Posted 13 January 2016
By Zachary Brennan
The European Medicines Agency (EMA) on Wednesday released all 393 stakeholder comments on its proposal to change how a database of adverse drug reactions can be accessed, though the final draft of the proposal, released in late December, shows EMA backtracking on some of its controversial language that commenters disputed, particularly with EMA’s plan to possibly restrict academic studies using the database.
First launched in December 2001, EudraVigilance is a database for reporting and evaluating suspected adverse drug events during the development, and following the marketing authorization of drugs in the European Economic Area (EEA).
In 2010, EMA’s Management Board adopted a EudraVigilance Access Policy, which came in force in July 2011 and outlined the data elements for and instructions on how to access Individual Case Safety Reports (ICSRs) from EudraVigilance for drug regulators, health professionals, patients and consumers, marketing authorization holders (MAHs) in the EEA as well as research organizations.
In August 2014, EMA offered a revision of its EudraVigilance access policy that makes some significant changes about how research papers can and cannot use data from the system, as well as how EMA would control that system.
More specifically, the draft revision said the agency “has the right to view any publication resulting from EudraVigilance data before submission (maximum period for initial Agency review will be six weeks) including a privacy check as regards possible re-identification of patients. Any issues raised by the Agency concerning incorrect analyses, unsupported inferences, misleading statements or the protection of personal data must be addressed to the satisfaction of the Agency before submission for publication.”
In addition, the draft said that a standard EMA disclaimer must be added to manuscripts and the EMA “reserves the right to reword the disclaimer to the manuscript in cases of unresolved disagreement over the interpretation of the data. The manuscript or its conclusions must not be disseminated in any way without the disclaimer.”
Of the 277 pages of comments, the vast majority come from individuals speaking on their own behalf, and most often commenting on what they consider to be essentially censorship from the agency.
“These principles would seem to give the EMA the right to supress [sic] anything in an academic paper that it disagrees with,” the AllTrials campaign, which calls for all for all clinical trials to be registered and results reported, said in its comment. “This is a profoundly outdated world view. Simply because the EMA is the body collecting this public data from EU patients does not give it the right to control how it is used. This would amount to state censorship of scientific discussion and analysis of public health data.”
The campaign also takes issue with EMA’s decision to use an internal panel to review research requests as it “is possible that some analyses of these data may draw close attention to regulatory decisions made by the EMA itself, since these are often close calls.”
On the other side of the spectrum, industry group European Federation of Pharmaceutical Industries and Associations (EFPIA) is calling for the access policy restrict the use of pre-marketing interventional clinical trials.
The group also says that although the “sharing of necessary data (to assess ‘clinical relevance, quantitative strength of the association, the consistency of the data, the exposure– response relationship, the biological plausibility, experimental findings, possible analogies and the nature and quality of the data’) is important to facilitate signal detection and analysis and therefore promote the safety of medicines as a whole,” the data set is not sufficient enough for companies to comply with their pharmacovigilance obligations.
The European Generic medicines Association (EGA) also noted that the heterogeneity of the datasets in EudraVigilance could lead to issues with signal detection.
The final draft, however, does not include either of the statements from the draft revision on EMA having the right to restrict publications based on data from EudraVigilance.
However, when academics are looking to use extended datasets, they will need to submit a request to EMA that “should address as a minimum the primary research question, the methodology to be used, the way that the results will impact on public health and the name and contact details of the person nominated by the academic institution to safeguard the EudraVigilance data for the research purpose.
“The Agency will not review the validity or soundness of the research proposal and will apply a standard timescale for response to requests,” EMA said. “The Agency may comment on the proposed data privacy check approach in the context of publications related to the research request.”
A panel with representatives from the Agency’s Pharmacovigilance Department and the Business Data and Analytics Department will review these specific academic’s requests.
And as far as the industry concerns, EMA noted, “MAHs will be provided with access to defined ICSR data element sets in support of their signal detection, validation and other pharmacovigilance obligations.”
The final draft was adopted by the EMA management board on 17 December.
Overview of comments received on 'Draft revision of EudraVigilance access policy for medicines for human use’
Final Draft of EudraVigilance Access Policy