Pharmacovigilance

Pharmacovigilance is the monitoring of medicines and treatments after they go on market sale. In the late 2000s, BEUC campaigned to improve the post-market surveillance of medicines. Up until then, only a few EU Member States had procedures in place which allowed consumers to report directly adverse effects of a medicine to their national authorities.

In 2010, we helped shepherd EU pharmacovigilance legislation which requires medicine producers to provide greater and clearer information to patients about a medicine’s adverse effects and allowed consumers to be able to report adverse effects they suffer to national competent authorities. The new rules apply as of 2012.

By allowing consumers to directly report adverse effects to authorities, the legislation ensured they get a more complete picture on the effects of medicines. This is because direct reports by consumers often provide more detailed descriptions, such as on the impact of the adverse effect on their everyday life, than reports from healthcare professionals or those filtered by the companies. By enabling consumers to play a more direct role in medicines’ safety monitoring, the legislation helps improve the consumer’s management of their own health.

One clear outcome includes the development in September 2013 of an inverted black triangle on medicines indicating when further monitoring is needed.