Professor Clare Bradley, CEO of Health Psychology Research Ltd., submitted a response to the consultation on the European Medicines Agency’s (EMA) Reflection Paper on Patient Experience Data.

As the developer of a substantial number of Patient Reported Outcome Measures, Professor Bradley draws attention to the lack of mention of copyright and the prevention of copyright infringement by the EMA in this reflection paper.

Health Psychology Research Ltd. has found that some researchers use questionnaires they find online without permission from the copyright holder. In some cases, the questionnaires have been translated and/or modified in ways that undermine their validity. Inviting researchers to post their clinical trial documents on the EMA website without acknowledging the importance of protecting copyright gives the wrong impression that the questionnaires are in the public domain for others to use. This leads to unlicensed use and copyright infringement, which could result in researchers being unable to publish their research. Professor Bradley points out how such problems can be prevented by providing clear instructions to those submitting information about their clinical trial/study. Those instructions need to be clear that copyrighted questionnaires should only be uploaded with permission from the copyright holder, and that redacted versions of the questionnaires (approved by the copyright holder) may be needed.

You can read Professor Bradley’s full response to the consultation here.