New EU-wide medicine monitoring system will save lives

Posted by Bronwen Maher on September 21, 2010 at 12:36 PM

With almost 200,000 deaths per year in the EU caused by adverse reactions to prescribed drugs, Nessa Childers has today welcomed moves to bring in a new EU system to monitor the safety of medicines which have already been approved for use by doctors. Adverse reactions, she said, are the fifth most common cause of hospital death in the EU.

The so-called pharmacovigilance legislation sets out the rules and procedures for monitoring the safety profile of medicinal products once they have been authorised and placed on the market.

Speaking in the debate on the new laws in the European Parliament today in Strasbourg, Nessa Childers said: “The new powers will equip national and EU authorities to target the growing problem of forged or falsified medicines which pose an enormous threat to public health.

“Until now, little focus had been applied to the adverse reactions associated with some prescribed approved medicines which research shows accounts for 5% of all hospital admissions. The proposals approved today will save lives and should cut the cost of administering the pharmacovigilance system by around €145bn a year.

“The more up to date information that is available to the healthcare sector and to individual patients on the safety of medicines in common use, the better it is for the health and safety of all European citizens. Equally, we must be wise to the need to toughen up EU laws to tackle growing problem of falsified medicines entering the supply chain.

“Under the legislation, a European medicines web-portal will be created, which will be linked to national medicines web-portals in each Member State where patients will be able to find information about the safety of the medicine they are taking.

“The legislation will also provide for more user-friendly, easy to understand packaging information. It will also ensure that patients will find it much easier to report adverse side-effects to medicines to national and EU authorities.”

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