May 29, 2014

Heading in a Different Direction? The European Medicine Agency’s Policy on the Public Release of Clinical Trials Data

EMA study cover graphicThe purpose of this briefing paper is to examine and compare the draft guidelines issued in 2013 by the European Medicines Agency (EMA), titled “Publication and Access to Clinical-Trial Data,” with existing practices in the European Union (EU) and internationally regarding regulatory data protection and data transparency initiatives.

The paper has as its conceptual starting point the unique situation that arises when a biopharmaceutical product is submitted and evaluated for market approval. Specifically, the fact that the trade secrets and data generated by a biopharmaceutical innovator in the pursuit of developing a new product or technology is (prior to the product being allowed to enter a given market) required to be deposited with a governmental or regulatory body for evaluation. Under these circumstances, the regulatory or governmental body charged with evaluating these trade secrets and data becomes a custodian of them. In return, this body grants a form of protection and a commitment not to release or rely on the information submitted by the innovator in its evaluation of other product applications unless authorized to do so by the innovator.

The core question examined in this paper is where control over these deposited trade secrets and data—which have not been created by the relevant regulator or governmental body—resides. Does it reside with the regulator and evaluator of the trade secret or with the innovator who invested the time, financial resources, and effort to create the actual secret? This question is at the heart of how regulatory agencies such as the EMA are shaping their disclosure and transparency policies on submitted biopharmaceutical tests and clinical data.

The paper looks at the legal and conceptual basis for providing terms of data protection and the different core elements that make up a pharmaceutical regulatory data protection (RDP) framework and examines current international practices as they relate to RDP, the protection of submitted regulatory test data, and regulatory disclosure and transparency initiatives. Case study analysis of the clinical trials and data transparency and disclosure policies in place is provided for four major markets: the EU, United States, Canada, and Australia.

Key Findings:

First, that the EMA guidelines on data transparency are a break from preceding EMA practices, in which the release of clinical test data and related information did not take place. The agency’s change in policy raises fundamental questions about its views on the inherent confidentiality of the data submitted to it as part of a market authorization application as well as its role as a custodian of this information.

Second, the paper finds that while drug regulatory authorities in all the case-studied countries are considering and consulting on the issue of increasing clinical trial transparency, no country is seeking to emulate EMA’s policy in full. The U.S. Food and Drug Administration (FDA) in its “Transparency Initiative” launched in 2010, made a clear distinction between the manner and, more important, the extent to which “summary” versus “non-summary” clinical trials data would be published and placed in the public domain. Although the agency’s most recent (June 2013) consultations are not as clear, they nevertheless still differ significantly from the EMA’s. Other countries’ proposed initiatives are also cognizant of the need to balance greater clinical trials transparency with the need to protect proprietary and confidential information. For example, the Australian drug regulatory authority TGA (Therapeutic Goods Administration) in its own transparency proposals is not proposing to proactively publish this information. The agency is also statutorily obliged to consult with the owner of the information prior to the disclosure or publication of the information.

Third, the EMA’s proposed policies also stand in stark contrast to those initiatives taken by the private sector and research-based biopharmaceutical manufacturers. Beginning in 2014, members of the European and American biopharmaceutical trade associations EFPIA and PhRMA have committed to increasing transparency and release of information and data relating to their clinical research. These initiatives include enhanced data sharing with scientific researchers, making publicly available synopses of clinical study reports as well as a renewed commitment to seek publication of all clinical research results regardless of the research outcome.

Finally, the new transparency policies put in place by the EMA may have unintended consequences and result in placing commercially confidential information into the public domain not only in the EU but also internationally. A number of countries and legal jurisdictions predicate the protection of information on that information not already being in the public domain. Generally speaking, multinational and international biopharmaceutical manufacturers obtain such protection independently in each legal jurisdiction in which they wish to operate. Manufacturers must apply for marketing authorization in each jurisdiction. The publication of large volumes of clinical trials and test data submitted as part of a marketing authorization application in one country or jurisdiction risks putting into the public domain a significant amount of information that may be used by applicants in other jurisdictions as part of new market authorization applications for the same product or technology. Consequently, mechanisms such as RDP that are contingent on the information submitted in a marketing authorization application being protected and not  publicly available, may not be available to manufacturers as a result of the EMA’s disclosure of the same or similar information. The case of Australia provides a scenario that illustrates the potential for this to happen.


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