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16th June 2020
Consumer, Health & Environment Internal Market

Analysis: “The Court of Justice rules that EU law prohibits the distribution of free samples of prescription-based medications to pharmacists” by Johanna Jacobsson

On 11 June 2020, the Court of Justice gave its judgment in Ratiopharm (C-786/18), a preliminary ruling requested by the German Federal Court of Justice (Bundesgerichtshof) on the interpretation of Directive 2001/83/EC on the Community code relating to medicinal products for human use. At issue was whether Directive 2001/83 prohibits the distribution of free samples of medicinal products to pharmacists. If the answer was in the negative, it was asked whether the Directive leaves it open for the Member States to prohibit such distribution.

The German Court had highlighted in its preliminary ruling request that there are discrepancies between the different language versions of the Directive. While in most language versions the right to receive free samples of medicinal products is reserved to ‘persons qualified to prescribe them’ (Article 96(1) of the Directive), at least in the Greek and Polish versions the text refers both to persons qualified to prescribe medicinal products and to persons qualified to supply them. Instead of focusing on this discrepancy, the Court’s analysis is, however, based on the differentiation that the Directive makes between those medications that require a prescription and those that do not.

Based on the wording of Article 96 alone, it was not possible to settle whether the rules regarding free samples concern all medicinal products as defined in Article 1(2) of the Directive or only such medicinal products for which a prescription is required as defined in Article 1(19). Because of this uncertainty, the analysis of the Court of Justice interprets Article 96 through the general aims of the Directive and particularly in light of the second paragraph of its preamble, which recognises the need to safeguard public health as the essential aim of any rules governing the production, distribution and use of medicinal products. In the Court’s opinion, the protection of public health is thus the primary objective of the directive. At the same time, the Directive contributes to the objective of the free movement of medicinal products in the internal market.

Taking the need to safeguard public health as the starting point, the Court bases its conclusions on the differentiation between medications that require a prescription and those that do not. According to the Court, that differentiation is relevant also in light of the advertising rules to which Article 96 belongs. Those rules differ depending on whether a medication is subject to a prescription or not as advertising to the general public is allowed only for prescription-free medications. Considering the potential risks relating to prescribed medications and the need to control their use, read together with Article 96 which includes strict requirements that free samples of medicinal products must fulfil, the Court concluded that free samples of prescription-based medications can be distributed only to such persons that are qualified to prescribe them. Such a right cannot be extended to pharmacists.

To conclude, the Court clarified that the Directive nevertheless does not prohibit the distribution to pharmacists of free samples when they regard medicinal products for which a prescription is not required. National law can allow this practice so that pharmacists familiarise themselves with new medicinal products and acquire experience with their use.

The judgment once again underlines the importance of interpreting the EU’s secondary legislation in light of its context and purpose. Where the different language versions of the Directive were not entirely consistent, the Directive’s principal goal to safeguard public health led the Court to conclude that the possibility to provide free samples of prescription-based medications exists only with regard to those who are entitled to prescribe them. At the same time, the aim of the Directive is not to prohibit pharmaceutical companies from providing free samples of non-prescription based medications to pharmacists.

 

Johanna Jacobsson is Assistant Professor at IE University in Madrid, Spain. Her most recent publications include ‘Preferential Services Liberalization: The Case of the European Union and Federal States’ (Cambridge University Press 2019).

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