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.

Directorate General for Health

The commission department most directly involved, the Pharmaceuticals Unit, is part of the Directorate General for Health and Consumers, under Commissioner John Dalli. This 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, the fight against falsified medicines, pharmacovigilance, information to patients, and better regulation. During 2011, consultations took place on—among other subjects—the revision of the clinical trials directive, with formal proposals now scheduled to appear in 2012.

However, the Directorate General for Enterprise, under Commissioner Antonio Tajani, retains some responsibilities for aspects of pharmaceuticals, including the rules that govern member states procedures on pricing and reimbursement of medicines—on which new proposals are scheduled to appear in late 2011 or early 2012. Tajani is also spearheading an initiative 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. A series of working parties have been exploring these themes during 2011, and are due to deliver a set of recommendations by mid-2012.

A wider range of commission departments is also involved in strategies with an impact on health, related to healthy aging, health technology assessment, and e-health.

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.

A new Executive Director was appointed during 2011, after the controversial departure of Thomas Lönngren to work in the private sector. The agency also came under criticism during the year over potential conflicts of interest, and its management of human resources and procurement and financial procedures. The European Parliament, which has oversight responsibility for the agency's budget, took the unprecedented step early in the year of refusing to sign off on the agency's accounts for the previous year, as a result of concerns over these issues. Only after protracted exchanges of correspondence and extensive agency assurances did the parliament finally approve the accounts in October. The agency also suffered some of the fall-out of the year's growing controversy over pharmacovigilance, prompted in particular by the debates over adverse side-effects of Servier's Mediator anti-diabetic in France. Although this product had never been the subject of an authorization via the agency, repeated suggestions were made that the agency should have been more energetic in checking on the drug's performance during its years on the market.

*Three non-EU countries, Iceland, Liechtenstein, and Norway, have also reached an agreement to bring many of their policies, including 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

Paola Testori Coggi +32 2 2953430, Paola.testori@ec.europa.eu Pedro Ortun +32 2 2952054, Pedro.ortun@ec.europa.eu

European Federation of Neurological Associations

Mary Geraldine Baker +44 1483 763626, bobandmary@btinternet.com

European Patients Forum

Mike O'Donovan +44 (0)1344 623680, mikeodonovan@yahoo.co.uk

Secretary-General Standing Committee of European Doctors (Vice-chair)

Lisette Tiddens-Engwirda +33 206 7020 402612, lisette.tiddens@cpme.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

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

Cyprus

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

Czech Republic

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

Denmark

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

Estonia

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

Finland

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

France

Dominique Maraninchi +33 0155 87 30 17, Dominique.Maraninchi@afssaps.sante.fr

Germany

Walter Schwerdtfeger +49 1888 441 11 00, walter.schwerdtfeger@bmg.bund.de Björn Lemmer +49 621 3839704, bjoern.lemmer@pharmtox.uni-heidelberg.de

Greece

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

Hungary

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

Iceland

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

Ireland

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

Italy

Luca Pani +39 06 59784205, l.pani@aifa.gov.it Giuseppe Nisticò +39 36 63532608, nistico@uniroma2.it

Latvia

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

Liechtenstein

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

Lithuania

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

Luxembourg

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

Netherlands

Aginus A.W Kalis +31 70 3567450, aaw.kalis@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

Simona Bodoi +40 21 3171102, Simona.bodoi@anm.ro

Slovakia

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

Slovenia

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

Spain

Belén Crespo Sánchez-Eznarriaga +34 91 8225020, sdaem@agemed.es

Sweden

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

United Kingdom

Kent Woods (chair) +44 20 3080 6546, kent.woods@mhra.gsi.gov.uk

EMA Personnel

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, website: www.ema.europa.eu. Executive staff personnel e-mail addresses use the following address construction: forename.surname@ema.europa.eu

Executive Director

Guido Rasi +44 20 7418 8406

Executive Support, Head of Sector

Martin Harvey Allchurch +44 20 7418 8699

Senior Medical Officer

Hans-Georg Eichler +44 20 7523 7491

Head of Legal Sector

Vincenzo Salvatore +44 20 7418 8460

Head of Internal Audit Sector

Edit Weidlich +44 20 7523 7039

Head of Human Medicines Development and Evaluation

Patrick Le Courtois +44 20 7418 8649

Head of Human Medicines Special Areas

Agnès Saint Raymond +44 20 7523 7017

Head of Safety and Efficacy of Medicines

Xavier Luria Oller +44 20 7418 8512

Head of Quality of Medicines

Alexis Nolte +44 20 7523 7188

Head of Patient Health Protection

Noël Wathion +44 20 7418 8592-8550

Head of Compliance and Inspections

Fergus Sweeney +44 20 7523 7026

Head of Medical Information

Isabelle Moulon +44 20 7418 8443

Head of Pharmacovigilance and Risk Management

Peter Arlett +44 20 7523 7108

Head of Regulatory Affairs and Organizational Support

Anthony Humphreys +44 20 7418 8583

Head of Administration

Andreas Pott +44 20 7418 8405

Head of Human Resources

Frances Nuttall +44 20 7418 8475

Head of Infrastructure Services Sector

Sara Mendosa +44 20 7418 8403

Head of Finance and Budget

Michael Lenihan +44 20 7418 8466

Head of Information and Communications Technology

Hans-Georg Wagner +44 20 7523 7119

Head of Meeting Management and Conferences Sector

Sylvie Bénéfice +44 20 7418 8651

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.

European Commission Staff

EUROPEAN COMMISSION

Pharmaceuticals Unit, Directorate General for Health and Consumers, 200 rue de la Loi, B-1049 Brussels, Belgium, +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, +32 2 295 3946

Head of Unit

Thomas Heynish (acting), Thomas.Heynish@ec.europa.eu