Free samples of medicinal products to pharmacists. Yes or no?

In a dispute between two pharma companies in Germany, a question was raised about whether it was legal to distribute free samples of medicinal products to pharmacists. Plaintiff claims that such distribution is contrary to German Law on Medicinal Products which lists doctors but not pharmacists among those to whom free samples of medicinal products may be distributed (similar provision is contained also in the Slovak Act on Advertising).

A preliminary question was raised by the Federal Court of Justice, Germany, with the aim to obtain an interpretation of Article 96 (1) and (2) of the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended (the "Directive"), according to which free samples shall be provided on an exceptional basis only to persons qualified to prescribe them.

The Court ruled that the Directive does not authorise pharmaceutical companies to distribute to pharmacists free samples of medicinal products available only on prescription.

According to the Court, the Directive must be interpreted as meaning that only persons entitled to prescribe medicinal products subject to medical prescription, namely doctors, may receive free samples of such medicinal products, which thus excludes pharmacists. Such medicinal products may not be used without medical supervision in view of the danger that may arise from their use or the uncertainty regarding their effects.

Nevertheless, the Court has also concluded that the Directive does not prohibit the distribution to pharmacists of free samples of medicinal products for which a prescription is not required, so that the pharmacists can familiarise themselves with new medicinal products and acquire experience with their use. Such advertising however is subject to regulation on a national level.

According to the Slovak Advertising Act, the samples of medicinal products can be provided only to persons authorised to prescribed them, i.e doctors. From the wording of the relevant provisions of the Act, it seems that such restriction applies regardless of product cathegories. Whether the latest Court´s decision will have an impact on the interpretation of the Slovak Advertising Act, in particular with respect to the products for which a prescription is not required, or will open up space for new legislation remains to be seen.