How Successful Are Your Compliance Policy Implementation Efforts?
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To our clients and colleagues,

In this issue of our e-newsletter, we address the gaps that exist for many companies between their written compliance policies and the effective implementation of these policies. We provide guidelines on how to assess your compliance policy implementation efforts and explain the advantages of performing this diagnostic.
Advantages of Determining Gaps in Compliance Policy Implementation
Since 2003, pharmaceutical companies have been required by the OIG to have a written compliance policy. However, the growing number of prosecutions and fines for their commercial practices reveal gaps between written policies and effective policy implementation. A less painful method for companies to discover these gaps is to perform an internal diagnostic on the effectiveness of current compliance policy implementation efforts.

An organizational diagnostic of current compliance policy implementation efforts should examine existing compliance knowledge, practices, and organizational culture. The following components should be assessed:

Existing compliance training methods: Effective training should result in sustained changes in knowledge and behavior.
  • Is compliance training for field sales designed to facilitate transfer of compliance knowledge to the field?
  • Do compliance training efforts result in sustained behavior change in the field?
Behavioral monitoring for field promotional activities: Without a good picture of field conduct, the organization cannot determine the effectiveness of compliance training or detect compliance risks.
  • Are field representatives delivering compliant sales messages?
  • Can they handle questions and objections with effective on-label statements?
Systems and reporting procedures:  Reporting systems should collate data from monitoring efforts to uncover areas of heightened risk.
  • Are reporting systems able to deliver timely information about potential compliance violations to the appropriate internal parties?
  • Do procedures exist to ensure appropriate follow-up action is taken?
  • Can the organization proactively track individual and group performance and identify trends?
The organization's compliance culture: 
This assessment may identify specific barriers to change and reveal the need for initial education before compliance policy implementation efforts, such as commercial readiness training. 
  • Is there a company-wide commitment to compliant conduct at all levels of the organization?
  • Is there a discrepancy between stated standards and what is reinforced by the organization?
  • Is commercial readiness training needed to convince commercial colleagues that it is possible to have an ethical and effective organization and reduce organizational resistance to compliance efforts?
Benefits of an Organizational Assessment: Sales, marketing, and compliance all stand to benefit from performing this diagnostic.

  • Sales receives information on whether training is producing effective sales behavior in the field.
  • Marketing receives information on how effectively marketing messages are being translated to the field. 
  • Compliance can identify what is needed to improve field based monitoring, reporting, and knowledge transfer to commercial colleagues.
The design of a thorough diagnostic to assess the effectiveness of your company's compliance policy requires careful planning.  For more information on how to conduct a diagnostic and how this analysis can help achieve organizational goals, please contact WLH Consulting, Inc.
WLH Consulting, Inc. brings twenty years of experience in the biopharm industry, plus expertise in organizational and individual assessment, behavioral-based training, cultural change, and cross-functional alignment to provide compliance information and practical solutions to our compliance and commercial clients.

Feel free to contact WLH Consulting, Inc. for specific information on best practices and lessons learned for pharmaceutical leaders, compliance officers, and trainers.  
Wendy Heckelman, Ph.D.
WLH Consulting, Inc.
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