Magistral and hospital preparations

Magistral and hospital preparations are medicinal products prepared by a pharmacist, without a marketing authorisation, to meet a need that no available or suitable proprietary medicinal product covers. Article L. 5121-1 of the French Public Health Code defines the magistral preparation, made up according to a medical prescription for a specific patient, and the hospital preparation, made up by a hospital pharmacy according to the pharmacopoeia and dispensed on prescription to one or more patients. The officinal preparation, made up according to the pharmacopoeia for the pharmacy’s patients, follows the same logic.

The regime

These preparations are exempt from marketing authorisation, since Directive 2001/83/EC excludes magistral and officinal formulae from its scope. They are subject to good preparation practice, and hospital preparations must be declared to the ANSM. They may not permanently replace an authorised and available proprietary medicinal product, as their justification lies in the absence of an alternative. During a shortage, the authorities may encourage their preparation to make up for the unavailability of a proprietary product.

The preparation exemption in patent law

Under Article L. 613-5 of the French Intellectual Property Code, the rights conferred by a patent do not extend to the extemporaneous preparation, for individual cases, of medicines in community pharmacies in accordance with a medical prescription, nor to acts concerning the medicines so prepared. The Agreement on a Unified Patent Court provides for an equivalent limitation for patents within its jurisdiction. The exemption is to be construed strictly. It requires an individual, extemporaneous and prescribed preparation, and does not cover series manufacture.

The question of hospital preparations

The French provision refers to community pharmacies. Its application to hospital preparations made up by hospital pharmacies, often in batches intended for several patients, is uncertain and debated. A hospital preparation reproducing a patented composition may therefore amount to infringement, and the question is particularly acute where institutions themselves prepare costly products. Patent rights then remain enforceable, subject to the ex officio licence in the interest of public health.

Key points

Magistral and hospital preparations fill the gap left by the absence of a suitable proprietary product, outside the marketing authorisation regime. Before preparing any protected product, it should be checked that the strict conditions of the preparation exemption are met. For hospital preparations made up in series, the freedom to operate analysis must be conducted as for industrial manufacture.

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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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