Borderline product and legal classification

A borderline product is a product whose legal classification wavers between several regimes, most often between the medicinal product and the medical device, the food supplement, the cosmetic product or the biocide. Classification determines the applicable regime, from the authorisation required to the rules on distribution and advertising. Directive 2001/83/EC resolves any doubt in favour of the medicinal products regime where, taking into account all its characteristics, a product may fall within both the definition of a medicinal product and that of a product covered by other Union legislation.

Classification criteria

A product is a medicinal product by presentation where it is presented as having properties for treating or preventing disease, and a medicinal product by function where it can restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or make a medical diagnosis. The Court of Justice requires a case-by-case assessment, taking into account composition, pharmacological properties as established by current scientific knowledge, manner of use, extent of distribution, consumers’ familiarity with the product and the risks associated with its use. A product with no significant effect on physiological functions at the doses used is not a medicinal product by function.

Authorities and tools

Classification is primarily a matter for national authorities, subject to review by the courts, with the risk of divergent outcomes from one Member State to another. The Commission publishes guidance documents and manuals on borderline products, which are not legally binding, and Regulation (EU) 2017/745 allows it to decide on the status of a product under medical devices legislation. In France, the ANSM rules on the status of a product, and incorrect classification exposes the operator to the penalties attached to breach of the pharmaceutical monopoly or to placing on the market without authorisation.

Patent implications

Classification has consequences for intellectual property protection. Only a product authorised as a medicinal product can benefit from a supplementary protection certificate and from data exclusivity. The same substance may be claimed for a therapeutic use, in the form of a second medical use, and for a cosmetic use, which escapes the exclusion of methods of treatment. The boundary between cosmetic and therapeutic effect then becomes an issue of validity and scope of the claims, assessed in the light of the patent description and the technical data available.

Key points

The classification of a borderline product determines its entire regime, and any doubt operates in favour of the medicinal products regime. It depends as much on the product’s presentation as on its actual effects at the doses used. Classification should be checked before any launch and before any claim is drafted, since a poorly calibrated health claim can tip a food supplement or a cosmetic into the medicinal products regime.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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