Half day session on 17 November 2011
De Montil, Affligem

13h30 Introduction
Annabelle Bruyndonckx & Carla Sterk, BRAS Education Group

13h35 Legal Framework
Intellectual property rights used to protect medicines:
- Patents,
- Trademarks,
- SPC,
- Data exclusivity,
- Others
Parallel Import:
- Parallel import: at the crossroad between free movement of goods,
intellectual property rights and competition law
- Intellectual property rights used to combat parallel import
- Theory of Community exhaustion
- Repackaging: conditions and main issues
Counterfeiting:
New Directive on Falsified Medicine, as part of the Pharmaceutical Package, amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source
- Introduction (Context of the Directive)
- Definition of “falsified medicine”
- Monitoring of manufacturers and distributors of active ingredients
- New obligations imposed on the actors of the distribution network
- Main innovation: obligatory authenticity feature on the outer packaging and possible issues with repackaging in the framework of parallel import
Olivier Mignolet, Attorney, Simmons & Simmons LLP and lecturer at the Catholic
University of Louvain (UCL)
Jérémie Doornaert, Attorney, Simmons & Simmons LLP

14h35 A point of view from the Industry
Counterfeiters are more and more reactive and efficient to copy the genuine medicines, at least visually.
• How counterfeit medicines are putting patient health and safety at risk.
• How counterfeiters succeed to turn around the fences set up by legislations, regulations, controls and security measures.
• How a pharmaceutical company like Pfizer is handling this threat.
Pierre Souverain, Senior Manager Global Security Europe, Middle East and Africa, Pfizer

15h10 Questions & Answers

15h25 Coffee Break

15h40 Belgian Provisions on Parallel Import: an update
Belgian Legislation
Christine Putteman, FAMHP

16h10 Counterfeiting
- Legislation (European and Belgian legislation related to Customs)
- International initiatives: Medicrime Convention adopted by the Committee of
Ministers Council of Europe
- Real life examples and the internet
Roy Vancauwenberghe, Pharmacist-Inspector, FAMHP

17h00 Questions & Answers

17h15 End of the session
Annabelle Bruyndonckx & Carla Sterk, BRAS Education Group