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France: Free samples of medicinal products only available on prescription must not be distributed by pharmaceutical companies

16 June 2020

On a judgment C-786/18 issued on 11 June 2020 (available in French here, the English translation has not been published yet), the Court of Justice of the European Union holds that pharmaceutical companies may not distribute to pharmacists free samples of medicinal products only available on prescription.

However, the Court specifies that EU law does not prohibit the distribution of free samples of medicinal products for which a prescription is not required.

In the case at hand, the pharmaceutical company Novartis Consumer Health GmbH manufactures a medicinal product called Voltaren Schmerzgel, which is a pain reliever gel containing the active substance diclofenac. Novartis asked the German courts to prohibit the generic manufacturer Ratiopharm GmbH from distributing, to German pharmacists, free samples of the medicinal product Diclo-ratiopharm-Schmerzgel, which contains the same active substance. The samples’ packaging bears the mention “for demonstration purposes”. Novartis claimed that such distribution is contrary to German Law which lists physicians but not pharmacists among those to whom free samples of medicinal products may be distributed. Novartis considers that this distribution is equivalent to the granting of prohibited advertising gifts. The German Federal Court of Justice (Bundesgerichtshof) requests the Court of Justice to interpret the Community code relating to medicinal products for human use as to whether it must be interpreted as meaning that pharmaceutical companies are entitled to distribute finished medicinal products free of charge to pharmacists when the packaging is marked “for demonstration purposes”.

According to the Court, the abovementioned code shall be interpreted as meaning that only persons entitled to prescribe medicinal products subject to medical prescription, namely physicians, may receive free samples of such medicinal products, which thus excludes pharmacists. Such medicinal products may not be used without medical supervision in light of the risk that may arise from their use or the effects uncertainty.

However, the Court of Justice specifies that the said code does not deprive pharmacists of the possibility, under national law, of receiving free samples of medicinal products for which a prescription is not required so that they can get acquainted with new medicinal products and acquire experience.