European Regulatory Agencies

December 1, 2005
Applied Clinical Trials
Volume 0, Issue 0

Political and technical tensions in the EU.

The year 2005 has seen the European pharmaceutical environment become an even more complex combination of political and technical tensions.

At the political level, the European Commission has been trying to stimulate innovation and to promote an enterprise culture, in the face of persistent major divergences among EU member states about the right way for Europe to respond to the new pressures of globalization. These discussions have repeatedly degenerated into polarized views about whether Europe should focus on protecting the jobs it has, or on creating new ones—and are still, towards the end of the year, totally unresolved.

Although pharmaceuticals is demonstrably one of the most successful of Europe's industrial sectors and continues to create high-quality jobs, it is a victim of this strategic confusion. Thus the commission's announcement of a new industrial strategy for Europe, angled towards innovation and enterprise, ran straight into heavy fire from French President Jacques Chirac, determined to demonstrate to his electorate that he was going to make no concessions to a policy that did not pay as much attention to job protection as job creation.

Similarly, the ambitious earlier drafts of new commission strategies specifically for pharmaceuticals and biotechnology had to be watered down to a shadow of their initial aims to avoid offending sensitivities in key member states. As a result, both of these supposedly major plans turned out to be very little more than repetitions of earlier formulae adorned with lavish expressions of pious hope and empty rhetoric.

At the technical level, 2005 has been a challenging year for the European Medicines Agency in London. Its main responsibility remains unchanged: the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The Agency continues to coordinate the evaluation and supervision of medicinal products throughout the EU, bringing together the scientific resources of the 25 EU member states in a network of 42 national competent authorities, and it has maintained its close cooperation with international partners.

The Agency marked its 10th anniversary in operation during the year, and saw the full entry into force of new legislation that is shaping its future development. At the same time it is having to cope with the emergence of new medical technologies and therapies; the increasing globalization of the pharmaceutical industry and its regulatory environment; the competitiveness of Europe's biotechnology, pharmaceutical, and health care industries; and the increased expectations of society on information access, communication, and transparency. At the last official count, it had about 360 staff members, and a network of some 3500 European experts underpins its scientific work and committees.

Particular attention has been given to reinforcing the safety of medicines, accelerating the availability of medicines to EU patients, and creating the right environment to stimulate research. These initiatives include implementation of the concept of risk management plans, expansion of the scope of medicines to be authorized through the EU's centralized procedure, and the establishment of accelerated assessment, conditional authorization, and compassionate use procedures, as well as procedures for authorization of biosimilar and generic products.

Similarly, and also at technical level, there is also continual expansion in the range of activities that the pharmaceutical unit in the commission covers. It continues to cover its classic areas of responsibility for health-related matters, such as marketing authorizations, clinical trials, blood- and plasma-derived medicines, vaccines, and good manufacturing practice. It retains a strong role in economic affairs too, overseeing competition policy, transparency of pricing and reimbursement, parallel imports, and penalties for noncompliance with EU rules. But it has had to take on additional or intensified tasks, ranging from orphan drugs and pediatric medicines to pharmacovigilance and international harmonization and cooperation, and from counterfeit medicines, pharmacogenetics, and human tissue engineering to making preparations for the accession of future member states to the EU.

At the same time, the staffing situation in the commission remains imperfect. There are only some 20 officials in the unit, and even a year after it lost its senior official (she was transferred to the private staff of European Commission President Jose Manuel Barroso), a permanent head of unit is still to be confirmed, and it remains under the leadership of only an acting head.

Peter O'Donnell, the View from Brussels columnist for Applied Clinical Trials, is a freelance journalist who specializes in European health affairs. He is based in Brussels, Belgium.

THE EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS

7 Westferry Circus, Canary Wharf, London E14 4HB, +44 20 7418 8400 (extensions below), fax +44 20 7418 8416

Executive Director

Thomas Lönngren ext. 8406

Integrated Quality Management/Audit

Marijke Korteweg 8556

Administration Unit

Head of Unit

Andreas Pott 8405

Head of Sector, Personnel and Budget

Frances Nuttall 8475

Head of Sector, Infrastructure Services

Sara Mendosa 8403

Head of Sector, Accounting

Gerard O'Malley 8466

Communications and Networking

Head of Unit

Hans-Georg Wagner 7119

Head of Sector, Document Management and Publishing

Beatrice Fayl 8426

Head of Sector, Meetings and Conferences

Sylvie Bénéfice 8651

Head of Sector, Project Management

Tim Buxton 8631

Head of Sector, Information Technology

David Drakeford 8599

Unit for the Pre-authorisation Evaluation of Medicines for Human Use

Head of Unit

Patrick le Courtois 8649

Head of Sector, Scientific Advice and Orphan Drugs

Agnès Saint Raymond 7017

Head of Sector, Quality of Medicines

John Purves 8402

Head of Sector, Safety and Efficacy of Medicines

Agnès Saint Raymond 7017

Deputy Head of Sector, Safety and Efficacy of Medicines

Marisa Papaluca Amati 8436

Unit for the Post-authorisation Evaluation of Medicines for Human Use

Head of Unit

Noël Wathion 8592

Head of Sector, Regulatory Affairs

Anthony Humphreys 8583

Head of Sector, Pharmacovigilance

Panos Tsintis 7108

Deputy Head of Sector, Pharmacovigilance

Sabine Brosch 8569

Head of Sector, Medical Information

Isabelle Moulon 8443

EUROPEAN COMMISSION PHARMACEUTICALS UNIT, DIRECTORATE GENERAL FOR ENTERPRISE

200 rue de la Loi, B-1049 Brussels, Belgium

Head of Unit

Nils Behrndt +32 2 295 4128

Human Medicines

Birka Lehmann +32 2 295 5371

EMEA Board

The management board is the supervisory body of the EMEA. Representatives are appointed for three years. The board appoints the executive director and adopts financial regulation.

European Commission Fernand Sauer, Georgette Lalis, Patricia Brunko

European Parliament Gianmartino Benzi, José-Luis Valverde

Austria Robert Schlögel, Christian Kalcher

Belgium André Pauwels, Johann van Calster

Bulgaria Emil Ivanov Hristov, Meri Borislavova Peycheva

Cyprus Louis Panayi, Panayiota Kokkinou

Czech Republic Milan Smid, Alfred Hera

Denmark Jytte Lyngvig, Paul Schüder

Estonia Kristin Raudsepp, Alar Irs

Finland Hannes Wahlroos (chairman), Pekka Järvinen

France Philippe Duneton, Jean Marimbert

Germany Walter Schwerdtfeger, Ilse-Dore Schütte

Greece Dimitrios Vagionas, Vassilis Kontozamanis

Hungary Tamás L Paál, Beatrix Horváth

Iceland Ingolf J. Petersen, Rannveig Gunnarsdóttir

Ireland Pat O'Mahony, Joan Gilvarry

Italy Nello Martini, Silvia Fabiani

Latvia Jãnis Ozolin, Inguna Adovica

Lichtenstein Brigitte Batliner, Peter Malin

Lithuania Mindaugas Plieskis, Juozas Jokimas

Luxembourg Mariette Backes-Lies, Claude Hemmer

Malta Patricia Vella Bonanno, Kenneth Mifsud

The Netherlands Aginus A.W Kalis

Norway Gro Ramsten Wesenberg, Hal Hanse

Poland Piotr Blaszczyk, Jacek Splawinski

Portugal A J Maria Rui Vasco, Filipe Hélder Mota

Romania Magdalena Badulescu, Rodica Badescu

Slovakia Dagmar Stará

Slovenia Stanislav Primozic, Vesna Koblar

Spain Val Diez, José Martines Olmos

Sweden Gunnar Alvan, Anders Broström

United Kingdom Kent Wood, Steve Dean