Regulatory News

European Court Says French Decree Violated Transparency Rules

The European Court of Justice (ECJ) has issued a judgment clarifying EU transparency rules for products covered by national health insurance as they apply to ongoing legal battles in France.

The judgement pertains to two complaints filed against France's Minister for Finance and Public Accounts and the Minister for Social Affairs and Health over the removal of two medicines from the list of products covered by the country's health insurance scheme.

Background

The medicines in question are Alfalastin and Javlor, made by LFB Biomédicaments (LFB) and Pierre Fabre Médicament (PFM), respectively.

On 21 February 2012, a decree by the French government removed the medicines from the list of products covered by the national health insurance scheme. While the decree removed the products from the aforementioned list, they were still paid for by health insurance through fixed payments for the duration of hospitalization.

The plaintiffs in the case argued that the government was required to state its reasons for removing the products from the list, as the decree had the potential to lower the amount of reimbursement for their products. The French government countered by saying the decree did not, in effect, prevent the products from being covered.

The issue at the center of this case is whether the French government is required to give notice and reasoning to a company when a product's coverage is restricted.

The companies in the suits point to requirements found in Article 6(3) and 6(5) of Council Directive 89/105/EEC, which state:

"Article 6 – The following provisions shall apply if a medicinal product is covered by the national health insurance system only after the competent authorities have decided to include the medicinal product concerned in a positive list of medicinal products covered by the national health insurance system:

3. Before the date [31 December 1989] referred to in Article 11 (1), Member States shall publish in an appropriate publication and communicate to the Commission the criteria which are to be taken into account by the competent authorities in deciding whether or not to include medicinal products on the lists.

5. Any decision to exclude a product from the list of products covered by the health insurance system shall contain a statement of reasons based on objective and verifiable criteria. Such decisions, including, if appropriate, any expert opinions or recommendations on which the decisions are based, shall be communicat

 

ed to the person responsible, who shall be informed of the remedies available to him under the laws in force and the time limits allowed for applying for such remedies."

ECJ's Judgment

France's Conseil d’État (Council of the State), which originally heard the cases last year, found that the decree in question did not have "the effect of excluding the medicinal products … from the list of proprietary products covered by health insurance," as the products are still paid for by fixed payments during hospitalization. However, the companies argued that Articles 6(3) and 6(5) of Council Directive 89/105/EEC still apply, as previous judgments have led to the Article 6 being interpreted broadly by the courts.

To get clarification on the issue, the Conseil d’État forwarded its questions to the ECJ. The ECJ accepted the companies' claim, finding that even though the decree did not exclude the products from coverage, "the decision does change the terms or level of reimbursement for those medicinal products and may thus restrict the conditions of reimbursement or reduce the level of coverage."

The ECJ went on to rule that the intent of Council Directive 89/105/EEC is to "ensure transparency of pricing … and to provide public access to pricing arrangements for all those involved."

 In this view, the ECJ ruled that Member States must give reasons per Articles 6(3) and 6(5) for any "decision which restricts the conditions of reimbursement or reduces the level of coverage of a medicinal product by excluding it from the list of proprietary medicinal products covered by compulsory health insurance schemes in addition to services relating to hospital treatment covered by fixed payments in respect of periods of hospitalization and hospital care."

ECJ Ruling