EMA Postpones Clinical Trial Regulations

The European Medicines Agency (EMA) announced in a press release that it has postponed its rules for clinical trials and publication of data. The EMA had planned to present the final rules in June 2014 but is now working on publication for October 2014. The agency has been struggling to develop policies in the absence of a legal framework, such as the new European Union (EU) Clinical Trial Regulations drafted by the Council of the European Union which is slated to go into effect no earlier than mid-2016. EMA management says that it “remains committed to introducing this additional measure towards transparency as soon as possible, so as to enhance citizens’ awareness and confidence in the EU authorization system for medicinal products.”

EMA Postponement

The postponement occurred because the agency was having a difficult time striking an appropriate balance between making records transparent without compromising personal data or proprietary industry data. The EMA states that clarifications are needed pursuant to its agreement with the EU and Article 80 of Regulation (EC) No 726/2004. EMA Board members intend to discuss practicalities and wording of the regulations internally and externally with stakeholders. The Board has indicated support for the existing policy, especially the user-friendly process to download, save, or print data. The EMA says that this additional period for reflection will help address the technical aspects of the rules as well as the political and ethical issues that have arisen.

Need for Regulations

The EMA states that delays in implementing regulations prevent citizens, academics, and non-commercial researchers from “enjoying the benefits of proactive publication of clinical trial data.” The pharmaceutical industry is concerned that the benefits to the public conflict with its need to contain commercially confidential information (CCI).

The EMA’s postponement action is, in part, an effort to eliminate industry’s objections to the new rules by enacting procedures to protect sensitive information, proprietary data, and intellectual property (IP). The industry could expect measures such as redaction, blocking text that the EMA deems sensitive. The industry would have a clear set of procedures to allay its concerns over CCI or other objections to the regulations.

Interested parties can review the EMA’s guidance on CCI. The document defines the different types of information including CCI (Commercially Confidential Information), PPD (Protected Personal Data), CBC (Case-by-Case Analysis), and CBR (Can Be Released).