EU to bring in tougher rules on monitoring of medicines

Posted by Bronwen Maher on April 27, 2010 at 03:58 PM

With almost 200,000 deaths per year in the EU caused by adverse reactions to professionally prescribed drugs, Labour MEP Nessa Childers has welcomed moves today to bring in a new EU system to monitor the safety of medicines already approved for use by doctors.

The Leinster MEP also said that she looked forward to the proposed new system which was voted through at a meeting of the Parliament’s Environment and Public Health in Brussels today targeting the growing problem of forged or falsified medicines which she says poses an enormous threat to public health.

“The whole area of pharmacovigilance (systems used to monitor the safety of medicines after they have been approved for public use) has been examined closely by the EU in recent years. The life-saving qualities of medicines are well-established but little focus had been applied to the adverse reactions associated with some medicines which research shows accounts for 5% of all hospital admissions. Adverse reactions are the fifth most common cause of hospital death in the EU.

“The Commission has estimated that 197,000 deaths per year in the EU are caused by adverse drug reactions. The proposals discussed today by my Committee should save lives and cut the cost of administering the pharmacovigilance system by around €145bn a year, we believe.

“There is an unanswerable case for a more transparent and proactive system of ongoing monitoring and on a basis where there is closer co-operation between Members States, the pharmaceutical industry, consumers, patient groups, medical professionals and a beefed-up European Medicines Agency.

“As far as I am concerned, 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 prevent tackle the problem of falsified medicines entering the supply chain.”

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