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MEDICAL SCIENCE LIAISON GUIDELINES 2024

The MSL Activity Guidelines serves as a global framework for a more standardized and increasingly valuable MSL role as it continues to evolve.

What are the MSL Guidelines?

Medical Science Liaisons (MSLs) and their managers play a crucial role in the pharmaceutical and healthcare sectors, particularly in bridging the gap between clinical development and clinical practice. Thus, utilizing MSL activity guidelines effectively is key to this role.

The purpose of the MSL Guidelines is to create a clearer understanding of the MSL role and provide comprehensive recommendations for the activities of MSLs . The guidelines serve as a global framework for a more standardized and increasingly valuable role that MSLs bring to those they support and to ensure that the primary essence of the MSL role is not lost as it continues to evolve.

These guidelines are intended to provide guidance to the global MSL profession and the companies that employ them and contains information generally applicable globally, and can be used as the basis for company specific Standard Operating Procedures (SOPs) for MSL related activities.

What’s Inside?

  • Overview
  • Preamble and Disclaimer
  • Purpose of This Document
  • MSL Role Defined
  • Scientific Engagement with KOLs and DOLs
  • Proactive KOL Planning
  • Introductory Meetings
  • Scientific-Exchange Meetings
  • Patient Interaction
  • Non-Promotional Interaction
  • Providing Items of Value
  • Proactive Discussion Topics
  • Documenting Scientific Exchange
  • Presentation Materials
  • Educational Programs and Group Meetings
  • Scientific Education Programs
  • Congress Support
  • Responding to Medical Information Requests
  • Adverse Events
  • Joint HCP Visits with Sales Representatives
  • Evidence Generation
  • Company-Sponsored Studies
  • Investigator-Initiated Trials Clinical Audits
  • Health Economics and Outcomes Research
  • Insight Gathering
  • Collecting Insights
  • Proactive Insight
  • Surveys/Interviews
  • Advisory Boards
  • Internal Support
  • Sales Representatives and MSL Role Clarification
  • Internal Training and Mentoring
  • Speaker Programs and Speaker Training Meetings
  • Internal Projects
  • Summary
  • References

What’s New in the 2024 MSL Guidelines?

Social Media Usage

MSL social media behavior based on company policies and guidelines, including reactions, engagement, and material to post online.

Use of Artificial Intelligence (AI)

A new section discussing how to use AI in alignment with corporate policies and guidelines to ensure compliance.

Health Economics and Outcomes Research (HEOR)

Guidelines revolving around HEOR, which provides important information for making healthcare coverage and access decisions.

Rationale Behind the MSL Guidelines

The Medical Science Liaison career has experienced substantial growth over the last several years. In fact, according to the MSL Society’s 2023 Annual Salary & Compensation Survey, 57% of Global Executive Management/VP of Medical Affairs plan to expand their MSL team within the next 12 months. Thus, the MSL community has expressed the need for a reference document to help standardize the understanding of the various activities of MSLs.
DISCLAIMER: Although the intention is to provide guidance to the global MSL profession and the companies that employ them, they should NOT be viewed as a code or rules or laws; these guidelines do not supersede local laws and regulations, regional codes, and individual company codes of conduct.

How the MSL Guidelines Help MSL Professionals

The MSL Activity Guidelines serves as a foundational framework for MSLs and their corresponding activities, as it encompasses ethical standards, compliance with regulatory requirements, and best practices in scientific engagement. By adhering to these guidelines, MSLs ensure that their interactions with healthcare professionals (HCPs) are focused on scientific exchange and patient outcomes, rather than promotional activities.

For managers, these guidelines are instrumental in shaping and forming Standard Operating Procedures (SOPs). SOPs are essential for ensuring consistency and quality in the activities of MSLs across different regions and therapeutic areas. Managers can use the MSL activity guidelines to develop clear, actionable SOPs that align with both the organization’s objectives and regulatory requirements.

Utilization of the MSL Activity Guidelines by MSLs and their managers is integral to the development of robust SOPs. These SOPs, in turn, guide MSLs in conducting their roles effectively, maintaining compliance, and upholding the integrity of scientific exchanges in the healthcare industry.

Guidelines Vs. Policy:
What’s the Difference?

GUIDELINES
A statement by which to determine a course of action
Aims to streamline particular processes according to a set routine or sound practice.
By definition, following a guideline is never mandatory, are not binding, and are not enforced.
May be used by any organization to make the actions of its employees more predictable, and presumably of higher quality.
Does NOT supersede company policy.
POLICY
A policy is a law, regulation, procedure, administrative action, incentive, or practice.
A deliberate system of principles to guide decisions and achieve rational outcomes.
A statement by which to determine a course of action
A statement of intent; implemented as a procedure or protocol.

How the MSL Guidelines Were Developed

Time1


In September of 2016, an MSL Guidelines committee was formed consisting of a large group (30+) of volunteers including MSL managers, MSL trainers, MSLs, and executive leaders representing large pharma, small pharma, biotech, and medical device companies from the U.S. and multiple other countries. Over a 2 year period, during countless webinar discussions, multiple versions of a draft guidelines were written and tweaked based on continual feedback from the committee.

Time2


After a final agreed upon draft document was created, it was shared with the global MSL community via a month long “open comment” period that ended March 29th, 2018 . This allowed the MSL community to read and consider the guidelines that had been thoughtfully developed by a broad global array of MSL leadership and MSLs with the intent to offer constructive information to guide MSL field work. During the “open comment” period, 879 reviews from 68 countries were collected and ALL comments and feedback submitted were reviewed by the MSL Guidelines committee.

Time3


Upon incorporating the numerous comments and feedback obtained during the “open comment” period, the group then had multiple conference calls with a U.S. based pharmaceutical association, who provided input and reviewed each respective section of the guidelines resulting in numerous improvements.

Time4


The final document was then submitted to two separate professional editing firms.

Time5


The culmination of these steps has resulted in the creation of the first-ever official global non-regulatory industry-wide guidelines for Medical Science Liaison activities.

Time6


Based on numerous feedback from the MSL community, it was decided the guidelines needed to be updated to incorporate a additional new sections. The group again had multiple communications with a U.S based pharmaceutical association, who provided input and reviewed each new respective section of the guidelines resulting in three new sections and multiple improvements for 2024.

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What MSL Leaders Say


“I’m so proud to have participated in this project, created by several people of different cultures but with the same values regarding this topic. It will be a great added value for all people working as MSLs or MSLs Leaders, but also for those colleagues from different functions that need to understand the importance of our roles.”

Mila Renoldi, PhD

Sr. Medical Manager Emicrania Teva Pharmaceuticals


“The guidelines serve as a global framework for a more standardized and increasingly valuable role that MSLs bring to those they support and ensure that the primary essence of the MSL role, fostering ethical KOL relationships, is not lost as the MSL role continues to evolve.”

Cherie Hyder, PharmD, MSL-BC

Senior Director Global Medical Affairs Excellence and Operations Syneos Health


“ Medical Science Liaison guidelines aimed at defining the multi-faceted, high-level scientific/medical knowledge of an MSL in the pharmaceutical industry and its extension into medical and pharmacy communities are a great advancement as the MSL role continues to grow, Importantly, these guidelines finally clearly differentiate MSLs as fair-balanced, therapeutic area experts and professionals who provide medical and scientific knowledge and facilitate research in the medical community to those less familiar with the MSL role.”

Wendy Toler, PharmD

MSL


“Preparing MSL guidelines applicable across multiple industries is already a challenge as there is wide range of regulatory oversight based on the varying patient risks in the different medical product industries. However, making these guidelines global seemed an impossible task. Through the sheer persistence of the MSL Society team, along with an incredible committee of MSL leaders across multiple disciplines, we have achieved exactly that. The need for standardization of baseline MSL activities to move the profession forward globally has taken a huge step forward with the publication of the first ever Universal MSL Guidelines.”

Linda Traylor, PhD, MSL-BC

VP, Head of Medical Excellence Acceleration Point


“I’m so proud to have participated in this project, created by several people of different cultures but with the same values regarding this topic. It will be a great added value for all people working as MSLs or MSLs Leaders, but also for those colleagues from different functions that need to understand the importance of our roles.”

Mila Renoldi, PhD

Sr. Medical Manager Emicrania Teva Pharmaceuticals


“The guidelines serve as a global framework for a more standardized and increasingly valuable role that MSLs bring to those they support and ensure that the primary essence of the MSL role, fostering ethical KOL relationships, is not lost as the MSL role continues to evolve.”

Cherie Hyder, PharmD, MSL-BC

Senior Director Global Medical Affairs Excellence and Operations Syneos Health


“ Medical Science Liaison guidelines aimed at defining the multi-faceted, high-level scientific/medical knowledge of an MSL in the pharmaceutical industry and its extension into medical and pharmacy communities are a great advancement as the MSL role continues to grow, Importantly, these guidelines finally clearly differentiate MSLs as fair-balanced, therapeutic area experts and professionals who provide medical and scientific knowledge and facilitate research in the medical community to those less familiar with the MSL role.”

Wendy Toler, PharmD

MSL


“Preparing MSL guidelines applicable across multiple industries is already a challenge as there is wide range of regulatory oversight based on the varying patient risks in the different medical product industries. However, making these guidelines global seemed an impossible task. Through the sheer persistence of the MSL Society team, along with an incredible committee of MSL leaders across multiple disciplines, we have achieved exactly that. The need for standardization of baseline MSL activities to move the profession forward globally has taken a huge step forward with the publication of the first ever Universal MSL Guidelines.”

Linda Traylor, PhD, MSL-BC

VP, Head of Medical Excellence Acceleration Point

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