Members of the European Parliament's Environment, Food and Safety Committee approved today a report to strengthen the legal framework for the surveillance of medicines on the market.

The main issue of the report is not re-open the debate on the progress made by the 2010 revision, but   rather to strengthen the provisions on prevention and detection possibilities as well as improve the coordination of procedures at European level to address safety concerns of new or existing products.

However, 'stress' tests have shown that the necessary measures are still not sufficient to prevent another medical scandal like a "Mediator" case. 

MEPs welcomed the Commission's proposals based on an extended list of medicines being placed under additional surveillance.

The report also calls for an obligation of pharmaceutical firms to indicate clearly the reasons for which they withdraw a medicine from the market, asking public authorities for urgent investigation and intervention if necessary. MEPs also want the recently approved legislation to enter into force by 1st July this year.

MEP Antonyia Parvanova (NMSP, Bulgaria) on behalf of the ALDE Group commented: "Following the "Mediator" case in France, the European Commission has rightly identified a necessary update to our European pharmacovigilance framework, notably to ensure that our European alert mechanisms works swiftly and without any loopholes when safety concerns arise from a medicinal product on the market."

"The European Parliament has today supported and strengthened safety provisions for medicinal products on the market, with one and the same objective in mind: patients' safety. Our Union is not only about a common market for medicines, but also about guaranteeing the highest level of public health protection with an efficient system to monitor adverse reactions to drugs".