European & National Medicines Regulatory Systems:
challenges for an equitable, timely and suitable access to innovation
10th May 2017, 10:00 – 14:00
European Economic and Social Committee - Room VMA1
rue Van Maerlant 2, 1040 Brussels

Vytenis Andriukaitis

Vytenis Andriukaitis
2014 - present: Commissioner for Health and Food Safety. 2014: Vice-President of the World Health Assembly. 2012-14: Minister for Health in his Country. 2001-04: Deputy Speaker of the Lithuanian Parliament. 1999-2000: Party leader of Lietuvos Socialdemokratų Partija (LSDP, Social Democratic Party of Lithuania).

Brando Benifei
European Federalist, is one of the youngest MEPs and is from La Spezia, Italy. His main fields of legislative work in the EP are Employment and social affairs and Foreign affairs. He is co-chair of the Youth Intergroup and vice-chair of the Disability Intergroup. He was responsible for key legislative and non-legislative reports on the social inclusion and integration of refugees into the EU labour market; on youth employment policy such as the Youth Guarantee and the Youth Employment Initiative.

Neil Betteridge
He now runs Neil Betteridge Associates (UK), a company offering patient insight at a strategic level to UK and international projects involving patient associations, health professional organisations and private companies. He currently helps to coordinate much of the European work of GAfPA, the Global Alliance for Patient Access. He is International Liaison Officer, Public Affairs, for EULAR and in the UK he is Co-Chair of the Chronic Pain Policy Coalition. Formerly CEO of the patient group Arthritis Care (UK), he has also been a UK ministerial adviser on both health and disability issues.

Qualified as a Speech & Language Pathologist in 1995, obtained a Masters Degree in Health Services Management in 2003. She works as Allied Health Practitioner (SLP) and Communications Officer within the Office of the Commissioner for Mental Health, Malta. On a voluntary basis she has been serving within various health related organisations including Honorary Secretary of the Malta Health Network Since 2007. Over the past 10 years she has become a Patient advocate and has contribute to raise awareness on a national level of Patients’ Rights and issues related to the Health sector.

Rob Campbell
Communications Coordinator at the European Patients’ Academy (EUPATI), a project on patient education and engagement in the research system, for 3.5 years. He has been part of Eurordis as consultant in patient group growth since 2008 and has worked on surveys on patient satisfaction with clinical care. He has recently signed up as a volunteer for the EMA on patient information on alternative treatments. Rob was involved in the US AIDS Treatment Activists Coalition in its Drug Development Committee. He worked with the European AIDS Treatment Group from 1995 – 2002. He started in HIV advocacy in 1991 in Spain as a member of ACT UP Barcelona. He helped create two national treatment teams in Spain, FIT and GTT.

Cser, Ágnes

Ágnes Cser
European Economic and Social Committee member, EESC Group: Various Interests Group (Group III). Section for Transport, Energy, Infrastructure and the Information Society. Section for External Relations
President of MSZ EDDSZ (Hungarian Social and Healthcare Workers' Democratic Trade Union).

Regine Deniel Ihlen
She is a lung cancer long time survivor. Started her commitment for lung cancer patients in 2006. Co- founder and 1st President (2007-2013) of Lung cancer organization on Norway, a national non- profit patient support and advocacy organization. Currently involved in Lung Cancer Europe (LuCE) as the treasurer which added a new focus on the EU Policy. She have been working as a Patient Advocate with a particular focus on: C create awareness of lung cancer A access to the best possible treatment R reduce mortality through early detection E equality of care throughout Europe.

Arnaud Emériau
Arnaud Emériau has been president of the European Social Insurance Platform (ESIP) since 30 November 2016. Previously, he worked at the French National Health Insurance Fund for Salaried Workers (CNAMTS) then in the public affairs consulting firm nile, specifically on health issues. Since September 2013, Arnaud Emériau has held the position of permanent delegate at the European Representation of the French Social Security System (REIF) and continues to do so.

Gottfried Endel
General Practitioner since 1989, joined the Austrian Social Insurance Authority for Business (SVA), central office, department for Prior Authorization and Physicians’ Control in 1988 and is since 01.05.2004 Head of the department of Evidence Based HealthCare in the Main Association of Austrian Social Insurance Institutions

Eleonora Evi
Member of the European Parliament (Member of ENVI, EMIS and PETI) for the Five Stars Movement, EFDD Group. She has studied Product, Service and Strategic Design at the Politecnico di Milano, where she has developed a strong interest in good design, as the design that offers new solutions to people needs based on environmental sustainability and social-added values. Her parliamentary work aims at protecting the environment, as the home for humans, animals and nature, through transparency in decision-making processes and people’s involvement in politics. For Evi these are the keys for re-prioritizing what is needed for ensuring a better life in today society and for future generations.

Antonio Gaudioso
He is currently General Secretary of Cittadinanzattiva, an Italian civic organization that promotes civic participation and protects citizens' rights. He started his collaboration with Cittadinanzattiva in 1996. In 2002 he contributed to the drafting of the European Charter of Patients’ Rights promoted by Active Citizenship Network, the European branch of Cittadinanzattiva.

César Hernández García
César Hernández (1963) MD, PhD. Specialist in Rheumatology. I joined the Spanish Agency for Medicines and Medical Devices as Head of Department of Medicines for Human Use in 2009. I was deputy Medical Director at the Hospital Clínico San Carlos in Madrid (2002-2005) and worked as rheumatologist at the same Hospital for 16 years being also associate professor of Medicine and principal and associate investigator in several research projects.

Andrey Kovatchev
MEP, Member of the Presidency of the European Parliament as well as the Committee on Foreign Affairs and the Delegation for Relations with the US. He is a substitute member of the Committee on the Environment, Public Health and Food Safety and the Delegation to the EU-Former Yugoslav Republic of Macedonia Joint Parliamentary Committee. Since 2011 he is the Vice-President of the Union of European Federalists and is also president of the Bulgarian section of the organization. In the current term Dr. Kovatchev initiated an informal interest Group on Access to Healthcare in the European Parliament that provides a forum for action and debate on equal access to healthcare and ensures that the issue features on the EU policy agenda.

Penka Dimitrova Georgieva-Babacheva
She represents the following patient organisations: Patients' Organizations With you, Institute Innovations, Association of Reproductive Health, Pregnancy and Childcare "Smile", Alliance of Transplanted and Operated ATO "Future for All", Association of Patients with Cardiovascular Diseases. They are civic & patient organisations working respectively at national and European level. She was patient representative in the National Health Insurance Fund. These organizations are registered as legal non-profit organizations. They carry out public benefit activities. Patient organizations aim to: initiation and participation in public debates and dialogue with the institutions in connection with the strengthening of citizen participation in the management and control of the health care system.

Veska Gergova
Graduated from the University of Sofia with master’s degree in Law and the Medical University of Sofia with master’s degree in Public Health and Health Management. Interested in Pharmaceutical Law and Administrative Law. Currently working at Bulgarian Drug Agency as a senior legal advisor in Legal, Administrative, Financial Services and Quality Management Department. Her leading activities and responsibilities include providing legal support to BDA in relation to Bulgarian and EU legislation, drafting of legal opinions related to the activities of BDA and legal representation in relation to litigation.

François Houÿez
He is working at the European Organisation for Rare Diseases Eurordis where he is Director of Treatment Information and Access, and Policy Advisor. He has always been working as a patient advocate since the early 90s. He represents Eurordis at the Patients’ and Consumers’ Working Party at the European Medicines Agency (EMA) and in the European Network of Health Technology Assessment Agencies (EUnetHTA). François is also a patient.

Marco Marchetti
Graduated in medicine at Università Cattolica del Sacro Cuore (Rome) and postgraduate in Hygiene and Public Health and Legal Medicine. Since January 2017 he is the Director of the National Center for the 'Health Technology Assessment of the Istituto Superiore di Sanità. He collaborates with the Health Technology Assessment (HTA) and Innovation Unit of the Fondazione Policlinico Universitario “Agostino Gemelli”, Università Cattolica del Sacro Cuore and is also the Eu Director of the International Master Program in HTA and Management since 2001 ( He is the Co-Chair of the Local Organizing Committee of the 2017 Health Technology Assessment Meeting (Rome, June 2017) and the Special Interest Subgroups of HTA international- “Hospital based HTA”. 

Andrew Powrie-Smith
Communications Director at EFPIA, the European Federation of Pharmaceutical Industries and Associations. He previously worked for ABPI, the Association of the British Pharmaceutical Industry, where he served as a Director responsible for the creation and delivery of the association's reputational strategy. He is also a former Director of the British Lung Foundation Scotland and Northern Ireland where he played a key role in the campaign for clinical standards on COPD, the development of British Lung Foundation Nurses in Scotland and the growth of patient support groups. Previously, he worked in the UK and abroad for the British Red Cross, Amnesty International and Scope.

Joop van Griesven
President of Pain Alliance Europe(PAE), Treasurer of the European Network of Fibromyalgia Associations (ENFA) , and special representative for Fibromyalgia and Society(F.E.S.) within the Dutch Patient advisory Board of CBG/MEB. With that background his input within the regulatory body is focused on the theme’s where quality of life as a reference point in granting a marketing authorisation and patients involvement, in the largest range as possible, is at stake. That is not so strong embedded in European Countries and European bodies that patients choices are making a real difference in the final approval.

Annemiek van Rensen
Senior advisor at PGO support, a networking organisation for Dutch patient organisations. In 2015, she was appointed member of the Dutch Medicines Evaluation Board (CBG-MEB) with patient / consumer perspective as area of special interest. Her expertise is in the area of patient participation in research, health policy and quality of care. Dr Van Rensen studied Bio-Pharmaceutical Sciences at Leiden University and obtained her Ph.D in Bio-Pharmaceutics and Immunology at Utrecht University in the Netherlands. Since 2006, she has been active in the field of patient participation in various roles and positions.

Thomas Sannié
President of the Association française des hémophiles. He is a former lawyer. Today, he is the Administrative Manager of a Regional Network in charge of training healthcare providers and patients associations to establish educational programs for patients with chronicle disease. Ex-officio, he is now a member of different boards in organizations such as the French National Blood Transfusion, the AP-HP (1st European University Hospital) and the National School of Public Health. He is also a member of the Economics and Public Health Evaluation Committee of the French National Authority for Health (HAS). 

Martin Seychell
Graduated in chemistry and pharmaceutical technology, he specialized in Chemical analysis. He has held important positions on several government boards and commissions in Malta (Food Safety Commission and the Pesticides Board). He occupied the post of Head of Directorate at the Malta Standards Authority (2001-2006). He has been responsible for the implementation of a number of EU directives in the areas of risk assessment, food safety, chemicals and cosmetic products legislation. He held the post of Director of Environment in Malta (2006-2011). He was appointed Deputy Director General for Health and Consumers at the European Commission in March 2011.

Alessia Squillace
She work in the Italian Civic association Cittadinanzattiva Onlus, in the Tribunal for Patient Rights. She is project manager of several health- related projects. She manages research activities, study and analysis of measures, laws and resolutions about public health policies at national and regional level, editing reports, documents for public hearings etc.

Josep Torrent Farnell
Qualified Pharmacist with a degree in Medicine and Surgery from the University of Barcelona as well as postgraduate courses in Pharmacology and Toxicology, Public Health and European Institutions, Josep is a specialist in Internal Medicine and Clinical Pharmacology and obtained his doctorate in Clinical Pharmacology from the Autonomous University of Barcelona (UAB). He became a member of the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency in 2000, serving as Chair for 2 mandates. He is Professor of Clinical Pharmacology and Therapeutics at the Autonomous University of Barcelona and Head of medicines area of the Catalan Health Service (May 2016).

Marie-Christiane Vekemans
Senior Hematologist at the Department of Hematology, Cliniques universitaires Saint-Luc, Université Catholique de Louvain, Brussels. Her main topics are plasma cell dyscrasia, acute leukemia and mastocytosis. She is involved in several clinical trials on myeloma and acute leukemia. She is member of several scientific societies, member of the Intergroupe Francophone du Myélome and member of the board of HOVON. She is the Vice-President of the Belgian Hematology Society since 2013.

Mariano Votta
Director of Active Citizenship Network and Responsible for European Affairs at Cittadinanzattiva. He has more than 10 years of experience in the field of protection of citizens’ rights, stakeholder engagement, communication and civic information. His was the idea to encourage and promote the Member of the European Parliament Interest Group “European Patients' Rights & Cross-Border Healthcare” at the European Parliament during 2015.

european patients rights day 2017


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