The draft bill for the financing of the social security scheme for 2019, under discussion in the Parliament, contains, in its Article 43, amendment proposals to the French Public Health and Social Security Codes in favor of generic and hybrid drugs.
1. Generic substitution
The draft bill aims to increase the substitution rate of princeps drugs by their generic versions and proposes to amend Article L. 5125-23 of the Public Health Code and Article L. 162-16 of the Social Security Code to that effect.
Today, under Article L. 5125-23 of the Public Health Code, physicians can exclude the substitution of a reference drug by a generic of the same generic group by an express written mention “non substitutable”, and this for any “particular reasons relating to the patient”. These reasons do not have to be indicated on the prescription.
The draft bill proposes to limit the possibility for physicians to exclude substitution to medical situations to be specifically listed in an act (arrêté) of the Ministry of Health, following an opinion by the ANSM (the French Medicines Agency). The exclusion would have to be justified, notably on the prescription, following specific modalities to be specified in the same arrêté.
Concerning reimbursement, the draft bill also provides that, without medical justification excluding substitution, even where the prescription would refer to the proprietary medicinal product (and not to the INN only), the reimbursement of the patient would be limited to the reimbursement it would have obtained for the most expensive generic of the same group. Thus, a patient specifically requesting the reference drug would not be fully reimbursed.
If adopted, the amended provisions would be applicable as of 1 January 2019.
2. New status for hybrid drugs
The draft bill provides for the creation of a status for hybrid drugs, analogous to the one applicable to generic drugs:
- It proposes the following definition of hybrid drugs:
“Hybrid medicinal product of a reference medicinal product, a medicinal product that does not fall within the definition of a generic medicinal product because it comprises vis-à-vis the reference medicinal product differences relating to the therapeutic indications, strength, pharmaceutical form or route of administration, or where the bioequivalence vis-à-vis the reference medicinal product could not be demonstrated through bioavailability studies. The marketing authorization of a hybrid medicinal product is based at least partly on the results of the appropriate preclinical and clinical studies determined depending on these differences” (draft amended Article L. 5121-1 CSP)
This definition is inspired by Article 10(3) of Directive 200/83 and Article R. 5121-28 of the Public Health Code, requiring preclinical and clinical studies where a drug does not meet the conditions to qualify as a generic. A difference resides in the fact that a hybrid drug must have the same active substance as that of the reference drug.
- Like for generics, it is provided that the MA can be granted before the expiry of IP rights on the reference drug and that the ANSM informs the holder of the MA of the reference drug, upon grant of the MA of the hybrid drug (draft amended Article L. 5121-10 CSP).
- Similarly to what exists for generics, it proposes the creation of a hybrid group corresponding to the “grouping of a reference medicinal product and corresponding hybrid medicinal products” (draft amended Article L. 5121-1 CSP).
- It proposes the creation of a register of hybrid groups (draft amended Article L. 5121-10 CSP): the ANSM would be in charge of registering a hybrid drug in the register, under conditions to be specified by an implementing decree. This would apply only to classes of drugs to be listed in an arrêté (and not to all hybrid drugs, which differs from generics).
- Substitution among hybrids of the same group would be possible, but limited to medical situations listed in an arrêté, to take into account the specificities of hybrid drugs which although close to the reference drug present some differences.
The provisions relating to hybrid drugs, if adopted, would enter into force one year later, on 1 January 2020.