Question 25510 — pharmacy and medications

Summary

Mr. Jean-Pierre Door draws the attention of the Minister of Solidarity and Health to the implementation of article 66 paragraph I. of Law No. 2018-1203 of December 22, 2018 on the financing of social security for 2019, which provides for the creation of a register of hybrid medicines and extends the right of pharmacists to substitute these hybrid medicines. The concept of hybrid specialty is covered in French law in the framework regulatory framework of the abbreviated procedure for obtaining a marketing authorization (AMM), this abbreviated procedure being a transposition, at national level, of the abbreviated procedure provided for in Article 10 of Directive 2001/83 EC establishing a Community code relating to medicinal products for human use. The demonstration of the effectiveness of a hybrid specialty cannot be done by bioequivalence studies as for the specialty generic. In this context, the National Agency for the Safety of Medicines and Health Products (ANSM) has already granted hybrid marketing authorization to certain medicines in an abbreviated procedure, with excipient compositions different from the reference specialty, without any formal clinical study of the medicine concerned, on the basis of a simple reference to clinical studies carried out on other products. Decree no. 2019-1192 of November 19, 2019 relating to the directory of generics, the register of hybrid groups and the abolition of the anti-tobacco fund defines the modalities for developing the register of hybrid groups and the procedures for registration and deletion of hybrid specialties and specialties referenced in this register. It entrusts the ANSM with the mission of ruling on the therapeutic classes concerned, the molecules substitutes and the rules of substitutability of this new category of medicinal products under French law, mentioning the nature of the differences observed between the hybrid specialty and the reference specialties of the hybrid group observed. He would therefore like it to indicate precisely the guarantees provided, particularly in terms of method, to be certain that patients do not risk being substituted with products whose the equivalence of effectiveness has not been demonstrated clinically or may cause more or less serious adverse effects, particularly in the case of chronic treatment.

Machine translation from French. The official text remains authoritative.

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