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Abstract(s)
O presente estudo tem por base a análise da responsabilidade civil da indústria farmacêutica por danos causados por medicamentos. Trata-se de um tema que se insere na responsabilidade objetiva do produtor, matéria à qual se aplica o regime da responsabilidade civil do produtor, DL n.º 383/89 de 6 de Novembro. Neste trabalho, é analisado a natureza jurídica do medicamento e a sua caracterização como produto na asserção do DL n.º 383/89. No âmbito desta questão são analisadas também as reações adversas medicamentosas, bem como a entidade responsável pela fiscalização e autorização da comercialização dos medicamentos, o Infarmed. Para além disso, é ainda abordado o caráter defeituoso do medicamento e as suas repercussões na responsabilização da indústria farmacêutica. É em especial analisada a responsabilidade civil do produtor e a verificação dos respetivos pressupostos, destacando-se a responsabilidade da indústria farmacêutica. Por fim, é abordada a questão da desadequação do regime da responsabilidade do produtor quando aplicado aos danos causados por medicamentos, onde se procede à análise de um diploma legal do ordenamento jurídico alemão que assegura eficazmente a tutela do lesado por danos causados por medicamentos.
The present study is bases on the analysis of the pharmaceutical industry liability for damages caused by medicinal drugs. It is a theme that fits in the objective producer liability, theme where it applies the producer's liability regime, In this paper, we analyze the legal nature of the medicinal drug, and its definition as a product. Within the scope of this issue are analized the adverse drug reactions, as well as the entity responsible for the supervision and authorization of the medicinal drugs marketing (ou Responsible for the supervision and authorization of the marketing of medicinal drugs). Furthermore, it is still analyzed the defect of the medicinal drug, and its consequences on the pharmaceutical industry liability. In particularly is also analyzed the objective producer liability and the proof of its requirements, highlighting the pharmaceutical industry liability Finally, we discuss the objective producer liability inconsistente issue when applied to damage caused by medicinal drugs, where we analyzes the legislation of the German legal system which effectively ensures the protection of the injured by medicinal drugs.
The present study is bases on the analysis of the pharmaceutical industry liability for damages caused by medicinal drugs. It is a theme that fits in the objective producer liability, theme where it applies the producer's liability regime, In this paper, we analyze the legal nature of the medicinal drug, and its definition as a product. Within the scope of this issue are analized the adverse drug reactions, as well as the entity responsible for the supervision and authorization of the medicinal drugs marketing (ou Responsible for the supervision and authorization of the marketing of medicinal drugs). Furthermore, it is still analyzed the defect of the medicinal drug, and its consequences on the pharmaceutical industry liability. In particularly is also analyzed the objective producer liability and the proof of its requirements, highlighting the pharmaceutical industry liability Finally, we discuss the objective producer liability inconsistente issue when applied to damage caused by medicinal drugs, where we analyzes the legislation of the German legal system which effectively ensures the protection of the injured by medicinal drugs.
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Keywords
Medicamento Defeito Reações adversas Produto defeituoso Responsabilidade do produtor Responsabilidade da indústria farmacêutica Medicinal drug Defect Adverse drug reactions Defective product Producer liability Pharmaceutical industry liability