1. Market Research
  2. > Healthcare Market Trends
  3. > MSL-KOL Engagement: delivering value under new rules

MSL-KOL Engagement: delivering value under new rules

  • May 2013
  • -
  • Firstword Pharma
  • -
  • 107 pages





The role of MSLs is changing. Once a position that straddled the area between scientific insight and sales, global demands for transparency and disclosure in MSL-KOL relationships have caused a seismic shift.

For the pharmaceutical industry, the fallout is clear: companies are now examining how MSLs are engaging with KOLs and creating distance between their unbiased, informational role and explicit, promotional behaviours. Even where there is no clear, official guidance overseeing MSL-KOL relations, many companies are implementing their own rigorous measures for handling training, standard operating procedures and monitoring.

Like its best-selling predecessor, MSL-KOL Engagement: delivering value under new rules tackles the evolving MSL-KOL relationship head on. Cast against tougher regulations being implemented worldwide such as Sunshine Act in the US, the report not only addresses the heightened need for measurable, demonstrable MSL compliance, but how companies can better grasp the legislative landscape and develop on-going strategies to support long term MSL-KOL interactions. In an era of increased scrutiny, penalties and skepticism, MSL-KOL Engagement: delivering value under new rules is an invaluable and timely roadmap for any company. This report provides:


Access to the most current and up-to-date strategies developed by companies ensuring MSL-KOL relationships remain without censure
Insight into the very latest US and European regulations and legislation governing MSL-KOL interactions
Discussion of proactivity versus reactivity, off-label information, standard operating procedures, training/tracking, and how to incentivise MSLs
Measures that demonstrate MSL value without crossing the line into promotion
Insight into how MSL-KOL relationships can be maintained over the long term








Key Benefits


Under the scrutiny of the Sunshine Act and similar legislation, the time has come for companies to address MSL training, metrics and activities from a far different viewpoint than in the past. MSL-KOL Engagement: delivering value under new rules offers clear and concise guidelines for doing so. Amongst the benefits, this report will help you to:

Understand the regulatory environment in order to protect and support MSLs
Grasp the key issues that may arise and develop preventative strategies
Negotiate ‘grey-area’ compliance issues in MSL-KOL interactions, such as off-label information and proactive versus reactive MSL activities
Better know the value of MSL operations and the metrics that can be used to measure and demonstrate compliance
Expert views from Bayer, Bausch & Lomb, Philips Healthcare, Quintiles, Sequenom, PDI Healthcare, Scientific Advantage and LNR Enterprises







Key Questions Answered
MSL-KOL Engagement: delivering value under new rules answers key questions:

What is the current state of affairs for legislation and regulation governing MSL-KOL relationships?
What guidance is currently available?
How can a company develop self-governing strategies where no official guidelines exist?
How can MSLs maintain integrity and credibility while demonstrating their value?
What future is there for compliant MSL-KOL interactions?







Expert Views Include:


Doral Fredericks, Vice President, US medical affairs and global communications, at Bausch & Lomb
Elizabeth Kupferer, Sr. Director, Medical Affairs at Sequenom
Dr. Hudson Garrett, Senior Director of Clinical Affairs at PDI
Kevin Appareti, Senior Director, Global Medical Science Liaison at Philips Healthcare
Michelle Stith, Founder of SpendTrenz
Mitch Trujillo, Vice President of Medical Affairs and Head of Global MSL Excellence at Bayer HealthCare
Robin Winter-Sperry, MD, President and Chief Executive Officer of Scientific Advantage
Stewart Rosen, Vice President Medical Affairs at Quintiles
Yanis Saradjian, Director of Consulting at Cutting Edge Information



Key Quotes

“The-peer to-peer relationship an MSL achieves creates greater access. With the traditional sales model, access became more limited, so for a few years we were seeing companies utilising MSLs to drive sales. We learned, however, that in a regulated environment we need to take a role that has greater access and use it appropriately.” – Stewart Rosen, Vice President Medical Affairs, Quintiles

“If we come up with a specific activity for an MSL, the first people we talk to are legal and compliance. We run the idea past them, we get their blessing before we move any further. And before we implement, we are again assured that we’ve been approved to do so by legal and compliance.” – Mitch Trujillo, Vice President of Medical Affairs and Head of Global MSL Excellence at Bayer HealthCare.

“We definitely in the past have been a much more reactive organisation from a clinical standpoint. We have definitely moved into a more proactive stance. And we’re not being advocates: it’s addressing the different challenges and complex problems and dealing with those upfront rather that reacting to them.” – Dr. Hudson Garrett, Senior Director of Clinical Affairs. PDI Healthcare.

“The MSL function in the US is really strictly focused on traditional KOL development and things like that, whereas I’m finding in the more global areas, it has to be more than just a medical affairs function. The rules surrounding MSL-KOL interactions in emerging markets are as a whole, a little bit less regulated right now. But I will say with those areas it’s really important to have your local team and compliance take the lead on what is appropriate in a given region.” – Doral Fredericks, Vice President, US medical affairs and global communications, Bausch & Lomb



Table Of Contents

MSL-KOL Engagement: delivering value under new rules
1. Executive summary
2.Introduction
3.Why compliance matters
3.1.Scientific emphasis
3.2.Sceptical attitude
3.3.Legal and regulatory parameters
4.Sunshine Act impact
4.1.Physicians are nervous
4.2.More US drivers
4.2.1.Social media impact
5.Evolving environment
5.1.Enough guidance
5.2.The Caronia First Amendment case
6.A global phenomenon
6.1.New regulations
6.2.France's ‘Sunshine Act'
6.3.Other European requirements
6.4.Belgium
6.5.Germany
6.6.Italy
6.7.Spain
6.8.United Kingdom
6.8.1.Taking it seriously
6.8.2.UK guidance
6.8.3.Formulating the MSL role
6.8.4.Staying within the boundaries
6.8.5.Legitimate exchange
6.8.6.Level playing field
7.How they comply
7.1.Difficult decisions
8.Where the MSL sits
8.1.Not so cut and dried
8.2.Not too big
9.Reactive or proactive?
9.1.A more proactive stance
9.2.Primarily strategic
10.SOPs and compliance departments
10.1.Onus on companies
10.2.Not just toeing the line
10.3.Local or global
10.4. Another layer of protection
11.Compliance support
11.1.Training and tracking
11.2.Staying on track
12.Valuing MSLs compliantly
12.1.Abstract nature
12.2.The bottom line
12.3.The right piece
12.4.Two-way traffic
12.5.Net promoters
13.Long-term relationships
13.1.Shifting focus
13.2.Pre- and post-launch
13.3.Digital opportunities
13.4.For the long run
14Acknowledgments

View This Report »

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 24 Million searchable statistics with tables, figures & datasets
  • More than 10,000 trusted sources
24/7 Customer Support

Talk to Veronica

+1 718 514 2762

Purchase Reports From Reputable Market Research Publishers
2016 Virology and Bacteriology Analyzers and Reagents in 33 Countries: Supplier Shares and Strategies, Sales and Segment Forecasts for 100 Microbiology Tests, Technology Trends, Opportunities for Suppliers

2016 Virology and Bacteriology Analyzers and Reagents in 33 Countries: Supplier Shares and Strategies, Sales and Segment Forecasts for 100 Microbiology Tests, Technology Trends, Opportunities for Suppliers

  • $ 54501
  • Industry report
  • October 2016
  • by Venture Planning Group

This unique 33-country survey from VPGMarketResearch.com contains over 2,100 pages, 875 tables and provides data and analysis not available from any other published source. The survey is designed to assist ...

2016 Infectious Disease Testing Analyzers and Reagents in 33 Countries: Supplier Shares and Strategies, Sales Segment Forecasts for 100 Microbiology Tests, Technology Trends, Opportunities for Suppliers

2016 Infectious Disease Testing Analyzers and Reagents in 33 Countries: Supplier Shares and Strategies, Sales Segment Forecasts for 100 Microbiology Tests, Technology Trends, Opportunities for Suppliers

  • $ 54501
  • Industry report
  • October 2016
  • by Venture Planning Group

This unique 33-country survey from VPGMarketResearch.com contains over 2,100 pages, 875 tables and provides data and analysis not available from any other published source. The survey is designed to assist ...

2016 Microbiology Analyzers and Reagents in 33 Countries: Supplier Shares and Strategies, Sales Segment Forecasts for 100 Molecular Diagnostic, Microbial Identification, Antibiotic Susceptibility, Blood Culture, Urine Screening, and Immunodiagnostic Tests

2016 Microbiology Analyzers and Reagents in 33 Countries: Supplier Shares and Strategies, Sales Segment Forecasts for 100 Molecular Diagnostic, Microbial Identification, Antibiotic Susceptibility, Blood Culture, Urine Screening, and Immunodiagnostic Tests

  • $ 47500
  • Industry report
  • October 2016
  • by Venture Planning Group

This new 33-country survey from VPGMarketResearch.com contains over 1,000 pages and 550 tables, and provides granular data and analysis not available from any other published source. The survey is designed ...


ref:plp2013

Reportlinker.com © Copyright 2016. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.