The decision is found illegal for not having displayed the rationale of such a decision.
This is a consequence of the Directive 89/105/CEE relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (the “Transparency Directive”). A new piece to the case law, the Conseil d’Etat, has started to build for a couple of years, which will have significant impact on the relationship between the French payers and pharmaceutical companies.
The French administration is therefore under the obligation to state the reasons for all its decisions relating to reimbursement. This obligation may reveal particularly burdensome in cases where it has the possibility to implicitly reject a request.
1. Extension of the scope of the obligation to state reasons
In June 2018, the Ministry of Health registered Trimbow, a product authorized for the treatment of chronic obstructive pulmonary disease, in the lists of reimbursed products. On July 4, 2018, the order was amended in order to condition the reimbursement to the prescription by a specialized pulmonologist.As a reminder, Article 6, paragraph 2 of the Directive provides that “any decision not to include a medicinal product in the list of products covered by the health insurance system shall contain a statement of reasons based upon objective and verifiable criteria, including, if appropriate, any expert opinions or recommendations on which the decision is based. In addition, the applicant shall be informed of the remedies available to him under the laws in force and of the time limits allowed for applying for such remedies”.
The interpretation of this provision gave rise to one of the few questions referred by the Conseil d’Etat to the European Court of Justice (“ECJ”). On April 16, 2015, the ECJ ruled that an extensive interpretation of these provisions should prevail. Despite the fact that they refer to refusal decisions, they should also apply to circumstances where a product is delisted from a specific reimbursement list (liste en sus) and, more generally, any and all decisions affecting the conditions or level of reimbursement. The Court recalled that the Transparence Directive aims at encompassing all decisions controlling prices or strengthening the conditions of reimbursement (cases C-271/14 and C-273/15).
In November 2017, the Conseil d’Etat had already applied these provisions to annul an implicit decision refusing the inscription of a medicine on the lists of reimbursed products. The solution was particularly demanding on the CEPS and the Ministry, as it significantly reduced the possibility, under French law, to adopt implicit decision. The Conseil d’Etat nonetheless considered that, pursuant to the Transparence Directive, the applicants had the right to know the reasons of a refusal, and that it was not sufficient to know the Health Authority’s (HAS) opinion, which was not necessarily endorsed by the CEPS (Conseil d’Etat, 17 November 2017, Laboratoire AbbVie).
In the present case, the Ministry referred to the opinion of the HAS. However, the Conseil d’Etat notes that the opinion does not mention the reasons why the reimbursement should depend on the prescription by a specialist.
Such ruling therefore increases the obligation for the CEPS and the Ministry to carefully justify their negative decisions, the scope of which should be understood broadly.
2. Remedy against the absence of action against the HAS’ opinion?
This is not the sole interesting takeaway of such a ruling.In practice, the reasons that could be put forward by the CEPS are rather limited, as its decisions mainly rely on the therapeutic and cost-efficiency assessment carried out by the HAS.In the present case, the Conseil d’Etat noted that the HAS opinion did not detail the reasons why the prescription should be restricted to certain practitioners.However, it is settled case law that the opinions from the HAS cannot be challenged before administrative courts, as they are deemed preparatory opinions to administrative decisions (Conseil d’Etat, 17 November 2017, Laboratoire AbbVie).The Conseil d’Etat therefore found a way to indirectly control the HAS’ opinion. It may also be an additional step towards direct control of these opinions.