Pharmaceutical monopoly

The pharmaceutical monopoly reserves to pharmacists the preparation of medicinal products for human use, their wholesale, their retail sale and their dispensing to the public, together with those of certain other products exhaustively listed in the French Public Health Code. It is coupled with a monopoly of pharmaceutical establishments over manufacture, import, exploitation and wholesale distribution. It is justified by the protection of public health, which EU law recognises as a legitimate ground for restricting trade.

Scope of the monopoly

The monopoly covers all products meeting the definition of a medicinal product, including medicinal products by presentation, together with certain neighbouring products, such as certain dressings and the medicinal plants listed in the pharmacopoeia. Regulations release certain plants and certain categories of products from it. Food supplements, cosmetics and parapharmacy products may be sold freely, provided they do not claim curative or preventive properties that would cause them to be classified as medicinal products.

Interplay with EU law

The Court of Justice of the European Union accepts that Member States may reserve the retail sale of medicinal products to pharmacists and prohibit the distance selling of prescription-only medicinal products, in the name of public health protection. It nonetheless reviews the proportionality of restrictions that go beyond that objective. Directive 2011/62/EU harmonised the framework for the online sale of medicines, which in France remains an activity of the community pharmacy.

Sanctions for breach of the monopoly

The illegal practice of pharmacy is a criminal offence, and the French Chamber of Pharmacists may join the proceedings as a civil party. A breach of the monopoly may also ground an unfair competition action by competing pharmacists, since the operator that sells products covered by the monopoly without meeting its conditions frees itself from regulations its competitors comply with. This monopoly over professional practice has nothing to do with the exclusive right of exploitation conferred by patent rights, which belongs to the owner of the invention.

Key points

The pharmaceutical monopoly determines who may prepare, distribute and sell a medicinal product. The classification of the product should be checked before any plan to distribute outside pharmacies, because the borderline between a medicinal product and a consumer product governs the application of the monopoly. For a protected medicinal product, this professional monopoly operates alongside that of the patent holder without ever merging with it.

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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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