The confidentiality of the information contained in the administrative file of a fixed-dose combination medicinal product and the need for an opinion on relevance in order to lift such level of protection

Rita Reyes

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In some recent and interesting proceedings, a Central Contentious Administrative Court in Madrid refused to provide further information contained in the administrative files of two pharmaceutical companies (codefendants) and hence the confidential information could not be obtained that was included in the registration files for fixed-dose combination medicinal products based on two authorised active ingredients for treating cholesterol.

The aforementioned judgements were ruled in two contentious administrative proceedings filed against the grant of two marketing authorisations for the fixed-dose combination of medicinal products in which the competent authorities (in this case the Spanish Medicine and Health Products Agency, with initials in Spanish “AEMPS”) had been requested to send the administrative files to the court, according to Article 48 of the Act regulating the contentious administrative jurisdiction (hereinafter referred to by its initials in Spanish “LJCA”).

The appellant claimed that the administrative files sent by the AEMPS were incomplete and hence requested the marketing authorisation applications for the medicinal products along with the Public Assessment Report (PAR).

The court agreed to provide the appellant with the PAR; however, it expressly stated that “the file to be submitted by the authorities must only include issues strictly related to the dispute in question and must exclude any other matters that fall outside the scope thereof, and when documents are involved that include both kinds of information (personal or confidential data), only the non-confidential information related to the dispute may be provided, but not the entire document”. The court therefore refused to provide the marketing authorisation applications of fixed-dose combination medicinal products to the appellant.

Subsequently, the appellant again requested the completion of the administrative file with documents that, according to the appellant, were relevant for the purposes of the claim. These documents were related to the marketing authorisation dossier which had been prepared in the reference Member State, as these were decentralised marketing authorisation procedures.

The decision of the court
The contentious administrative court deemed that the files did not need to be completed since that would far exceed the terms specified by the court regarding limited access to personal and confidential information.

The court criticised the lack of an opinion on relevance that would justify both the need for the requested documents in order to support specific aspects of the claim and the arguments that such information had no confidential content.

Regarding the aforementioned opinion on relevance, we should recall the explanations provided by Ms. Ana Isabel Martín Valero, a Senior Judge of the Contentious Administrative Division of the Spanish Court of Appeal, in her article “Confidential documents and contentious administrative proceedings” in which she states the following: “This opinion on relevance must in all cases be casuistic, as ruled by the Spanish Supreme Court, and requires the collaboration of the litigants seeking to revoke the confidentiality, which hold the burden to provide the reasons they consider exist to claim the removal of this level of protection and the resulting access to the protected documents. In this respect, it is the party requesting the documents to be provided that must not only prove such documents form an integral part of the administrative file, but must also provide arguments that the process of technical and legal reasoning resulting in the administrative decision cannot be checked by examining only the non-confidential documents, but requires a study of the protected documents, specifically each of the documents that are requested to be submitted. If the reasons provided for such purpose have a sufficiently good basis from the standpoint of the fundamental rights of defence and effective judicial protection, lifting the confidentiality obligation would be legally mandatory, otherwise, if the need to obtain the confidential material is not explained in a satisfactory manner, the protection that the legal system grants to the confidentiality must prevail”

In accordance with the foregoing, the court decided to refuse the new petitions to obtain further information included in the administrative files because such petitions lacked sufficient justification and were mere generic arguments.

The contentious administrative case law of the Spanish Supreme Court provides a series of criteria for the procedural treatment of confidential documents. The confidentiality afforded through administrative channels must also be applicable to contentious administrative proceedings and to the enforcement stage of the judgement, as a logical extension of the level of protection granted to the information contained in the file and provided by the defendant.

In this respect, it is “unacceptable to consider the contentious administrative appeal as a way of obtaining information about competing products or companies that is not available in any other manner, nor may the legal proceedings be used as an inquisitorial way for the appellant to obtain elements for a challenge that it did not originally have”, as pointed out by the court in the aforementioned proceedings.

The mere fact of lodging an appeal against an administrative decision cannot be used per se as an instrument to obtain confidential information from a third party, which is a competitor in the cases in question. In any case, the appellant holds the burden justify fully the need for certain information that is confidential and why this right, acknowledged by Spanish law, should be violated by merely filing a contentious administrative appeal.

It is one thing to be obliged to provide the company’s confidential information to the authorities so that they can assess whether or not the requirements imposed by the obligation to protect citizens’ health are met and quite another thing for a third party, a competitor, to challenge an administrative decision in order to obtain confidential information that such company, in its bilateral relationship with the public authorities, needed to submit in the process to obtain a marketing authorization, because something more than the mere abstract right to lodge an appeal would be required for such purpose.