An interesting ruling by the highest court of Europe, the Court of Justice, rendered in June of last year might have slipped under your radar (if you were out enjoying the post-lockdown early summer). It was related to an article of the Community Code concerning free drug samples that has a huge impact on the pharmaceutical industry (‘the Code’). Previously, it was assumed that medicinal products could only be offered to (and by) those qualified to prescribe them, which basically means doctors. But the Court of Justice has now clarified that, under EU law, non-prescription drug samples can in principle also be distributed to pharmacists. This is a win-win situation for both pharmacists and pharmaceutical companies, not to mention the end consumer.
Pharmaceutical companies have the possibility to distribute free samples of non-prescription medicinal products to pharmacists so that they can get to know new products on the market in order to gain experience in dealing with them.
The benefit to pharmacists is also great – it allows them to stay informed and current about the latest available products, as well as being able to offer a better, more up-to-date service to their clientele.
In 2013, the German company Ratiopharm GmbH distributed free samples of a generic pain reliever gel with the active substance diclofenac to pharmacists within Germany. They were sued by Novartis (who has a competing product on the market called Voltaren Schmerzgel) for infringing the German Medicines Act (AMG). Novartis claimed that the distribution of the gel amounted to granting advertising gifts, which is illegal under national law.
The German Supreme Court (Bundesgerichthof) asked the Court of Justice to clarify the matter. In its reasoning, the Court of Justice made a clear distinction between prescription and non-prescription drugs. Because of the inherent potential risks of the former category, the distribution of free samples should be restricted and supervised by persons who are legally authorized to prescribe them, i.e. doctors. Non-prescription drugs, however, do not necessarily pose the same risks. For this and other reasons, the Court of Justice concluded that the Code does not prohibit the delivery of non-prescription drugs to pharmacists. After all, pharmacists too should have the possibility to be informed so that they can explain the use of the new medicinal products to patients or clients.
Keep in mind that, while pharmaceutical companies can freely give out samples of non-prescription medicine among its other forms of advertising, this can only happen as long as the benefit derived from it is relatively low. These free-of-charge medicines cannot be used for the purpose of promoting them to the public. And, here’s a slightly annoying, but important, footnote: despite the Court of Justice’s ruling, the laws in each Member State surrounding this issue might vary so be sure to check for locals differences.