INSURANCE LAW DEPARTMENT - SPAIN
Mutualising development risks: strict liability within the field of clinical trials
Taking part in a clinical trial with
drugs entails facing not only the health sector risks but also the
risks inherent in biomedical research: the uncertainty as to the
effectiveness of a drug under trial and its potential side effects. For
that purpose, the lawmaker has chosen to establish the strict liability
regime, introducing a rebuttable presumption on the causal relationship.
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