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ARTIGO ARTICLE S1

Windows of opportunities and technological
innovation in the Brazilian pharmaceutical
industry

Janelas de oportunidades e inovação tecnológica
na indústria brasileira de medicamentos

Ventanas de oportunidades e innovación
tecnológica en la industria brasileña de
medicamentos
Paulo Bastos Tigre 1
Caio Victor Machado França do Nascimento 1
Laís Silveira Costa 2

Abstract

The Brazilian pharmaceutical industry is heavily dependent on exter- 1 Universidade Federal do Correspondence
Rio de Janeiro, Rio de Janeiro, P. B. Tigre
nal sources of inputs, capital, and technology. However, the emergence of Brasil. Rua Barão da Torre 436, apto.
technological opportunities and the development of biotechnology and 2 Escola Nacional de Saúde 301, Rio de Janeiro, RJ
Pública Sergio Arouca, 22411-002, Brasil.
the decline of the patent boom and resulting advances by generic drugs Fundação Oswaldo Cruz, Rio pbtigre@gmail.com
have opened windows of opportunities for the local industry. The article de Janeiro, Brasil.
examines the Brazilian industry’s innovative behavior vis-à-vis these op-
portunities, showing that although the industry as a whole invests little
in innovation, a few large Brazilian companies have expanded their mar-
ket share and stepped up their investments in research and development,
supported by public policies for innovation.

Drug Industry; Generic Drugs; Sustainable Development; Innovation

http://dx.doi.org/10.1590/0102-311X00103315 Cad. Saúde Pública, Rio de Janeiro, 32 Sup 2:e00103315, 2016

making inter- nal research and development (R&D) activities Trends and structure of the feasible for these companies? National compa. but some authors argue that production of generics will generate The Brazilian pharmaceutical industry is un- an environment of accommodation. The pharmaceutical patent fails to capture the industry’s innovations result- boom peaked in the late 20th century. In Brazil. tures. they cently succeeded in establishing their capability still fail to present the desirable segmentation in in biopharmaceuticals. Next now a significant growth in the share of generics. and funding sources. the PINTEC is sulting in an increase in the share of generics on the main indicator of innovative efforts by Brazil- the market. However. innovative behavior. tion rates. Rio de Janeiro. tem the patents that were filed abroad but could The article consists of five sections. The sales volume also shown growing interest in biopharmaceuti. We then present some final cess to knowledge derived from expired patents thoughts and remarks.S2 Tigre PB et al. in Brazilian pharmacies alone nearly tripled in cals. However. re. reaching a total turnover of zil’s domestic industry is taking full advantage of BRL 60 billion in 2013 (Sindicato da Indústria de the fact that such knowledge is still in the initial Produtos Farmacêuticos no Estado de São Pau- phase of development. the Introduction. 32 Sup 2:e00103315. Indicadores econômicos Sindusfarma. innova- along with an increasing market share for labora. thus allowing international the pharmaceutical industry. Introduction The study was built upon qualitative and quantitative secondary data. in the wake ing from new health care procedures and struc- of the Agreement on Trade-Related Aspects of In. but there is industry. Cad. but have re. since the survey in 2008. harmful to dergoing an important period of expansion and technological innovation 5.7. Other data sources were the the leading companies have moved ahead on the last two editions (2008 and 2011) of the Survey learning curve and detained tacit knowledge that on Industrial Technological Innovation by the is very difficult to be reproduced by new entrants. separating the phar- cess in fine chemicals in the past. (PINTEC/IBGE). emphasizing the role of generics. Although the industry an unique opportunity for companies and re. maceutical and fine chemicals industries. 2014. data have been more extensively disaggregated search organizations that have not achieved suc. tors that can be compared in qualitative studies. medicines for human versus veterinary use and For latecomers to the technological race. A review of the re- Windows of opportunities for innovation emerge cent literature examined the innovation process- in the gaps in existing technological trajectories. pharmaceutical industry in Brazil nies sustain that hypothesis. the the medical and hospital materials and devices last 20 years have witnessed a gradual decrease industry. Brazilian Institute of Geography and Statistics thereby raising strong entry barriers. but these have a more direct impact on tellectual Property Rights (TRIPS). Is ac. In velopment 6 (OECD). ganization for Economic Cooperation and De- panies specialized in the new technologies 2. vation in the industry. contributing to process improvements and an increase in the production scale. Saúde Pública. Despite these limitations. semination of generics in the Brazilian industry’s novation 1. with an average annual growth Brazilian companies and laboratories have rate around 10% since 2004 5. The second section discusses This procedure had postponed the development recent trends in the Brazilian pharmaceutical of generics in Brazil for several years. besides not be granted under the previous legislation 4. 2016 . an. highlighting the nature of spending Brazilian companies and research organizations on these activities. lo. The fourth sec- tories with Brazilian capital. the development comparisons. Over the course of a given trajectory. The fifth section reviews the have taken advantage of such opportunities to main available policy tools for promoting inno- innovate and increase their market share. es in biopharmaceuticals and the role of the dis- creating new needs for capacity-building and in. which is beyond the current study’s in the rate of introduction of new molecules 3. in order to innovate. tion analyzes the investment profile in innovative The purpose of this article is to analyze how activities. adherence to the pipeline ian industry and presents a wide range of indica- mechanism brought into the country’s legal sys. scope. the last 10 years. The survey also the way for generics. However. opening tinct technological challenges. disruptive technological changes can alter the PINTEC uses internationally consolidated capabilities and knowledge needed to innovate methodologies from the Oslo Manual of the Or- and produce. We should mention the limitations of a biotechnology-based trajectory represents of this research source. the pharmaceutical preparations that entail dis- other opportunity is patent expiration. opening opportunities for com. consolidation. it is worth verifying whether Bra. we examine the companies’ strategies.

Indica. but not necessarily a novelty for tic technological development through the the national or international market.br/cadastro/index. which reinforces price competition. with domestic capital ranked among the eleven leading pharmaceutical companies in the coun- try. drugs. The network also helps ing new and more advanced products. accessed on 13/Sep/2014). 2016 .11. accessed on 13/Sep/2014). Rio de Janeiro.gov. Pharma- production of drugs that are neglected by the ceutical companies thus innovate by incorporat- private sector 10. examine this question by highlighting the differ- As shown in Table 1. the number in terms of units sold and from 8% to 24% in of companies producing drugs and medicines in sales value (Sindicato da Indústria de Produtos Brazil decreased by 7%. this segment’s share of ers and acquisitions (M&A) in Brazil. from 2008 to 2011.org. nies. nies. medicines accounted for tween reference products and generics can be 24% of this amount and fine chemicals another recommended by the pharmacist at the mo- 23% (Secretaria de Comércio Exterior. totaling more than 30 therapeutic class- imports of patent-protected products.php/ achieved reasonable self-sufficiency in vaccine site/ap_indicadores. has not been accompanied by a corresponding Brazilian National Health Regulatory Agency increase in the supply side. even while the nominal net sales revenue dores econômicos Sindusfarma.br/cadastro/index. government laboratories lies in its potential innovation is something new for the institution to promote the social orientation of domes. According the Brazilian market increased from 9% to 27% to the PINTEC.5 billion in 2014. Reflecting a world trend. developing original innovations.br/. It is expected that mation systems than those previously used. which require organizational. In the last ten years. 32 Sup 2:e00103315. generic medicines cover an estimated 95% nological development. http:// (NSR) increased by 29%.php/site/ From the point of view of innovation. In addition. including a major share of the most is met by imported products 8. TECHNOLOGICAL INNOVATION IN THE BRAZILIAN PHARMACEUTICAL INDUSTRY S3 http://sindusfarma. The importance of the network of According to the OECD and IBGE guidelines. The country shows (Anvisa) has already registered generics products a growing deficit on the balance of trade for the comprising more than 500 different active ingre- pharmaceutical sector. very few companies and favoring a reduction in public expenditures on organizations adopt offensive strategies aimed at medicines and helping guarantee access 11. six companies ent sources of knowledge in the industry. http://aliceweb. At the international up policies for the sector’s industrial and tech.org. to the reference medicines 15. Innovation strategies in the Brazilian Brazil also has 21 institutions belonging to pharmaceutical industry universities and the state and federal govern- ments 9. the upward trend productive. As vant question for this study is whether the higher observed internationally. the network of public laboratories has the incremental innovations generated by the Cad. producing mainly generics and similars. Brazil ranks 6th worldwide in pharmaceutical The regulations on generics (Law 9. Aliceweb2. covering prevalent diseases in the Brazilian mately 30% of the national demand for medicines population. from 495 to 458 compa- Farmacêuticos no Estado de São Paulo. This partly explains the trend towards merg- ics. the rele- ap_indicadores. switching be- US$ 11. The next two sections 40% of all medicines sold in the coming years. By the manufacturing output of public laboratories defining innovation technologies as new only will have an impact on price formation. es. do Desenvolvimento. Economic-Industrial Complex (HEIC) reached As provided by the legislation. and commercial efficiency standards in the domestic pharmaceutical industry is as. ahead of other important emerging require a minimum price drop of 35% in relation countries like India and Russia. Approxi. Indústria e Comércio Ex.12. the deficit of the Health of existing diseases 16. equipment. worldwide. Maintenance of profit margins in this scenario terior.787/1999) markets. that adopts it. Ministério ment of sale. organi- strengthen the country’s regulatory capacity by zational models. with the existing technological plat. for those that adopt them. the generics segment scales of production favored by M&A are actually is expected to be a driving force in the Brazilian contributing to changes in Brazilian companies’ pharmaceutical market. level. and production scales typical of large compa- sociated with the commercial success of gener. sindusfarma. Despite stepping prevalent chronic diseases.10. The increase in the production scale and forms. depends on production structures that allow accessed on 19/Feb/2015). in 2013. expansion of the Brazilian market differences are even greater due to competition. the statistics bureaus larly for compounds of continued treatment. competitive costs.13. reaching approximately technological strategies. production 14. particu. mainly resulting from dients. found that. 2014. Saúde Pública.mdic. but in practice the However. and infor- performing tests and essays.

edge accumulated by the leading companies over firmed in the survey’s latest edition.900.) remained stable. number of pharmaceutical companies that re- In addition to lack of real growth. training. since the tacit knowl- and in relation to NSR. or tak- troduced new or substantially new products or ing advantage of the opportunities generated by Cad. the companies surveyed. both in absolute terms are particularly difficult. 2016 . unethical Roche Switzerland 1. tive activities 19.20. Although generics vation rate in the Brazilian pharmaceutical in- are copies of innovative medicines with expired dustry dropped from 64% to 54%. copies Eurofarma Brazil 738.9 Generics. Such concentration is Few companies in Brazil develop intensive consistent with the downward trend observed in R&D activities.6 Generics. gener. copies. copies. unethical União Química Brazil 254. a fact which was not con. were supported by public funds. veterinarian Teuto Brazil/United States 246. ics need to pass bioequivalence tests in human In the target period. originals.6 Reference. consumer Pfizer United States 1. unethical Novartis Switzerland 1. er. However. Company Origin of capital Sales revenue in 2013 (US$ millions) Main markets Hypermarcas Brazil 1. the decades is very difficult to reproduce. troduced new products and processes in the two etc. copies.6 Generics. PINTEC in 2008 and 2011 shows that the inno- through “learning by doing”. unethical Aché Brazil 587. years prior to the surveys. To reach the consumer market. and financial resources are significantly limited cal industry that invested resources in innova. Howev- Another important indicator is the innova. Saúde Pública. unethical. and distribution. Meanwhile. copies. previous editions of More aggressive innovation strategies are thus the PINTEC show advances in the total volume relatively rare. from the PINTEC 17. disruptive new technologies like biotechnol- tion rate. 2008 17 and 2011 18 shows a nominal increase By 2011.6 Reference drugs. when compared to global leading companies. 32 Sup 2:e00103315. Rio de Janeiro. unethical AstraZeneca United Kingdom/Sweden 429. According to data ceutical equivalence tests. unethical EMS Sigma Pharma Brazil 809. the share of public fi- beings to guarantee that they will be absorbed at nancing of private internal R&D activities in- the same concentration and rate as the reference creased substantially due to federal government medicines. R&D projects in 17% of the companies of only 26% on spending in innovation. their production requires technical impression that innovation is concentrating in capability to meet the rigorous quality control fewer companies. insuf.2 Generics.2 Reference drugs. consumer Source: prepared by the authors based on the list “Maiores empresas do Brazil em 2013” in Exame magazine 49. in 2008 approximately Table 2 lists the characteristics (scarcely in.18. equipment purchases. while only 7% received public funding. policies and measures 8. Table 1 Eleven largest pharmaceutical companies in Brazil. 92% of innovative companies covered the costs novative) of Brazil’s domestic pharmaceutical of the internal R&D activities with their own re- industry.S4 Tigre PB et al. there was a ceived public funding for other innovative activi- decline in the number of companies that had in.5 Generics.532.3 Generics. unethical Merck Germany 472. ties (licensing. quality management. ogy offer opportunities for leapfrogging. The data may also reflect a de- standards demanded by the health regulatory cline in innovation efforts throughout the manu- agency.054. copies. facturing industry following the crisis in 2008. A comparison of the cesses. or the number of companies that in. besides the requirement of pharma. and information made publically available by the companies listed.0 Reference drugs. introduction of generics in the product portfolio processes on the market as a proportion of all generally accelerates learning in industrial pro. unethical. confirming the patents.098. the ficient to maintain investments at 5% of NSR.2 Reference. Innovations in chemical synthesis invested in innovation. possible because their technical the number of companies in the pharmaceuti. unethical. A comparison of PINTEC data from sources.

that is still in the consolidation phase. competencies for strengthening the produc- ity for the development and production of bio. an important part of the strat- (Figure 1). knowledge networks. Yet the long-term sustainability also affect and limit the capacity to produce and of this process will require stepping up invest. indicated for treatment of rheu. poor quality of The trend suggests that capacity-building for education.28. Such bottlenecks include the country’s tory diseases (Etanercept) 23.0 26. precarious infrastructure. and production of strategic inputs for the internal R&D activities in biopharmaceuticals SUS 11.22. which have con- services. egy for domestic industrial capacity-building To enter the biopharmaceuticals market. PINTEC 2011 18 eration. Years Number of companies Spending on innovative activities (in BRL billions) Investment/NSR (%) 2008 301 1. among other fac- The Cristália laboratory took a more indepen. and an adverse tax system vis-à-vis productivity pharmaceuticals. behind the global technological frontier 27. When disruption occurs on a tech. 2016 . tors.8 Variation (%) -30. given the expected increase in strategy of strengthening the capability for gen- their use by health systems 21. ciety such as extreme inequality. these laboratories as useful institutions to sup- ducted activities in biotechnology. by low communication rate between the or- dent development path. all of which requires cooperation between Biotechnology refers to the application of companies and universities. the technology underlying a non-new biophar.5 4. Brazil has witnessed growing interest by tributed to the development of the necessary laboratories in obtaining technological capabil. vation System (SNIS) is limited.1 NSR: nominal net sales revenue. 32 Sup 2:e00103315.9 4. contrary erates with external partners. use. innovate Brazilian health industries 20. Cad. technological capacity-build- 28 pharmaceutical companies were developing ing. tation of laboratory techniques to the industrial coded and thus more difficult to transfer. structural problems in Brazilian so- biosimilars 25.18. Saúde Pública. effectiveness of Brazilian National Health Inno- zilian Unified National Health System (SUS) 24. scale.0 -0. ganizations and institutions in the SNIS. and develop future-bearing technology plat- matoid arthritis and other chronic inflamma. and adap- science in which knowledge tends to be more en. Biotechnology is a science diate steps.9 2011 211 1. precarious the production of biosimilars is an indispensable information technology in the national territory. Rio de Janeiro. Of this total. Meanwhile Orygen marginal participation in the above-mentioned Biotechnology signed a cooperation agreement global knowledge networks. positive evaluation by Anvisa to produce three In addition. The policy aims to overcome the prevailing maceutical product. hereinafter referred to here bottlenecks in Brazil’s domestic industrial base as a biosimilar. having received a to the trend in more mature innovation systems 29. radical innovation to enter cutting-edge technol.30. ments in R&D and greater participation in global ogy areas without needing to go through interme. many of the new capabilities are still many gaps in scientific knowledge. The country still lags with a Korean company to develop two biosimi. TECHNOLOGICAL INNOVATION IN THE BRAZILIAN PHARMACEUTICAL INDUSTRY S5 Table 2 Fine chemical and pharmaceutical manufacturing companies that implemented product and process innovations.26. The lars on the list of strategic products for the Bra. tion and innovation base in health. agement structure and growing investments in ogy transfer agreement with Merck to receive technological capability 14. and diffusion of new technologies in identified 74 companies manufacturing drugs or the last decade acknowledged the need to qualify medicine that implemented innovations or con. and there nological pathway. Source: prepared by the authors based on data from Survey on Industrial Technological Innovation (PINTEC) 17. stage for the development and production of bio. In Brazil. goods. in health involved modernization of the public Brazilian companies have turned to different laboratories through improvement of the man- technology sources. port regulation. science and technology to living organisms with A significant share of Brazil’s R&D efforts the purpose of producing knowledge. Thus. forms. although it also coop. or involves public laboratories. the pharmaceuticals. Bionovis entered a technol. meth- required for production are still in the field of ods for the manipulation of molecules.

Recent years have seen doubled. R&D spending more than personalized therapies 8. in previous years 19. aimed at the development of more tween 2008 and 2011. R&D: research and development. Be- netics tools. Moreover. reaching BRL 920 million. pared to other sources of innovation. 2009-2011. R&D ef- nessed the growing leadership of biotechnology forts are associated directly with technological in the health area. of pharmaceutical companies’ innovative poten- tion of biopharmaceuticals. Brazil. Biolab. but without internal spending in R&D (Table 3) when com. there was a whole. In Cad. for example. and Eurofarma.33. capability and are the most important indicator the use of genetic engineering for the produc. Despite advances. R&D spending in the activities Brazilian pharmaceutical industry falls far short of the 15% to 20% of net annual revenue spent by The recent history of the Brazilian pharmaceuti. spent by Indian companies 32. Despite in an increase in funding for the development a slight drop in the number of companies that of the pharmaceutical sector and the HEIC as conducted internal R&D activities. an increase in R&D as a percentage of NSR. Figure 1 Pharmaceutical companies that implemented innovations and/or projects and conducted activities in biotechnology.S6 Tigre PB et al. vestment profile in innovation. This tendency had already been observed therapy. In technological terms. emphasizing the need to implement an increase in internal R&D among innovative mechanisms to stimulate health innovation and companies. besides the application of pharmacoge. domestic companies like Aché. In the same period. A disaggregated Table 3 shows that the number of companies analysis of PINTEC data indicates that compa. leading global companies. but to a lesser extent. which involves. or even the 6% to 7% cal industry shows important changes in the in. Source: prepared by the authors based on data from Survey on Industrial Technological Innovation (PINTEC) 2011 18. Rio de Janeiro. penditure as part of their net revenues. vaccines. reflected of all investments in health innovation. 2016 . Saúde Pública. and gene tial 31. that rely on external acquisition of R&D in Bra- nies in this sector have significantly increased zil also increased during the period. Cristália. the country has wit. invested above the sector aver- Investment profile in innovative age 21.34. 32 Sup 2:e00103315. about half various guidelines and policy tools. pharmaceutical intensify technology transfer to domestic public companies operating in Brazil increased R&D ex- laboratories 30.

057 1. Saúde Pública.467. TECHNOLOGICAL INNOVATION IN THE BRAZILIAN PHARMACEUTICAL INDUSTRY S7 Table 3 Spending on key innovative activities by the Brazilian pharmaceutical industry.00 0. this discount rate will be Cad. ing for acquisition of machines and equipment.00 59.827 3.00 430. The degree of openness in ably reveals a reduction in productive invest- R&D appears to relate positively to pharmaceu. ments by Brazilian companies in a period char- tical companies’ innovation rate and commer. Even so. an increasingly important source for Brazilian companies turned to imports to meet the growth pharmaceutical companies.709 50.00 289.40 Acquisition of external R&D 2008 59 20. the diffusion of cutting-edge A major increase occurred in spending on medicines on the Brazilian market is limited by professional training.60 Acquisition of other knowledge 2008 34 11. ies can reach US$ 200 thousand 36. tor.316 . Although tion is concentrated in the largest companies. From this angle.00 187.336 13. ties plays an important role in complementing more than a change in innovation strategy.00 15.00 0.009 12.00 0.18.792 1.00 1.00 2.05 Software acquisition 2008 63 21.00 219.80 Training 2008 157 52. 4. the mean cost of companies that invested in training. but there has been a nominal drop in invest- the knowledge generated by external R&D activi. copies are expected to cost 15% to 40% less than Purchase of machinery is still the most prevalent the reference drugs. For example. 32 Sup 2:e00103315. due to the extreme- innovation activity among companies in the sec.30 2011 157 74.00 1. 2016 .982 29. ly high initial prices. 1.849. expanding access to more advanced therapies. products obtained by biotechnology are par- Meanwhile. 4.00 0. there was a decrease in the number ticularly affected. from 1% (approximately rising R&D costs.00 920.40 2011 137 65. showing of treating a patient with monoclonal antibod- that the intensification of this source of innova.00 0. NSR: nominal net sales revenue.00 0.00 19.00 0.00 24. given their limited in local demand. directly impacting the final BRL 15 million) to 3% (BRL 59 million) of total prices of new compounds.90 2011 211 . prob- internal capabilities.518 1.255 16. development of new products 35.10 2011 28 13.10 2011 54 26. Source: prepared by the authors based on data from Survey on Industrial Technological Innovation (PINTEC) 17. the production of biosimilars holds promise for There has also been a major drop in spend. Rather than expanding production capacity. new investments in innovation during the period. Rio de Janeiro.436 1.00 0.00 40.60 2011 67 32. 1. ments as a proportion of NSR.20 Total 2008 301 . Outsourcing of R&D activities is real.805 3.00 379. acterized by strong appreciation of the Brazilian cial success 32.00 19. Importantly.037 .00 0.10 Acquisition of machinery and equipment 2008 210 70.10 2011 92 44.903 26. This indicator.80 R&D: reserach and development. Activity/Year Number Rate among Amount (BRL Share of the total Percentage of ofcompanies that the innovative thousands) invested NSR (%) invested companies (%) (%) Internal R&D 2008 144 48. This perception is based on the technical and financial capability for the internal recent increase in the sector’s trade deficit. the innovation chain in drugs and medicines.

authors 12 the state’s purchasing power as a mechanism for have highlighted the unfavorable position of less stimulating innovation 48. jectories for growth and innovation in Brazilian port the Development of the Health Industrial pharmaceutical companies. Meanwhile. government measures to foment in. some encoded knowledge as a source of innovation.39. reducing the relative importance funding for production. have increased their efforts in capacity-building has featured the concept of risk-sharing to favor and innovation. developed countries as a function of the lack of specific medicines for their populations’ needs. the largest Brazilian companies ventions program. chemical innovations. which allows waiving public policies have aimed at technological in. the Industrial Development Policy (PDP) to use tion systems 43. like Law 12. Along the same line. public tenders in the case of strategic technol- novation in companies seeking to mitigate the ogy transfers for the SUS.349/2010. which. services. providing market entry. 100 projects had been approved or were under Given the global reduction of productivity in fine analysis.S8 Tigre PB et al. Investments are sup- ported for research. Centralization of purchases of strategic country’s internal scientific effort is highlighted products within the National Policy for Pharma- by the argument that different epidemiological ceutical Assistance is linked to the proposal of profiles lead to different demands on the innova. tion of revenue. however. insufficient to guarantee broad access to given channels offered by the principal funding agen- treatments 37. The concentration of R&D activities in public bids. Saúde Pública. pendence on imports of pharmaceutical prod.38. As for demand polices. source of innovation. totaling BRL 3 billion in financing. The importance of each example. innovation. and exports. Such issues reinforce the perception that the au. cies. Reducing the de. Ad. ing advantage of opportunities related to the ex- The Brazilian Federal Government acts in fi. The advent of new Complex (PROFARMA) and the Technological technological routes based on biotechnology has Fund (FUNTEC) of the National Economic and altered the nature of technological barriers to Social Development Bank (BNDES). financial risks associated with the initial product which regulates government purchases as an development stages.45. and that even zilian Ministry of Health in managing the acqui- when they exist. Final remarks tonomy of productive segments in health is re- lated to public policy sovereignty. policies novative products. the Financing Agency for Studies and ent greater potential for Brazilian industry. and related In Brazil. company of tacit knowledge and increasing the value of restructuring. Other authors 42 ry framework. In addi- increasing abandonment of the more vulnerable tion. the CT-Biotec Sector Fund.715/2012. contemplating those needed to build novation in drugs and medicines have been intangible capital and physical infrastructure in motivated historically by imbalances in the the chain of R&D and production of biotechno- sector’s balance of payments. The increase in R&D ac- nology appears in the creation of exclusive credit tivities is probably associated with technological Cad. development. some important ucts has been a strategic objective of various changes have occurred in the regulatory frame- industrial policies 40. strengthening the role of this ment programs to biotechnology and nanotech. This group has been responsible innovation 7. logical products 46. for nearly doubling R&D spending as a propor- The importance assigned by Federal Govern. allowing the application of to stimulate internal R&D activities are justified a preference margin up to 25% for products by their potential sociopolitical and geographic manufactured by Brazilian companies without impacts.27 call attention to the fact that it is precisely the focused on this analysis. and Law 12. to cite another necessarily accessible. work. described in detail in studies 14. pansion of generics and new technological tra- nancing innovation through the Program to Sup. Research (Finep) coordinates the economic sub. biopharmaceuticals pres- ditionally. 32 Sup 2:e00103315. recent years seen advances in the regulato- segments of the population. the existing treatments are not sition of medicines for the SUS. PROFARMA. Rio de Janeiro. instrument to open the market to domestic in- In addition to commercial aspects. More recently. There is also another poorest and most underprivileged areas that line to this strategy involving action by the Bra- have few or no health care options. As of 2013. when the object of the purchase is a few countries and global companies has led to the result of technological innovation 47.41. and Finep’s calls for bids for economic subventions earmark specific funding to foment innovations Public policies for innovation in biopharmaceuticals. since its conception. among other This article has raised relevant questions for tak- areas of national development 44. 2016 .

Contributors Acknowledgments P. Cad. Council (CNPq. and In short. and intensification of R&D activities. any part be investigated and resolved appropriately. This move has been mainly supported by growth in the domestic market. try is slowly and gradually moving towards the which have expanded the availability of financ. and government purchases. and tak. C. writing parts of the article and critically revising ing this research. F. Nascimento and L. Tigre contributed substantially to the study’s con. guaranteeing of Public Health. The authors wish to thank Brazilian National Research ception. 2016 . as well as the Rio de Janeiro Federal it. and technological opportunities. generics. Saúde Pública. process n. University (UFRJ) and Sergio Arouca National School ing responsibility for the article’s integrity. and taking responsibility for the article’s integrity. Costa contributed to the study’s conception. consolidation of its industrial base. approving the final version for publication. participating in the data analysis and interpre. tax incentives. greater tech- ing. writing parts of the article and criti- cally revising it. nological capability. the Brazilian pharmaceutical indus- public policies for technological development. V. participating in the data analysis and interpretation. S. approving the final version for publica- tion. 32 Sup 2:e00103315. greater capacity-building. 405077/2013-0) for support- tation. Rio de Janeiro. B. guaranteeing that any questions regarding precision or accuracy of any part be investigated and resolved appropriately. TECHNOLOGICAL INNOVATION IN THE BRAZILIAN PHARMACEUTICAL INDUSTRY S9 opportunities. Oswaldo Cruz Foundation (ENSP/Fio- that any questions regarding precision or accuracy of cruz. project ENSP-007-LIV-07-5). M.

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El surgimiento de opor- dades tecnológicas. sumos. Resumo Resumen A indústria farmacêutica brasileira caracteriza-se La industria farmacéutica brasileña se caracteriza pela grande dependência de fontes externas de insu. O surgimento de oportuni. por su gran dependencia de fuentes externas de in- mos. entretanto. embora o conjunto da luz de esas oportunidades. Indústria Farmacêutica. Industria Farmacéutica. asociadas al desarrollo de la da biotecnologia e ao fim do boom das patentes com biotecnología. revelando que. Inovação Desarrollo Sostenible. 2016 . consecuente avance de los medicamentos genéricos-. aunque el indústria mantenha baixos níveis de investimentos conjunto de la industria mantenga bajos niveles de em inovação. capital y tecnología. Innovación Submitted on 01/Jul/2015 Final version resubmitted on 23/Feb/2016 Approved on 23/Feb/2016 Cad. un pequeño grupo de gran- nacionais vem ampliando sua participação no mer.S12 Tigre PB et al. para la industria local. Desenvolvimento Sustentável. capital e tecnologia. y al fin del boom de las patentes -con el o consequente avanço dos medicamentos genéricos. de innovación. Este artículo examina el com- tamento inovador da indústria brasileira à luz dessas portamiento innovador de la industria brasileña a la oportunidades. Saúde Pública. Medicamentos Genéricos. Rio de Janeiro. Este artigo examina o compor. vem abrindo janelas de oportunidades es paralelo a la apertura de ventanas de oportunidad para a indústria local. Medicamentos Genéricos. um pequeno grupo de grandes empresas inversión en innovación. 32 Sup 2:e00103315. revelando que. des empresas nacionales está ampliando su participa- cado e intensificando seus investimentos em pesquisa ción en el mercado e intensificando sus inversiones en e desenvolvimento. associadas ao desenvolvimento tunidades tecnológicas. apoyados por políticas públicas de inovação. apoiados por políticas públicas pesquisa y desarollo.