As if the fight for reasonable returns on investment into drug development, currently exemplified by the discussion on the pricing of innovative products, is not enough, the pharmaceutical industry is facing one of its biggest challenges in Europe: the protection of commercially confidential information ("CCI") contained in the marketing authorization dossier, the DNA of a product.

This Alert discusses the "Policy on Publication of Clinical Data for Medicinal Products for Human Use" adopted by the European Medicines Agency ("EMA") on October 2, 2014. It also summarizes the action points that industry should take to safeguard its investments in drug development.

Scope

This is the first part of EMA's endeavor to grant to the public access to data contained in marketing authorizations. The policy covers proactive disclosure, by EMA, of all clinical data in a marketing authorization dossier, except for the individual patient data. For those readers familiar with the Common Technical Document, or CTD, format, Modules 2.5, 2.7, 5, and the appendices thereto (Modules 16.1.1, 16.1.2, and 16.1.9) are at stake. In plain English: The clinical overviews, clinical summaries, clinical study reports, and their appendices, including the protocol and the documentation of statistical methods, are implicated. The title of the policy, referring to "clinical data," is a misnomer; obviously, the clinical study reports and the protocol also include a product's essential chemistry, manufacturing, quality, and pre-clinical information.

Timing

For applications filed as of January 1, 2015, and for line extension applications (variations) filed as of July 1, 2015, EMA will proactively release an application's clinical data in conjunction with the Agency's decision on the application, allowing the general public and researchers to access the data. 

Right of Access

The policy sets out a registration process and terms of use for the general public (with low registration hurdles, resulting in on-screen access only) and for research purposes (more detailed registration process, allowing download and printing of the data). The terms of use prescribe noncommercial use only, and the documents will be automatically watermarked against commercial use upon access. However, EMA explicitly rejects any responsibility for compliance with the terms of use, the technical hurdles can be easily overcome. The only sanction in the case of violation of the terms would be deregistration, which is not a relevant sanction.

Protection of CCI

From an industry perspective, the biggest challenge will be the protection of CCI. Industry is fighting an uphill battle from the start: EMA, in general, does not consider clinical data commercially confidential data. This is erroneous, without any legal basis, and in clear violation of the obligations of the European Union under the Agreement on Trade-Related Aspects of Intellectual Property, or TRIPS. The policy does set out, in Annex 3, categories of information that, in the eyes of EMA, "may be considered CCI." These include, for example, the product development rationale, certain pharmaceutical information, specifics on assays used by an applicant, etc. However, judging from EMA's position in pending disputes over the release of CCI, be it in the context of freedom-of-information requests ("FOI Requests") or the publication of the European Public Assessment Report, serious disputes are in store for industry over the scope of CCI.

The policy describes the process by which EMA aims at ensuring the protection of CCI. The applicant must submit a redacted version of the dossier, after submission of the application but before the Committee for Medicinal Products for Human Use issues its opinion, indicating the parts that the applicant deems commercially confidential. EMA will review this redacted version and decide whether or not to accept the redactions proposed by the applicant. To the extent EMA disagrees, a consultation process is started, during which the applicant may comment on the rejections of EMA. Based on this consultation, EMA intends to decide on the final version, which will be conveyed to the applicant. The policy is silent on any further remedies, but given that EMA is taking a decision on publication, the recourse to the EU General Court will be open as in the case of FOI Requests, i.e., a request for preliminary injunction, combined with an action to annul the decision and enjoining EMA from disclosure. 

Action Points for Industry

The implications are manifold. First and foremost, every applicant should be extremely careful to gauge which information is included in the marketing authorization application in the first place. Obviously, the essential information has to be provided in order to obtain the marketing authorization. However, all nonessential information should be revisited and removed from the application. 

In a second step, but ideally in parallel with the drafting of the application, a redacted version of the dossier should be compiled. This requires intense cooperation between the regulatory, intellectual property, business development, and marketing functions, and it will pose a daunting task to industry for its sheer complexity and volume of the review required. The applicant, in particular, has to ascertain to what extent information has already been released to the public; EMA will carry out a search for any information that the applicant claims to be confidential and will point the applicant to information contained in the European Public Assessment Report (which should be combed by the applicant for CCI in itself), the Summary of Product Characteristics, public dockets of patent infringement cases, scientific publications on the product, any information made public by another regulatory agency, etc. Search engines are powerful tools nowadays. Ideally, a CCI tracker tool is set up, capturing all information in a marketing authorization contained in the clinical data sections that the applicant deems confidential. This is a living document, which has to be continuously updated to take into account further dissemination of information on the product and to capture possible rejection by EMA, reasons for the rejection, and potential defenses. 

Third, every applicant has to prepare to fight EMA, in addition to substantive questions regarding the application itself, over the disclosure of CCI. A product "SWAT" team, comprising representatives of all functions who are deeply familiar with the dossier, should be created, in order to review and assess EMA's rejections of requested redactions. As a conservative estimate, and based on existing cases of disputes over disclosure involving essentially the same documents, applicants will want to protect 100 to 200 items of information within the summary sections alone. This figure does not even include the clinical study reports themselves, with their product-related information. 

Finally, every applicant has to prepare for litigation against EMA, on two fronts: to protect the CCI in clinical (and non-clinical) data contained in the dossier against proactive disclosure, and against the looming threat of FOI Requests by third parties beyond the proactive disclosure.