The European Medicines Agency (EMA) published yesterday information about the new pharmacovigilance legislation that came into force, after having been adopted in December 2010 (Directive 2010/84/EU and Regulation No. 1235/2010). The goal is to better protect public health in Member States by strengthening the EU system for medicines safety. On the one hand, it will influence consumers just by limiting the number of unnecessary risks that they are exposed to when taking medicines. This will be achieved by increasing control mechanisms over medicines and making them more transparent. The second effect on consumers is more direct, namely as of now patients are supposed to be more involved in the regulatory process. This includes patients being able to directly report suspected adverse drug effects.
"The new pharmacovigilance legislation will help us to make the system more robust for public health and more transparent. It gives regulators a range of new or improved tools to ensure that patients are not exposed to unnecessary risks when taking medicines. It also increases the efficiency of medicines regulation for the benefit of all stakeholders." said Guido Rasi, EMA's Executive Director (New pharmacovigilance legislation comes into operation)