EMA Enacts New Plan To Enhance Data Transparency

The European Medicines Agency (EMA) has enacted a new policy, effective January 1, 2015, compelling pharmaceutical companies to publicize clinical data from trials supporting regulatory applications for new medicines following the EMA's decision about the drug. The agency publicized its decision in a press release, stating that the policy goes into effect well before the EU’s Clinical Trial Regulations in 2016. The EMA expects the new policy to benefit patients and increase trust in the agency’s decisions. Additionally, the rules will benefit researchers as they access data sets, avoid duplication of trials, and develop new medicines faster.

Guido Rasi, EMA Executive Director, said, “The adoption of this policy sets a new standard for transparency in public health and pharmaceutical research and development. This unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia and industry.”

EMA Trial Policy

The new EMA policy, “European Medicines Agency policy on publication of clinical data for medicinal products for human use,” states that the available information will not contain commercially confidential information and cannot be used for commercial purposes. The agency may make decisions regarding redactions, limiting the publication of some information.

When the EMA released a draft of its plan in 2013, several companies filed suit, alleging that the policy infringed on their Intellectual Property (IP) rights. The Wall Street Journal reports that, even though the new policy has given researchers the right to print and view data away from a computer (a hot point of contention with earlier drafts), there are still several major concerns. Some of these include the fact that U.K. courts will handle any disputes about “terms of use,” as well as the fact that the “redaction of commercially confidential information” is unclear and could result in the elimination of info patients need to know about a drug’s performance in trials.

The EMA will implement the policy in phases beginning on January 1, 2015. The agency also intends to publish patient data with specific and detailed information on each individual. However, due to legal and technical issues, the EMA intends to implement those policies and procedures in the future. First, the agency intends to consult with patients, patient groups, physicians, and industry since, “it is critically important for EMA that the privacy of patients is adequately protected before their data are released.”

Transparency Procedure

When the policy goes into effect next year, the EMA will publish the clinical trial data and reports submitted in support of an application once the medicine has been approved. The agency will publish supporting data for indication extensions if the application was submitted after the policy took effect. The EMA notes that the new policy does not replace its existing document policy and that it will review the policy by June 2016 at the latest.