Toujeo: Decision of the Council of State of France (Conseil d’État) 1 August 2022 – Case No. 453036; ECLI:FR:CECHR:2022:453036.20220801

Ministers may not encourage the prescription of certain biological medicinal products in preference to others by using the concepts of “similar biological medicinal products” or “biosimilar medicinal products” in a sense that is different from that resulting from the provisions of Art. L. 5121-1 Public Health Code cited in para. 2. In order to take incentive measures applicable to medicinal products with all or some of the same therapeutic indications but not belonging to the same generic group or the same similar biological group as defined by Art. L. 5121-1 Public Health Code, the conditions under which the prescription of one medicinal product must, in such a situation, be considered more relevant and efficient than that of another must be specified. The ministers may take measures concerning the prescription of the first medicinal product, even though it does not belong to the same generic group or the same similar biological group as the second, provided that these medicinal products have in part the same therapeutic indications and that the measures taken by the ministers are intended to improve the relevance and efficiency of the prescription. By stating only that the medicinal products in this group share “overlapping therapeutic indications”, that they belong to the same anatomical, therapeutic and chemical class (ATC) recognised by the World Health Organization and that the development of alternative prescriptions is likely to “diversify the sources of supply” and “create financial flexibility” for the health insurance scheme by allowing competition through prices, the ministers do not justify the conditions in which the prescription of a similar biological medicinal product should be regarded as more relevant and more efficient. The concept of efficiency, as applied to hospital prescriptions supplied in general practice, presupposes an analysis of the costs, taken as a whole, imposed on the health insurance scheme by the assumption of costs implied by the different prescriptions relevant to a single therapeutic indication.