ECJ - Free Supply of Medicine Samples to Pharmacists "For Demonstration Purposes"

• 19/04/2019
• Articles

The case-list of the Court of Justice of the European Union (“ECJ”) now features a request for a preliminary ruling submitted by the German Bundesgerichtshof (“BGH”) involving samples of medicines (see attached). The BGH seeks to learn whether the rules governing the supply of medicine samples to physicians as defined by Article 96 of Directive 2001/83/EC on the Community Code relating to medicinal products for human use could also be extended to pharmacists.
 
In a dispute with Ratiopharm, Novartis Consumer Health tries to prevent the supply of samples of a generic version of “Voltaren Schmerzgel” (active substance: diclofenac) “for demonstration purposes” to pharmacists. Depending on the regulatory framework, pharmacists play in many countries a crucial role in the competitive dynamics between pioneer pharmaceuticals and their generic copies. Despite the seemingly clear terms of Article 96, the BGH would still seem to harbour doubts regarding its applicability to pharmacists and regarding the compatibility with that provision of a statutory ban on supplying medicine samples to pharmacists.