Resumo

OJUELOS GOMEZ, FJ. The CJUE Ruling of June 21, 2017: nothing new beyond the stir associated with the "anti-vaccine debate". Rev Pediatr Aten Primaria [online]. 2017, vol.19, n.75, pp.133-140. ISSN 1139-7632.

The European Court of Justice Ruling of 21 June 2017 lays down the criteria for interpreting the EU rules on the requirements of evidences in a procedure of claim of damages attributed to an allegedly defective vaccine, on the basis of Directive 85/374. In the process that analyzes the cause-effect relationship between the administration of a vaccine against hepatitis B and the development of a disease that has not its etiology established by medical research such as multiple sclerosis, a causal link between the defect and the damage suffered may be made out by serious, specific and consistent evidence, analyzing each case individually. If science does not know how multiple sclerosis occurs, an irrefutable evidence connecting a cause with a consequence whose mechanism of production is unknown is not possible. A shift of the burden of proof from the injured party to the producer is contrary to law. It is not possible to establish a system whereby the law or the courts stipulate that, on the basis of certain types of circumstantial evidences, the defect imputed to a vaccine may be considered as causing specific damage when the medical investigation has not proved the cause-effect relationship. The Ruling does not establish different criteria to those that were being applied until now. The conclusions of the Tribunals setting the facts cannot establish what science has not demonstrated.

Palavras-chave : European Union; Multiple sclerosis; Adverse effects; Hepatitis B vaccine.

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