EMA Unveils New Structure and Conflicts of Interest

October 1, 2013

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-10-01-2013, Volume 22, Issue 10

The European Medicines Agency has revealed more information about its new organizational structure.

The European Medicines Agency (EMA) has revealed more information about its new organizational structure. Also, conflicts of interest declarations made by senior staff have been published on the agency's website, as part of the campaign to increase transparency and openness.

The reorganization introduces a new operating model for how medicines are managed through their entire lifecycle, and separates scientific and procedure management. Given the increasing number and complexity of applications being handled by EMA, this is intended to reinforce robustness and quality and allow development of greater specialities able to respond and support the work of the committees, according to an agency statement issued on September 16.

A division for stakeholders and communication will aim to improve relations with stakeholders, particularly patients and healthcare professionals, as well as giving support to small and medium-sized enterprises.

Also, new advisory groups will assist Guido Rasi, EMA's Executive Director, and other staff on operational and scientific issues in their fields of expertise. Two newly created posts, the Chief Policy Adviser and Head of Program Design Board, will strengthen the agency in this area.

"The changes will reshape the EMA so that it is ready to handle future challenges and seize opportunities," said Rasi. "My aim is to give our scientific committees the best possible support, alongside the expertise from the national agencies, to help them keep delivering high-quality, consistent opinions. These changes will enable us to use our resources more efficiently and effectively and ensures that the agency is better prepared for future legislative and policy challenges."

He explained that the changes reflect a renewed focus on three key elements: how to better support the scientific work of the EMA committees; how to better share the knowledge and information the agency holds throughout the EU medicines regulatory network; and how to better meet the need of the agency's stakeholders and partners.

At the heart of the revised structure are four new divisions with responsibilities right through the lifecycle of a medicine for human use, from development to use in patients, Rasi commented. These comprise the Human Medicines Research and Development Support Division, Human Medicines Evaluation Division, Procedure Management and Business Support Division, Inspections and Human Medicines Pharmacovigilance Division.

The revised processes are expected to be complete by next year, but the agency has pledged to ensure continuity during the transition period. Applicants, marketing authorization holders, and other stakeholders should continue to work with their current liaison staff and product team leaders unless informed otherwise, noted the EMA statement.

In the conflicts of interest declarations for senior staff, also released by the agency on September 16, no major surprises appear to be on offer, but some interesting information is given. For instance, the Head of Information Technology, Luc Verhelst, revealed that his son, Jeroen Verhelst, is employed as a desktop specialist on the payroll of Manpower Business Solutions. Jeroen currently works on the service desk of Sanofi-Aventis Benelux in Brussels, giving support to staff.

Also, Agnès Saint Raymond, Head of the Program Design Board at the EMA, declared that she received payments from the World Health Organization. She was paid £1,532.16 in 2011 for drafting pediatric clinical trials guidance, in addition to £1,195 for travel and accommodation to evaluate the Tanzanian Food & Drug Authority and $7,500 to cover accommodation costs during a three-month stay at the WHO.

"My understanding is that the WHO funds come from the Bill and Melinda Gates Foundation, but I have no contact with them other than through my interaction with WHO administration," she wrote. Her appointment to the United Nations Commission on life-saving commodities for women and children does not attract any payment.

Her colleague Emer Cooke, line manager for the International Affairs organizational entity, declared she worked for the European Federation of Pharmaceutical Industries and Associations between 1991 and 1994, and then part-time from 1996 to 1998.

Enrica Alteri, EMA's head of the Human Medicines Evaluation division, revealed that she was employed by Merck-Serono between 1998 and 2011. Her portfolio included centrally authorized products such as Rebif, Erbitux, Gonal-f, Kuvan, Luveris, Pergoveris, Cetrotide, Cyanokit, and Ovitrelle.

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