Direct Patient Reporting in the European Union. A Snapshot of Reporting Systems in Seven Member States
(2015; 18 pages)


Direct patient reporting to regulatory authorities is of particular relevance in that it avoids the conflict of interest situation that arises when patients report suspected adverse reactions directly to MAHs. Without independent verification, there is a higher risk that spontaneous ADR reports received by a pharmaceutical company are stripped of clinical significance when encoded and subsequently transferred to the regulatory authorities.

By introducing a legal right for patients to report suspected ADRs directly to regulatory authorities, the EU acknowledges patients and consumers as key sources of information on medicines safety and paves the way for a faster—and more comprehensive—collection of data on adverse drug reactions.

But to maximise the benefits of direct patient reporting, appropriate reporting systems must be in place. The general public must also be made aware of the possibility to initiate ADR reports and guided throughout the process. To contribute knowledge on patient reporting, particularly on direct reporting to regulatory authorities, we aim to describe the reporting systems of selected EU Member States to identify best practices and issue recommendations for improvement.

This publication follows Health Action International’s 2010 report, Direct Reporting of Adverse Drug Reactions: A Twelve-country Survey and Literature Review, which advocated for the implementation of direct patient reporting in EU pharmacovigilance legislation.

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