La responsabilità per danno da farmaco a trent'anni dall'attuazione della direttiva sulla responsabilità del produttore

This article concerns the implementation of product liability directive with respect to pharmaceuticals products damages. Thirty years after the directive 85/374, which implemented a strict liability regime, the italian case law are mainly addressed to protect the consumers against defective products of pharmaceutical companies, regarding medical devices, medicines, vaccines and other blood products and transfusions. With respect to UK, the directive implementation through the Consumer Protection Act (1987) has introduced a strict liability and has made easier the burden of proof of plaintiff. In this context, the Court of justice interpretation concerning pharmaceutical products liability has contributed to give deadlines to member States in applying the directive. This aspect is confirmed also by the Commission's evaluation of 2018, who enforces that the Directive has added the value consisting in the harmonization of the product liabilities rules and of the right balance between consumer’s protection and innovation in Europe.