On 11 June 2020, the Court of Justice of the European Union (CJEU) confirmed that it is prohibited to distribute free samples of prescription-only medicines to pharmacists but clarified – against the Advocate General's opinion of 20 January 2020 – that the prohibition does not extend to over-the-counter (OTC) products.
Background
Before the German courts, Novartis successfully objected to the supply by Ratiopharm of free samples of a generic version of Novartis' Voltaren Schmerzgel (a pain relief gel with the active ingredient diclofenac) to pharmacists "for demonstration purposes". Ratiopharm appealed to the Bundesgerichtshof, which submitted a request for a preliminary ruling based on Article 96 of Directive (EU) No 2001/83/EC relating to medicinal products for human use (hereinafter the "Directive"). This provision permits, under strict conditions, the supply of free samples of medicinal products to persons qualified to prescribe them, i.e. physicians. In short, the Bundesgerichtshof asked the CJEU whether the supply of free samples under Article 96 of the Directive extends to pharmacists.
Distinction between prescription-only and OTC medicinal products
Article 96(1) of the Directive sets out the conditions under which samples of medicinal products can be provided to "persons qualified to prescribe medicinal products" (limitation on the number of samples, only upon written request, subject to an adequate system of control and accountability and an obligatory summary of product characteristics). Article 96(2) authorises the Member States to adopt more restrictive measures in this regard.
The CJEU confirmed that Article 96 cannot be interpreted as authorising the supply of free samples of medicinal products to pharmacists, since they do not belong to the category of "persons qualified to prescribe medicinal products".
However, the CJEU went on to find that Article 96(1) applies to prescription-only medicinal products, which are potentially dangerous and whose use requires supervision by a physician, not to all medicinal products. Article 96(2) must be read in conjunction with Article 96(1) and has the same scope. Consequently, it relates only to medicinal products requiring a prescription.
In its interpretation, the CJEU relied on the Directive's distinction between OTC and prescription-only medicinal products, including the impact of this distinction on the possibility to advertise the products. Prescription-only medicines give rise to certain risks in relation to their use or effects and require supervision by persons qualified to prescribe them. Over-the-counter medicinal products, on the other hand, are not associated with the same risks. The CJEU mentioned Recital 51, which states that, under certain restrictive conditions, it should be possible to provide samples of medicinal products free of charge to persons qualified to prescribe (i.e. physicians) or supply (i.e. pharmacists) them, so that they can familiarize themselves with new products and acquire experience in dealing with them.
These considerations led to the conclusion that the Directive allows the supply of free samples of medicinal products to pharmacists under national law, subject to strict conditions in keeping with the Directive's purpose and provided the products concerned do not require a prescription.
Application to Belgium: Royal Decree of 11 January 1993
In Belgium, the Royal Decree of 11 January 1993 restricts the supply of free samples of medicinal products to persons qualified to prescribe them and hospital pharmacies (Article 1 in conjunction with Articles 2 and 5).
As the CJEU ruled that national law cannot prohibit the supply to pharmacists of free samples of OTC medicinal products, Belgian law will have to be amended to allow for this possibility.
