MSL-KOL Engagement: Ensuring Compliance -





Published: June 2011 | 47 pgs 

After its initial function to build rapport with KOLs, the MSL role has evolved from being a support to sales reps to the forefront of pharmaceutical practice. Lode Dewulf, chief medical affairs officer at Brussels-based UCB, reflects on this central transformation in the pharma business. “In many ways, MSLs have developed as a new role over the past two decades as did the Medical Affairs function itself,” he says. “Medical Affairs now has the mandate for all medical activities related to marketed products and also provides input to both clinical development and to commercialisation. Within Medical Affairs, the MSLs are the field-based medical partners for physicians and other healthcare stakeholders.” 

Yet with that role has come a responsibility to comply with regulations governing off-label promotion. Once deemed ‘a cost of business’, fines are now ‘big business’: In September 2009, Pfizer paid $2.3 billion to settle charges of improperly promoting four products. The question is, how does the industry ensure, and be seen to ensure, no off-label promotion?  

Report OverviewHow can MSLs reduce their risk of breaching regulatory requirements when their company’s products are used off-label? MSL-KOL Engagement: Ensuring Compliance examines how MSLs are being used to engage physicians in a way that traditional sales no longer can. Casting a net over the current regulatory environment both in the US and EU, the report addresses the increasingly critical need for MSLs to be compliant with the rules on off-label promotion while also connecting with physicians who may be using a product for “off-label” use. Offering insight into the increased scope of the MSL and the importance of having Standard Operating Procedures in place, the report delves into tracking and reporting, compensation metrics and key enforcement policies. 

Key FeaturesMSLs, their function and how they manage promotion vs education with reports of off-label usage
Overview of the rules governing MSL activities in the US and EU
Review of Corporate Integrity Agreements
Importance of Standard Operating Procedures for MSLs
MSL training and enforcement policies
Analysis of tracking and reporting systems as well as compensation metrics
Expert views from Bristol-Myers Squibb, UCB, Philips Healthcare, Medical Science Liaison World (MSL WORLD), Scientific Advantage, Lener Medical Consulting and Cutting Edge Information
Insightful case studies examining how high-risk situations are mediated by two leading companies
 

Key Questions AskedHow is the role of MSLs changing?
How are other leading companies utilizing and protecting their MSL team?
How are industry leaders building compliant MSL-KOL relationships?
How are industry leaders protecting themselves from an external audit?
How is MSL performance evaluated?
 

Who Should Read This ReportMedical Science Liaison personnel
Medical and Scientific Advisors
Medical and Scientific Affairs personnel
Medical communications experts
KOL development leaders
Regulatory Affairs teams and advisors
 

Key Quotes“…by not dealing with MSLs in the right way, by not having SOPs in place, will create the trigger for the regulators to reject MSLs. That would be a disaster because MSLs play a unique and important role in being available to inform interested doctors about new medical treatments and scientific information.”
– Lode Dewulf, vice-president of medical affairs at UCB Pharma.
 

“We have SOPs for clinical research, medical information, so why not have them for Medical Science Liaison activity?”
– Zlata Caric MD, managing director of Lener Medical Consulting.
 

“The specifics of any sales information should never be shared with the MSLs because their decisions should be based on educational demands and clinical support needs. There are cross-over sometimes because MSLs and reps may see the same healthcare provides but they are seeing for very different and distinct purposes.”
– Robin Winter-Sperry, director of medical affairs consultancy, Scientific Advantage.
 

Expert ViewsDr. Samuel Dyer, CEO of Medical Science Liaison World (MSL WORLD). 

Dr. Drew Macgregor, European Medical Operations Manager, Bristol-Myers Squibb. 

Dr. Lode Dewulf, Vice-President of medical affairs, UCB. 

Dr. Robin Winter-Sperry, President and CEO, Scientific Advantage. 

Kevin Appareti, Global Director of MSLs, Philips Healthcare. 

Dr. Dale Kummerle, Director, Medical Education, Bristol-Myers Squibb. 

Dr. Zlata Caric, Managing Director, Lener Medical Consulting. 

Dr. Eric Silfen, Chief Medical Officer, Philips Healthcare. 

Yanis Saradjian, Director of Consulting at Cutting Edge Information. 

Executive summary  


Evolution of the MSL role > What do MSLs do?
> Education versus promotion
 


Regulations governing MSLs> US rules on off-label promotion
> EU rules on off-label promotion
 


Off-label marketing cases > A growing concern
> Off-label prescribing
> The clinician's perspective
> Off-label strategies
 

 
Corporate integrity agreements > Increased scope of CIAs 


Standard operating procedures > Firewalling
> Clarification
> What SOPs should address
> Globalisation
 


MSL training > Frequency of training 


Tracking and reporting systems> Technological advances 


Compensation and metrics > Quantitative metrics
> Qualitative metrics
 


Case study 1: mid-size pharmaceutical company  

Case study 2: medical device company 

 
Board considerations
 

 Enforcement policies > Enforcement policy in the UK
> Enforcement policy in the US
> Individual responsibility
 


Acknowledgements