Compliance as business strategy
Finding the right training and educational best practices for employees is important, and so is the establishment of a robust
documentation process, which can be used to show regulators that a company has acted in good faith, and has promoted the right
kinds of policies and practices, even when a single employee makes a mistake, or goes rogue. Following OIG guidance, in addition
to PhRMA's code on interaction with healthcare professionals, and building a solid internal documentation process can also
help protect executives from the Responsible Corporate Officer Doctrine, or Park Doctrine, which has recently come back into
vogue with some regulators (including FDA and DOJ); Lundbeck's Eglite says the doctrine keeps him up at night, because as
chief compliance officer, he's "on the hook for that."
Percentage of Companies
In compliance, defensive measures are part and parcel of a strong offense, inverting the old adage: the best offense can in
fact be a strong defense against non-compliance. Employees must be certain that their superiors won't protect unlawful business
practices, internally or externally. But compliance also needs to be able to defend company practices, if there is ever a
question from regulators.
The compliance officer, still a relatively new position, continues to evolve, but already "we are viewed as strategic partners"
at most pharma companies, says Costopoulos. "We're an important part of the process that champions ethics and compliance and
accountability and responsibility and integrity." Reputational issues are important to pharma, and "there's very little that
we don't know about in an organization, and I think we provide great value to the organization" as a result, says Costopoulos.
A good compliance function and a company with a good record is good for business, a point that's often underemphasized, says
Eglite. "It helps in partnering with other companies. Companies with high compliance standards don't want to do business with
a partner that has problems all the time, and is going to be paying fines," he says. "So it's worth the money to have a good
compliance function that's reasonable and yet completely within the rules of law."
Compliance is no longer just a box to check. Its strategic function within the organization is more important than ever, which
means that the compliance officer has a responsibility to "get all levels of management engaged," says Novartis's Cetani.
"Have them involved in helping to shape [the compliance program], and build it into what they need it to be to meet any of
the many standards that apply in a highly regulated business." Compliance is successful when it's "built for the needs of
the business, which is really what these programs should be about."
Ben Comer is Pharm Exec's Senior Editor. He can be reached at firstname.lastname@example.org