Análise comparativa da concentração industrial e de turnover da indústria farmacêutica no Brasil para os segmentos de medicamentos de marca e genéricos

Rosenberg, Gerson; Fonseca, Maria da Graça Derengowski; d´Avila, Luiz Antonio

doi:10.1590/s0104-06182010000100005

Cited by 8 publications

(5 citation statements)

References 10 publications

(9 reference statements)

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“…According to Rosenberg (2010), reference drugs require major investments, because they are unique and derived from research and development, are protected by patents, and necessarily legalized by the responsible and regulatory body that carry out a strict control to verify their quality, bioavailability, safety and efficacy, that in Brazil the body responsible for this function is ANVISA (National Agency of Sanitary Surveillance). This agency has issued a series of decrees and ordinances to enable the production, dispensing of generic drugs, registration and prescription, directing the course of implementation of drug policies in Brazil (Carvalho et al, 2006).…”

Section: Bibliographic Surveymentioning

confidence: 99%

Prevalence of the use and social acceptance of generic drugs

Silva¹,

Silva²,

Miranda³

et al. 2022

S. F. J. of Health

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The objective of this study was to point out the prevalence of generic drug use and popular acceptance in the municipality of Itumbiara-GO, besides presenting the relationship between cost and benefit, efficacy and factors that influence user acceptance. The study consisted of a bibliographic and field study, through the application of a quantitative methodology, through a structured questionnaire that was applied and a group of 50 randomly selected people. It was verified that most of the group of interviewees has knowledge about generic drugs, as well as their low costs; but reported that they receive information from unreliable sources, which state that the generic medication does not have the same efficacy as a reference drug. The research also related that public policy actions development lives by the Ministry of Health and health professionals are mental foundations for the popularization of generic products. It was possible to conclude that the actions of dissemination and education by health agencies should be continuous, since they have the purpose of informing the community and thus, contributing to the promotion of health, especially, of the low-income population.

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Section: Bibliographic Surveymentioning

confidence: 99%

Prevalence of the use and social acceptance of generic drugs

Silva¹,

Silva²,

Miranda³

et al. 2022

S. F. J. of Health

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“…Todavia, cabe destacar nesse período que a indústria farmacêutica no Brasil optou por 897 investir na produção de medicamentos genéricos (CAPANEMA; FILHO, 2010;ROSENBERG et al, 2010;HASENCLEVER et al, 2010).…”

Section: Transformações Da Indústria Farmacêutica No Brasilunclassified

Transformações recentes da indústria farmacêutica: um exame da experiência mundial e brasileira no século XXI

Kornis

Braga

Paula

2014

Physis

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Resumo: O artigo discute as características e tendências da indústria farmacêutica mundial e brasileira no século XXI, suas transformações e tendências setoriais, e seus atores. Foram utilizadas a pesquisa qualitativa e a técnica de análise documental, que permitiram verificar que, no início do século XX, a indústria farmacêutica mundial apresentava estrutura homogênea e oferta reduzida de seus produtos. Após a Segunda Guerra Mundial, houve fortalecimento da produção de medicamentos baseados na síntese química e diversificação da oferta e demanda por medicamentos. O mercado farmacêutico passou da competição mais ampla para uma de caráter oligopólico. Nos anos 1990, o portfólio dessas indústrias ampliou-se para áreas de saúde animal, produtos de higiene/cuidado pessoal e de nutrição/ dietética. Na década de 2000, a indústria farmacêutica mundial intensificou esse processo, e devido à expiração das patentes dos medicamentos, se concentrou no segmento dos genéricos, adquirindo empresas nos mercados emergentes. O setor farmacêutico brasileiro seguiu os moldes da indústria farmacêutica mundial e passou a investir na produção de medicamentos genéricos, fitoterápicos e no avanço dos biotecnológicos, com o apoio financeiro público do BNDES. Esse contexto continua a exigir avanços na inovação em saúde, e reclama da regulação sanitária o enfrentamento dos desafios advindos dessa grande transformação. Cabe destacar os desafios relativos aos custos dos medicamentos e de seus fortes impactos sobre os sistemas de saúde, em especial aqueles de caráter mais inclusivo. Palavras-chave: indústria farmacêutica; medicamentos; aquisições; produtos biotecnológicos; regulação sanitária.

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“…During 2005 and 2006, the regulatory authorities from the EMEA's Committee of Human Medical Products published a specific guide for biosimilars, whose focus was to evaluate the security and efficacy of these molecules [42]. The mode by which biosimilars and generics can replace the original pharmaceutical compounds varies among countries, but the main difference is their price [43]. In Brazil, all the patents of medical components are made under the Intellectual Property Code -CPI/96, which introduced the concepts of patents in pipeline and patents under revalidation.…”

Section: Expired Patents and Biopharmaceutical Medicinesmentioning

confidence: 99%

Biopharmaceutical and Biosimilar Products in Brazil: From Political To Biotechnological Overview

Basso¹

2013

J Bioequiv Availab

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According to the World Health Organization (WHO), one third of the world's population don't have the necessary access to pharmaceutical products, including essential drugs. In Brazil, the Governmental Health System (SUS) distributes some medicaments for free to the population. They were, then, classified into three categories in the country: basic, strategic and specialized components. Among these categories, the last one is highlighted due to the expensive costs of its products, which are essential for the treatment of rare and specific diseases. For this reason, the Ministry of Health created, in 1993, the Program for Specialized Medicaments, where all the drugs included in this category were distributed for free through Clinics and Hospitals. During the first year of this Program's implementation, there were 15 different items distributed into 31 distinct presentations. Nowadays, the list expanded to 150 different items dispensed into 310 presentations. Hence, the availability of imported pharmaceutical products in Brazil overloaded the expenses by the Brazilian Ministry of Health. Only during 2011, US$ 1.5 billion were spent on these products, where 30% of this amount was related to specialized ones. In order to reduce costs, the Brazilian Federal Government developed, in 2004, the Technological Innovation Law. According to the Decree number 6.041, the National Politics for Biotechnology and the National Committee of Biotechnology were created in order to stimulate the development of Biotechnology for human health, targeting mainly the national production of biopharmaceuticals. Furthermore, the end of patents for several medicaments during the last 5 years enhanced the motivation for national production of new drugs. In this way, some Governmental Institutions, in partnership with International Pharmaceutical Industries, started developing the first biosimilar molecules. Therefore, this report describes the evolution of Biotechnology in Brazil, relating the laws, regulations and Programs created along the last 20 years for Human Health application.

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Análise comparativa da concentração industrial e de turnover da indústria farmacêutica no Brasil para os segmentos de medicamentos de marca e genéricos

Cited by 8 publications

References 10 publications

Prevalence of the use and social acceptance of generic drugs

Prevalence of the use and social acceptance of generic drugs

Transformações recentes da indústria farmacêutica: um exame da experiência mundial e brasileira no século XXI

Biopharmaceutical and Biosimilar Products in Brazil: From Political To Biotechnological Overview

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