Is Euroland Following the US Disclosure Lead? - Pharmaceutical Executive


Is Euroland Following the US Disclosure Lead?

Pharmaceutical Executive

Preparing for the Deluge?

Figure 1: Anticipation of Level of Investment on Aggregate Spend for 2011
Despite this basic uncertainty, the Cegedim survey found near universal consensus—93 percent of those polled—that compliance is going to be a key strategic challenge in Europe. Some 75 percent of respondents agreed that this challenge would follow the pattern laid out in the US in terms of requirements to track and disclose promotional spend. Hence the need for better awareness and training in proactive ways to be ready for the disclosure requirements when the regulatory agenda becomes more fixed.

Figure 2: Areas of Concern Complying with the FCPA and Anti-Corruption Regulations
Nevertheless, most companies in Europe believe they are well positioned to manage the transition, with the survey noting that 73 percent of respondents claim they can handle requirements already in place or under way. There is less certainty about the future, as expressed in results (see Figure 1) that anticipate a much higher level of internal investment in meeting promotional spend mandates over time—42 percent of respondents expect their commitments to increase. Following on that metric, companies cite confusion about the very kinds of "relevant data" to collect as the most pressing issue in managing their exposure to compliance issues (see Figure 2).

Elusive Definitions

Figure 3: How Challenging are the Following Processes?
The awareness is compounded by the absence throughout most of Europe of clear definitions that can be applied to classify the status of a healthcare provider; without this, building a data set to track relations with them obviously becomes a major hurdle, a conclusion exemplified in Figure 3, where 37 percent of those surveyed see "managing disparate formats and standards" as the process point that will be most difficult to adhere to using the compliance tools companies now have on hand.

Current standard of practice in this area lags behind the US, with nearly a quarter of the survey population still relying on Excel spreadsheets to meet their data retrieval obligations. One approach that can bear fruit in Europe is expansion of the key account management (KAM) structure adopted with vendors by many companies in the US, which provides a platform for the implementation of customized software and information bases that can both define and identify transactions carrying potential compliance risks.

Not surprisingly, the most significant practical finding in the survey is the expectation that promotional spending by the industry in Europe is set to drop. Nearly two thirds—62 percent—of the group agreed this would be the outcome.

Clearly, it sets the stage for the kind of debates that have already taken place in Europe over support for patient groups: Will governments and the European Commission move in to fill the gap left by the private sector and create subsidies to fund high-profile—and highly valued—activities such as continuing medical education? As this issue evolves, expect many other ramifications that companies will be required to address. These extend well beyond data management to encompass the industry's place and positioning as providers of useful information to the healthcare community. But without building a good practice around compliance the opportunity to enhance reputation will likely be squandered.


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