Cinquant’anni dalle prime leggi europee sulla farmacovigilanza: tutto è nato dalla vicenda del Talidomide.


Il 28 settembre a Bruxelles si è svolta una conferenza dedicata al Cinquantennale delle prime leggi europee sulla farmacovigilanza. Quelle leggi si sono rese necessarie in seguito allo scandalo del Talidomide, che aveva provocato la nascita di migliaia di bambini malformati.
Questa è la prefazione agli atti della conferenza, scritta da Vytenis Andriukaitis (Commissario Europeo per la Salute):

In 1965, the first law on pharmaceuticals was adopted making sure that all medicinal products were marketed with prior authorisation after a proper clinical research had taken place. From then on, a large body of legislation has been developed and today the European Union has one of the safest and most advanced systems for monitoring the safety, quality and efficacy of medicinal products.
It took a disaster to happen to trigger the minds of all. 50 years ago thousands of babies were born with limb deformities. Confidently their mothers were taking thalidomide as a sedative during pregnancy with no idea that it could ever lead to such a tragedy and longlasting pain. 50 years ago alarm bells rang for us all. This disaster shook public health authorities and the general public.
It made it clear that we must take action to safeguard public health. The painful lesson we have learnt should never leave our sight. From the thalidomide tragedy, the establishment of a centralised authorisation procedure, creation of the European Medicines Agency, pharmacovigilance and clinical trials legislation.