Corporate Compliance

A Corporate Compliance program is fundamentally a management and operational tool that executives adopt as a means of ensuring that an organization is in compliance with laws and regulations relating to its business activities. It establishes the ethical standards for the organization’s business operations. An organization must also demonstrate that it has the mechanisms in place to detect potential compliance risks, and to address or mitigate compliance risks.

In evaluating the established guidance related to what we think of as “U.S. Commercial Compliance” (the laws and guidance related to sales and marketing practices in the United States) in the Pharmaceutical Industry, one looks first to the publication in April 2003 by the Office of Inspector General “Recommendations to Pharmaceutical Manufacturers.” There are a few key principals that have been established based upon the OIG guidance, and used in investigations, coordinated with The Center for Medicare and Medicaid Studies (CMS), The Veteran’s Administration (VA), the Department of Justice (DOJ) and State Attorney Generals. The key principals are summarized and paraphrased below:

  • The OIG has established three key risk areas in the Pharmaceutical industry related to Commercial Compliance, they include:
    • Kickback and Illegal Remuneration
    • Sample Accountability
    • The Integrity of Data Reported to the Government

  • The OIG has established a basic structure for Corporate Compliance Accountabilities, and would expect that any Pharmaceutical Manufacturer operating in the United States understand and apply the concepts of that structure within the context of their own business. The guidelines include definitions of the role and function of a Corporate Compliance Officer, and the establishment of compliance policies and procedures, as well as mechanisms for monitoring, auditing, anonymous reporting of potential compliance issues, and an objective investigative response procedure.
  • The OIG establishes the False Claims Act as the underlying legal basis behind its investigative activity. Defrauding the government or submitting false information to the government related to any area within US Commercial Compliance is a potential False Claims Act Violation. Furthermore, the OIG has established that a manufacturer that fails to have sufficient policies and procedures in place to ensure compliance may also be facing a False Claims Act violation based upon their own negligence.
  • Manufacturers establish Transparency in their operations related to US Commercial Compliance by having written documentation in place that guides their day-to-day operations, and can demonstrate that individuals understand and follow the policies and procedures within the written documentation.

CIS has the expertise and services to deliver all of the elements required by the OIG:

CIS can help write and/or implement all of the key elements contained within the OIG guidance, including:

  • Implement written policies and procedures and a Code of Business Conduct
  • Designate a Corporate Compliance Officer and Corporate Compliance Committee
  • Establish effective Training and Monitoring
  • Establish Effective Lines of Communication
  • Develop tools for Internal Monitoring and Auditing
  • Enforcie standards through well-publicized disciplinary guidelines
  • Respond promptly to detected problems