Early lessons from the ECJ on access to documents included in a marketing authorization dossier
The appellants sought to have the ECJ overturn the judgments of the General Court, which had dismissed their actions seeking annulment of the decisions under which the European Medicines Agency (EMA) had granted third parties access to documents containing information (namely toxicology reports and a clinical study report) submitted during the course of the MA procedure.
In this instance, the ECJ dismissed the appeals, confirming the General Court’s rulings and, consequently, the EMA’s decision to give third parties access to such documents (subject to some redaction), according to EU Regulation No. 1049/2001 regarding public access to documents held by EU institutions.
Principles stated by the ECJ
Under these rulings, the ECJ stated the following main principles:
- The application of a general presumption of confidentiality claimed by the appellants is merely an option for the institution concerned and the latter always retains the right to carry out a specific and individual examination of the documents to determine whether they are protected, in whole or in part, by one or more of the exceptions to public access set forth in Article 4 of Regulation No. 1049/2001;
- A person seeking application of one of the exceptions set forth in Article 4 of Regulation No. 1049/2001 must explain how access to those documents could specifically and concretely undermine the interests protected by one of those exceptions; in the cases in question, the ECJ found that before the ruling was issued claimants had not provided the EMA with an explanation of the nature, purpose, and scope of the data at issue, which supported the conclusion that there was a risk of misuse, and that they also had not specifically and precisely identified before the EMA the passages of the reports in question that could undermine their commercial interests if disclosed;
- The lawfulness of a decision relating to the disclosure of a document may be assessed only on the basis of the information available to the institution on the date on which it made that decision. (Accordingly, it was up to the appellants to submit to the EMA, during the administrative procedure, explanations concerning the nature, purpose, and scope of the data whose disclosure would undermine their commercial interests.)
Moreover, the appellants’ criticism of the decision made by the General Court relied on the concept that disclosure of the reports in question during the data-exclusivity period would seriously undermine the decision-making process regarding any applications for generic medicinal product MA during that period. For its part, the ECJ held that those relate to decision-making processes that are separate from the decision-making process concerning MA for medicinal products—a process that the General Court established had been completed on the date of the request for access to the reports in question.
Criteria for application of the new EMA policy
Such precedents are of great interest to both pharmaceutical companies and the EMA itself, not only in relation to managing access requests under Regulation No. 1049/2001, but also in relation to evaluating requests not to publish certain information generated by the performance of clinical trials in accordance with the new EMA policy (Policy/0070)—and, in the future, the EU Regulation on clinical trials.
In fact, the EMA policy on publication of clinical data for medicinal products for human use (Policy/0070), adopted by EMA on October 2, 2014 and then superseded by a new version adopted on March 21, 2019, introduced the EMA’s new approach to the transparency of clinical trial information (and, in particular, clinical reports and individual patient data). This went from reactive access, upon an interested party’s request, to proactive publication of the information, making it accessible to everyone.
The new European policy on transparency is grounded in inverting the approach to the confidentiality of clinical data: previously, the baseline was to consider such data confidential, with the possibility of giving access to a third party considered on a case by case basis; now the baseline is for the data to be considered public, except for certain types of information and in specific circumstances.
According to Policy/0070, clinical data shall be published only after a final decision on the marketing authorization application has been made by the EMA (or the request has been withdrawn by the applicant), in order to safeguard the EMA’s and the European Commission’s deliberations and decision-making processes.
As an exception to the transparency principle, Policy/0070 recognizes that in a limited number of cases, clinical data may also include confidential information. Therefore, the interested party may ask the EMA not to publish certain specific information, providing adequate justification for such redaction. One of the legitimate justifications not to publish certain clinical data is the protection of “commercially confidential information.”
How to protect commercially confidential information
“Commercially confidential information” (CCI) is defined in Policy/0070 as “any information contained in the clinical reports submitted to the Agency by the applicant/MAH that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH.” Therefore, applicants have to indicate the innovative content of the information they want to protect and explain how the disclosure of such information could undermine their legitimate economic interests. The policy does not actually help formulate these justifications. It only provides some support in identifying items in the clinical reports and common technical documentation for registration of medicinal products that might be considered CCI (see Annex 3 to the Policy/0070).
To support applicants in the redaction process, in March 2016 the EMA issued External Guidance on the Implementation of the EMA Policy (External Guidance), which provides instructions for identifying CCI (most recently updated in October 2018). In particular, EMA External Guidance clarifies which sections of clinical reports might contain CCI. This means that the applicant has to indicate which data included in those sections should be considered confidential and explain in detail the reasons for such confidentiality. The External Guidance also describes the redaction procedure in detail: the final decision is up to the EMA and the applicant is given a brief time period to ask the General Court to suspend the effectiveness of such a decision should it disagree with the EMA’s assessment. In such cases, the EMA limits publication to non-disputed data.
In consideration of the above, it is essential for the applicant to identify the information that it wants to keep confidential at the time of submission to the EMA of the dossier for marketing authorization for a medicinal product. Otherwise, the EMA will automatically argue that all the information contained in clinical reports can be published and the company will not have the opportunity to object.
Lessons learned from these ECJ judgments may be useful in focusing on criteria to be applied to support redaction requests and confirm that private companies need to be as specific and concrete as possible in describing the grounds for such requests and in explaining what serious and irreparable damage could be caused by disclosure.
Experience garnered during application of Regulation (EC) No. 1049/2001 and Policy 0070 will also help to set limits on publication of clinical trial information and guide any future assessment of the confidentiality requirements under Clinical Trial Regulation No. 536/2014 (CT Regulation). Indeed, one of the pillars of that CT Regulation is transparency of clinical trials, implemented by establishing a European database where all trials conducted in Europe will be recorded and made accessible to all European citizens.
 These judgments came after the General Court ordered interim measures suspending the EMA’s decisions in order to prevent “serious and irreparable harm” to the applicants’ interests. During these disputes, the General Court stated that the balance between the public health interest that pushes toward transparency and the private commercial interest that requires confidentiality is not so “obvious,” and disclosure requires a delicate assessment of the interests involved.