Thoughts on Global Medical Affairs
We are little over a year (Sept. 30, 2013) away from the date when Department of Health and Human Services (HHS) has committed to having the first round of Sunshine Act data made available to the public via the web. Allow me to stipulate that we may have more time since the HHS has managed to miss every other deadline they have had with regards to the Sunshine Act. And, allow me to stipulate that a fully Republican controlled government may actually repeal Obamacare and the Sunshine Act with it.
But, as we head into the 2013 planning season, I think it would be wise to assume this is actually going to happen and thus budget and plan accordingly.
Up to this point, we have discussed the Sunshine Act purely from an administrative point of view – how to collect this data and meet the immediate 2012 requirements. But, in 2013 this information is going to be made public and we run the risk of losing the trust and support of the very KOLs that we have all invested so much time in developing.
It is critical that your company take a proactive stance on this situation:
I will discuss some approaches to this in hopes that it aids in your budget and planning efforts.
The first challenge to overcome in addressing this issue is intra-function coordination. The data provided HHS includes payments from all company elements, including research, development, medical affairs and commercial. Therefore, in addressing this to KOLs, a single cross-functional approach needs to be created.
I would suggest a meeting with the other relevant functions to address the corporate approach and name members to a task force. MA is the logical leader for this given its role as straddling the worlds of products in and out of development.
Once this Task Force is formed, I would suggest the following approach:
This should be a straight forward communication project, but it will be easy to put off as more urgent issues begin to crowd it out in 2013 so it will take consistent leadership to get it done.
What are your plans for supporting the rollout of HHS reporting of the Sunshine Act? Leave your comments or questions (below) or email me directly (link on the right).