More mature technology capabilities were observed among the PPC, especially in production and marketing. However, with few exceptions, the PPC lack experience and expertise in the production of API, and much of their success is due to the rise of India and China as global producers of low-cost pharmaceutical chemicals, which, along with Brazil’s Generics Act, fueled the growth of these companies in the past 15 years. The R&D activities of the PPC were more efficient in terms of generating patents and new products and processes, although the degree of novelty is usually at the national level, with cases of new drugs at the global level being scarce. Among the start-ups, the gap in productive and complementary competencies is remarkable, precisely because they are initiatives, generally associated with university researchers who decided to market their research projects. On the other hand, it was only among those companies that a more radical technological development was evident—the search for new drugs via a world-class biotechnological path.
620
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635
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The companies surveyed have, in general, 37% of the technological competencies assessed, as shown in Table 11; the table includes the innovative and operational activities, as well as the aggregate levels of capabilities. The SOL had a low innovative technological capability, while the PPC were more efficient in generating results from their R&D departments. Moreover, the start-ups manifested a higher degree of novelty, albeit in a restricted number of companies. The PPL also presented a better productive structure; the SOL, only basic technological capabilities; and the start-ups, practically zero operational capabilities, especially in industrial production. Similarly, the highest levels of complementary competencies, such as the ability to address regulatory and marketing issues, were observed among the PPC, which appear better prepared to absorb foreign technology. But, as the percentages suggest, there are many gaps to be filled by the companies in order to reach a level of technological competencies on a par with world-class companies. The PDP basic strategy for technology transfer is a form of learning geared toward production that at the same time can drive revenues through the State’s purchasing power; domestic companies can then reinvest in innovative R&D in a second phase. Whereas the SOL seem comfortable with this strategy, the PPC and start-ups have sought other measures to improve their strategic position. In this sense, it seems the PPC can better take advantage of the opportunity the PDP is offering to the national pharmaceutical companies. Thus, the research has identified the potential and the limitations/obstacles to Brazil’s pharmaceutical industry being able to catch up in terms of technology. It is worth mentioning that the industrial development processes, as in the Asian experiences, involved a long-term maturing of investments and accumulation of technological competencies—something achieved, however, proactively and not automatic/passively. Thus, the policy of the PDP can be seen as an initial phase of production capability building; however, to be successful, it must migrate to other fronts to develop innovative technological capabilities. The combination of public and private efforts, in light of international experience, appears to be a sine qua non condition for technological catching up. Technology transfer in the molds of the PDP results in a specific type of learning—learning by doing—which does not necessarily drive to technological capability building in the sense of Bell and Pavitt (1993). This will only be possible with other forms of learning, such as learning by (re)searching, which inevitably involves training for conducting R&D projects for new products and processes based on the new technological paradigm of the pharmaceutical industry: biotechnology—a more promising area than traditional searching for new drugs via chemical synthesis. More promising because biotechnology allows molecules of higher complexity to be produced, either for the treatment of new diseases or as a more effective treatment than is currently available with existing drugs.
645
650
655
660
665
670
675
680
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This article presents two main contributions: (1) the development of a methodology for collecting and analyzing data about the technological capabilities that addresses the difficulties of operationalization of theoretical concepts, and (2) unpublished data in relation to the industrial policy of the Ministry of Health, which can serve as input for future critical analysis of public policy still underway in Brazil. The main limitation of the study is that the results cannot be generalized to the Brazilian pharmaceutical industry as a whole, since they were derived from a small, albeit representative, sample of the pharmaceutical companies that are involved with biotech PDP. In addition, it is strongly recommended for future research to use a more robust statistical tool, such as cluster analysis, to be able to group companies a priori according to their main characteristics and not by subgroups.
685
690
695
Notes 1. According to documents published by Department of Health Industrial Complex of Minister of Health (DECIIS), Retrieved May 25, 2015 from . 2. These associations are representatives of start-up companies. 3. For reasons of confidentiality, this list cannot be reproduced here. 4. Refers to the ability of a substance to induce an immune response in the body. 5. In Tables 3 and Table 4, certain criteria allow scoring of only the intermediate and advanced levels. If an organization was ranked as intermediate level in such cases, it was also considered to dominate the basic level of that specific technological competence. The same reasoning was applied in the case of scoring at the advanced level in a particular technological competence—scoring both at the basic level as well as at the intermediate level. This criterion explains the maximum score on each level in Tables 5. 6. Although the average is a limited measure and of the dispersion presented in the sample of this research, the use of the averages for comparison of the data between subsets proved sufficient for the purposes of our analysis. 7. It was not possible to calculate the percentage of spending on R&D based on Net Sales Revenue, because, as already mentioned, the data reported by the organizations were divergent. Not all organizations had information available on Net Sales; thus in some cases Total Gross Revenue or Net Operating Revenue was provided. 8. For example, companies seeking to introduce new pharmaceutical products to the domestic market, by obtaining a registration from ANVISA and importing, thus operating as intermediaries of foreign drug companies with little or no participation in the domestic market. 9. In Brazil, ANVISA does not use the term “biosimilar,” but rather “biological products” and “new biological products,” the first corresponding to the term biosimilar. 10. Companies derived from technological research in universities.
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