Inclusion on the list of reimbursable medicinal products

Inclusion on the list of reimbursable medicinal products, provided for by Article L. 162-17 of the French Social Security Code, is the decision by which the ministers responsible for health and social security admit a medicinal product to reimbursement by the national health insurance system when it is dispensed in a community pharmacy. It is made by ministerial order, at the company’s request, after an opinion of the Transparency Committee of the French National Authority for Health. A separate list, that of medicinal products approved for hospital use, concerns purchasing by healthcare institutions.

Conditions for inclusion

Inclusion requires a marketing authorisation and an actual clinical benefit that is at least low in the indication concerned. It may be limited to certain indications or to certain prescribing conditions. For a medicinal product with no improvement in actual clinical benefit, it is possible only if the product generates savings in the cost of treatment. Inclusion is granted for five years and is renewable, which gives rise to a reassessment by the Transparency Committee.

Procedure and time limits

In practice, the company files an application for inclusion and a price application at the same time. Directive 89/105/EEC, known as the Transparency Directive, requires Member States to decide on price and reimbursement within an overall period of one hundred and eighty days and to state reasons for refusals, indicating the available remedies. The time actually taken in France frequently exceeds that period, which fuels a recurring debate. Removal from the list follows an adversarial procedure and occurs in particular after an unfavourable reassessment.

Listing of generics and patents

A generic may obtain its authorisation, and then its inclusion on the list, before the expiry of the patent or certificate protecting the reference medicinal product. EU law precludes, at least as regards marketing authorisation, patent linkage, that is, making administrative decisions conditional on the absence of a patent. Inclusion does not, however, authorise the marketing of an infringing product. For the patent holder, publication of an inclusion order signals imminent entry and may justify a saisie-contrefaçon or an application for provisional measures.

Key points

Inclusion on the list moves the medicinal product from regulatory authorisation to the reimbursed market. Applications for inclusion and price should be filed as soon as authorisation is obtained, and the time limits monitored against the Transparency Directive. For a patent holder, monitoring the inclusion orders published in the Official Journal is an essential watch reflex ahead of any generic entry.

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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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