Proprietary medicinal product (spécialité pharmaceutique)

A proprietary medicinal product is a medicinal product prepared in advance, presented in a particular pack and identified by a special name. Defined by the French Public Health Code, it designates the industrially manufactured medicinal product as sold in pharmacies or dispensed in hospital, as opposed to preparations made for a specific patient or department. The proprietary medicinal product is the basic unit of pharmaceutical law, since it is the product that receives the marketing authorisation, the price and reimbursement.

Elements of the definition

Preparation in advance distinguishes the proprietary medicinal product from magistral and hospital preparations, made on request and outside any industrial channel. The particular pack refers to a defined presentation, with approved labelling and package leaflet. The special name is either an invented name, which must not be liable to confusion with the common name of the substance, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder. The Public Health Code also defines the generic proprietary medicinal product, in Article L. 5121-1, by reference to a reference proprietary medicinal product.

The regime of the proprietary medicinal product

Before being marketed, every proprietary medicinal product must obtain a marketing authorisation granted by the ANSM under Article L. 5121-8 of the Public Health Code, or by the European Commission under the centralised procedure. Each presentation may then be included on the list of reimbursable medicinal products provided for in Article L. 162-17 of the French Social Security Code. Its price is then set by agreement between the company and the Economic Committee for Health Products (CEPS) or, failing agreement, by decision of the Committee, in accordance with Article L. 162-16-4 of the same Code.

The name of the proprietary medicinal product and trade mark law

The invented name of a proprietary medicinal product is usually registered as a trade mark. It must avoid any risk of confusion with another medicinal product, which the health authority checks at the authorisation stage, and satisfy the conditions of trade mark law, which exclude descriptive signs and signs derived too directly from the common name. The two reviews are independent. A registered trade mark may be refused as the name of a medicinal product by the health authority, and acceptance of the name by that authority offers no protection against an infringement action based on an earlier trade mark.

Key points

A proprietary medicinal product is an industrial medicinal product prepared in advance, packaged and named, which receives the authorisation, the price and reimbursement. It is distinct from preparations made individually. Its name falls under both health authority review and trade mark law, two regimes that do not replace each other. Before choosing the name of a new proprietary medicinal product, a trade mark clearance search and a review of compatibility with existing medicinal product names should be carried out in parallel.

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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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