AUTH/3084/9/18: Director v Boehringer Ingelheim — Clinical trial disclosure (No breach after appeal) | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/3084/9/18
Parties	Director v Boehringer Ingelheim
Topic	Clinical trial disclosure (EUCTR posting timelines)
Source trigger	BMJ paper: “Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource” (Goldacre et al, 12 September 2018)
Complaint received	12 September 2018
Case completed	22 January 2020
Applicable Code year	2016
Initial EUCTR metric cited	340 total trials on EUCTR; 90 due; 83 due with results; 92.2% reported (per Goldacre et al)
Panel view (before appeal)	No breach for 4 never-started trials; out of scope for 2 no-UK-nexus trials; breach of Clause 9.1 for 1 UK-nexus trial (results not appearing on EUCTR within required timeframe)
Appeal Board final decision	No breach of Clause 9.1; no breach overall (exceptional circumstances; BI not sponsor; trial arguably not requiring EUCTR posting; results posted 17 Feb 2018 before complaint notification)
Clauses considered/listed	1.11, 2, 9.1
Sanctions	None stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

The PMCPA Director took up a complaint (Paragraph 5.1) after a BMJ paper (Goldacre et al, 12 Sept 2018) assessed whether sponsors posted due results to the EU Clinical Trials Register (EUCTR) by the European Commission’s final compliance date (21 Dec 2016).
The BMJ paper reported Boehringer Ingelheim (BI) had 90 due trials on EUCTR, 83 with results posted (92.2%), implying 7 due trials were unreported at the time of the dataset download.
BI explained the 7 “missing” trials were legacy studies and broke them down as: four trials never started (no results possible); two trials had no UK involvement; one trial had UK sites and was the focus of the Panel’s breach finding.
BI later appealed out of time (after an unusual procedural step where companies were offered the chance to appeal following outcomes in related cases) and provided additional information that the UK-nexus trial was not sponsored by BI but by an academic organisation (International Antiviral Therapy Evaluation Center, IATEC), and that the trial was retrospective observational with no trial medication administered.
BI stated it had posted results for the trial on EUCTR on 17 February 2018 (before being notified of the complaint) and that the trial was also published in scientific literature.

⚖️

⌄

Final outcome (Appeal Board): No breach of the Code.
The Appeal Board overturned the Panel’s breach of Clause 9.1, noting exceptional circumstances and that BI was not the sponsor of the trial at issue.
The case is recorded as No breach (Applicable Code year: 2016).

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access