EU considers work sharing to improve pharmacovigilance efficiency

Work sharing is being considered as part of a plan to improve the operational efficiency of pharmacovigilance within the EU, according to Noel Wathion, head of the EMEA's post-authorisation medicines' unit.

He pointed out that work sharing is already used in the preparation of safety update reports - where one member state undertakes the assessment and the results are recognised by the others - and this concept could be extended into other areas.

"We are currently looking at signal detection [of adverse drug reactions]. EudraVigilance is now available to member states, and it is not a good use of resources if everyone looking at the same issue at the same time," he said. "This is a debate that is ongoing ... there could be other examples where the principle [of work sharing] could be further applied."

Wathion was responding to recent comments by Martin Terberger, head of pharmaceuticals in the enterprise and industry directorate-general at the European Commission, who believes there is scope to improve health protection with the same or fewer resources.

The EU drive for greater operational efficiency appears to be in sharp contrast to the situation in the US, where the FDA announced plans recently to recruit 1,300 more staff.

Wathion said that in Europe an estimated 360 full-time staff equivalents work in pharmacovigilance across the EU network.

"What the Commission would like to do is rationalise pharmacovigilance. There are proposals to improve the efficiency of operation. There is a certain degree of duplication within the network," he said.

Another idea for change would affect the screening of worldwide literature reports, which would be done by the EMEA instead of industry. "The proposal is that it would come to the EMEA, and you could do that if you had sufficient staff."

Wathion stressed that although some staff would be needed for new activities, there was no certainly no need in Europe to recruit as many new staff as the FDA.