Can a medicinal product be required to be treated identically to other specialties?

The principle of equality requires the administration to settle identical situations in an identical manner^[1].

In a decision dated April 6, 2022, the Council of State provided interesting clarifications on the application of this principle between pharmaceutical specialties^[2].

At issue was the application by the ANSM of the regulation of poisonous substances. As a reminder, this regulation provides that : 

• in principle,  medicinal products classified as poisonous substances or containing such substances may only be supplied on medical prescription; 
• as an exception, the ANSM may exempt from this regime medicinal products containing classified substances in very low doses or concentrations or which are used for a very short treatment period (article R. 5132-2 of the Public health code).

A pharmaceutical company operating a medicinal product on list II (compulsory prescription) had asked the ANSM to allow its medicinal product – like its competitors – to be dispensed without a prescription. The ANSM rejected the request, considering that the contraindications and toxicity of the medicinal product prevented it from being classified in list II.

It is in this context that the laboratory appealed to the Council of State against the ANSM’s refusal decision, invoking in particular the violation of the principle of equality.

The question asked to the Council of State was therefore the following: when can the principle of equality between medicinal products be usefully invoked?

The following is a summary of the similarities and differences between the two specialties compared by the the Council of State:

The Council of State considered that the specialties examined were closely comparable in terms of their effects, their mode of action and their place in the therapeutic strategy, and that they presented the same risk profile. It concluded that the ANSM had disregarded the principle of equality and therefore annulled the decision refusing the benefit of the exemption from the regulation of poisonous substances.

In practice, what can we learn from this ruling ?

Firstly, for manufacturers exploiting medicinal products classified as poisonous substances or containing such substances: 

• when closely comparable medicinal products with the same risk profile are not treated identically (particularly with regard to prescription rules), the “disadvantaged” laboratory should be able to obtain the restoration of equality with its competitors; 
• however, the ANSM is free to re-establish equality by aligning the medicinal products either with the most unfavourable treatment or with the most favorable treatment. Following the Council of State ruling of April 6, 2022, the ANSM could therefore make ibuprofen subject to compulsory prescription, rather than making fenoprofen subject to optional prescription. 

Secondly, for all manufacturers of health products, the clarifications provided by the Council of State d’Etat could be usefully invoked on the conditions governing the reimbursement of health products and possibly the setting of their price.