AMBIENTUM BIOETHICA BIOLOGIA CHEMIA DIGITALIA DRAMATICA EDUCATIO ARTIS GYMNAST. ENGINEERING EPHEMERIDES EUROPAEA GEOGRAPHIA GEOLOGIA HISTORIA HISTORIA ARTIUM INFORMATICA IURISPRUDENTIA MATHEMATICA MUSICA NEGOTIA OECONOMICA PHILOLOGIA PHILOSOPHIA PHYSICA POLITICA PSYCHOLOGIA-PAEDAGOGIA SOCIOLOGIA THEOLOGIA CATHOLICA THEOLOGIA CATHOLICA LATIN THEOLOGIA GR.-CATH. VARAD THEOLOGIA ORTHODOXA THEOLOGIA REF. TRANSYLVAN
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Authors: JUANITA GOICOVICI.
DOI: 10.24193/SUBBiur.68(2023).1.4
Article history: Available online June 12, 2023; Available print July 19, 2023.
©2023 Studia UBB Iurisprudentia. Published by Babeş-Bolyai University.
pp. 100-127
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Abstract: The commentary addresses the issues of the role played by the perception of the ‘average consumer’ in the regimentation of a product in one of the categories of pharmaceutical products, through the lens of the interpretative directions retained by the C.J.E.U. in the text of the decisions pronounced in the joint cases C‑495/21, C‑496/21 and in case C-616/20, for the hypotheses in which the main mode of action of a product with potential therapeutic efficacy is not scientifically ascertained, not being accredited in based on research carried out by the manufacturer. Starting from the findings that, conceptually, that product does not correspond either to the definition of the notion of ‘medical device’ in the sense of the provisions of Directive 93/42, as amended by Directive 2007/47, nor to that of ‘medicine according to the criterion of function’, in the sense of the provisions of Directive 2001/83, as amended by Directive 2004/27, and the definition of the notion of ‘medicine according to the presentation criterion’, in the meaning retained in the text of Directive 2001/83, as amended by Directive 2004/ 27 involves reporting to the criterion of subjective perception generated to consumers, on the therapeutic functions of the product, C.J.E.U. held that the elements evoked by the referring court, such as the choices made by the manufacturer regarding the presentation of the product in question as having curative properties or being capable of mitigating pathological manifestations, the references to drug interactions and adverse reactions, as well as an exclusive distribution in pharmacies represent elements which, considered as an ensemble of aspects, „are capable of making the products concerned appear to an averagely well-informed consumer to have the properties of a pharmaceutical product”.
Key words: pharmaceutical products, average consumer, presentation criterion, therapeutic functionality, curative properties.
