Problematic Issues of Liability in Clinical Trials of Medicinal Products
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Abstract
In Lithuania, as well as in other Eastern European countries, there is a relatively high number of people participating in clinical trials of medicinal products. In foreign countries an increasing number of lawsuits against investigators, clinical trial sponsors and heath care institutions are raised seeking compensation for the damage inflicted during clinical trials, This indicates the risks involved. The protection of rights and interests of trial participants is thoroughly regulated by international, EU and the Lithuanian legal acts. From 2004, EU Member States have to implement the Clinical Trials Directive. The Directive specifies that it is without prejudice to the civil and criminal liability of the sponsor or the investigator. The Directive does not require no-fault compensation. It requires insurance or indemnity covering liabilities of the sponsor and investigator.
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Authors retain copyright of their work, with first publication rights granted to the Association for Learning Technology.
Please see Copyright and Licence Agreement for further details.
