The precautionary principle and its metamorphosis

4^th International Conference on Pharmaceutical Regulatory Affairs

September 08-10, 2014 DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA

Margherita Paola Poto

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

The paper investigates the evolution of the precautionary principle applied in case of malpractices in the pharmaceutical sector. The Court of Justice of the European Union has recently stated that in accordance with the precautionary principle, as interpreted by the Court?s case-law, where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent. Although the Court has admittedly already held that the risk assessment cannot be based on purely hypothetical considerations, it has, however, also added that where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists should the risk materialize, the precautionary principle justifies the adoption of restrictive measures.

Biography :

Margherita Paola Poto has completed her PhD in Public Law at the age of 26 from University of Pavia and Postdoctoral studies from Max Planck Institute of International Law in Heidelberg and Wageningen University, the Netherlands. Since 2004, she is Attorney, and since 2013 she has been qualified as Associate Professor in Administrative Law (Ministry of University and Research, Italy). She has published more than 100 works, including two monographs and has been serving as an editorial board member of repute.