Find out today what the legal world will be talking about tomorrow.
Free samples of prescription medicines can’t be given to drugstores, ECJ rules. But leaves the door open for over-the-counter medications
The decision was based on a legal dispute between the pharmaceutical companies Novartis and Ratiopharm, both of which manufacture and sell pain-relieving gels containing the active ingredient Diclofenac. In 2013, Ratiopharm employees distributed free samples of their drug to pharmacies labeled "for demonstration purposes”. Novartis filed for injunctive relief on the grounds that the free samples constituted “unauthorized distribution of promotional gifts” whose distribution was prohibited under the Medicines Act. The Federal Court of Justice (BGH) stayed the proceedings as the case raised significant issues around the interpretation of European Union law. The BGH therefore approached the ECJ, submitting questions on the interpretation of the provision on free samples in the European Community Codex for medicinal products for human use (Directive 2001/83/EC). This took place via the so-called preliminary ruling procedure. The ECJ came to the conclusion that the European regulation must be interpreted to mean that it is not permitted to supply free samples of prescription medicines to pharmacists. Free samples of prescription medicines may only be given to persons who are allowed to prescribe such medicines. The ECJ justified this on the grounds that prescription drugs may not be used without medical supervision because of their effects and risks. However, it may be interesting and significant for the industry that the ECJ also made it clear that this European regulation does not prohibit drugstores from dispensing free samples of non-prescription medicines.
The ECJ decision once again illustrates the enormous hurdles companies face when marketing prescription drugs. It remains to be seen whether the ruling will open up brand new possibilities for advertising non-prescription drugs. A thorough, legal, examination of planned marketing projects is still advisable in order to avoid the risk of unnecessary costs due to possible regulation infringements.