The EU Court of Justice ruled on Thursday 11 June that pharmaceutical companies may distribute samples of medicines free of charge provided that they are not subject to a prescription (Case C-786/18).
This judgment follows a preliminary ruling by the Federal Court of Justice in Germany (Bundesgerichtshof) on the interpretation to be given to the Community code relating to medicinal products for human use (Directive 2001/83/EC). The pharmaceutical company Novartis, which manufactures the pain-relieving gel Voltaren Schmerzgel, wanted the distribution of samples of Diclo-ratiopharm-Schmerzgel by the generic manufacturer Radiopharm to pharmacists to be banned. Novartis based its argument on the fact that German law mentions doctors, but not pharmacists, as recipients of free samples.
In its judgment, the EU judge suggests that a distinction should be made between pharmacists and doctors with regard to medicines subject to medical prescription. It takes the view that Directive 2001/83/EC does not authorise pharmaceutical companies to distribute samples of prescription-only medicines free of charge to pharmacists, that competence being reserved to doctors, who alone are entitled to prescribe such medicines because of the danger involved in their use or the uncertainty surrounding their effects.
However, it does allow pharmacists to receive samples of non-prescription drugs “so that they can become familiar with new medicines and gain experience with their use”.
See the ruling (in French): https://bit.ly/37lcxWZ (Original version in French by Sophie Petitjean)