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The implementation of the bioequivalence certification policy in Chile: an analysis of market authorization data
Kaplan, Warren A; Cárdenas, Jorge; Mansilla, Cristián; Tobar, Tatiana; Wirtz, Veronika J.
Afiliação
  • Kaplan, Warren A; Boston University School of Public Health. Department of Global Health. Boston. US
  • Cárdenas, Jorge; Ministry of Health Chile. Santiago. CL
  • Mansilla, Cristián; Ministry of Health Chile. Santiago. CL
  • Tobar, Tatiana; Ministry of Health Chile. Santiago. CL
  • Wirtz, Veronika J; Boston University School of Public Health. Department of Global Health. Boston. US
PLoS One ; 14(5): 1-12, May 2019.
Artigo em Inglês | PIE | ID: biblio-1021475
Biblioteca responsável: BR1.1
ABSTRACT
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. To study the implementation of the bioequivalence certification policy in Chile. 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. 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. 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.
Assuntos

Texto completo: Disponível Coleções: Bases de dados internacionais Contexto em Saúde: Agenda de Saúde Sustentável para as Américas / ODS3 - Saúde e Bem-Estar Problema de saúde: Objetivo 5 Medicamentos, vacinas e tecnologias sanitárias / Meta 3.8 Atingir a cobertura universal de saúde Base de dados: PIE Assunto principal: Medicamentos Genéricos / Política de Medicamentos Genéricos / Acesso a Medicamentos Essenciais e Tecnologias em Saúde Tipo de estudo: Estudo prognóstico Idioma: Inglês Revista: PLoS One Ano de publicação: 2019 Tipo de documento: Artigo Instituição/País de afiliação: Boston University School of Public Health/US / Ministry of Health Chile/CL

Texto completo: Disponível Coleções: Bases de dados internacionais Contexto em Saúde: Agenda de Saúde Sustentável para as Américas / ODS3 - Saúde e Bem-Estar Problema de saúde: Objetivo 5 Medicamentos, vacinas e tecnologias sanitárias / Meta 3.8 Atingir a cobertura universal de saúde Base de dados: PIE Assunto principal: Medicamentos Genéricos / Política de Medicamentos Genéricos / Acesso a Medicamentos Essenciais e Tecnologias em Saúde Tipo de estudo: Estudo prognóstico Idioma: Inglês Revista: PLoS One Ano de publicação: 2019 Tipo de documento: Artigo Instituição/País de afiliação: Boston University School of Public Health/US / Ministry of Health Chile/CL
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