AUTH/3779/6/23 & AUTH/3780/6/23: Ex-employee complaint about alliance promotional material approval process (BI/Lilly)

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Key facts

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Case numbers	AUTH/3779/6/23 (Boehringer Ingelheim) and AUTH/3780/6/23 (Eli Lilly)
Parties	Ex-employee (anonymous, non-contactable) v Boehringer Ingelheim and Eli Lilly
Issue	Concerns about the alliance promotional material approval process (PMAP): SOP accessibility/version control; training accessibility/documentation; alleged “agreements outside PMAP”
Applicable Code	2021
Clauses considered	Clause 5.1; Clause 9.1
Outcome	No breach of Clause 5.1; No breach of Clause 9.1 (both cases)
Complaint received	19 June 2023
Case completed	21 August 2024
Appeal	No appeal
Sanctions	None stated

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

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An anonymous, non-contactable complainant (described as a former employee) raised concerns about the promotional material approval process (PMAP) used within the Boehringer Ingelheim (BI) and Eli Lilly alliance.
Allegations focused on: (1) accessibility of the most up-to-date approved SOP, (2) accessibility and documentation of training (including onboarding and refreshers), and (3) alleged “agreements outside of the PMAP between individual job originators and certifiers”.
BI said the PMAP SOP was formally approved by both companies’ Country Managing Directors, stored in BI’s Quality Management System (Vault Quality Docs) and linked via BI’s internal Legal & Compliance SharePoint; Lilly staff accessed the effective SOP via an Alliance MS Teams channel/folder.
BI acknowledged that a working draft Word version of the SOP had at times been housed in the same MS Teams folder and said it removed the draft to avoid confusion.
Both companies said training was provided and recorded (BI via Learning One Source; Lilly provided training slides and training records for relevant staff/contractors).
The Panel noted the complainant provided no supporting evidence (eg, the alleged tracked-changes SOP file, examples of “agreements outside PMAP”, or evidence of training inaccessibility).

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No breach of Clause 5.1 in both cases.
No breach of Clause 9.1 in both cases.
The Panel considered the complainant had not established the allegations on the balance of probabilities.
The Panel queried what procedures ensured Lilly always had the most up-to-date SOP in MS Teams after BI QMS updates; Lilly made no submission on that point, but the Panel still ruled no breach based on the information before it.

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Clause 5.1 – Requirement to maintain high standards at all times
Clause 9.1 – Requirement that all relevant personnel concerned with the preparation or approval of material or activities covered by the Code must be fully conversant with the Code and the relevant laws and regulations

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