Access to Documents in the EU in the field of Pharmaceutical Law – Recent CJEU Rulings

The e-presentation critically analyses the impact of three recent rulings by the General Court related to the European Medicines Agency’s policy of access to documents. It gives a useful indication for applicants as to what might be considered in the future as commercially confidential information and offers useful advice on the drafting of clinical trial documents to be submitted to the EMA.

Brian Kelly

Information

Free version

This version of the e-presentation shows the complete e-presentation.

No certificate can be provided for using this version.

Start

Premium version

The premium version offers free navigation, downloadable slides, MP3 version, offline video version and the seminars background documentation as additional value.

It is also eligble for the acquisition of CPD points.

Buy

Question 1 of 3

Question 1: Under Art 4(2) of the Information Society Directive (Directive 2009/29) , the distribution right shall not be exhausted:

within the Community in respect of the original or copies of the work, except where the first sale or other transfer of ownership in the Community of that object is made by the right holder or with his consent.

at international level in respect of the original or copies of the work, except where the first sale or other transfer of ownership of that object is made by the right holder or with his consent.

within the Community in respect of the original of the work, except where the first sale or other transfer of ownership in the Community of that object is made by the right holder and without his consent.

Question 2 of 3

Question 2: According to the Information Society Directive, exhaustion of the distribution right applies:

to the intangible object of a protected work.

to the tangible object of a protected work.

to both intangible and tangible object of a protected work.

Question 3 of 3

Question 3: In order to avoid infringement of reproduction right, the original acquirer reselling copy of a computer program:

must make own copy unusable.

must make own copy usable for a limited time period.

must save a copy of the work.