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Parliamentary questions
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2 January 2020
E-000001/2020
Question for written answer
to the Commission
Rule 138
Patrick Breyer
 Subject: Unpublished results of clinical trials on medicinal products

At the end of 2019, the BUKO Pharma Campaign and TranspariMED organisations reported that German university hospitals had entered the results of only 32 clinical trials out of the 477 undertaken (6.7%) into the EudraCT database. Under EU law, results must be entered within 12 months. The Paul Ehrlich Institute, which is the responsible body in Germany, is said to have told a university that, in accordance with Section 13(9) of the GCP Regulation, there is no obligation on sponsors to publish the results of trials in the EudraCT database in Germany. (1)

Are German universities, as public law bodies, currently required, under EU law, to enter summaries of results and/or the full data sets of paediatric and non-paediatric clinical trials which they have sponsored into EudraCT within 12 months? If so, what is the legal basis for this?

Does the Federal Republic of Germany check whether the results of clinical trials are submitted to the EMA, in accordance with Section 4.7 of Guideline 2012/C 302/03? Does Section 13(9) of the GCP Regulation comply with EU law?

Has the Commission initiated an infringement procedure against the Federal Republic of Germany for possible breaches of EU law in connection with either of the above questions, or does it intend to seek a remedy by other means (please give justification)?

(1) https://bukopharma.de/images/aktuelles/CT_Transparency_German_Uni_2019.pdf
Original language of question: DE
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