French Public Health Code
In forceI. - Except in cases of force majeure, in the event of a stock shortage of a medicinal product of major therapeutic interest for which a stock shortage or risk of a stock shortage presents a serious and immediate risk for patients, or of a vaccine mentioned in the second paragraph of article L. 5121-31, and where neither the medicinal product alternatives that may be available on national territory nor the measures communicated by the operating pharmaceutical company make it possible to cover national needs, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, after carrying out an adversarial procedure, require the defaulting pharmaceutical company to import any medicinal product alternative in proportion to its share in covering needs during the six months preceding the stock shortage, in accordance with the procedures laid down in Article L. 5124-13 and for the duration of the stock shortage.
The defaulting pharmaceutical company shall pay to the Caisse nationale de l'assurance maladie the difference between the amounts reimbursed by the health insurance scheme for the imported alternative and those which would have resulted from reimbursement for the initial medicinal product during the period of stock-out referred to in the first paragraph of this I, up to the limit of its share in the coverage of needs during the six months preceding the stock-out.
II. - Pharmacy pharmacies may dispense at retail level medicinal products with an import authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) to compensate for a shortage of a medicinal product of major therapeutic interest by decision of the Director General of the Agency, published on its website.
