The phenomenon of counterfeit medicinal products in the European Union has grown in recent years due to
the increasing amount of merchandise crossing borders. The European Union has responded to this challenge
by adopting a proposal for a Directive (COM(2008) 668 final) on the prevention of the entry into the legal
supply chain of medicinal products which are falsified in relation to their identity, history or source, and
submitted to a first parliamentary reading expected in September 2010.

This briefing, which will offer two different perspectives from the originator and the parallel trade, will present
and discuss the major issues of the proposal currently debated within the European Parliament, such as:

- Definitions of „falsified medicinal products“ and „brokering of medicinal products“
- Production in third countries and grey markets
- Transparency of the supply chain
- Cost of effectiveness of traceability systems
- New requirements for GMP and GDP (good manufacture and distribution practices)
- Consequences for Internet pharmacies and Internet sales
- Impact on parallel trade

Speakers:
Alexander Natz, Director of Brussels office, Bundesverband der Pharmazeutischen Industrie (BPI),
Brussels;

Thilo Bauroth, Member of the Board of Directors, Kohlpharma, Merzig

Chairperson: Peter Bogaert, Partner, Covington & Burling LLP, Brussels

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