Free samples for pharmacist: RX no, OTC yes?
Novartis sued ratiopharm to cease and desist from distributing, to pharmacists, free samples of the medicinal product Diclo-ratiopharm-Schmerzgel.
Novartis claimed 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. That distribution therefore amounts to the granting of prohibited advertising gifts.
The German Bundesgerichtshof (Federal Court of Justice, Germany) requested the Court of Justice to interpret the Community code relating to medicinal products for human use (‘the code’) in that regard. It had doubts as to whether that code authorises pharmaceutical companies to distribute free samples of medicinal products to pharmacists.
By judgment C-786/18 of June 11, 2020, the Court held that the Community code relating to medicinal products for human use does not authorise pharmaceutical companies to distribute to pharmacists free samples of medicinal products available only on prescription.
Nevertheless, the code does not prohibit the distribution to pharmacists of free samples of medicinal products for which a prescription is not required.
According to the Court, the code 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 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 familiarise themselves with new medicinal products and acquire experience with their use.
Consequently EU law does not prohibit the distribution to pharmacists of free samples of OTC medicinal products. This judgment consequently might also change the Austrian law on free samples for OTC products.