An open door to more open access to Agency documents? The General Court rulings on the EMA transparency policy

By Sabrina Röttger-Wirtz

Transparency is a persistently hot topic with regard to European Agencies. Especially the balance between granting access to documents and the protection of commercially confidential information, which might be contained in documents that third parties submit to Agencies in the context of administrative procedures, seems to be rather difficult to strike.

As Emilia Korkea-Aho and Päivi Leino already discussed in a TARN blog post in December, the legal frameworks governing access to documents, ownership of such documents, and copyright protection seem to intersect rather than interact, leading to a lack of legal certainty regarding the publication of documents by European Agencies. Recent judgements by the General Court in the field of pharmaceuticals now provide some guidance on this difficult conundrum.

The three cases concern access to documents requests addressed to the European Medicines Agency. In the case  Case T-718/15, PTC Therapeutics International v EMA, the access to documents request from a pharma company concerned a clinical study report submitted by another company in the context of a marketing authorization procedure for medicinal products. The two other cases also concerned competitor access to documents submitted to the EMA by companies concerning similarity and superiority reports with regard to an orphan medicinal product (Case T-235/15, Pari Pharma v EMA) and toxicology tests for a veterinary medicine ( Case T-729/15, MSD Animal Health Innovation and Intervet International).

In all these cases, the EMA wanted to grant access to the respective documents, while the companies that had submitted the documents to the Agency in the first place challenged the EMA for granting access in front of the Court. The central question in all of these cases was if the respective documents would benefit from a general presumption of confidentiality, or alternatively, if parts of the documents fall under the exception of Article 4(2) of Regulation 1049/2011 on access to documents. Article 4(2) of Regulation 1049/2011 protects commercial interests from access to documents, unless an overriding reason of public interest would justify the publication.

Why are these cases so interesting? On the one hand, because they provide an

insight into how the General Court strikes a balance between transparency and protecting commercial interests. On the other hand, because the General Court makes some interesting statements about the general purpose of transparency of Agency activities.

With regard to the question of commercially sensitive information, the Court ruled in all three cases that once the administrative proceedings of a marketing authorization application have been finalized, the reports drawn up by the Agencies scientific committees, containing all the documents concerned in the cases, are not subject to a general presumption of confidentiality. This means that the EMA carries out an assessment of each individual document to see if it contains commercially sensitive information.

In this regard, none of the companies could convince the Court that the information they deemed commercially sensitive would indeed avail itself of the protection of Article 4(2) of Regulation 1049/2011. According to the Court, this exception to the general rule of access, justified by the protection of commercial interests, has to be strictly delimited. It requires that publication would seriously damage commercial interests, and this damage has to be proven extensively. In the case Pari Pharma v EMA the Court examines this in detail in paragraphs 61-79. According to the Court ‘it is for the applicant to show how access to that document could specifically and actually undermine the interest protected.’ Moreover, the Court gave further indication upon which type of information could be deemed commercially sensitive in the first place, which includes business strategies or ‘information particular to that undertaking which reveals its expertise’. Merely compiling publicly available studies or scientific reports will not satisfy this hurdle, whereas adding value to such data by drawing novel scientific conclusions or developing an inventive strategy can satisfy the conditions.

So why does the General Court delimit the commercially sensitive information so strictly? The answer seems to lie in a commitment to enhancing transparency in Agency processes.

In Pari Pharma v EMA the Court states:

‘In the field of medicinal products, that requirement of transparency is justified by the need for supervision of the EMA’s activities and, in particular, by healthcare and research professionals, (…).’ (Paragraph 99)

However, the benefits of transparency are not medicines specific, as can be concluded from a statement of the Court in the case MSD Animal Health Innovation and Intervet International that seems to be equally viable for other European Agencies:

‘it should be pointed out that the transparency of the process followed by the EMA and the possibility to obtain access to the documents used by that agency’s experts to prepare their scientific assessment contribute to such an authority acquiring greater legitimacy in the eyes of the persons to whom that measure is addressed and to increasing their confidence in that authority and to ensuring the authority is more accountable to citizens in a democratic system.’ (Paragraph 44)

The EMA in this regard has celebrated the General Court rulings as confirmation of its transparency policy.

Now, one should make very clear that in all these cases, the beneficiaries of the access to documents were competitors with equally commercial rather than public interests.

However, as already pointed out by Emilia Korkea-Aho and Paivi Leino, especially in the area of chemicals, foodstuffs and medicines regulation, the respective Agencies increasingly deal with contentious issues of high public interest. The judgements of the General Court in this regard would open the door for European Agencies to be more transparent. It could enhance their willingness and ability to grant access to documents upon requests, but also to more proactively publish information which they might have been reluctant to share due to their potential commercially sensitive nature until now.

Finally, it should be noted that two of these judgements are now under appeal, so this topic will remain an area to watch for anyone interested in transparency of European administrative procedures.

Sabrina Röttger-Wirtz is Assistant Professor of EU Health Law at the Tilburg Institute for Law, Technology, and Society (TILT) at Tilburg University.


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