2023 Programme
08 June 2023

opening words

Arnaud Thysen
Director General
European Business Summits


Sandra Gallina

Europe’s Revision of the Pharmaceutical Package Legislation: Delivering for the next 20 years

Sandra Gallina

István Ujhelyi
Member of the European Parliament

Sirpa Pietikäinen
Member of the European Parliament

Antonella Cardone
Cancer Patients Europe
Laura Campo
Executive Director International Corporate Affairs, Alzheimer’s Disease
Eli Lilly and Company
Mariam Zaidi
Euronews, Euractiv, NBC

With the publication of the proposed revision to Europe’s pharmaceutical legislation seeking to ‘future proof’ the regulatory framework and address availability, access, and affordability of medicines, what are going to be the dividing and unifying issues underpinning the debate as Member States and the European Parliament review the legislative text? Central to the revision is striking a balance between improving patient access to medicines across and within the EU’s 27 Member States, whilst attracting investment and boost Europe’s competitiveness in innovation on the global stage. Does the Commission’s proposal meet expectations, from economic competitiveness through to equity of access? As Europe continues to recover from the COVID-19 pandemic, with ongoing and pressing issues of medicines shortages, we look at where the legislation offers up solutions, and where more work may need to be done outside of that process.

Will Europe miss out on the next wave of innovation?

Lilia Luchianov
Policy Officer

Elisabetta Zanon
Director of EU Public Affairs and Advocacy
Alliance for Regenerative Medicine

Heike Prinz
Head of Commercial Operations EMEA for the Pharmaceuticals Division
ExCo Member at Bayer AG

Enrico Lugli
Group Leader and Head of Facility
Humanitas Research Hospital

Elizabeth Kuiper
Associate Director
European Policy Centre

Mariam Zaidi
Euronews, Euractiv, NBC

We have entered a new era of medicine with breakthrough innovation, fuelled by the convergence of biology, chemistry, data, leading to new therapy options that could potentially stop or reverse progression of a disease. Europe has extensive expertise in the biotech sector, something which became clear in the fight against the pandemic. We have a diverse research landscape, with almost half of the world’s top 100 life science universities located in Europe. However, innovation in Europe doesn’t get translated into patents and products as efficiently as it should, and it comes at a cost to patients in Europe. We want to ensure that patients and Europe don’t miss out.

The review of the Pharma Legislation can be an opportunity to future-proof Europe’s innovation ecosystem. But some of the current proposals under discussion would be detrimental to the European Innovation agenda if adopted.

The current system and regulatory conditions in Europe sometimes hinder, rather than promote success. This can be seen with advanced therapy medicinal products (ATMPs). This new era of medicines with breakthrough technologies such as Cell and Gene Therapies (CGT) is not addressed in the current proposal of the Commission. We need to scale up frameworks that enable translating European cutting-edge science into concrete innovations.

Resilient EU Health Systems - How to secure patient access to supply critical medicines?

Csaba Kontor
Health Attaché
Permanent Representation of Hungary to the European Union

Martine Pergent
International Patient Organization for Primary Immunodeficiencies

Patrick Stockebrandt
Head of Division
Centre for European Policy

Ruediger Gatermann
Senior Director EU Policy Strategy
CSL Behring

Mehul Mehta
Chief Medical Officer
Dentons Global Advisors

Sarah-Taïssir Bencharif
EU Health Journalist

The COVID-19 pandemic has placed the notion of health systems resilience at the center of the stage at European and global political levels, prompting efforts to strengthen the capacity of health systems to forecast, prevent, detect, absorb, adapt and respond to a wide range of shocks as well as longer term stresses. 

The crisis exacerbated challenges with continuity of supply of essential medicines and health systems’ readiness to ensure timely patients’ access. This situation has stimulated debates over Europe’s strategic autonomy and calls for the scale up of strategies to prevent and mitigate future crisis issues. The debate over availability has proved particularly relevant in the context of plasma-derived medicinal products (PDMPs) such as immunoglobulins where the starting material, human plasma, is marked by a geographical imbalance in supply and dependency on third countries. In this session, speakers will discuss upcoming changes in existing legislative frameworks (e.g., SoHO Regulation General Pharmaceutical Legislation) and their impact on the plasma ecosystem; and exchange on the relevance of supply continuity measures for health systems resilience and rare disease patients’ care.

12:30 – 12:35

closing words

Arnaud Thysen
Director General
European Business Summits

How to get to residence Palace

It is advised to take the public transport as parking space is not available at Residence Palace. 

Metro stop: Schuman, Maalbeek

Bus stop: Brussels Toulouse

Nearest Parking lots: Parking Indigo Bruxelles Thon, Interparking Loi Wet, BePark- Parking Gare de Schuman, BePark- Parking Maelbeek