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20 January 2021
In 2018 the so-called 'implant files' journalistic investigation concerning the certification and control of medical devices put on the market made media headlines.
In this context, the Société éditrice du Monde newspaper requested access to certain documents held by the National Metrology and Testing Laboratory (LNE) and its affiliate GMED, the French certification body for medical devices.
This request was rejected and in May 2018 the Société éditrice du Monde seized the Commission for Access to Administrative Documents (CADA, the French independent administrative body which is in charge of ensuring freedom of access to administrative documents and public archives), which must be seized prior to any judicial proceeding on this topic.
The request specifically concerned the communication of:
On 25 October 2018 CADA rejected the Société éditrice du Monde's request.
When handing down its opinion, CADA first examined whether GMED – a company wholly owned by the LNE, a public industrial and commercial body – could be concerned by the legal provisions allowing access to administrative documents.
CADA considered that the medical device certification bodies were accomplishing a mission of general interest, pursuant to which they were invested with prerogatives of public power. As a result, CADA found that these bodies were entrusted with a public service mission and thus fell within the scope of Article L 300-2 of the Code of Relations Between the Public and the Administration, which defines 'administrative documents'.
However, CADA refused to give access to the requested documents on the basis that such communication would prejudice business secrecy pursuant to Article L 311-6 of the Code of Relations between the Public and the Administration, which, along with Article L 311-5,(1) limits the right to the communication of administrative documents to the public on request provided by Article L 311-1 of the code.
CADA also considered that the list of medical devices which had been refused CE markings could not be communicated due to the fact that such communication would shine a spotlight on manufacturers' behaviour, which could prejudice them.
The implant files have again become the centre of media attention due to a ruling handed down by the Paris Lower Administrative Court on 15 October 2020, which was seized pursuant to CADA's refusal to grant the Société éditrice du Monde's request and the LNE and GMED's refusal to communicate the requested documents.
Qualification of requested documents
In regard to the question of the qualification of the documents detained by GMED, the court adopted a similar approach to CADA and ruled that:
Assessment of infringement of business secrecy
However, in considering whether any limitation could apply to the communication request, the court did not reach the same decision as CADA, which had adopted a more global position.
The court considered that the communication of the list of medical devices which had been given a CE marking by the LNE or GMED and which had been put on the market did not infringe the business secrecy of the commercial or industrial strategies of manufacturers which had asked for such certification. Moreover, the court added that this list would contain only the name of the medical devices at stake and would violate no secret in relation to trade processes or economic or financial information.
However, the court found that the communication of the list of medical devices which had not been put on the market – either because the CE marking had been refused or because of the manufacturer's commercial strategy – would violate the secrecy of the manufacturers' commercial and industrial strategies as it would expose their intention to commercialise a specific medical device in the future.
Assessment of infringement of freedom of expression
The Paris Lower Administrative Court also examined whether the limitation of communication allowed by Article 311-6 of the Code of Relations between the Public and the Administration contravened Article 10 of the European Convention on Human Rights on the freedom of expression in the present case.
The court applied the well-known proportionality principle and ruled that access to all information detained by a public authority could not be granted but that communication was possible when such information was decisive for exercising freedom of expression and, in particular, freedom to receive and communicate information. In this context, the following should be considered:
The court added that refusal to grant access to the requested information would amount to interfering with the exercise of the right of freedom of expression. However, this could be justified if it:
In the present case, the court found as follows:
This decision highlights the inherent difficulty which lies in balancing various contradictory – but nonetheless important – rights. Notably, the court made a detailed analysis of the interests at stake and their application to the communication request, resulting in it being partially granted.
In light of the sensitivity of the context, this decision may be appealed.
For further information on this topic please contact Armand Aviges or Delphine Lapillonne at Altana by telephone (+33 0 1 79 97 93 00) or email (firstname.lastname@example.org or email@example.com). The Altana website can be accessed at www.altanalaw.com.
(1) Article L 311-5 sets specific limits in relation to the particular sensitivity of the document in light of its administrative nature and Article L 311-6 limits communication which, in certain specific cases, could prejudice a third party.
The exercise of these freedoms, since it carries with it duties and responsibilities, may be subject to such formalities, conditions, restrictions or penalties as are prescribed by law and are necessary in a democratic society, in the interests of national security, territorial integrity or public safety, for the prevention of disorder or crime, for the protection of health or morals, for the protection of the reputation or rights of others, for preventing the disclosure of information received in confidence, or for maintaining the authority and impartiality of the judiciary.
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