• Competition and intellectual property law
• Medical data and innovative technologies
• Access to medicines in the context of Brexit

On 21 November 2018, the Court of Justice of the European Union adopted its awaited Lucentis / Avastin decision (CJEU, case C-29/17) . This new judgement on the reimbursement of medicinal products used off-label has a major impact for the pharmaceutical sector. 

For more information on the impact of this case and on other recent developments in the pharmaceutical sector, 
please click here.

Objective 

This annual conference will bring legal practitioners working with the pharmaceutical sector up-to-date on the latest relevant regulatory developments, legislative initiatives and case law.

Key Topics 

Competition law 
Recent rulings from the CJEU and ongoing European Commission cases on pay for delay, off-label use and more

Patent law 
SPC manufacturing waiver, specific mechanism for parallel imports

Data exclusivity
Revised EU definition of similar orphan designations, impact of recent General Court rulings on significant benefit

Emerging legal issues linked to new technologies and Digital Health
3-D printing and artificial intelligence, medical data, data sharing and “personalised medicines”

EU pharmaceutical law round-up
Recent developments on pricing and access to medicines, HTA post 2020, Brexit “preparedness” 

Networking 

This conference is a great opportunity to meet and network with speakers and participants from whole Europe.

Who should attend? 

In-house counsel, lawyers in private practice, lawyers in national ministries and authorities dealing with regulation of the sector

Online registration and programme

Languages: English

Organiser: Academy of European Law (ERA), Florence Hartmann-Vareilles

Event number: 219R05

   Speakers 

Rainer Becker, Head of Unit, DG COMP, European Commission, Brussels

Peter Bogaert, Partner, Covington & Burling, Brussels

Martin Fitzgerald, Deputy Director General, GIRP (European Healthcare Distribution Association), Brussels

Edith Frénoy, Director, Market Access/HTA, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels

Emmanuelle Huck, Programme/Policy Officer, DG CNECT, European Commission, Brussels

Catherine Longeval, Partner, Van Bael & Bellis, Brussels

Lokke Moerel, Professor, University of Tilburg, Senior Of Counsel, Morrison & Foerster, Berlin

Ingo Müller, Lawyer, Kohlpharma, Merzig

Alexander Natz, Secretary General, EUCOPE, Brussels

Jörg Plessl, Director, EU Affiliates, Regulatory Affairs, Norgine, Wettenberg

Christian Tillmanns, Partner, Meisterernst Rechstanwälte, Munich

Laura Whiting, Counsel, Freshfields Bruckhaus Deringer, London