Hosted by the Member of the European Parliament Tomislav Sokol (EPP group), co-chair of the MEPs Interest Group “European Patients' Rights and Cross-border Healthcare”, the initiative was organized by Active Citizenship Network, the EU branch of Cittadinanzattiva, with the aim of contributing to providing a multi-stakeholder vision for equitable patient access to ATMPs.
Moderator: Mariam Zaidi, Journalist - EURACTIV
16:00 – 16:20 Welcome address
- MEP Tomislav Sokol, Group of the European People's Party (Christian Democrats), co-chair of the MEPs Interest Group “European Patients' Rights and Cross-border Healthcare” and member of the TRANSFORM MEP Interest Group
- Mariano Votta, Director - Active Citizenship Network
16:20 – 16:40
The economic evaluation of Advanced Therapy Medicinal Products (ATMPs): characteristics and reasons for a new economic and accounting approach
- Mauro Maré, Professor of Public Economics - University of Tuscia and LUISS University
16:40 – 17:40 Panel discussion
- Paschalia Koufokotsiou, Policy officer - European Commission, DG SANTE - Unit D1: medical products, quality, safety, innovation
- Sarah Garner, PhD, Senior Policy Advisor Access to Medicines and Health Products - World Health Organization (WHO) Regional Office for Europe
- Giorgio Alleva, Professor of Statistics - Sapienza University of Rome; Former president - ISTAT (Italian National Institute of Statistics)
- Androulla Eleftheriou, Executive Director - Thalassemia International Federation; Director - Cyprus WHO Collaborating Centre of the Cyprus Ministry of Health. For a technical issue she couldn’t attend please click here to find her ppt presentation.
- Jasna Karačić, PhD, President - Croatian association for the promotion of patient's rights; Head of Health Diplomacy Unit - International Council of The Patient Ombudsman; Health attaché during the Croatian Presidency of the Council of the European Union
17:40 – 17:50 Comments from the floor
17:50 – 18:00 Conclusions
- Daniele Manca, Member of the Senate of the Italian Republic; Promoter of the Interest Group “Sustainable Innovation in Healthcare”. For a technical issue he couldn’t attend please click here to find his speech.
- Mariano Votta, Director - Active Citizenship Network
About the speakers
Giorgio Alleva is Full professor of Statistics at the Faculty of Economics at Sapienza University of Rome and Director of the Department of Methods and Models for Economics, Territory and Finance. Prof. Alleva is Former President of the Italian National Institute of Statistics (ISTAT) and, as a President of ISTAT, he has been a member of the European Statistical System Committee, the high-level group on Quality, the Working Party on Statistics of EU Council. He represented Italy in the UN Statistical Commission.
Since 2005 to-date Dr Eleftheriou is the Director of the Cyprus WHO Thalassemia Collaborating Centre. Since 2006, Dr. Eleftheriou has been the Executive Director of the Thalassemia International Federation (TIF) and regularly acts, since 1996, as a WHO consultant on issues related to her field of expertise. She has authored of a number of books and publications in peer reviewed journals, as well as a number prepared in collaboration with WHO and other international bodies on a wide range of scientific and patients’-oriented topics.
Sarah Garner, PhD, BPharm, is currently the Senior Policy Advisor, Access to Medicines and Health Products, WHO Regional Office for Europe. Sarah is a pharmacist specializing in global access issues and she is responsible for the strategic planning and delivery of policy dialogue and technical support to improve patient access. This includes pharmaceutical systems strengthening, regulation, selection, HTA, pricing and procurement.
Jasna Karacic is the Head of the Health Diplomacy Unit of International chair in bioethics (Former UNESCO chair). She has a Ph.D. in health diplomacy. She served as a diplomat during the Croatian Presidency of the Council of the European Union 2020, delegated from the Ministry of Health. Due to the effort made for the engaging scientific rule in person-centered medicine elected a Patient Ombudsman by the International Council of the Patient Ombudsman© on general assembly. She is a counselor for the health policy, and she contributes significantly to health diplomacy scientific research. She holds consultative status with the United Nations and she got the Rector's Award for Achievements at the UNESCO level for human rights in medicine. She is assigned "Young Leader" for health crisis management in 2021 and serves as national coordinator for a worldwide association of women forensic experts.
Paschalia Koufokotsiou has a MSc in Veterinary Epidemiology & Public Health from the University of London, Royal Veterinary College. Currently, she is a Policy officer at the European Commission, DG SANTE - Unit D1: medical products, quality, safety, innovation - for the ATMPs, including the following aspects: the revision of pharma legislation in the context of implementation of the European Pharma Strategy; the hospital exemption ; the GMO assessment in the authorisation of clinical trials involving the and market authorisation of ATMPs; the decision making process for the authorisation of ATMPs; the borderline between ATMP and SOHO framework. EC representative in the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) overlooking the correct implementation of EU regulatory framework of ATMPs.
Former mayor of Imola, in 2018, he was elected Senator of the Italian Republic in the Democratic Party group. He was a member of the Parliamentary Committee on Regional Issues and is the Democratic Party's group leader at the Senate Budget Commission and promoter of the Parliamentary Intergroup Sustainable Innovation in Healthcare. In September 2022 he has been re-elected Senator of the Italian Republic for the 19th legislature.
Mauro Marè is Full Professor of Public Economics at Viterbo’s Tuscia Univerity and Full Professor of Public Economics at Rome’s LUISS University. He has been personal advisor of the past three mandates of Ministry of Finance, member of the supervisory board of the Human Technopole Foundation in Milan, Head (and member) of the Italian delegation in some OECD and EU working groups such as: the Network on Fiscal Relation of the OECD (Vice Chairman), the WP1, the EDRC and the working group on Quality of Public Finances of the European Commission. Visiting Professor at the Department of Economics at Harvard and President of the LUISS Osservatorio Welfare.
MEP Tomislav Sokol
Tomislav Sokol was born in Zagreb in 1982. He obtained his first degree in law at the Faculty of Law, University of Zagreb, in 2006, magna cum laude. He then obtained a Masters of Law (LL.M.) specialising in European Union Law at the Katholieke Universiteit Leuven (KUL), Belgium, in 2009, magna cum laude. He defended his PhD at KUL, dealing with free movement of cross-border health care services in the EU and its impact on national health insurance systems in 2014. He was a Member of the Croatian Parliament until July 2019, when he became a Member of the European Parliament. He is a Member of the Committee on the Internal Market and Consumer Protection (IMCO), Special Committee on the COVID-19 pandemic: lessons learned and recommendations for the future (COVI) and also EPP Vice Coordinator in COVI Committee, and a Substitute Member of the Committee on the Environment, Public Health and Food Safety (ENVI) and Committee on Regional Development (REGI) in the European Parliament.
Mariano Votta is responsible for EU Affairs of the Italian NGO Cittadinanzattiva and the Director of its EU branch called “Active Citizenship Network” (ACN). Mariano has over 20 years of experience in advocacy, stakeholder engagement, European projects, communication, and civic information. In 2015 he led the launch of the MEP Interest Group "EU Patients' Rights & Cross-Border Healthcare," endorsed by nearly 100 organisations across Europe, and the MEP Interest Group "SDGs for wellbeing and consumer protection” in 2021. In 2016 Mariano has won the Efhre International University Excellence Awards on patients’ rights and in 2017 he was appointed as Secretary-General at European Consumer Union. Along the mandate 2016/2019, he was also appointed by the EU Commission to represent Italian Consumer Associations in the EU Consumer Consultative Group. Mariano holds an MSc in Political Science and two post-graduate courses in EU Public Relations and Corporate Social Responsibility.
Mariam Zaidi is an international news presenter, reporter and expert on the EU. Also specialising in politics and foreign affairs she has more recently steered coverage on the Ukraine war and the energy crisis for Euronews. As a seasoned moderator and master of ceremonies for Euractiv, EU institutions and global corporate clients she is a master of many trades. A law grad with an MA in Journalism she has worked for the BBC, ITV, CGTN, APTN and CNBC.
To know more:
- Rationale of the initiative
- An overall overview about ATMPs
- Technical Policy Report from the #VITA Working Group “The economic evaluation of advanced therapy medicinal products: characteristics and reasons for a new economic and accounting approach” (EN – IT).
- The EU training seminar ATMPs revolution: empowering leaders of EU civic and patients’ advocacy
Under the patronage of the Czech Presidency of the Council of the EU
With the unconditional support of #VITA – Value and Innovation for Advanced Therapies which includes:
Bristol Myers Squibb, Gilead Sciences, Janssen, Pfizer, PTC Therapeutics, Roche, Vertex which is coordinated by LS Cube Global Law Firm.
For further information don't hesitate to contact Maddalena D'Urso:
Last update: October 2022