Court of Justice of European Union Holds That Pharmacists Cannot Benefit From Free Samples of Prescription-Only Medicines
On 11 June 2020, the Court of Justice of the European Union (CJEU) held that under applicable European rules pharmaceutical companies are not allowed to supply free samples of prescription-only medicines to pharmacists (case C-786/18, ratiopharm GmbH v Novartis Consumer Health GmbH). By contrast, European rules do not stand in the way of national rules that would permit pharmacists to receive free samples of over-the-counter (OTC) medicines.
The case arose in Germany when Novartis, the then-holder of the marketing authorisation for Voltaren Schmerzgel ®, requested a German court to prohibit ratiopharm from distributing to pharmacists free samples of Diclo-ratiopharm-Schmerzgel ®, a medicine which, like Voltaren Schmerzgel ®, is based on the active substance diclofenac. At the relevant time, both medicines were in Germany only available on prescription.
According to Novartis, under German law, only physicians are allowed to receive free samples of prescription medicines. As a result, giving free samples to pharmacists amounts to a prohibited form of advertising. The litigation reached the CJEU which was requested to apply the Community Code governing medicinal products for human use as contained in Directive 2001/83/EEC (Community Code).
In response, the CJEU held that pursuant to Article 96 of the Community Code, only persons entitled to prescribe medicinal products subject to medical prescription can benefit from free samples. Therefore, only physicians qualify and not pharmacists. The CJEU considered that in restricting the group of potential beneficiaries of free samples of prescription-only medicines, the Community Code had sought to deal with a potential danger inherent in such medicines. According to the CJEU, OTC medicines do not present such a danger and this would explain the possibility for pharmacists to receive samples of medicines which belong to the OTC category. However, it remains to be seen whether the various Member State rules governing samples, gifts and the advertising of medicines will actually permit that possibility.
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