In the name of the freedom to inform on public health subjects, the Council of State decided, in a judgment rendered on Friday April 8, to push back the boundaries of business secrecy. In terms of principles, a new step forward is thus engraved in case law, on the occasion of a dispute that arose in 2018 in the context of the “Implant Files”.
This survey, conducted by 59 media, including The world, within the framework of the International Consortium of Investigative Journalists (ICIJ), had revealed deficiencies in the control, by the health authorities, of the placing on the market of medical devices (pacemakers, stents, vaginal wicks, etc.). Some devices marketed legally in Europe were defective, even dangerous.
The Council of State was seized of a dispute which for four years has opposed The world and its journalist Stéphane Horel to the organization having the monopoly in France of the certification of these materials, the National Metrology and Testing Laboratory (LNE) and the company GMED, which is a result of it. The daily had asked for the list of medical devices that had obtained the valuable certificate of “European conformity” (CE), as well as the list of those to which the French organization had refused this CE label.
Faced with the refusal by the certifying body, the newspaper had seized the Commission for Access to Administrative Documents (CADA), which, in a decision of October 25, 2018, had ruled that the communication of these elements “would be likely to infringe business secrecy”. French associations of journalists or the fight against corruption have denounced in this invocation an attack on the free circulation of ideas and information in a field of public interest.
“Question of general interest”
The case was therefore brought before the Paris administrative court, which, in a judgment of October 15, 2020, drove a first corner into this secrecy. Disavowing the CADA, the judges partially agreed with the World. The court gave LNE-GMED one month to communicate the list of medical devices already on the market having obtained the CE label from this body. “Communication of this information relating to medical devices already on the market contributes significantly to the public debate on a question of general interest and also allows better traceability of defective devices, in accordance with the public health objective of guaranteeing the safety and reliability of medical devices, said the judgement.
On the other hand, the court rejected the request concerning the materials which failed to obtain the label. Here again, the protection of the secrecy of the commercial strategies of the manufacturers was invoked. For The world, this decision was unsatisfactory, because one of the main flaws of the European system comes from the “shopping” practiced by certain manufacturers. A company having suffered a refusal in France has the right to submit its product to the certifying body of another member of the European Union, perhaps less demanding, and thus open the doors to the French market. A cassation appeal has been lodged against this judgment.
Contrary to what was pleaded The world and his lawyer, Patrice Spinosi, the Council of State confirms today the analysis of the administrative judge on the nature of the information which constitutes a refusal of certification. “The combined communication of the name of the medical devices subject to a CE marking application (…) and that of their manufacturers is likely to reveal the products which the latter have developed and which they plan to market and, consequently, to reveal their commercial strategy”, we read in the judgment. But, specifies the Council of State, the court “was based in particular on the fact that the risks that faulty medical devices would represent for public health remain theoretical as long as they have not been put on the market”. This is no longer the case as soon as they are marketed.
The right to inform takes precedence
Result, we read in the judgment, the business secrecy “cannot justify the refusal to communicate an administrative document after the products in question have been placed on the market. This secrecy cannot therefore legally justify the refusal to communicate the list of medical devices which have been placed on the market after the “CE” marking has been refused to them, in France, by the LNE or the company GMED, but has been issued by another assessment body within the European Union”.
As soon as a product is on the market, the right to inform, in particular in terms of public health, now takes precedence over the protection of business secrecy. This principle is enshrined rejoices Patrice Spinosi.
There remains the implementation of this principle in the particular case of this case. The Council of State refers to the administrative court the task of determining the practical methods and possibilities of communication of this list. And the high court goes so far as to warn that the court could refuse to impose such a communication “if the request would involve making inquiries with other bodies or would result in a disproportionate workload”. Because the certifying body is not informed of the products placed on the market…
The issue before the administrative court of Paris, again seized, will now be whether the right of access to these documents, officially enshrined today, could be reduced to nothing by practical considerations. Response in eight to twelve months. For the time being, the LNE-GMED, which the judges had ordered in 2020 to communicate within one month to the World a first list of documents, still did not run.