7. 11. 2023, 12 pm - 5 pm
Permanent Representation of the Czech Republic to the European Union (15, Rue Caroly, Brussels)
Programme
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Moderator: Jenni Nordborg, Director for International Affairs, Lif Sweden
Download the agenda on this link.
About event
April 26, 2023, the Commission adopted the proposal for a reform of the EU pharmaceutical legislation (so-called General Pharmaceutical Legislation, GPL) with the aim of improving the accessibility and availability of innovative medicines for European patients and ensuring Europe's global competitiveness in the field of innovation. The proposal contains, among others, measures to simplify and accelerate regulatory processes or calls for a cut of the baseline for Regulatory Data Protection (RDP).
Four national associations of the innovative pharmaceutical industry, Czech AIFP, Swedish Lif, Spanish Farmaindustria, and Belgian pharma.be with the support of the European Federation of Pharmaceutical Industries and Associations (EFPIA), are organising a high-level conference under the auspices of the Ministry of Health of the Czech Republic.
The content of the conference will focus on incentives for the innovation of medicines, in particular intellectual property rights, their role from an investment decision-making perspective of innovative companies, a comparison across continents, and an assessment of their impact on health systems, the health of European citizens, and the availability of innovative treatments in Europe. Furthermore, it will strive to answer questions about how the above will be affected by the proposed reform of the European legislative framework for medicines and its potential to improve the European situation.
Speakers
Edita Hrdá
Permanent Representative of the Czech Republic to the EU
Edita Hrdá took up the post of the Czech Permanent Representative to the EU in October 2020. Prior to that, she served as Managing Director for the Americas of the European External Action Service (2015-2020) and as Permanent Representative of the Czech Republic to the United Nations in New York (2011-2015). She served as Ambassador of the Czech Republic to Argentina and Paraguay (1999-2003). At the Ministry of Foreign Affairs of the Czech Republic, she worked as the Director of the Department of Latin America, Director for Central Europe, as well as Director General of the Section of the Minister, Chief of Staff.
Sandra Gallina
Director-General | Directorate General for Health and Food Safety (DG SANTE)
Sandra Gallina joined the European Commission in 1988. She is currently the Director-General for Health and Food Safety. Before joining DG SANTE, she was Deputy Director-General for Trade between 2018 and 2020. Between 2014 and 2018, she was the Director for DG TRADE Directorate D "Sustainable Development; Economic Partnership Agreements - African, Caribbean and Pacific; Agri-food and Fisheries". Sandra Gallina was also the EU chief negotiator for the EU-MERCOSUR Free Trade Agreement. Between 2001 and 2009, she was the EU Lead Negotiator for Non-Agricultural Market Access in the WTO Doha Round. In that capacity, she defined and presented EU policy for the Doha Development Agenda on non-agricultural market access negotiations. Before joining DG TRADE, she worked in the Directorate General for Taxation and Customs Union (DG TAXUD) at the end of the 1990s.
Jakub Dvořáček
Deputy Minister | Ministry of Health of the Czech Republic
During the Czech Presidency of the Council of the European Union, his primary focus as the Deputy Minister of Health was on the healthcare field. Jakub Dvořáček has many years of experience in project management and international R&D team management. He worked as a Project Manager for the organization People in Need. He also worked at the CzechInvest agency as an Executive Director of investments and advisor to the Minister of Education, Youth and Sports. He has got a vast experience in the pharmaceutical industry. He served as CEO of the Czech Association of the Innovative Pharmaceutical Industry and chaired the Board of the National Medicines Verification Organisation.
Juan Yermo
Director General | Farmaindustria
Juan Yermo took up his functions as Director General of Farmaindustria in May 2022. He has previously worked at Bankers Trust International in London, the World Bank in Washington, and the OECD, where he held several positions over the last two decades. He was the Chief of Staff of two Secretaries-General. He has published widely on social security, ageing and pension fund regulation. Mr Yermo holds a PhD (DPhil) and MPhil in Economics from Oxford University and an MA in Economics from Cambridge University.
Charlotte Weyne
Senior Legal Counsel & European Policy Advisor | pharma.be
Charlotte Weyne qualified as a lawyer at the Brussels bar, where her practice combined intellectual property litigation and regulatory work with a focus on the life sciences sector. At pharma.be, she has built up extensive experience in EU & Belgian regulatory and IP policy.
She is a member of the Council for Intellectual Property, a consultative body made up of experts and representatives of the sectors that are involved with intellectual property resorting to the Belgian FPS Economy, which is responsible for intellectual property in its entirety.
Ondřej Knotek
Member | European Parliament
MEP Ondřej Knotek is a Czech Member of the European Parliament (MEP), part of the Renew Europe Group since May 2019. Knotek is the co-chair of the TRANSFORM MEP Interest Group which aims at promoting dialogue on transformative gene and cell therapies, as well as a member of the Committee on the Environment, Public Health and Food Safety (ENVI), and recently a member of the newly formed Sub-Committee on Public Health (SANT). Previously, he worked as quality manager at ROTAREX, a Luxembourgish medical device company, where he implemented EU legislation on medical products such as the Medical Device Regulation (MDR) and at LONZA, a Swiss pharmaceutical company. MEP Knotek holds a degree of chemical engineering from the Institute of Chemical Technology.
Nathalie Moll
Director General | European Federation of Pharmaceutical Industries and Associations
Nathalie Moll joined EFPIA as Director General in April 2017 after working 21 years in the biotech industry at the national and European level. Before joining EFPIA, between 2010 and 2017, Nathalie was the Secretary General of EuropaBio, ranked as the most effective European Trade Association in Brussels in 2013. Nathalie won the Technovisionaries Women Innovation Award organised by Women & Technologies®. She was named one of the fifteen leading women in biotech in Europe in 2017 and recognised as one of the „20 Women Who Shape Brussels“ by POLITICO Europe in 2020. Nathalie holds an Honours Degree in Biochemistry and Biotechnology from St Andrews University, Scotland.
Laetitia Szaller
General Counsel, Strategic Advisor & Life Science Expert
Laetitia has over 20 years of experience in multiple sectors, including 15 in the pharmaceuticals and medical device industry, leading and managing complex multi-jurisdiction operations, including global multimillion M&A deals, licensing and collaboration partnerships. At AM-Pharma, she was responsible for the company's Legal Operations and Corporate Development. Before joining AM-Pharma in April 2020 as General Counsel, VP Corporate Development and Corporate Secretary, she was at UCB as global Associate General Counsel BD, M&A and Antitrust. Prior to UCB, Laetitia was Legal Director, Emerging Markets EMEA, Central European Region and Benelux at Zoetis and has also led the EMEA legal department for the Abbott Vascular division at Abbott. She also held global positions at the Carlson Rezidor Hotel Group and the automotive division at American Standard. Laetitia is a qualified lawyer in the UK and Belgium with extensive international experience, regularly speaking at various legal conferences.
Radka Maxová
Member | European Parliament
Radka Maxová was a member of the Parliament of the Czech Republic between 2013 and 2019, and she has been representing the interests of the Czech Republic in the European Parliament since 2019. Both at the national and European level, she focuses on social policy, the rights of people with disabilities, equal opportunities, and the protection of vulnerable groups. Additionally, her agenda includes health issues such as mental health, rare diseases, patients' rights, and access to medical care for all. Currently, she serves as Vice-Chair of the Committee on Women's Rights and Gender Equality. She is also a substitute member of the Committee on the Environment, Food Safety and Public Health and the Subcommittee on Public Health. She is also a board member of the Parliamentary Disability Intergroup, the Parliamentary Interest Group of the Mental Health Alliance, and a member of the Structural Heart Disease Coalition.
Julian Isla
Scientific Director | Dravet Syndrome European Federation
The Dravet Syndrome European Federation (DSEF) is a European organisation for patients with Dravet Syndrome founded by Mr Isla seven years ago. The DSEF is committed to finding new treatments for Dravet Syndrome, an epileptic encephalopathy characterised by prolonged epileptic episodes resistant to treatment. Individuals with Dravet Syndrome also experience major developmental delays as a main symptom. Isla’s son, Sergio, is 11 years old and has Dravet Syndrome.
Despite having no neuroscientific or medical experience, Julian Isla has gained the necessary skills to become a member of the EMA’s Committee for Orphan Medicinal Products as a patient representative. He is a member of the Therapeutic Action Group for EURODIS, the largest organisation representing European rare disease patients. He is also a member of CIBERER (Biomedical Research Networking Centre on Rare Diseases) scientific advisory group in Spain.
Claus Runge
SVP, Head Market Access, Public Affairs & Sustainability | Bayer
As a pharmacist and health economist, Claus Runge earned a PhD from Humboldt University in Berlin and contributed to journals focused on health economics and quality of life research. With more than 20 years of experience in the pharmaceutical industry, he held key roles at GSK, Wyeth, and AstraZeneca. In his current role, Claus Runge shapes global Market Access and drives sustainability at Bayer.
Elaine Cruikshank
Founding Partner, Acumen
Elaine has over 30 years of agency experience with Hill & Knowlton (H&K) and now with Acumen on EU public affairs. Her background is in the UK government's Foreign Office: she worked in London and Brussels. Elaine has worked with a range of blue-chip companies, trade associations, ad hoc coalitions, governments, NGOs and international institutions. Current healthcare include: The European Federation of Pharmaceutical Manufacturers and Industries Association (EFPIA), Vaccines Europe, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Merck, Sharpe & Dohme (MSD), J&J, Roche, and Novartis.
David Kolář
Executive Director | Association of Innovative Pharmaceutical Industry
David Kolář is in his eighth year at the AIFP. He is mainly responsible for the strategic management of the association, development activities and the implementation of AIFP’s goals. He is a graduate of the Faculty of Law of Charles University, Prague and a member of the Czech Bar Association.
Jenni Nordborg
Director for International Affairs | Lif Sweden
Jenni Nordborg is an experienced policy maker with an in-depth systemic overview, active in strategic innovation policy development and implementation within health and life science on national and international levels. She has experience from senior management positions in both the private and public sectors, an entrepreneurial background from the commercialisation of research, and worked with international collaborations and marketing and sales management. Jenni established and headed the Office for Life Sciences at the Government Offices of Sweden. She was responsible for the Swedish National Life Sciences Strategy and was previously the Director and Head of the Health Division at Vinnova. She is an active board member in life sciences investments and health economics research.
The bios will be continuously updated in the coming days.
Location
Basic information
The Permanent representation is located close to the city center, within walking distance from the European Parliament (5 minutes) and the seat of the European Council and the European Commission on the Schuman Roundabout (15 minutes).
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Organisers
Auspices
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Contact person
Jakub Nikl
Association of Innovative Pharmaceutical Industry
Project Manager Specialist
+420 731 281 263
events@aifp.cz