Interinstitutional agreement postponed
By Sophie Petitjean | Tuesday 19 June 2012
The interinstitutional three-way talks on legislative proposals on pharmacovigilance, held on the afternoon of 19 June, failed to seal an agreement.
Europolitics has reason to believe that the failure was due to a “procedural problem,” expected to be settled in the coming days.
The draft directive and regulation presented by the European Commission in February 2012 aim to remedy shortcomings identified in the EU’s pharmacovigilance system in the wake of the Mediator scandal and to improve the safety of medicinal products for human use. They propose to draw up a list of medicines subject to additional surveillance and to oblige marketing authorisation holders to notify the withdrawal of their product to the European Medicines Agency (EMA), which in turn should inform all member states. The co-legislators amended the text so as to increase coordination between regulators and to enhance surveillance of products like Mediator (a treatment used for diabetes that caused a large number of deaths in Europe).
This was the co-legislators’ second meeting to discuss the subject. According to the press service of the European Parliament’s rapporteur, Linda McAvan (S&D, UK), there will not be another session of three-way talks. “We are waiting to receive more information from the next meeting of the Committee of Permanent Representatives before formalising the agreement,” explained a source after the meeting.
The objective of the three institutions is to reach early agreement on these texts so that they can enter into force simultaneously with the 2010 text on pharmacovigilance (see