Compliance Programs:
...standards called for by any applicable Governmental regulation weighs against a finding of an effective program to prevent and detect violations of law.
Although the guidelines do not ensure escape from some punishment, they provide good examples of what preventive actions the Government will consider as being a good faith effort to prevent or detect some type of variance from statute and regulation.
The Merck-Medco case is the first time that a contractor has been adjudged in violation of a criminal statute in part because their compliance program was substandard and insufficient. Therefore, some suggestions to strengthening the compliance program are:
A. Prepare and publish a code of conduct for your company as quickly as possible if it is not already promulgated.
B. The Manager of Compliance must be designated as a high-level position with direct
responsibility for all compliance actions, and who has direct access to the Chief Executive Officer and the Board of Directors.
C. The Manager of Compliance must be given the authority and responsibility for independently investigating and acting on matters related to statutes and regulations that require the company to act or not act in certain ways.
D. All employees of the company must be informed of the existence and the details of the company's compliance program.
E. Regular reports, at least quarterly, must be given to the Board of Directors regarding any internal investigations.
F. Establish periodic internal audits and establish methods of monitoring compliance and continuously monitor the hotline for notices of violations and protect reporters.
