Council and EP seal agreement
By Sophie Petitjean | Wednesday 20 June 2012
The co-legislators worked out a final agreement, on 20 June, on the legislative proposals meant to remedy weaknesses identified in the EU’s pharmacovigilance system. The European Parliament and the Council settled the question of the timeframe, left in suspense at the previous day’s second three-way meeting, thus clearing the way for a first-reading agreement.
The new rules will strengthen surveillance of medicines and risk prevention in the wake of the Mediator scandal (a diabetes treatment that resulted in the death of a large number of Europeans). They oblige marketing authorisation holders to give reasons for the withdrawal of their product on safety grounds and will place more drugs on the list of products subject to additional surveillance. They supplement the pharmacovigilance rules proposed in the pharmaceuticals package, adopted in December 2010.
“I am very satisfied that we have acted swiftly to the benefit of patient safety. It is vital that patients can have full confidence in the medicines they are taking. The change to the law adds further guarantees that any serious problems will be properly detected and acted upon across the EU,” said Linda McAvan (S&D, UK), Parliament’s rapporteur on pharmacovigilance. “I am very proud that the Danish Presidency has succeeded in working out new rules. Today’s agreement will help reassure patients about the safety of the medicines they take,” added Astrid Krag, Danish health minister.
The European Parliament is set to adopt the compromise officially at its September plenary session. The Council will give its formal approval in the coming months. The transposition deadline is six months for the regulation and 12 months for the directive.