Pharmaceutical companies must not distribute free samples of medicinal products which are available only on prescription to pharmacists, the Court of Justice of the European Union (CJEU) has recently affirmed. The EU’s Community Code relating to medicinal products for human use prohibits such distribution.
EU law through what is termed as the Community Code regulates the authorisation of medicinal products for human use. It also lays down criteria for the sale, production, labelling, classification, distribution and advertising of such products within the EU.
The Code also makes provision for strict controls insofar as the advertising of medical products to the public is concerned. Any information which is given to the public must be presented objectively and cannot exaggerate an item’s properties. It must also not be misleading. As part of the information and advertising regulatory regime of medicinal products, the same Code also delineates what is permissible or otherwise insofar as the distribution of free samples of medicinal products is concerned.
In this regard, the law clearly states that free samples of medicinal products must be provided on an exceptional basis and only to persons qualified to prescribe them. Such distribution must also satisfy a number of conditions, such as, the fact that the number of samples for each medicinal product each year must be limited and that each sample must be marked ‘free medical sample – not for sale’ or must show some other wording having the same meaning. The Code also provides that member states may in their national laws place further restrictions on the distribution of samples of certain medicinal products.
EU ensures that medicinal products are administered and used safely by fully-informed consumers
The facts of this case which came before the CJEU were briefly as follows. The pharmaceutical company Novartis manufactures the medicinal product Voltaren Schmerzgel, a pain reliever gel containing the active substance diclofenac. It requested the German courts to prohibit the generic manufacturer Ratiopharm from distributing to pharmacists, free samples of the medicinal product Diclo-ratiopharm-Schmerzgel, which also contains diclofenac. Novartis claimed that such distribution is contrary to German law on medicinal products which specifies that free samples of medicinal products may be distributed to doctors but not pharmacists.
The German court seized of the case filed for a preliminary ruling from the CJEU, requesting guidance as to whether the EU’s Community Code permits the distribution of samples of medicinal products to pharmacists.
In its observations, the Court made a distinction between medicinal products available only on prescription and those which do not require any such medical prescription. It noted that the Community Code does not authorise pharmaceutical companies to distribute free samples of medicinal products available only on prescription to pharmacists. It affirmed that only persons entitled to prescribe such medicinal products, namely doctors, may receive free samples of such products. This is so since such medicinal products may not be used without medical supervision in view of the danger which may arise from their use or the uncertainty regarding their effects.
However, the CJEU went on to emphasise that the Code does not prohibit the distribution of free samples of medicinal products for which a prescription is not required to pharmacists, in order for the latter to familiarise themselves with new products and acquire experience with their use.
The objective of the EU’s legal framework for medicinal products is to ensure that there are high standards of quality and safety in place and this in order to safeguard the health of EU citizens. To this end, it does not only seek to guarantee that only safe products are placed on the market via an EU-wide marketing authorisation scheme but also to ensure that medicinal products are administered and used safely by fully-informed consumers.
Mariosa Vella Cardona, M’Jur, LL.D., freelance legal consultant