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Abstract(s)
O presente estudo analisa os regimes de responsabilidade civil no âmbito da manifestação de reações adversas por danos verificados após a administração de medicamentos defeituosos. O principal objetivo foi examinar: numa primeira fase, pré-comercial, ínsita em ambiente (controlado) de ensaio clínico, uma responsabilidade direta do laboratório farmacêutico produtor, porque é aquela que melhor satisfaz os interesses em jogo; numa segunda, a contar da colocação do medicamento (defeituoso) no mercado de consumo, o confronto das realidades nacionais (dos regimes comuns de responsabilidade civil, por um lado; às expetativas de um regime especial, por outro) e europeias (do regime comunitário de responsabilidade do produtor; às tentativas estaduais de superação das adversidades), contra os perigos de uma indústria farmacêutica massificada, cujos riscos de desenvolvimento marcaram a história mundial.
This paper analyzes the effects of product liability law under adverse reactions caused by defective drugs. The main goal was to examine: initially, in a pre-commercial stage, in a controlled clinical trial environment, a direct responsibility of the pharmaceutical manufacturing company, just because it is the one that fits the interests at stake; and then, after the placement of the defective drug in the consumer’s market, the confrontation between national realities (common products liability on one hand, and the expectations of a special treatment on the other) and Europeans’ (from the European Union products liability law to the member states attempts to overcome adversities), against the dangers of pharmaceutical companies, whose development risks marked the world history.
This paper analyzes the effects of product liability law under adverse reactions caused by defective drugs. The main goal was to examine: initially, in a pre-commercial stage, in a controlled clinical trial environment, a direct responsibility of the pharmaceutical manufacturing company, just because it is the one that fits the interests at stake; and then, after the placement of the defective drug in the consumer’s market, the confrontation between national realities (common products liability on one hand, and the expectations of a special treatment on the other) and Europeans’ (from the European Union products liability law to the member states attempts to overcome adversities), against the dangers of pharmaceutical companies, whose development risks marked the world history.
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Keywords
Medicamentos Defeitos Reações adversas medicamentosas Responsabilidade civil Riscos de desenvolvimento Medicinal drugs Defects Adverse drug reactions Product liability law Development risk