EU Agencies Update

Regulatory and policy responsibility for pharmaceuticals in the European Union is divided between the governments of the 27 member states* and the EU's institutions. The principal EU bodies concerned are the European Commission in Brussels and the European Medicines Agency in London. However, the decision-making process also involves other EU institutions—including notably the European Parliament and the EU Council of Ministers. The Commission maintains and updates EU pharmaceutical legislation, and ensures that it is properly implemented within the EU. It is the Commission that formally grants marketing authorizations for the EU market. It also supports member states in mutual recognition and decentralized authorization procedures. It promotes international regulatory harmonization, and negotiates and applies mutual recognition agreements with non-EU countries.

The Commission department most directly involved, the Pharmaceuticals Unit, was shifted in early 2010 from the Directorate General for Enterprise to the Directorate General for Health and Consumers, under Commissioner John Dalli. This now handles the legal framework governing medicinal products for human use, medicines for children, orphan medicines, advanced therapies, traditional herbal medicines, clinical trials, quality of medicines and the fight against falsified medicines, pharmacovigilance, information to patients, and better regulation.

The full impact of this switch is still being played out, but there are widespread industry concerns that ensuring a high level of protection of public health is starting to take precedence over the more enterprise-related objectives of developing and maintaining a favorable environment for medicines, easing trade, and fostering a stable and predictable environment for pharmaceutical innovation. However, the Directorate General for Enterprise, under Commissioner Antonio Tajani, retains some responsibilities for aspects of pharmaceuticals. Tajani launched an initiative in late 2010 on corporate responsibility in pharmaceuticals, aimed at delivering "a balanced approach to societal and industrial challenges" through "discussions on ethics and transparency" and on "non-regulatory conditions for better access to medicines after their marketing authorization"—both in Europe, in the context of pricing and reimbursement, and in developing countries, with a focus on Africa.

The main responsibility of the European Medicines Agency is the evaluation and supervision of medicines. It conducts the scientific evaluation of applications for EU marketing authorizations via the centralized procedure, and monitors the safety of medicines through a pharmacovigilance network, taking action if adverse drug reaction reports suggest changes to the benefit/risk balance of a medicine. The agency also has a role in stimulating innovation and research in the pharmaceutical sector, with scientific advice and protocol assistance to companies for the development of new medicinal products. It publishes guidelines on quality, safety, and efficacy testing requirements. A dedicated office provides special assistance to smaller firms.

The agency's scientific committees comprising representatives from the member states* conduct the main scientific work—notably the Committee for Medicinal Products for Human Use, the Committee for Orphan Medicinal Products, the Pediatric Committee, and the Committee for Advanced Therapies. The Agency brings in a network of over 4,000 European experts. It also contributes to the European Union's international activities.

* Three non-EU countries, Iceland, Liechtenstein, and Norway, have also reached an agreement to bring many of their policies, including those for pharmaceuticals, into the EU regime. The eight countries that feature in the EU's current enlargement policy—Turkey, and seven states in the Western Balkans—are also bringing their pharmaceutical regulation and policies in line with the EU.

EMA Board

The Management Board has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency's performance.

European Commission

Heinz Zourek +32 2 299 80 01, Heinz.Zourek@ec.europa.eu

Isabel de la Mata +352 4301 33988, isabel.delamata@ec.europa.eu

Nathalie Chaze +32 2 2964816, nathalie.chaze@ec.europa.eu

Austria

Marcus Muellner +43 50 55536000, marcus.muellner@ages.at

Christian Kalcher +43 1 711 00 48 94, christian.kalcher@bmgf.gv.at

Belgium

Xavier De Cuyper +32 2 5248400, xavier.decuyper@fagg-afmps.be

Greet Musch +32 2 524 80 01, Greet.Musch@fagg-afmps.be

Bulgaria

Jasmina Mircheva +359 9 889666979, Jasmina.Mircheva@bda.bg

Alexander Yankov +359 2 8903555, Alexander.Yankov@bda.bg

Cyprus

Panayiota Kokkinou +357 22 40 71 03, pkokkinou@phs.moh.gov.cy

George Antoniou +357 22 407112, gantoniou@phs.moh.gov.cy

Czech Republic

Jiří Deml +420 2 72185870, deml@sukl.cz

Jiří Bureš +420 541 518275, bures@uskvbl.cz

Denmark

Jytte Lyngvig +45 44 88 95 55, jyl@dkma.dk

Estonia

Kristin Raudsepp +372 7 37 41 40, kristin.raudsepp@ravimiamet.ee

Alar Irs +372 7 374 140, chmp@ravimiamet.ee

Finland

Sinikka Rajaniemi +358 9 47334200, Sinikka.Rajaniemi@fimea.fi

Pekka Järvinen +358 9 16 07 38 00, pekka.jarvinen@stm.fi

France

Jean Marimbert +33 1 55 87 30 14, jean.marimbert@afssaps.sante.fr

Marc Mortureux +33 1 49771350, m.mortureux@dg.afssa.fr

Germany

Björn Lemmer +49 621 3839704, bjoern.lemmer@pharmtox.uni-heidelberg.de

Walter Schwerdtfeger +49 1888 441 11, 00, walter.schwerdtfeger@bmg.bund.de

Hans-Peter Hofmann +49 228 4411120, hans-peter.hofmann@bmg.bund.de

Greece

Ioannis Tountas + 30 21 06507211, president@eof.gr

Hungary

Tamás L Paál +36 1 88 69 320, tpaal@ogyi.hu

Beatrix Horváth +36 1886 9320, horvath.beatrix@ogyi.hu

Iceland

Rannveig Gunnarsdóttir +354 520 2100, rannveig.gunnarsdottir@imca.is

Ireland

Pat O'Mahony (chair) +353 1 634 34 53, pat.omahony@imb.ie

Rita Purcell +353 1 634 3438, rita.purcell@imb.ie

Italy

Giuseppe Nisticò +39 36 63532608, nistico@uniroma2.it

Guido Rasi +39 06 59784205, g.rasi@aifa.gov.it

Silvia Fabiani +39 06 59 78 43 17, s.fabiani@aifa.gov.it

Latvia

Inguna Adovica +371 670 784 31, Inguna.Adovica@zva.gov.lv

Dace Kikute +37 1 67078411, dace.kikute@zva.gov.lv

Liechenstein

Brigitte Batliner +423 236 7325, Brigitte.Batliner@ag.llv.li

Lithuania

Gintautas Barcys + 370 5 2639264, gintautasbarcys@vvkt.lt

Jonas Milius +370 5 2780470, jmilius@vet.lt

Luxembourg

Mariette Backes-Lies +352 478 55 90, mariette.backes-lies@ms.etat.lu

Claude A Hemmer +352 478 55 20, claude.hemmer@ms.etat.lu

Malta

Patricia Vella Bonanno +356 23 43 90 00, patricia.vella@gov.mt

The Netherlands

Aginus A.W Kalis +31 70 3567450, aaw.kalis@cbg-meb.nl

Rob De Haan, r.d.haan@cbg-meb.nl

Norway

Gro Ramsten Wesenberg +47 22 897700, gro.wesenberg@legemiddelverket.no

Poland

Grzegorz Cessak +48 22 4921101, grzegorz.cessak@urpl.gov.pl

Portugal

Jorge Torgal +351 21 798 71 09, jorgetorgal@infarmed.pt

Romania

Daniel Boda +40 21 3171102, daniel.boda@anm.ro

Slovakia

Jan Mazag +421 2 50701 119, mazag@sukl.sk

Dagmar Stará +421 2 50 70 12 51, dagmar.stara@sukl.sk

Slovenia

Martina Cvelbar +386 8 2000508, martina.cvelbar@jazmp.si

Vesna Koblar +386 8 2000502, vesna.koblar@jazmp.si

Spain

Cristina Avendaño Solá +34 91 8225028, sdaem@agemed.es

Laura Franqueza García +34 91 8225040, lfranqueza@agemed.es

Sweden

Christina Åkerman +46 18 174600, Christina.Akerman@mpa.se

Johan Lindberg +46 8 4052077, johan.lindberg@social.ministry.se

European Commission Staff and EMA Personnel

United Kingdom

Kent Woods +44 20 70842546, kent.woods@mhra.gsi.gov.uk

Steve Dean +44 1932 338301, s.dean@vmd.defra.gsi.gov.uk

EUROPEAN COMMISSION

Pharmaceuticals Unit, Directorate General for Health and Consumers, 200 rue de la Loi, B-1049 Brussels, Belgium Phone +32 2 299 1111

Head of Unit

Patricia Brunko

(patricia.brunko@ec.europa.eu)

Healthcare Industries and Biotechnology Unit, Directorate General for Enterprise, 200 rue de la Loi, B-1049 Brussels, Belgium Phone +32 2 295 8090

Head of Unit

Giulia del Brenna

(giulia.del-brenna@ec.europa.eu)

EUROPEAN MEDICINES AGENCY (EMA)

7 Westferry Circus, Canary Wharf, London E14 4HB, +44 20 7418 8400, fax +44 20 7418 8409, e-mail: info@ema.europa.eu, www.ema.europa.eu. Executive staff personnel email addresses use the following address construction: forename.surname@ema.europa.eu

Acting Executive Director

Andreas Pott +44 2074188406-8415

Head of Sector, Executive Support

Martin Harvey

Allchurch +44 2074188699

Senior Medical Officer

Hans-Georg Eichler +44 2075237491

Head of Sector, Legal

Vincenzo Salvatore +44 2074188460

Head of Sector, Internal Audit

Edit Weidlich +44 2075237039

Administration Unit

Head of Administration

Andreas Pott +44 2074188405-8412

Head of Sector, Personnel and Budget

Frances Nuttall +44 2074188475

Head of Sector, Infrastructure Services

Sara Mendosa +44 2074188403

Head of Sector, Accounting

Gerard O'Malley +44 2074188466

Communications and Networking

Head of Information and Communications Technology

Hans-Georg Wagner +44 2075237119

Head of Sector, Document Management and Publishing

Beatrice Fayl +44 2074188426

Head of Sector, Meeting Management and Conferences

Sylvie Bénéfice +44 2074188651

Head of Sector, Project Management

Timothy Buxton +44 2074188631

Head of Sector, Information Technology

David Drakeford +44 2074188599

Authorization Evaluation of Medicines for Human Use

Head of Human Medicines Development and Evaluation

Patrick Le Courtois +44 2074188649

Head of Patient Health Protection

Noël Wathion +44 2074188592-8550

Head of Scientific Advice and Orphan Drugs

Agnès Saint Raymond +44 2075237017

Head of Quality of Medicines

Alexis Nolte +44 2075237188

Head of Safety and Efficacy of Medicines

Xavier Luria Oller +44 2074188512

Head of Regulatory Affairs and Organizational Support

Anthony Humphreys +44 2074188583

Head of Pharmacovigilance and Risk Management

Peter Arlett +44 2075237108

Head of Medical Information

Isabelle Moulon +44 2074188443

Head of Compliance and Inspections

Fergus Sweeney +44 2075237026

The EMA peer review evaluation system works through a network of European experts made available to the Agency by the national competent authorities of the 27 European Union Member States and of Iceland, Liechtenstein and Norway. These experts serve either as members of the EMA scientific committees, of the working parties or as part of the scientific assessment teams.