The circumstances in which clinical data concerning authorised medicinal products can be disclosed by the European Medicines Agency (EMA), continues to generate debate. In the recent case of Amicus Therapeutics v European Medicines Agency (EMA) (Case T-33/17), the General Court (Second Chamber) of the European Union has confirmed that there is no general presumption of confidentiality of certain categories of documents submitted in the context of a marketing authorisation application, and in particular clinical study reports.
Recent years have seen a growing demand for transparency concerning the clinical data on which regulatory decisions are based. On the one hand patient groups and researchers have sought a better understanding of regulatory decisions based on clinical data, whilst on the other, companies are of course keen to access and make use of the clinical data of their competitors.
Broadly speaking, clinical data submitted and held by the EMA can be accessed in one of two ways: through the EMA’s dedicated website of clinical data published following the grant of a marketing authorisation; or by making a public access request in accordance with Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents (Regulation 1049/2001).
Under both routes, there are exceptions to accessing certain data where its disclosure would undermine commercial interests (including intellectual property rights) unless there is an overriding public interest in disclosure. These exceptions are outlined in the EMA’s conditions for publishing data on its website, and in Article 4(2) of Regulation 1049/2001 which provides an exception to disclosure of commercially sensitive information following receipt of an access request.
One of the ongoing problems in this area has been the scope of the exception and what constitutes commercially sensitive information, and the extent to which it may be redacted. Hence, the courts have often become involved when there is disagreement over what should be withheld from disclosure, as in the present case.
Background to the dispute
In May 2016, Amicus Therapeutics UK, a developer of therapies to treat rare diseases, was granted a marketing authorisation and orphan designation by the EMA for its product ‘Galafold’, used to treat a genetic form of a lysosomal storage disorder (Fabry disease). In August 2016, the EMA informed Amicus that it had received a public access request under Regulation 1049/2001 for access to several documents relating to the marketing authorisation application dossier for Galafold.
In November 2016, the EMA invited Amicus to submit its comments on a batch of documents it was preparing to release, and which included the clinical study report submitted for Galafold. In response, Amicus proposed limited redactions to the clinical data in order to remove certain personal data. Later in November, the EMA informed Amicus of its intention to disclose the report, taking into consideration some, but not all, of the redactions proposed by Amicus. In response, Amicus informed the EMA that its position was now that it considered the clinical report to be commercially confidential in its entirety, and so should not be disclosed. Amicus also referred to pending proceedings in PTC Therapeutics v EMA (Case T-718/15) and requested that the EMA should not, in any event, disclose the report until the Court had interpreted the concept of commercially confidential information in that case.
The EMA refused to grant a deferment pending judgment in Case T-718/15, and stated that the Article 4 exceptions were to be applied strictly and that according to Article 4(6) of Regulation 1049/2001 access could only be refused if an exception applied to the entire contents of the document request, not just a part. In the EMA’s assessment, Amicus had not provided any evidence to show that every element of the report was commercially confidential. As a result, Amicus UK and its US parent company brought a claim before the General Court for the EMA’s decision to be annulled or in the alternative an injunction and remittal to the EMA for re-examination following consideration of further submissions by Amicus on which parts should be redacted.
The Court’s decision
The Court rejected Amicus’ alternative head of claim on the basis that it was well established that in an action for annulment, the jurisdiction of the Courts of the European Union is limited to reviewing the legality of the decision and that the Court may not issue directions to EU institutions.
The Court’s decision focused on the annulment claim, and made it clear that the existence of a general presumption of confidentiality of certain categories of documents constitutes an exception to the obligation imposed by Regulation No 1049/2001 to make a specific and individual assessment of each document, in order to determine if it falls within the scope of one of the exceptions provided by Article 4(2) of the Regulation.
Amicus argued that Regulation (EC) No 726/2004 concerning the procedures for authorising medicinal products contains detailed provisions on information held by the EMA that should not be disclosed in the context of this Regulation’s attempt to balance the legitimate public interest considerations with private rights and interests (confidentiality). Amicus further argued that Article 39(3) of the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) precludes the disclosure of commercially valuable information.
The Court rejected these arguments and held that there is no general presumption of confidentiality of certain categories of documents of a dossier submitted in the context of a marketing authorisation application for a medicinal product, and in particular clinical study reports. In arriving at this decision, the Court also gave consideration to the fact that the request for access was made following the grant of the marketing authorisation for Galafold, and so the requested report did not relate to an ongoing administrative procedure, and so the disclosure of the report could not in any way alter that procedure.
The Court also rejected the submission that Regulation (EC) No 726/2004 restricts access to documents to the ‘parties concerned’ or to ‘complainants’, and noted that this Regulation actually requires the EMA to proactively provide and publish three documents (the European Public Assessment Report (EPAR), a summary of characteristics, and a user leaflet), after deletion of all information of a commercially confidential nature.
In rejecting the applicants’ argument under TRIPS, the Court stated that Article 39 of the TRIPS Agreement cannot be interpreted to mean that protection of intellectual property rights must be given absolute precedence over the principle of disclosure of the information submitted in the context of a marketing authorisation application for an orphan medicinal product.
The Court also dismissed the second plea, that the only legally permissible outcome of a proper balancing exercise under Article 4 of Regulation 1049/2001, would have been a decision not to release the report at this time.
In rejecting both of Amicus’ pleas, the General Court has confirmed that clinical study reports cannot be considered to enjoy a general presumption of confidentiality on the implicit ground that they are, as a matter of principle and in their entirety, covered by the exception relating to the commercial interests of marketing authorisation applicants. Each document should be examined and considered individually for the purposes of the Article 4(2) exception.
Following this latest decision, it seems clear where the Court stands on the disconnect between what the EMA and what the pharmaceutical industry considers should be withheld from disclosure. In its assessment, and in considering the competing interests of both sides, the Court has favoured transparency and has indicated how the fundamental rights of pharmaceutical companies remain protected: their data is still eligible to enjoy a period of data exclusivity, and commercially sensitive information may be redacted, including information concerning the manufacturing process, and other technical and industrial specifications of the quality processes adopted to the manufacture the medicine.
In order to forestall any inadvertent public disclosure of commercially confidential information by the EMA, marketing authorisation applicants should familiarise themselves with the EMA’s policy and redaction principles. Particularly important is being aware that justification for the redaction is necessary; such justification being based on various factors, including the nature of the product concerned, the approval status in other jurisdictions and the competitive status of the therapeutic market.
It is interesting to note that data transparency is also a focus of the new Clinical Trials Regulation 536/2014/EU, which will become effective throughout the EU in 2019, and which will require full clinical study reports to be released following product authorisation, refusal or withdrawal.
Finally, as an aside, we note that as of August 1st 2018, the EMA has temporarily suspended all new activities related to clinical data publication as the agency prepares for its relocation to the Netherlands in light of Brexit.