Access to toxicity study reports and protection of commercial interests

Pharmaceuticals 8 min
November 22, 2019

Gerard Hogan, Advocate General at the Court of Justice of the European Union (“CJEU”) recently delivered an opinion in the pending case between MSD Animal Health Innovation (“MSD”), Intervet international (“Intervet”) and the European Medicines Agency (“EMA”).[1] In his opinion, due to their commercial value toxicity study reports are covered by a general presumption of confidentiality and their disclosure may only be granted under very strict conditions.

Accordingly, Advocate General Hogan recommends the annulment of the General Court’s previous judgment, which ruled in favour of the widest possible access to such reports. Although the Advocate General’s opinions are not binding this position illustrates the ongoing contest before the CJEU on one of the major topics for the life-science industry.

Facts of the matter

The case concerned the access to toxicology test reports held by the EMA which were submitted in the context of a market authorisation application.

In 2014, Intervet received authorisation to market Bravecto, a veterinary medicinal product used to treat tick and flea infestations in dogs. MSD was the sponsor of five toxicology tests which were submitted to the EMA in the form of detailed non-clinical trial reports.

A third party requested access to the five toxicology reports contained in the Bravecto file on the basis of Regulation 1049/2001 regarding public access to European Parliament, Council and Commission documents (“Regulation 1049/2001”). The EMA informed MSD and Intervet its intention to disclose three of the toxicology reports and invited them to send their proposed redactions.

MSD and Intervet argued however, that all of the toxicology reports were subject to a general presumption of confidentiality. They asserted that such confidentiality was necessary to avoid the reuse of the toxicity test reports in connection with any new market authorisation applications and they provided specific redactions to the reports accordingly.

However, the EMA decided to grant access to the concerned documents with redactions over only the concentration range of the active substance, the standards used for the analytical tests and the references to future development plans. After several discussions between the parties, the EMA confirmed its decision to disclose the documents which, in its view, were not confidential.

MSD and Intervet sought annulment of the EMA’s decision before the General Court.

Judgment of the General Court: Favouring the widest access possible to toxicology reports

In its judgment dated 5 February 2018,[2] the General Court decided to reject MSD’s and Intervet’s action for annulment.

To provide context to the judgment, Article 4 of Regulation 1049/2001 lists exceptions where a European institution shall refuse access to a document it possesses. In order to apply for one of these exceptions, the concerned European institution should carry out a specific and individual examination of the content of every document subject to the request.

The CJEU has previously allowed a European institution to rely on general presumptions for certain categories of documents.[3] In such circumstances the burden of proof to rely on one of the Article 4 exceptions has been softened. It is sufficient for the concerned institution to find that the document subject to a request for access belongs to a category of documents falling within one of the Article 4 exceptions – without the need to conduct a thorough analysis of the document itself.

So far, the CJEU has recognised five categories of documents which enjoy general presumptions of confidentiality:

  • documents in an administrative file relating to a procedure for reviewing State aid;
  • submissions lodged in proceedings before the courts of the European Union, as long as those proceedings remain pending;
  • documents exchanged between the Commission and notifying parties or third parties in the course of merger control proceedings;
  • documents relating to an infringement procedure during its pre-litigation stage; and
  • documents relating to proceedings under Article 101 TFEU.[4]

In the case between MSD, Intervet and the EMA, the General Court was asked to recognise a new category of document, finding that

no general presumption of confidentiality existed over the toxicology studies. The reasoning behind the General Court’s conclusion was twofold:

  • the toxicology test reports did not relate to an ongoing administrative or judicial procedure; and
  • Regulation (EC) No 726/2004 applicable to authorisation of medicinal products for human and veterinary use does not contain specific rules restricting access to documents.

In addition, the General Court considered that the infringement of the protection of the commercial interests of a person is not necessarily determined by reference to the financial value of the information subject to disclosure. It must be shown that the documents at issue contain elements which may, if disclosed, seriously undermine the commercial interests of a legal person. In particular, where the requested documents contain commercially sensitive information relating to the business strategies of the undertakings concerned, to their commercial relations or where those documents contain information particular to that undertaking which reveal its expertise.

Finally, the General Court considered whether the applicable legislation, particularly Directive 2001/82,[5] was sufficient to avoid the possibility of a third party using the toxicity study reports to circumvent data exclusivity.

MSD and Intervet decided to appeal to the CJEU.

In sharp contrast: The Advocate General’s Opinion finding in favour of the most effective protection possible for commercial interests

In contrast with the position of the General Court, Advocate General Hogan considered that the toxicity study reports benefited from a general presumption of confidentiality.

In order for this general presumption of confidentiality to be applicable, it is not necessary for the set of documents concerned to belong to a file relating to ongoing administrative or judicial proceedings. It is sufficient to assess whether the disclosure of the type of document would undermine the interest protected by the exception in question.

As far as toxicology test reports are concerned, the Advocate General stressed the fact that the granting of access to such documents would undermine the commercial interests of applicants and the investments of know-how, finance and time in submitting test reports for market authorisation.

In the case at hand, the Advocate General pointed out that Bravecto was tested on more than 2,000 dogs with the longest toxicity test lasting 90 days and involving daily administration. The preparation of this study was undoubtedly costly and time consuming.

As a result, the Advocate General considered that toxicology test reports constitute a category of document covered by a general presumption of confidentiality. Access to such documents would undermine the interest protected by the exception for commercially confidential information.

Another point of disagreement between Advocate General Hogan and the General Court is the definition of “commercial interest” in Regulation 1049/2001. Unlike the General Court, the Advocate General considered that “novelty” is not an indispensable prerequisite to consider a document to be commercially sensitive. In his opinion, the General Court erred in considering that in order to be commercially sensitive, the documents at issue should seriously undermine the commercial interests of a legal person. In doing so, the General Court used an elevated standard to assess whether the disclosure of the toxicity study reports were contrary to Regulation 1049/2001.

Finally, Advocate General Hogan considered that current European regulations, such as Directive 2001/82, do not provide effective protection to toxicology test reports as they are only applicable within the territory of the European Union and European Economic Area. There is a real risk that non-redacted parts of a toxicity study report might subsequently be used outside of the European Union in an application for a market authorisation for a generic product even prior to the end of the data exclusivity period.

Stay tuned…

The ball is now in the court of the CJEU. As explained above, Advocate General Hogan disagrees, on several aspects, with the position of the General Court. These aspects are not specific to the case at hand. They concern issues of principle in the field of access to documents detained by European institutions, more particularly toxicity study reports submitted to the EMA as part of a market authorisation request. One of the points on which the judgment of the CJEU is highly anticipated is whether or not toxicity study reports should be considered as a new category of documents which enjoy presumptions of confidentiality even when they do not belong to a file relating to ongoing administrative or judicial proceedings.

In any event, the decision of the CJEU will have a significant impact not only on the current case-law of the General Court, but also on the practice of market players in the life sciences industry and the EMA.

[1] C-178/18 P – MSD Animal Health Innovation and Intervet International v EMA

[2] T-729/15, EU:T:2018:67

[3] C-57/16 P – ClientEarth v Commission – EU:C:2018:660, paragraph 79

[4] C-57/16 P – EU:C:2018:660, paragraph 81

[5] On the Community code relating to veterinary medicinal products

Written by
Kevin Munungu
Kevin Munungu
I am an associate in the Regulatory, Public & Administrative Law department in our Brussels office. I advise both Belgian and international clients on regulatory matters across several sectors. I offer both contentious and non-contentious advice to Belgian and international clients in regulated sectors, such as life sciences, and food and beverages. My areas of expertise include European public procurement and related litigation.

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