My recent flight to Shanghai provided plenty of opportunity to reflect on the challenges that exist for pharmaceutical companies operating in China. Top of mind are the logistical challenges in a country of such scale and diversity and how this impacts compliance initiatives, specifically managing HCP interactions.
With Corporate Integrity Agreements in the US commonplace and the increasing focus on the expansion of transparency reporting initiatives around the world, it seems reasonable to assume that managing HCP interactions in a compliant manner has become a strategic imperative. Or is it?
The Open Payments reporting obligations created equal amounts of concern and frustration in the US, as Life Sciences companies tried to determine the most effective and cost efficient way to consolidate data from multiple disparate systems. Many millions of dollars later, I believe most companies have declared a victory of sorts, with data being submitted as requested to various regulatory bodies, albeit with a certain fragility to the process.
So, with the transparency reporting obligations under control, can’t we all now relax and breathe a collective sigh of relief? Well, not so fast. The journey has only just begun. What may have been viewed as a “tactical necessity” and a somewhat unique requirement of the US market is now spreading steadily across other important global markets. This tactical necessity is rapidly becoming a strategic imperative in many companies, where global or regional Compliance, IT and Procurement teams are trying to control the proliferation of local market initiatives to solve for their own in-country legislation.
Their macro-level challenge is extensive and goes beyond the foundational need for strong master data management. The requirement is for an enterprise level compliance approach to HCP interactions which includes standardization on an IT platform to support both data and process considerations. Add to this a material governance and change management initiative and you will begin to understand the complexity.
This challenge is not unique to China or other emerging markets, it’s global in nature and solutions are best approached from that perspective. Having been fortunate enough to have visited China on other occasions and to have travelled to the birthplace of Confucius, l felt compelled to seek some of his wise words that may be applied to these global compliance challenges. The following seemed to resonate.
“By three methods we may learn wisdom: First, by reflection, which is noblest; Second, by imitation, which is easiest; and third by experience, which is the bitterest.”
When it comes to gaining wisdom about globally managing HCP interactions, the goal must be to achieve through methods one and two. As Confucius concludes, the third method should be avoided, as the bitterness will manifest itself in increased costs and compliance risk!
Nigel J. Whitehead, CEO, AHM
Nigel J. Whitehead joined AHM as the CEO in 2013. Nigel brings 30 years experience providing technology enabled business solutions to the Global Life Sciences market including senior positions at CSC, First Consulting Group and Cegedim (formerly Dendrite International).