CJEU

On 2 March 2023, the Court of Justice of the EU (“CJEU”) issued a preliminary ruling  clarifying various aspects around the classification of products as foods for special medical purposes (“FSMPs”).  The CJEU reinforced and supplemented its prior ruling in Case C-418/21 Orthomol (see our blog here for further details).

This case touches on a number of concepts in the FSMP definition.  As a reminder, Article 2(2)(g) of Regulation (EU) 609/2013 (the “FSG Regulation”) defines an ‘FSMP’ as:

“food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone” (emphasis added).

In summary, the CJEU concluded:

  • In determining the borderline between an FSMP and a medicine, all characteristics of the product need to be taken into account to determine whether it is intended to meet particular nutritional requirements or to prevent or cure human disease.
  • The concept of ‘dietary management’ has to be understood to require a link between the disease and the nutritional requirements arising from it, the satisfaction of which is indispensable to the patient.  The nutritional requirements do not necessarily have to be satisfied through digestion.  
  • The concept that the dietary management of the patient cannot be met through ‘modification of the normal diet alone’ means that meeting nutritional requirements through supplementing or changing the normal diet is impossible, dangerous or very difficult for the patient.
  • The term ‘nutrient’ has to be interpreted in accordance with Regulation (EU) 1169/2011 on food information to consumers (the “FIC Regulation”). 
  • A product is ‘used under medical supervision’, “if the recommendation and subsequent assessment of a health professional are necessary in light of the dietary management needs arising from a particular disease, disorder or health condition and the effects of the product on the patient’s dietary management and on the patient” (paragraph 81).
  • In determining the borderline between an FSMP and a food supplement, all characteristics of the product need to be taken into account to determine whether it is intended to meet the nutritional requirements of a patient that could not be achieved through regular diet or whether it is intended to supplement the normal diet.

Continue Reading CJEU Provides Further Clarifications on Food for Special Medical Purposes

On 22 December 2022, the Court of Justice of the European Union (CJEU) — sitting in Grand Chamber — published its judgement in case C-530, Euroaptieka. The judgement adds further commentary to the meaning of “advertising medicinal products” in the EU and the competencies of EU Member States to restrict drug advertising activities. The judgement has particular implications for advertising “unspecified medicinal products”. No doubt, this judgement will be of interest to pharmaceutical companies and pharmacies looking at the communications activities they carry out in the EU and the risks entailed.Continue Reading CJEU Rules on the Advertising of “Unspecified Medicinal Products” in the EU

On the 27 October 2022, the Court of Justice of the EU (“CJEU”) issued a preliminary ruling  regarding the definition of foods for special medical purposes (“FSMP”).  The CJEU held that for a food product to be classified as an FSMP, it must cover the increased or specific nutritional requirements caused by the disease.  It is not sufficient that the product counteracts the disease or alleviates its symptoms, as that would blur the lines between foods and medicinal products. 

1. Background to the Dispute

This ruling arose in the context of an action brought by Verband Sozialer Wettbewerb e.V. (“VSW”) against Orthomol pharmazeutische Vertriebs GmbH (“Orthomol”) regarding two Orthomol products classification as FSMPs.  This action was brought before the Landgericht Düsseldorf (Regional Court, Düsseldorf, Germany) at the first instance and was then appealed to the Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf, Germany) which then referred the case to the CJEU for a preliminary ruling. Continue Reading CJEU clarifies the Food for Special Medical Purposes Definition