Thoughts on Global Medical Affairs
I was talking with a friend the other day who is charged with running the medical information (MI) function for their small pharma company. Currently they outsource the MI function and she was wondering if it made sense to bring the function in-house of keep the current arrangement. We discussed how effectively the outsourced MI function works with the current MA group, including the MSL field force, and the answer is that they have some formal links but rarely talk. We talked some more and reached some conclusions, but I thought this might be a good topic for a post.
MI is both a regulatory mandated function, and a critical component in achieving MA’s educational and public outreach goals. It is possible to structure and run the MI function merely to meet the regulatory requirements but that would represent a significant waste of an opportunity.
From a regulatory perspective, the MI function needs to be structured to answer calls from both patients and healthcare professionals (HCPs), differentiate between inquires and pharmacovigilance calls and route the calls appropriately, answer questions directly when appropriate, distribute accurate and approved materials to appropriate audiences, and develop outgoing medical communications on important issues (Dear Doctor letters). It needs to be staffed by people with appropriate qualifications to answer medical and technical questions about the use of company’s products.
But, some organizations gain much more benefit from their investment in MI. For one thing, MI is often the first sign that a problem is occurring relating to our products or issues are being raised concerning the scientific underpinnings of our products. Spikes in the type and content of questions help provide a Zeitgeist view of the needs for education in the HCP community. But, this only works if MA listens. There must be processes and systems in place to ensure that MI is coding their contacts in a manner that allows for analysis and reporting in place to ensure that the information is summarized on a timely basis. Finally, clear responsibilities need to be established for who will review and respond to this information.
Other organizations utilize the MI resources to more effectively partner with the MSL field force. MI and MSL groups tend to talk with related but mutually exclusive audiences. Given the limitations on MSL time, they need to focus that time on those HCPs that can offer the greatest impact on the medical community, the so-called Key Opinion Leaders (KOLs). Based on research I have seen in the past, it is very rare for a KOL to call MI. They tend to expect the answers to come to them through MSLs or research on the internet. Non-KOL HCPs tend to call MI. Given that, the opportunities for MSLs and MI to interact is not in terms of serving the same HCPs but instead in terms of “having each other’s backs.” Often when MSLs are interacting with HCPs, they need to provide those HCPs with additional information and support. MI is well suited to provide that information and support. And, when MI is answering questions for HCPs they encounter situations that require more in-depth support, and MSLs are well positioned to provide it.
Establishing a strong partnership between MI and MSL groups brings value to both sides, yet it is not as common as you might expect. Sometimes it’s due to organization structure – the two groups have unrelated reporting relationships and thus lack incentive to interact. Other times it’s due to a difference in philosophy, where one of the two groups does not see value in interacting with the other. Regardless, there is value in establishing this relationship, but it needs to be clearly structured and actively managed to avoid either group “dumping” on the other.
This leads back to the discussion of outsourcing MI. To really gain value from MI, it needs to tie in easily with the rest of the MA organization. It may be possible to pull that off with an outsourcer, but its unlikely. For that reason, I suggest that insourcing MI brings more value to the organization.
My final thought on MI relates to technology. A call does not have to be a phone call. Web chats are significantly more efficient to manage and allow for careful scripting of responses. Providing this service on an after-hours basis may allow more of those KOLs discussed earlier to actually connect. And, I have yet to see a company develop an MI app, but I think we can’t be too far from having one – just tap the icon and link directly to an MI chat or other dialog.
What has been your experience with MI and how it relates to other function in MA? Please leave your comments below. And if this is your first time on the blog, please sign up on the right to receive email updates of the latest posts – don’t worry its spam free.