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E.C. plans tougher safety laws for medicines


BRUSSELS, Belgium— The European Commission plans to introduce a new legal framework to cover the safety and monitoring process for the European Union medicines market in 2008.

The Commission said today that a recent public consultation found that the current system of medicines safety monitoring, known as pharmacovigilance, needs rationalization and strengthening.

According to the E.C., the current E.U. legal framework is complex and duplicative and roles and responsibilities need to be clarified.

Differing implementation by member states has led to complex and diverse reporting requirements for the industry and decision-making at E.U.-level is overly complicated, said the commission.

Commission Vice-President responsible for enterprise and industry, Gunter Verheugen said that its new proposals would clarify the roles and responsibilities for pharmacovigilance, simplify reporting rules and ensure that robust safety studies are carried out to support "rapid" E.U. decision-making.

The reforms will provide better public health protection and the safe use of new and innovative medicines, claimed Mr. Verheugen.

"We will improve and strengthen the monitoring of the safety of medicines so that safety issues are rapidly detected, and effectively dealt with on the basis of more robust data," said the Commissioner.

"Rationalization of the E.U. medicines safety system will free up resources which can then be directed to better protecting the health of E.U. citizens. This is an example of reducing administrative burdens for enterprises, without compromising safety," continued Mr. Verheugen.

The E.C. explained that the current EU system of pharmacovigilance has slowly evolved over the past 40 years.

It said that there is now a need to strengthen and rationalize the system so that it is "appropriate" for an enlarged E.U. with innovative products.