How do pharma and biotech companies build a scientific relationship with key opinion leaders before launch without breaching the separation of medical and commercial?
We provide interim MSL teams and take on KOL mapping, advisory board management, and scientific peer-to-peer communication before and after launch. The medical science liaison function operates non-promotionally: it conveys evidence, it does not sell. The point that is often underestimated: credibility with the KOL does not come from the message but from the demonstrable organizational separation between Medical Affairs and Commercial. Where that separation is not documented, the conversation loses its scientific status and falls under advertising rules.
- Pharma
- Biotech
Overview
What sets the MSL function apart from sales and marketing?
Interim MSL teams for pre-launch and launch · non-promotional peer-to-peer communication · KOL mapping & advisory board management
Last updated: 2026-06-13
The medical science liaison function is a Medical Affairs role: it conducts a scientific dialogue on equal terms with key opinion leaders, investigators, and medical societies. The legal framework determines whether a conversation counts as scientific exchange or as drug advertising, and it is precisely at this boundary that the mistakes occur:
- Advertising versus information: the Heilmittelwerbegesetz (HWG) strictly regulates statements about medicinal products directed at healthcare professionals. Scientific exchange on non-approved indications is only permissible outside of promotion; the MSL function must demonstrably operate non-promotionally.
- Off-label and pre-launch: prior to approval, or for non-approved indications, no advertising is permitted. An MSL may respond to specific unsolicited scientific inquiries; the distinction from active promotion must be documented.
- Separation of medical and commercial: the FSA Code and the EFPIA Code of Practice require the separation of scientific from commercial activities. The MSL's reporting lines, performance objectives, and material approval must not be tied to sales targets.
- Transparency of payments: fees for advisory boards and speaking engagements are subject to the disclosure obligations under the FSA Code and the EFPIA Code of Practice; contracts, services, and consideration must be appropriate and documented.
- Investigator-initiated trials: where the company supports trials initiated by the investigator (IITs), the requirements of Good Clinical Practice under ICH E6 apply; the scientific and the financial roles must remain clearly separated from promotion.
Services
How we support you
Interim MSL teams
Provision of experienced medical science liaisons on a temporary basis for pre-launch, launch, or to bridge vacancies, including an onboarding dossier, therapeutic briefing, and defined non-promotional scope of activity.
KOL mapping & engagement
Identification and prioritization of relevant key opinion leaders by indication and region; the result is a documented KOL map with influence assessment and an aligned, non-promotional engagement plan.
Advisory board management
Planning and execution of scientific advisory boards: agenda, participant selection, contracts, and fee structure in line with the FSA Code and the EFPIA Code of Practice, along with a traceable record capturing documented insights.
Scientific messaging & scientific communication
Development of an evidence-based, non-promotional scientific narrative, including approved medical information material and a reactive response strategy for unsolicited scientific inquiries, clearly delineated from promotional statements under the HWG.
IIT support
Assessment and oversight of investigator-initiated trials: structured review of incoming study concepts, clarification of the sponsor role, and ensuring the separation of scientific support from promotion within the framework of GCP under ICH E6.
Learn more →Medical Affairs governance
Establishing the organizational separation of medical and commercial: reporting lines, SOPs for MSL interactions, material and approval processes, and documentation templates for non-promotional activity.
How we work together
What it comes down to
The medical science liaison function depends on a sequence that many companies reverse: first comes the demonstrable separation of Medical Affairs and Commercial, then the scientific dialogue. Anyone who sets up the MSL role before reporting lines, performance objectives, and approval processes establish independence from commercial goals is building credibility on sand. The Heilmittelwerbegesetz (HWG) draws the sharp line: prior to approval and for non-approved indications, no advertising is permitted, while a response to an unsolicited scientific inquiry remains permissible. The only robust difference between the two is the documentation. Anyone who does not record that information was provided reactively cannot later show that it was not promotion.
The real crux in pre-launch is therefore rarely the KOL mapping, but the governance behind it. Advisory boards and investigator-initiated trials are the points at which scientific support and impermissible payment lie closest together: fees must be tied to a specific service, in line with market rates, and disclosed under the FSA Code and the EFPIA Code of Practice, and for IITs the sponsor role must remain cleanly delineated from the obligations of Good Clinical Practice under ICH E6. Anyone who puts these structures in place before the first KOL contact gains time during launch, because every single interaction holds up without after-the-fact justification.
Our approach
Our approach
Step
Result
Therapeutic & regulatory briefing
Aligned onboarding dossier with a defined non-promotional scope of activity and documented separation of medical and commercial.
KOL mapping
Prioritized KOL map by indication and region with influence assessment as the basis for engagement planning.
Engagement planning
Non-promotional engagement plan with conversation objectives, approved scientific content, and a documentation routine.
Scientific dialogue & advisory boards
Conducted peer-to-peer conversations and advisory boards with contracts and fees in line with the FSA Code/EFPIA and documented insights.
Insight feedback
Structured capture of medical insights for Medical Affairs, separated from commercial reporting.
Handover & continuity
Documented KOL history and activity record for handover to the internal team or the next phase.
Common pitfalls
Where projects commonly fail
MSL activity is measured against sales targets.
As soon as bonuses or performance objectives are tied to sales, the separation of medical and commercial required under the FSA Code and the EFPIA Code of Practice is breached, and the conversation loses its scientific status.
Pre-launch communication slips into advertising.
Statements about not-yet-approved indications or products may not be advertised under the Heilmittelwerbegesetz (HWG); an active message instead of a response to an unsolicited inquiry turns scientific exchange into impermissible advertising.
Advisory board fees are not appropriate or not documented.
Where a description of services, the market conformity of remuneration, and disclosure under the FSA Code and the EFPIA Code of Practice are missing, the suspicion arises of a covert payment rather than scientific advice.
Unsolicited scientific inquiries are not separated from proactive communication.
Without a documented distinction, it cannot later be demonstrated that off-label information was a response and not promotion; this is the central piece of evidence in scientific dialogue.
IIT support blurs the sponsor role and funding.
Where the company supports a trial initiated by the investigator, the obligations under Good Clinical Practice (ICH E6) and the distinction between scientific support and promotion must be cleanly governed, otherwise the trial becomes vulnerable to being treated as a covert marketing instrument.
FAQ
Frequently asked questions
Sources
- Heilmittelwerbegesetz (HWG): primary text on advertising of medicinal products to healthcare professionals
- Arzneimittelgesetz (AMG): primary text
- FSA Code for Professional Circles (Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V. - Voluntary Self-Regulation for the Pharmaceutical Industry)
- EFPIA Code of Practice (European Federation of Pharmaceutical Industries and Associations)
- ICH E6 Good Clinical Practice (GCP): guideline
- https://theentourage.de/expertise/msl-services/ (existing page content, revised)
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Case Studies
What this looks like in practice
Regulations & standards considered
- Arzneimittelgesetz (AMG) - German Medicinal Products Act
- Heilmittelwerbegesetz (HWG) - German Act on Advertising in the Healthcare Sector
- FSA Code for Professional Circles (Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V. - Voluntary Self-Regulation for the Pharmaceutical Industry)
- EFPIA Code of Practice (European Federation of Pharmaceutical Industries and Associations)
- ICH E6 (Good Clinical Practice, GCP)
Related topics
Clinical & Medical Affairs →
The Medical Affairs function in which the MSL role is embedded
Real-World Evidence →
Evidence base for scientific dialogue before and after launch
Market Access Strategy →
Strategic market access that the MSL function supports scientifically
Good Clinical Practice (GCP) →
Framework for investigator-initiated trials under ICH E6
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