Eu sei o que esse medicamento fez no verão passado: a farmacovigilância como um mecanismo de proteção ao consumidor
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https://doi.org/10.11606/issn.2316-9044.rdisan.2023.192083Palabras clave:
Proteção ao Consumidor, Medicamentos, Farmacovigilância, PrevençãoResumen
Os medicamentos são, por sua própria natureza, produtos especialmente arriscados, em especial aqueles que acabaram de chegar ao mercado e foram desenvolvidos em um curto espaço de tempo, como as vacinas contra a covid-19. Os possíveis riscos que esses produtos podem apresentar para os pacientes/consumidores exigem medidas adicionais de proteção ao consumidor, além da estrutura jurídica geral de responsabilidade do fabricante. Este artigo se concentrou em uma dessas medidas adicionais: a farmacovigilância, ou seja, o monitoramento pós-comercialização de produtos farmacêuticos, sob a perspectiva da legislação europeia. O objetivo deste estudo foi demonstrar o papel da farmacovigilância na prevenção de danos causados por medicamentos defeituosos e na consequente proteção do consumidor, destacando seus benefícios e falhas. A farmacovigilância não é uma solução milagrosa e tem suas falhas. Entretanto, pode ser uma ferramenta útil para o gerenciamento da relação risco-benefício a fim de garantir o uso adequado de medicamentos após a comercialização. A responsabilidade por produtos defeituosos trata apenas da indenização por danos já ocorridos, enquanto a farmacovigilância intervém ex-ante para evitar a ocorrência de alguns desses danos.
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Universidade de Macau
Números de la subvención MYRG2019-00035-FLL
