Regulatory Focus™ > News Articles > EMA Releases Transparency Policy with Focus on a Tiered Release Model for Clinical Data

EMA Releases Transparency Policy with Focus on a Tiered Release Model for Clinical Data

Posted 25 June 2013 | By Alexander Gaffney, RAC

The European Medicines Agency (EMA) has released a draft policy for public consultation that calls for the publication of patient-level clinical trials data, laying out three categories for public data access that appear geared toward satisfying critics of the agency's data policy.


EMA has been moving toward a formal policy of clinical data transparency since at least November 2010, when it first announced its intent to eventually publish all research data provided to it in support of a regulatory dossier or application.

That plan has won rave reviews from some transparency advocates, including those behind the AllTrials campaign, which is campaigning for the release of all clinical data. Industry, however, has been far less supportive, with at least two-AbbVie (formerly of Abbott Laboratories) and InterMune-suing the agency to stop it from releasing what they called "commercially confidential information."

In April 2013, Abbvie and InterMune won a legal victory in the EU General Court ordering EMA to stop moving forward with its transparency plan. At the time of the order, EMA said it remained "committed to transparency and openness of information to meet the legitimate public interests to enable scrutiny of the Agency's recommendations on medicines."

As an interim measure, the agency said it planned to allow select access to the contested documents on a "case-by-case" basis-a measure already in place and responsible for the release of nearly 2 million documents since November 2010 when its access-to-documents policy first began.

Transparency: Two Models

The new draft policy seems to be the manifestation of that plan, with EMA saying it will allow access to documents in three ways, all structured in such a way as to protect commercially confidential information.

The first category of information is "open access" information, which covers all clinical data or documents that do not contain patient-level personal data, which will be accessible through EMA's website and at the time of the release of an European public assessment report (EPAR), including positive, negative and withdrawal decisions.

A second category covers "controlled access" to information that contains patients' personal data, such at patient data sets, individual patient line-listing, individual case report forms and related information. "Protection of personal data is a fundamental right of European Union (EU) citizens, enshrined in EU legislation," EMA explained.

Regulators said they will work to de-identify data according to a "minimum standard" and to restrict access to the data only to researchers who have "fulfilled a number of requirements, including the signing of a data-sharing agreement."

Those requirements include positive identification, legal status as a citizen of the EU, agreeing to only use the data in the interest of public health and "in the spirit of informed consent," agreeing to avoid attempting to identify patients, refrain from using clinical trials data to "gain a marketing authorization in a non-EU jurisdiction," not share any clinical trials data with anyone else, awareness of good analysis practices, and agreeing to have their name and purpose published by EMA.

All research conducted on the data will need to be published "within a reasonable period of time," and the raw data destroyed once the analysis is completed.

Commercially Confidential Information

A third and final category regards "commercially confidential information" (CCI), including the details of an investigational product or in vitro or bioanalytical study data on the products' characteristics. "The Agency respects and will not divulge commercially confidential data or information," EMA explained in the policy. "In general, however, clinical trials data cannot be considered CCI; the interests of public health outweigh considerations of CCI."

From EMA's explanation, its understanding of CCI seems limited to information about the properties of the product, not its effects on patients.

The policy is now open to three months of public consultation, but EMA noted that its implementation - now scheduled for 1 January 2014 - depends largely on the outcome of the aforementioned legal case and legislative proposals now working their way through the European parliament to replace the Clinical Trials Directive (CTD).

EMA: Policy 70: Publication and access to clinical-trial data

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