Reforming pharmaceutical regulation: A case study of generic drugs in Brazil

Fonseca, Elize Massard da

doi:10.1016/j.polsoc.2014.03.004

Cited by 8 publications

(5 citation statements)

References 14 publications

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“…From 1990 to 1998, both the price of medicines and the sectoral profits tripled (Vieira, 2022). To make matters worse, pressure on the sector became more intense after scandals related to inactive birth control pills and fake cancer medication were unearthed in 1998 (Fonseca, 2014). As the government came under pressure to act, lobbying efforts against stricter regulations were also watered down by the public outcry.…”

Section: National Companies and Diffuse Counter-movements: The Case O...mentioning

confidence: 99%

The Sectoral Politics of Industrial Policy Making in Brazil: A Polanyian Interpretation

de Gaspi,

da Silva

2024

Development and Change

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This article considers why Brazilian industrial policies have varied across sectors since the mid‐1990s. It relies on a Polanyian‐inspired framework to propose that the strength of counter‐movements against corporate welfare shapes the sector‐specific capacity of policy makers to exert state discipline over business interests and diverges from neoliberal scripts of industrial policy making. The authors use prototypical case studies on the automotive, animal protein and pharmaceutical sectors to support their argument. In the automotive industry, the continuous pressure from powerful and cohesive labour unions led to the emergence of a neo‐corporatist sectoral regime that was characterized by a tripartite policy design and encompassed conditionalities. In the case of animal protein, the lack of bottom‐up pressure culminated in a disembedded neoliberal sectoral regime, in which business owners received almost unconditional benefits, turning industrial policies into corporate welfare. Finally, in the pharmaceutical industry, the combination of diffuse societal demands and unions with intermediate relevance led to an embedded neoliberal sectoral regime that combined selective conditionalities with some space for non‐business participation in policy design.

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Section: National Companies and Diffuse Counter-movements: The Case O...mentioning

confidence: 99%

The Sectoral Politics of Industrial Policy Making in Brazil: A Polanyian Interpretation

de Gaspi,

da Silva

2024

Development and Change

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“…No Brasil, a qualidade de medicamentos genéricos e similares é regulamentada por meio do conceito de bioequivalência em relação ao fármaco originador do medicamento de referência (GUTTIER et al, 2016;FERREIRA et al, 2017). Esta regulamentação torna pouco efetiva a discussão de méritos e controle de qualidade (FONSECA, 2014). Ainda, alguns fatores como a credibilidade atribuída aos medicamentos referência, a bioequivalência não comprovada de alguns medicamentos genéricos e similares (DUNNE; DUNNE, 2015; FITZGERALD; JACOBSON, 2011) e também a consideração negativa da mídia à falta de controle de qualidade de algumas empresas farmacêuticas nacionais (ALISKI, 2014;BARATA-SILVA et al, 2017), reduzem ainda mais a credibilidade de profissionais da saúde e consumidores com relação aos medicamentos genéricos e similares.…”

Section: Atributo Qualidadeunclassified

Análise De Atributos Na Preferência Entre Consumo De Medicamentos Genéricos E Similares Ou Medicamentos De Referência

Luppe

Rossi

Torres

et al. 2020

RGO

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O objetivo principal do estudo foi analisar a importância dos atributos marca, qualidade e preço no processo de decisão de compra dos consumidores de medicamentos genéricos, similares e de referência na cidade de São Paulo e nos municípios da região metropolitana. Definiu-se para a coleta de dados o método de pesquisa quantitativo do tipo survey, via plataforma online, com amostragem não probabilística por conveniência. Os resultados indicam que a maioria dos respondentes da pesquisa têm conhecimento da diferença entre esses medicamentos. Quanto as motivações que levam a preferência por esses tipos de medicamentos, preço, qualidade e confiança são os principais motivadores para a compra de medicamentos genéricos e similares, e qualidade, confiança e recomendação médica para os medicamentos de referência. Analisadas as motivações quando os respondentes realizam a compra para outra pessoa (shopper), padrão similar foi observado nas motivações na compra desses medicamentos. Em paralelo, a influência de profissionais da saúde na decisão de compra dos consumidores, quanto à recomendação médica ou à recomendação do balconista da farmácia, também se mostrou expressiva, resultados esses semelhantes aos obtidos em outros estudos relacionados ao tema deste trabalho.

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“…ANVISA created a fast track approval process for local firms prepared to register generic products and local industry adapted rapidly to this regulatory environment. [14].…”

Section: Introductionmentioning

confidence: 99%

The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data

et al. 2019

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Background Affordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with reference products. Typically, bioequivalence certification is established in order to demonstrate such interchangeability. Objective To study the implementation of the bioequivalence certification policy in Chile. Methods We used Chilean Market Regulatory Authority data for analysis to study the number of products that obtained bioequivalence certification, the time until bioequivalence certification and associated factors to obtain bioequivalence. Results As of January 2017, out of 2,336 products with a valid market authorization containing at least one of the 167 APIs that required BE certification, 1,026 products actually have BE certification (1,026/2,336, 43.9% compliance). Where data were available, the time between submission of the market authorization as a bioequivalent product to final authorization by the national medicine regulatory authority for most products varied between 4–6 months. The fraction of all BE products containing a given API out of the total marketed products containing that API varies considerably, e.g. for the API olmesartan there was only a single BE product marketed, the API diclofenac had none. Conclusions Although the implementation of Chile’s bioequivalence policy increased the number of bioequivalent products, over 50% of generic products requiring bioequivalence that did not obtain this certification. Also for some of the API none or very few BE products are marketed which limits the success of a substitution policy. Further studies are required to identify the apparent lack of incentives to obtain bioequivalence certification. Studies of sales volumes and prices of the products are needed to identify whether generic products without bioequivalence certification either become bioequivalent or eventually exit the market.

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Reforming pharmaceutical regulation: A case study of generic drugs in Brazil

Cited by 8 publications

References 14 publications

The Sectoral Politics of Industrial Policy Making in Brazil: A Polanyian Interpretation

The Sectoral Politics of Industrial Policy Making in Brazil: A Polanyian Interpretation

Análise De Atributos Na Preferência Entre Consumo De Medicamentos Genéricos E Similares Ou Medicamentos De Referência

The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data

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