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: Ensuring Compliance (2nd Edition) 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: Ensuring Compliance (2nd Edition) 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
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: Ensuring Compliance (2nd Edition) 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
“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
MSL-KOL Engagement: Ensuring Compliance (2nd Edition) 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
- How MSLs can stay within compliance boundaries without impeding scientific exchange
- How can MSLs and their managers negotiate grey-area compliance issues such as off-label information or proactive versus reactive MSL activities
- A country-by-country breakdown of new and established MSL compliance regulations, as well as insight into regional challenges
- Understand ways in which MSL value to your organisation can be measured and demonstrated compliantly
- How other emerging medical affairs roles are creating challenges in reporting